The SRA Symposium - College of Medicine

2005 Symposium Proceedings 

The SRA 

Symposium 

“Enriching the art 

and science of research 

administration through 

scholarship and 

professional inquiry.” 

Contributed Papers, Posters, and Future Proposals 

2005 SRA Annual Meeting 

Milwaukee, Wisconsin 

October 15 - 19, 2005 

Edward F. Gabriele and Valerie J. Ducker 

General Editors 

Society of Research Administrators International 

© 2005

2005 Symposium Proceedings Book 

2005 © Copyright by the Society of Research Administrators, International located at 1901 N. 

Moore Street, Arlington, VA 22209. 

All rights reserved. Reproduction in whole or in part without written consent of the authors in 

prohibited. Authors have permission to re-publish or re-present their work ad libitum.

Dear Colleagues and Friends, 

October 1, 2005 

Welcome to the 2005 SRA International meeting in Milwaukee! And welcome to the 2005 SRA 

Symposium. I grew up on the East Coast in the inner city. I first encountered the City of Milwaukee 

in undergraduate and graduate studies. Over the years, I became deeply enamored of the marvelously 

rich cross-cultural heritage of this city and the Fox River Valley. Over my student years, I 

often felt caught up in the cultural “swirl” between such diverse traits as Milwaukee’s stalwart German 

heritage combined with the deep and mysterious richness of the Native American communities 

of Wisconsin. This wonderful mix of cultures provides our 2005 Symposium with a powerful 

mix of metaphors. Let me explain. 

Research administration is an executive profession with a distinct scholarly and professional body 

of knowledge. Today, our profession is seeing swift new challenges and opportunities. Indeed we 

are on the march. The drumbeat of our march resonates with a stalwart strength so well characterized 

by the heritage of this proud city. Our drumbeat also resonates with the rich cross-cultural 

mix of this extraordinary region. Like the total heritage of the Milwaukee cultural geography, 

research administration has a rich and stalwart tradition that is today being stretched by new 

challenges and opportunities for research and research management. Let me suggest, then, that 

our coming to Milwaukee is a highly poetic moment in time for us to celebrate the 2005 Symposium. 

Here we cherish and advance our SRA Symposium Tradition of scholarly inquiry and the 

exploration of emerging needs and services for our investigators and institutions. The 2005 Symposium 

mirrors in a marvelously “coincidental way” the diverse geography of research administration 

with the rich cultural heritage of our proud hosts in Milwaukee. 

In this wonderful city with its marvelous cross-cultural historical heritage, we bring our rich tradition 

of Symposium scholarship for the advancement of our body of knowledge and the development 

of this profession we call research administration. Exploring and adapting with strength and 

respect for the rich mystery of what we do, the 2005 Symposium is dedicated this year as always 

to furthering what we do to assist those whose genius is itself dedicated to the progress of human 

quality of life. May our time together enrich and stretch us to do more and be more for those who 

rely upon our Tradition of Genius and Industry as research administrators. 

With warm personal regards, 

Dr. Edward F. Gabriele 

Symposium Program Director & 

2005 Symposium Chair

Table of Contents 

Poster Abstracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

Lisa M. Brown. Clinical Research Study Budgeting Trends . . . . . . . . . . . . . . . . . . . . . . . 3 

Jess Dalton. Does Granting Permission to Retain DNA Samples for Future Genetic 

Studies Identify A Biased Population? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 

Mary E. Dougherty. Modeling a Successful Cash/Resources Management System for 

Scientific Research Field Sites in Developing Countries . . . . . . . . . . . . . . . . . . . . . . . 5 

Carol Fedor. The Role of a Research Administration Program in Adverse Event Reporting . . . . . 6 

Peggy Fischer. Making the Case for an Effective Compliance Program . . . . . . . . . . . . . . . . 7 

Gary Lee Frye. Creating a “Value Added” Center by Expanding the Development Office 

Role Within the Larger Community . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 

Gus Godoy. Partnership Between VA Research and Development and Non-Profit 

Corporations – Its Impact on Research and Improved Medical Care . . . . . . . . . . . . . . . 9 

William S. Kirby. “Best Practices” in Electronic Research Administration for Small and 

Mid- Sized Institutions: Selected Phase I Results . . . . . . . . . . . . . . . . . . . . . . . . . 10 

Bruce Linn. ERA Reporting: The Measures that Matter. . . . . . . . . . . . . . . . . . . . . . . . 11 

Bruce Linn. Effort Certification: The Time is Now. . . . . . . . . . . . . . . . . . . . . . . . . . . 12 

Joseph L. Malone. The Department of Defense (DoD) - Global Emerging Infections 

System (GEIS) Program. A Case Study in Administering Research Projects 

that Build Public Health Epidemiological and Laboratory Capacity. . . . . . . . . . . . . . . 13 

Joseph Augustine Menna. Toward an Alternative Basis for Mentoring: Whole 

Brain Learning as an Alternative Pedagogy for the Education of Research 

Administrators and Research Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 

Martha F. Nelson. Performance Evaluation Metrics for Research Administrators . . . . . . . . . 15 

Gayle Simon. San Diego State University’s Site Visit Program: A Model for Collaboration 

and Enhanced Ethical Practices in Human Research Protections . . . . . . . . . . . . . . . . 16 

Luc Simon. Benchmark IT! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 

Marie F. Smith. Making the Team Work: Being Part of a Collaborative Venture . . . . . . . . . . 18 

Sabrina L. Smith. Envisioning the Research Administration Structure in an 

Integrated Health Care System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 

Cliff Studman. Research Capacity Building in Africa . . . . . . . . . . . . . . . . . . . . . . . . . 20 

Renee J. Vaughan. Ethical Communication in Research Administration . . . . . . . . . . . . . . 21 

Angela Willis. Perceptions of the Research Office . . . . . . . . . . . . . . . . . . . . . . . . . . . 22


Karen M. Wilson. A “Roadmap” to Re-organization . . . . . . . . . . . . . . . . . . . . . . . . . 23 

Papers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 

Chris Asmann-Finch. Contextual Difficulties in IRB Deliberations – 

Principlist vs. Narrativist Ethical Frameworks. . . . . . . . . . . . . . . . . . . . . . . . . . . 27 

Karolis Bauza. One On One Mentoring: A Case Study . . . . . . . . . . . . . . . . . . . . . . . . 35 

William R. Belisle. External Resource Acquisition and Management: 

“ A Tool for MSI Research and Sponsored Programs Administrators” . . . . . . . . . . . . . . 44 

Paula Bistak. The Utility of Gender, Race, and Ethnicity Reporting in 

Clinical Trials as an Indicator of Distributive . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 

Stephen W. Brabbs. Creating A Community of Research Administrators . . . . . . . . . . . . . . 61 

Philip A. Cola. The Development, Implementation and Evaluation of a Prospective 

Research Monitoring Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 

John J. Gillon. After A Day of Infamy, December 7, 2003—What Regulatory 

Ethics Have Become at the National Institutes of Health by August 31, 2005 . . . . . . . . . . 77 

Mark Gorringe. Developing A Formal Quality Management System and Measuring 

Perceptions of Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 

Rene Hearns. Process of Legitimizing a Profession: Research Administration . . . . . . . . . . . . 95 

Mark Hochhauser. Informed Consent: Writing? Readability? Understanding? Deciding? . . . . 105 

Mark Hochhauser. Liabilities of “unreadable” consent forms . . . . . . . . . . . . . . . . . . . . 115 

Elizabeth Holmes. The Unconscious Expression of Ego Defenses: 

Increasing Self-Knowledge for the Research Administrator . . . . . . . . . . . . . . . . . . . 123 

Hoyman. A Profile of the IRB Infrastructure at Comprehensive and Predominantly 

Undergraduate Institutions in the South: Project Initiation and 2005 Update . . . . . . . . 127 

Jose Jackson. Focusing on Development: Strategies for Strengthening Research at the 

University of Botswana . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132 

William S. Kirby. “Best Practices” in Electronic Research Administration for 

Small and Mid Sized Institutions: Selected Phase I Results . . . . . . . . . . . . . . . . . . . 144 

Ed Mason. The Role of Development in a Research Administration Office . . . . . . . . . . . . 151 

Isaac N. Mazonde. Research Management in Southern African Higher 

Learning Institutions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161 

Stuart McKissock. European and Federal Funding Comparison: 

Ever thought about getting research funding from Europe?. . . . . . . . . . . . . . . . . . . 172


Rebbecca A. Moen. Virgin Territory: The Role of Research Administrators in 

Mentoring Junior Faculty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186 

Elsa G. Nadler. Human Subjects Research and Protections: A Brief History. . . . . . . . . . . . 194 

Sandra M. Nordahl. Mentoring and Motivating: Bring Your Staff Along . . . . . . . . . . . . . 208 

Robert Porter. Helpful Gatekeepers: Positive Management of the Limited Submission Process . . 215 

Thomas J. Roberts. Perceptions of Research Administrators on the Value of Certification . . . . 221 

Debra S. Schaller-Demers. Why Do Ethical Scientists Make Unethical Decisions? . . . . . . . . 233 

Marie F. Smith. The Ups and Downs of Collaborative Ventures: 

A Case Study on Being a Collaborator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241 

Theresa Ann Strakos. How to Develop a Centralized Pre-award Infrastructure Successfully Within 

a Climate Where the Number of Clinical Trials Sponsored by Pharmaceutical Industry Has 

Decreased Since 2001 – A Large Multi-Specialty Academic Medical Center Perspective. . . 248 

Cliff Studman. Evaluation of Strategies for Building a Research Culture – 

an Empirical Case Study at an African University . . . . . . . . . . . . . . . . . . . . . . . 258 

Michael Whitecar. Peer-to-Peer Discovery: Beyond Knowledge Management . . . . . . . . . . 269 

Symposium Future Proposals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275 

Jennifer Conway. Humanism in Medicine: A Case Study in Mentor/Trainee 

Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277 

Edward Gabriele. The Invisible Cartology of Culture: The Challenge of Cultural Paradigms in the 

Development of International Medical Research And Healthcare Policy . . . . . . . . . . . 278 

Cindy Kiel. FOIA and the FAR: Fear or Freedom . . . . . . . . . . . . . . . . . . . . . . . . . . 279 

Bruce Linn. Reporting for Electronic Research Administration: The Measures That Matter . . . 280 

David F. Steele. “Unwitting Human Subjects: Living in the Shadow of the Bomb in 

[town to be determined]” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281

Poster Abstracts

Poster Abstract 

2005 Symposium 

Annual Meeting of the Society of Research Administrators International 

Milwaukee, WI 

October 16-19, 2005 

Principal Author: Lisa M. Brown, MBA 

Author Affiliation: Center for Clinical Research 

University Hospitals of Cleveland 

Author Email: LisaM.Brown@uhhs.com 

Author Address: Center for Clinical Research 


11100 Euclid Avenue, LKS 1400 

Cleveland, Ohio 44106-7061 

Secondary Authors: David K. Ehlert, Center for Clinical Research, 


Philip A. Cola, M.A., Center for Clinical Research, 


Title: Clinical Research Study Budgeting Trends 

Abstract: 

Poster Abstracts 

The Center for Clinical Research at University Hospitals of Cleveland (UHC) provides legal and 

budget review, and administrative support, for over 360 clinical studies annually, which span 

twenty-four academic and clinical departments. Each study is governed by unique legal and fiscal 

terms. The budgets for these studies must not only reimburse for the fair market value of the 

medical services provided, but must also comply with numerous regulations designed to protect 

the interests of subjects enrolling in these studies. 

Many factors cause these budgets to differ. A review of 120 clinical research study agreements and 

budgets executed in 2004 was conducted across the various medical disciplines to understand 

where trends existed in clinical research budgets. These budgets were reviewed to determine the 

effects of the differences in the per subject reimbursement: (i) by medical discipline; (ii) by the 

phase of the study drug/device development as determined by the FDA; (iii) of drug studies compared 

to the per subject reimbursement of device studies; and (iv) as a function of indirect rates 

provided by sponsors. The results of this sample reveal trends in budgeting that provide useful 

information to research administrators during clinical research study budget negotiations. 

2005 Symposium Proceedings Book 3





Milwaukee, WI 

October 16-19, 2005 

Presenting Author: Jess Dalton, MSPH 

Author Affiliation: Obstetrics and Gynecology 

University of Utah Division of Maternal-Fetal Medicine 

Author Email: Jess.Dalton@hsc.utah.edu 

Author Address: Obstetrics and Gynecology 


30 N. 1900 E., Suite 2B200 

Salt Lake City, Utah 84124, USA 

Primary Author: Kjersti Aagaard-Tillery, MD, PhD 

Obstetrics and Gynecology 


Title: DOES GRANTING PERMISSION TO RETAIN DNA 

SAMPLES FOR FUTURE GENETIC STUDIES IDENTIFY 

A BIASED POPULATION? 

Abstract: 

From April 2000 to 2001, 5188 pregnant women were enrolled in a multicenter, prospective observational 

study. All participants provided a DNA sample to ascertain the estimated rate of adverse 

pregnancy outcomes. Enrolled women were asked if their samples could be used in a non-identifiable 

fashion for future genetic studies without their permission, whether permission must be 

obtained prior to future use, or whether their samples were to be destroyed following index study. 

Of 5188 women enrolled, 5003 women indicated a preference. Overall, 72.5% gave unrestricted 

permission, 7.4% desired to provide authorization for future analyses, and 20.1% requested that 

samples be destroyed after primary analysis. Univariate analysis revealed that African-American 

women chose to discard samples more often than Caucasian/Jewish women (19.9 vs. 11.6%, 

p




Milwaukee, WI 

October 16-19, 2005 

Principal Author: Mary E. Dougherty-Program Coordinator 

Author Affiliation: Division of Medicine/Department of Infectious Disease 

University of Alabama at Birmingham 

Author Email: mdougher@uab.edu 

Author Address: Alabama Vaccine Research Clinic 

University of Alabama at Birmingham 

908 20th Street South 

CCB 328 B 

Birmingham, Alabama 35294 USA 

Secondary Authors: Susan Allen, MD, MPH Emory University, Rollins School of Public Health. 

Third Authors: Rwanda/Zambia HIV Research Group-Zambia Emory HIV Research Project 

(ZEHRP Lusaka, Zambia) and Project San Francisco (PSF Kigali, Rwanda) 

Title: Modeling a Successful cash/resources management system for 

scientific research field sites in developing countries. 

Abstract: 


In this poster we will detail the cash/resources management system utilized by scientific research 

field sites in Kigali, Rwanda (1984), Lusaka, Zambia (1994), Ndola and Kitwe, Zambia (2004). 

These field sites and this system were established and or developed by Susan A. Allen, MD, MPH 

of Emory University/Rollins School of Public Health. The method revolves around the use of a rotating 

Imprest (petty) cash fund. Utilizing this fund effectively allows for many benefits including 

smooth transfer of funds from the US to the project field site. It also allows for careful documentation 

and review of expenditures, as well as accountability and transparency for both the sponsoring 

agency and the funded institution. Our approach also guarantees maximum security of funds 

that are available for use in country by the project field sites. Through the past 18 years, use of this 

system has demonstrated the ability to safeguard resources of the project in often unstable political 

and or economic environments. The design of this system is both flexible and transparent making 

it ideal for use by researchers and public health officials in many parts of the world. 






Milwaukee, WI 

October 16-19, 2005 

Principal Author: Carol Fedor, ND, Clinical Research Manager 

Author Affiliation: The Center for Clinical Research, UHC 

Author Email: carol.fedor@uhhs.com 

Author Address: The Center for Clinical Research 

University Hospitals of Cleveland (UHC) 

11100 Euclid Avenue 

Cleveland, OH 44024, US 

Secondary Authors: Philip Cola, MA, Director 

& Louise Haffke, MPH, Research Compliance Specialist 

The Center for Clinical Research, UHC 

William Dahms, MD, Vice-Chair 

UHC Institutional Review Board 

Title: The Role of a Research Administration Program in 

Adverse Event Reporting 

Abstract: 

The reporting, analysis, and management of adverse events (AEs) provide an ongoing assessment 

of risk in the context of a clinical trial and ensures the protection of human research participant 

safety and informed consent. Effective and efficient review of adverse events has been a longstanding 

challenge for Institutional Review Boards (IRBs) and Research Administration programs 

especially as protocols and ethical/legal issues become more complex. Furthermore, AE reporting 

is governed by many different regulations and sources, with inconsistencies in standards and 

requirements. Reporting standards for AEs were adopted when single-center trials were the norm. 

With the increased prevalence of multi-center trials, IRBs are now inundated with AE reports with 

some IRBs receiving more than 10,000 reports annually. This poster will review the current issues 

in AE reporting and the challenges faced by a research administration program in the process of 

re-evaluating current policies and procedures and implementing a significantly revised reporting 

policy. The implementation plan and educational strategies used with the investigators and 

research staff will be described. Preliminary outcome data will be presented to evaluate the policy 

revisions and to take into consideration the concepts of “quality of analysis” versus “quantity of 

reporting”. 

6 2005 Symposium Proceedings Book




Milwaukee, WI 

October 16-19, 2005 

Principal Author: Peggy Fischer, PhD 

Author Affiliation: Associate Inspector General for Investigations 

National Science Foundation Office of Inspector General 

Author Email: pfischer@nsf.gov 

Author Address: Office of Inspector General 

National Science Foundation 

4201 Wilson Blvd., Suite II-705 

Arlington, VA 22230 USA 

Secondary Authors: William J. Kilgallin 

Head, Investigative Legal and Outreach 

National Science Foundation Office of Inspector General 

Title: Making the Case for an Effective Compliance Program 

Abstract: 


The poster communicates points of advocacy for use in making a case to university management 

for funds and personnel necessary for an effective compliance program. The poster illustrates both 

the need for, and value of, such a program. It asks and answers the questions: “How can I argue for 

establishment of an effective compliance program when competing for money and staff? What do I say 

to get management’s attention when other issues are begging for attention? How do I keep ethics and 

integrity in the spotlight?” The poster summarizes the major developments that have changed the 

research environment in this area, namely, Enron, Sarbanes-Oxely, SAS 99, Sentencing Guidelines 

for Organizational Offenders, June 05 CoGR Guide, etc. It presents a visual depiction of the true 

costs for poor compliance (money and imposed compliance plans, settlements, qui tam suits, etc.). 

It displays the elements of an effective compliance program. It presents an illustrative university 

“heat map” that identifies contracts and grants management as the highest risk and highest impact 

activity. And it sets out the two ways to get to compliance, namely imposed or adopted and the 

costs/benefits of both routes. 






Milwaukee, WI 

October 16-19, 2005 

Principal Author: Dr. Gary Lee Frye 

Author Affiliation: Director of Development and Grants 

Lubbock-Cooper Independent School District 

Author Email: glfrye@lcisd.net 

Author Address: Central Office 

Lubbock-Cooper ISD 

16302 Loop 493 

Lubbock, Texas 79423-7805 

Title: Creating a “Value Added” Center by Expanding the Development Office 

Role within the Larger Community 

Abstract: 

This poster shows how Lubbock-Cooper ISD’s Development Office expanded its role in the community 

to provide value added services. The Development Office developed a funded 21st Century 

Community Learning Center grant which was a consortium of five area school districts. To 

meet a grant requirement of having a plan to continue the program beyond this grant’s funding 

the Llano Estacado Rural Communities Foundation was created. The foundation’s by-laws expanded 

the role of the grant writing and other fund raising activities into the area of “improving 

the quality of life” for all community stakeholders in the five communities. Through the creation 

of the foundation the philanthropic activities in these communities has been greatly increased by 

developing grants for several agencies which before this did not see their missions as overlapping. 

These activities are leading to the development of a community/regional-wide mind-set of looking 

meeting the needs of community stakeholders by blending the activities of various agencies 

and service providers. This blending is allowing resources from various agencies to be used to 

meet community needs and develop stronger multi-agency consortiums which are now working 

together to submit grant proposals. 




Annual Meeting of the Society of Research Administration International 

Milwaukee, WI 

October 16-19, 2005 

Principal Author: Gus Godoy, CRA 

Author Affiliation: Executive Director and Administrative Officer for R & D 

South Florida VA Foundation for Research and Education 

Author Email: Gustavo.godoy@med.va.gov 

Author Address: Executive Director and Administrative Officer for R & D 

South Florida VA Foundation for Research and Education 

Miami VA Medical Center 

1201 N. W. 16th Street, room 2A102, 

Miami, FL, 33125, USA 

Title: “Partnership between VA Research and Development and 

Non-Profit Corporations – Its Impact on Research and Improved 

Medical Care”. 

Abstract: 


The enactment by Congress of Public Law 85-857 in 1958 established Research and Development 

as an official component of the health care mission of the Department of Veterans Affairs (VA). In 

recent years, in order to sustain their research programs in the face of shrinking VA support, VA 

research scientists have increasingly sought support from extramural sources, including other Federal 

agencies, research foundations and industrial companies. This extramural support has steadily 

increased over the years and in FY 2003 it was approximately $185 million, nearly one-half of the 

total current support for VA investigators ($406 million). To regulate the administration of these 

non- federally appropriated funds, Congress enacted Public Law 100-322, which allows the establishment 

of VA non-profit research corporations and governs how they shall function. The existence 

of these foundations has provided a greater degree of flexibility in administration of funds, 

purchasing, and personnel actions, compared to federally operated programs, and it has proven 

to be a major boon to VA medical research. Consequently, research foundations have contributed 

substantially to the VA researchers’ constant seeking of new ways to prevent, treat and cure disease 

for veterans and Americans. 






Milwaukee, WI 

October 16-19, 2005 

Principal Author: William S. Kirby 

Author Affiliation: Principal Investigator 

Research and Management Systems 

Author Email: wkirby@crosslink.net 

Author Address: P.O. Box 717 

Heathsville, VA 22473 

Secondary Authors: Michael R. Dingerson 

Professor 

Department of Educational Leadership and Counseling 

Darden College of Education 

Old Dominion University 

Norfolk, Virginia 23529-0157 

Title: “Best Practices” in Electronic Research Administration for Small 

and Mid Sized Institutions: Selected Phase I Results 

Abstract: 

As a part of an NIH SBIR award to Research and Management Systems, the authors conducted a 

review of three universities recognized as leaders in eRA. The purpose of the study is to develop 

an understanding of the leading institutions’ approach to eRA planning, systems and software, 

staffing and other practices used in moving their eRA efforts forward. The goal of the research is 

to describe and characterize common principles and conditions that may contribute to success for 

these institutions. In the second phase of this study, the authors reviewed several small and mid 

sized institutions that have completed or are in the process of implementing eRA systems to identify 

“lessons learned” from those implementations. By examining what happens in small and mid 

sized institutions, one can begin to describe 1) the extent to which the principles and practices 

identified in leading institutions are applicable in a small and mid sized institution setting, and 2) 

implications for government-wide plans for universal electronic submission. 





Milwaukee, WI 

October 16-19, 2005 

Principal Author: Bruce Linn 

Author Affiliation: Director Database Development 

ERA Software Systems, Inc. 

Author Email: blinn@erasoftwaresystems.com 

Author Address: ERA Software Systems, Inc 

357 Castro Street, #6 

Mountain View, CA 94041 USA 

Title: ERA Reporting: The Measures that Matter 

Abstract: 


The automation of grant management via Electronic Research Administration (ERA) offers clear 

opportunities for improved process efficiency, accountability, and integrity. That said, the most 

exciting benefits of ERA may well be the potential of placing a wealth of meaningful information 

within easy reach of key users – in the form of a dynamic and accessible ERA reporting system. 

This poster is intended to provide a graphical introduction to the essential elements of electronic 

reporting systems for funded research. Two topics are addressed: first, what are the key user 

requirements, and expected benefits, of ERA reporting. Second, what are the critical business 

analyses that can be answered most effectively with ERA reporting. The poster will use several real 

world example of ERA reports which highlight effective analysis in the areas of funding forecasts, 

cost share and salary cap, certification of time and effort, and managing award expenditures. 






Milwaukee, WI 

October 16-19, 2005 


Author Affiliation: Director Database Development 



Author Address: ERA Software Systems, Inc 

357 Castro Street, #6 

Mountain View, CA 94041 USA 

Title: Effort Certification: The Time is Now 

Abstract: 

Effort certification is a hot topic within sponsored research institutions, and with good reason. 

The Office of the Inspector General has emphasized effort reporting in their 2005 Work Plan for 

future audits. Many institutions are currently at risk – unable to reliably collect, certify, and document 

the award related effort expended by their own research personnel. This poster will provide 

a graphical ‘checklist’ designed to introduce the key concepts and critical requirements of effective 

effort certification and reporting for electronic research administration. Key problem areas 

in effort reporting will be identified, and best practices for effort certification and reporting will 

be introduced. A ‘typical’ electronic effort reporting system that meets audit requirements will be 

graphically illustrated and described. 





Milwaukee, WI 

October 16-19, 2005 

Principal Author: CAPT Joseph L. Malone, MC, USN, MD 

Author Affiliation: Director, Department of Defense - 

Global Emerging Infections System (DoD-GEIS) 

Author Email: joseph.malone@na.amedd,army.mil 

Author Address: Walter Reed Army Institute of Research (WRAIR)/ 

Naval Medical Research Center (NMRC) 

503 Robert Grant Avenue, 

Silver Spring, MD 20910-7500 

Secondary Authors: Mr. Stephen Gubenia (DoD-GEIS, WRAIR) 

Ms. Jennifer Rubenstein (DoD-GEIS, WRAIR) 


Title: The Department of Defense (DoD) - Global Emerging Infections System (GEIS) Program. 

A Case Study in Administering Research Projects that Build Public Health Epidemiological and 

Laboratory Capacity 

Abstract: The complexity of conducting medical protocols involving public health surveillance in 

developing countries involving research laboratories within the United States poses many challenges 

to research administrators. DoD-GEIS identifies and contains infectious threats worldwide 

especially at five DoD overseas medical research laboratories through cooperative arrangements 

with CDC, with WHO, and with the governments of foreign countries. DoD-GEIS also promotes 

outbreak response preparation within the United States by supporting public health laboratory 

and epidemiology investigation functions throughout the military medical research laboratory 

system and military health system that provides clinical care for the 8,595,000 military medical 

beneficiaries worldwide. Although some DoD-GEIS projects such as outbreak investigations 

are typically considered public health practice rather than medical research as defined by federal 

regulations, many DoD-GEIS activities are administrated through cooperative arrangements and 

with protocols that are typical for public health surveillance projects, and that involve professional 

training and public health capacity building. This poster will detail the unique mission and administrative 

challenges of the program. The poster will present for research administrators the 

complexities of management and oversight for a large, multinational medical and research-related 

program of inquiry and service. 






Milwaukee, WI 

October 16-19, 2005 

Principal Author: Very Reverend Joseph Augustine Menna, AIHM 

Author Affiliation: Belmont Charter School 

Author Email: JMennaAIHM@aol.com 

Author Address: 340 Media Station Road, A302 

Media, PA 19063 

Title: Toward an Alternative Basis for Mentoring: Whole Brain Learning as an 

Alternative Pedagogy for the Education of Research Administrators and 

Research Personnel 

Abstract: 

Research Administration has enjoyed a 60 year history of service to scientific personnel. It has 

grown far beyond the minimal standard of regulatory compliance. However, research administrators 

and investigators too often still do not understand the far reaching importance of proactive 

research management standards for strategic planning and development of research institutions. 

The antipathies between research administrators and investigators are often the result of a lack of 

understanding or the lack of a positive panorama of management possibilities. Whole brain learning, 

as typified in the 4-MAT pedagogy, provides an alternative paradigm upon which to build 

mentoring and education programs and curricula in research management for administrators and 

investigators. The approach offers an enthusiastic forum in which to bring together administrators 

and researchers as positive partners in the processes of research management. Whole brain 

learning research, as typified in the 4-MAT pedagogy, utilizes the latest in psychological, physiological, 

and developmental research to map how we as human beings, intake, process, and utilize 

information. These current theories in education and learning styles have been implemented from 

classroom education to Fortune 500 company management and training sessions and they hold 

impressive possibilities for research administrators and investigators. 





Milwaukee, WI 

October 16-19, 2005 

Principal Author: Martha F. Nelson, RN MS MPA 

Author Affiliation: Office of Clinical Trials 

United Health Services Hospitals, Inc. 

Author Email: Martha_Nelson@uhs.org 

Author Address: 33-57 Harrison Street 

Johnson City, NY 13790 

USA 

Secondary Authors: none 

Title: Performance Evaluation Metrics for Research Administrators 

Abstract: 


With current brouhaha over lapses in accountability and responsibility among industry leaders, 

performance management is becoming a strategic imperative for organizations. Some organizations 

have led by developing clear policies, firm controls and commitment to excellence. In developing 

that culture, an organization needs to define specific targets using measurable tools, allocate 

resources, and connect processes with its core values and principles. The Campaign for Excellence 

(C4E) celebrating its third year at UHSH identified six key pillars that affect overall performance 

of employees. Using the pillars People, Service, Quality, Finance, Growth, Community, the author 

designed a Leader Evaluation Metrics for performance measurement. Each pillar carries a 

weighted value. Goals with concurrent results are scaled 1-5, (1 Poor -5 Excellent). By multiplying 

these factors, one gets an average score for that area. Add up scores for each pillar, an overall 

performance score is reached where 5.0 is the highest. Devised for self-evaluation, the process is 

reported quarterly to senior management. Taking this deliberative approach, the metrics’ form 

becomes a formal mechanism to honestly document and report with integrity one’s accomplishments. 

Moreover, it presents a locus to reward and recognize achievement which creates an incentive 

that enables one to seek exemplary performance. 






Milwaukee, WI 

October 16-19, 2005 

Principal Author: Gayle Simon, M.P.H. 

Author Affiliation: Graduate & Research Affairs 

Institution: San Diego State University 

Author Email: gsimon@projects.sdsu.edu 

Author Address: Graduate & Research Affairs, Division of Research Administration 

5500 Campanile Drive, MC 1643 

San Diego State University 

San Diego, CA 92182-1643 

Title: San Diego State University’s Site Visit Program: A Model for 

Collaboration and Enhanced Ethical Practices in Human Research 

Protections 

Abstract: 

Efforts to enhance protection of human research subjects are a priority among research institutions 

with educational initiatives mandated and quality improvement emphasized. Problems 

and controversies unique to social/behavioral sciences research also require attention specific to 

education and oversight. One initiative developed by SDSU to improve oversight of responsible 

research practices involved conducting proactive ‘not for cause’ site visits as part of its continuing 

review program for human subject’s protections. While site monitoring may be an expected 

activity within the biomedical community, this aspect of continuing review was novel to social and 

behavioral sciences investigators. This poster describes the process used to develop and implement 

a Site Visit Program at SDSU. The program objectives were to: 1- create an environment where 

on-site monitoring is accepted/valued; 2- enhance IRB awareness of practical issues from the 

investigator’s perspective; 3- promote communication between researchers and the IRB; and, 4- 

increase opportunities for training of ethical/responsible research practices. Steps taken to initiate 

development required careful planning and engagement of the research community in the process. 

Methods involved conducting interviews and focus groups with investigators, drafting procedures, 

pilot testing and implementation. The program is now operational and a valued part of SDSU’s 

human research protection program. 





Milwaukee, WI 

October 16-19, 2005 

Principal Author: Luc Simon, Ph.D. 

Author Affiliation: Planning and Institutional Research Office 

Université Laval 

Author Email: Luc.Simon@vrex.ulaval.ca 

Author Address: BPEI 


1556 Education bldg 

Quebec, Qc, G1K 7P4 Canada 

Secondary Author: Richard Massé, M. Sc. 

Planning and Institutional Research Office 


Title: Benchmark IT! 

Abstract: 


A tool to facilitate the organization and exchange of benchmark data amongst institutions has 

been developed. The secretariat of the Canadian G10-DE, a data exchange consortium linking the 

institutional research offices of the 10 most research intensive Canadian universities has recently 

begun using it. Rapid deployment in each of the consortium universities is planned. The functionality 

of this information system will be presented, as well as the potential impact of its adoption by 

other institutions. 






Milwaukee, WI 

October 16-19, 2005 

Principal Author: Ms. Marie F. Smith, CRA 

Author Affiliation: Grants Office, Institute of Ecosystem Studies 

Author Email: smithm@ecostudies.org 

Author Address: Institute of Ecosystem Studies 

PO Box AB 

65 Sharon Turnpike 

Millbrook, NY 12545, USA 

Title: Making the Team Work: Being Part of a Collaborative Venture 

Abstract: 

Successful scientists work in teams, with their productivity relying on effective teamwork among 

collaborators. When everything goes well, collaborations result in higher quality research than 

could have been accomplished by scientists working alone (Kotok, 2004). Multi-organizational, 

multi-disciplinary research projects are on the rise. Research Administrators are partners with 

Research Investigators in collaborative ventures. Research Administrators seek to facilitate collaborative 

ventures while protecting the interests of the institution and the institutional research 

investigator. We must take care to facilitate not impede the collaborative process by providing a 

helpful and supportive framework that balances the needs of the institution, the investigator and 

the funding agency. 





Milwaukee, WI 

October 16-19, 2005 

Principal Author: Assistant Vice President, Sabrina L. Smith, MHA, CRA 

Author Affiliation: Office of Contracts and Grants Management 

MedStar Research Institute 

Author Email: Sabrina.L.Smith@MedStar.net 

Author Address: Office of Contracts and Grants Management 


6495 New Hampshire Avenue, Suite 201 

Hyattsville, Maryland 20783 USA 

Secondary Authors: Marsha A. Allen, MA 


Title: Envisioning the Research Administration Structure in an 

Integrated Health Care System 

Abstract: 


This poster is a descriptive analysis of MedStar Research Institute’s research administration (RA) 

structure and the provision of RA services to the MedStar Health system. MedStar Research Institute 

is a stand alone subsidiary of the larger system comprised of five tertiary care hospitals, two 

sub-acute hospitals and other affiliates. The provision and structure of the RA services to each site 

is impacted by the disparate geographic sites, differing organizational cultures, expectations, and 

varying levels of research acumen of the staff. Moreover, the information and financial systems at 

the sites are designed to capture patient level data and not geared toward research administration 

activities. The administrative services core has adapted to these challenges by developing working 

relationships with the hospital staff and the central business office of the system to devise internal 

modifications and procedures that can be uniformly applied across the system. This helps to facilitate 

the research so that it appears to be seamless to the principal investigators. As the research 

enterprise continues to expand, future administrative services will need to be based on effective 

use of information technology, on-going grass root training of research and non-research staff, 

and a shared vision of research. 



Contributed Poster Abstract 



Milwaukee WI 

16-19 October 2005 

Principal Author: Professor Cliff Studman, PhD, Dip Ed, BSc. 

Affiliation: Pie Squared Pty 

Author Email: Studman@Botsnet.bw 

Author Address: Pie Squared Pty 

Box 45371 Riverwalk 

Gaborone, Botswana 

Title: Research Capacity Building in Africa 

Abstract 

In recent years there has been a significant increase in interest in African Studies. As a result 

research interest in the continent has grown, and with it the desire to collaborate with researchers 

within Africa, particularly on projects in health, or environmental and social science. However 

an analysis of data demonstrates that the continent itself lags behind the rest of the world 

in terms of all measurable outputs. Internally there is a desire to change this situation, but there 

are constraints, including resources, staff retention, and research management expertise. On the 

other hand in most countries the continent now has significant numbers of staff in Universities 

trained to the level of PhD. Research managers should be aware of the need for sensitivity and 

understanding of the situation in the potential host country when researchers propose projects in 

Africa. Based on specific examples of attempts at collaboration and capacity building, this poster 

will present some do’s and don’ts for potential researchers wishing to collaborate with African colleagues, 

including an African view of how collaborations should work. It also indicates the importance 

and potential of research management as a significant component in facilitating research 

capacity building. 


Contributed Poster Abstract 



Milwaukee, WI 

October 16-19, 2005 

Principal Author: Renee J. Vaughan, M.Div., M.A., CRA, RCC 

Director, Research Communication and Compliance 

Author Affiliation: Department of Psychiatry and Behavioral Sciences 

Duke University Medical Center 

Author Email: vaugh008@mc.duke.edu 

Author Address: Research Communication and Compliance Program 

Department of Psychiatry and Behavioral Sciences 

Duke University Medical Center 

2218 B-2 Elder St., Suite 119, Box 3257 

Durham, NC 27710, USA 

Secondary Authors: None 

Title: Ethical Communication in Research Administration 

Abstract: 


Research administration as a profession necessitates the utilization of communication principles 

and strategies for successful interaction with stakeholders in a systemized approach to managing 

sponsored projects and regulatory compliance. Communication theories are inextricably linked to 

ethical reasoning through common principles of truth and honesty, trust and relationships, reputation 

and integrity, conduct and justice. Research Administrators through their relationships and 

values engage in communication in order to establish common agreements, policy and regulations. 

Further, ethical communication processes in the building of knowledge networks and risk reduction 

facilitate compliance. This poster will highlight the integrated framework of communication, 

ethics and compliance in research administration. It will detail a communication ethics mapping 

technique as a strategy to impact myriad issues encountered by the research administrator. 






Milwaukee, WI 

October 16-19, 2005 

Principal Author: Ms. Angela Willis, MPA 

Author Affiliation: Office of Research and Sponsored Programs 

University of Arkansas at Little Rock 

Author Email: aewillis@ualr.edu 

Author Address: Office of Research and Sponsored Programs 

University of Arkansas at Little Rock 

2801 S. University Ave. 

Little Rock, AR 72204-1099 

Title: Perceptions of the Research Office 

Abstract: 

The Office of Research and Sponsored Programs (ORSP) at the University of Arkansas at Little 

Rock (UALR) was concerned with how its faculty and professional staff perceived the office. The 

office wanted to determine the level of satisfaction of the services it provides; determine which 

services researchers appreciate and which need to be improved; and determine what factors effect 

faculty and professional staff who have not sought funding within the past four years. The surveys, 

adapted Eastern Michigan University, went to A) only for those who have submitted proposals 

and have been funded in the past four years; B) only for those who have submitted proposals, 

but have not been funded in the past four years; C) only for those faculty who have not requested 

external funding in four years or more, or those faculty who have never requested external funding; 

D) Only for those staff persons who manage grants and contracts received by the university. 

Four hundred ninety-one surveys were distributed to all four groups, and a total of 71 surveys 

were received. This poster will present the surveys used and present the findings from the surveys 

received by group. Note: The effort cited here was reviewed by the Institutional Review Board that 

determined that it was exempt from regulations under 45 CFR 46.101. The poster will include this 

information and will also include the official protocol number. 



Annual Meeting of the Society of Research Administrators 

Milwaukee WI 

16-19 October 2005 

Principal Author: Karen M. Wilson, Associate Director for Administration & Facilities 

Author Affiliation: Association of Universities for Research in Astronomy 

National Optical Astronomy Observatory 

Author Email: kwilson@noao.edu 

Author Address: AURA/NOAO 

950 N. Cherry Ave 

Tucson AZ 8572 

Title: A “ROADMAP” TO RE-ORGANIZATION 

Abstract: 


Senior Research Administrators are continually faced with the challenge of reorganizing operations. 

Whether it is due to obtaining a new position in their existing organization or another 

institutions, project management, overall institutional restructuring, budget pressures or mission 

changes there are common principals, practices and new opportunities and trends to guide our 

senior administrators to success. Developing a master plan prior to implementation of reorganization 

is the key. Knowing what to consider, review and use, and discard is the success factor. 

Focusing on making sure the right team, service and operational needs are met is a must. Formal 

education is this area is limited and accumulated personal knowledge and experience or corporate 

culture usually influences the individual on how to approach these tasks. This model or “roadmap” 

is a compilation of useful trends, processes and concepts that can be adapted to meet each unique 

situation, however focusing on a process for implementation. The outcome of its use is the basis 

for knowing where your organization is in the process, pinpointing where you want to go, what 

you need and how to get there, i.e. your master plan! 


Papers

Contextual Difficulties in IRB Deliberations – 

Principlist vs. Narrativist Ethical Frameworks 

Chris Asmann-Finch, M.S., LNHA 

Doctoral student, Medical Humanities 

Caspersen School of Graduate Studies 

Drew University 

36 Madison Avenue 

Madison, NJ 07940 

Email: asmannfinc@aol.com 

Abstract 

The Belmont Report identified three principles, respect for persons, beneficence and justice, that 

should guide the conduct of research involving human participants. Yet, in the absence of knowing 

or understanding the values of participants, whose values do IRB members’ use to evaluate the 

ethical principles? How do they apply them operationally to the social interactions that assure participants’ 

opinions and choices are recognized, respected and unrestrained, or that risk and benefit 

have been proportionately balanced in a way meaningful to the participants? Do IRB assumptions, 

in fact, safeguard the ethical principles as conceptualized by the participants? These contextual 

difficulties, critics claim, are reflective of ethics deliberations that fail to account for social context. 

The Report’s three quintessential requirements for ethical conduct in research are shaped within 

a principlist framework, a framework that expresses the general values underlying rules in the 

common morality. Narrative ethicists, on the other hand, hold the conviction that every moral 

situation is unique and unrepeatable, and their meaning cannot be fully captured by appealing to 

universal principles. This project will identify the conceptual difficulties faced by IRBs and explore 

the contributions each theoretical approach offers to provide greater safeguards to participants of 

clinical research. 

Text 

Papers 

The Belmont Report, created in 1974 by the National Commission for the Protection of Human 

Subjects of Biomedical and Behavioral Research and published in 1979, was created to establish 

the basic ethical principles that should guide the conduct of biomedical and behavioral research 

involving human participants. The Report identified three principles, or “prescriptive judgments”: 

respect for persons, beneficence and justice. Respect for persons included two ethical considerations, 

“first, that individuals should be treated as autonomous agents, and second, that persons 

with diminished autonomy are entitled to protections.” Beneficence included convictions of doing 

what is in the best interest of the participant and nonmalfeasance. Finally, justice was defined as 

distributive justice, in the sense of “fairness in distribution” or “what is deserved” (National Commission, 

1979). 

Organizations that conduct clinical research involving humans are required to delegate oversight 

responsibility for protection of these ethical imperatives to Institutional Review Boards (IRB). Defined 

as an “administrative body” composed of scientists and nonscientists, IRB’s are “established 

to protect the rights and welfare of human research subjects recruited to participate in research activities 

conducted under the auspices of the institution with which it is affiliated” (Peckman, 2002, 

p.17). The IRB conducts reviews of research protocols, prospectively and periodically thereafter for 

the duration of the project, to assure the ethical principles have been safeguarded. 


Papers 

The principles of respect for persons, beneficence and justice appear deceptively simple. In the 

absence of knowledge of the participants or their values, how do IRB’s safeguard these standard 

bioethical principles? How do they apply them operationally to the social interactions that assure 

participants’ considered opinions and that their choices are recognized, respected and unrestrained, 

or that risk and benefit have been proportionately balanced in a way meaningful to the 

participants? 

The Belmont Report instructs that the application of the general principles to the conduct of 

research occurs through careful consideration of informed consent. The Common Rule, a federal 

law consolidating a number of related regulations on the topic, outlines a plethora of elements that 

informed consent to conduct research must address. The informed consent document must provide 

a description of the research protocol and an explanation of its purpose and goals. It outlines 

for the participant the duration of the project, treatment or non-treatment alternatives, foreseeable 

and unforeseeable risks and discomforts, benefits of participation, protection of privacy and confidentiality, 

and costs and compensation, as applicable, and how a participant can withdraw from a 

study (DHHS, 1991; FDA, 1981). 

Even though the informed consent document is considered the cornerstone of an IRB’s review and 

has been accused of “absorb(ing) an inordinate amount of an IRB’s time and resources” (Penslar, 

2002, p. 233), it has not provided unequivocal protection of the general principles. Articles on the 

topic number in the thousands (Sugarman et al., 1999), and a multitude focusing on the adequacy 

of the informed consent document have identified profound shortcomings. Misunderstandings are 

so numerous and widely publicized that national advocacy organizations have formed to protect 

trial participants from these failures (Alliance for Human Research Protection). 

In attempts to address the problems of the informed consent document, much money and time 

have been spent redesigning the form. Studies focused on document format elements such as 

length, completeness or arrangement of content, print size, graphics and media type, as the culprit 

for misunderstanding have found that modifying the design does not substantially improve communication 

(Coyne, et al, 2003; Flory and Emanuel, 2004; Agre, et al., 2003). However, studies that 

focus on contextual issues, such as the context of the wording, setting, contact between researcher 

and participant, and illness context have improved understanding (Siminoff, 2003). 

Contextually, research has identified that, regardless of the reading level of the document, wording 

is problematic because there is no uniform understanding of the clinical trial’s impact on a 

participant’s life. One study found “serious side effects” required a scientific background to understand 

the meaning of “side effects” as they were intended by the sponsor and required a personal 

value judgment to fully appreciate the impact of “serious” on one’s life (Hochhauser, 2003, pp. 8-9). 

Serious pain means different things to different people. Another found that contrary to a clinician’s 

common understanding of “experiment” and “research,” a participant without a clinical background 

considered “experiment” to imply using drugs whose effects were unknown, whereas “research” 

was a process whereby doctors “were trying to find out more about you in depth” (Appelbaum, 

et al., 1987, p. 22). My own research found that administrative matters such as boilerplate 

language for medical record access could be misconstrued as prognosis for survival. “We would 

like to keep track of your medical condition for three years,” distorted hope for the participants 

whose projected mortality was measured in months, not years. While participants interpreted 

wording in the context of their personal lives, medical professionals did so within the context of 

their medical and administrative expertise – their professional lives. Thus, the contextual interpretation 

of the language created vastly different meanings for the different readers. Such differences 

had a profound impact on informed consent. 


Papers 

Additionally, participants and physician-researchers alike contextualize their relationship in ways 

that create complex effects. Studies found that participants held tenaciously to the belief that medical 

professionals will always act in the best interest of the participant regardless of the wording of 

the informed consent document creating a therapeutic misconception (Kusek, et al., 1996; Schron, 

Wassertheil-Smoller, & Pressel, 1997; Joffe, et al., 2001; Miller, 2000) and a failure to understand 

the ramifications of randomization in their care (Mills, et al., 2003). Physicians validated these 

misconceptions by weaving standard doctor-patient language of individual care and hope with researcher-subject 

language of generalized knowledge and unknown outcomes (Sankar, 2004; Miller 

and Brody, 2003; Vanderpool and Weiss, 1987). 

These contextual difficulties in the interpretation of protocols by participants, critics claim, are reflective 

of how ethics deliberations fail to account for social context (Sankar, 2004; Pullman, 2002; 

Galarneua, 2002). Such criticism has been debated in the bioethics community in recent years 

between those who hold a view that universal principles are at the center of moral life and those 

who believe communication is at the center (McCarthy, 2003, p. 65). The former belief is generally 

labeled principlism; the latter, has become known as narrative ethics. 

The Belmont Report’s “three quintessential requirements for ethical conduct in research” (Penslar, 

2002, p. 233) are shaped within a principlist framework, a framework that expresses the general 

values underlying rules in the common morality, and then function as guidelines for professional 

ethics leaving considerable room for judgment (Beauchamp and Childress, 2001, p. 12). In 

fact, The Report was specifically designed as a general framework. It states that the principles are 

“stated at a level of generalization that should assist scientists, subjects, reviewers and interested 

citizens to understand the ethical issues inherent in research involving human subjects.” It goes on 

to say that the objective of such a design is to “provide an analytic framework that will guide the 

resolution of ethical problems arising from research involving human subjects” (National Commission, 

1979). Feminist theorists counter, however, that a principlist framework, with its topdown, 

deductive approach, assumes participants share the same experience creating opportunities 

for dominant culture to override an individual’s interpretation and values, and interpret them 

in homogenized, usually masculine ways (Donchin, 2001; Potts, et al., 2004) that tend to claim 

colonial rights over the body of the individual (Wolf, 1996; Frank, 1995; Sharp, 2000; Fan and Tao, 

2004). 

A narrative ethics approach holds that every moral situation is unique and unrepeatable, and their 

meaning cannot be fully captured by appealing to universal principles. Rather, a narrative ethic 

recognizes that experiences are embedded in the total narrative of a person’s life. Choices are not 

isolated from all else that happens, but are made part of an ongoing narrative. When we make 

choices of value and moral judgment we privilege one narrative over another (Nicholas and Gillett, 

1997). Borrowing the analytic tools of literary criticism, narrativists claim that careful listening to 

an analysis of the “story,” a thorough understanding of the context in which it is analyzed, and a 

reflexive critique of our own interpretations as readers identifies the course of moral action that 

should be taken (Nicholas and Gillett, 1997; Chambers, 1999). 

In the context of IRB deliberations, the framework chosen to guide protocol review has profound 

implications on the review process. The principlist approach is not about the actions of the participant. 

It is an ethical action guide for medicine, providing the standards of conduct of medical 

professionals – “those values, norms, and rules intrinsic to the actual practice of health care” 

(Ten Have, 1994, p. 102). As such, the protocol outlines a story that describes what a researcher 

is going to do to a participant. The researcher is active; the participant is passive, the recipient of 

the actions of the researcher. The task of the IRB reviewer is to assure that the active character, the 

researcher, meets the plotline criteria of respect for persons, beneficence and justice. 


Papers 

The narrative approach, on the other hand, “seeks to contextualize and particularize the conflicts” 

and “seeks to recognize the narrative coherence, however obscured, of the patient’s life” (Charon, 

1994, p. 261). In this approach, the IRB member faces narrative tasks in identifying the multiple 

tellers of the story – the sponsor, the protocol writers, the researchers, the administrative and legal 

editors, and the multiple readers – the IRB, the potential participant, and the public. Additionally, 

in that vein, they must address the contradictions among the story’s multiple plotlines, conflicts 

among tellers and listeners, and the ambiguities of the projected events. All characters in the story 

are now active, producing a different rendering of respect for persons, beneficence and justice. 

The standard language contained in the informed consent document assures the participant 

that withdrawal from a study is possible at any time without consequences. Within a principlist 

framework, such language adequately meets the criteria of autonomy. The active character offers 

the passive character an opportunity to act, a choice to withdraw. Within a narrativist framework, 

contextualizing the interaction and rendering all characters active, the participant’s world beyond 

the protocol is recognized. Once the experimental agent is injected or consumed, the categories 

of the participant’s body dysfunction and disintegration defined, the inflections and gestures of 

prognosis insinuated, the effects are irretrievable. They are now a permanent part of the lived experience 

of the participant, complete with its unknown consequences and complications, positive 

and negative, to the personal identity and body of the participant. Within a principlist framework, 

which is decontextualized, recognizing only the actions of the researcher in an atemporal setting, 

autonomy is real and satisfied using the standard language of withdrawal. Within a narrativist 

framework, which is contextual, recognizing the actions of the researcher and the participant and 

temporally situated, autonomy is an illusion and unsatisfied. It becomes clear that the participant 

has enrolled in the Hotel California clinical trial. She can check out from the clinical trial anytime 

she likes, but she can never leave. 

Participants, plotted as the passive characters, may not choose what study drugs they want to 

experiment with or when. They may not choose what diagnostics should be used on their bodies. 

They may not choose when they meet with the study physician or learn the progress, or lack 

thereof, of the study drugs. Participants may not choose which “adverse events” are adverse, the 

meaning of symptoms, remission or cure. They are discouraged from discussing their experience 

with other participants in the same trial. Because of the rules of study disclosure, they may never 

know whether their participation in the study was meaningful or contributed to the greater good 

of society. If there is no opportunity for choice - the expression of value and preference, no opportunity 

for communication – the negotiation or clarification of needs, desires and motivations, 

on what information does beneficence, “in the best interest of the participant,” by the researcher or 

IRB reviewer rest? 

In the absence of contextual information, whose values do IRB members use to evaluate the 

ethical principles? Do IRB members share uniform definitions of autonomy, physical or mental 

integrity, and respect for privacy, risk, benefit or what it means to be adequately informed with 

the participants they are entrusted to protect? Do IRB members conceptualize participants as 

homogenous or diverse in their interests and motivations? Are the principles uniformly applied 

by all IRB members to all participants regardless of trial or disease process and more importantly, 

should they be? How might consideration of their own contextual assumptions safeguard respect 

for persons, beneficence, and justice? 


Papers 

No systematic studies exist analyzing the contextual components of IRB deliberations. If they 

did exist, we might find that in the absence of regulatory guidance, IRB members approach IRB 

deliberations within their own frame of reference. They may impose their own expectation, or 

storyline, of the motivations of persons enrolled in clinical trials and the subsequent impact on 

the participants’ lives. The stories may be master narratives that are familiar to us all, such as the 

belief that cancer patients want to live at all costs, or may be plotlines in which the participant’s, 

or “hero’s”, sacrifice to science leads to medical innovation that results in the greatest good for the 

greatest number of people. The narratives may be unique to the individual IRB member’s lived 

experience, for example, reflections of a disease that personally affected their own inner circle of 

family and friends. Such studies might reveal that the researchers’ and reviewers’ experiences and 

values vary as much from each other’s as from the participants’. 

How can an IRB contextualize protocols? Their understanding of the participants and their interests 

and understandings is severely limited. Researchers are reluctant to include the input of participants 

in protocol design (Dresser, 2001, pp. 33-35; Heymann, 1995). The IRB membership that 

reviews the protocol design is constructed primarily of professionals, not persons with the disease 

at the focus of the study, or former participants in similar clinical trials. The lay community members 

on the board may understand the global needs of the community at large but not the needs 

of the participants of a specific trial. Further, the trend toward regional IRBs and the increase in 

nationally developed protocols further distances IRBs from a contextual frame of reference. 

Communication of the status of participants’ experiences in progress and at the conclusion of a 

clinical trial to the IRB would facilitate greater contextualization. Currently, there is no regulatory 

requirement for reflection points in a study. First-person accounts are neither available nor 

required, and there is no requirement for satisfaction surveys during or following participation in 

a study. Results of surveys that are completed are not reported back to the IRB. Further, the design 

of satisfaction surveys that are conducted is usually administrative in function, serving to assess 

researchers’ own performance or their facilities’ services, or is deductive, imposing researcher categories, 

failing to subjectively report participants experiences (Jenkinson, 1995). Designing studies 

with periodic evaluative reflection points, or that incorporate a “patient-centered” approach, a 

concept borrowed from primary care (Mead and Bower, 2000), or that utilize methodological 

techniques such as process consents, “a mutually negotiated, ongoing process between researcher 

and participant,” (Smythe and Murray, 2000, p.330), may strengthen an IRBs’ understanding of the 

participants they wish to protect. 

Principles-based ethics is valuable because it offers a common language and standards of conduct 

for medical professionals. However, it is an incomplete tool for IRB deliberations. The development 

of narrative competence by IRB members and the strengthening of operational strategies 

that improve communication between the IRB and participants and their experiences are necessary 

considerations in order to provide adequate assurance that the ethical principles of respect for 

persons, beneficence and justice have been safeguarded. 


Papers 

References 

Agre, P., Campbell, F.A., Goldman, B.D., Boccia, M.L., Kass, N., McCullough, L.B., Merz, J.F., 

Miller, S.M., Mintz, J., Rapkin, B., Sugarman, J., Sorenson, J., and Wirshing, D. (2003). 

Improving Informed Consent: The Medium is Not the Message. IRB: Ethics and Human Research 

Supplement 25(5): S11-S19. 

Alliance for Human Research Protection. 2002. Retrieved 3/30/2005 from 

. 

Appelbaum, P.S., Roth, L.H., Lidz, C.W., Benson, P., and Winslade, W. (1987). False Hopes and 

Best Data: Consent to Research and the Therapeutic Misconception. Hastings Center Report 

17(2): 20-24. 

Beauchamp, T.L., and Childress, J.F. 2001. Principles of Biomedical Ethics. Fifth Edition. 

New York: Oxford University Press. 

Chambers, T. (1999). The Fiction of Bioethics: Cases as Literary Texts. New York: Routledge. 

Charon, R. (1994). Narrative Contributions to Medical Ethics: Recognition, Formulation, Interpretation, 

and Validation in the Practice of the Ethicist. In E.R. DuBose, R.P. Hamel, and L.J. 

O’Connell (Eds.), A Matter of Principles? Ferment in U.S. Bioethics. (pp. 260-283). Valley 

Forge, PA: Trinity Press International. 

Coyne, C., Xu, R., Raich, P., Plomer, K., Dignan, M., Wenzel, L.B., Fairclough, D., Habermann, 

T., Schnell, L., Quella, S., Cella, D., and the Eastern Cooperative Oncology Group. (2003). 

Randomized, Controlled Trial of an Easy-to-Read Informed Consent Statement for Clinical 

Trial Participation: A Study of the Eastern Cooperative Oncology Group. Journal of Clinical 

Oncology 21: 1836-1842. 

Department of Health and Human Services (DHHS). (1991). 45 CFR 46.116 General 

Requirements for Informed Consent. 56 FR 28003 (June 18, 1991). 

Donchin, A. (2001). Understanding Autonomy Relationally: Toward a Reconfiguration of 

Bioethical Principles. Journal of Medicine and Philosophy 26(4): 365-386. 

Dresser, R. (2001). When Science Offers Salvation: Patient Advocacy and Research Ethics. 

New York: Oxford University Press. 

Fan, R., and Tao, J. (2004). Consent to Medical Treatment: The Complex Interplay of Patients, 

Families, and Physicians. Journal of Medicine and Philosophy 29(2): 139-148. 

Flory, J., Emanuel, E. (2004). Interventions to Improve Research Participants’ Understanding in 

Informed Consent Research. Journal of the American Medical Association 292(13): 1593- 

1601. 

Food and Drug Administration (FDA). (1981). 21CFR 50.20. General Requirements for Informed 

Consent. 46 FR 8951 (Jan. 27, 1981, as amended at 64 FR 10942, Mar. 8, 1999). 

Frank, A.W. (1995). The Wounded Storyteller: Body, Illness, and Ethics. Chicago: University of 

Chicago Press. 


Galarneau, C.A. (2002). Health Care as a Community Good: Many Dimensions, Many 

Communities, Many Views of Justice. Hastings Center Report 32(5): 33-40. 

Papers 

Heymann, S.J. (1995). Patients in Research: Not Just Subjects, But Partners. Science 269(5225): 

797-798. 

Hochhauser, M. (2003). Concepts, Categories, and Value Judgments in Informed Consent Forms. 

IRB: Ethics and Human Research 25(5): 7-10. 

Jenkinson, C. (1995). Evaluating the Efficacy of Medical Treatment: Possibilities and Limitations. 

Social Science and Medicine 41(10): 1395-1401. 

Joffe, S., Cook, E.F., Cleary, P.D., Clark, J.W., and Weeks, J.C. (2001). Quality of Informed Consent 

in Cancer Clinical Trials: A Cross-Sectional Survey. The Lancet 358(9295): 1772-1777. 

Kusek, J.W., Lee, J.Y., Charleston, J., Faulkner, M., Levell, B., Milligan, S., and Norris, K., for the 

AASK Pilot Study Investigators. (1996). Participant Satisfaction in the African American 

Study of Kidney Disease and Hypertension (AASK) Pilot Study. Controlled Clinical Trials 

16: 47S-54S. 

McCarthy, J. (2003). Principlism or Narrative Ethics: Must We Choose Between Them? Journal of 

Medical Ethics; Medical Humanities 29(2): 65-71. 

Mead, N., and Bower, P. (2000). Patient-Centredness: A Conceptual Framework and Review of the 

Empirical Literature. Social Science and Medicine 51: 1087-1110. 

Miller, F.G., and Brody, H. (2003). A Critique of Clinical Equipoise: Therapeutic Misconception in 

the Ethics of Clinical Trials. Hastings Center Report 33(3): 19-28. 

Miller, M. (2002). Phase I Cancer Trials: A Collusion of Misunderstanding. Hastings Center Report 

30(4): 34-42. 

Mills, N., Donovan, J.L., Smith, M., Jacoby, A., Neal, D.E., and Hamdy, F.C. (2003). Perceptions of 

Equipoise are Crucial to Trial Participation: A Qualitative Study of Men in the ProtectT Study. 

Controlled Clinical Trials 24: 272-282. 

National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. 

(1979). The Belmont Report: Ethical Principles and Guidelines for the Protection of 

Human Subjects. Washington, DC: Department of Health, Education, and Welfare. 

Nicholas, B., and Gillett, G. (1997). Doctor’ Stories, Patients’ Stories: A Narrative Approach to 

Teaching Medical Ethics. Journal of Medical Ethics 23(5): 295-299. 

Peckman, S. (2002). A Shared Responsibility for Protecting Human Subjects. In R.A. Amdur and 

E.A. Bankert (Eds.), Institutional Review Board: Management and Function (pp. 17-21). Sudbury, 

MA: Jones and Bartlett. 

Penslar, R.L. (2002). The IRB’s Role in Editing the Consent Document. In R.A. Amdur and E.A. 

Bankert (Eds.), Institutional Review Board: Management and Function (pp. 233-235). Sudbury, 

MA: Jones and Bartlett. 


Papers 

Potts, A., Grace, V., Gavey, N., and Vares, T. (2004). Viagra Stories: Challenging ‘Erectile Dysfunction’. 

Social Science and Medicine 59: 489-499. 

Pullman, D. (2002). Conflicting Interests, Social Justice and Proxy Consent to Research. Journal of 

Medicine and Philosophy 27(5): 523-545. 

Sankar, P. (2004). Communication and Miscommunication in Informed Consent to Research. 

Medical Anthropology Quarterly 18(4): 429-446. 

Schron, E.B., Wassertheil-Smoller, S., and Pressel, S. (1997). Clinical Trial Participant Satisfaction: 

Survey of SHEP Enrollees. Journal of the American Geriatrics Society 45(8): 1772-1777. 

Sharp, L.A. (2000). The Commodification of the Body and Its Parts. Annual Review of Anthropology 

29: 287-328. 

Siminoff, L.A. (2003). Toward Improving the Informed Consent Process in Research with Humans. 

IRB: Ethics and Human Research 25(5): S1-S3. 

Smyth, W.E., and Murray, M.J. (2000). Owning the Story: Ethical Considerations in Narrative 

Research. Ethics & Behavior 10(4): 311-336. 

Sugarman, J., McCrory, D.C., Powell, D., Krasny, A., Adams, B., Ball, E., and Casell, C. (1999). Empirical 

Research on Informed Consent: An Annotated Bibliography. Hastings Center Report 

29(1):S1-S42. 

Ten Have, H. (1994). Principlism: A Western European Appraisal. In E.R. DuBose, R.P. Hamel, 

and L.J. O’Connell (Eds.), A Matter of Principles? Ferment in U.S. Bioethics (pp. 101-120). 

Valley Forge, PA: Trinity Press International. 

Vanderpool, H.Y., and Weiss, G.B. (1987). False Data and Last Hopes: Enrolling Ineligible Patients 

in Clinical Trials. Hastings Center Report 17(2): 16-19. 

Wolf, S.M. (1996). Introduction: Gender and Feminism in Bioethics. In S.M. Wolf (Ed.), Feminism 

and Bioethics: Beyond Reproduction (pp. 3-43). New York: Oxford University Press. 


Authors Note 

One – on – One mentoring: A case study 

Karolis Bauza 

Belmont Abbey College, 

100 Belmont 

Mt. Holly Rd., 

Belmont, North Carolina 28012, USA 

TEl.: (704) 677-4193 

e-mail: karolis_bauza@yahoo.com 

DR. BRENT L. HOUSE, PH.D.,LT-USN, 

NMRC 

503 ROBERT GRANT AVENUE 

SILVER SPRING, MARYLAND 20910-7500, USA 

TEL.: (301) 319-9370 

e-mail: houseb@nmrc.navy.mil 

MICHAEL STOCKELMAN, PH.D., LT-USN 

NMRC 

503 ROBERT GRANT AVENUE 

SILVER SPRING, MARYLAND 20910-7500, USA 

TEL.: (301) 319-7592 

e-mail: stocklemanm@nmrc.navy.mil 

We would like to thank the Naval Medical Research Center and the Jackson Foundation for 

sponsorship of Karl’s summer internship. We would also like to thank the NMRC Commanding 

Officer, Captain Louis E. Antosek for accommodating Karl and becoming a close friend and ally. 

Abstract 

Papers 

The Responsible Conduct of Research, as put forth by the Office of Research Integrity of the Public 

Health Service, contains nine core instructional areas. One of those areas focuses on mentor/trainee 

responsibilities. In science, every research project must go through a process where the scientist 

puts concepts together, determines the inputs, and envisions the outcomes. The starting point of 

training is generally the first time the trainee spends in the lab with a mentor, during which time 

the trainee not only learns basic techniques, but also work ethic, writing style, and scientific approaches. 

Moreover, a good mentor can also be influential in the development of the trainee’s professional 

personality. Unfortunately, in many cases, poor or absent mentoring leads to the perpetuation 

of bad scientific habits. In May of 2005, the United States Navy sponsored a college student 

to spend eleven weeks at the Naval Medical Research Center, providing him with an opportunity 

to explore the scientific environment and learn fundamentals for effective scientific research. In 

this case study, the student received one-on-one mentoring aimed at positively contributing to his 

future development as a research scientist. 


Papers 

Introduction 

Day by day society becomes more and more dependent on scientific research. Extraordinary discoveries 

are made around the globe on a regular basis. Society’s continued scientific development 

is ultimately dependent upon each and every individual scientist. Here we will focus on one aspect 

of the training of each of these scientists – mentoring. 

For the scientist-in-training the starting point in his or her career is usually spent in the lab next 

to a mentor(s). During this crucial mentoring/training phase, the budding scientist not only 

learns basic laboratory techniques, but also develops work ethic, writing style, and approaches 

to scientific experimentation. Moreover, the mentor is often very influential in the development 

of the trainee’s professional personality. Sadly, not every scientist can honestly say that his or her 

first steps in the lab were taken following a good mentor. Consequently, poor or completely absent 

mentoring leads to the perpetuation of bad scientific habits. 

Today, mentors are seen as advisors, supporters, teachers, masters, sponsors, examples, and 

friends. Ultimately, mentors should genuinely care about the well being of their trainees. In a 

broad sense, a mentor is someone who takes a special interest in helping another to develop into 

a successful person. To effectively train a scientist, it takes a lot of effort, hard work and a genuine 

sense of trust between the mentor and trainee. 

In order for this trainee/mentor relationship to be most beneficial, both parties must assume and 

carry out some basic responsibilities (see Table 1). Though this is not a complete list, we believe it 

comprises a set of important characteristics needed to train a new scientist. Some responsibilities 

apply equally to the mentor and to the trainee, while others are unique to either. 

Table 1. Responsibilities in the Mentor/Trainee relationship. 

Mentor Trainee 

Friendship 

Good Listening Skills 

Be Available Ask Questions 

Provide Other Mentor Options Work Hard 

Develop the Trainee’s Professional Network Be Curious 

Teach Basic Skills 

Be Sensitive to the Trainee’s Needs 


Case Study 

Introduction 

Our case study followed Karl, a foreign student attending a small private college in North Carolina. 

He had just finished his first year of undergraduate education in the spring of 2005 when he 

was invited to spend 11 weeks at the Naval Medical Research Center. His mentor was Dr. House, 

a research microbiologist. The main objectives of his internship were: 1) to have an opportunity to 

do basic science; 2) to learn laboratory techniques; 3) to improve speaking and writing skills; and 

4) to gain experience establishing professional networks. 

In our case study, meeting these objectives required the mentor and trainee to assume the abovementioned 

responsibilities. For example, in order for Karl to learn basic laboratory techniques, Dr. 

House was available to answer questions. In addition, Dr. House provided the trainee with other 

mentor options, mentors having knowledge and skills that Dr. House did not have. Dr. House also 

taught Karl aspects of scheduling, writing, and presenting his research. Lastly, Karl’s curiosity enabled 

him to meet many different scientists and insightful people who taught him the importance 

of establishing a professional network. 

Karl: My dream is to attend medical school in the United States. The most difficult thing about attending 

U.S. medical schools is getting accepted. Students go insane trying to convince admissions 

departments that they are fit for medical school. It is not enough anymore just to keep high GPAs 

and score well on the MCAT. For example, research-oriented medical schools tend to accept students 

that are relatively experienced scientists, doing laboratory research over summer breaks or 

during the school years. Because of this, competition for these undergraduate research positions is 

tough - procuring a research position sometimes seems as difficult as winning the lottery. 

I was fortunate, because I was offered summer research positions at the National Institutes of 

Health (NIH) and the Naval Medical Research Center (NMRC). Each offered a great opportunity 

working in a top-notch program with experienced scientists. However, through the encouragement 

of Captain Antosek, the Commanding Officer at the NMRC, and my excitement to work 

in malarial genetics, I decided to accept the position at the NMRC. The day after my last final I 

packed my bags and set out to explore the extraordinary world of scientific research. 

Mutual Responsibilities 

Papers 

Friendship. The mentor and trainee must develop a friendship. This does not have to mean that 

they spend time together going fishing, shopping for shoes, or sharing childhood memories. But 

they must at least be friends in the professional setting, allowing a feeling of trust and openness to 

exist. The trainee, seeing that the mentor is not only “another teacher”, will be more open to asking 

difficult questions, trusting the mentor as one of his or hers friends. It is also easier and more 

enjoyable to accomplish objectives, when working in a friendly environment, compared with an 

environment full of tension and mistrust. 

Karl: The Naval Medical Research Center is located in Silver Spring, Maryland just outside of 

Washington D.C. One Saturday Dr. House invited me to go with him and his two oldest children 

to visit Washington D.C.’s historical sights and experience the nation’s capital. This time and other 

times spent together have strengthened our mentor-trainee relationship, providing each of us with 

a better understanding of the other. 


Papers 

Brent: Karl has been a great friend to me, my family, and all those with whom he has interacted 

at the Naval Medical Research Center. He put forth the effort to talk and become friends with as 

many of the people around him as possible. I invited him over for dinner a few times, and my family 

and I enjoyed his company. It is much easier to be a mentor to someone who is genuinely your 

friend. 

Good Listening Skills. In any productive relationship, good communication is key. The mentor 

should be a good listener, never being bound to his or her perspective by misjudging or misinterpreting 

the trainee. A mentor should always listen to exactly what the trainee is trying to say, 

not what the mentor expects or wishes to hear. The mentor should pay attention to the “subtext” 

of the trainee’s words, including his or her tone, attitude, and body language. When the trainee 

believes to have understood a point, it is helpful to repeat it back to the mentor, making sure this 

understanding is correct. The same principles of good listening for the mentor should be applied 

to the trainee. Effective communication, requiring good listening skills, is essential to a productive 

mentor/trainee relationship. 

Karl: Dr. House’s ability to listen was one of the factors that contributed most to my experience 

here. Dr. House never interrupted me when I was talking. Moreover, he never unduly persuaded 

me to adopt his opinion - this was very helpful for me, because I could learn more and was not 

bound by unnecessary limits. Our listening-based communication was a keystone for my project, 

especially at the beginning when most of my time was spent reading and asking questions. 

Brent: Good communication is fundamental in a mentor/trainee relationship. During Karl’s stay 

here, I always felt that he listened well to instructions and training given to him. For example, each 

morning we would discuss the previous day’s results and the upcoming projects. At each of these 

discussion sessions, I would give him instructions for the day’s work. He would almost always do 

what was discussed – and if he was confused about one thing or another, he would immediately 

come and talk to me about it. 

The Mentor’s Responsibilities 

Be Available. The mentor should make himself available to the trainee. Too many scientists-intraining 

are left to their own devices during the crucial initial phases of their careers, because 

mentors are very busy and may not be able to reserve large blocks of time for the trainee. But 

through effective communication, and a solid commitment from the mentor, time can be made 

available for training. The mentor should also keep in mind that some students require more time 

than others. It might be quite possible for some, more talented and/or experienced scientists to 

just “check in” once or twice a week. But some students will require, especially in the beginning, a 

larger portion of the mentor’s time. In any case, the mentor should not forget his or her trainee(s) 

and should arrange times for weekly or even daily meetings. 

Karl: To read as much as possible and to learn the theoretical side about molecular biology was 

one of my objectives during this internship; therefore I read a lot in the first few weeks in order to 

understand the work that I would be doing in the lab. During this reading time, my mentor was 

always available if I had questions. This was great since none of my objectives could have been 

accomplished if Dr. House had been unavailable. Dr. House, in order to make sure that I understood 

the material well, was spending even more time talking about the material than I needed. 

Throughout the laboratory exercises, Dr. House was almost always available if I needed him as 

well. 


Papers 

Brent: Though at times my schedule was relatively busy, I tried to make myself available to Karl. 

Being available does not mean that the mentor must always be around. But by planning ahead, I 

found that I could communicate to Karl the times that I would be away, so that he could plan his 

work accordingly. It is easy to convince yourself that your own work is more important than training 

a new scientist, but I felt that giving off my time to be available for Karl was or at least could 

have been important for his career. 

Provide Other Mentor Options. No one mentor has the knowledge and experience necessary to 

sufficiently train a modern scientist. Therefore, a good mentor will provide the trainee with names 

of other mentors. Having more than one mentor will broaden the trainee’s knowledge and understanding 

about the field in which he or she is interested. The perfect or ‘complete’ mentor is not 

one person, but an assembly of several mentors, each contributing a piece of the training ‘pie’. 

Karl: I had many questions related to research and especially medical schools that Dr. House 

could not answer, so he introduced me to a variety of other scientists at the NMRC and explained 

my situation to them. After that, I was welcomed in each scientist’s office to talk about medical 

schools, research and even about bike rides. This was nice, since this provided me with more in 

depth discussions and answers – things Dr. House could not provide for me himself. Here are 

some examples of people who contributed in fulfilling all my objectives: 

One of the virology department scientists, Dr. Kevin Porter, gave me much advice regarding 

Duke Medical School, the school from which he graduated. Dr. Porter also gave me 

the ‘crazy’ idea that each day, after working at the NMRC, I could perform volunteer duties 

for the Red Cross at the National Naval Medical Center (NNMC). 

Dr. Thomas Richie, Director of the Malaria department, was also very generous with his 

time and sat and talked with me about some of the differences in getting an M.D./Ph.D. 

verses just an M.D. He also shared with me his experiences in the military traveling the 

world to work with Malaria. 

As an introduction to my laboratory research project, Dr. Joao Aguiar spent a significant 

amount of time explaining to me the main goals of his lab and how molecular biology 

works. He also helped me understand why Malaria is one of the deadliest killers in the 

world today, why Malaria has been and is still so difficult to eradicate, and what problems 

contemporary scientists face in creating an effective vaccine. Dr. Aguiar sharing his 

life-long experiences with me has impacted my thinking about the threat of the Malaria 

parasite. 

Brent: I am very new to the Naval Medical Research Center and to the field of Malaria. And 

though I have done much reading about Malaria, I knew that Karl would benefit from the mentorship 

of many scientists who were more experienced in the field (and other fields). I think that Karl 

learned much and really enjoyed his discussions with all of the other researchers in the facility. 

Develop the Trainee’s Professional Network. The mentor is the keystone in building a trainee’s 

professional network. Once initial training is completed, the trainee will eventually need or want 

to move on (to school or to a career). In most cases, the mentor will have many more professional 

contacts than the trainee. By introducing the trainee to different contacts within (or outside) the 

field, the mentor provides the essential groundwork that the trainee can use in finding the appropriate 

schooling or career when the time comes to do so. Building a network is a lifelong process, 

one that should begin with the scientist’s first mentor/trainee relationship. 


Papers 

Karl: During my time at the NMRC I realized that networking is a very important aspect of developing 

my career. Since broadening my professional network was one of our objectives throughout 

my internship, I was provided with an opportunity to talk to many other scientists about the best 

ways of accomplishing my specific experiments. Moreover, many scientists advised me about 

medical schools as well. I also met many medical school students, who where simply doing their 

internships or working as regular employees in order to pay back the military for their education. 

They gave me their perspectives as students, and advised me on ways to prepare for the MCAT. 

But more importantly, they became quick friends, whose influences may help me in my future 

career. A student’s networking must start with a good mentor effectively conveying the notion that 

professional networks in science can be immensely helpful throughout a scientist’s career. 

Brent: A short summer internship, like Karl’s, does not present a great opportunity to set up a 

broad professional network. But certainly Karl was able to meet with many people here at the 

NMRC and at the NNMC and build friendships that will hopefully serve him in the future. Karl 

will finish his internship understanding the importance of networking throughout his career. 

Teach Basic Skills. There are several basic skills a scientist needs to acquire if he or she wishes to 

be successful. Unfortunately, many mentors take these for granted and do not sufficiently provide 

training for these basic skills: 

1) Many beginner scientists have little experience in planning, organizing tasks, and making 

good use of their time. The mentor can help them acquire this skill, possibly beginning 

with simple scheduling, where the mentoring appointments are used as a basic framework. 

2) Clear writing is essential to most careers. In science, writing is especially significant, as 

most scientists participate in writing research articles, review articles, grant proposal applications, 

article reviews, recommendation letters, etc. Very early on, the mentor should 

therefore engage students in writing tasks, provide meaningful feedback, and emphasize 

its importance. 

3) Public speaking is also a much-needed skill. Scientists have a huge advantage in their 

fields of study when they are able to present scientific ideas and results effectively to other 

scientists and engineers, as well as to the lay public and specialists in other fields. The 

training required will vary greatly from trainee to trainee. Some may be naturally confident 

in front of groups, while others may display varying levels of anxiety towards giving 

public or class presentations. In extreme cases, trainees may benefit from professional 

training, via speech classes or consultation. 

Karl: Dr. House not only taught me the basic laboratory techniques, but he also understood the 

importance of basic skills such as planning, writing and speaking. Before I came to the NMRC, 

Dr. House prepared a schedule with all the things I had to do during my internship. However, the 

schedule was open to change, therefore we were able to move things around and adjust them to 

be more convenient and useful. During my stay I had to write a scientific paper, which was a very 

new experience for me. I also prepared and gave a presentation about Malaria to the entire NMRC 

Malaria department.This was the first big public presentation that I have given. Practicing all these 

basic techniques at an early stage will contribute greatly to my future career. 

Brent: Before Karl arrived, I organized a calendar of projects that he would have while he was here. 

Karl wrote a research paper, created a poster and gave a PowerPoint (PP) presentation, learning 

some basics about writing and public speaking. 


Be Sensitive to the Trainee’s Needs. The mentor should constantly keep track of all of his or her 

trainees and their needs. A sensitive and vigilant mentor can help to avert or solve most problems 

before they become serious. Even a trainee who is experienced and competent will need occasional 

communication and guidance. 

The mentor also should not forget that he or she will find themselves advising students of varying 

cultural backgrounds, abilities (or disabilities), and communication and learning styles. Trainees 

may be from discrete rural or urban communities in the United States or from abroad. In any case 

the mentor should become familiar and comfortable with these differences. It is of utmost importance 

for the mentor to demonstrate a willingness to communicate with and to understand each 

student as an individual with unique traits and cultural differences. 

Karl: My training at the NMRC was very interesting, exciting and, of course, difficult. But at the 

same time it was easy, because Dr. House was very patient with me and explained concepts and 

procedures as many times as I needed. Moreover, he understood that if he did everything for me, 

it would not leave any space for me to learn. Therefore, most of the time Dr. House showed me the 

major things I needed to know and then allowed me to do many things on my own. That was very 

nice, as I learned the basics much more quickly that way. 

Brent: Karl is a very ambitious, energetic, and aggressive young man. I found that with a little 

guidance up front, he was able to do many things on his own – and I believe he preferred it that 

way. There were times when I had to ‘reel him in’, as he would tend to get ahead of himself. But 

daily communication allowed me to keep a pulse on what his needs were. 

The Trainee’s Responsibilities 

Papers 

Ask Questions. The responsibilities for the mentor are great, but there are also responsibilities that 

apply to trainee as well. A good mentor is always ready to explain principles, problems, and solutions 

as many times as is needed for the trainee to understand. However, it is the trainee’s responsibility 

to ask questions whenever he or she needs clarification. Not only will this allow for the 

provision of an answer to the question, but it will also give the mentor a glimpse into the trainee’s 

understanding of the material. 

Brent: Karl was not afraid to ask questions. There were many mornings when Karl would come 

to my office and ask at least a dozen questions about Microbiology, Molecular Biology, Malaria, 

Medical School, General Medicine, and sometimes life in general. But these questions were crucial 

in my understanding of his progress and understanding of concepts and ideas. And these questions 

have certainly allowed him to learn a great deal of information that would have been unavailable 

to one who did not ask questions. 

Karl: I always liked asking many questions, because it gave me good ideas about what I needed to 

learn and what I already know. At times, reading the Microbiology or Genetics textbooks was confusing 

and difficult to understand. I knew that if I did not ask questions, I would not accomplish 

my internship’s objectives - deeper in the forest there are always more trees. 


Papers 

Work Hard. Another very important responsibility is the willingness to work hard. In the mentor/trainee 

relationship, the trainee must work hard to implement the training that is given by the 

mentor. Setting and attaining goals is a big part of becoming a good scientist. A good mentor can 

lead the trainee to water, but cannot make him drink. If the trainee is not willing to work hard in 

the lab or at home reading supporting materials, the desired results will not be reached. Diligent 

preparation for classes, presentations, and research work is a habit directly related to scientific efficiency 

and the initiation and development of a successful career. 

Brent: After the first week of Karl’s internship, I knew that he was going to be a diligent worker. 

After volunteering to work with the Red Cross, Karl’s workday exceeded 15 hours. He would work 

at the NMRC from 7:00 am until 3:30 pm, and usually work at the NNMC (with the Red Cross) 

from 5:00 pm until midnight. When Karl was not working at the NNMC, he spent his nights and 

weekends reading, writing, and preparing for his projects at the NMRC. 

Karl: When I signed up with the Red Cross to volunteer nights and weekends at the NNMC, I 

knew that it would be difficult to work some eighteen-hour days, but I knew that medicine is what 

I really enjoy. I also knew that by working at the hospital I would see how physicians work and 

would gain knowledge about medicine and contemporary medicine’s problems. 

Be Curious. Intellectual curiosity is also an essential trait and responsibility of the scientist. When 

a training scientist is genuinely interested in his or her field of research, he or she is willing to work 

hard, ask many questions and put the necessary hours in for the achievement of scientific goals. 

Science is the pursuit of knowledge and truth as it relates to observable and measurable phenomena. 

A training scientist must be curious about his or her field of research to become a knowledgeable 

and productive member of the scientific community. 

Brent: Karl has and insatiable desire to learn. When he first arrived, knowing that he had not had 

any previous exposure to Microbiology, I assigned him reading in a general microbiology textbook. 

He not only finished this book, but began reading textbooks about genetics, immunology, 

and molecular biology. Each day, he would come to me and say “Now, I understand.” 

Karl: During my time at Navy Medical Research Center, I decided to volunteer for an anti-Malaria 

drug study. I thought that this experience would be useful for me in many ways. This experience 

allowed me to learn about clinical research, which is a very important part of the bio-medical areas 

of scientific research. I believe that in order for me to understand the whole process of vaccine 

development, I needed to explore both angles: initial development at the laboratory bench and 

product analysis at the hospital bed. 

Conclusions 

Before Karl’s internship, some basic objectives were created as primary goals we wished to accomplish. 

Some objectives were met and exceeded, such as doing basic science, gaining experience 

in establishing professional networks and improving speaking, writing, and scheduling skills. We 

conclude that one-on-one mentoring was an effective means of providing Karl with these important 

aspects of scientific training. 


However, the goal of learning laboratory techniques was not completely fulfilled, as laboratory 

experiments did not produce desirable results. Due to technical problems, much time was lost 

repeating steps over and over again. In the end, we decided to use alternative methods to finish the 

project. However, the laboratory failures had some value as well, because Karl was forced to think 

more in depth and search for alternative ways towards the success of the experiment. This is essential 

in research, because failures are a common thing for scientists. Failures force researchers to 

think critically about experiments, evaluating the methods and outcomes for future studies. 

A productive mentor/trainee relationship requires that the mentor and trainee assume some basic 

responsibilities. Regardless of the specific responsibilities one thinks must be taken on by the mentor 

and the trainee, ultimately TIME and COMMITMENT are required from both the mentor and 

trainee. The question remains whether or not one-on-one mentoring can be feasibly implemented 

in our scientific institutions today. Currently, there may not be enough “trained” mentors available 

to teach each new scientist, and the costs (in time and money) will be great to correctly train 

a sufficient number of new mentors. And even if time and money are available, many would-be 

mentors may not believe that they need any extra training – they are already good mentors. If 

mentoring is to become an effective means of training new scientists, the attitude in the scientific 

community must be changed dramatically. The initial cost of one-on-one mentoring will pale in 

comparison to the long-term benefits reaped by science, as well-trained scientists enter their fields 

of study. 

Karl: In my opinion, everybody should have an opportunity for one-on-one mentoring. This experience 

has helped to broaden my educational background, taught me hands-on scientific research, 

and prepared me for my future career. 

WORKING BIBLIOGRAPHY 

1. http://ori.dhhs.gov/education/ 

2. http://ori.dhhs.gov/education/products/columbia_wbt/rcr_mentoring/ 

3. http://www.nap.edu/readingroom/books/mentor/ 

Papers 


Papers 

External Resource Acquisition and Management 

“Tool for MSI Research and Sponsored Programs Administrators” 

William R. Belisle, Ph. D. *Principal Author 

Grants, Sponsored Research and Contracts Officer 

Southern University at New Orleans 

6400 Press Drive, New Orleans, Louisiana 70126 

(504)284-5539, wbelisle@suno.edu 

Author Notes. Acknowledgements and many thanks to the contributing authors Jeronimo Dominguez 

– University of New Mexico, George French – Miles College, Haven Gorneau – 

Fort Peck Community College, Ron LaDue – Blackfeet Community College, and Cynthia Daniels 

Cellers – Fort Valley State University, the National Association for Equal Opportunity for Higher 

Education (NAFEO), the W. K. Kellogg Foundation, and the Alliance for Equity in Higher 

Education. 

ABSTRACT 

The generation of money and resources by Minority Serving Institutions is generally a result of 

student enrollment, state support, grant and foundation activities, legislative appropriations, gifts, 

donations, auxiliary income, and campaigns. A significant amount of the resources generated and 

received by MSIs are associated with the institution’s research and sponsored programs administrative 

offices. The appropriate management of resources and money generally involves financial 

and budgetary activities and external entities such as federal, state, and local agencies, sponsors, 

accrediting organizations, and higher education associations. MSIs, especially smaller public MSIs, 

receive less external monies and resources compared to the levels received by other higher education 

institutions. This paper presents a multitude of resources which may be used by MSI research 

and sponsored programs administrators and presidents to acquire and manage and close-out 

financial resources and activities. Resource information specifically for Historically Black Colleges 

and Universities and Hispanic Serving Institutions is presented. This paper also presents several 

recommendations for MSI research and sponsored programs administrators including a simple 

model for external resources acquisition and management. The information presented in this 

paper is a useful tool for new and seasoned MSI research and sponsored programs administrators 

and presidents. 

INTRODUCTION 

The W. K. Kellogg Foundation supported a one-year Minority Serving Institution (MSI) 

Leadership Fellowship Program with the purpose of preparing the next generation of presidents 

and senior administrators for minority serving institutions. Ten fellows from the National Association 

for Equal Opportunity in Higher Education (NAFEO), Hispanic Association for Colleges 

and Universities (HACU), and American Indian Higher Education Consortium (AIHEC) were 

selected to participate in the class for 2004-2005. Six fellows representing NAFEO, HACU, and 

AIHEC and which include the six authors, met periodically during the one-year period to discuss 

and develop a project and useful materials that addressed MSI finances and financial management. 

Money and resource acquisition and management were researched for the represented MSIs and 

for MSIs in general. Based upon information and data collection, there is a clear indication that 

MSIs are not acquiring adequate external money and resources. Because the money and resources 

are inadequate and are not in amounts similar to present majority institutions, information and 

tools regarding the acquisition and management of external money and resources for MSIs was 

prepared and is presented in this manuscript. A significant responsibility for acquisition and 

management of external money and resources is within the MSI research and sponsored programs 

offices. Note that some MSIs may not have research or sponsored programs offices, and instead 

may have a research or sponsored programs activity within other offices. Many MSI research and 


sponsored programs offices have very small infrastructure and capacity relative to the external 

resources available and to the effort required to acquire needed external resources. Also note that 

a large amount of money and resources available to higher education institutions may not be available 

to many MSIs as it relates to required institutional infrastructure and capacity. Information 

and materials are presented in this paper that addresses the acquisition and management of money 

and resources for MSI research and sponsored programs administrators and presidents. 

GENERATING RESOURCES 

Papers 

Every job description for a President, Chancellor, or Chief Executive Officer of an institution of 

higher education (IHE) contains language that requires the president to lead the effort to raise 

money. Bringing in resources and managing these resources are key responsibilities of a presidency. 

For new presidents, this requirement may be somewhat overwhelming. Yet accepting a 

presidency means that you understand and can do the job. In most instances, the responsibility of 

acquiring and managing research and externally sponsored funds and gifts, donations, and fund 

raising is assigned to the research or sponsored programs administrator and development offices, 

respectively. 

Obtaining external funds is never easy, especially for MSIs. As financial support from state and 

federal sources declines, IHEs must become successful at finding other sources of funds, thus, the 

need for fundraising. IHEs cannot continue to rely on tuition increases to keep the doors open, 

build strong programs, provide comprehensive quality student services, and keep up with the 

competition. Without new dollars, IHEs, specifically a large number of MSIs, will be at a disadvantage 

in recruiting students, attracting and retaining high quality faculty, and in general, maintaining 

the quality standards of their institutions. 

Successful student enrollment information may be provided by Noel Levitz regarding student access, 

recruitment, retention, graduation, and customer service. The web site is http://www.noellevitz.com. 

Foundation and philanthropic resources may be identified by accessing The Foundation 

Center at http://fdncenter.org or http://fdncenter.org/funders/. Federal agency resources may be 

identified by accessing www.grants.gov; federal legislative branch information may be accessed at 

http://www.firstgov.gov; the U.S. Senate may be accessed at http://www.senate.gov/senators/index. 

cfm; the U.S. House of Representatives may be accessed at http://www.house.gov/house/Tying_it_ 

all.html. 

The United States Department of Education Center for Education Statistics indicates that grants, 

cooperative agreements and other sources of federal funds represent a significant portion of the 

operating budgets of HBCUs nationwide. However, private gifts represent one-fourth less than 

federal funds; hence there is an apparent need for HBCUs to increase private giving. Statistics for 

HBCUs, for example, indicate operating budgets of approximately 25.5% from tuition and fees, 

21.6% from the federal government, 24.8% from state government, 2.7% from local government, 

5.8% from private gifts, grants, and contracts, 0.8% from endowment income, 17.9% from sales 

and services, and 1.9% from other sources. While the need for private gifts is evident, it is less easy 

to identify the sources of private gifts for which HBCUs nationwide may compete. Succinctly, the 

majority of the private gifts given to colleges are from individuals (alumni). Further, when the 

private gifts are not from alumni, they are from community residents who have an interest in the 

local HBCU community. Thus it is impracticable to define a useful database from which HBCUs 

may solicit private gifts. However, it is interesting to note that through the new Kresge HBCU 

Initiative, Kresge is attempting to encourage private gifts to HBCUs by giving national recognition 

to individuals who make significant contributions to HBCUs. 


Papers 

Generally speaking, fundraising at public institutions is way behind when compared to these efforts 

at private institutions. Privates out-raise publics by a ratio of 2 to 1. The role of trustees at privates 

is different from that of government-appointed regents at publics. The perception of private 

and public institutions is very different. Public institutions are seen as state-supported. Private institutions 

receive corporate support and large private gifts, while this is not generally the norm for 

publics. The need for publics to raise money is fast becoming the single greatest challenge in public 

education. Resources from federal and state agencies are on the decline, the cost of keeping “the 

door open” is increasing, and there is pressure on public institutions to compete for the “best and 

brightest.” This has created a need for better faculty, better facilities, and better programs. Public 

institutions must find resources in order to remain competitive. Publics have turned to fundraising 

/ major campaigns to help finance public higher education. In fact, publics are meeting with very 

good success and are closing the “giving/fundraising gap” between public and privates. Publics 

are creating organizational structures to conduct fundraising. Institutional foundations that are 

independent of the state political process, governance, and regulation are being created to conduct 

the business of fundraising. Publics must sell the “value” of their institution to be successful in the 

philanthropic arena. Privates have historically relied on high tuition cost, large endowments, and 

successful fundraising. Publics, on the other hand, are viewed as taxpayer-supported with modest 

tuition cost. In general, the public accepts that privates must raise money to maintain their 

elite status. Alumni from privates are expected to give back and indeed do, by a much higher ratio 

than those of publics, in both percentage and amounts when compared to publics. In more recent 

times, publics are closing the gap and experiencing success. They are now cultivating large donors. 

Alumni from publics are finding their way into large corporations, are accumulating wealth, and 

are giving back to their schools. Public institutions are maturing rapidly in conducting major campaigns 

and are becoming very successful. A challenge of large publics is the records management 

of alumni that is key to successful campaigns. Large public institutions (30,000 – 50,000 students) 

with rapidly growing alumni, must invest in data management systems to be successful in fundraising. 

One area of major concern to two-year institutions is that their alumni go on to four-year 

schools and give to the four-year school vs. the community college. Community colleges are trying 

to figure out how to reverse this trend. 

Many MSIs, especially smaller ones, have not been involved in a “major campaign” or successful 

fundraising. Major campaigns require a total commitment from the institution, both in human 

and fiscal resources, as well as a substantial time commitment in order to be successful. There 

must be “buy in,” a strong statement on benefits to the institution and community. This is the opportunity 

to tell and sell your institution’s story. Involvement in the campaign includes the board 

of regents/trustees, the president, senior administrative staff, academic units, and everyone at the 

institution, especially, the development office. Whether your institution hires a firm (outsources 

the campaign) or hires in-house staff to conduct the campaign, the commitment will be significant 

and the campaign will be 5-10 years in duration. Campaigns are not a sprint, but rather a marathon. 

There are many decision points that an institution must meet as it prepares to determine to 

enter into a major campaign. A review of the literature will assist the institution in determining if 

it is ready to assume a major campaign. 

In general, MSIs have not conducted major campaigns, even though the financial needs of MSIs 

are often greater than those of private and larger comprehensives, and research schools. It is often 

the case of the rich getting richer and the remaining poor, getting poorer. Prior documentation 

regarding capital/major campaigns will greatly assist “new presidents” (maybe some veterans, as 

well) in preparing, managing, and celebrating campaigns. 


Papers 

In the July/August (2004) issue of CASE publications, CURRENTS, the roots of minority giving 

are discussed. In her article, M. Ann Abbe talks about understanding the philanthropic tradition 

of different cultures and how to solicit them more effectively. The author examines minority giving. 

If MSIs are expecting to increase giving from minority constituents and alumni, they must 

understand how minorities give, who they give to, and why they give. It is not always as simple as 

a question of wealth. Minorities are not only growing in numbers; their buying power and economic 

power are also growing. As the minority population continues to grow and participate in 

higher education, obtain better jobs, and accumulate wealth, this group becomes a prime target 

for giving, especially to causes that have helped them succeed and to causes in which they believe. 

The question is not whether development offices at MSIs should target minorities, but rather how. 

Development staffs need to be educated on how to go about getting minorities to give to MSIs. A 

good start would be to hire more minorities to do development. MSI administrators, faculty, and 

staff need to look like their student population, their community, and their state. It is important 

for the development office to learn all it can about minority populations, their giving history and 

cultural differences. It is necessary for development offices to reach out to minority groups and not 

to assume that just because they haven’t given, they won’t. The bottom line is to learn more about 

minority givers. This knowledge can be used and put to work to get minority groups to give to 

your institution. 

Various capital campaign phases and activities are required for success including the planning 

phase, the first phase, announcing and launching the campaign, wrap-up and celebration, and 

troubleshooting the campaign. Generally, the first phase involves answering questions such as: 

Why are we doing a campaign? What will the money be used for? Is there support for the campaign? 

Announcing and launching the campaign involves a very critical communication plan. 

Wrap-up and celebration involves thanking your volunteers, evaluation, and financial records. 

Troubleshooting involves seven categories of capital campaign problems including dollar goals, 

people, specific gifts, public relations, organizational issues, project difficulties, and natural disasters 

or acts of God. 

MANAGING RESOURCES 

Appropriate management of these resources requires an understanding of financial statements. 

An understanding of financial statements may be obtained from the United States Small Business 

Administration (SBA) and ‘Understanding financial statements is critical to good business’ and 

may be found at www.sba.gov/managing/financing/statement. Another resource for understanding 

financial statements is Bizzer Professional Training – Understanding Financial Statements 

‘An introduction to financial statements and financial statement concepts’ which may be found 

at http://bizzer.com/images/Financial. Books, journals, and periodicals that may contribute to a 

better understanding of managing resources include Good to Great authored by Jim Collins, #1 

Bestseller – Why Some Companies Make the Leap……and Other’s Don’t, Influence: Science and 

Practice authored by Robert B. Cialdini. This will help executives make better decisions and use 

their influence wisely. The Majority in the Minority, Expanding the Representation of Latina/o 

Faculty, Administrators and Students in Higher Education, Edited by Jeanett Castellanos and Lee 

Jones, and Presidential Compensation in Higher Education authored by Robert H. Atwell and Jane 

V. Wellman are also good reference materials. Additional materials that may contribute to appropriate 

resource management include Policies & Best Practices Native American Colleges authored 

by Paul Boyer, Progress & Prospects, Accounting & Budgeting in Public and Nonprofit Organizations 

authored by C. William Garner, A Managers Guide, Field Guide to Academic Leadership 

edited by Robert M. Diamond, A publication of the National Academy for Academic Leadership 

– ISSN 1533-7812, Journal of Higher Education Policy and Management – ISSN 1360-080x, The 

Journal of Career and Technical Education – ISSN 1531-4952, and The Journal of Higher Education 

– ISSN 00221546. 


Papers 

Organizations and websites that may contribute to appropriate management of resources include 

the Council of Independent Colleges found at www.cic.org, and the National Association of Colleges 

& Universities Business Officers (NACUBO) found at www.nacubo.org. The Government 

Accounting Standards Board (GASB) – provides links to Associations, Directories and other 

Resources, Government agencies and Research and Advocacy groups and may be found at www. 

gasb.org/rlinks/collanduniv.html. Additional organizations and websites that may contribute to 

appropriate management of resources include the Hispanic Association of Colleges & Universities 

(HACU) - The Champions of Hispanic Success in Higher Education found at www.hacu.net, 

the National Association for Equal Opportunity in Higher Education (NAFEO) found at www. 

nafeo.org, the American Indian Higher Education Consortium (AIHEC) - The Collective Spirit 

and Voice of Our Nation’s Tribal College and Universities found at www.aihec.org, the American 

Accounting Association www.aaahp.org, the Non-Profit Resource Center www.1800net.com/nprc, 

and the Government Accounting Standards Board www.gasb.org. 

Federal financial management information for MSIs may be obtained from several Office of 

Management & Budgeting Circulars including OMB Circular A-87 – Cost Principles for State, 

Local, and Indian Tribal Governments, OMB Circular A-21 – Cost Principles for Educational 

Institutions, OMB Circular A-110 – Uniform Administrative Requirements for Grants and Other 

Agreements with Institutions of Higher Education, Hospitals, and Other Non-profit Organizations, 

OMB Circular A-133 – Audits of States, Local Governments, and Non-profit Organizations, 

and OMB Circular A-134 – Financial Accounting Principles and Standards. 

Accrediting organizations may also contribute to an understanding of required management of 

resources and include the Middle States Association of Colleges and Schools (MSA) www.neasc. 

org, www.msache.org, the New England Association of Schools and Colleges (NEASC-CIHE) & 

(NEASC-CTCI) www.neasc.org, the North Central Association of Colleges and Schools (NCA- 

HLC) www.nwccu.org, the Southern Association of Colleges and Schools (SACS) www.sacscoc. 

org, and the Western Association of Schools and Colleges (WASC-ACCJC) & (WASC-ACSCU) 

www.accjc.org, and www.wascweb.org. Examples of concerns and requirements associated with 

these accrediting organizations and financial management include sound financial base, demonstrated 

financial stability and adequate physical resources, institutional audits, and a statement of 

financial position of unrestricted net assets. Examples also include the annual budget, an acceptable 

Quality Enhancement Plan, control of fundraising activities, an institutionally based foundation, 

an intellectual properties policy, recent financial history, financial statements, financial aid 

audits, control over financial and physical resources, appropriate environment, maintenance of 

physical facilities, and the availability of information and resources to students and the public. 

Generally, accrediting organizing such as SACS for example, relies on documentation forwarded 

by the U.S. Secretary of Educational. 

Higher Education Associations that may contribute to the management of resources include the 

American Association for Higher Education, the American Association of Community Colleges, 

the American Association of State Colleges and Universities, the American Council on Education, 

the Association of American Colleges and Universities, the Council for Advancement and Support 

of Education, and the Council for Higher Education Accreditation. Additional organizations 

include the Hispanic Association of Colleges and Universities, the National Association for Equal 

Opportunity in Higher Education, the National Association of College and University Business 

Officers, the National Association of State Universities and Land-Grant Colleges, the College 

Board, and the United Negro College Fund. 


Nine keys to the essentials financial management include: 1. Administration of Finance - the quality 

of financial management (A multi-year financial plan, Debt management policies, Investment 

policies, Budgeting and monitoring the budget and Growth and vision.) 2. Sources of Revenue 

- Student Fees, (Institutional philosophy-Price vs. Cost, How are price increases determined? 

Tuition as a percentage of education and general expenditures, Special fees-Student activity fees, 

Athletic and Others, Investments, Grants, gifts & contracts, and Auxiliary enterprises.) 3. Expenditures 

(academic, auxiliary and athletic.) 4. Accounting and Reporting (Monthly financial reports, 

Budget reports, financial aid budgets, financial aid reports, and Auxiliary enterprise reports.) 5. 

Budgeting – Planning (Establish clearly state institutional objectives and Develop clearly defined 

philosophy of institutional finance), Preparation – (Establish policy on tuition and fees charged, 

Enrollment objectives, Faculty student ratios) and +Compensation (Fringe benefits, full and part 

time positions.) 6. Debt Management - Debt management reports (Short term, Long term, Interest 

due per year, and Principal per year.) 7. Audits - Annual audits (A-133 Audit of Federal Programs 

and Internal.) 8. Endowments: investment, spending formula, and reporting.) 9. Administration of 

Financial Aid. 

A financial checklist for new college presidents includes questions such as has the institution generated 

operating deficits? What is the size of unrestricted endowment per FTE, per faculty? Are 

there funds functioning as endowment? At what level, and with what certainty, will the primary 

source continue to provide funding – tuition and fees? What is the status of debt serviced payments? 

Which institutional assets can be liquidated? Federal Grants-To what extent are faculty 

salaries funded by grants? How will the future be impacted by grants? What is the reimbursed 

indirect cost rate? Are federal funds reimbursed timely and in compliance with federal requirements? 

What is the status of cash and short-term investments? What is the actual cost of fringe 

benefits? To what extent are monies borrowed from current restricted funds, endowment or 

outside sources to pay normal operating expenses? Are receivables converted to cash on a timely 

basis? Are vendor payments made on time? Is there adequate working capital and are there shortterm 

loans? and What is the status of the annual audit? 

A financial aid checklist for new college presidents may include questions such as: Who is the senior 

administrator responsible for monitoring financial aid? Who establishes and approves policies 

for awarding financial aid? What is the composition of the institutions’ financial aid by source and 

by type (loan, scholarship, employment, etc.)? How do peer group institutions’ student financial 

expenditures compare? To what extent are unrestricted funds used to finance student aid? What is 

the distribution of financial aid by class? What are the potential changes in federal or state policies 

that will affect the availability of financial aid? What is the number and percentages of students 

who receive financial aid? What are the default rates for Perkins loans and the cohort default rate 

for FFEL loans? 

RESOURCES FOR HISTORICALLY BLACK COLLEGES AND UNIVERSITIES 

Papers 

Founded after the Civil War during a period when African-Americans were denied admission 

to colleges nationwide, black colleges naturally awarded most of the degrees earned by African- 

Americans. However, following integration efforts of the 1950s and 60s, new educational opportunities 

were extended to African Americans within predominantly white schools, resulting in 

migration to these white schools, thus weakening many black colleges. They lost students, faculty, 

their best athletes and of course a large portion of their revenue base – student tuition. 

According to the Christian Science Monitor, since 2000, more than 25% of the black college presidents 

have resigned in recent years, with most citing the stresses and strains of fundraising as their 

primary obstacle. 


Papers 

Public HBCUs and smaller church-supported schools nationwide are having challenges even raising 

a fraction of the money needed for long-term substance through private gifts and donations. 

Nor are state legislatures stepping in to make up the difference. Again, as Rep. James Clyburn (D) 

of South Carolina noted in the April 23, 2003 Christian Science Monitor, “We seem to be developing 

a cottage industry of dumping on the have-nots. The research dollars are not going to these 

institutions and the maintenance efforts are not being put forth.” 

While fundraising efforts at most HBCUs is an arduous task, the mission of the HBCU has 

remained consistent. Graduation statistics suggest black colleges educate 270,000 students each 

year. While they enroll 16 percent of African-American college students, HBCU students are more 

likely to graduate than peers at predominantly white institutions. 

As a result, a quarter of black students receiving bachelor’s degrees earn them at HBCUs, according 

to the American Council on Education, Office of Minorities in Higher Education. Xavier University 

in New Orleans produces more African-American medical students than any other school 

in the country, with Spelman close behind. 

While there needs to be a significant increase in federal support given to HBCUs nationwide, the 

federal government at times appears to make an effort to financially support HBCUs. The “President’s 

Advisory Board on Historically Black Colleges and Universities” (formed in November 1993 

by Executive Order 12876) was designed to address increased financial support of HBCUs. 

The recommendations of the Advisory Board urge: (1) increased agency support from discretionary 

funding; (2) placement of federal centers at HBCUs; (3) HBCU participation in federal 

programs; (4) strengthening and broadening the undergraduate curriculum; (5) enhancement 

of doctoral education at selected campuses; (6) development of an urban grant university center 

program; (7) a role in public health for HBCUs; and (8) improved support for capital projects at 

HBCUs. 

Several resources are available for the identification of federal government resources for HBCUs. 

These resources include the Catalog of Federal Domestic Assistance – Educational Facilities 

http://www.cfda.gov/public/browse_sub.asp?subcode=GC, Grants.Gov http://www.grants.gov, 

Title III Part B, Strengthening Historically Black Colleges and Universities Program http://www. 

ed.gov/programs/iduestitle3b/index.html, and the U.S. Department of Education Grants and Contracts 

Information http://www.ed.gov/topics/topics.jsp?&top=Grants+%26+Contracts. Additional 

resources include the Historically Black Colleges and Universities Historic Building Restoration 

and Preservation Act http://thomas.loc.gov/, the National Science Foundation Opportunities 

for research and education funding in all areas of science and engineering http://www.nsf.gov/, 

and the Department of Defense annual Broad Agency Announcements for the Historically Black 

Colleges and Universities at http://brin.sc.edu/army.asp. The National Institute of Health (NIH) 

Cooperative Agreements for building capacity at HBCUs and information to enhance the careers 

of research scientists may be found at http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-98-005. 

html. Health and Human Services programs include Research and Demonstration Grants for Universities 

(HBCUs) and the Health Services Research Grant Program to support HBCU research 

at http://www.cms.hhs.gov/researchers/priorities/grants.asp. The NSF Historically Black Colleges 

and Universities-Undergraduate Program (HBCU-UP) at http://www.nsf.gov/funding/pgm_ 

summ.jsp?pims_id=5481, the Louis Stokes Alliances for Minority Participation (LSAMP) Program 

at http://www.nsf.gov/funding/pgm_summ.jsp?pims_id=5477, and the HUD HBCU Program at 

http://www.hud.gov/progdesc/hbcu.cfm are also excellent resources. 


RESOURCES FOR HISPANIC SERVING INSTITUTIONS (HSIs) 

Papers 

Federal agencies are a major source of funding for MSIs. The federal government supports research 

and development and other higher education activities such as infrastructure, equipment, 

funds that support partnerships between higher education and community economic development. 

Significant dollars flow from the federal government to state agencies and find their way to 

IHEs. Additionally, special earmarks are awarded and many grant opportunities are available from 

several federal agencies. 

Specifically, for HSIs the major source of funding is from the Department of Education Title V 

appropriation. In 2005, $125 million was made available to support undergraduate education 

at HSIs. The request for 2006 is $175 million. While the Department of Education is the major 

source of federal funds for HSIs, it is not the only source. Other federal agencies, such as the U.S. 

Department of Agriculture (USDA), the U.S. Department of Housing and Urban Development 

(HUD), the Department of Defense (DOD), the Department of Health and Human Services within 

the National Institutes of Health (NIH), the National Science Foundation (NSF), and NASA, 

award money to HSIs through competitive grants, line items, and other funding mechanisms. 

Though considerable ground has been gained through intensive lobbying in the past several years, 

the effort must continue. HACU’s annual Capitol Forum has been invaluable in getting the word 

to Congress. This effort, along with HACU’s government relations office in Washington, D.C., is 

making a difference. HACU will continue to press on with a very aggressive legislative agenda. 

Legislation like the “next Generation Hispanic-Serving Institutions Act” co-sponsored by Senator 

Jeff Bingaman (NM) and Senator Kay Bailey Hutchison (TX) targets Hispanics to pursue baccalaureate 

degrees as well as graduate degrees. The Hispanic voice is being heard in Washington and 

there is optimism that federal funds will be more readily available to the more than 200-plus HSIs. 

The most significant current sources of funding include the U.S. Department of Education – Titles 

II, IV, V, and VI. There are literally thousands of foundations in the U.S., and many more throughout 

the world, with resources for specific purposes. Many foundations give in special areas like 

the arts and humanities, civic and public affairs, and research. Within these categories, grants are 

made to a variety of entities from state government agencies, public schools, non-profit organizations 

and many other types of agencies representing various groups. One only needs to think of a 

specific cause, i.e., getting youth involved in golf, and you will find a foundation that supports this 

type of activity. The Tiger Woods Foundation is but one example. 

Many foundations spread their wealth in many different ways. A certain percent may be set aside 

for higher education that addresses very specific priorities--math and science, for example. A 

percent of the foundation holdings may be set aside for civic and public affairs, arts projects or 

humanitarian efforts. Development officers and presidents of MSIs, specifically those of HSIs, need 

to identify foundations that prioritize giving to Hispanic Serving Institutions and that also have a 

history of giving for a variety of projects. For example, the Hispanic Scholarship Fund awards over 

$31 million annually in scholarships to deserving Hispanic college-bound students. The Coca- 

Cola Company awards over $37 million annually to many higher education institutions, including 

many MSIs/HSIs, for a variety of projects. Some foundations will only sponsor /support projects in 

their own state and for very special groups, i.e., Native American populations. Many foundations 

will only give seed money. Some foundations require matching funds, while others will fund entire 

projects. Some are for a single year, while others may be for multiple years. HSI leaders and their 

development officers must narrow the foundation field to those foundations that identify Hispanic 

affairs as a priority and that have a history of supporting HSIs. 


Papers 

There are key databases available to assist institutions in narrowing their searches and in identifying 

key foundations that are high-likelihood targets from which to request support for HSIs. The 

world of foundations is huge and competitive. Some foundations like the W.K. Kellogg Foundation 

and the Ford Foundation have millions to give, while others like the United Latino Fund may only 

have thousands available. One of the most important first steps is for HSI presidents and development 

staffs to identify several key foundations, visit with them, get to know their key decision 

makers, invite them to the campuses, tell them about the need, and have them meet students and 

faculty. It is important for the HSI to tell its story, and show the foundation why investing in the 

institution is a good idea. Show the potential funding source some accomplishments and demonstrate 

how the funds will take successful projects to the next level. 

RECOMMENDATIONS 

1. Simple Model for External Resources Acquisition and Management 

Student tuition and fees are primary sources of institutional funding; whether provided privately, 

federally, through scholarships, or other means. Presently, most public higher education institutions 

are supported only in part by State allocated funds. Many of the MSI do not have large 

amounts of gifts and donations as compared to institutions such as Harvard and MIT or even the 

more well-off MSIs such as Howard and Xavier. Considering the multitude of resources available 

from the federal government, foundations, states, corporate organizations, and local organizations, 

and even considering the large amounts of resources available only to HBCUs and MSIs, 

many MSIs do not have the infrastructure, monies, technology, or other resources to acquire such 

resources. Normally, and irregardless of the greatest need, larger amounts of legislative funds are 

designated for the larger flagship schools as compared to small or moderate size MSIs. Very few 

MSIs have participated in the sale or licensing of intellectual property and even fewer have reaped 

the benefits of these commonly large amounts of resources. Similarly, many MSIs do not participate 

in the contract versus grants processes available from numerous funding organizations. With 

these concerns in mind, MSI presidents find themselves in an even greater position to identify, 

acquire, manage and perform, and close out external resources appropriately. 

The simple model for incoming external resources and the required management and performance 

suggests that institutional components should be in place for resource needs assessments, 

resource identification, resource acquisition, resource management and performance, and resource 

close-out. The need for MSI institutional protection components regarding the external 

resources that are acquired is of great importance. 


All incoming resources and the required management and performance regarding such resources 

may be referred to as X. Therefore, mathematically we may write 

X=All incoming resources + All required management and performance 

Regarding external resources and sponsored programs, the term X may be further defined 

mathematically as 

X = A + B + C + D + E + F 

where 

A=needs assessments + mission + vision + strategic directions 

B=appropriate grantsmanship 

C=resource identification OR project/program need… 

D=resource acquisition 

E=appropriate management + performance + assurances + certifications + reports… 

F=appropriate close out + record maintenance 

Since D is defined as resource acquisition, we may further define D as 

where 

D=a + b + c + d + e + f + g + h + i 

Papers 

a=student tuition and fees 

b=state allocated funds 

c=gifts and donations 

d=externally sponsored programs including research 

(+overhead +salaries + personnel + consultations +acquired property and other 

resources) 

e=other generated funds 

(fund raisers+auxillary+capital campaigns+annual giving+planned giving+etc.) 

f=legislative funds 

g=intellectual property sales or licensing 

h=partner’s resources (money, facilities, personnel, equipment, student/faculty development, etc.) 

i=contracts 

The simple model poses a possibility for greater success a) because the model is very simple, and 

b) because the model addresses the parameters described throughout this paper for appropriate 

external money and resource acquisition and management. 


Papers 

2. Basic Institutional Components for Research and Sponsored Programs Administration 

The National Council of University Research Administrators and the Society for Research Administrators 

International has prepared the “Topical Outline of the Essential Elements of Research 

Administration” (1998) which addresses Research Administration – The Profession, Infrastructure 

– The Framework for Research, Project Development – The Pre-Award Stage, Project Administration 

– The Post-Award Stage, and the Public Responsibility – Fulfilling the Public Trust. The National 

Association for Equal Opportunity in Higher Education (NAFEO) Kellogg Foundation Minority 

Serving Institution (MSI) Leadership Fellowship Program provided opportunities to attend 

training activities and workshops with information presented predominantly by present and past 

MSI presidents. Several major training activities and workshops involved MSI finance and budgetary 

management and external resource acquisition. Suggested components for external resource 

acquisition and research administration include research vision and strategic planning, mission, 

function, research or external resources, research and development planning, an evaluation plan, 

methods for increasing research or external resource capacity, increasing general capacity, internal 

programs, external programs, certifying capabilities, research culture and values, performance 

indicators, funding for professional development, foundation, corporate, and industry fellowships, 

additional federal, state, and local funding, sabbaticals, mini grants, plan execution, and express 

the win-win-win proposition. The NAFEO and Kellogg Foundation web sites are www.nafeo.org 

and www.wkkf.org. 

3. Use the information in this paper as a tool for appropriate money and resource acquisition and 

management. 

CONCLUSION 

This paper presented various methods of generating and managing resources and monies for 

MSIs. The generation of resources and monies is generally a result of student enrollment, foundation 

and grant activities, legislative appropriations, gifts, donations, and auxiliary income, and 

campaigns. The management of resources and monies generally involved financial and budgetary 

activities and entities associated with MSIs such as accrediting organizations, federal, state, and local 

requirements, and higher education associations. This paper presented a multitude of resources 

which may be used by MSI research and sponsored programs administrators and presidents to 

identify required money and resources as well as to manage and close-out financial resources 

and activities. The information presented in this paper is a useful tool for the tenures of new and 

seasoned MSI presidents. 

Working Bibliography 

1. Classic CURRENTS: Campaigns (2002). CASE. 

2. CASE Report of Educational Fund-Raising Campaigns: 2002-2003. (2004) CASE. 

3. Gearheart, D.G. (1995). The Capital Campaign in Higher Education. CASE. 

4. Kihlstedt, A. (2002). Capital Campaigns: Strategies that Work (2nd Edition). CASE. 

5. Pettey, J.G. (2002). Cultivating Diversity in Fund Raising. CASE. 

6. Quigg, Jr., H.G. (1986). The Successful Capital Campaign: from Planning to Victory 

Celebration. CASE. 

7. Shafritz, Jay M. (2004, May). Federal Government Grants: No Free Lunch, Part I: The truth 

about federal grants [Electronic version], American Government & Politics, U.S. Government 

Information/Resources, usgovinfo.about.com. 


Papers 

8. Federal Grants News for Colleges and Universities (December 2003/January 2004). NIH Revises 

its Grants Policy Statement, National Council of University Research Administrators and 

the National Association of College and University Business Officers. 

9. Webster’s Ninth New Collegiate Dictionary (1990) Merriam-Webster Inc. 

10. Calabrese, Paul H., and Gellman, Michael (2003). Understanding Federal Grants for Not For 

Profits, Rubino & McGeehan, ISG Solutions. 

11. National Council of University Research Administrators and the Society of Research Administrators 

(1998). NCURA/SRA Topical Outline of the Essential Elements of Research Administration. 

12. The Grantsmanship Magazine (2003). Issue #51, Fall 2003 

13. U.S. Department of Justice (2002). Application Kit, Office of Justice Programs, Bureau of Justice 

Assistance, BJA Discretionary Grants. 

14. U.S. Department of Education (2001). Education Department General Administrative Regulations 

(EDGAR), Title 34 Code of Federal Regulations Parts 74-86 and 97-99, March 5, 2001 

edition. 

15. Chronicle of Higher Education (2004). Harvard University Fined for Improperly Charging 

Against Federal Grant, Compliance News, Case Western Reserve University, Research Newsletter, 

June 2004. 

16. Chronicle of Higher Education (2004). Compliance News, Case Western Reserve University, 

Research Newsletter, March 1, 2004. 

17. Whitman, Michael E. and Mattord, Herbert J. (2003). Principles of Information Security, 

Thompson Course Technology, Boston, Massachusetts. 

18. New Orleans Conference on State and Federal Personnel Laws (2004). Human Resource 

Council, New Orleans, Louisiana, July 22. 

19. University of California (1995). Costing policy & analysis, Research and Administration Office, 

Memo: Operating Guidance, No. 95-12, October 20. 

20. CNN (2003). Hampton University Loses Journalism Funding [Electronic version], CNN.com, 

November 12. 

21. Associated Press (2003) Financial aid error could cost Mankato university $700,000, Star Tribune, 

Published November 7. 

22. Workplace Substance Abuse Advisor (2004). Lawsuit stemming from student study settled for 

90,000, LRP Publications, Vol. 18, No. 12, May 13. 

23. Chronicle of Higher Education (2004). Northwestern U. Pays Fine for Animal-Research Violations, 

Vol. 50, Issue 19, January 16. 

24. British Medical Journal (2003). University is criticized for accepting tobacco money, BMJ, Vol. 

326, Issue 7388, March 8. 

25. Associated Press (2003). Lax Security Fount at Many College Labs, November 21. 

26. New York Times (2003). Fund Scandal Puts College Saving Plans on Alert, November 23. 

27. Teamer, Charles C. Sr. and McDemmond, Marie (2004). What Every New College President 

Should Know About Finance and Finance and Management, NAFEO Fellows Leadership 

Session, New Orleans, LA on October 23. 


Papers 

The Utility of Gender, Race, and Ethnicity Reporting in Clinical Trials as an 

Indicator of Distributive Justice 

Paula Bistak, RN, MS, CIP 

Joseph Cosico, RN, MA, CCRC 

Atlantic Health System 

Office of Grants and Research 

95 Madison Avenue, Suite 303 

Morristown, New Jersey 07962 

(973) 971 -7060 

paula.bistak@ahsys.org 

Author’s Note: Special thanks to Carol Soricelli for data review assistance and to Christine Asmann-Finch 

for unprecedented moral support. 

Abstract 

The evolving interpretation of what is responsible conduct of research demands that the research 

community continually examine its practices, policies, and quite possibly the very values upon 

which it is founded. Justice, one of the fundamental ethical principles upon which all human 

subject research must be evaluated, perhaps remains the most subjective consideration for Institutional 

Review Boards (IRBs). 

The paper briefly describes the attempt of the Atlantic Health System, an independent academic 

medical center in New Jersey, to ensure its protocol review process adequately addresses issues of 

justice and that selection of subjects is equitable. 

Introduction 

“Who ought to receive the benefits of research and bear it burdens?” Even before the National 

Commission for the Protection of Human Subjects of Biomedical and Behavioral Research posed 

this question of justice in its monumental treatise The Belmont Report in 1979, the awareness 

of the societal inequities of research participation was impacting the public consciousness. The 

exploitation of vulnerable subsets of the population was evident in highly publicized exposes such 

as the Tuskegee experiments involving poor, black men from the rural South; the Willowbrook 

State Institution hepatitis viral experiments on children with mental impairments; and the tragic 

Thalidomide treatments for pregnant women. 

History demonstrates while the burdens of human subject research fell largely on the poor and 

vulnerable populations, the benefits of such research were enjoyed by the wealthy and powerful 

segments of society. (Amdur, p156) This “injustice” of unequal distribution of risks and benefits 

prompted federal regulators to impose additional protections for vulnerable populations most at 

risk for exploitation. In 1977, the Food and Drug Administration (FDA) issued guidance excluding 

women of childbearing potential from participation in early studies of new drugs. Department 

of Health and Human Services (DHHS) 45 CFR Part 46 Subparts B, C and D deal with specific 

additional requirements for conducting research with pregnant women, prisoner, and children 

respectively. 


However, while these protections sought to remove undue burdens from vulnerable populations, 

much important scientific information was lacking concerning the variability of effects of many 

therapies and drugs on women, children, and even some ethnic populations. An intrinsic conflict 

exists between ensuring that research benefits are equitably distributed and protecting vulnerable 

populations (Amdur, p156). In an attempt to offset these access disparities, in 1994 the National 

Institutes of Health (NIH) issued its formal policy and guidelines requiring the inclusion of 

women and minorities in clinical research. To assure compliance, the policy requires that federally 

funded research protocols must describe the sexual and racial/ethnic composition of the proposed 

study population. 

The administrative body empowered to monitor the conduct of research with human subjects is 

the Institutional Review Board (IRB). One of the essential responsibilities assigned to IRBs when 

determining whether a research study is approvable is “the examination of issues of justice and 

the determination that the selection of subjects is equitable (45CFR46.111).” While, participation 

of vulnerable populations in research requires additional mandatory protections, IRBs also are 

instructed not to overprotect to the extent that vulnerable populations are systematically excluded 

from the benefits of research (OHRP Guidebook, Chap III). As part of their assessment as to the 

equitable selection of subjects, the IRB committee is to take into account “the purposes of the 

research and the setting in which the research will be conducted” (OHRP Guidebook, Chap III). 

In compliance with the NIH directive Atlantic Health System (AHS) has been collecting subject 

composition information for its research studies involving human subjects. However, how or if 

this aggregate data required by the NIH should be considered by the IRB as part of their determination 

that justice has been satisfied has not been fully explored. 

Does this exercise of required reporting support equitable inclusion in research trials? What is the 

utility of gender, race, and ethnicity reporting in clinical trials? Can it be a mechanism to support 

distributive justice or does it falsely lead to the supposition that equal access automatically translates 

into equitable distribution? 

Background 

Papers 

One of the AHS research coordinators was following up on a request from a sponsor and 

queried the IRB office, “Do you know the racial and ethnic breakdown of enrollment in research 

for AHS?” At the time our “homegrown” database did not record this information, although as 

directed by the NIH guidelines, this information was collected for individual research studies during 

the time of continuing review and was available in each study file. The coordinator request was 

therefore not fulfilled; however, it prompted much discussion and attention to the need for our 

organization to have a better understanding of who was enrolling in our research studies and how 

well they represented the community we served. 

With the help of a research intern, the AHS Office of Grants and Research created a 

database including the demographic information of enrollees in all research trials throughout the 

system. For comparison, we gathered census information from our catchment area and race/ethnicity/gender 

reports from each of our member hospitals. Our plan was to evaluate whether or not 

we were serving the principle of justice by a simple equation: if our percentage of minority/gender 

enrollment in research matched in equal proportion our institutional data about the public we 

served, then our research enrollment was equitable. Or was it? 


Papers 

As a three hospital health care system, the demographics of the populations that AHS 

serves are very different. Morristown Memorial Hospital is in Morris County whose minority 

population is 18% of the total, whereas Overlook Hospital is in Union County with a 46% minority 

population and Mountainside Hospital is in Essex County with the highest number of minorities 

representing 62% of the total of that county’s population. A cursory glance at the enrollment 

numbers was all that we needed to see that, while the participation of women in our studies was 

reflective of our population, our minority participation was low – lower than we expected. But, we 

rationalized, the IRB had always reviewed the application and protocol noting that inclusion and 

exclusion were properly outlined and if a study might serve a non-English speaking population, 

the consent form would be duly translated. 

Before our Human Subject Protection Department began a zealous campaign to improve 

our minority participation numbers, a more thorough understanding of why our enrollments were 

unsatisfactory was necessary. The issue before us certainly was deeper than just a mathematical 

equation. It was more than merely developing a simple tool for the IRB to check off a box to document 

that all regulations had been met. What follows is a discussion of some of the basic concepts 

we began to explore as we sought to better understand this principle of justice. 

What is Fair? What is Equitable? 

The underlying premise of the NIH directive is that it is unfair for minorities or women 

not to be represented in research. It infers that fairness is measured by distribution. “The term distributive 

justice refers to fair, equitable, and appropriate distribution determined by justified norms 

that structure the terms of social cooperation” (Beauchamp, p 226). While, there may be several 

possible goals of minority inclusion in research (Corbie-Smith), there is general agreement that 

overcoming disparities in research would have a positive effect in overcoming specific minority 

healthcare disparities as well. 

But looking to reporting mechanisms as measurement of this inclusion is problematic. 

Do we, as was our initial inclination, expect the percentage of minorities in our research studies 

to mirror those of our community? This negates the importance of looking at the disease process 

itself. For example, African American males have a much higher incidence of prostate cancer than 

white males. The New Jersey aged-adjusted incidence rates for 2000 were 191.4 per 100,000 white 

men and 281.4 for African American men and the age-adjusted prostate cancer mortality rate 

among African American men was 2 ½ times the rate for white men (Center For Health Statistics, 

2003). Thus a one to one match would still indicate a glaring disparity. 

In addition, looking only at enrollment numbers retrospectively gives a snapshot of what 

is happening at an institution, not necessarily what should be happening. It is important to view 

the NIH directive from at least two perspectives: 1) minorities should be represented in the studies 

that are offered by an institution and 2) research institutions should be offering studies that address 

the unique needs or interests of minority populations. A community member from the IRB 

of the University of Medicine and Dentistry NJ speaking at one of their recent conferences, while 

praising the many contributions to science of the institution, challenged the group asking for more 

research on the infectious diseases that ex-prisoners and drug addicts are bringing back to the 

streets. He continued, noting that practically every home in Newark has a nebulizer, that there is 

an imperative need for more asthma studies in his community. 


Our IRBs may carefully look for selection bias in the enrollment of our studies, but race 

and ethnicity are largely socio-political concepts and the label “minority” may carry assumptions 

and stereotypes rather than reflecting the inequitable power relations within our society. How does 

an IRB determine whether there is a selection bias inherent to our study designs or offerings? Can 

an IRB be expected to be knowledgeable about all the specific health disparities in the community 

it serves? 

Beyond the IRB 

There is an expectation that it is an institution’s IRB that sets the barometer for the ethical 

conduct of research. However, the current IRB review of protocols for equitable subject selection 

is study specific. That is, the IRB reviews the ethical merits of the study at hand not whether or 

not the institution should be involved in other studies that may be more attractive or meaningful 

to minority populations. IRBs have the authority to “review and approve, require changes in, 

and/or disapprove proposed research.” But they are not expected to make recommendations to 

investigators as to what studies they should be conducting to better accommodate the needs of the 

community. This is a responsibility that must be shared by the research office or, more generally, 

the institutional administration. Since it is often there that the broader strategic plans for research 

endeavors are discussed and implemented. 

The Office of Sponsored Programs/Office of Grants and Research is by design the first 

place that equitable enrollment should be analyzed. For it is here that enrollment numbers are 

measured against projections and investigators negotiate for support for future projects. The data 

represented in the NIH tables might be utilized better by decision makers at this level rather than 

assuming it is the IRB that is the sole advisor. 

Conclusion 

Papers 

Ensuring that our research studies are fair and equitable requires considerably more 

exploration and discussion than mentioned here. However, acknowledging that this responsibility 

for equitable research is not an exclusive goal, an institution can support efforts towards ensuring 

distributive justice from the very inception of a research study. 


Papers 

References 

Amdur, R., Bankert, E. (2002) Institutional Review Board Management and Function. 

Sudbury, MA: Jones and Barlett Publishers 

Beauchamp, T., Childress, J. (2001) Principles of Biomedical Ethics. New York, Oxford 

University Press. 

Center for Health Statistics, State of New Jersey. (2003) Monthly Health Data Fact Sheet. 

http://www.state.nj.us/health/chs/monthlyfactsheets/sept03prostate.pdf. 

Corbie-Smith G. St. George DMM, Moody-Ayres S. & Ransohoff DF. (2003) Adequacy of 

Reporting race/ethnicity in clinical trial in areas of health disparities. Journal of Clinical 

Epidemiology 2003: 56: 416-20. 

National Institutes of Health. National Commission for the Protection of Human Subjects of 

Biomedical and Behavioral Research. (1979) The Belmont Report. Bethesda, Maryland. 

Department of Health, Education, and Welfare. 

Office for Human Research Protections. Institutional Review Board Guidebook. 

http://ohrp.osophs.dhhs.gov/irb/irb 


Abstract 

Creating A Community of Research Administrators 

Stephen W. Brabbs, BA, MS 

Division of Research Development and Administration 

University of Michigan 

3003 South State Street 

Ann Arbor, Michigan 48109-1274, USA 

stewalt@umich.edu 

Sally E. Sivrais, BA 

Stephen M. Ross School of Business 


701 Tappan Street 

Ann Arbor, MI 48109-1234, USA 

sivrais@umich.edu 

Carrie Disney 

Institute of Gerontology 


300 North Ingalls Street 

Ann Arbor, MI 48109-2007, USA 

cdisney@umich.edu 

The University of Michigan, along with most other major research universities in the country, 

experienced a number of significant changes in the 1990’s. These changes, which include dramatic 

growth in research volume, advancements in technology, and increased regulatory and compliance 

requirements have had a profound impact on the administration of the research enterprise. 

Research administrators received very little specialized training and frequently worked in isolation 

with time pressures and with policies they often were not aware of but were expected to follow. 

To respond to both internal and external changes, a core group of senior leaders at the University 

decided to develop integrated programs to expand research administration, education, and training; 

foster professional identity among research administrators; and nurture a sense of belonging 

within the research community. This paper outlines steps taken to build a research community 

and discusses efforts to sustain the culture. Interlocking activities have been put into place based 

on the fundamental principals of how people learn (Beckhard & Pritchard, 1992) and the process 

of creating change (Kotter, 1995). These efforts have developed a community which emphasizes 

education, recognition, and collaboration. 

Background 

Papers 

During the last fifteen years, the following factors have had an impact on the research enterprise at 

the University of Michigan. 


Papers 

• Dramatic Growth in Research Volume 

The University of Michigan’s research volume in fiscal year 1994 was $386 million and is projected 

to be $804 million in fiscal year 2005. This dramatic growth placed an increasing burden on central 

level administrators and led to the increase of unit level staff. As the research funding levels 

grew, workloads grew, as did individual frustrations. 

• Technological Changes 

The University of Michigan has seen significant changes in the use of technology and software 

in managing research and other institutional administrative functions. The Internet, a multi-tier 

remote computing application database (Peoplesoft), and electronic grant submissions all have 

affected day-to-day grant management. These changes have necessitated the distribution of many 

central research administration functions to the unit level. This decentralization created a significant 

need for training and communication among unit level administrators. 

• Regulatory and Compliance Environment 

From A21 to human subjects to export controls, the environment of sponsored research regulation 

has changed dramatically in the last decade. The government’s improved ability to track compliance 

(enhanced by its own use of improved technology) and the addition of new regulatory/compliance 

requirements has greatly impacted research administration. Research administrators at 

all levels need to be more educated about a wider variety of regulations and act as educators and 

enforcers of those requirements close to where the research is being performed. 

• Decentralized Operating Environment 

The University of Michigan has a fairly decentralized operating environment for research administration. 

At the unit level over 800 staff are involved in the day-to-day administration of research. 

According to Jim Randolph, the Senior Associate Director of the Division for Research Development 

and Administration (DRDA), the University’s philosophy for research administration is “to 

surround the principal investigators with well-trained unit level administrators who manage the 

administrative details and allow the investigator to focus on the science.” The central offices: Office 

of the Vice President for Research (OVPR); Division for Research Development and Administration 

(DRDA); and Financial Operations, Sponsored Programs Office (SPO) are the focal points for 

sponsored projects administration. 

The Impact of Change 

These changes created a critical need for education, training, and a professional community in 

research administration at the University of Michigan. Due to the growth of research, many people 

without grant management experience became involved in research administration. They required 

education and training to effectively assume their new roles. 

The University of Michigan’s Response 

Senior leadership in OVPR, DRDA, Financial Operations, and several units across campus recognized 

the impact of the change and decided to take action. They embarked on an integrated strategy 

to improve the research administration environment at the University of Michigan. This strategy 

was comprised of four components: 1) creating education and training programs; 2) building a 

sense of community among research administrators; 3) creating cross functional problem solving 

teams to build a more collaborative environment; and 4) developing programs for recognition to 

foster professional identity. 


• Education and Training 

A guiding coalition from central and unit level administration was formed in 1997 to develop the 

Research Administrators Instructional Network (RAIN). It spent two years refining the curriculum, 

a process which involved over 100 colleagues. RAIN training is offered three times a year 

and participants are required to make a four week commitment – a full day of training each week. 

While nearly 75 applications are received for each session, only 24 research administrators are 

selected for attendance. Since its inception in 1999, more than 400 research administrators have 

completed the RAIN program. It is increasingly common for research administration job postings 

at the University of Michigan to list RAIN training as a desired qualification. The current RAIN 

program agenda follows. 

Introduction: The Research Administration Environment 

Ethics and Compliance 

Electronic Research Information Resources 

Proposal Development, Budgets and Submission 

Initiation and Financial Administration of Projects 

Human Resources Management 

Working with Industry Sponsors 

Media Relations and Research 

Papers 

During the four day program, up to thirty central and unit administrators present topics. In addition 

to the benefits of the comprehensive agenda, a sense of community and collaboration is 

encouraged by scheduled group lunches with the presenters and others in central administration. 

In 2001 DRDA allocated funds to create a dedicated staff position to manage education and training 

programs and advance DRDA’s educational goals. This individual identifies training needs, 

oversees the development of new programs, and coordinates program delivery for the research administration 

community. In addition to the advancements in education and training, the existence 

of this position has been instrumental in creating an open environment for ideas and implementing 

programs in direct response to both central and unit administrator’s concerns. 

DRDA and Financial Operations have also collaborated to create additional training programs for 

new and experienced research administrators. Currently, fifteen programs, ranging in topic from 

proposal development to budgets and financial administration, are offered regularly. As of 2004, 

enrollment in these programs totaled over 1,900. 

• Creating a Sense of Community 

Michigan established the Research Administrators Network (RAN) in 2001. The Network is meant 

to provide continuing education in the area of research administration and enable unit administrators 

to interact with each other and leaders in central administration. A planning committee, 

made up of mostly unit administrators, sets the agendas for the quarterly meetings. The meetings 

include an educational topic, as well as updates critical to the Michigan research community. Thus 

far, fourteen RAN meetings have been held with an average attendance of 250. The meetings have 

become an effective and enjoyable tool for sustaining the sense of community in research administration 

at Michigan. 

A website has been created, RAN Online, to provide a place where research administrators can 

share documents, templates and ideas that may be of use to their colleagues. A web-based research 

administrators’ “Toolkit” was developed to assist research administrators to quickly locate information 

related to their jobs (www.research.umich.edu/ralinks/index.html). 


Papers 

• Cross Unit Collaboration and Problem Solving 

In October 2001, the Sponsored Programs Implementation Team (SPIT) was commissioned for 

two years to develop improvements in pre- and post-award research administration. Specifically, 

SPIT was charged to validate a list of issues and priorities, to complete a situation analysis, and to 

deliver solutions. Many of these issues related to making central administration more responsive 

to the needs of unit administrators. Others focused on maximizing the value of the new financial 

system (PeopleSoft). SPIT was a cross-functional representation of research administrators from 

the University of Michigan’s central and unit level administration. Its main areas of focus were: 

Financial Reporting 

Project Administration 

Project Initiation 

Organization/Communications 

The SPIT model has created new leadership opportunities for unit research administrators. After 

SPIT’s commission ended, a “Sponsored Projects Advisory Team” (SPA Team) was formed. The 

SPA Team’s basic purpose is to identify emerging issues, evaluate them, recommend solutions, and 

monitor their progress after changes are implemented (www.spateam.umich.edu). 

These types of team efforts have set the standard for collaboration between unit research administrators 

and staff in central offices. The communication and, in some instances, turf barriers which 

once hindered problem solving are being overcome with the use of the SPIT model. It has also had 

the effect of making staff in all units feel a sense of collective support and responsibility, which 

now defines the research community at Michigan. 

• Recognition Programs 

As part of the strategy to elevate and recognize professional research administration at Michigan 

the Office of the Vice President for Research (OVPR) established the annual Distinguished Research 

Administrator and OVPR Exceptional Service Awards in 2001. Nominations are requested 

campus-wide. 

The Distinguished Research Administrator Award honors individual staff members from any unit 

at Michigan who have demonstrated over a number of years distinguished service exemplifying 

the goals of professional research administration. The OVPR Exceptional Service Award honors 

individuals or teams involved in any area of research administration work who have made outstanding 

contributions which go beyond the ordinary fulfillment of the position’s duties. Each 

winner receives an honorarium and an award plaque. 

The Results 

The University of Michigan has created a recognizable professional community, which can be used 

as a model for other internal professional groups. Research Administrators Instructional Network 

(RAIN) education and training programs are effective in building skills and knowledge. Research 

Administrative Network (RAN) meetings have provided a gathering place for the community. The 

emphasis on networking has also created an environment where administrators are more comfortable 

communicating with their peers to share information and to problem solve. The cross-functional 

problem solving teams (SPIT & SPA) have had a dramatic impact, not only by creating and 

implementing solutions to issues affecting administrators, but also by serving as a model for the 

process of crossing boundaries to solve problems. The Office of the Vice President for Research 

(OVPR) awards brought university-wide recognition to the contributions of research administrators. 


The Future 

Michigan continues to refine its vision of a community of professional research administrators. 

New approaches are being developed for future success. Educational programs are created on an 

on-going basis. A new leadership development program is currently being designed to prepare the 

next generation of research administration leaders. The Sponsored Programs Advisory Team is 

getting ready for a transition to new leadership and membership. New sub-teams are being created 

to address specific complex issues. There is positive energy in the research community, making 

progress sustainable. 

The strategy for building a research community has transformed research administration at Michigan. 

It is a model which could bring success to other colleges and universities that are responding 

to internal and external changes. 

References 

Beckhard, Richard, & W. Pritchard. (1992). Changing the Essence: The Art of Creating and Leading 

Fundamental Change in Organizations. San Francisco: Jossey-Bass Publishers. 

Kotter, John P. Leading Change. Boston: Harvard Business School Press, 1995. 

Papers 


Papers 

The Development, Implementation and Evaluation of a 

Prospective Research Monitoring Program 

Philip A. Cola, MA, Principal Author 

Center for Clinical Research 



Cleveland, OH 44106, USA 

(216) 844-5568 

Philip.Cola@uhhs.com 

Carol Fedor, ND, CCRC, Co-Author 





(216) 844-5568 

Carol.Fedor@uhhs.com 

and 

Louise Haffke, RN, MPH, Co-Author 





(216) 844-5568 

Louise.Haffke@uhhs.com 

Authors Note: 

The opinions in this paper are those of the authors and do not reflect the official policy of the Center 

for Clinical Research, University Hospitals of Cleveland. Mr. Philip Cola is the corresponding 

author and can be contacted as above. 

Abstract: 

Historically, monitoring of clinical research predominantly occurred in industry-funded studies 

through which Clinical Research Coordinators (CRCs) and Principal Investigators (PIs) were 

audited by external sponsor-provided “monitors”. The purpose of this paper is to evaluate preliminary 

results of an internal pilot prospective monitoring program. This program was developed 

and implemented to proactively enforce responsible conduct of research, to monitor the informed 

consent process, to serve as a support service to CRCs and PIs, to ensure clinical research data 

integrity, and to investigate overall research compliance. This program differs from the historical 

monitoring model in its prospective informed consent monitoring, its internal implementation 

and relationship to the Institutional Review Board (IRB) for compliance matters, its attempt to 

proactively improve data integrity, and its potential to monitor clinical research that is not currently 

audited (i.e., certain Federally or Foundation-sponsored or investigator-initiated trials). 


Data results will evaluate the impact of internal prospective monitoring on human subject protections 

and data integrity by virtue of quality improvement activities. Furthermore, internal prospective 

monitoring will provide an opportunity through which the “compliance monitor” may 

evaluate non-compliance trends and identify needed areas of continuing research education for 

CRCs and PIs which promotes the responsible conduct of research. 

Introduction: 

Papers 

The various roles of research administrators have become increasingly broad as this discipline 

moves toward continued professionalization. Research administrators are responsible for the legal, 

fiscal, ethical, scientific and compliance reviews of protocols from their inception and that responsibility 

continues beyond protocol or grant completion. In the past, research administrators were 

viewed as predominantly grant or IRB administrators. The profession has grown and currently 

research administrators include grant writers, CRCs, human subject protection and compliance 

specialists, investigator support personnel and research billing professionals. This development has 

lead to increased awareness and understanding of the crucial roles that research administrators 

play in the conduct of both basic science and clinical research. 

A particular area that has gained considerable momentum recently has been the role of the clinical 

research compliance monitor or specialist. Similar to other academic or business specialties, the 

process of conducting clinical research is heavily monitored and historically this monitoring has 

been performed by external sources (i.e., the sponsor, contract research organization, or Federal 

agencies). During the past decade it has become evident that relying solely on external monitoring 

is insufficient to maintain the responsible conduct of research in light of the tremendous growth in 

clinical research during this period in the United States. Not only has Federal funding for research 

doubled in the past decade, but from 1997 to 2000, the estimated number of participants in Federally 

funded research increased from 7 million to 12 million. Non-Federally sponsored research has 

grown at a similar pace (Slater, 2002). 

These trends have driven the desire and need to create internal research compliance monitoring 

functions in an effort to improve research programs and to provide supportive services to investigators 

that allow them to conduct clinical research effectively. Some institutions have developed 

these programs in response to specific compliance findings discovered by external monitoring 

activities (Steinbrook, 2002a). Such shortcomings in Human Subject Protection programs at major 

institutions should serve as a catalyst for all institutions, researchers and IRBs that are charged 

with not only promoting clinical advances, but first and foremost, protecting the human subjects 

involved in the process (Shalala, 2000). 

Additionally, the continuing education of research administrators and institutional officials make 

it clear that internal compliance auditing programs that proactively monitor clinical research at 

the institution are necessary. Research institutions must commit to regular and routine internal 

auditing of all research activities. Critical self-examination can bring to light weaknesses and other 

issues before significant errors occur (Icenogle, 2003). 

It is believed that in order for research compliance programs to be effectively related to other areas 

of research administration (i.e., the administrative functions of an IRB and grant accounting), the 

compliance programs should be established in Offices of Sponsored Projects at Universities and 

Clinical Trial Offices of the Hospital arms of Academic Medical Centers (AMCs). Research compliance 

monitoring is not merely a routine monitoring function of these types of institutions, but 

rather a specialized monitoring function that enhances the overall research administration effort. 


Papers 

Background: 

IRBs in AMCs have oversight for a tremendous amount of human subject research. Over 

the past six years detailed descriptive statistics have been maintained at University Hospitals of 

Cleveland (UHC) through an IRB database related to the total number of protocol actions taken 

by the UHC IRB on an annual basis (see Table 1). The data indicate a 29% growth rate in the 

amount of research reviewed from 2000 through 2005 which is a direct result of continued increases 

in grant funding to the institution. It is from such trends that IRBs come under increased 

scrutiny and pressure as the key component of the Human Research Protection Program (HRPP). 

Furthermore, in June 1998, the Office of Inspector General of the Department of Health and Human 

Services issued four investigative reports, which indicated that IRBs have excessive workloads 

and inadequate resources (Shalala, 2000). The inadequate resources included insufficient staff, 

expertise, space, and equipment such as databases. 

It is still difficult to completely ascertain the accuracy and impact of these reports on the behavior 

of AMCs, however, the information provided has forced research institutions to define the role 

of the IRB in greater detail and to expand the scope of programs better designed to ensure the 

protection of human subjects in research. These programs have been developed by institutions 

through research administrative offices in order to provide assurances of their compliance with 

regulations (Sherwin & Fromell, 2002). Out of these developments the focus has shifted from traditional 

research administration toward a prospective compliance focused approach. 

Initially, UHC responded in this area by creating an office of grant administration over 

a decade ago which merged with the IRB office to form an Office of Institutional Review. The 

national trends in the late 1990s and the desire for the best possible protections of human subjects 

caused further development of an educational component related to the responsible conduct of 

research. The next natural development, formed to administratively support and compliment the 

other areas of research administration especially that of the IRB, was the compliance component. 

Together these components currently form the UHC Center for Clinical Research. These developments 

were not unique to this particular institution as most entities conducting clinical research 

are attempting to synthesize the essential resources necessary to deal with the growth of this 

industry while ensuring the highest level of human subject protections and research integrity. 

The fusion of internal monitoring programs and research administration activities into central 

research offices has also led to the creation of external accrediting bodies for Human Research 

Protection Programs (HRPPs). This may be attributed to the concept that preparation for voluntary 

accreditation includes a self-assessment of the overall research protection programs including 

compliance and safety (Burke, 2005). These programs are often construed as being synonymous 

with IRB accreditation, however the scope and purpose of such programs goes beyond the operational 

matters of an IRB and its corresponding administrative office and assesses many more 

components (i.e., institutional support and understanding; congruence with grant administration; 

research educational programs for investigators, CRCs, research administrators, research participants; 

and research compliance programs). Accreditation must approach the HRPPs broadly from 

an organizational perspective that is beyond a focus of IRB operations to examine whether policies 

and procedures of the organization as a whole result in a coherent, effective scheme for the protection 

of human research participants (Speers & Cooper, 2003). 


There are two main accrediting bodies, “The National Committee for Quality Assurance” (NCQA) 

and the “Association for the Accreditation of Human Research Protection Programs, Inc. (AAH- 

RPP). In 2003, The NCQA and the Joint Commission on Accreditation of Healthcare Organizations 

(JCAHO) joined forces to develop the “Partnership for Human Research Protection” 

(PHRP), an independent accreditation organization to broaden the NCQA’s former range from 

Veterans Affairs Medical Centers to public and private hospitals, AMCs, and research facilities 

(National Committee on Quality Assurance [NCQA], 2003). 

AAHRPP was incorporated in 2001 as an amalgamation of several renowned biomedical and 

academic research organizations, including but not limited to, the Association of the American 

Medical Colleges (AAMC), the Association of American Universities, the National Health Council, 

and Public Responsibility in Medicine and Research (PRIM&R). The guiding premise behind 

AAHRPP’s accreditation program is that the protection of human research participants should be 

a responsibility shared amongst institutional review boards, investigators, and organizations with 

the oversight of an accrediting body (Speers & Cooper, 2003). 

Efforts aimed at improving HRPPs would be remiss if comprehensive education was not an 

integral component of the approach. As Shalala (2000) notes, “The never-ending challenge for 

academic institutions and other organizations participating in research is to make sure that researchers 

and other personnel have up-to-date training and a thorough knowledge of their responsibilities. 

Those responsibilities include communicating with IRBs, ensuring that procedures 

for informed consent are followed, monitoring compliance with protocols, and reporting on safety 

issues.” Comprehensive education efforts for the entire research program at AMCs should be 

focused on not only facilitating the understanding of Federal regulations and institutional policies 

and procedures, but also on the results of their own compliance activities. Through compliance 

activities, AMCs are able to scrutinize the clinical research conducted at their institution, monitor 

for common non-compliance trends, and identify areas of needed continuing research education. 

Furthermore, improved educational efforts and compliance activities in conjunction with all components 

of research administration serve to improve the overall quality of the research, increase 

the quality of human subject protections, and enhance the efficiency of the IRB (Sugarman, 2000). 

This paper aims to describe the development, implementation and evaluation of a prospective 

approach to research compliance monitoring at an Academic Medical Center. The information 

described and presented will allow research administrators and investigators from other institutions 

to gain knowledge and ultimately share best practice experiences in this area while maintaining 

a focus on the role of research administration functions in the responsible conduct of clinical 

research. 

Methods: 

Papers 

The various types of research administration activities aforementioned were developed to supplement 

the grant and IRB administrative functions at UHC beginning in 1999. With the development 

of education and compliance monitoring programs the institution needed to create policies 

and procedures for collecting internal outcome data and to be able to respond appropriately to the 

data it was collecting. 


Papers 

Institutional Quality Improvement Reviews: 

UHC developed Quality Improvement Review processes that compared the implementation of 

clinical research protocols by the investigator and his\her staff to the specifics of the IRB-approved 

protocol. The IRB and compliance staff perform this type of review through access to research 

and/or medical files. These reviews occur on a continuing basis and reports are made available to 

the institutional officials and affiliated institutions subject to various IRB Authorization Agreements. 

UHC determined that it would review whichever was greater, 5% or 15 active protocols 

during a calendar year under this initiative. Confidential summaries were provided to the designated 

Institutional Official (i.e., the individual signing the Federalwide Assurance document on 

behalf of the institution) and to affiliated institutions with active IRB Authorization Agreements 

with UHC. 

Institutional Research Audits: 

Prior to seeking institutional accreditation the UHC IRB set a standard that it must be audited 

periodically, but not less than once every three years, by an external entity not reporting to the 

Institutional Official or to the Center for Clinical Research office in any manner. Results of an 

audit or even of a failed accreditation review will be made available to the Institutional Official 

and confidentially to the other affiliated institutions bound by IRB Authorization Agreements, as 

applicable. 

Institutional Educational Responsibilities: 

In 2001, UHC began to require appropriate personnel (i.e., all key personnel on NIH grants and 

any individual that obtains informed consent on a clinical research protocol) to participate in a 

continuing education program focused on the protection of human research subjects. Initially, 

this was accomplished in the baseline year through the use of the Dunn and Chadwick (1999) 

textbook, “Protecting Study Volunteers in Research” which included a 50 question examination 

where a score of 80% or higher was considered passing. Certification in human subject protections 

was active for a period of three years before re-certification was necessary. The re-certification 

requirement is currently met by the on-line course for biomedical or behavioral researchers offered 

through the administration of the University of Miami’s Collaborative IRB Training Initiative 

(CITI) at the https://www.citiprogram.org/default.asp website. 

Institutional Accreditation in Human Subject Protection Programs: 

In considering recommendations made to academic institutions in order to improve their HRPP 

and in the effort to remain at the forefront of clinical research and continue to develop its quality 

improvement initiative, the UHC Center for Clinical Research is currently seeking AAHRPP accreditation. 

In the process of applying for accreditation, an extensive self-evaluation of the Center’s 

policies and procedures is underway. Through this self-evaluation, many policies and procedures 

have been updated and improved upon. 

Prospective Research Compliance Monitoring: 

The UHC Center for Clinical Research recognized the need to develop a prospective Research 

Compliance monitoring program to carry out all the duties described above in this Methods section. 

This proactive program is separate from the other research administrative functions in the 

office and also serves as a form of investigator support services. 


For benchmarking and self-evaluation purposes the data from the methodological activities 

described herein have been collected and analyzed to ensure a continuous quality improvement 

process. These data are described in detail below. 

Results: 

Institutional Quality Improvement Review Findings: 

Papers 

The UHC Center for Clinical Research has collected data on informed consent documents, via a 

JCAHO tool, during monthly audits conducted from January 1999 through March 2005. In that 

time period, 911 informed consents were audited from 731 different clinical research protocols. 

On average, 150 consent forms are reviewed annually at UHC. During the JCAHO audits, the 

informed consents are reviewed for the following required elements: 

• Description of benefits to be expected 

• Description of potential discomforts and risks 

• Description of alternative services 

• Full explanation of procedures to be followed 

• Assurance of right to refuse to participate 

• Name of person who supplied prospective participant with information 

• Date form was signed 

• Address the right to patients’ right to privacy and confidentiality 

Eighty-eight percent of the deficiencies or missing required elements of the informed consent 

noted were readily correctable issues in the content of the informed consent document itself. Only 

12% of deficiencies noted were in the supporting medical documentation of the informed consent 

process. Of the deficiencies noted, the “description of alternative services” was the most frequently 

noted discrepancy (see Figure 1). 

In terms of trends across the time period (i.e., 6 years and 3 months), the data reveals significant 

decreases beginning in the second year of auditing through the fourth year of auditing. The decreases 

are by approximately one-third of the total number of discrepancies found during that four 

year period starting in 2000 through 2003. However, there was a significant increase in the number 

of discrepancies found in 2004 raising the total for that year to be equal to the baseline years of 

1999 and 2000. It is believed that this increase back to the baseline periods is in part attributable to 

changes in auditing personnel that occurred in 2004. It is expected that the raw number of identified 

discrepancies will continue to increase in 2005 (projected annualized total of 28 which would 

be greater than any of the previous year total to date) and beyond as a function of the development 

of specialized clinical research monitoring functions with additional personnel specifically trained 

to identify such discrepancies (see Figure 2). 

More importantly, the overall level of discrepancies found by number of consent forms and protocols 

audited over the six year period is very low. Only 11.6% of the total consent forms had some 

level of inadequacy and 14.4% of the protocols (see Table 2). Again, the discrepancies found were 

readily correctable and none were deemed serious discrepancies. These data show that the overall 

protocol review and monitoring systems is performing well with the expectation of continued 

improvement over time. 


Papers 

Institutional Audit Findings: 

Potential non-compliance issues that are discovered during either the IRB review of research, 

previous internal auditing activities conducted by the Center for Clinical Research or by self-disclosure 

of the Principal Investigator or research staff, are investigated by the Compliance Officer, 

Clinical Research Manager, and Compliance Specialist of the Center for Clinical Research. A thorough 

investigation of the non-compliance allegation is conducted and a detailed summary with 

supporting documentation is presented to a full IRB committee. The non-compliance allegation is 

discussed and deliberated upon and the IRB votes on whether the non-compliance allegation is a 

case of non-serious non-compliance, serious non-compliance, or not an issue of non-compliance. 

From January 2002 through March 2005, the UHC IRB reviewed 35 non-compliance allegations 

(see Table 3). As demonstrated by the data, the majority (74.3%) of the non-compliance allegations 

were determined to be non-serious non-compliance. Table 3 also illustrates the overall low 

frequency of non-compliance issues that arose for determination by the UHC IRB as compared to 

the total number of actions the UHC IRB took during the respective time period. 

Of the 26 non-serious non-compliance determinations, the majority (80.8%) of non-serious 

non-compliance findings noted during this time period were attributable to the erroneous use of 

expired, unapproved and/or unstamped consent forms. In terms of the 5 serious non-compliance 

findings, the trends noted ranged from the failure to obtain informed consent to the failure to 

report adverse events to the IRB. It should be noted the trends demonstrated in the non-compliance 

determinations are consistent with the audit findings of other institutions as presented by the 

Department of Health and Human Services Office of Human Research Protections. 

Conclusions: 

The information outlined in this paper reinforces the basic construct that research compliance 

monitoring must span the “entire life of a protocol” (i.e., from the time of receipt in a research 

administration office and even after completion of the study). In order for this level of complete 

monitoring to occur the review mechanisms must include all areas of research administration and 

not merely IRB review. 

Historically, the UHC Center for Clinical Research conducted internal auditing of research activities, 

but found that when non-compliance allegations arose, the investigations involved were 

extremely resource-intensive. Therefore, integral to the development of the Research Compliance 

program at UHC was recognizing that dedicated personnel with particular expertise was needed 

to staff the program as opposed to further increasing the burdensome work load of IRB coordinators 

and specialists. Research compliance offices are now becoming a standard component in most 

research institutions and there is momentum toward independent internal review by compliance 

specialists who are versed in regulatory compliance for all areas of research administration (Icenogle, 

2003). 

Of additional importance is to conduct these centralized research compliance monitoring activities 

in a prospective fashion for active studies in order to confirm congruence with required study 

monitoring plans, Federal regulations, and good clinical practice (GCP) guidelines (Sherwin & 

Fromell, 2002). Comprehensive monitoring programs are readily integrated with the operations of 

IRBs, grant offices and data and safety monitoring boards in ensuring the responsible conduct of 

research across a broad continuum. 


Papers 

Although UHC had conducted research compliance activities previously, it was through the process 

of applying for accreditation that the structure of the research compliance program became 

solidified. Institutions seeking accreditation for human subject protection programs by definition 

must create quality improvement activities during the application and review process. An example 

of such internal quality improvement activities at UHC was the revision of the IRB policy and procedure 

manual as a focused effort to ensure that all regulatory requirements were current with the 

regulations. This emphasizes that accreditation can primarily be a self evaluative and educational 

process that results in constructive feedback for institutions to act upon (Speers & Cooper, 2003). 

The movement toward comprehensive research compliance monitoring also provides the impetus 

to actively engage the institutional research community in education and training on necessary 

changes to longstanding institutional policies and procedures. This education and training will 

result in the facilitation of improved awareness and compliance with regards to human subject 

protections and overall research integrity. 

The results of compliance monitoring at UHC to date have generally been reassuring in that it is 

rare to find many instances of research compliance issues or to have serious non-compliance issues 

arise especially considering the overall volume of research conducted. Therefore, although other 

institutions have faced barriers or resistance to their compliance programs due to their culture, a 

complete cultural change is not needed at UHC because the resources and understanding to integrate 

research compliance into the Center for Clinical Research is a natural progression of existing 

administrative activities. Knowledgeable and attentive leadership establish the required culture 

for the continued growth of research administration in major research institutions (Ellis, 1999). 

Interviews at Johns Hopkins after their Federally supported research was suspended revealed 

the general sentiment of researchers was that “oversight and regulatory processes are a barrier to 

research and are to be reduced to the minimum rather than serving as an important safeguard 

(Steinbrook, 2002b). UHC has attempted to form a collaborative (not adversarial or punitive) 

relationship between research administration and investigators and their staffs to ensure that the 

basic tenets of research integrity are maintained. Research does not occur effectively unless the PIs 

and CRCs recognize the team of professionals that work diligently and in collaboration with them 

to ensure the responsible conduct of research. If the research administration processes are seen as 

punitive they are more likely to fail (Sherwin & Fromell, 2002). 

The UHC compliance monitoring program has positive momentum and is gaining, but it is still an 

appropriate work in progress. The next steps are to commence with a systematic process designed 

to prospectively and collaboratively monitor ongoing research with investigators and their staffs. 

This type of monitoring function will allow for early intervention into potential research compliance 

issues so that they can be dealt with immediately and not grow into larger programmatic 

problems that tend to have significant ramifications. Also, an additional development under this 

compliance program will include monitoring of the informed consent process on a random basis 

across the institution. Finally, the program will identify needed areas of education for all staff 

involved in research and thereby serve in a PI and CRC support services capacity. 

These activities in combination with IRB and grant administration, educational programs, investigator 

support services and accreditation will ensure the trust of human subjects who voluntarily 

participate in research protocols while guaranteeing the integrity of the research data and the 

investigators. 


Papers 

References: 

Burke, G.S. (2005). Looking into the Institutional Review Board: Observations from Both Sides of 

the Table. Journal of Nutrition, 135, 921-4. 

Dunn, C.G., & Chadwick, G.L. (1999). Protecting Study Volunteers in Research: A Manual for 

Investigative Sites. Boston, MA: Thomson Centerwatch. 

Ellis, G.B. (1999). Keeping Research Subjects Out of Harm’s Way. Journal of American Medical 

Association, 282, 1963-5. 

Icenogle, D.L. (2003). IRBs, Conflict and Liability: Will We See IRBs in Court? Or it is when?” 

Clinical Medicine & Research, 1, 63-68. 

National Committee for Quality Assurance. (2003). Protecting Research Volunteers: NCQA’s 

Human Research Protection Accreditation Program. Research Practitioner, 4, 28-30. 

Shalala, D. (2000). Protecting Research Subjects- What Must Be Done. The New England Journal 

of Medicine, 343, 808-810. 

Sherwin, J.R., & Fromell, G.J. (2002). Post-IRB-approval monitoring of clinical trials: Assessment 

of investigator compliance documentation and training. Research Practitioner, 3, 73-80. 

Slater, E.E. (2002). IRB Reform. The New England Journal of Medicine, 346, 1402-1404. 

Speers, M. & Cooper, J. (2003). Accreditation Comes of Age. Research Practitioner, 4, 24-27. 

Steinbrook, R. (2002a). Improving Protection for Research Subjects. The New England Journal of 

Medicine, 346, 1425-1430. 

Steinbrook, R. (2002b). Protecting Research Subjects- The Crisis at Johns Hopkins. The New 

England Journal of Medicine, 346, 716-720. 

Sugarman, J. (2000). The Role of Institutional Support in Protecting Human Research Subjects. 

Academic Medicine, 75,687-692. 


Figure 1 

Figure 2 

Papers 


Papers 

Table 1 

Total Number of Protocol Actions taken by the UHC IRB from 2000 through 2005 broken down 

by the Type of Review 

Year Number of Expedited 

Review Protocol Actions 

Number of Full Review 

Protocol Actions 

Total Number of Protocol 

Actions Annually 

2000 1,055 674 1,729 

2001 1,515 813 2,328 

2002 1,525 1,053 2,578 

2003 1,721 1,365 3,086 

2004 1,658 1,392 3,050 

2005* 1,517 1,606 3,123 

Total 8,991 6,903 15,894 

*annualized 

Table 2 

Number of JCAHO Consent Form Discrepancies Found as a Function of the number of Documents 

Audited and Protocols Audited 

Year Discrepancies Consents 

Audited 

Consents 

Audited 

Percentage 

Protocols 

Audited 

Consents 

Audited 

Percentage 

1999 19 106 17.9 % 81 23.5 % 

2000 22 149 14.8 % 101 21.8 % 

2001 14 129 10.9 % 108 13.0 % 

2002 13 158 8.2 % 132 9.9 % 

2003 7 158 4.4 % 137 5.1 % 

2004 18 166 10.8 % 136 13.2 % 

2005* 28* 180* 15.6 %* 144* 19.4%* 

Total 121 1046 11.6 % 839 14.4 % 

*annualized 

Table 3 

UHC IRB Actions from January 2002 through March 2005 Broken down as Non- 

Compliance reviews versus Not Non-compliance reviews 

UHC IRB Actions from January 2002 through March 2005 Number Frequency 

Determination: Not an issue of non-compliance 4 .05 

Determination: Non-serious non-compliance 26 .28 

Determination: Serious non-compliance 5 .06 

UHC IRB actions that did not involve potential compliance allegations 

9,542 99.6 

Total Number of Actions the IRB took during time period 9,577 n/a 


After A Day Of Infamy, December 7, 2003—What Regulatory Ethics 

Have Become at the National Institutes of Health by August 31, 2005 

John J. Gillon, Jr., J.D., M.P.H. 

Senior Attorney 

Office of Petitions, U.S. Patent and Trademark Office,U.S. Department of Commerce 

Visiting Fellow, Center for Biomedical Ethics/University of Virginia Health System 

Serves pro bono on the Institutional Review Boards of Walter Reed Army Institute of Research, 

Walter Reed Army Medical Center, and the American Red Cross Biomedical Services 

2921 Stanton Avenue 

Silver Spring, MD 20910-1218 

Phone/FAX (301) 589-6527 

john.gillon@starpower.net 

Authors’ Note 

The views presented are those of the author and do not represent the policy or opinion of the 

Government of the United States or any of its agencies. 

Comments from Society members are welcomed. 

Papers 

Abstract 

For the 17,500 employees of the National Institutes of Health there may have been a sense of 

unprovoked attack when they awoke to find that Los Angeles Times reporter David Willman 

had targeted their institution with allegations that conflicts of interest and their corrupting influences 

were standard operating procedure at the NIH. The Congressional and Inspector General 

investigations of these allegations demonstrated that fewer than 70 scientists—maybe fewer than 

50—had violated ethics rules then in place. Yet, the newspaper’s indictment of the NIH staff was 

carried as a top story by news operations throughout the nation, even The Washington Post buried 

on page the vindication of the many thousands of dedicated women and men at the NIH. Why 

and how the staff and institutes of NIH came under—in the last half of the 20th Century—an 

unmeasured and almost wholly undefended attack is lucidly and elegantly discussed by Evan G. 

DeRenzo, Ph.D., in a recent article for the Kennedy Institute of Ethics Journal, and need and will 

not be re-examined here. Better now to reflect upon the substance of some of the changes that 

have taken place over the last decade—that is, to look at the regulations in the wake of legislation 

and the administration of former NIH Director, and Nobel Prize winner, Harold Varmus, M.D., 

and how those regulations have been changed twice in 2005 following the December 2003 L.A. 

Times allegations. Whether any of the feared mass exodus of scientific talent from the NIH occurs 

likely will have more to do with whether the monies and the freedoms to engage in challenging 

and state-of-the-art scientific research continue to be made available to NIH staff than what stocks 

NIH staffers can own and for whom they can consult. 

Introduction 

Flooded with 1,300 comments by employees and threats of high-level defections, the head of the 

National Institutes of Health agreed [on August 25, 2005,] to loosen some of the ethics rules he 

unveiled in February. 

* * * 

Congress prompted the new regulations after lawmakers discovered that dozens of scientists had 

not revealed income and other perks they received from for-profit companies, as required. 

(Emphasis supplied) 

-- The Washington Post, Friday, August 26, 2005 (Connolly 2005) 


Papers 

Sunday, December 7, 2003. 

Déjà vu . . . all over again. (Berra. Undated.) 

There may well have been the sense of an unprovoked dawn attack for the 17,500 employees at 

the site of a former meadow in Bethesda, Maryland—the main campus of the National Institutes 

of Health (NIH)—when they awoke to find that Los Angeles Times reporter David Willman had 

targeted their institution from 2,700 miles away with allegations that conflicts of interest and their 

corrupting influences were standard operating procedure at the NIH. (Willman 2003.) 

At their endgame more than a year later, the Congressional and Inspector General investigations 

of these allegations demonstrated that fewer than 70 scientists—maybe fewer than 50—had violated 

ethics rules then in place. 

Yet, while the Los Angeles Times-published indictment of the staff of the United States’ premiere 

medical research institution(s) was splashed across page one by news operations throughout the 

nation, even home-town press The Washington Post buried on page A21 the vindication of the 

many thousands of dedicated women and men at the NIH. . (Weiss 2005.) 

By The Post’s own account, those involved constituted between 0.29 and 0.40 percent—in a worstcase 

scenario four-tenths of one percent—of the NIH staff. (Weiss 2005.) Yet, as evident from The 

Post quotation at the top of this article, even as of this writing the news media continue to suggest, 

whether by ignorant or intentional statement and inference, that wrong-doers are in significant 

numbers at NIH when the facts belie such suggestions. (Connolly 2005) 

Moreover, the record appears quiet as to any official endorsement of the 99.6 or greater percent of 

the NIH staff, who were good and loyal employees and played by the rules. 

Why and how the staff and institutes of NIH came under—in the last half of the 20th Century—an 

unmeasured and almost wholly undefended attack is lucidly and elegantly discussed by Evan G. 

DeRenzo, Ph.D., in a recent article for the Kennedy Institute of Ethics Journal (DeRenzo 2005), 

and need and will not be re-examined here. 

Better now to reflect upon the substance of some of the changes that have taken place over the last 

decade—that is, to look at the regulations in the wake of legislation and the administration of former 

NIH Director, and Nobel Prize winner, Harold Varmus, M.D., and how those regulations have 

been changed twice in 2005 following the December 2003 L.A. Times allegations. 

1 Connolly and her editors fail to provide up front for their readers any perspective of what “dozens of scientists” 

means in relation to the total number of scientists working in the immediate NIH family of researchers. But, then, 

a statement that less than one-half of one percent of NIH staff had violated ethics rules does not catch the attention 

of a reader in quite the way that “dozens of scientists had not revealed income and other perks they received from 

for-profit companies, as required.” (Emphasis supplied.) 


1. The Predicate 

DeRenzo explains that then-Director Varmus was confronted with the mandates of several 

pieces—ten by actual count—of Congressional legislation, an executive order and the results of 

an audit by the Office of Governmental Ethics (OGE) before setting into place rules that not only 

seemed an appropriate follow-on to the go-go legislative and executive mandates of the 1980s and 

even the 1990s, but also conformed to the limitations on the regulations that the OGE audit had 

indicated were required by law. (DeRenzo 2005.) 

The major legislation alone included the: 

• Stevenson-Wydler Technology Innovation Act of 1980(P.L. 96-480); 

• Bayh-Dole Action (also known as the Patent and Trademark Law Amendments Act) of 1980 

(P.L. 96-517); 

• Small Business Innovation Development Act of 1982 (P.L. 97-219); 

• Federal Technology Transfer Act of 1986 (P.L. 99-502); 

• Omnibus Trade and Competitiveness Act of 1988 (P.L. 100-418); 

• National Competitiveness Technology Transfer Act of 1989 (P.L. 101-189); 

• American Technology Preeminence Act of 1991 (P.L. 102-245); 

• Small Business Research and Development Enhancement Act of 1992 (P.L. 102-564); 

• National Department of Defense Authorization Act for1994 (P.L. 103-160); and 

• National Technology Transfer and Advancement Act of 1995 (P.L. 104-113). (The Green Book 

2002.) 

The executive order: Executive Order 12591 (1987). (The Green Book 2002.) 

Papers 

As a body—a whole construct—this legislation and the executive order mandated intense cooperation 

by government research labs with university and private industry research and development 

programs. The force of the legislative focus was made clear by requirements that government 

scientists be evaluated on their on-the-job performance by the contributions they made to commercialization 

of research—and that they be compensated for those efforts and accomplishments 

with a percentage of the licensing revenues from the products and systems developed. (The Green 

Book 2002; DeRenzo 2005.) 

2 Also among the category of major legislation was the Technology Transfer Commercialization Act of 2000 (P.L. 

106-404), enacted after the Varmus rules. Lesser known pieces of legislation pre-dating the Varmus rules included: 

• The Cooperative Research Act of 1984 (P.L. 98-462) (established several R&D consortia and eliminated some of the 

antitrust concerns of companies wishing to pool R&D resources; 

• The Trademark Clarification Act of 1984 (P.L. 98-620) permitted patent license decisions to be made at the laboratory 

level in GOCO laboratories, and permitted contractors to receive patent royalties to support the R&D effort; 

• The Japanese Technical Literature Act of 1986 (P.L. 99-382) improved the availability of Japanese science and engineering 

literature in the U.S.; 

• The National Institute of Standards and Technology Authorization Act for FY 1989 (P.L. 100-519) permitted contractual 

consideration for intellectual property rights other than patents in cooperative research and development 

agreements (CRADAs); 

• The Defense Authorization Act for FY 1991 (P.L. 101-510) established model programs for national defense laboratories 

to demonstrate successful relationships between the federal government, state and local governments, and 

small businesses and permitted those laboratories to enter into a contract or a Memorandum of Understanding 

with an intermediary to perform services related to cooperative or joint activities with small businesses; 

• The National Defense Authorization Act for FY 1993 (P.L. 102-484) extended the potential for CRADAs to some 

Department of Defense-funded Federally Funded Research. (The Green Book 2002.) 


Papers 

Similarly, the OGE audit indicated that the stringent limits on the outside activities of NIH senior 

management (the NIH Director, deputy directors and associate directors, as well as institute and 

center directors and deputy directors) were not in compliance with OGE regulations affecting all 

executive branch agencies. (Working Group 2004, at 46 – 47.) Those limits, too, had to go. 

Thus, several prohibitions on NIH employees that had been in place fell in compliance with the 

OGE review. Stones of this tumbled Jericho wall had prohibited NIH employees from: 

• engaging in outside activity with entities having involvement with the employee’s institute, 

center or division; 

• accepting compensation in excess of $25,000 from outside firms—and no more than $12,500 

from any one firm; 

• performing in excess of 500 hours per year of compensated outside service; 

• accepting stock for themselves, their spouses and minor children as compensation for outside 

work; and 

• serving as managers or on boards of directors of related activities. (Working Group 2004.) 

And so, with a Federal Register notice (61 FR 147 (1996) to the public and a memorandum from 

Director Varmus to his staff, the old restrictions were out and the new permissiveness in—all apparently 

with not only the approval of but a mandate from Congress, the Executive and the OGE. 

(Working Group 2004.) 

As of the end of July of 1996, the “Varmus rules” were in place. (61 FR 147, 1996). 

2. The New-er Predicate: February 3, 2005 

The Presidential elections of 2000 came and went. 

January of 2001 arrived—soon thereafter so did a new Executive administration. 

Thirty-five months later the L.A. Times published Willman’s exposé. 

Congress was shocked. And appalled. And held hearings. 

In its Federal Register Interim Final Rule Notice of February 3, 2005, that followed those hearings, 

the Department of Health and Human Services (HHS) stated that it was making changes to the 

ethics regulations “based on the experience that has been garnered by the Department in implementing 

the regulation since it was issued in 1996”—since, i.e., the Varmus rules—to “establish [ ] 

more specific requirements with respect to [NIH employee] requests for approval of outside activities 

and impose [ ] an annual reauthorization process.” (70 FR22 (2005), at 5543.) 

By way of explanation, the Notice continues: 

Outside activities with entities substantially affected by NIH programs, policies, or 

operations must be further restricted in order to avoid the potential for real or apparent 

conflicts of interest that may threaten the integrity of the critically important research 

conducted and sponsored by the NIH. This assessment is informed by recommendations 

of the Advisory Committee to the NIH Director that were presented in the June 22, 

2004, Report of the NIH Blue Ribbon Panel on Conflict of Interest Policies (Blue Ribbon 

Panel Report), available at http://www.nih.gov/about/ethics_COI_panelreport.htm, but is 

predicated upon a consideration of various outside activities of NIH employees that have 

been subject to inquiry and the desire to advance sound public policy. Many of the panel 

recommendations and related issues were highlighted and discussed at Congressional 

hearings on outside consulting arrangements by NIH employees. Panel recommendations 

to liberalize certain current restrictions were not adopted in this rule. Additional restrictions 

are necessary because NIH operations increasingly require significant interaction 


Papers 

with * * * companies (referred to within the regulation as “substantially affected organizations”) 

* * * ; and NIH research findings are broad in range and influence within the 

health care sector. Moreover, in light of recent Congressional oversight and media reports, 

HHS has determined that the existing rules governing outside activities have not prevented 

reasonable public questioning of the integrity of NIH employees and the impartiality 

and objectivity with which agency programs are administered. (Emphasis supplied.) (70 

FR 22, 2005, at 5546.) 

Thus, the Notice expressly stated that the HHS focus in imposing the regulatory changes was the 

appearance of, and not necessarily the actual, impropriety—and the resulting public inquiry. In 

addition, while the agency acknowledged the existence of the report by and recommendations of 

the NIH Blue Ribbon Panel—i.e., the Working Group—the recommendations simply “informed” 

the agency and did not deter it from acting in response to Congressional oversight and media 

reports, rather than specific findings of fact. 

The changes at 5 C.F.R. §5501.102(c)(1)(iii) made clear that the “separate agency designations” applies 

for employees of the NIH not only as to determining prohibited sources for outside gifts, but 

also for prior approval for outside employment and activities, and receipt of gifts. 

Changes at 5 C.F.R. §5501.106(d)(2)(i) brought employees of the NIH under the same requirements 

for prior approval of any outside employment—compensated or not—or self-employment 

activity as applied to employees of the Food and Drug Administration (FDA). 

Moreover, the HHS amendment of 5 C.F.R. §5501.106(d)(3) imposed a requirement that the supervisor 

of an NIH employee “review the request for approval of the outside activity and provide a 

statement addressing the extent to which the employee’s duties are related to the proposed outside 

activity”—and “[t]his information [was to] be forwarded to an agency designee [e.g., an ethics officer] 

to make a final determination with respect to the request.” (70 FR 22 (2005), at 5545.) 

The HHS Federal Register Notice then set out a laundry list of information that would be required 

in this inquiry: 

The amendment also specifies that the following information be included with the request: 

the employee’s step within a grade, appointment type, and financial disclosure filing status; 

a description of how the employee’s official duties will affect the interests of the outside 

employer; whether stock or other remuneration in cash or in-kind will be received in 

connection with the activity; the amount of compensation to be received in connection 

with the activity; the amount and date of compensation received, or due for services performed, 

within the prior six years; a syllabus, outline, summary, synopsis, draft, or similar 

description of content and subject matter if the activity involves teaching, speaking, or 

writing; and other information as determined by the designated agency ethics official, or 

the HHS component with the concurrence of the designated agency ethics official, to be 

necessary or appropriate to evaluate whether the request is prohibited by statute or regulation. 

(70 FR 22 (2005), at 5545.) 

The amendment of 5 C.F.R. §5501.106(d)(4) made clear that “a request for approval of outside employment 

or other outside activity may not be granted unless there is an affirmative determination 

that the employment or other activity is not expected to involve conduct prohibited by statute or 

regulation.” And the new provisions at 5 C.F.R. §5501.106(d)(5) trimmed to a single year the term 

of approval of such employment or activity, with an automatic requirement for reevaluation of the 

approval if there was a change of position or duties of the employee or in the nature of the outside 

activity. (70 FR 22 (2005), at 5545 - 5546.) 


Papers 

Changes to 5 C.F.R. §5501.109 made clear that not even the requirements set forth by the OGE (at 

5 C.F.R. part 2635, subpart H) and the HHS supplemental standards of employee ethical conduct 

(at 5 C.F.R. §5501.106) satisfied HHS that Congress and the public would find the actions of NIH 

employees sufficiently ethical. Thus, in addition to prohibiting: 

* * * 

. . . employees of the NIH and other employees of HHS from providing certain services, 

for compensation, in the preparation of grant applications, contract proposals or other 

documents to be submitted to HHS, and from compensated outside employment with 

respect to a particular activity funded by an HHS grant, contract, cooperative agreement, 

or other funding mechanism authorized by statute, or conducted under a cooperative 

research and development agreement (CRADA) 

* * * 

[under Interim Final Rule Sec. §5501.109(c)(1)] all NIH employees are also prohibited 

from engaging in employment (which includes serving as an officer, director, or other 

fiduciary board member, serving on a scientific advisory board or committee, and consulting 

or providing professional services) and compensated teaching, speaking, writing, 

or editing with a substantially affected organization; a hospital, clinic, health maintenance 

organization, or other health care provider (defined comprehensively to include the 

types of entities that are eligible to receive payments under the Medicare program for the 

provision of health care items or services); a health insurer; a health, science, or health 

research-related trade, professional, consumer, or advocacy association; or a supported 

research institution. (70 FR 22 (2005), at 5546.) 

A “Substantially affected organization” was defined at paragraph (b)(8) to include those entities, 

irrespective of corporate form, that are engaged in the research, development, or manufacture 

of biotechnological, biostatistical, pharmaceutical, or medical devices, equipment, preparations, 

treatments, or products. The term includes those organizations a majority of whose members are 

engaged in such activities. (70 FR 22 (2005), at 5546.) 

After first quoting and then generally disregarding the National Academy of Sciences observation 

in On Being Scientist, that: 

Science is inherently a social enterprise . . . . 

* * * 

The social mechanisms of science do more than validate what comes to be known as 

scientific knowledge. They also help generate and sustain the body of experimental 

techniques, social conventions, and other ``methods’’ that scientists use in doing and 

reporting research. * * * Because they reflect socially accepted standards in science, their 

application is a key element of responsible scientific practice. (NAP 1994.) (Cited at 70 FR 

22 (2005), at 5549.) the HHS Federal Register Notice set forth examples of myriad exceptions 

to the newly-imposed rules, which exceptions would free the NIH employee to enjoy 

“[t]he social mechanisms of science” in the face of the 5 C.F.R. §5501.106(d)(3)-imposed 

requirement for vetting of those social mechanisms the employee’s supervisor and then 

the designated agency ethics officer. (70 FR 22 (2005), at 5549 - 5550.) 

The February 2005 Interim Final Rule created at new provision at 5 C.F.R. §5501.110, which 

prohibited NIH employees who filed public or confidential financial disclosure reports (as well as 

their spouses and dependent children) from owning any financial interest—stock or otherwise—in 

“substantially affected organizations,” while those who did not have to file such reports were al- 


lowed holdings capped at $15,000.00. (70 FR 22 (2005), at 5550 - 55510.) But even this exception, 

the HHS Federal Register Notice cautioned, might violate the provisions of the criminal conflict of 

interest statute at 18 U.S.C. §208. 

Mandatory divestitures by NIH employees had to come within 90 days—180 days on showing of 

“good cause.” Certificates of financial divestiture could provide deferred tax consequences under 

subpart J of 5 C.F.R. part 2634—but only if the employee delayed divestiture until having complied 

with “the requisite procedures.” (70 FR 22 (2005), at 5551.) 

Under the February 2005 Notice and the provisions of 5 C.F.R. §5501.111, HHS “depart[ed] from 

executive branch uniformity” such that senior NIH employees “and others with official responsibility 

for matters affecting donor organizations” were prohibited from accepting certain awards 

from outside sources—and in any case awards in excess of $200.00. (70 FR 22 (2005), at 5552.) 

The Notice allowed the NIH Director to grant a written exception for acceptance of a Nobel Prize 

in Physiology or Medicine or a Lasker Medical Research Award because “the award will further an 

agency interest because it confers and exceptionally high honor * * *.” (70 FR 22 (2005), at 5553.) 

HHS amendments at of 5 C.F.R. §5501.112 generally barred any NIH employee who have accepted 

an award within a year otherwise permitted under of 5 C.F.R. §2635.204(d) or §5501.111 from 

participating in any matter in which the award donor was involved. (70 FR 22 (2005), at 5554.) 

3. The New-est Predicate: August 31, 2005 

In the wake of the 2003 dawn attack, the 2004 Congressional hand-wringing and public thrashings 

and the Februry 2005 first round of draconian regulations, NIH employees were promised on August 

26, 2005, that the new and Final Rule would be posted on the agency website by the next day. 

HHS missed its self-imposed deadline. (To be wholly accurate, the deadline had been announced 

by NIH management.) 

But on Wednesday, August 31, 2005, the agency published its Final Rule at 70 FR 168, at 51559 

– 51574. (70 FR 168 (2005)). 

Some of the changes from the February 3, 2005, rules follow. 

Papers 

The regulations at 5 C.F.R. §5501.101(c) provided that terms used in part 5501 were—unless specifically 

defined otherwise—to be defined and understood consistently with the meanings set out 

in parts 2635 and 2640 of the regulation. Terms included in that listing include “holdings,” “pension 

plan,” and “sector mutual funds.” (70 FR 168 (2005), at 51560.) 

Changes in the regulations at 5 C.F.R. §5501.102, HHS said, clarified a prior ambiguity in the 

definition of an “employee” to focus on “the regularly assigned duties and responsibilities of an 

individual employee rather than that person’s location within the organization.” (70 FR 168 (2005), 

at 51560.) 

The amendments at 5 C.F.R. §5501.106 revised the exception to the FDA prohibited outside activity 

rule at §5501.106(c)(3). The Notice continued: 


Papers 

* * * 

However, § 5501.106(c)(3) will continue to prohibit a public or confidential filer at FDA 

from serving as a salesman for a beverage distributor or as a pharmaceutical company representative 

engaged in wholesale transactions. 

Section 5501.106(d)(2)(i) as amended by the interim final rule required FDA and NIH 

employees to obtain prior approval for any outside employment or self-employed business 

activity. Prior to the interim final rule, this requirement applied only to the FDA. A number 

of commenters objected to extending the requirement to the NIH, citing the increased 

paperwork and administrative burden. They claimed that the expanded prior approval 

requirement would discourage participation in outside activities and lead to a decrease in 

civic engagement in community groups, volunteer efforts, and non-profit organizations 

that allegedly pose no conflict of interest for NIH employees. 

* * * 

Despite the benefits of requiring prior approval for all outside activities, many commenters 

questioned whether requiring advance permission to paint houses, teach piano, 

or coach a sports team, for example, was warranted. The Department concurs that such 

activities generally are unlikely to pose conflicts or other ethics concerns. Consideration 

was given to excluding these examples and a list of similar activities from the prior approval 

requirement using the existing authority in 5501.106(d)(6), now codified as paragraph 

(d)(7). Upon further evaluation, the Department has decided to remove entirely the 

requirement that FDA and NIH employees must obtain prior approval for all outside activities. 

In its place, paragraph (d)(2) has been revised to require an FDA or NIH employee 

to obtain prior approval for any outside employment, as defined in 5 CFR 2635.603(a), 

with, or any self-employed business activity involving the sale or promotion of products or 

services of, any person or organization that is a prohibited source of the employee’s agency 

component. The term ‘‘prohibited source’’ is defined in 5 CFR 2635.203(d) as any entity 

that seeks official action from, does business or seeks to do business with, or conducts activities 

regulated by the employee’s agency; has interests that may be substantially affected 

by the performance or nonperformance of the employee’s official duties; or is an organization 

the majority of whose members are such entities. The Department has designated 

separate agency components in § 5501.102 that define an ‘‘employee’s agency’’ for purposes 

of outside activity prior approval. The FDA and the NIH have been so designated. 

As a result of the revised prior approval requirement, if an outside activity does not 

involve professional or consultative services; teaching, speaking, writing, or editing that 

relates to official duties; or board service; an FDA or NIH employee no longer needs prior 

approval, unless the activity involves employment undertaken at the invitation of or performed 

for a prohibited source of the FDA or the NIH respectively. (70 FR 168 (2005), at 

51561.) 

Notably, the prior approval exceptions for activities with political, religious, social, fraternal, or 

recreational organizations formerly contained in paragraphs (d)(1)(iii) and (d)(2)(ii) are placed in 

a new paragraph (d)(3)(i), and are applicable to all categories in the general approval requirement 

of (d)(1) and to (d)(2). (70 FR 168 (2005), at 51562.) 

The amended (d)(4)(ii)(D) through (d)(4)(ii)(O) set forth information to be supplied by an 

employee who requests prior approval to engage in an outside activity. And the new (d)(4)(ii)(F) 

addresses travel reimbursement information separately because that item is treated differently in 


Papers 

various ethics rules dependent upon the employee’s status and other circumstances. (70 FR 168 

(2005), at 51562.) 

HHS revised the rules at 5 C.F.R. §5501.109 “to accommodate a significant number of comments 

from professional associations, constituent groups, university observers, employees and their 

families regarding the new restriction on employment, including 

consultation and board service, with ‘related trade, professional or similar associations.’” 

The Department reported that “the comments expressed concern that restrictions imposed on 

the ability of NIH employees to participate fully as members of the greater scientific community 

would negatively affect the public health because NIH scientists 

would become isolated from their counterparts in the private and academic sectors * * *[.]” 

HHS acknowledged that “a reduction in recruitment and retention at NIH would result, and returned 

to the reference to the National Academy of Sciences commentary (NAP 1994). (70 FR 168 

(2005), at 51562 -51563.) 

The regulations at 5 C.F.R. §5501.109(c)(3)(iii)—setting an exception to the outside activity prohibition 

for clerical or similar services—was amended to correspond with the changes to the FDA 

counterpart at 5 C.F.R. §5501.106(c)(3)(ii)(B). And the final rule identifies four additional activities 

exceptions: 

• 5 C.F.R. §5501.109(c)(3)(i)(B) permits compensation for a single class. 

• A new 5 C.F.R. §5501.109(c)(3)(vii) permits an compensation exception not only continuing 

professional education but for Grand rounds. 

• For service on Data Safety Monitoring Boards (DSMBs). And 

• For service on grant and scientific review committees for private foundations and other grantmaking 

entities. (70 FR 168 (2005), at 51563 -51564.) 

The regulations at 5 C.F.R. §5501.109 addressing prohibited financial interests applicable to 

NIH employees was amended to define “senior employee” to include: 

• the NIH Director and the NIH Deputy Director; 

• members of the senior staff within the Office of the Director who report directly to the NIH 

Director; 

• the Directors, the Deputy Directors, Scientific Directors, and Clinical Directors of each NIH 

institute and center (IC); 

• extramural program officials who report directly to an IC Director; and 

• any employee of equivalent levels of decision-making responsibility who is designated as a 

senior employee by the designated agency ethics official or the NIH Director, in consultation 

with the designated agency ethics official. 

Moreover, the rules continue to bar senior employees, their spouses, and minor children from 

holding financial interests in substantially affected organizations, subject to the exceptions for pensions 

and other employee benefits, diversified mutual funds, and the “exceptional circumstances” 

that existed under the interim final rule. (70 FR 168 (2005), at 51564 -51566.) 

The regulations at 5 C.F.R. §5501.111 were amended to set a uniform rule for employees governed 

by whether the award donor has matters pending under the employee’s official responsibility. The 

definition of “official responsibility” is that in 18 U.S.C. §202(b), to wit: “the direct administrative 

or operating authority, whether intermediate or final, and either exercisable alone or with others, 

and either personally or through subordinates, to approve, disapprove, or otherwise direct Government 

action.” (70 FR 168 (2005), at 51566 -51567.) 


Papers 

4. Conclusion 

The NIH February 2005 winter of discontent may not have been made glorious summer by the 

August 2005 amendments to the ethics rules—but the winds of change no longer blow quite so 

cold as they once did. 

Whether any of the feared mass exodus of scientific talent from the NIH occurs likely will have 

more to do with whether the monies and the freedoms to engage in challenging and state-of-theart 

scientific research continue to be made available to NIH staff than what stocks NIH staffers can 

own and for whom they can consult. 

The National Academies of Science was on target more than a decade ago when it stated that: 

“[w]ith few exceptions, scientific research cannot be done without drawing on the work of others 

or collaborating with others.” (NAP 1994.) It is that force of collaboration which has made the 

NIH the center of gravity for world medical research for in the last half of the Twentieth Century. 

While the faces, the buildings and the tools of research change, the underlying physics and effects 

of research critical mass do not. 

References 

Berra, Lawrence Peter “Yogi” (Berra Undated) Born: May 12, 1925, St. Louis, Missouri; attributed to. 

Connolly, Ceci (Connolly 2005), “Director of NIH Agrees To Loosen Ethics Rules,” The 

Washington Post, Friday, August 26, 2005; A19, http://www.washingtonpost.com/wp-dyn/ 

content/article/2005/08/25/AR2005082501664.html . 

DeRenzo, Evan G. (DeRenzo 2005), “Bioethics Inside the Beltway: Conflict-of-Interest Policy at 

the National Institutes of Health: The Pendulum Swings Wildly,” Kennedy Institute of Ethics 

Journal, Vol, 45, No. 2 199-219 (2005 Johns Hopkins University Press). 

Federal Laboratory Consortium for Technology Transfer, Federal Technology Transfer Legislation 

and Policy/The Green Book (The Green Book 2002), at vii - x. 

National Academy of Sciences, On Being a Scientist. (Washington, D.C. National Academy Press, 

1994) (NAP 1994). Cited at 70 FR 22 (2005), at 5549. 

Report of the National Institutes of Health Blue Ribbon Panel on Conflict of Interest Policies, 

A Working Group of the Advisory Committee to the Director National Institutes of Health 

(June 22, 2004) (Working Group 2004). 

Weiss, R. (Weiss 2005), “44 Violated Ethics Rules, NIH Director Tells Panel: Conflict-of-Interest 

Inquiry Focused on Work Done by 103 Current and Former Employees,” The Washington 

Post, Friday, July 15, 2005; A21, http://www.washingtonpost.com/wp-dyn/content/article/2005/07/14/AR2005071402116.html 

Willman D., (Willman 2003) “Stealth merger: Drug companies and government medical research,” 

Los Angeles Times, December 7, 2003, A1, http://www.latimes.com/news/nationworld/nation/ 

la-na-nih7dec07. story. 

61 FR 147 (Tuesday, July 30, 1996), pages 39755 – 39767 (61 FR 147 (1996)). 

70 FR 22 (Thursday, February 3, 2005), pages 5543 - 5565 (70 FR 22 (2005)). 


DEVELOPING A FORMAL QUALITY MANAGEMENT SYSTEM AND 

MEASURING PERCEPTIONS OF SERVICE QUALITY 

Principal Author: Mark Gorringe: Masters in Administrative Management (in progress) 

Co-Author: Dr. Mark Hochman: PhD 

University of South Australia 

Research and Innovation Services 

Mawson Lakes Boulevard 

Mawson Lakes, South Australia, 5095 

Tel: 08 83025143/ Fax: 08 83023921 

Email: mark.gorringe@unisa.edu.au; mark.hochman@unisa.edu.au 

Abstract 

The Australian higher education sector has seen growing pressure for universities to be more 

accountable for the quality of both teaching and research. Universities are also seeking greater 

financial support from external companies to sustain research activity. These emphases result 

in universities being placed in a position where they are now a ‘products and services’ provider. 

The University of South Australia has developed an ISO9001:2000 certified quality management 

system, which includes systems and processes for managing research and consultancy projects. 

The development of a formal quality system is discussed in terms of its principles, requirements 

and intent. Importantly to manage research and consultancy projects this paper not only addresses 

how ISO9001:2000 has been implemented and applied but reveals how a formal system has been a 

key factor in driving improvement strategies – thus achieving competitive advantage. 

The concluding section of the paper explains how we (UniSA) capture, measure and analyse 

industry or client feedback via an external survey, which enables us to assess whether we are 

delivering services our clients value. Within this section the paper reveals some survey results and 

discusses areas of strength and perceived weakness and how these have been addressed. 

Introduction 

Papers 

The University of South Australia’s (UniSA) mission is: to advance, disseminate and preserve 

knowledge through the provision of a teaching, learning and research environment that fosters 

excellence in scholarship, innovation and social responsibility (http://www.unisa.edu.au/research/ 

researchatuni/default.asp). 

Based on this mission statement the goal is to conduct research and consultancy with an emphasis 

on application of knowledge in collaboration with government, industry, commerce, the professions 

and other community groups. 

UniSA’s Research and Innovation Services Office facilitates research activity by providing advice 

on research policy implementation and interpretation, providing legal advice in relation to research 

and consultancy, administering research grants and fellowships, managing research degrees 

and scholarships, collecting, maintaining and distributing research information and monitoring 

ethical practices. 


Papers 

Within the context of a management control system and striving to achieve competitive advantage 

this paper describes the University’s ISO9001 Quality Management system which is used for the 

management of research and consultancy. The first section of this paper defines ISO in terms of its 

principles, requirements and intent. The second section explores how ISO9001 has been applied 

and implemented at UniSA, and importantly reveals how a formal management system has been 

key in driving improvement strategies – thus achieving competitive advantage. 

What is ISO? 

In the pursuit of competitive advantage, it is increasingly important to identify the demands and 

values of current and potential customers (Menzer, Flint, Kent, 1999). 

As we enter the 21st Century it is imperative that we consider the complexities of our environment 

such as technology, globalisation, competition, change, speed of change and complexity itself 

(Tetenbaum 1998) as these factors contribute to the challenges of our organisational existence. If 

organisations (including University Research Offices) accept these complexities and challenges, 

we must then address them by seeing knowledge, or the attainment thereof, as a prerequisite for 

sustainability. The key is how do we address these conditions and challenges and achieve competitive 

advantage – thus giving rise to a sustainable future? 

It would be naïve to suggest that ISO9001 is the complete answer; however, for UniSA it does provide 

a formal management system for identifying customer requirements, setting organisational 

objectives, assigning responsibilities, managing processes (human and material) and monitoring 

the output of the system, including customer satisfaction, with a view to continual improvement. 

This being the case the formalised system enables controlled interaction with the environment in 

which we operate. 

The ISO9000 model contains eight management principles, designed to enable continual improvement. 

They are: 

1. Customer focus 

2. Leadership 

3. Involvement of People 

4. Process Approach 

5. Systems approach to management 

6. Continual improvement 

7. Factual approach to decision making 

8. Mutually beneficial suppler relationships 


Complementing these underlying principles are a series of requirements that need to be met in 

order to be certified (or registered as it is often referred to in North America). They are: 

1. Management Responsibility – The systems responsibility rests with the ‘top management’ of 

the organisation – thus at a strategic level. 

2. Resource Management – Sufficient human and physical resources are available to carry out the 

process. 

3. Product Realisation: There are necessary processes in place to produce the product or provide 

the service 

4. Measurement. Analysis and improvement – There are measurements in place that allow the 

system to be objectively measured, which give rise to the provision of information on how the 

system is performing in relation to customer 

Unlike many of the ISO standards, ISO9001: 2000 is a “generic” standard. Within the context of 

this paper “generic” means that it can be applied to any organisation, regardless of size or type. 

The model’s four requirements function in a similar way to the PLAN-DO-CHECK-ACT (PDCA) 

improvement process that was popularised by W. Edwards Deming. It is a process approach; therefore 

its model (figure1) illustrates how customer requirements drive the input and how customer 

satisfaction drives the output. The process approach emphasises the importance of: Understanding 

and fulfilling the requirements of the customer; The need to consider processes in terms of added 

value; Obtaining results of process performance and effectiveness and Continual improvement of 

processes based on objective measurement (Joint Technical Committee QR-008, 2000). 

Figure 1 

Papers 


Papers 

As illustrated (Figure 1) the process based quality management system shows the significant 

role that clients have in defining requirements as inputs. The continual improvement of a quality 

management system is derived from monitoring the satisfaction of clients, by evaluating information 

relating to their perception, as it is this that determines whether an organisation has met the 

requirements of their client (AS/NZS ISO, 2000). 

UniSA – A Formal management system 

The issue of quality has been recognised as being critically linked to an organisation’s success 

(Buzzell & Gale, 1987; Gronroos, 1990; Howat, Milne & Crilley, 1996). Embracing the principles of 

quality, UniSA has developed a framework, which includes a suite of tools and systems for managing 

its research and consultancy projects. The aim of developing this quality framework has been 

built on enabling a level of process consistency and gaining a better knowledge of our clients. 

To be able to objectively measure client satisfaction one must have a consistent approach. To 

achieve this the Research and Innovation Services Office has developed policy and procedures for 

the project management of research and consultancy along with mechanisms for the continual review 

and improvement of its processes. This approach is consistent with Johnson’s (1993) concept 

of ISO quality, suggesting that ISO9000 is about meeting client (or customer) requirements with a 

system that is appropriate, planned, controlled, documented and fully understood. 

At a functional level a reliable approach to the management, tracking and recording of research 

and consultancy projects has been achieved through the development of a web-based project management 

system called the Project Quality System (PQS). The PQS enables projects to be managed 

from proposal stage through to project completion, as its process tracks and records client details; 

intellectual property opportunities; risk assessment; capacity approval; budget entry and client 

feedback. It is this latter component, client feedback, which is in many ways most important as it 

enables us to assess whether we are delivering services our clients value. 

Service Quality Perceptions – The Clients’ Perception 

The initial question to be addressed therefore is “what do our clients value or want in their interactions 

with UniSA’s research services?” In 2001 UniSA undertook a project to answer this question. 

A portfolio of service attributes were identified by conducting two external client focus groups. 

Service quality issues were then incorporated into a self administered questionnaire and subsequently 

piloted with a sample of clients from the PQS database. The self administered questionnaires 

use a tailored service specific version of SERVQUAL, a conceptual service quality model 

able to facilitate the monitoring of customers’ service quality expectations and performance 

(Parasuraman, Zeithaml & Berry, 1985 and 1988). 


The adaptation of SERVQUAL is dependent on two variables: expected service and perceived service. 

The two variables are compared so that the ‘perceived service quality’ is interpreted from the 

differences in degree and direction between perceptions and expectations. 

The inaugural survey of external clients was conducted in March 2001, where a response rate of 

around 40% was achieved. Subsequent factor and other analysis on the 2001 data set resulted in 

improvements to the questionnaire, which included the identification of three industry specific dimensions 

of service quality, these were categorised as ‘product/service delivery’, ‘human resources’ 

and ‘assurance and reliability’. 

Each year since, the Research and Innovation Services Office has contracted an independent 

research centre elsewhere in UniSA that specialises in these types of surveys to survey our clients 

under the guidance of a pre-determined set of criteria. The response rate during the last four years 

has ranged from 34 to 40 per cent. 

The first two years annual surveys looked only at UniSA’s service delivery. The project has since 

extended to include other like institutions. The main advantage of extending the survey to several 

institutions was that it enabled benchmarking and identified areas of best practice. Each participating 

organisation thus receives an individual report with their results and a separate section 

where these are compared to the benchmark average. 

Since continuous improvement is a key theme in ISO9001:2000 it is not enough just to measure 

customer satisfaction - the standard requires the level of satisfaction to be improved. There are 15 

individual attributes measured – complete list can be obtained from the author. This paper now 

examines a small sample of survey results listing areas that are considered to be strengths and 

areas that require monitoring or attention. Furthermore it explores an area that was highlighted as 

‘requiring further attention’ and explains how the process was identified and improved. 

The attribute below (Figure 2) is the “summary” attribute, i.e. “overall satisfaction” 

Papers 

Figure 2. The measurement shows that overall satisfaction with UniSA has increased (6.00 in 2004 

from a maximum of 7.00) from the previous surveys (5.91 &5.65). This is considered a strength as 

overall satisfaction has increased consistently over a three year period. 

Similarly, another positive attribute (Figure 3) is that of “recommendation to others” 


Papers 

Figure 3. Recommendation levels in the 2004 survey remained reasonably consistent with previous 

year’s results, particularly in the percentage of respondents who would ‘recommend’ UniSA 

Research Services to others (50% in 2002, 52% in 2003 and 53% in 2004). 

By requesting respondents to rate their levels of importance and performance in relation to attributes 

of service quality, the 2004 survey highlighted a number of other attributes that may also be 

considered as competitive strengths: 

1. Employee knowledge and experience. 

2. Key contact person clearly identified. 

3. UniSA’s working knowledge of industry requirements. 

4. Assuring trust and confidentiality. 

5. Flexible Approach. 

6. Intention to use UniSA research services in future. 

The benefits of these results are: a confidence amongst researchers and research admin staff that 

their services are valued by clients, use in external marketing and knowledge of what processes can 

be maintained and which need improvement. For example, in the 2003 survey an attribute identified 

as requiring further consideration was that of “Administrative Processes”. To gain a better 

understanding of ‘administrative processes’ an external focus group was conducted with external 

clients. The focus group results identified ‘financial processes’ as an area where there was high 

concern. Free text responses (eg financial monitoring takes a number of calls to sort out, incorrect 

invoices) from the survey reinforced this aspect of service quality as one requiring immediate attention. 

To address this, an internal review was conducted on the processes that support the financial management 

of projects. A number of interviews were conducted, documented and reviewed with the 

aim of identifying common issues and opportunities. Based on the findings an action relating to 

the invoicing process was implemented and communicated to appropriate staff. 


In an effort to better comprehend and track financial processes the 2004 survey instrument was 

modified, whereby the ‘administrative processes’ attribute was removed and replaced by two questions, 

one focusing on ‘financial processes’ and the other on ‘legal processes’. The results of the 

2004 survey project show that the gaps (importance v performance) are smaller than the gap for 

the previously included ‘administrative processes’. Future surveys will assist in reinforcing these 

results, however, preliminary investigations suggest that 2004 survey respondents have had a better 

experience in relation to this aspect of UniSA’s service provision. 

Conclusion 

Papers 

Australian education continues to be faced with a number of challenges as it strives to provide the 

nation with advanced knowledge and innovative research and development (Australian Vice- 

Chancellors’ Committee, 2004). As a consequence of increased challenges and pressures universities 

are acknowledging they belong to a ‘market’ that will become increasingly competitive. One 

area of university operations that has historically been overlooked in the ‘quality’ forum is that 

of research. The Government currently measures performance based upon successful research 

student completions, research publications and research income. The latter is equally reliant upon 

private and public funding, which can involve substantial resource inputs by the partner. Devoid 

in the evaluation process to date has been the consideration of the services provided to the 

research partner. Prior to 2001 there existed no systematic way for Australian higher education 

research managers to measure the level of service quality provided to their clients. 

The development of this formal quality framework, which includes the ongoing objective measurement 

of client feedback, enables UniSA’s Research and Innovation Services Office to identify 

its strengths and address areas requiring attention as perceived by its external clients. Through this 

measurement we are then able to improve our services by reviewing and where appropriate re-engineering 

the processes that support the management of research and consultancy projects. 

The survey discussed in this paper is a cost-effective source of manager and decision maker 

friendly information that enables us to better understand the service perceptions and expectations 

of our clients. Competitive advantage or superior market positioning is thus achieved through this 

identification of client values and demands – thus giving rise to a sustainable future. The survey 

and the quality framework that grounds it provide UniSA with the ability to consistently, accurately 

and strategically evaluate service quality. 


Papers 

References 

Australian Vice-Chancellors’ Committee (2004). Pursuing the Vision for 2020. Election 2004: 

the next challenges for universities. Retrieved 7 July 2004, from http://www.avcc.edu.au/ 

Buzzell, R.D. & Gale, B.T. (1987). The PIMS Principles, Linking Strategy to Performance. New York, 

NY: The Free Press. 

Gronroos, C. (1990). Service Management and Marketing. Lexington, MA: Lexington Books. 

Howat, G., Milne, I. & Crilley, G. (1996). ‘Monitoring customer service problems and 

their resolution for leisure services’. New Zealand Recreation Association, Annual 

Conference Proceedings, Palmerston North, New Zealand, November 1996. 

Johnson, P.L., (1993). ISO9000 – Meeting the New International Standards. New York, 

NY: McGraw-Hill Inc. 

Joint Technical Committee QR-008. (2000). AS/NZS ISO9004:2000 Quality Management 

Systems – Guidelines for Performance Improvements. Sydney, Australia: Standards 

Australia International Ltd, and Standards New Zealand. 

Mentzer, J.T., Flint, D. J. and Kent, J. L. (1999). Developing a logistics service quality scale. 

Journal of Business Logistics, Vol. 20, No. 1, pp. 9-32 

Parasuraman, A., Zeithaml, V.A., & Berry, L.L. (1985). ‘A conceptual model of service 

quality and its implications for future research’. Journal of Marketing, Vol 49, pp. 41-50. 

Parasuraman, A., Zeithaml, V.A., & Berry, L.L. (1988). ‘SERVQUAL: a multiple-item scale or 

measuring consumer perceptions of service quality’. Journal of Retailing, 

Vol 64, pp. 12-40. 

Tetenbaum, T. (1998). ‘Shifting Paradigms: from Newton to Chaos’. 

Organisational Dynamics. Spring, pp. 21-32. 

University of South Australia (2005). Research at UniSA. Retrieved 18 June, from 

http://www.unisa.edu.au/research/researchatuni/default.asp 


Process of Legitimizing a Profession: Research Administration 

Rene Hearns, MPA, CRA 

Fiscal Officer & Budget Manager 

Cleveland State University 

Urban Dean’s Office 

2121 Euclid Avenue UR 320 

Cleveland, Ohio 44115 

216.687.2205 

rene@urban.csuohio.edu 

and 

Vera Vogelsang-Coombs, PhD 

Associate Professor & Director of the MPA Program 

Cleveland State University 

Department of Urban Studies 

121 Euclid Avenue UR 248 

Cleveland, Ohio 44115 

216.687.9223 

vera@urban.csuohio.edu 

AUTHOR’S NOTE 

I would like to thank the Society of Research Administrators, International (SRA) for all their 

support, especially Bill Caskey for his guidance and wisdom. 

Abstract 

Papers 

This study examined the field of research administration to determine if it meets the established 

criteria for a “profession”. Such criteria include understanding a body of knowledge, governed by 

a set of standards or code of ethics, continuing education and training, and advanced study and 

specialized training. A needs assessment demonstrated that the sample population has a strong 

interest in obtaining a graduate level degree/certification in research administration. Presentations 

of the data and subsequent discussions with an organization’s public administration faculty and 

administrators determined that research administration is an appropriate specialty (concentration) 

within their public administration masters program. Finally, the process creating a graduate 

level track for research administration within public administration was begun through the 

creation of a graduate certificate program that focuses on research administration. 


Papers 

The Problem and Its Statement 

The Problem 

In a matter of three business days, more than 35 professionals who subscribe to the research administration 

list-serv discussed the qualifications necessary to be a research administrator during 

a very intense and thorough electronic conversation. The outcome of the discussion culminated in 

the perceived need for academic educational programming without any clear direction on how to 

realistically fulfill this need. 

The Hypotheses 

Hypothesis 1. Research administration is a profession. 

Hypothesis 2. Research administrators want academic programming devoted to 

the profession. 

Hypothesis 3. Given its established body of knowledge and code of ethics, 

public administration is the logical intellectual educational track for research 

administration. 

The Definitions of Terms 

Profession is an occupation that has technical expertise as well as a set of ethical standards. 

Research Administration encompasses the administration and management issues from the concept 

of the research through the completion of the project and associated paperwork. 

Academia (Academic) is representative of institutions of higher education. 

Professionalization is the process of giving a professional character to an occupation. 

The Assumptions 

The professionals randomly drawn for the sample population are representative of the professionals 

in the field of research administration. 

The Need for the Study 

This study will evaluate an academic institution’s programs to determine if research administration 

readily aligns within the field of public administration, as well as performing a needs assessment 

of a sample of the profession to determine its interest in the academic professionalization of 

the occupation and, if the assessment substantiates the hypothesis, begin the process of creating a 

graduate program educational track in research administration. 

The Review of Related Literature 

Professionalization of a Profession 

Historically, occupations were deemed professions when they met a set of criteria. There is still 

a lack of consensus on what exact criteria constitutes a profession. Webster’s defines a profession 

as “an occupation usually requiring advanced study and specialized training. The entire group of 

persons practicing a profession.” 

The literature defines a profession as a group of individuals who understand a body of knowledge, 

contribute to society, require continued training, and are governed by standards (Fleisher, 

2003; Labuschagne, 2004; Essays, 1998 and American College of Sports Medicine (ACSM), 2003). 

Friedson takes the argument one step further by expanding on the literature and theorizing that 

economic feasibility determines if an occupation is a profession. 


Many specialties struggle with the perception of their lack of professionalism-from public administration 

through engineering. Public administration continues to discuss different concepts 

concerning its professional status (Spicer). Troen and Boles indicate that the teacher crisis is due to 

the lack of a career ladder, thereby preventing it from being considered “a real profession, similar 

to medicine and law.” Software engineers struggle with the concept of developing a certification 

or licensure similar to other engineering disciplines and are addressing the need for continuing 

education and certification of various grades of practitioners as found in the essays of Griss, 

Gotterbarn, and Shaw. 

These views may differ but the underlying precepts are the same. A profession requires dedication, 

education, involvement, ethics, and standards. The public demands accountability after unfortunate 

or isolated instances of unethical behavior occur (ACSM). These incidents or pressures from 

increasing risk usually force associations to focus their efforts on becoming a recognized profession, 

which when achieved, provides confidence in the behavior of its members. 

The Population of the Profession 

Papers 

Professional Organizations 

Research administration requires knowledge from many disciplines as emphasized by the variety 

of professional organizations available to promote continuing education (Appendix 1). The two 

main associations for research administrators provide continuing education for more than 10,000 

professionals through the utilization of list-servs, workshops, lectures, conferences, and networking 

to provide them the knowledge of regulations and techniques for decision-making. 

Body of Knowledge 

Members of NCURA and SRA developed the topical outline to assist institutions and professionals 

in developing the expertise necessary to support their research (Appendix 2). The Research 

Administrators Certification Council (RACC) utilizes the body of knowledge to prepare its certification 

examination. The topics of which a certified research administrator needs to have a sound 

understanding are: identification of funding opportunities, proposal development, budget preparation, 

administration of awards, ethics and professionalism, conflict of interest, bioethics, human 

subjects, animal care, responsible conduct in research, intellectual property, governing regulations, 

accounting, auditing, facilities management, contracting, procurement, records management, and 

human resource management. 

Code of Ethics 

An example of a research administrator’s code of ethics as found in SRA’s policy and procedure 

manual is: 

The Society of Research Administrators exists to improve the efficiency and effectiveness 

of the administration of research and sponsored programs. This improvement 

is accomplished, in part, through the development and promotion of professional 

standards. Accordingly, every member of the Society shall be governed by 

the following code of ethics. 

As a research administrator, I will: 1) Maintain the highest level of professional 

and personal conduct to enhance our organization and profession in order to gain 

the trust and respect of our peers, employer, researchers, research funding agencies, 

and the public at large. 2) Accept responsibility to enhance my professional 

competence and freely share my professional knowledge with others. Follow the 

letter and the spirit of the laws, regulations, and sponsorship agreement affecting 

research administration responsibilities. 3) Inform individuals who are associ- 


Papers 

ated directly or indirectly with my services of those policies, procedures, and 

regulations impacting conduct of research and research administration. 4) Avoid 

conflicts of interest, whether actual or perceived, and address such issues with the 

appropriate authorities of my employer or the society when the need arises. 5) 

Ensure that I maintain fairness and due process in research administration and 

the Society activities in which I am engaged. 

Education and Certifications 

The profession has a variety of certifications available for its professionals. RACC provides an 

examination on the generally accepted body of knowledge. Should the examinee pass the test, the 

Council issues the designation of Certified Research Administrator (CRA). The Association of 

Government Accountants provides a certification of governmental financial manager (CGFM). 

General Procedures 

The research administrators’ list-serv discussed the need for academic programming for the third 

time in as many years. An inquiry made to the leadership of the Maxine Goodman Levin College 

of Urban Affairs as to the possibility of incorporating the needs of this profession into the current 

programming produced the need for data. The subsequent conversations, program evaluation, 

and needs assessment were conducted to supply the necessary data for the academic institution’s 

consideration of expanding its educational programming. 

Program Evaluation 

A representative and distinguished faculty of SRA met with the authors to determine if the current 

educational programming would be able to be modified to meet the needs of the profession. During 

the conversations, potential courses for a graduate certificate program were identified, along 

with the development of a mission and vision statement. The group also identified the courses 

required for an advanced certificate program and what is desired for a concentration within a 

master’s program. The outcomes from the program evaluation became the basis for the institutional 

required needs assessment. 

Needs Assessment 

This assessment drew a sample of the SRA’s members, and it was determined that a sample size 

of 525 would provide a 95% confidence rate. The survey solicited information regarding the 

respondent’s demographics, attitudes regarding a graduate program certificate and preferred 

course content, attitudes regarding a master’s program and course content, tuition reimbursement, 

educational format’ and institutional policies governing leave. The instrument was distributed to 

a group of six individuals for evaluation and input to reduce issues associated with the response 

bias and improves the internal and external reliability of the survey. After the incorporation of the 

team’s comments, the survey was coded and placed on a designated website. 

The sample population was randomly selected by downloading the SRA membership email addresses 

into a spreadsheet format, randomly assigning a six-digit number, sorting the number 

in ascending order, and selecting the first 525 entries. Then the sample was assigned a randomly 

selected five-digit identification code to enter as a password to begin the survey. 


Selected members received an email indicating the purpose of the survey and requesting their participation 

with instructions. After having the survey available for four weeks, the survey results were 

downloaded and a query run against the identification code to determine which codes were non-responders. 

A second email requesting participation was issued to the non-responders. This procedure 

was repeated twice at two-week internals. After the deadline date, the data was downloaded to 

determine the feasibility of educational programming in the field of research administration. 

Treating the Data 

Review of the data indicated that it required cleaning to create uniform answers for comparison 

purposes. Standard mathematical rules were used, for instance if a respondent indicated years in 

the profession as 4.3 the cleaned entry listed the answer as four (4). Likewise, state of residence 

was made uniform using the standard two-letter identification code. If a response indicated an 

international affiliation, this category was separated into Canada and International, since Canada 

has similar professional development as the United States. After all the data represented uniform 

entries, various statistical calculations were performed. 

Certificate Program Development 

After analysis of the data, the initial group reconvened to determine the course selection, the 

proper format for providing the educational opportunity, the admission requirements, and what 

qualifies a person to be an instructor. The proposal incorporated the suggestions from the team 

and the institutional representatives. 

After the proposal received the executives’ support, it was presented to the Master of Public Administration 

faculty for evaluation and determination if it was something that they endorsed for 

development. After receiving their unanimous support, the entire department’s faculty reviewed 

the tract’s recommendation and also voted unanimously to incorporate the new programming into 

the college’s course offering. Since this is an additional certificate program, it required the approval 

of both the graduate council and the university’s board of trustees. After review, the proposal 

received both approvals. 

The Results 

Papers 

The needs assessment garnered 155 participants or approximately a 30% response rate. Generally, 

the respondents were from the United States, had held a mid-level position for five to fifteen 

years, and had either a bachelor’s or a master’s degree (see Table 1). The sample data appear to be 

reflective of the entire population: the SRA’s total international membership is five percent, and the 

international response rate was six percent. Even though it is reflective of the association’s population, 

the rate still may pose bias towards a certain type of demographic of the profession. 


Papers 

Table 1: Survey Respondents Demographics 

Work 

Location 

Management 

Level 

Organization type Education 

level 

Years in 

RA 

United States 145 Upper Level 47 Educational Institution 90 Doctoral 24 20+ yrs 11 

International 5 Middle Level 74 For-profit Business 5 J.D./Law 4 15-20 yrs 14 

Canada 5 Lower Level 34 Governmental Unit 10 Masters 54 10-15 yrs 44 

Test of the Hypothesis 

Medical Facility 17 Bachelors 58 5-10 yrs 78 

Nonprofit Business 19 Associate 6 0-5 yrs 8 

Research Facility 14 Some College 1 

High School 8 

155 155 155 155 155 

Hypothesis 1. The literature search found that the profession of research administration 

meets all of Fleisher & Lewis’ requirements to be considered a profession, as well as all of 

Labuschagne’s criteria except the requirement of advanced studies. The occupation has a body of 

knowledge, code of ethics, associations, certifications, peer reviewed journals, and various training 

opportunities, thereby meeting the established criteria of a profession. 

Hypothesis 2. When you compare the missing component of advanced studies to the 

survey results, you find that the respondents are very interested in the institutionalization of the 

profession in academia. This substantiates the interest found in the list-serv discussion. 

The survey reveals that even though 53% of the respondents already hold a master’s degree or 

higher, 75% of them are interested in obtaining a graduate certificate in research administration 

(Table 2). The sample populations’ interest is not as strong in pursuing a master’s degree. Surprisingly, 

88% of the respondents indicated that they would like to begin the program within one year. 

Table 2: Respondents interest in academic 

Interested in obtaining: Graduate Certificate Masters with a 

RA concentration 

Yes 117 75% 85 55% 

No 38 25% 70 45% 

How soon would you start: 

155 155 

ASAP 63 54% 39 46% 

In 1 year 40 34% 33 39% 

In 2 years 10 9% 4 5% 

In 3 years 4 3% 8 10% 

117 84 

The data indicates that the respondents believe they need or desire continuing education that 

culminates in a certificate or degree, as seen through the high response rate found in Table 2; 

however, these respondents do not believe that a graduate certificate or a master’s degree will assist 

them in receiving a promotion (Table 3). This reflects the lack of a career ladder for the profession, 

which academic programming corrects. 


Table 3: Will it provide you a promotion? 

Help receive a promotion? Certificate Master’s degree 

Yes 79 51% 87 56% 

No 76 49% 68 44% 

155 155 

Hypothesis 3. The interaction with the representatives from SRA provided the insight as to 

how the body of knowledge (Appendix 2) corresponds perfectly with the organizational structure 

of the university’s Master of Public Administration (PA) program. The goals and the mission of 

the PA program and the profession have plenty of common ground. Some research administrators 

may find that healthcare administration enhances their technical expertise better, but at the 

university where the program was evaluated, the master’s program in public administration has a 

healthcare track. This only exemplifies the marriage between the profession and public administration. 

Other Findings 

The lack of definitions within the survey may have caused respondents to misrepresent the types 

of organizations represented. For example, some institutions are a medical facility within a university; 

some respondents may view themselves as the medical facility while others may identify 

as a university. The study did not ask specific questions about the respondents’ views on whether 

the career ladder can require relocation or whether they were looking to receive a promotion or to 

maintain their current position. 

Approximately 10% of the respondents’ additional comments indicate that academic programming 

is needed, but do not believe that the profession is able to institutionalize the program. 

Summary of Results 

75% of the respondents indicated that they are interested in pursing an academic certificate, with 

54% wanting to begin immediately. Another 34% indicated that they would like to begin the program 

within one year. This equates to 136 SRA members who would enroll in an academic certificate 

program within two years of the survey. Considering the course enrollment size limitations of 

30 students, the academic course would have a four-year waiting list. 

Summary, Conclusions, and Recommendations 

Papers 

Summary 

The profession of research administration is pursing formal education in addition to the required 

continuing education that is supplied by its associations. Surveying a sample of one professional 

organization substantiates the hypothesis that the professionals are in search of academic education 

that incorporates the needs of their specialization. Presenting the results to an academic 

institution verified the need of this specialization, thereby placing the system in motion for the 

academic institution to institutionalize the needs of the profession in academic programming. 


Papers 

Conclusions 

With the creation of a graduate certificate program, research administration will meet all of the 

criteria found in the literature to be deemed a profession. If one extrapolates the survey results 

only to the populations of the two main research administration associations, the graduate certificate 

program has a four-year waiting list if each cohort were limited to 30 participants. Reviewing 

the accepted body of knowledge, the principles and structure directly relate to the governance and 

standards of the field of public administration. 

Recommendations 

There is a dramatic need for more than one academic institution to offer graduate education in 

research administration. This would not only provide the recognition that these administrators 

have a field of expertise, but that they are professionals. Academic institutionalization would create 

the necessary career ladder to retain the best and the brightest. 

Bibliography 

American College of Sports Medicine. (2003). Efforts underway to professionalize health and 

fitness and clinical exercise physiology occupations. Retrieved June 28, 2005 from ACSM website 

via http://www.acsm.org/ 

Berg, J. H. (2005, April). Board certification during teaching’s second stage: Redefining the profession 

through roles. Presented at the American Educational Research Association Annual 

Conference, Montreal, Quebec, Canada. 

Brint, S. (1993, August) Eliot Friedson’s contribution to the sociology of professions. Work and 

Occupations. 20, 259-278. 

Essays of an Information Scientist. (1983). How IFSEA and other editor’s associations are helping 

to professionlize Scientific Editing. Vol. 6 p 330-337, 1983 Current Contents, #41, p 5-12, October 

10, 1983. retrieved from http://www.garfield.library.upenn.edu/essays/v6p330y1983.pdf 

Fleisher, C. (2003). SCIP’s new journal important to professionalize CI. Retrieved June 1, 2005 

from Society of Competitive Intelligence Professionals website via http://www.imakenews. 

com/scip2/e_article000141362.cfm 

Gotterbarn, D. (1998, November). Software engineering as a profession. Presented at the 6th Association 

for Computing Machinery Special Interest Group on Software Engineering (ACM 

SIGSOFT) international symposium on Foundations of software engineering, Lake Buena 

Vista, Florida, United States. Pages: 205 - 206 

Griss, M. (1998, November). Software engineering as a profession: Industry and academia working 

together. Presented at the 6th ACM SIGSOFT international symposium on Foundations of 

software engineering, Lake Buena Vista, Florida, United States. Pages: 203 - 204 

Labuschagne, L. (2004, October). Professionalizing PM to enable growth in South Africa. Presented 

at the 3rd Project Management South Africa- Kwazulu Natal conference, 

Lewis, C. W. (1991). The ethics challenge in public service: a problem-solving guide. Jossey-Bass Inc., 

Publishers. 


Shaw, M. (1998, November). A profession of software engineering: Is there a need? Yes. Are we 

ready? No. Presented at the 6th ACM SIGSOFT international symposium on Foundations of 

software engineering, Lake Buena Vista, Florida, United States. Pages: 207 – 208 

Spicer, M. (1995) The founders, the constitution, and public administration: a conflict in world 

views. Georgetown University Press, Washington DC 

Troen, V. and Boles, K.C. (2005). Principal: Politics and the principalship, speaking out. National 

Association of Elementary School Principals. January/February 2005, Vol. 84, No. 3. 

Webster’s II New Riverside Dictionary Revised Edition 1996 

APPENDIX 1 

Association for the Assessment and Accreditation of Laboratory Animal Care International 

“AAALAC” 

American Association for the Advancement of Science “AAAS” R&D Page 

American Association for Cancer Research (AACR) 

American Association for Clinical Chemistry “AACC” 

The American Speech-Language-Hearing Association (ASHA) 

American Veterinary Medical Association “AVMA” 

Public Responsibility in Medicine and Research (PRIM&R) 

Association of Biomolecular Resource Facilities “ABRF” 

Association of Clinicians for the Underserved 

Association of Government Accountants 

Association of Independent Research Institutes “AIRI” 

Association of American Medical Colleges “AAMC” 

Association of American Universities “AAU” 

Association of Proposal Management Professionals (APMP) 

Association of University Technology Managers “AUTM” 

Council on Governmental Relations “COGR” 

European Association of Research Managers and Administrators “EARMA” 

Federation of American Societies for Experimental Biology “FASEB” 

Foundation for Biomedical Research “FBR” 

Government Finance Officers Association 

Government-University-Industry Research Roundtable “GUIRR” 

MidAmerica Congress on Aging -- Internet Resources for the Aging 

National Academy of Sciences “NAS” 

National Association for Biomedical Research “NABR” 

National Association of College and University Business Officers “NACUBO” 

National Association of State Universities and Land Grant Colleges “NASULGC” 

National Council of University Research Administrators “NCURA” 

Radiation Research Society 

Research Administration Certification Council 

Swiss Association of Research Managers and Administrators “SARMA” 

European Association of Research Managers and Administrators 

**This list is not considered comprehensive 

Papers 


Papers 

APPENDIX 2 

I. Research Administration – The Profession 

A. Research Administration 

B. The Research Administrator 

C. The Research Mission 

D. Core Values 

E. Interactions with Researcher 

F. Research Administration and Other Institutional Operations 

G. General Management 

H. Institution/Organization Setting for Research Administration 

II. Infrastructure – The Framework for Research Administration 

A. Organization for Research and Research Administration 

B. Regulatory Environment 

C. Legal Framework 

D. Institutional Capacity Building 

E. Institutional Investment in Research 

III. Project Development – The Pre-Award Stage 

A. Strategy Formulation 

B. Collection and Dissemination of Funding Opportunity Information 

C. Sponsor Structure, Protocol, and Practices 

D. Types of Proposals 

E. Proposal Development and Submission 

F. Collaborative Project Development 

G. Marketing Research 

H. Pre-Award Sponsor Activities 

I. Post-Submission Communications 

IV. Project Administration – The Post-Award Stage 

A. Award Process 

B. Basic Agreements 

C. Project Implementation 

D. Project Support Systems 

E. Departmental Administration 

F. Close-Out 

G. Post-Project Activities 

V. Public Responsibility – Fulfilling the Public Trust 

A. Compliance & Assurances 

B. Project Integrity 

C. Preserving the Public Trust 

D. Dynamics of Public/Private Collaborative Research 

E. Intellectual Property 

F. Technology Transfer 

Source: http://www.srainternational.org/ 


Informed Consent: Writing? Readability? Understanding? Deciding? 

Mark Hochhauser, Ph.D. 

Readability Consultant 

3344 Scott Avenue North 

Golden Valley, MN 55422 

Phone: 763-521-4672 

Fax: 763-521-5069 

E-mail: MarkH38514@aol.com 

Papers 

Abstract: 

This article analyzes the consent form both from the writer’s perspective (Writing and Readability) 

and the subject’s interpretation (Understanding and Deciding). The Writer (Part I) suggests consent 

form improvements via 1) a plain English Summary and 2) document design recommendations. 

Because regulators and IRBs assume that consent form “readability” affects understanding, 

Part II (Readability) explains 1) consent form readability, 2) why reading and understanding are 

not the same, and 3) the difficulty of writing consent forms at a 6th-8th grade reading level. The 

Subject (Part III) 1) summarizes consent form comprehension studies showing that consent forms 

written at lower grade levels improve comprehension only slightly, 2) identify flaws in consent 

form comprehension research, and 3) describe how to reduce therapeutic misconceptions by contrasting 

research and treatment. Part IV (Deciding) points out how brain anatomy affects consent 

form understanding, 2) why logic and emotion influence consent decisions, 3) the relationship 

between working memory and information overload, 4) how prospective subjects use “heuristics” 

to make decisions under uncertainty and 5) how “cognitive illusions” can affect consent form understanding 

and the decision making process. 

Introduction 

The Writer: Federal regulations (45 CFR 46) state that: 

“The information that is given to the subject or the representative shall be in 

language understandable to the subject or the representative.” 

The Nuremburg Code states that: 

“The person involved…should have sufficient knowledge and comprehension of 

the elements of the subject matter involved as to enable him to make an 

understanding and enlightened decision.” 

The World Medical Association Declaration of Helsinki states that: 

“In any research on human beings, each potential subject must be adequately 

informed of the aims, methods, anticipated benefits and potential hazards of the 

study and the discomfort it may entail.” 

But implementing those broad recommendations into the consent form process has proved difficult, 

if not impossible. Unfortunately, these three documents do not suggest how consent form 

writers can produce consent forms in “understandable language” so potential subjects can “be 

adequately informed” in order to make “an understanding and enlightened decision.” This writing 

problem is compounded by the requirement that consent forms include the FDA’s eight “basic 

elements” of informed consent, six “when appropriate” elements of consent, plus as many as six 

to eleven HIPAA privacy topics. Such requirements lead to average (oncology) consent forms of 

2,700 words in eleven pages (Sharp, 2004). 

But HIPAA adds even more words and topics to the consent form. Whether HIPAA information 

is included as part of the consent form or as an addendum to the consent form, it still contributes 

to the prospective subject’s cognitive load. Researchers must consider the all 20-25 topics in the 

consent process/consent form, because the topic count gives an idea of the information overload 


Papers 

facing patients being recruited for clinical trials. Consent form writers face difficult conflicts. 

While they’re expected to write consent forms that are compliant with the three requirements 

listed above, they must also include up to 25 topics in the consent form, even though a prospective 

subject’s working memory can store only about three-to five pieces of information. 

Writing and designing consent forms: Considering the consent form as a “form” to be designed 

and not just pages of text to be typed offers new ways of presenting consent form information. 

Hochhauser (2003) identified several plain English strategies that might improve understanding, 

including: 

• one-page plain English consent form summary that addresses the 14 “basic” and 

“when appropriate” elements of informed consent, 

• a table of contents to help readers find key section in the consent form, 

• a question and answer format, 

• use of larger fonts and bold or italicized text to emphasize key points, 

• using tables to summarize monthly visits, risks, etc., 

• using bullet points instead of sentences to summarize lengthy topics, 

• including space for a subject’s questions and the researcher’s responses after 

each section. 

Added to these plain English strategies are standard document design techniques that enhance the 

visual appeal of the consent form. These include text choices (serif type faces, at least a 12 point 

font and lowercase text), headings and subheadings (lowercase with no periods and close to the 

next line to avoid “floating” headings), and formatting (about 8-12 words per line, equal spacing 

between words, unjustified margins, a two-column newsletter format, etc.). Too many consent 

forms look as though they have been typed instead of designed; they have no visual appeal. 

Readability issues 

Because consent forms are required to be written in understandable language to adequately inform 

subjects so they can make enlightened decisions, both federal regulators and IRBs have arbitrarily 

chosen reading grade level as a way to meet those requirements. That’s why the standard recommendation 

is for consent forms to be written at a 6th to 8th grade reading level. But that simplistic 

recommendation fails on several counts. 

Formula validity and reliability: Readability formulas are 30 to 65 years old; the classic Flesch 

Reading Ease Score was developed by Rudolf Flesch in the mid 1940s. It’s not clear that what 

Flesch meant by an 8th grade reading level in 1945 is the same as an 8th grade reading level in 

2005. Although most readability formulas were designed to be calculated “by hand,” computers 

made it possible to convert such formulas into readability software programs. Unfortunately, that’s 

more difficult than is usually recognized. While it’s easy for a person to count syllables, words, and 

sentences, it’s much harder to write a software program to do that. Because readability software 

programs aren’t as accurate or consistent as they should be, many consent form readability studies 

are seriously flawed. For example, the Flesch-Kincaid readability formula is widely used because 

it’s included in Microsoft Word. But most consent form writers don’t know that Microsoft’s version 

of the Flesch-Kincaid does not report grade levels above 12, although the formula can calculate 

up to a grade 17 level. While the formula’s results should be the same in every software package, 

it isn’t. Hochhauser (1997) compared six software programs that used the Flesch-Kincaid on one 

consent form. He found that the Flesch-Kincaid grade levels reported ranged from 12.1-14.5—a 

difference of 3.5 grades. 


Papers 

Readability vs Comprehension: Grade level recommendations assume that consent forms written at 

a 6th- 8th grade level will be more understandable than those written at a college grade level. Unfortunately, 

that assumption isn’t supported by the evidence. A 2004 review (Hochhauser, 2004b) 

of comprehension of hard-to-read original documents vs easy-to-read revised documents found 

only small improvements in reader understanding, perhaps an improvement of about 10%-15% 

in understanding. But even that degree of improvement was weakened by the way comprehension 

was measured. Of the nine studies reviewed, only two addressed the validity and reliability of the 

comprehension measures. Unless such measures are shown to be both valid and reliable, their reliance 

on “face validity” is scientifically meaningless. Equally important is that comprehension was 

often measured by true-false or multiple choice questions. But true-false measures suffer from the 

limitation that since there are only two choices, a respondent can get half the answers correct by 

guessing; multiple choice questions have a similar problem, insofar as a question with four choices 

can be answered correctly 25% of the time by guessing. With such scientifically weak comprehension 

measures, the assumption that the recommended 6th- 8th grade consent form will significantly 

increase comprehension over a 14th grade consent form remains to be proven. 

Writing at a 6th-8th grade level: Even if the recommended goal for a consent form is a 6th-8th 

grade reading level, reaching that goal will be difficult, if not impossible. Because readability formulas 

calculate grade level based on the average number of words in a sentence and the average 

number of syllables in a word, the only way to get a consent form down to a 6th-8th grade level is 

to write shorter sentences with fewer words. Flesch’s Reading Ease score (Flesch, 1949) estimates 

that documents written at a 6th-8th grade reading level will average 14-17 words per sentence and 

139-147 syllables per 100 words. Given technical language of a typical consent form, it’s unlikely—if 

not impossible—to write consent forms at that recommended level. Writers can “write to the 

formula” (e.g., changing one long sentence into three shorter sentences) but readability researchers 

do not recommend that strategy because it often results in shorter, but choppier sentences that 

don’t communicate very well and might not improve comprehension. Paradoxically, consent forms 

written at a statistically more “readable” level may not be more “understandable.” 

The Subject 

Understanding informed consent: Because research shows that documents rewritten to lower grade 

levels do not improve comprehension very much, it’s crucial to ask what comprehension means 

to both researchers and prospective subjects. What researchers communicate isn’t always what’s 

understood. 

As noted above, consent form comprehension studies show that consent forms written at lower 

grade levels don’t improve comprehension very much. But because of study limitations, even those 

small improvements may not generalize to understanding informed consent in the clinical trial 

setting. While those studies that found some improvement in comprehension with consent forms 

written at lower grade level, those studies often used consent forms that were fairly brief, anywhere 

from 300 to 1,000 words, while Sharp’s (2004) analysis of oncology consent forms found them 

to average eleven pages and about 2,700 words. But it may be worse than that. Sharp’s analysis 

only included the typical informed consent form—not the newer consent forms that often include 

HIPAA information. Although the FDA does not require HIPAA information to be part of 

the consent form which would require it to be reviewed by the IRB, many sponsors have added 

HIPAA information to the consent form instead of including it as an addendum—which does not 

have to be reviewed by the IRB. Additional HIPAA information can add another 500-900 words 

to the consent form, making the typical oncology consent form about 3,500 words long—over ten 

times as long as some consent forms in the comprehension studies. 


Papers 

Even if prospective subjects can recall key elements of the clinical trial when asked, such recall 

may reflect only rote memory with little influence on subjects’ decision making process. For 

people with average memories, let alone those patients whose memories may be affected by psychological 

stress, emotions, their illness or drug treatments, remembering every piece of information 

in the consent process would be psychologically overwhelming, making a carefully reasoned 

decision virtually impossible. 

Better understanding via enhanced consent forms? Because of concerns about participants’ ability 

to understand the information given to them in the informed consent process/consent form, some 

researchers have tried to improve subjects’ level of understanding, usually by trying to modify 

and improve the consent form. In their review of these efforts, Flory and Emanuel (2004) found 

that enhanced consent forms didn’t significantly improve participants’ understanding—but more 

person-to-person contact by a study team member or neutral educator did improve understanding. 

As they note, much of the “enhanced” research has emphasized the consent form, although 

the informed consent process includes both conversational and written components. While they 

noted that this research varied in terms of methodologies and measurement instruments, they did 

not explore the psychologically relevant issues of instrument validity and reliability. If measures 

of consent form comprehension were not developed with an awareness of validity and reliability 

issues, the findings from those studies are scientifically meaningless. 

Similar conclusions were reached by Campbell, Goldman, Boccia, et al (2004) who compared informed 

consent information recalled via four presentations: 1) original written forms, 2) enhanced 

print—simpler language, topic headings, pictures, 3) narrated videotapes, 4) self-paced Power- 

Point laptop presentations with bullet points, picture, and narration. They found no overall differences 

in the amount of information recalled, but did find recall improvements with the enhanced 

print version for subjects with 8th grade or lower reading comprehension scores. But the links 

between memory, understanding, and decision making are presumed, not proven. 

Over the past 20 years, Paul Appelbaum and his colleagues (Appelbaum, Roth, Lidz, 1982; Appelbaum, 

Roth, Lidz, et al 1987) have written extensively about “therapeutic misconception” in 

clinical trials—the mistaken belief held by many patients that research projects will directly benefit 

them. A recent study (Appelbaum, Lidz, and Grisso, 2004) found about 30% of participants having 

inaccurate beliefs about the degree of individualized treatment they would get in a clinical trial; 

about 50% had unreasonable beliefs about the benefits of being in a clinical trial. These researchers 

have consistently suggested that the informed consent process include specific information to 

patients so that they do not believe that a clinical trial is just another form of treatment. One possible 

way to address these issues is to have a summary (see Table #1) of how research differs from 

treatment that can be discussed with patients during the informed consent process. 


Table #1: Dealing with Therapeutic Misconception 

Research is not treatment because… Treatment is not research because… 

You are a subject in research, not a patient getting 

standard treatment for your disease 

You are a patient getting standard treatment for 

your disease 

All subjects get standard treatment All patients get individualized treatment 

Research produces generalizable results that 

might help others; it might not help you 

You may get an experimental treatment, standard 

treatment or a placebo 

Your treatment will be based on random assignment 

Research requires inclusion and exclusion 

criteria for each subject 

Research MDs to not now what drug you get in 

a double-blind study 

You have human subject rights; your research 

information may be shared with... 

Research is not treatment; informed consent is 

always required. 

Treatment is expected to help you 

Papers 

You will get the best available standard treatment 

Your treatment will be based on your individual 

needs 

Standard treatment does not have inclusion or 

exclusion criteria for your to be treated 

Personal MDs know what drugs you are taking 

You have patient rights; your patient information 

may be shared with... 

Treatment is not research; informed consent is 

sometimes required. 

Deciding to be in a clinical trial: Decision research has not been incorporated into research on informed 

consent in clinical trial, although Princeton University Psychologist Dan Kahneman won 

a 2002 Nobel Prize for his work on “…human judgment and decision making under uncertainty.” 

(Kahneman, 2003). “Analyses of decision making commonly distinguish risky and riskless choices” 

(Kahneman & Tversey, 2000, p 1). But consent forms usually to not “frame” risks and benefits 

in ways they make them easily understood or usable to prospective subjects. 

How do prospective subjects interpret: “You might have all, some, or none of the following side effects…” 

followed by a bulleted list of 39 possible side effects? Or, “All medications have side effects 

and, with an investigational drug, these can sometimes be unforeseen. The risks and discomforts 

currently seen include but may not be limited to the following…” followed by almost two pages of 

text listing every possible risk. Or, “Some of the less common side effects include…” and “Some 

uncommon but potentially serious side effects include…?” What does “less common” mean? What 

does “uncommon but potentially serious” mean? If prospective subjects don’t have a psychological 

frame for the risks, how can they emotionally and logically judge the study’s risk potential? 

Like risks, benefits are usually not explicitly described: “Although XYZ is being tested as a treatment 

for a condition that you may have, there is no guarantee that you will receive any medical 

benefit.” Or “Information obtained from this study will benefit the sponsor of the study and may 

benefit patients in the future” or “The study drugs are still being clinically tested so it is not possible 

to predict whether they will be of benefit to you.” Perhaps as a way of trying to reduce therapeutic 

misconceptions about the benefits of being in a clinical trial, consent form writers often use 

ambiguous language to describe a trial’s benefits. In the context of gene transfer research, King, 

et al (2005) have categorized benefit statements as 1) Contentless (2% of consent forms) defined as 

having no nature information, with examples such as “You may or may not benefit…”, 2) Surrogate 

Endpoints (65% of consent forms), defined as a lab measurement that represents a clinical endpoint, 

such as tumor shrinkage, and 3) Clinical Endpoint (2% of consent forms), defined as a specific benefit 

that subjects can feel or experience, such as living longer, having fewer bleeds and 4) Surrogate 

and clinical endpoints (31% of consent forms). Unlike lists of risks, consent forms don’t include 

a list of possible medical benefits, only ambiguous statements about “medical benefits,” although 


Papers 

sponsors must have some idea of what they expect (hope?) the experimental drug will accomplish. 

While researchers walk a fine line between informing vs misleading subjects about possible benefits, 

how can subjects make an informed decision if they can’t compare specific risks and specific 

benefits? 

But deciding to be in a clinical trial requires that subjects understand the risks and benefits of being 

in that trail. But if risks and benefits are not clearly articulated, how can patients be expected 

to make an informed decision? Although risks are often described as “common,” “uncommon” or 

“rare,” unless those terms are defined, patients will make their own definitions. Berry, et al (2003) 

compared the frequency of drug-related adverse events by study participants to the frequencies 

defined by the European Commission (EC) for events that were “very common,” “common,” 

“uncommon,” “rare,” or “very rare.” In every case the study participants rated the risks as likely 

to be more frequent than the EC definition. For example, while the EC defined a “very common” 

adverse event as one that affected more than 10% of patients, study participants defined “very 

common” as one affecting 65% of patients. The EC defined as “rare” an adverse event that affected 

.01% - .1% of patients, but the study participants defined “rare” as an adverse event that affected 

8% of patients. The point made by both of these studies is that unless risks and benefits are explicitly 

defined in measurable ways, patients will be unable to made an informed decision, because 

that decision will be based on incomplete or even missing definitions of risk and benefits. 

Conventional thinking implies that if only patients could better understand the consent form, 

they would use that understanding to make an “informed decision” about whether to volunteer to 

be in a clinical trial or not. But beyond that simplistic assumption, the regulatory and bioethical 

literature does not address the specifics of how patients actually make that kind of decision—even 

though there is considerable psychological research on how people make decision, especially under 

conditions of uncertainty. Table #2 summarizes five strategies that can be used by subjects to 

arrive at a decision—whether they understand the consent process or not. 

Table #2: Decision-making strategies for informed consent 

Decision-making strategies Explanation 

1. Brain anatomy 1. Informed consent takes place in the brain 

2. Logic and emotion 2. Brain includes areas for logical analysis and 

emotional reactions 

3. Intuition 3. Fast, selective unconscious thinking 

4. Heuristics 5. Mental shortcuts to reduce uncertainty or 

information overload 

5. Cognitive illusions 6. Decisions affected by how information is 

“framed” 

All decision-making strategies are based on how the brain processes specific information about a 

clinical trial from the consent process/consent form, as well as patients’ experiences in the health 

care system, their patient-doctor relationship, etc. 

1) Brain anatomy: Obviously informed consent takes place in the brain (Hochhauser, 2005). While 

the importance of the brain functioning is usually acknowledged if a clinical trial involves subjects 

with schizophrenia, or elderly patients with dementia, or unconscious emergency patients, the 

role of how the brain processes information in patients without those obvious brain disorders is 

seldom recognized. Federal regulators, bioethicists, and consent researchers won’t understand the 

consent process unless they understand how the brain processes complex information. 


Papers 

2) Logic and emotion: “Everyone knows that emotions play a significant role in decision making 

and choice” (Hastie & Dawes, p 206). Or do they? Because the brain includes areas that process 

information logically (the frontal area) and emotionally (the limbic system), the informed consent 

process is both logical and emotional (Hochhauser, 2004a). The continuing emphasis on informed 

consent strictly as a logical process based on rules of rational thinking ignores the limbic system’s 

emotional reaction and response to the consent process. Moreover, research on “risk as feelings” 

(Loewenstein, Weber, Hsee & Welch, 2001; Finucane, Peters & Slovic, 2003) implies that clinical 

trial risks aren’t just analyzed logically by prospective subjects, but subjectively “felt” in ways that 

help them decide whether to become clinical trial subjects. 

3) Intuition: Defined by Random House Webster’s College dictionary as “direct perception of 

truth, fact, etc. independent of any reasoning process,” intuition is one way patients can make 

quick decisions about whether to be in a clinical trial or not. In those cases where patients say 

“No” almost immediately after being approached by a researcher, it’s obvious that they’ve made a 

decision based on something other than a careful analysis of the clinical trial’s informed consent 

process. Or in those cases where patients say “Yes” almost immediately, not even taking the time to 

read or understand the consent form, that decision may be intuitive. 

Gladwell (2005) describes research showing that people make some intuitive decisions in the 

“blink of an eye” by “thin-slicing”—“the ability of our unconscious to find patterns in situations 

and behavior based on very narrow slices of experience.” (p. 23) There is so much information in 

the consent process/consent form that most patients probably decide very quickly whether to be in 

a clinical trial or not. Gladwell notes that a surgeon’s traits such as lack of warmth, hostility, dominance 

and anxiousness were good predictors of which surgeons got sued for malpractice. From a 

patient’s perspective, malpractice isn’t based just on a surgeon’s skills, but on intuitive judgments 

about that surgeon’s demeanor. In the same way, the decision to be in a clinical trial may based on 

the researcher’s outward demeanor. If some researchers consistently find it harder to recruit subjects 

than other researchers, perhaps the recruiting problem isn’t the research, but subtle negative 

cues detected by patients. 

Because risk perception is only slightly related to actual risks, understanding clinical trial risks 

isn’t the strictly rational process that it seems to be. Myer’s analysis of intuition (2003) notes that 

people tend to overestimate well-publicized risks, while they underestimate others. A well-publicized 

death in a clinical trial will probably cause most patients to think that clinical trials are much 

more risky than they actually are, since there’s no publicity about the people who have not died in 

clinical trials. Why did subjects overestimate risk in the Berry, et al (2003) study: Probably because 

a person’s risk assessment has little to do with a statistical understanding of risk and more to do 

with their intuitive and emotional feeling about risk. Of course, intuitive decisions aren’t always 

the right decisions, but they may lead to right decisions more often than not. 

In the context of informed consent for medical treatments, Ubel and Loewenstein (1997) 

concluded that while such consent is often based on a communication model in which physicians 

present relevant information to patients to make informed treatment decisions. But that model 

does not include decision analysis strategies or intuitive factors (such as hope and fear) that are 

often unrecognized aspects of the consent process. Holmes-Rovner and Wills (2002) reviewed 

behavioral decision theory’s implications for two different aspects of informed consent: informing 

patients and consenting patients in clinical trials. Because they require different conceptual 

and decision making strategies, they recommended new debiasing techniques both for informing 

(based on effectiveness) and consenting (based social and individual values) prospective subjects 

Psychologically, there’s much more to these decisions than listening to a consent presentation, 

reading a consent form, and arriving at a decision. 


Papers 

4) Heuristics: Since the consent process/consent form includes too much information, patients 

must find ways to reduce the amount and complexity of that information to a more usable level. To 

do that, they’ll use “heuristics”—strategies used to simplify complex choices. Heuristics that may 

be used in the consent process include 1) availability—information a patient thinks about during 

the consent process, such as remembering media stories about clinical trials or “guinea pigs” in 

research, their own healthcare experiences, etc.; 2) representativeness—the similarity of the actual 

clinical trial experience to their mental model of a clinical trial. Therapeutic misconception may 

arise because patients confuse their history of medical care with medical research. If their only 

experience is with treatment, they may interpret clinical trias as another form of treatment.(e.g., 

Applebaum, Lidz and Grisso, 2004); or 3) vividness—information that is vivid and concrete has 

more impact on the decision making process than dull, abstract information. Television reports 

about the pharmaceutical industry’s problems and clinical trials may be so vivid and powerful 

(and representative) that such reports can overwhelm the researcher’s informed consent presentation. 

The brain has other strategies to deal with too much information. Dougherty, Gronlund, and Gettys 

(2003) suggest that judgment and decision making is based on key aspects of memory, such 

as the ability to store and retrieve information. The serial position effect, in which information 

from the beginning or end of a list document is more easily remembered than information from 

the middle, means that prospective subjects would be expected to better remember those topics 

covered at the beginning and end of the consent process—but not all 20-25 topics. 

5) Cognitive illusions: As the brain can be fooled by optical illusions, so can it be fooled by cognitive 

illusions—default strategies that the brain uses to analyze complex information. Unfortunately, 

while there are intriguing findings on how our brains can be fooled (e.g., Piatelli-Palmarini, 

1994; Pohl, 2004), the possible relationship between such illusions and informed consent has yet 

to be studied. Research on cognitive illusions has not included any studies on informed consent in 

clinical trials, and research on informed consent in clinical trials has not included any research on 

cognitive illusions. 

From this perspective, some issues in the informed consent process may be explained via cognitive 

illusions. For example, while “therapeutic misconception” has been identified in as many as 60% of 

subjects (Appelbaum, Lidz & Grisso, 2004), there is not yet a good explanation for why therapeutic 

misconception occurs. Such misconceptions may be influenced not only by “representativeness,” 

but also by magical thinking (where prospective subjects perceive an inappropriate correlation between 

research and treatment) and “probability blindness” (where study risks are not well understood), 

especially if such risks are not statistically “framed.” 

Conclusion: Researchers are encouraged by federal regulators and IRBs to write consent forms at 

about an eighth-grade reading level, presumably because such consent forms will be made more 

understandable and more understanding makes for a better “informed” decision. But the presumed 

links among readability, understanding and informed decisions may be based more on 

overconfidence and magical thinking of regulators and IRBs than on solid empirical evidence. 

Cognitive illusions exist not only in the minds of prospective subjects, but in the minds of regulators, 

researchers and consent form writers as well. 


References 

Appelbaum, P.S., Roth, L.H., Lidz, C.W. (1982) The therapeutic misconception: Informed consent 

in psychiatric research. International Journal of Law & Psychiatry, 5(3-4), 319-329. 

Appelbaum, P.S., Roth, L.H., Lidz, C.W., et al. (1987) False hopes and best data: 

Consent to research and the therapeutic misconception. Hastings Center Report, 17(2), 10-24. 

Appelbaum, P.S., Lidz, C.W. and Grisso, T. (2004) Therapeutic Misconception in Clinical Research: 

Frequency and Risk Factors. IRB: Ethics & Human Research, 26(2), 1-8. 

Berry, D.C., Raynor, D.K., Knapp, P. & Bersellini, (2003) E. Patients’ Understanding of Risk 

Associated with Medication Use. Drug Safety, 26(1), 1-11. 

Campbell, F.A., Goldman, B.D., Boccia, M.L., et al.(2004) The effect of format modifications and 

reading comprehension on recall of informed consent information by low-income parents: a 

comparison of print, video, and computer-based presentations. Patient Education & 

Counseling, 53(2), 205-216. 

Dougherty, M.R.P, Gronlund, S.D. and Gettys, C.F. (2003) Memory as a Fundamental Heuristic for 

Decision Making. In Schneider, S.L. and Shanteau, J., eds. Emerging Perspectives on Judgment 

and Decision Research. Cambridge, UK: Cambridge University Press. 

Finucane, M.L., Peters, El. & Slovic, P. Judgment and Decision Making: The Dance of Affect and 

Reason. In Schneider, S.L. and Shanteau, J., eds. Emerging Perspectives on Judgment and Decision 

Research. Cambridge, UK: Cambridge University Press. 

Flesch, R.(1949) The Art of Readable Writing. New York: MacMillan. 

Flory, J. & Emanuel, E. Interventions to Improve Research Participants’ Understanding in Informed 

Consent for Research.(2004) Journal of the American Medical Association, 292(13), 

1593-1601. 

Gladwell, M. (2005). blink. The Power of Thinking Without Thinking. New York: Little, Brown. 

Hastie, R & Dawes, R.M.(2001) Rational Choice in an Uncertain World. Thousand Oaks, CA: Sage 

Publications. 

Hochhauser, M. Some Overlooked Aspects of Consent Form Readability. (1997) IRB: A 

Review of Human Subjects Research, 19(5), 5-9. 

Papers 

Hochhauser, M. The Informed Consent Form: Document Development and Evaluation. (2000) 

Drug Information Journal, 34(4), 1309-1317. 

Hochhauser, M. (2003) Improving Patients’ Understanding of Research: A Plain English Summary 

and Informed Consent Form. Clinical Researcher, 3(12), 16-30. 

Hochhauser, M. (2004a) Emotion and logic in the informed consent process. Research Practitioner, 

5(4), 138-141. 


Papers 

Hochhauser, M. Informed Consent: Reading and Understanding Are Not the Same. 

(2004b) Applied Clinical Trials, 13(11), 42-44; 46; 48. 

Hochhauser, M. (2005) The Anatomy of Informed Consent. Applied Clinical Trials, 14(3), 82. 

Holmes-Rovner, M. & Wills, C.E. (2002) Improving Informed Consent. Insights From 

Behavioral Decision Research. Medical Care, 40(9), Supplement, pp V-30-V-38. 

Kahneman, D. & Tversky, A. (2000) Choices, Values, and Frames. In Kahneman, D. & Tversky, A. 

(eds.) Choices, Values, and Frames. New York: Cambridge University Press. 

Kahneman, D. (2003) A Perspective on Judgment and Choice: Mapping Bounded Rationality. 

American Psychologist, 58, 698-720. 

King, N.M.P., Henderson, G.E., Churchill, L.R., et al. (2004) Consent Forms and the Therapeutic 

Misconception: The Example of Gene Transfer Research. IRB: Ethics & Human Research, 

27,(1) 1-8. 

Loewenstein, G.F., Weber, E.U., Hsee, C.K. & Welch, E.S. (2001). Risk as Feelings. Psychological 

Bulletin, 127, 267-286. 

Myers, D.G. (2002) Intuition. Its powers and perils.(2002) New Haven: Yale University Press. 

Piatelli-Palmarini, M. (1994) Inevitable Illusions: How Mistakes of Reason Rule Our Minds. 

New York: John Wiley & Sons. 

Pohl, R. (ed.) (2004) Cognitive Illusions. A Handbook on Fallacies and Biases in Thinking, 

Judgement and Memory. New York: Psychology Press. 

Sharp, M. (2004) Consent documents for oncology trials: Does anybody read these things? 

American Journal of Clinical Oncology, 27(6), 570-572. 

Ubel, P.A. & Loewenstein, G. (1997) The role of decision analysis in informed consent: choosing 

between intuition and systematicity. Social Science and Medicine, 44(5), 647-656. 


Liabilities of “unreadable” consent forms 

Mark Hochhauser, Ph.D. 

Readability Consultant 

3344 Scott Avenue North 

Golden Valley, MN 55422 

Phone: 763-521-4672 

Fax: 763-521-5069 

E-mail: MarkH38514@aol.com 

Papers 

Abstract: 

Although federal agencies, research departments and IRB web sites commonly recommend that 

consent forms be written at a 6th-8th grade reading level, readability research consistently finds 

consent form templates and consent forms to be well above that grade level. The gap between 

recommended grade level vs actual grade level—a potential compliance issue--creates liabilities 

for research administrators, researchers, and sponsors. The University of South Florida and Tampa 

General Hospital agreed to a $3.8 million out-of-court settlement in 2000 because of one study’s 

“unreadable” consent forms. To prevent such liabilities, departments that rely on readability formulas 

must ensure that their researchers and IRBs are familiar with readability formula limitations 

identified by technical writing experts over the past twenty years. These include the relevance, 

validity and reliability of readability formulas when applied to consent forms, adolescent vs adult 

reading differences, readability estimates vs consent form content, layout and design, text comprehension 

factors, and recommendations for reader testing instead of consent form testing. Without 

such insights, researchers and IRBs will have to deal with the legal, financial, ethical and public 

relations liabilities created by the continuing use of “unreadable” consent forms. 

Do incomprehensible consent forms cause “dignitary harm?” 

A class action lawsuit by 5,000 pregnant women (Hanlon & Shapiro, 2003) was brought against 

Tampa General Hospital and the University of South Florida College of Medicine. The plaintiffs 

claimed that they became research subjects without being told that required medical tests were 

for research (not treatment), and without being asked to consent. Their lawyers argued that the 

three-page, single-spaced, grade 14 reading level consent form created “dignitary harm.” Subjects 

were presumably harmed by researchers who took away their autonomy to make informed decisions 

and thus denigrated them as human beings—even though the subjects were not physically 

harmed in the research. The case was settled out-of-court for $3.8 million. The plaintiff ’s lawyers 

noted that: 

“All parties also agreed, by the end of the case, that readability alone is not sufficient for an 

informed consent document….A host of other factors—design, cultural relevance, format, 

length, density, and style—all enter into the question of the document’s potential for effective 

communication…” (p. 4) 

But the legal implications of incomprehensible consent forms go beyond just readability issues. 

The authors believe that: 

“…a complex and difficult-to-understand informed consent document is conducive to 

a coercive atmosphere in the enrollment process in biomedical research. The document 

itself is coercive, intentionally or not, when it is unduly long, complex, and incomprehensible. 

This type of document sends a message to proposed human subjects that they have 

no meaningful role in the process because it is something that can be understood only by 

people with greater knowledge than they possess.” (p. 4-5) 


Papers 

How “readable” are consent forms? 

FDA requires that “the information that is given to the subject or representative shall be in language 

understandable to the subject or the representative,” and that “technical and medical 

terminology should be avoided or may be explained.” Although the FDA does not require consent 

forms to be written at a specific grade level, IRBs and researchers often require consent forms to 

be written at an 8th grade reading level, assuming that consent forms at that grade level will be in 

language that subjects can understand. But consent forms seldom meet such required standards. 

IRB readability recommendation discrepancies 

A 2003 study looked at IRB readability standards for informed consent forms at 61 of 114 web 

sites of US medical schools and compared those standards to the consent forms’ actual readability 

(Pasasche-Orlow, Taylor, Brancan, 2003). They found that while readability standards ranged from 

5th-10th grade (with an average 8th grade recommendation), the average readability score of sample 

text from consent forms exceeded those standards by about 2.8 grades. The authors concluded 

that the sample texts given to researchers by medical school IRBs didn’t meet the readability standards 

of those IRBs. What they did not conclude was that such discrepancies might represent legal 

non-compliance should a lawsuit be filed over unreadable consent forms. 

Oncology consent form discrepancies 

Sharp’s (2004) analysis of 107 oncology research consent forms found an average 11.9 grade level 

(Gunning Fog Index); none of the consent forms was written at or below an 8th grade reading 

level. Since the National Cancer Institute recommends 8th grade for oncology consent forms and 

OHRP recommends a 6th-8th grade level, all 107 consent forms were non-compliant with federal 

recommendations. However, using a different readability formula—such as the Flesch-Kincaid— 

may have resulted in lower grade level, since the Fog Index tends to score “high” on technical 

materials. Since readability formulas do not all give the same results, perhaps researchers should 

report grade levels from several readability formulas instead of only one. 

Institutional risks of readability discrepancies 

On the one hand, such findings continue to point out that consent forms are probably too hard for 

average patients to understand. On the other, data showing consent forms written at grade levels 

exceeding OHRP, NCI and IRB recommendations suggests that these consent forms are non-compliant 

with regulatory recommendations. One IRB website states that “Consent documents should 

be written in a language appropriate to the subject population, but never higher than 8th grade 

readability level.” Never? Does that IRB document its refusal to approve consent forms above an 

8th grade level? 

One Medical College Human Assurance Committee states that “Children’s Assent documents 

should be written on a second grade reading level.” Based on the Fry Readability Scale, a second 

grade reading level equals about 8 – 10 words per sentence and about 110-120 syllables per 100 

words; in other words, very short sentences with very short words. Even if that statistical grade 

level could be met, do young children have the cognitive skills to understand the FDA’s “basic elements” 

of informed consent even if they are written at a second grade level? 

Given federal agency and IRB recommendations, how is it even possible for statistically unreadable 

consent forms to reach an IRB? Even though instructions for writing consent forms include 

readability recommendations, they do not include a requirement that researchers certify that their 

consent forms are in compliance with those recommendations. Either researchers are completely 

ignoring readability recommendations, or finding that they cannot write consent forms at the 

grade levels recommended by federal agencies and IRBs. 


For subjects experiencing research-related injuries or “dignitary harm,” could your institution 

legally justify sponsors and researchers who write and IRBs that approve consent forms that do 

not meet federal or institutional guidelines? Could your institution justify in a deposition or in 

court the extensive use of consent forms at a grade 12-14 reading level—4 to 8 grades higher than 

recommended? If not, is your institution willing to deal with media stories such as “University 

approves unreadable research” or “Hospital violates own ethics rules?” What impact would these 

stories have on the reputation of your institution and researchers, and their ability to recruit future 

research subjects? 

Informed consent communication problems 

Both proponents of readability formulas (such as Klare) and opponents (such as Redish, Shriver) 

agree on some of the most common problems found with readability formulas, the writers who 

use and misuse them, and reader understanding. Federal agencies and IRBs that uncritically 

recommend readability formulas seem completely unfamiliar with the extensive research done on 

the use and misuse us of these formulas (e.g., Davision & Green, 1988; Zakaluk & Samuels, 1988; 

Chall & Dale, 1995). Although consent form researchers often cite other studies on informed consent 

readability, they almost never cite research on the strengths and weaknesses of readability formulas 

themselves. Such omissions suggest that researchers, journal editors, and peer reviewers are 

unaware of readability formula research issues. Table #1 summarizes major readability problems 

in the context of informed consent, addressing issues that are not covered in regulatory agency or 

IRB readability guidelines. 

Table #1: Summary of informed consent problems 

Readability formula problems Consent form writer problems Consent form reader problems 

Formula relevance Consent form layout/design Adolescent vs adult readers 

Validity and reliability Not cleaning files Text comprehension 

Readability estimates vs consent 

form content 

Papers 

Misusing readability formulas Reader testing vs consent form 

testing 

Readability formula problems: 

Formula relevance: Are readability formulas relevant for clinical trial consent forms? Most formulas 

were designed for textbook selection in elementary and secondary schools to ensure 

that students weren’t expected to read books that were too hard to understand. Such readability 

formulas are about 30-60 years old; Rudolf Flesch’s Reading Ease formula dates from 1948, while 

the revised 1995 Dale-Chall Formula is based on data collected in the late 1970s. Because reading 

level estimates are based on how reading skills from 50 years ago, it’s not at all clear if an 8th grade 

reading level in 1948 (original Dale-Chall) or 1968 (Gunning Fog Index) or 1975 (Flesch-Kincaid) 

is easier, the same, or harder than an 8th grade level in 2005. 

Validity and reliability: Some formulas, such as the Flesch-Kincaid, were developed for technical 

materials, but no readability formulas have been developed specifically for informed consent 

forms. Thus, there is no data on the validity and reliability of readability formulas for informed 

consent forms in adult population. 

Reliability usually refers to an instrument’s ability to give consistent results over time. But in the 

context of readability formula software, reliability means the ability of different readability software 

programs to give the same result for the same formula. Readability formulas generally rely on 

counts of the number of words in a sentence and the number of syllables per word. While that’s an 

easy calculations for researchers to do “by hand,” it’s much harder to write software programs to 

accurately count words and syllables. Some programmers estimate syllables based on the number 


Papers 

of vowels per word, some on the number of consonants per word. Some count a sentence whenever 

a period, question mark or exclamation point is found, some whenever a colon or semi-colon 

is found. 

Hochhauser (1997) analyzed one consent form using six software programs, not including Microsoft 

Word. As shown in Table #2, they did not all agree. 

Table #2: Comparison of six readability software programs 

Six readability 

programs 

Number of 

sentences 

Number of 

syllables 

Words per 

sentence 

Flesch 

Reading Ease 

Flesch- 

Kincaid 

Range 30-35 1,201-1,313 22-25 37-45 12.1-15.5 

Average 31.9 1,279 22.9 40.5 14.0 

Using the same readability formula but in different programs found the Flesch-Kincaid varying 

from 12.1 to 15.5—a difference of 3.4 grades! Such software differences show that readability grade 

levels will vary considerably for the same formula depending on which software program is chosen 

to calculate reading grade level. That’s a major problem for consent form readability research. 

Writing computer programs to count sentences, syllables and words is more difficult that it appears. 

In an early attempt to computerize readability formulas, Fang (1968) developed a computer 

program for the Flesch Reading Ease Score, but noted that “The basis of the syllable counter is 

that one vowel equals one syllable. However, there are many exceptions, and many exceptions to 

the exceptions. Two years later, Coke and Rothkopf (1970) stated that “A word may be defined 

as any set of alphanumeric characters delimited by blanks and punctuation marks, while a sentence 

can consist of all words occurring between two periods.” But consent forms usually include 

headings or subheadings that would become part of the next sentence, as well as many periods 

(such as M.D., R.N., e.g., etc.), colons, semicolons and hyphenated technical terms that make exact 

counts difficult. Counting syllables is even harder. Coke and Rothkopf tested three methods for 

estimating syllable counts in readability formulas: 1) total number of vowels, including “y”, 2) total 

number of consonants, and 3) total number of letters, and concluded that the number of vowels 

per word had the best correlation to the researcher’s syllable count by hand. 

Since readability software programs do not disclose the methods used to count sentences, words 

or syllables, it’s impossible to know if computerized formulas are consistent with the scores that 

would be obtained if calculated by hand. These computational choices explain the puzzling findings 

by Mailloux, Johnson, Fisher, et al, (1995) who found inexplicable differences in their comparison 

of four readability software programs: “It is interesting to note that, despite the fact that 

the Flesch-Kincaid formula and Gunning Fog Index formulas were reported to be identical across 

software programs the Flesch Reading Ease Formulas were nearly identical, the software programs 

provided different grade results. This finding is difficult to explain because if the formula were 

truly identical, no discrepancy should be found” (p. 224). Unfortunately, they did not compare the 

computerized readability grade levels with a level calculated by hand, so they could not state which 

software readability was most or least accurate; that comparison study has yet to be done. 

But such discrepancies should be expected if different programmers choose different ways to 

count sentences, words, and syllables. The discrepancies are not with the formulas, but with the 

programmers who convert the formulas into software code. The discrepancies found by Mailloux, 

et al, might also be due to their methodology of scanning the documents into a computer and analyzing 

them via readability formulas. Plus, they did not state if they “cleaned” the file (to remove 

extra periods) before running the readability formulas. 


Readability estimates vs consent form content: Because readability formulas measure writing style 

based only on sentences, words and syllables, they cannot address the content of consent forms. 

Reading researchers have long known that word choice affects reading ease. Common (short) 

words are easier to understand, rare (long) words are harder to understand. Unfortunately for prospective 

subjects, consent forms are full of hard-to-understand words. For example, based on work 

by Doak, Doak, and Root (1996) Hochhauser (2003a) identified concepts (words easily misunderstood 

because they describe general ideas, abstract concepts, or references), category words (words 

that describe groups of things, and value judgment words (words that usually describe amount of 

thresholds for action). Writing consent forms at an 8th grade level means only that the consent 

form has the same number of words per sentence and the same number of syllables per word as do 

the 8th grade materials from 30-60 years ago. Because readability is only a statistical comparison, 

equivalent reading grade levels do not mean that vocabularies are the same, or that the reader’s 

level of understanding is the same. 

Table #3 lists a few concepts, categories and value judgments that might be hard for prospective 

subjects to understand unless such words included definitions and concrete examples. Although 

a standard recommendation is to write consent forms using plain language to minimize medical, 

scientific and legal jargon, translating some these phrases into plainer English is not easy. Most 

IRBs have experienced conflicts with sponsors who refuse to change a few words in the consent 

form. How willing will sponsors be to completely rewrite consent forms in plain language to try 

to meet an IRBs readability requirements? How willing are IRBs to reject consent forms that don’t 

meet those requirements? How much time does it take to write a consent form at a 6th-8th grade 

level from a grade 14 level; is that kind of rewriting even possible? 

Table #3: Examples of Concepts, Categories and Value Judgment Words in Consent Forms 

Concept Words Category Words Value Judgment Words 

Assigned by chance Adverse reactions Absolute confidentiality 

Childbearing potential Concomitant medications Decrease the likelihood 

Double-blind study Hypersensitivity reactions Fullest extent possible 

Feasibility My legal rights Long-term 

Investigational drug Regulatory authorities Negative impact 

Placebo Regular blood tests Potential possibility 

Retrospective study Requested intervals Reasonable medical costs 

Sponsor database Scientific purposes Timely manner 

Tolerability Treatment cycles Very rarely 

Papers 

Consent form writer problems: 

Layout and design: Too often regulatory agencies and IRBs only recommend that consent forms 

be written at a 6th-8th grade reading level. But grade level itself is practically meaningless if the 

consent form layout and design is inadequate. For example, the National Cancer Institute’s recommendations 

for simplified consent forms states that: “Use of active voice, short sentences, personal 

pronouns, clear page layout with “white space” borders, and large fonts make documents easier to 

read. The use of simple outlines, flow charts, diagrams, study schemas, calendars and other graphics 

are encouraged.” But those recommendations are ignored as often as the 6th-8th grade reading 

level recommendation; in the 11 years I’ve served on an IRB I’ve seen very few consent forms 

with simple outlines, flow charts, diagrams, study schemas, calendars, other graphics, or tables of 

content and consent form summaries (e.g., Hochhauser 2003b.) For example, instead of including 

long sentences listing all the risk factors, some consent form have stated that: “You might experience 

all, some or none of the following side effects, and they may be mild, moderate or severe” 


Papers 

followed by 39 side effect bullet points. That’s hardly an improvement. 

Misusing the formula. Many IRBs recommend using the Flesch-Kincaid readability formula in Microsoft 

Word. Unfortunately, the authors who make this recommendation apparently do not know 

that Word’s version of the formula is flawed, since it does not report scores above grade 12, even 

though the formula itself score up to grade 17 (Hochhauser, 2003c). Some IRB websites even misuse 

readability formulas to analyze one or two sentences from consent forms to show high grade 

levels with original language and lower grade levels with revised language. But readability formulas 

were not designed for one or two sentences. Because most readability formulas require 200-300 

words for analysis, using readability formulas for one or two sentences is completely inappropriate, 

meaningless, and probably indefensible in a lawsuit. 

Cleaning the file: Consent form files must be “cleaned” before running them through a readability 

formula. Cleaning a file refers to removing extra periods in abbreviation (e.g., i.e., M.D., etc.) 

because readability formulas count a sentence every time they find a period. Readability formulas 

were designed for narrative text, so consent form writers should remove all titles, headings, subheadings, 

bullet points, charts, tables, or anything else that is not a complete sentence. Otherwise 

the formula will give inaccurate reading grade level estimates. Some IRB web sites show researchers 

how to use the readability statistics function with Microsoft Word. But since these recommendations 

don’t describe how to clean the consent file, simply clicking on “show readability statistics” 

will give an inaccurate reading grade level, in addition to the reporting limit of grade 12. If you 

were deposed in a readability related lawsuit, could you justify the way in which your researchers 

or IRB calculated reading grade levels? 

Consent form reader problems: 

Adolescent vs adult readers. Because readability formulas were developed to select school books, 

most formulas are based on reading skills of children and adolescent—not adults throughout the 

lifespan. Clinical trials often include subjects who range in age from 18-80, or from 18 to no upper 

limit, or somewhere during childhood and adolescence. Research has not shown that readability 

formulas based on children and adolescents—the Dale Chall is based on words known to 4th 

graders-- is relevant for all adults. 

Eighth-grade students probably have very different reading skills than 40-year old adults who have 

an eighth grade education. The common assumption that a consent form written at an 8th grade 

level can be understood by anyone with eight years of education is false; there’s no consent form 

comprehension research to support that assumption. Anyone who believes that a consent form at 

a 6th- 8th grade level can actually be understood by 8th graders should give it to groups of 6th- 

8th graders and see how well they understand it. If they don’t understand it very well—which they 

probably won’t because they haven’t yet developed abstract thinking skills or a research vocabulary—what 

does that mean for the continued recommendation of an 8th grade consent form reading 

level? 

Text comprehension problems: Reliance on readability formulas alone implies that all patients are 

the same. Writing comprehensible consent forms requires writers to know patients’ educational 

attainment and intelligence, reading ability, their experiences with clinical research and ethical 

concepts, their motivation for reading the consent form (voluntary or involuntary), how much attention 

they’ll likely pay to the consent form, etc. Neither readability proponents (such as Klare) or 

opponents (such as Redish and Shriver) recommend “writing to the formula,” because there is no 

evidence that writing shorter sentences with smaller words does much to improve comprehension. 

Because no one in reading research recommends “writing to the formula,” recommendations from 

federal agencies or IRBs that consent forms be rewritten to the formula until they reach the magical 

6th-8th grade reading level are just wrong. Because readability formulas measure only what 


Papers 

can be counted (syllables, words, sentences), they cannot take into account other more important 

factors that are usually described as document design and layout. 

One way to approach patient understanding of consent forms is to comprehension skills needed 

to understand science materials (Chall, Bissex, Conard, et al 1996). While their analysis dealt with 

qualitative assessments of text difficulty in the sciences, their conclusions are relevant to science 

based consent forms in clinical trials. For patients to understand consent forms, they must possess 

cognitive abilities not measured by readability formulas, such as: 1) large vocabulary, so they can 

understanding uncommon words used in abstract and theoretical discussions, 2) sentence structure 

familiarity—understanding long and complicated sentences, often with embedded phrases, 

3)extensive prior knowledge—analyzing and synthesizing abstract, theoretical, and technical 

information, as well as hypothesis testing and applied science principles. 

Subject testing: The real measure of comprehension is not the grade level score of a readability formula, 

but how well prospective subjects actually understand the consent process. Wendler (2004) 

suggests using postdecision questionnaires (PDQs)to formally assess every subject’s consent not 

just cognitively impaired subjects. However, that approach requires some agreement by informed 

consent researchers on the definition and measurement of informed consent “understanding,” as 

well as collaborative development of PDQs that are psychologically valid and reliable, not based on 

rote memory, or comprised of true-false questions (subjects can get 50% correct by guessing). If 

done appropriately, PDQs could eliminate some readability compliance flaws and legally be a more 

defensible approach to consent form understanding. 

Conclusion: 

Consent form noncompliance is risky. There are legal risks in which subjects may sue, perhaps in 

class action lawsuits, if they believe they experienced dignitary harm because they didn’t understand 

the consent form. There are the financial risks for institutions defending themselves against 

such lawsuits, and the potential for large financial settlements, either in out-of-court settlements 

or in a jury’s recommendations. There are the ethical implications that influence public perceptions 

of the researchers and the institution that’s being sued, and there are research risks associated 

with recruiting future research subjects. 

The inconsistencies found in readability formulas and the research that’s based on such formulas 

can be viewed as academic arguments to be discussed by researchers at professional conferences 

and in academic journals. But, readability isn’t just about research, it’s about compliance with federal, 

institutional, and IRB recommendations. Federal regulatory agencies, research administrators 

and IRBs should assess the variety of risks associated with consent forms written at grade leaves 

much higher than recommended. If readability compliance is as impossible and inappropriate 

as it seems to be, why repeat recommendations that consent forms be written at a 6th-8th grade 

reading level if it’s not only impossible to meet that goal, but has the potential to put organizations, 

IRBs, and researchers at risk? When it comes to readability of consent forms, be careful what you 

ask for; you might not get it. 


Papers 

References 

Chall, J.S. & Dale, E. (1995) Readability Revisited. The New Dale-Chall Readability Formula. 

Cambridge, MA: Brookline Books. 

Chall, J.S., Bissex, G.L., Conard, S.E. & Harris-Sharples, S. (1996) Qualitative Assessment of Text 

Difficulty. Cambridge, MA: Brookline Books. 

Coke, E.U. & Rothkopf, E.Z. (1979) Note on a Sample Algorithm for a Computer-Produced Reading 

Ease Score. Journal of Applied Psychology, 54(3), 208-210. 

Davison, A. & Green, G.M. (1988) Linguistic Complexity and Text Comprehension: Readability Issues 

Reconsidered. Hillsdale, NJ: Lawrence Erlbaum. 

Doak, C.C., Doak, L.G., & Root, J.H. (1996) Teaching Patients with Low Literacy Skills. 

Philadelphia, PA: J.B. Lippincott. 

Fang, I.E. (1968) By Computer Flesch’s: Reading Ease Score and a Syllable Counter. Behavioral 

Science, 13, 249-251. 

Flory, J. & Emanuel, E. (2004) Interventions to Improve Research Participants’ Understanding in 

Informed Consent for Research. Journal of American Medical Association, 292(13), 1593-1601. 

Hanlon, S.F. and Shapiro, R.S. (2003) Ethical Issues in Biomedical Research: Diaz v. Hillsborough 

County Hospital Authority. Human Rights Magazine, Spring 2003. http://www.abanet.org/irr/ 

hr/spring03/biomedicalresearch.html 

Hochhauser, M. (1997) Some Overlooked Aspects of Consent Form Readability. IRB: A Review of 

Human Subjects Research, 19(5), 5-9. 

Hochhauser, M. (2003a) Concepts, Categories, and Value Judgments in Informed Consent Forms: 

IRB: Ethics & Human Research, 25(5), 7-10. 

Hochhauser, M. (2003b) Improving Patients’ Understanding of Research: A Plain English Summary 

and Informed Consent Form. Clinical Researcher, 3(12), 16-30. 

Hochhauser, M. (2003b) Flesch-Kincaid in Microsoft Word is flawed. CA online, October 7, 2003. 

http://caonline/amcancersoc.org/cgi/eletters/52/3/130 

Hochhauser, M. (2004) Informed Consent: Reading and Understanding Are Not the Same. 

Applied Clinical Trials, 13(4), 42-44; 46; 48. 

Klare, G. (1974-75) Assessing readability. Reading Research Quarterly, 10, 62-102. 

Klare, G. (2000) Readable Computer Documentation. ACM Journal of Computer Documentation, 

24(3), 148-168. 

Mailloux, S.L., Johnson, M.E., Fisher, D.G., et al (1995) How Reliable is Computerized Assessment 

of Readability? Computers in Nursing, 13(5), 221-225. 

Paasche-Orlow, M.K., Taylor, H.A. and Brancan, F.L. (2003) Readability Standards for Informed- 

Consent Forms as Compared with Actual Readability. New England Journal of Medicine, 

348(8), 721-726. 

Redish, J.C. & Selzer, J. (1985) The Place of Readability Formulas in Technical Communications. 

Technical Communication, Fourth Quarter 1985, 46-52. 

Redish, J. (2000) Readability Formulas Have Even More Limitations Than Klare Discusses. ACM 

Journal of Computer Documentation, 24(3), 132-137. 

Schriver, K.A. (2000) Readability Formulas in the New Millennium: What’s the Use? ACM Journal 

of Computer Documentation, 24(3), 138-140. 

Sharp, S.M. (2004) Consent Documents for Oncology Trials: Does Anybody Read These Things? 

American Journal of Clinical Oncology, 27(6), 570-575. 

Wendler, D. (2004) Can We Ensure That All Research Subjects Give Valid Consent? Archives of 

Internal Medicine, 164, 2201-2204. 

Zakaluk, B.L. & Samuels, S.J., eds. (1988) Readability. Its Past, Present, and Future. Newark, DE: 

International Reading Association. 


The Unconscious Expression of Ego Defenses: 

Increasing Self-Knowledge for the Research Administrator 

Elizabeth Holmes Ph.D., ABPP 

700 St. George Barber Rd. 

Davidsonville, MD 21035 

Author’s Note 

The author gratefully acknowledges dialogue with two SRA Northeast Section members concerning 

the content and development of this paper: Associate Dean Sharon McCarl and Dr. Edward 

Gabriele. For questions and further dialogue concerning the context of this paper, the author can 

be reached as above. 

Abstract 

As a psychologist reflecting on numerous conversations and consultation with individual SRA 

members, a pattern of common questions about human behavior comes to mind. This paper attempts 

to assist research administrators to understand and have compassion for themselves and 

others when under stressful conditions. When under extreme stress, a person’s psychological 

balance will shift and less mature defenses emerge. Defense mechanisms are mostly unconscious, 

start early in life, protect the ego against pressure, and gratify the ego with reduced anxiety. We are 

all vulnerable to the unconscious use of defensive maneuvers. Becoming consciously aware of our 

preferred unconscious defensive tactics is the first and most important step towards improving the 

way we cope with anxiety under stressful conditions. This self-knowledge is critical for the professional 

development research administrators bring to the contributions they make to the research 

programs, institutions and investigators whom they lead and serve. 

Introduction 

As a psychologist reflecting on numerous conversations and consultation with individual SRA 

members a pattern of common questions about human behavior comes to mind. Why are people 

so defensive when they receive stressful (bad) news? Is being defensive normal? How much defensiveness 

is healthy? What are the defense mechanisms? Is one ego defense better than another? 

This paper will attempt to address these five questions with the intention of helping SRA members 

to understand and have compassion for themselves and others when under stressful conditions. 

Question 1 

Papers 

The first question – Research administrators who feel caught in the middle of multiple dilemmas 

often ask the question, “What is stress?” They tell me about the competing demands of feeling responsible 

to and for the institutions they work in, the investigators they review research proposals 

for, and the research subjects, both human and animal, involved in those studies. 

The term stress is derived from the Latin word “strictus” (Auerbach and Gramling 1998). In the 

past the term stress has been used to encompass both a stimulus event and a response to that event 

(Keefe, 1988). Today, stress can be conceived of as the changes within people as they are in a situation 

that they determine to interfere with their well-being. These changes include physical, psychological, 

and behavioral components. The circumstances, which provoke a stress response, are 

termed “stressors.” Coping responses vary from person-to-person and from situation-to-situation. 

Coping skills or abilities are our attempts to adjust to or manage the physiological and emotional 

aspects of our perceived stress. 


Papers 

Coping involves the effort to overcome, reduce, or tolerate the demands created by our perceived 

stressors. One type of coping technique is emotion-focused coping. Sigmund Freud believed that 

anxiety was a stressful emotion. He observed that people would fend off this distressing emotion 

with defense mechanisms (Weiten and Lloyd, 1990). Freud’s ideas were motivated by observing his 

patients dealing with anxiety, an intense, negative emotional experience. Anxiety is an unpleasant 

state experienced by a combination of an uneasy apprehensive feeling, and an increased physiological 

arousal such as elevated heart rate and blood pressure. It gives rise to various reactions. For 

example, are you defensive when coworkers criticize you or when you are not selected for a promotion? 

When coping with a failure over a work project or a competitive loss or when someone 

you care about disappoints you, do you tend to deny or distort the problem? Defensive coping is a 

common method to handling stress. Defensive coping mechanisms defend against feeling anxious. 

They protect our self-perceptions from ego-threatening stressors. 

Question 2 

The second common question SRA members are curious about regards the nature of defense 

mechanisms. Are they normal? Answer – We all use ego defenses, to some degree, on a regular 

basis. They fall within the action of normal patterns of emotional coping. Defense mechanisms 

armor us from the emotional discomfort brought on by stress. Defensive maneuvers are largely in 

the unconscious. Freud thought the unconscious contains thoughts, memories, and desires that 

are well below the surface of conscious mindful awareness, but that they nonetheless exert great 

influence on our behavior (Weiten and Lloyd, 1997). These unconscious defense mechanisms are 

mental maneuvers that work through self-deception. The primary emotion guarded against is 

anxiety, however anger and guilt are additional emotions people tend to evade through defensive 

tactics. Ego defensive maneuvers succeed by self-deception to create a false perception to lessen 

the threat to one’s self-esteem. 

Question 3 

Thirdly, people are curious to know if ego defenses are healthy. Freud developed the defensive 

mechanism concept along with his formation of the personality components of id, ego, and superego. 

The ego must defend the self from anxious feelings when the id demands pleasure and the superego’s 

morals are conflicted. Defending the self-image is hard work for the ego particularly when 

one’s sense of adequacy and worth are being challenged. Research administrators tell me they feel 

pressure to please others, they fear failure, and they are anxious about disappointing losses. All of 

these stressors threaten the ideal image of the superego. Defensive coping is an avoidance strategy 

and as such often does not solve one’s conflicts. 

Generally, defensive maneuvers are poor ways of coping with stress. This being a complicated issue, 

the answer is not simple. More often than not defense mechanisms are not health inducing; however, 

there is some suggestion (Taylor, 1989) that some self-deception may be adaptive to our wellbeing. 

“Normal” people tend to have overly favorable self-images, overestimate the degree to which 

they control chance events, and have unrealistic optimism about the future. Baumeister (1989) 

suggests defensive coping is a matter of degree and that there is an “optimal margin of illusion”. 


Questions 4 and 5 

Papers 

The last two frequent questions flow together as research administrators wonder about what are 

the defense mechanisms and whether some are better than others. There are defense mechanisms 

that can be categorized as defending by “withdrawal” such as: denial of reality that is refusing to 

recognize the threatening external event or piece of information. Examples include the tobacco 

addict who denies scientific evidence linking smoking to lung cancer. The “love is blind” perspective, 

the denial of death, and a “rose colored glasses” view of the world. Repression involves 

pushing unacceptable thoughts, feelings or impulses into the unconscious mind. Examples include 

“forgetting” dreams, dental appointments, childhood traumas, and repressing envious feelings. 

Regression is withdrawal into the past by readopting behaviors that previously brought satisfaction. 

Examples include a supervisor who has a temper tantrum when a subordinate makes a mistake, 

sulking when you do not get your way, or waiting to be “rescued”; acting childishly. Sublimation 

is placing unwanted impulses into socially acceptable behaviors. Examples include sexually 

forbidden desires being sublimated into creating works of art; an aggressive person redirecting 

that energy by going into the military or law enforcement professions. 

There are defense mechanisms that can be grouped into “defending by attacking”. These include: 

displacement, which is discharging pent-up feelings of frustration onto weaker, less dangerous 

persons, animals, or objects rather than back to the real threat. An example would be picking an 

argument with a spouse when you are really angry with a supervisor or coworker. Projection is 

disowning personal responsibility by externalizing blame. Examples would include a person who 

is angry at their supervisor but acts friendly toward him or her and then complains that the same 

supervisor is angry with them, or “seeing” lust, fear, or hostility in others when it is really caused 

by one’s own unacceptable urges. Intellectualization is separating unpleasant emotions or personal 

responsibility from a threatening event or situation by thinking or talking about it in “intellectual” 

terms. Examples include using intellectual arguments as excuses, analyzing too much to avoid feelings, 

or pontificating. Rationalization is explaining shortcomings, lessening disappointments, or 

reducing guilt by justifying with reasons or excuses. Examples include when being passed over for 

an award and saying, “I did not really want it anyway” or having defensive explanations for poor 

performance. 

Finally, there are some defense mechanisms that defend by capitulation. Introjection helps to 

avoid rejection and external threats when a person internalizes the values and beliefs of others. 

An example is “group think” in organizations. Identification is boosting one’s own ego and esteem 

by identifying with powerful or desirable persons, groups, or organizations. Examples include 

name-dropping, taking on the latest fad, or joining a special group to bolster an insecure self-image. 

Reaction Formation prevents unacceptable urges from being expressed by exaggerating the 

opposite behavior or viewpoint. Examples are when one “dost protest too much” and “smother 

love” covering up hostility. 

All defense mechanisms distort reality so reality becomes less threatening to our self-image. If you 

are criticized for a project, you can control your anxiety by blaming others (projection), by giving 

excuses (rationalization), by getting angry and throwing something (displacement), and you could 

suppress your anxiety (repression). 

When under extreme stress a person’s psychological balance will shift and less mature defenses 

emerge. Vaillant (1971) suggested that there is a continuum of the defense mechanism. He proposed 

that defense maneuvers range from mature defenses of altruism, anticipation, humor, 

sublimation, and suppression to the neurotic defenses of displacement, intellectualization, reaction 

formation, and repression to the immature defenses of acting out, hypochondriasis, passive aggression, 

projection and finally to narcissistic defenses of delusion, distortions, and psychotic denial. 


Papers 

Conclusion 

Defense mechanisms are mostly unconscious, start early in life, protect the ego against pressure 

and gratify the ego with reduced anxiety. Since they are unconscious they are not premeditated. 

When confronted by others about our defensive maneuvers we tend to become even more defensive. 

This may contribute to a spirally escalating self-deceptive way of coping with stress. If the ego 

cannot reduce stress by directly coping with reality it will indirectly cope by defensively distorting 

reality. We are all vulnerable to the unconscious use of defensive maneuvers. Becoming consciously 

aware of our preferred unconscious defensive tactics is the first and most important step 

towards improving the way we cope with anxiety under stressful conditions. 

References 

Auerbach, S M., and S E. Grammling. Stress Management Psychological Foundations. Upper 

Saddle River: Prentice Hall, 1998. 3, 27. 

Baumeister, F, D M. Tice, and D G. Hutton. “Self-Presentational Motivations and Personality Differences 

in Self-Esteem.” Journal of Personality os 57 (1989): 547-579. 

Freud, S. The Psychopathology of Everyday Life. Vol. 6. London: Hogarth, 1960. 

Freud, S. A General Introduction To Psychoanalysis. New York: Boni and Liberight, 1924. 

Keefe, T. “Stress - Coping Skills: An Ounce of Prevention in Direct Practice.” Social Casework os 

69 (1988): 475-482. 

Taylor, S E. Positive Illusions: Creative Self-Deception in the Healthy Mind. New York: Basic 

Books, 1989. 193. 

Vaillant, G E. “Theoretical Hierarchy of Adaptive Ego Mechanisms.” Archives of General 

Psychiatry os 24 (1971): 107-118. 

Weiten, W, and M A. Lloyd. Psychology Applied to Modern Life. Pacific Grove: Brooks/Cole 

Company, 1997. 108-110. 


A Profile of the IRB Infrastructure at Comprehensive and Predominantly Undergraduate 

Institutions in the South: Project Initiation and 2005 Update 

Kristy Hoyman, B.S. in Education 

Graduate Assistant working towards MPH in Biostatistics 

Office of Research Services and Sponsored Programs 

Georgia Southern University 

Office of Research Services and Sponsored Programs 

Georgia Southern University 

P.O. Box 8005 

Statesboro, GA 30460 USA 

(912)681-0843 

khoyman@georgiasouthern.edu 

Author’s Note 

The author would like to thank the co-author, Julie Cole, for her dedication to this project, as well 

as her kindness and understanding. 

Abstract 

The research community has both an ethical and publicly mandated responsibility to adhere to 

the strictest standards of compliance when conducting research with human subjects. Universities 

are being challenged to develop and maintain organizational infrastructures that ensure compliance, 

while providing a supportive atmosphere for research productivity. Clearly this is a concern 

among the large research institutions and organizations as the cost of compliance becomes 

a pressing issue of both scale and quality. For the smaller, less research intensive institutions, 

this dilemma is exacerbated by additional factors: awareness among senior administrators of the 

necessity and requirements for human subjects’ research; limited staff in research offices; limited 

access to the national dialogue relating to issues in human subjects’ protections; and other similar 

concerns. What is the state of human subjects’ compliance among predominantly undergraduate 

institutions? What infrastructure exists to support appropriate monitoring? How effective is 

the oversight provided? How well informed are researchers in the social sciences, education, and 

other non-medical fields? How invasive and potentially harmful is student-directed research at 

predominantly undergraduate institutions? In answering these questions and other related issues, 

a convenience sample from predominantly undergraduate institutions in the South is surveyed for 

use in this profile. 

Background of Human Subject Research 

Papers 

Throughout the past several decades, the protection of human subjects in research has gained 

extraordinary attention. Historical events, such as the Nuremberg trial and the Tuskegee study, 

caused the government to examine research in such a way that the protection of research participants 

became a major issue. Since 1991 when the Common Rule was mandated by the federal 

government, the expectations of protecting humans in research have continued to increase dramatically 

in academia. While research protections at one time applied to clinical trials and medical 

universities, predominantly undergraduate universities are noticing a trend to comply to these 

federal regulations as well. These less research intensive institutions recognize the need and importance 

to protect research participants, although the capacity of the research may not be medical 

in nature. There has also been a greater awareness after the closing of university research due to 

non-compliance, such as gene therapy studies at the Institute for Gene Therapy at the University 


Papers 

of Pennsylvania in 2000. In this instance, a research participant, who was an unhealthy 18-year old 

unqualified to participate, died as a direct result of gene therapy. Although federal regulations for 

the use of humans as research participants apply to research that is federally funded, there is an 

obvious need to apply the regulations to all research. This has affected a countless number of institutions 

in the South and nationwide, as they seek the resources and training necessary to achieve 

compliance. 

While institutions strive to comply with federal regulations, many problems exist that IRBs 

struggle to deal with. Emanuel, Wood, Fleischman, Bowen, et al (2004) identified fifteen problems 

with the research oversight system which they categorized into three broad areas, including structural, 

procedural, and performance assessment problems. First, the federal regulations regarding 

human subjects in research really only applies to research that is federally funded. However, institutions 

have written policies in recent years that require all research to adhere to federal regulations, 

despite the funding mechanism. This in itself causes controversy at less research intensive 

institutions, whose research typically involves mostly social sciences (“Protecting human beings,” 

2001). Other structural problems noted by Emanuel, Wood, Fleischman, Bowen, et al (2004) are 

inconsistency in regulations among agencies, the lack of an effective method for addressing ethical 

issues, possible and probable conflict of interest at institutions, sometimes repetitive reviews for 

collaborative research, lack of resources, and haphazard training/education of ethics. The second 

problem area of review procedure problems includes review time, lack of expertise of IRB members, 

lack of criteria and guidance in operating procedures, dissecting informed consent and other 

forms for minimal-risk studies, and process for reporting adverse events. Finally, Emanuel, Wood, 

Fleischman, Bowen, et al (2004) describe two performance assessment problems as having no 

measure of IRB performance and a lack of systematic monitoring. Many of these problems greatly 

affect institutions which conduct the greatest portion of their research in social sciences, as they 

attempt to abide by federal guidelines. However, these inconsistencies and deficiencies in the oversight 

system leave institutions relying on individual discretion, which can then lead to government 

reprimands. 

While federal regulations are left to be interpreted by each institution to the best of their ability, 

compliance agencies reprimand institutions for non-compliance through warning letters. Upon 

receipt of a warning letter, the institution must send written correspondence to the agency providing 

corrective actions taken to resolve the addressed concerns. According to Bramstedt and 

Kassimatis (2004), between January 1997 and July 2004 there was a total of 52 warning letters 

issued to institutional review boards by the FDA. Of those, only 9 (17%) were issued to university 

IRBs, which included 2 sent to institutions in both Georgia and Texas and 5 warning letters sent 

to Florida institutions. In general, it seems that universities are doing well with complying with 

federal regulations. Of the nine universities that received warning letters, 56% indicated failure to 

follow regulations regarding informed consent documents and process. Other reported problems 

leading to warning letters included failure to adhere to written IRB review procedures and inadequate 

monitoring of approved studies. It is apparent that the reasons for issuing warning letters are 

related to the research oversight problems indicated by Emanuel, Wood, Fleischman, Bowen, et al 

(2004). The most common reason for receipt of a warning letter was failure to adhere to written 

IRB review procedures, which may be a result of inconsistent regulation expectations by agencies. 

Other issues within IRBs at predominantly undergraduate institutions can be directly related to 

the oversight problems stated above. 


Project Update 

Papers 

Many flaws exist within the federal regulations and therefore among Institutional Review Boards. 

It is imperative to provide the information necessary for IRBs to grow and improve. With regulations 

that only loosely define terms and guidelines, this information needs to come from another 

source: other institutions like our own. We have all been struggling with attempting to understand 

and comply with federal regulations, but no one really knows what other institutions are doing. In 

order to be aware of what different institutions are doing in terms of the IRB, this project attempts 

to provide a profile of Master’s I colleges and universities, as defined by the Carnegie Classification 

of Institutions in Higher Education, in the South. This profile could be used as a benchmark for 

predominantly undergraduate universities, as they implement policies and procedures within their 

Institutional Review Boards. 

This type of a profile would benefit many institutions that may be in the process of writing policy 

or changing procedures. Many research administrators who work with the IRB communicate 

with other administrators for advice or guidance in key issues. However, others do not reach out 

for that guidance and are left trying to work through compliance issues themselves. If research 

administrators had a basic idea of what other institutions IRBs are doing and how they are handling 

these issues, we could more easily deal with our own. Hot topics in human subject research, 

such as training and resources, are often not addressed enough at the federal level and are left to be 

handled at the institutional level. Knowing what others are doing in providing training for investigators 

gives ideas to others in how to improve upon how to better train investigators. Research 

administrators are in need of this kind of support from others, as we struggle to find a balance in 

complying with federal guidelines and locating the resources necessary to do so. 

As I began to think about what information I wanted to gather from institutions, current issues 

discussed at my own institution led the way, as well as current literature about compliance issues. 

During the last couple years, Georgia Southern University has been updating policies and procedures 

in human subject research in order to comply with federal guidelines. There have been many 

trials and tribulations along the way, which have found ways of smoothing out. Because our institution 

is a Master’s I University and predominantly undergraduate, the type of research on campus, 

ease of understanding and use, and helpfulness to the investigators all had to be greatly taken 

into consideration. New application forms were made more user-friendly, as was our website and 

the resources offered through it. Our review processes became more streamlined for expedited requests 

while still following federal guidelines. We moved from reviewing all protocol as full board 

to sending expedited applications to only two board members to review. As new processes developed, 

policies were created and documented in the form of an IRB Manual. Throughout this entire 

process, several issues with the federal guidelines were discussed in detail and became the basis 

for our newly developed policies and procedures. It required great effort and discussion between 

administrators and members of the IRB to work through any difficulties. This led me to realizing 

that we did not know what issues other institutions were dealing with, and were they even experiencing 

the same problems? 

I now had general ideas of what data I was interested in and began to plan and create the project. 

The list of Master’s I Colleges and Universities in the South was obtained from the Carnegie Classification 

of Institutions of Higher Education. Those colleges and universities included in this project 

were researched via the internet for contact names, e-mails, and phone numbers of research 

administrators who work directly with the institution’s IRB. After much searching for contact 

persons at these institutions, an e-mail with the survey attached was sent requesting their time and 

effort in providing information about the infrastructure of their IRB. The survey included four 

sections: board composition, training and documentation, profile of IRB activity, and policies/procedures. 

Within these topics, specific questions were asked about popular issues, such as training 


Papers 

for board members, reviewing oral histories, and available resources. Though the information 

gathered from this survey could be very beneficial to research administrators, many difficulties 

arose while trying to gather the data. 

I encountered many barriers during the different steps of this project, which led to a mere project 

update rather than a complete project. First, while I was searching the web for contact names, some 

institutions did not provide information on their website about their IRB. Others were simply difficult 

to navigate and required a lot of digging to locate the contact information. Those for which I 

could not locate contact information I called inquiring about a person of contact for the IRB. Some 

institutions said they did not have an IRB, and some transferred me several times before finding 

that they could not help me. Those institutions that I was able to obtain contact information for 

were sent the survey via e-mail. However, some e-mail addresses would not send correctly or no 

longer existed. For these I made further attempts via the internet and telephone calls to obtain the 

correct contact information. Once I had done everything I could to contact IRB administrators, I 

waited for responses to the survey. After a couple of weeks, I sent reminders on two separate occasions 

to please complete the survey and send back to me. As of now, I have received only 38% of the 

surveys that I sent out. With those I did receive, there are some visible trends among Institutional 

Review Boards at predominantly undergraduate institutions in the South. 

Preliminary Results 

With a 38% return of the surveys sent to research administrators, I cannot draw any conclusions 

from the data. However, there are preliminary results that may represent current trends within 

IRB infrastructures. Included in these preliminary results is the degree of concern of pertinent issues 

that Institutional Review Boards are faced with. The importance of some of the issues reflects 

other information about Institutional Review Boards at the responding institutions. 

Overall, training of IRB members and investigators are of greatest concern among respondents. 

Although training is of top priority for research administrators and IRBs, the training requirements 

at these institutions do not reflect that concern. Of the data collected thus far, only 67% 

require all IRB applicants to complete training. Institutions that do require training utilize a 

variety of training sources, including the NIH/OHRP website, in-house training programs, videos, 

and the National Cancer Institute website. A larger percentage, 73%, provides training to student 

groups and classes, which is representative of the concern for training. Although training may not 

be required for all applicants at some institutions, there is an effort to educate and train students 

about research involving human subjects. At the Board level, training seems to be of greater importance 

with 87% of the responding institutions providing training to Board members through 

several different sources. Human subjects training at all levels is gaining greater importance as 

public awareness of human subjects protections increases. About half (53%) of the institutions 

have an IRB Manual, which will facilitate the attempt to educate and train investigators, IRB members, 

university communities, and the public about the protection of human subjects in research. 

The same percentage have a Federal Wide Assurance (FWA), which requires an IRB to have its 

policies and procedures readily available upon request by the Office for Human Research Protections. 

It may be that institutions only see the need to develop a policy and procedures manual if it 

is required to do so. With limited resources and staffing for Institutional Review Boards, developing 

a manual can be difficult and unfeasible. 


Obtaining knowledge about policy changes was ranked the third most important issue, though 

the resources needed to accomplish this are not available. The staffing necessary to keep up with 

new policies in human subject research does not seem to exist in predominantly undergraduate 

institutions in the South. Of the respondents, only 20% have full-time staff and 20% have parttime 

staff dedicated to working with the IRB. The remaining have full-time or part-time staff who 

devote a small portion of their work hours to the IRB. Only 27% of the institutions employ a fulltime 

Compliance Officer, who can dedicate larger amounts of time towards the IRB and keeping 

updated on new federal policies. There is a great dissonance between what research administrators’ 

needs and concerns are and the resources and staffing available to handle them. Because an 

incredible amount of work goes into human subject research, full-time staff is essential in ensuring 

that universities and administrators are aware of federal policy changes. However, the limited 

resources made available for compliance at Master’s I universities does not support this need. 

None of the surveyed institutions are provided a budget specifically used to support the IRB and 

their activities. Any money spent towards training, support staff, or compensation comes from the 

research office budget. Therefore, very few Board members receive any kind of compensation for 

their time and effort put into the IRB. Only 13% of the respondents provide compensation to IRB 

members, of which only the chairperson or non-affiliated member receive. 

With the completed surveys that have been returned, slight connections are visible among different 

aspects of IRBs infrastructure. Some of our greatest challenges as research administrators must 

be dealt with at the institutional level, since we have no affect at the federal level. Realizing that 

many of these issues seem to exist among most Institutional Review Boards in the South provides 

a clear picture of changes that need to be made. Many of us are dealing with the same issues, such 

as a lack of budget, providing training, and limited resources, which overlap and affect one another. 

Upon receipt of more completed surveys, I may begin to notice more defined trends and draw 

conclusions about the infrastructure of IRBs at Master’s I universities in the South. After identifying 

common problems and finding trends among IRBs and their infrastructure, research administrators 

may begin to discover ways in which they can be fixed. 

References 

Bowen, A., Fleischman, A., Emanuel, E., Wood, A., et al. (2004). Oversight of human participants 

research: Identifying problems to evaluate reform proposals. Annals of Internal Medicine, 

141(4), 282-291. 

Bramstedt, K., & Kassimatis, K. (2004). A study of warning letters issued to institutional review 

boards by the United States Food and Drug Administration. Clinical and Investigative Medicine, 

27(6), 316-323. 

Protecting human beings: Institutional review boards and social science research. 

(2001, May/June). Academe, 87(3), 55-67. 

Papers 


Papers 

Focusing on “Development”: 

Strategies for Strengthening Research at the University of Botswana 

Jose Jackson, PhD 

Office of Research and Development 

University of Botswana 

P.O. Box UB 00708 


Tel: 267-355-2903 

Email: maletej@mopipi.ub.bw 

Abstract 

Successful researchers globally have reported that their scholarly achievements have been due in 

part to acquiring effective habits of research and proposal writing early in their career. This they 

claim stimulated greater engagement in research with the outcome being high quality outputs. A 

survey was conducted at the University of Botswana (UB) between January - May 2005 to assess 

the constraints and incentives faced by academic staff to engage in research and seek funding for 

their programs. The findings indicated that personal commitment to research, career goals, presenting 

research findings, likelihood of attracting additional funds and the benefits of research to 

one’s teaching were leading incentives for academic staff in their pursuit of scholarship. The major 

barriers included workload issues, inadequate research budgets, lack of mentoring and collaboration, 

excessive requirements to develop proposals and limited time to write proposals. These issues 

clearly pose significant challenges for academics, particularly junior researchers with limited experience 

and who make up about 70% of the total academic staff on the UB campus. The strategic 

approach being implemented by the Office of Research and Development (ORD), which focuses 

on the development of UB academic staff, particular junior researchers, will be reported. 

Introduction 

The University of Botswana is a relatively young university, established in 1982 with a focus on 

undergraduate education. Since then, UB has grown considerably; becoming more research focused 

and in 1996/97 began offering research degrees (MPhil and PhD) in Chemistry, Biological 

Sciences and Mathematics. The 5-year University development plan, which ended in 2003 sought 

to increase research capacity across all disciplines, improve the quality of research conducted 

by academic staff, improve research training for undergraduate students, increase and improve 

research training for staff, increase efficiencies for research administration and extend researchbased 

knowledge for the benefit of the community and the nation (GOB, 1998). 

The University’s commitment to research was evidenced in 2001 by the establishment of the Office 

for Research Development (ORD) that reported directly to the Deputy Vice Chancellor for Academic 

Affairs. Until 1999, research was managed by the then National Institute for Development 

Research and Documentation (NIR), which was disbanded following a strategic planning exercise. 

This change has resulted in a re-emphasis on strategic management of research at UB. The current 

structure includes a Director with staff portfolios including Deputy Director, Assistant Director 

Research Quality Management, Assistant Director Research Funding and Assistant Director 

Commercialisation and Intellectual Property (vacant to be advertised) as well as 5 administrative 

officers with the responsibility to support and guide research at UB. 

Shaping the Future, which describes UB’s strategic and development plan from 2003 – 2008 and 

beyond, envisages the University as becoming a centre of excellence in Africa and the world (UB, 

2003a). From the recently filled positions of Assistant Directors and the ORD’s own strategic 

planning exercises, it is evident that repositioning research to a higher level is a priority at UB. 


A strong focus has been placed on funding for research, quality research outputs, partnership 

development, supportive and mentoring research environment, capacity building and networking 

opportunities, as well as recognition and achievement in research. 

UB Research Landscape 

Table 1 shows the academic staff and student numbers and the internal research funding budget 

(in Pula) for UB over the period 2002 – 2003. Although not the largest university by world 

standards, UB is a comparative mid-size university by African standards with a population of 

over 15,000 undergraduate and postgraduate students in 2003. The University’s academic staff 

comprises over 700 researchers with qualifications at the level of Masters and Doctoral degrees. 

Despite the clear focus on strengthening research through the establishment of a research office as 

well as employing staff with research capability, the internal budget allocations for research funds 

remained significantly low, at about 0.3% of the total University budget. The situation of underfunding 

research could have multiple effects, primary of which is the reduction in staff commitment 

to research and scholarship, as well as a sense of demoralisation and isolation from the international 

scholarly community. For a young university like the University of Botswana, this could 

only have negative effects on the University’s strategic focus for developing a research culture. 

Table 1: UB academic staff and student numbers compared to research budgets 

2,002 2,003 

Academic staff 770 760 

Graduate students 700 769 

Undergraduate students 12,083 14,656 

Internal Research Funds (Pula) 1,500,000 1,650,000 

Total Budget (Pula) 520,352,658 527,248,658 

Source: UB Annual Reports, (UB, 2002 and 2003b) 

US$ 1 = Pula 5 

Papers 

Figure 1 shows the comparison of UB’s internal and external funding budget for the period 1994 

– 2004, which shows that external funding has been on average 10 times more than internal funds. 

One important factor that must be emphasized about externally obtained resources in higher education, 

with the exception of endowment funding, is the question regarding longevity. These funds 

typically last for a number of years, and then disappear; leaving a promising program that was 

funded from these sources disadvantaged or, just as badly, dependent on the institution’s regular 

resources. Figure 1 shows clearly the effect of donor reliance as in 2002, donor funding was significantly 

reduced by almost 50%. Commitment by Government to pick up the support for activities 

that were started with external funds are often impossible. 


Papers 

Figure 1: Total UB Internal and External Research Funding, 1999 - 2004 

Views from Academic Staff at UB 

Questionnaires were distributed to academic staff attending a funding workshop organized by the 

ORD in February 2005. It was also sent to all academic staff at the University via electronic mail. 

Follow-ups with staff were made via email and then by personal visits between March and April 

2005. Self-reported responses representing 13% of the population of academic staff were received. 

The profile of respondents is shown in Table 2. About 64% were males and over 50% were at the 

lecturer level. The nationality of academic staff at UB showed 58% were from Botswana, 32% from 

other African countries, and 5.3% each were from European and Asian countries. Although all 

faculties were represented, the Faculty of Business had the least responses (only 5%). About 80% of 

the staff had PhD’s and the remainder had Masters degrees. 

Academic staff views regarding the research funding opportunities provided by the ORD are 

shown in Figures 2 and 3. It indicates that to a large extent, the University researchers relied significantly 

on the ORD, although they also used their own contacts and the funding databases such 

as the Community of Science and ResearchResearch to which the University subscribes (Figure 2). 

Over 70% felt that the quantity of alerts distributed were just right (Figure 3A) and were satisfied 

with the current electronic medium that is used (Figure 3B). A small percentage would prefer to 

receive hardcopies of the alerts and also for it to be posted on the ORD website (Figure 3C). Only 

a minority of researchers had been recipients of ORD or other funding opportunities (Table 3). 

Over 60% of the researchers felt that the funding opportunities distributed were relevant to their 

work either some or all of the time. Twenty six percent felt that it was either not usually or not at 

all relevant to their work (Table 3). 


Table 2: Profile of academic staff at the University of Botswana (n = 100) 

Papers 


Papers 

Figure 3: Academic staff views about the quantity of alerts currently sent by ORD (A), 

their satisfaction with the current medium of funding alerts (B) and preference for 

receiving funding alerts (C) 


Table 3: Characteristics of ORD Funding Opportunities 

Recipient of an ORD opportunity 

Percent 

No 68.9 

Yes 29.5 

No answer 1.6 

Recipient of another opportunity 

No 50.8 

Yes 44.3 

No answer 4.9 

ORD opportunities relevant 

Relevant to my work some of the time 49.2 

Not usually relevant to my work 23.0 

Relevant to my work all of the time 14.8 

No answer 6.6 

Not at all relevant to my work 3.3 

Other 1.6 

Don’t always read them 1.6 

Papers 

A worrying situation was the statistics on proposal submission (Figure 4). The majority of researchers 

(over 70%) indicated that they had never submitted a proposal for funding either prior to or 

since 2003. It was mainly Senior Lecturers and Associate Professors who reported on submitting 

proposals for external funding. This could have several interpretations, firstly that Lecturers were 

inexperienced in grant proposal writing, and therefore did not submit them. Secondly, having 

attained the rank of Professors resulted in reduction in effort by the most senior academic staff. 

Furthermore, it appeared that grant proposal writing significantly reduced since 2003. Of those staff 

members who reported on submitting a proposal for a funding opportunity either before or since 

2003, about 50% or more of them had obtained funding. Based on these yield rates, UB academic 

staff who apply for funding opportunities appear to be relatively qualified and competitive. 

Figure 4: Percent of staff and quantity of proposals submitted for funding before (b)and after (a) 

2003 


Papers 

Respondents’ evaluations of incentives and barriers to research/scholarship were very similar to 

their evaluations of incentives/barriers to the pursuit of external funding. Personal commitment 

to research/scholarship, achieving career goals, presenting research findings, likelihood of attracting 

additional funds and the benefits of research to teaching were leading incentives for academic 

staff in their pursuit of research/scholarship and external funding (Figure 5). Workload issues 

(teaching, advising and service), inadequate internal budgets, lack of mentoring and collaboration, 

excessive requirements to develop proposals and limited time to write proposals were leading 

perceived barriers to research/scholarship and the pursuit of external funding (Figure 6). 

Academic staff indicated in Figure 7 that an institutional policy governing teaching, research and 

service and how they are assessed, departmental flexibility with workload and targeted external 

funding opportunities would be most beneficial to support their research and funding endeavors. 

Mentoring and proposal development support would also be useful to them. Lecturers and 

Senior Lecturers reported having the greatest needs in all categories provided in the survey except 

targeted alerts. In this category, all Senior Lecturers, Associate and Full Professors reported having 

equal needs for additional information. 

The data on research outputs is indicated in Table 4. Most respondents reported publishing 1 to 

3 articles in peer-reviewed and other publications before and since 2003. As expected, Professors 

and Associate Professor had the highest publication record of about 9 and 4 articles prior to 2003 

and since 2003, respectively. Senior Lecturers had 7 and 3 articles prior to 2003 and since 2003, 

respectively. Only Lecturers had increased their publication record since 2003. 

Focusing on “Development” 

The low intensity of research investment in Botswana is especially worrying in light of the large 

and widening gap between R&D intensities in developing countries and industrialized countries. 

The recent findings of the Botswana UN Human Development Report for 2005 indicated 

that research institutions had failed to deliver and that Botswana needed to re-learn how to build 

research capacity. There is therefore an urgent need to find ways to reverse the current trends in 

funding for research, as well as more efficiently utilize current funds. The proposed research funding 

agency – the Botswana Research and Science Funding Agency (BRSFA) is expected to change 

the research landscape in Botswana by providing more funding for research that would strengthen 

basic and applied research, stimulate innovation, leverage private sector funds and guide science 

and technology in the country to achieve human and economic development needs. 

There is little doubt that strong public support to research will be needed for many decades into 

the future in Botswana. A critical examination is required of the workload of UB academic staff so 

that they are able to devote time needed to conduct research and write grant proposals in order to 

meet the criteria of BRSFA and deliver quality research outputs. An institutional policy on teaching, 

research and service that not only clearly indicates the assessment of these categories for career 

development, but also the relative importance of each for individual researchers. In addition, 

a university commitment to mentoring, recognition of collaborative research programs and provision 

of incentives would be required to create a conducive research environment. These needs are 

especially critical now in Botswana as public support of research through BRSFA is proposed to be 

competitive and performance based. 


Papers 


Papers 


Figure 7: Needs of academic staff to increase engaging in research and external funding opportunities 

by academic rank (0 = no answer, 1 = not at all a factor, 2 = not usually a factor, 3 = somewhat 

of a factor, and 4 = a major factor) 

Table 4: Research outputs reported by Academic staff 

No. of publications Percentage of staff 

Before 2003 Since 2003 

Papers 

Peer Review Other Peer Review Other 

0 26.7 31.7 23.3 30 

1-3 48.3 45 30 38.3 

4-6 20 19.9 16.6 10 

7-9 5 0 3.4 1.7 

≥10 0 3.3 26.7 20 

The ORD has an increasingly important role to play in this process. Academic staff members have 

recommended that ORD needs to be more proactive in terms of seeking external funding opportunities, 

providing targeted opportunities and that an ORD staff member should be assigned 

to each faculty / department. Through its current strategic planning process, ORD is developing a 

range of programs to establish effective habits of research and proposal writing by academic staff 

that would stimulate greater engagement in research and scholarly activities. 

Successful researchers have reported that success in getting external funding, is all about the 

numbers game - the more proposals a given academic staff member writes, the more likely s/he 

will find success. Therefore, the higher the percentage of staff members who are actively develop- 


Papers 

ing proposals, the greater the growth in the university’s research budget. The ORD has taken a 

strategic decision to focus on young researchers through the provision of competitive post-doctoral 

fellowships for returning PhD’s. This is because this group has the greatest potential to add 

to the university’s future crop of research winners and evidence has shown that those who fail to 

establish effective habits of research and writing early in their careers probably never will (Gibson, 

1992). The period of one year, will allow this group to write papers from their dissertation and 

focus on developing their research programs, while being mentored by a senior researcher at UB; 

all without the distraction of excessive workloads. Visiting research fellowships for experienced 

scholars will also be offered competitively so that the University could attract the best minds and 

strengthen its research capacity. 

A regular, academic development interactive workshop series that focuses on developing research 

skills has been established to build research capacity at UB and will be targeted at all levels of staff, 

but in particular, those at the Lecturer level. This will supplement the two workshops held annually, 

prior to the internal funding competition. These workshops immerse academic staff members 

and foster interactions with senior faculty role models to build collegial spirit in a problem-centered 

environment that allows opportunity for reflection, analysis and discussion. The workshops 

focus primarily on strengthening proposal writing including writing tips, adhering to instructions 

and review panels expectations; identifying sources of funding using databases; contract and 

grants procedures at UB; and agency specific initiatives. Other topics including research methodology, 

project management, and negotiating contracts are also offered periodically. 

Another strategy underway is the celebration and promotion of the University’s research successes 

externally in the UB newsletter, website and the national media. Success stories from young, 

emerging and experienced researchers, their profiles, recipients of awards as well as ongoing and 

completed projects and their outcomes are generally included. Publicizing internally at all UB fora 

including faculty funding meetings and workshops is also a continuous process. This increased 

publicity can have a powerful effect on the motivation of others to succeed; it greatly enhances the 

chances of reappointment and/or promotion, as well as increases academic freedom. Having funds 

can allow staff to recruit the best students, work with the best computers and software, travel to 

the most important conferences, afford page charges in the best journals, buy the best equipment, 

secure timely secretarial services, maximize the time they can devote to research (hire replacement 

staff) and in general have the freedom to do many more things than can be done on a typical 

university researcher’s budget. The information is promoted widely to stakeholders and potential 

collaborators in Botswana and internationally to market the expertise and research capacity available 

at UB. 

The ORD also works closely with the School for Graduate Studies to seek funding for the development 

of graduate programs that are linked to research development as this creates enormous 

opportunity for growing research at UB. Academic staff members with active research programs 

that supervise graduate students can assist in a long way to expanding research programs and the 

research culture at UB. To ensure that research and graduate studies are championed at the highest 

level, it is envisaged by the UB Management to establish a position of Deputy Vice Chancellor 

– Research, Innovation and Graduate Studies in the near future. 

Conclusion 

The appropriate mechanisms for developing critical local research capacity at UB will undergo 

considerable evolution. A new Director of Research has been appointed to lead the research 

infrastructure at UB to the next level and new staff members have also been recently appointed 

into new positions. These changes make this an exciting time to contemplate the development of 

research at the University of Botswana that will shape the University’s future. 


References: 

• Coombe T. 1991. A consultation on higher education in Africa, A report to the Ford Foundation 

and Rockefeller Foundation. 

• Geuna A., Martin B. 2003. University Research Evaluation and Funding: An International 

Comparison. Minerva 41: 277–304Government of Botswana (GOB). 1998. Government of 

Botswana National Development Plan No. 8 

• Mazonde I. 2004. Increasing the value of Research through Research Management. Proceedings 

of the 2004 Conference of the Society of Research Administrators (SRA), Utah, USA 

• Ministry of Communications, Science and Technology (MCST). 2004. Draft Bill for the 

Botswana Research, Science and Technology Investment Agency (BRSTIA). Government of 

Botswana, Gaborone, Botswana 

• National Science Foundation (NSF). 2002. Changing composition of federal funding for 

research and development and R&D Plant since 1990. Science Resources Statistics Info Briefs, 

NSF 02-315. NSF, Arlington, Virginia 

• The World Bank. 2004. Botswana Development Indicators, World Bank Report, Washington, 

DC 

• United Nations Development Programme (UNDP). 2005. Botswana Human Development 

Report 2005 - Harnessing Science and Technology for Human Development 

• University of Botswana (UB). 2002. Annual Report 2002/2003 

• University of Botswana (UB). 2003a. Shaping the Future: The University of Botswana Strategic 

Plan for NDP9 and Beyond 

• University of Botswana (UB). 2003b. Annual Report 2003/2004 

Papers 

• University of the Free State (UFS). 2004. University of the Free State Research Committee 

Meeting. June, Bloomefontein, South Africa 

• van der Meer P. 1999. Funding and Allocation of Resources in Higher Education: The Dutch 

Case’, Proceedings of the 3rd ALFA-BRACARA international conference on ‘Funding and 

Allocation of Resources in Higher Education’, Universidad Nacional Autonoma de Mexico, 

February 

• van Steen J., Eijffinger M. 1998. Evaluation Practices of Scientific Research in the Netherlands, 

Research Evaluation, 7 (2), 113–122. 


Papers 

Abstract 

“Best Practices” in Electronic Research Administration for 

Small and Mid Sized Institutions: Selected Phase I Results 

William S. Kirby 

Principal Investigator 

(wkirby@crosslink.net) 

Michael R. Dingerson 

Professor 

Department of Educational Leadership and Counseling 

Old Dominion University 

(mdingers@odu.edu) 

As a part of an NIH SBIR award to RAMS, Inc., the authors conducted a series of site visits and interviews 

with officials at three universities recognized as leaders in eRA. The purpose of the study 

was to develop an understanding of the leading institutions’ approach to eRA planning, systems 

and software, staffing and other practices used in moving their eRA efforts forward. The goal of 

the research is to describe and characterize common principles and conditions that may contribute 

to success for these institutions. In the second phase of this study, the authors will examine 

several small and mid-sized institutions that have completed or are in the process of implementing 

eRA systems to identify “lessons learned” from those implementations. By examining what happens 

in small and mid-sized institutions, the authors will seek to validate the extent to which the 

principles and practices identified in leading institutions are applicable in a small and mid sized 

institution setting. Grant Number 4U44RR018097-02 from the National Center for Research Resources 

supported the research described. The contents are solely the responsibility of the authors 

and do not necessarily represent the official views of the National Center for Research Resources 

or NIH. 

Background and Study Design 

From earlier research we found that while some small and mid sized institutions are planning to 

develop or purchase eRA systems, many are not proactive about eRA capability development or 

they are at very early stages of planning for eRA. Many institutions are in a “wait and see” mode 

– waiting to see what the federal government will require and what options they will have for 

electronic submission. Some institutions are unsure that they can afford a grants management 

system with e-grants capability. Some are just unsure what to do about eRA or how to proceed. 

We think that this perceived lack of understanding and motivation on the part of many institutions 

has implications for the success of the NIH eRA program and the government-wide e-grants 

initiative, generally. For example, NIH officials estimate that up to 10,000 proposals will be eligible 

for c-GAP submission in FY 2006. Yet, less than 200 have been submitted in FY 2005, and the vast 

majority of institutions are not in a position to take advantage of c-Gap either through existing 

service providers or using their own capabilities. Further, while grants.gov provides a low cost alternative 

for proposal submission, it may not be a viable option in the near term as start up related 

issues are resolved. In order for the government e-grants effort to succeed among research 

1 Kirby, W.S. and Michael R. Dingerson, “Selected Results from a National Survey of eRA Software Requirements for 

Small and Mid Sized Organizations”, Proceedings of the Sociey of Research Administrators, October 2004 


institutions, institutions must be motivated to act in ways that move them quickly to prepare for 

electronic submission either through available service providers or by developing their own capabilities. 

Success will depend on educating institutional officials about the advantages of electronic 

submission, and providing incentives for active participation. 

Our research is driven by the assumption that if we can understand what leading institutions do 

to be successful in moving their eRA efforts forward, other institutions could learn from them and 

apply some of those lessons to their own eRA efforts. In addition, government officials and service 

providers may be able to use knowledge about the conditions necessary for eRA success in helping 

their constituents and customers move forward. 

The study is designed to explore and describe how leading institutions go about eRA planning, 

development, and implementation. Phase I of the research consisted of a series of case studies 

examining the practices of “leading institutions” with respect to eRA generally and eRA systems 

implementation specifically. The authors, in consultation with NIH program officials, selected 

three institutions recognized for their leadership in eRA and for having successfully implemented 

significant systems supporting grants management: Pennsylvania State University, Colorado State 

University, and Massachusetts Institute of Technology. Site visits and interviews with officials 

responsible for eRa and grants management were conducted at these institutions in late 2004 and 

early 2005. 

Phase II will consist of a second series of case studies designed to evaluate the transferability of 

the “best practices” identified in Phase I to ERA systems implementation in small and mid sized 

institutions. 

While we did review the various eRA systems that were developed by these institutions, it is 

important to emphasize that the focus of the research is on the characteristics of the processes 

and approaches that move eRA efforts forward, and not on the technology employed or how the 

technology is used. 

The following outline was developed to provide a general framework for exploring a range of issues 

associated with eRA development. The interviews were designed to be open ended, and the 

outline was only used as a starting point and guidance for discussions. The first set of topics was 

focused on general approaches to eRA. The second set was focused on how specific projects get 

done. We understand that there is considerable overlap and interdependence among the topics. 

INSTITUTIONAL ERA LEADERSHIP 

What is the role and nature of leadership in driving institutional eRA planning and development? 

• What are the primary characteristics of that leadership? 

Papers 

• Is the vision for eRA developed primarily from the top-down and driven by senior research 

management (Chief Research Officer)? Or is it primarily “championed” by research administration 

management/practitioners or others? 

• What are the leadership factors that contribute most or have the strongest influence on success 

with eRA? 

• What processes are used to garner community and institutional support for eRA efforts? 


Papers 

INSTITUTIONAL ERA PLANNING AND BUDGETING 

What is the nature of the institution’s approach to eRA planning and budgeting? 

• Does the institution or the Research Office have a formal plan for eRA? 

• What process was used to develop the plan? How is it led? 

• Does the plan drive eRA budgeting? 

• Does the institution or the Research Office have an eRA budget, or do eRA projects compete 

for priority among general IT projects of the institution? 

• Who makes budgetary decisions with respect to investments in eRA systems? How does the 

process work? Where do the funds come from? 

• How are priorities set? 

ERA EXPERTISE 

How is the expertise necessary for a successful eRA program acquired, developed, and deployed? 

• Does the institution or Research Office have dedicated eRA staff, or does eRA compete for 

expertise provided by central IT? 

• How is it organized and deployed? What kinds of issues is it responsible for? 

GENERAL APPROACH TO ERA DEVELOPMENT 

What is the preferred approach to developing eRA projects and what factors influence those 

choices? 

• Which factors most inform this general approach? 

• How were eRA systems implemented? 

o Roll out strategy 

o Training 

o Communication 

o User Support 

o Vendor Support, if any 

o Community Involvement and Acceptance 

o Faculty Involvement/Acceptance 

GENERAL FINDINGS 

The following discussion summarizes our general findings. In summarizing these findings we have 

focused on the common themes and conditions that emerged from our discussions with institutional 

officials. Implications of these findings for institutions, government officials and service 

providers are also identified. 

LEADERSHIP 

Not surprisingly, strong leadership at multiple levels plays a vital and enabling role in making eRA 

a success. While all of the institutions we examined approached the mobilization of their eRA efforts 

differently, three common themes were observed. 

• Determined eRA “Champions” led the way 

• They developed strong business cases to bolster community and institutional support 

• They successfully secured support at senior institutional levels 


At all three institutions the initial vision and leadership for eRA was developed and championed 

primarily at the level of the Office of Sponsored Programs. This is not surprising because it is at 

this level that the potential benefits of eRA systems are most likely to be recognized. However, the 

successful development and implementation of eRA systems requires considerable resources that 

are usually not under the control of Sponsored Programs Offices. Success invariably hinges on successfully 

garnering senior administration and faculty support for those efforts. Using a variety of 

tactics and approaches champions at all three institutions were able to successfully garner the support 

they needed to move forward. At Penn State, eRA efforts foundered until support was secured 

from a new Chief Research Officer. Support was bolstered among other senior officials and faculty 

by sponsoring an institution-wide task force and review of research administration resources and 

needs. This task force report made a strong business case for the investment of institutional funds 

in information technology supporting research. A similar but streamlined mechanism – a Discovery 

Process – was used in developing a business case for eRA at MIT. In addition, the development 

of a “state of the art” eRA system was negotiated as a condition of the OSP director’s employment 

contract. At Colorado State, support from senior management came primarily from the office of 

the Chief Research Officer, who also has responsibility for university-wide information technology, 

and established a senior level position to oversee Sponsored Programs and the development 

of technology services to support researchers. 

It is clear that institutional leadership for eRA varies widely among institutions, and that the 

leadership exhibited at leading institutions is not typical of many institutions. Nevertheless, these 

findings suggest that there may be things that can be done at institutional levels, by government 

officials, and by service providers to provide support to existing “champions”. These things may 

include sharing information about the advantages and benefits of eRA, strategies for building 

institutional support, and methods to help develop qualitative and quantitative data to support the 

development of eRA business cases. 

STAFFING AND RESOURCES 

A key success factor at all three institutions appears to be the availability of dedicated information 

technology staff assigned to the Office of Research. These staff typically focus solely on the application 

of technology to support research administration, and have no other operational responsibility. 

Officials at all three institutions indicated that the availability of dedicated staff was the most 

important factor in being able to move their eRA efforts forward, and that success would have 

been far less likely had they had to compete for central IT resources to achieve their objectives. At 

Penn State and Colorado State these staff are in the office of the Chief Research Officer; at MIT in 

the Office of Sponsored Programs. 

We think this finding is significant because in our previous research we found that most institutions 

did not have dedicated staff resources. Based on our discussions with leading institutions, it 

(dedicated staff) appears to be a necessary condition for success. The implications of this finding 

are clear, and suggest that institutions should consider ways to dedicate staffing to their eRA efforts. 

While some institutions may not be able to afford the level of staffing employed by the leading 

institutions or may not be able to hire additional staff, it may be possible to re-deploy existing 

resources to achieve this, even on a temporary basis. 

PLANNING AND APPROACH TO SYSTEM DEVELOPMENT 

Papers 

Planning. One unexpected finding from our study is that none of the leading institutions had a 

formal plan or planning process for eRA. What “planning” there is can be characterized as informal, 

flexible, and focused on taking advantage of technology as it develops; rather than a formal 

process designed to achieve a desired result. These institutions approach eRA more as an ongoing 


Papers 

process than an end product; as an enabler, not an objective. Each leading institution continually 

looks at ways to use technology to improve research administration, and their process is 

iterative and responsive rather than aimed at a specific end product. They see an opportunity, do 

something, refine it, and then do something else. This iterative approach is at odds with the more 

“classic” approach to business process re-engineering and systems development, which is normally 

characterized by a more formal, and strategic planning process and step-wise action plans. 

Overall Approach. Another unexpected finding is that leading institutions do not view eRA as 

“electronic submission”, and it is not their major focus. They are driven primarily by data and information 

needs first – all three institutions started by defining data requirements first, and developing 

a database. Officials at all three institutions indicated that developing data requirements and 

a database was the first thing they did before even thinking about how they could use the database 

to automate business processes. Thus, their vision for eRA is as a data-driven, grants management 

system rather than an electronic proposal submission system. We think this finding has significant 

implications. 

Leading institutions understand the importance of data in improving the efficiency and effectiveness 

of their business processes. Yet, many institutions do indeed view eRA as primarily a way to 

submit proposals and other types of information electronically, rather than as part of an overall 

and integrated grants management strategy. We think this view leads inevitably to a reactive approach 

to eRA, which is dependent on what sponsors provide in terms of e-grants capability (e.g. 

FastLane, grants.gov, NIH Commons, etc). We think that a “system-to-system” transfer of data 

between institutions and sponsors best helps institutions realize the benefits of eRA in an integrated 

way, rather than the prevailing government model which relies on a “person-to-government 

system” web interface. Our previous research indicates that electronic submission will work best 

when data is generated and controlled locally and then transmitted as part of a system-to-system 

process. Thus, we think government eRA officials should be encouraging the use of, and citing the 

advantages of, systems that foster sound “cradle to grave” grants management, including electronic 

submission. The grants.gov concept of “one stop shopping” for all submissions is an important and 

desirable development. Nevertheless, the current emphasis on “person-to-system” proposal transactions 

decouples the submission of data from the business processes that generate it and the local 

systems that track it. We think this decoupling is undesirable from a local business management 

perspective, as well as unnecessary. The challenge for service providers is make the business case 

for the value of system-to-system solutions for both government and institutions. 

COMMUNITY INVOLVEMENT AND USER ACCEPTANCE 

We found little commonality among the three institutions in how they approached building community 

involvement and user acceptance of their eRA systems. However, based on our discussions 

with institutional eRA officials, we have formed some observations and tentative findings. 

As previously noted, eRA systems at all three institutions were initially focused primarily on the 

internal office of sponsored programs information and processing needs. Thus, the initial customers 

and users of the systems were primarily internal to OSP and external community involvement 

in system development and deployment was not a focus in moving forward. 

2 It should be noted that we did not interview faculty or many departmental administrators at any of the institutions, 

and therefore could draw no conclusions about the acceptance or satisfaction with any of the institutions’ systems. 

Thus, our findings are based on the perceptions and experience of each institution’s eRA officials. 


All three institutions are currently only at early stages of deployment for business process automation 

(e.g. proposal development, routing and approval, etc) that involve faculty and departmental 

administrators, and in no case is use of the system required. 

Our impression, formed in our discussions with institutional officials, is that at least two conditions 

appeared to have an impact on system acceptance (usage): 

• Community involvement, and 

• Integration of eRA into the institution’s overall web based services 

Papers 

Usage appears to be high where community involvement is high, and only one institution, Penn 

State, had a formal mechanism to accomplish this. This mechanism is an institution-wide research 

administration network of college and departmental administrators which is used for, among 

other things, eRA communication and training. 

Colorado State officials indicated that usage of the eRA system, which collects proposal data provided 

by faculty and administrators very early in the process, was high. They attributed the high 

usage, in part, to having the eRA system seamlessly integrated into the institution’s web portal 

system (as is the Penn State system). 

MIT officials indicated that system usage by departments and faculty was relatively low. However, 

they also indicated that they have only recently made efforts to increase usage a priority. They also 

noted that usage had increased after the recent release of a web-based interface for the eRA system 

(COEUS Lite). 

We also observed that in no case had the eRA system become fully integrated into the research 

administration business process for proposal development, routing, and approval. Thus, dual 

processes (paper and electronic) were in place. As these systems become more mature, the issue of 

standardizing procedures and requiring full deployment will become critical. 

MOVING TO FULL DEPLOYMENT OF ERA: SOME PRELIMINARY OBSERVATIONS 

The potential benefits of eRA will be achieved only if the resulting systems are accepted and used 

by relevant and appropriate segments of the community. The quality and capability of an eRA 

system alone will not assure full deployment, and the resources required to achieve it are considerable 

and sometimes underestimated. The nexus for institutional eRA deployment is the research/ 

sponsored programs office. The importance of full deployment suggests that institutions, regardless 

of whether they purchase or build an eRa system or ultimately rely on grants.gov, will require 

a concentrated and dedicated eRA effort. 

Similarly, the success of the government’s e-grants initiative is going to depend heavily on how well 

institutions achieve full deployment of grants.gov. While considerable progress has been made in 

the development of grants.gov, full deployment across agencies and by institutions does not appear 

imminent. Thus, most institutions do not feel the need to actively deploy it, and such deployment 

is unlikely to happen by itself. This suggests that the government consider a more strategic 

approach to assuring success. Under the current model, it appears that only some institutions 

– primarily those with the necessary interest, leadership and resources -- are able to develop a dedicated 

eRa effort. While such institutions may account for a significant portion of federal research 

dollars, many, perhaps most, institutions will not be able to achieve the full benefits of eRA. This 

will not only put many institutions at a competitive disadvantage, but also slow down the 


Papers 

realization of the benefits that government agencies hope to achieve through eRA. It is far from 

clear what types of strategic efforts might be undertaken by the government to help spur adoption 

of eRA. One approach might be the establishment of a formal network of institutional eRA “points 

of contact” and a formal outreach effort that would work with institutions to facilitate and assure 

eRA deployment. Another approach might be to consider incentives for, set standards for, or even 

establish a deadline requiring electronic submission. Institutions themselves may consider exploring 

how they might share resources in consortia or outsourcing arrangements. 

NEXT STEPS 

In the second phase of this study, we will examine several small and mid sized institutions that 

have completed or are in the process of implementing eRA systems to identify “lessons learned” 

from their experience. By examining what happens in small and mid sized institutions we will seek 

to validate the extent to which the principles and practices identified in leading institutions are applicable 

in a small and mid sized institutional setting. Based on our review of leading institutions, 

we anticipate that the issues facing smaller institutions will be similar, and that differences may be 

primarily in how these institutions approach the issues given resource differences. 


The Role of Development in a Research Administration Office 

Mr. Ed Mason, MA 

Assistant Director, Research and Sponsored Programs 

Illinois State University 

Campus Box 3040 

Normal, IL 61790-3040 

(309) 438-8595 

cemason@ilstu.edu 

Ms. Linda Learned, MBA 

Associate Director, Research and Sponsored Programs 

Illinois State University 

Campus Box 3040 

Normal, IL 61790-3040 

(309) 438-7913 

lglearn@ilstu.edu 

Authors Notes: The development and ideas for this paper derived from a presentation to the 

Midwest Regional SRA/NCURA Conference in May 2005. In the original presentation, we discussed 

how Illinois State University has developed some unique strategies through the Research 

and Sponsored Programs Office in assisting faculty and staff procures external funding for their 

programs and projects. The concept paper presented to the SRA National Conference in Fall 2005 

examines other universities and the field of higher education response to the ever changing environment 

of decreasing state appropriations, increasing and diversified student populations (traditional 

and nontraditional), and demands by state, federal and private funding agencies to develop 

collaborative relationships with other organizations in order to promote the transfer of services 

and technology to the general public. 

Abstract 

Institutions of higher education are facing the challenges of decreased state and federal funding, 

increasing numbers of traditional and non-traditional students, and imposed limits on tuition 

charges. At the same time, federal and state governments are directing institutions of higher 

education to collaborate not only with one another, but also local community agencies, underrepresented 

populations, K-12 school districts, and nonprofit organizations. Institutions of higher 

education consequently need to develop innovative programs to meet these needs generated by 

government agencies. The purpose of this paper is to discuss how some of the challenges facing 

higher education today might be met through expanding the activities associated with “development” 

to include facilitating the expansion of programs and services, and devising strategies to 

procure additional externally sponsored funding for these programs and services. Specifically, 

sponsored programs offices are often directed by their upper administration to develop such programs 

and assist faculty and staff in finding the external funding to make them possible, and are 

probably in the best position to do so. 

Introduction 

Papers 

This paper will essentially examine the demands for U.S. institutions of higher education to develop 

externally sponsored programs as an answer to the increasing challenges placed before them 

and the methods these institutions are using to do so. An institution of higher education will be 

defined in this paper as an organization that provides bachelors, masters and doctorate prepared 

degrees to qualified individuals. 


Papers 

State and private institutions of higher learning will be examined. Although there are some philosophical 

and funding differences between state and private institutions of higher education, they 

are still faced with many similar problems in creating innovative services and programs for society. 

Both state and private institutions also solicit and receive funding from common sources, including: 

(a) federal and state agencies, (b) private and corporate foundations, and (c) industries. 

As society has become more complex in the twentieth and twenty-first centuries, there have been 

increasing demands for institutions of higher education to offer new services, and become more 

adaptable to the world’s changing needs. With the evolution towards globalization, higher education 

institutions are challenged to transform their way of doing business while at the same time 

facing many roadblocks. 

The United States (U.S.) has changed rapidly since the end of World War II, from 1945 to 2005. 

Educational institutions have played a highly significant role in not only preparing our population 

for the technological changes taking place, but also bringing many innovative technologies and 

policy changes to our society in those 60 years. Consequently, state and federal legislators, who 

have been pivotal in funding many of the innovative research and service programs to institutions 

of higher education during that time demand that the education sector continue to develop and 

create opportunities for our ever-changing U.S. and international society—be it innovative curriculums, 

community service, or new technologies. The challenge of doing so is only compounded 

by the limitations of resources--the most limiting being lack of funding. 

The downturn in the economy has effected both private and state higher education institutions. 

State institution’s budgets are most directly affected through reductions in their appropriated dollars. 

However, all of higher education has to respond to the limitation on dollars available from 

external funding sources. The burden of increasing external funding is often placed on the sponsored 

programs offices. To do so, though, requires an expansion of the role of such an office. If we 

expand our view of Sponsored Programs offices as facilitators to include development, we see great 

possibilities in providing the needed resources to assist institutions of higher education in meeting 

some of the challenges they face today. 

Traditionally, the role of development is defined as assisting the institution in developing strategies 

and creating relationships specifically tied to fundraising activities with the target audience 

being individuals or corporations providing gifts through a university foundation. As we discuss 

development here, our definition differs from the traditional advancement fundraising efforts of 

institutions of higher education in that the target audience is more attuned to state or federal government 

or corporate entities providing funds through contracts or grants. 

The duties and tasks of sponsored programs offices are varied. Every research office is set up a little 

differently according to their organization’s structure and mission. However, the goal of all sponsored 

programs offices should be to facilitate the procurement of funding for sponsored programs, 

and the administration of the programs brought to fruition. They do so under three common 

functions categorized as: (a) pre-award, (b) post-award, and (c) compliance. Research offices are 

the institution’s rules enforcer and liaison with funding agencies and organizations. They play a 

pivotal role in interpreting and following federal and state guidelines for funding programs, and 

assuring compliance with institutional, state, and federal regulations, as applicable. Sponsored 

programs office personnel are also strategically positioned to advocate faculty and institutional 

specializations while also identifying funding opportunities. 

Society looks to institutions of higher education to resolve the academic and research needs of 

the world. Today’s challenges in meeting those needs include providing access to an ever-changing 

population and expanding upon and imparting the knowledge and technology required for a 

global economy. To answer these challenges while facing budget cuts further complicates the issue. 


Many institutions are focusing on increasing external funding, either through gifts, and/or grants 

and contracts. The sponsored programs office cannot increase the number and dollar of grants and 

contracts simply by requesting our faculty and staff increase their submissions. Instead, we must 

familiarize ourselves with the strengths and weaknesses of our institutions; develop collaborations 

and programs focused on those strengths, and strategies for procuring funding to support such 

programs. 

Challenges for Higher Education in the Twenty-First Century 

Papers 

The downturn in the U.S. economy in 2000 had immediate and far reaching repercussions for 

higher education funding. For example, higher education competes for state resources with programs 

such as Medicaid, elementary and secondary education, transportation and the department 

of corrections, to name a few. Because institutions of higher education have the capacity to raise 

funds through tuition, legislators often feel that education organizations have more flexibility to 

survive than traditional state agencies that are solely reliant on general appropriated funding. For 

this reason, in many states, higher education was targeted with a disproportionate share of the 

budget cuts. 

As an example, funding for public institutions in the State of Illinois has been declining since 

2002. Hebel (2004) reports that funding for Illinois public institutions declined 1.7% in 2004 and 

States in the Great Lakes area continue to lag behind the rest of the nation in rebounding from the 

economic recession in the early 2000s. Additionally, even states whose economies that have begun 

rebounding have not returned to pre-2000 funding levels for institutions of higher education. 

While these funding cuts have certainly made it difficult to manage the daily operations of an institution 

of higher education, the greater challenge is in providing the new programs and services 

our society and governments require with these limited resources. 

First, the primary challenge to higher education institutions today is in providing access and personalized 

service to a larger, further diversified, population of students. In 2009, it is projected that 

3.2 million students will graduate from high school, the largest class in the country’s history. The 

largest class to graduate previously was in 1977. In 1977, 51% of the graduates went on to pursue a 

postsecondary education, in 2005, 68% of high school graduates enroll in college (Selingo, 2005). 

Nontraditional or adult students are returning to university or community college campuses taking 

college courses at off-site locations, or enrolling in classes offered through their employer, or enrolling 

on-line to receive an additional degree or more training. Adult students need this flexibility. By 

the end of 2005, 1.2 million college students will be enrolled in college fully online, up from 438,000 

in 2002. By 2007, that number is expected to jump to 1.7 million (Selingo, 2005). Tuition costs at 

institutions of higher education continue to rise, principally because of decreasing support from 

state governments. This is causing an increasing amount of college costs borne by students and 

families. Access and affordability for students is being threatened. High academic achievers among 

low-income students have limited opportunities to attend college. They are no more likely to attend 

college than the lowest performing wealthy students. It is becoming that universities are attracting 

principally higher and middle income students and less lower-income students. 

A recent survey developed by Chicago Public Schools illuminates the problem of low income, 

minority students going to college (Cholo, 2005). About a third of Chicago Public Schools high 

school graduates who planned to attend college did not enroll in the fall semester. There were 

18,172 students that graduated from Chicago Public Schools in 2004. The percentage of 8,741 

Black students that attended college was 46%, Latino students numbered 6,198 and 38 % attended, 

White students numbered 2,206 with 60.2% attending and 999 Asian students graduated with 76% 

attending college. 


Papers 

Institutions of higher education that wish to attract more minority and first generation college 

students then face the increasing problems of reduced government subsidies and increasing loan 

rates. These students then may not have the opportunity to enter college. Universities, since the 

passage of the Civil Rights Act in the 1960s have become increasingly more committed to assisting 

first generation, low-income and underrepresented minority students attend college and earn 

undergraduate and graduate degrees. Reduced funding as proposed by the current 109th Congress 

(2005) and the Bush administration will make it more of a challenge for institutions of higher education 

meet their goals of assisting students from these target populations attends college. 

A second challenge brought before institutions of higher education through state and federal 

governments is the emphasis on collaboration between institutions of higher education, nonprofit 

organizations, K-12 school districts, state agencies, faith based organizations and municipalities. 

This movement to encourage collaboration became institutionalized by many federal agencies in 

the 1990s. 

For example, the United States Department of Agriculture (USDA) in the late 1990s developed the 

slogan of the three C’s to promote various organizations to receive funding for Economic Development 

Empowerment and Enterprise Zones. The three C’s are Cooperation, Collaboration and 

Consensus. This program encouraged universities, rural development nonprofit organizations, 

municipalities, businesses and school districts to be involved in a very complicated and time consuming 

planning activities to compete to become one of the successful recipients. 

Many more federal agencies now have made collaboration a focus, if not a requirement, for funding 

certain programs. Funding agencies as disparate as the National Institutes of Health (NIH), 

Department of Education (DOE), and Department of Housing and Urban Development, among 

others, all encourage collaboration in their Request for Proposals (RFPs) for competitive grant 

programs. 

State governments are following the federal government in calling for more collaboration for 

institutions of higher education with other organizations. The Illinois Board of Higher Education 

(IBHE) administers the Higher Education Cooperation Act Grants. The purpose of this particular 

grant program is “to support programs of inter-institutional cooperation in higher education 

that promote the efficient use of educational services, the development of innovative educational 

concepts that effectively deliver educational programs and involvement with the local community.” 

Eligible applicants are described in the RFP as including at least two public or private higher education 

institutions. Not-for-profit corporations organized to administer programs in inter-institutional 

cooperation of higher education and Illinois public schools also may participate in these 

programs” (Illinois Board of Higher Education, 2005). 

The increasing demands for institutions of higher education to develop collaborations or interact 

more with other organizations for competitive and non-competitive sources of funding means that 

there will be increased administrative costs. Many institutions of higher education are suspicious 

that the focus on collaborative programs is a strategy by federal, state and private funding agencies 

to shift the cost of administration from their sector to that of higher education. The increasing 

complexity of developing partners and collaborative programs has led to institutions of higher 

education being forced to spend more time in planning and relationship development with other 

organizations. This means that institutions of higher education bear more of the cost in developing 

unfunded projects than in the past. 

Institutions of higher education are facing the problems of (a) declining state revenues for higher 

education; (b) increasing student numbers, both traditional and untraditional and; (c) federal 

and state government and private funding agencies demand for more collaborative programs that 

makes it more costly and complicated for developing projects than in the past. Higher education 

institutions are in need of resources to manage these problems, or challenges. Within a higher 


education institution, who is responsible for acquiring these resources? More and more often, upper 

administration is turning to sponsored program offices—charging those offices with increasing 

externally funded grants and contracts. 

Programs Developed in Sponsored Programs Offices 

Papers 

Sponsored Programs offices have traditionally played the role of facilitator for faculty and 

staff during the grant application preparation and submission process, and throughout the life of 

a funded project. The functions of the office are typically categorized as pre-award, post-award, 

and compliance. Each sponsored programs office carries out these activities to a different degree, 

with the resources and personnel available for these functions dependent upon the institution’s 

level of funding, organizational reporting lines, and outlook on research. The role of facilitator 

requires review and interpretation of institutional, state, and federal guidelines and regulations, as 

applicable. It also includes acting as liaison between faculty/staff and funding agencies, or vendors 

and subcontractors. Often the sponsored programs offices have oversight or administrative duties 

associated with the Institutional Review Board and Institutional Animal Care and Use Committee, 

overseeing the use of human subjects and animals for research purposes. All of these traditional 

activities focus on facilitating the funding process for an existing, previously developed, idea or 

program. 

However, sponsored programs office personnel, or those with research administration 

experience, are maybe best strategically positioned to advocate innovative programs while also 

identifying potential funding sources. They are familiar with the strengths of the institution, the 

fundability quotient for certain programs, and potential funding sources. They are best situated to 

develop ideas and programs, and bring them to fruition. 

To this end, Sponsored Programs offices across the country have been developing new ways to assist 

their institutions in meeting these very demands for new programs and services. The emerging 

trends, revealed in an informal survey, are to create satellite offices or new positions within the 

existing office to offer various support services required in the development process. 

Research and Economic Development offices have been developed by institutions of higher 

learning to assist communities and regions. Some functions of these offices are (a) developing 

research parks for specific industries; (b) creating collaborative partnerships between communities, 

regions and institutions of higher education to attract industry funding; (c) developing business 

incubators for small businesses both on campus and in the community; (d) providing grant 

writing and professional expertise to attract federal and state funding for economic development 

projects for the community; (e) developing centers specifically that will attract industry, examples 

of these being in the areas of biotechnology, nanotechnology and health and; (f) providing expertise 

in technology transfer and intellectual property primarily for faculty and staff in transferring 

basic research to the marketplace. 

A recent survey by Wake Forest University found that economic development programs for universities 

and the communities they serve is becoming increasingly important. Wake Forest University 

surveyed one senior research administrator from each of 250 research universities. Their 

survey showed that over 50% of the universities play a large role in economic development and 

technology transfer, with 41% playing a slight role. The survey also revealed that larger universities 

with more than 10,000 undergraduates and research-extensive universities are more likely to 

be more assertive in developing economic development programs than institutions with less than 

10,000 undergraduates or research intensive universities (Wake Forest University, 2005). 


Papers 

Typically, all interactions between state and federal government and institutions of higher education 

were coordinated through an Office of Government Relations, or a governmental relations 

position reporting directly to the institution’s president. Some university Sponsored Programs 

offices have developed within their auspices Federal Relations Offices to deal with the increasing 

complexity of finding funding and maintaining contact with elected officials. The rise in congressionally-authorized 

grants or earmarks for organizations has made it increasingly more important 

for institutions of higher education to remain in contact with their elected representatives. Direct 

funding from state and federal agencies, especially through contracts and noncompetitive grants 

also makes it necessary for institutions of higher learning to develop contacts and relationships 

with department officials and program officers. 

Some functions for Federal Relations Offices are (a) selecting and advancing a short list of proposals 

from the university seeking congressionally authorized grants; (b) writing congressional 

briefings and presentations of programs; (c) identifying expert witnesses selected from faculty and 

staff to make presentations to congressional committees; (d) developing strong relationships with 

elected officials, legislative staff and agencies to advance the organization’s mission; (e) writing 

policy or briefing papers on federal policies and regulations and; (f) organizing events in Washington 

DC and on the home campus for legislators and their staff. 

Institutions of higher education are developing a more aggressive strategy in pursuing earmarked 

projects for funding. Although a federal relations office might coordinate activities related to the 

pursuit of federal earmark dollars, many universities are hiring lobbyists to handle those activities. 

Those lobbyists, then, work through an office or position created to facilitate governmental interactions 

related to sponsored programs, or at least with the knowledge of, and in conjunction with, 

the sponsored programs office. The total number of earmarks or ‘pork barrel spending” dollars for 

charities and government entities has increased six fold since 1994. (Chronicle of Higher Education, 

2005) 

Another type of support offered through sponsored programs offices or through a satellite office 

provides research consulting services. These offices or positions generally assist in the development 

of proposals, search for interdisciplinary opportunities, build teams (both external to the 

institution and internal), and identify funding opportunities. They may also delve into the grantwriting 

through development of boilerplate language for use in proposals and editing proposals. 

Some of the schools providing these innovative development services are the University of North 

Carolina, Louisiana State University, University of Kentucky, Western Michigan University, University 

of Washington and Ball State University. They are all offering additional services beyond 

the norm for those faculty and staff interested in promoting sponsored programs and ideas. They 

are taking a proactive role in their university’s growth. 

Illinois State University as a Case Study 

Several years ago, just prior to Illinois’ budget problems, upper administration charged 

our Sponsored Programs office with the task of increasing external dollars. To do so required a 

review of the university’s strengths and weaknesses, and development of a strategy. 

Illinois State University is a predominantly undergraduate university located in Normal, Illinois. 

Fiscal Year (FY) 04 data indicates 18,500 undergraduate students and 2,553 graduate students are 

enrolled. Forty three doctoral degrees were conferred. Colleges at Illinois State University are Arts 

and Sciences, Applied Science and Technology, Business, Fine Arts, Nursing and Education. 


The total Illinois State University budget in FY 2004 came from the following sources: (a) State of 

Illinois appropriations, 29.6%; (b) tuition and fees, 31.7%; (c) auxiliary enterprises, 21.9%; (d) government 

grants and contracts, 8.6%; (e) grants, contracts, gifts, 1.0% and; (f) other sources, 7.2%. 

Grants and contracts make up about 10 percent of the total funding allocations. However, these 

funds have been the focus over the past few years as they show more potential for growth than 

state appropriations, tuition and fees and auxiliaries. 

Funding levels for externally sponsored projects for Illinois State University are shown for 1999- 

2003 (figure 1). 

Figure 1 

Papers 

Illinois State University external funding for FY 04 was $20.5 million with 319 total grant awards. 

External funding has increased by 19% in the last five years. Generally, increases have been in 

Federal funding, while there were decreases in state and corporate sources between 2002 and 

2003. Funding from these sources increased in 2004, but not to the same levels as 2001. The State 

of Illinois has significantly decreased funding to public institutions of higher education both in appropriated 

funding and competitive grant programs since 2002 because of the economic recession 

which began in 2001. Although there has been some economic resurgence since 2003 in the Illinois 

economy, appropriated funds for institutions of higher education have not reached the same 

levels as 2001. However, Illinois State University has received more federal pass-through funding 

distributed by the State of Illinois for primarily education programs since 2001. 

Federal funding has continued to increase for Illinois State University. Primarily, this is because of 

a more concentrated approach by selected faculty to write competitive grants for federal programs 

and an organized attempt to procure more federal legislative earmarks from the Illinois Congressional 

Delegation. Pursuing federal funding opportunities has assisted Illinois State University to 

continue to grow despite shortfalls from the state and corporate sectors. 

ISU was awarded over three hundred grants and contracts last year. We receive very few six figure 

awards, and Sponsored Programs expends a great deal of time administering a lot of small projects. 

The Research and Sponsored Programs Office for Illinois State University is organized as 

illustrated below (figure 2): 


Papers 

Figure 2 

There are nine persons employed by the Research and Sponsored Programs Office at Illinois State 

University. The Director of Research and Sponsored Programs oversees all functions and persons 

in the office. The Director reports to the Associate Vice President for Research. Four persons are in 

the pre and post award department and they are responsible for management of data, mailing and 

copying of proposals, review of submissions, and negotiation of grant agreements and contracts. 

The compliance section, which includes IRB and IACUC employs three full-time persons and one 

part-time veterinarian. 

One of the assistant directors is filling a position created a few years ago as the sponsored programs 

office was charged with increasing external funding. Our Associate Vice President of 

Research realized the only way to do that was to have a staff person devoted to team-building, 

increasing multi-disciplinary partnerships, and making contacts at the state level for contract 

work, and the federal level for earmarked dollars. This assistant director position is really a hybrid 

position providing some of the services traditionally housed within a sponsored programs office, 

but adding components you might ordinarily find within governmental relations and development 

units. The first few months in this position were spent interviewing faculty and staff, analyzing the 

institution’s strengths, and beginning to set up teams. 

At about that same time, Illinois State University also hired a lobbying firm and the new assistant 

director began developing a notebook of brief proposals that Illinois State University would present 

to the congressional delegation. The work has progressed now to their assisting the University 

in setting up meetings with program officers in Chicago, Springfield or Washington DC, developing 

partnerships with outside organizations, writing support letters and proposals or planning 

documents as needed, and assisting teams in planning. One time-consuming aspect of this job has 

been in developing relationships with other organizations. ISU has worked on developing partnerships 

with associations, school districts, community colleges, businesses and other universities as a 

means of qualifying for some of those federal programs specifically requiring collaborative activity. 

In adding services to the Sponsored Programs office, we found a necessity to refocus or change 

the duties of the other staff. Some of the new activities, programs, and services we have instituted 

in the last couple of years are collaborations among the several functions of the office, others are 

solely the responsibility of the pre-and post-award areas, others the new assistant director manages 

on his own. All, though, promote externally funded programs, motivating faculty and bringing a 

“development” focus to the office. 


We offer various trainings at both the department and college levels—arranging a special meeting 

time or joining a regularly scheduled departmental meeting. These trainings include a combined 

“finding funding/submission process” presentation, hands-on funding searches within a computer 

lab using various searchable databases, and special sessions presented by visiting program officers. 

ISU hosted a regional NEH meeting on campus last year and brought several program officers 

from the State of Illinois on campus. This fall, we will be hosting an NSF day with program officers. 

This will be open to any institution in the state of Illinois. 

Sponsored Programs has devised several incentives programs in our attempts to encourage grantwriting 

efforts. Several universities are offering similar incentives. A travel award program was 

instituted to provide funds for travel to meet with program officers, and/or cooperating institutions 

if directly related to grant-writing. The grant-writing initiative award is a new competitive 

program designed to provide dollars as an incentive to write grants as well. A recognition reception 

is held each spring to acknowledge all faculty/staff who submitted grants in the previous 

year—funded or not 

Some of the development activities aimed at the pre-submission stage are meetings with external 

funding agencies with the goal being to build relationships for future projects, and further into 

the lifecycle of a project, facilitating the application process. There have been appointments with 

agency and program officers in Chicago, Springfield, and Washington, DC, about specific grant 

opportunities and research interests. 

Another activity we engage in is to arrange “brown bag” lunches with various faculty to discuss 

common research interests and potential funding sources. These are promoted as multi-disciplinary 

efforts. Topics covered in the past include bioterrorism, geriatrics, teacher recruitment, and 

nursing. We also will “shop” projects to various funding agencies—researching hot topics, and 

then promoting those programs within the university that meet each funding agency’s priorities. 

And lastly, our assistant director in the development area will act as an ad hoc team member— 

writing abstract proposals, taking minutes at meetings and disseminating, and setting goals for the 

team. If external partners are identified, he arranges meetings with those individuals and coordinates 

the effort. 

The objective for all of these activities is to develop: (a) new ideas, (b) programs from existing 

ideas, and (c) relationships with collaborators and funding agencies to promote the programs. The 

ultimate aim is to increase external funding providing resources that will allow the university to 

meet the needs of the student population and promote the transfer of services and technology to 

the general public. 

Conclusion 

Papers 

The rapid changes in society both in U.S. and internationally will cause institution of higher learning 

to have to become adaptable and flexible for change. Sponsored Programs Offices will become 

many times the drivers for change and will need to assist administration at institutions of higher 

education to assist in meeting with the community and developing strategies for finding the funding 

to provide services for projects, programs or centers. 

Strategic or long-term planning is a complicated process that needs the input of many participants. 

The questionnaire developed does not intend to take the place of these needed planning tools. Instead, 

the purpose of this suggested planning tool is to assist Research and Sponsored Programs by 

providing an abbreviated approach to begin assessing their ability to develop ways to respond to 

opportunities and demands either internally (institution of higher education) or externally (state, 

region or community) in providing additional services or demands. 


Papers 

Questions that can be discussed in the planning session are: 

1. What development activities are currently in place by Research and Sponsored Programs Offices? 

2. Can your office expand these services using current personnel? 

3. What new projects do you anticipate the administration of your institution will ask Research 

and Sponsored Programs to create or develop in the next five years? 

4. Are there demands by state government, regional entities or the community for your institution 

to meet needs for employment, training or creating centers in the next five years? If so, 

what will be the demands on Research and Sponsored Programs to provide services for the 

creation and administration of these collaborative efforts? 

5. Will Research and Sponsored Programs need to have additional funding or personnel to create 

or administer these new programs? 

6. Will administration in your organization be supportive of providing the additional resources 

for development? 

The planning session that discusses these issues may come up with ideas on how to provide more 

outreach to faculty and staff in writing competitive grant proposals without having to add more 

personnel for the office. External demands may be identified as the need to work more closely with 

the community to develop business incubators, creation of jobs and research parks. These activities 

will mean that there will be a need for more additional personnel and perhaps the creation of 

new departments in the Research and Sponsored Programs Office. 

Challenges for higher education will continue to grow in the twenty-first century and it will be 

essential for Research and Sponsored Programs Offices to work with their internal and external 

clients for developing innovative programs and strategies. 

References 

Cholo, Anna B. (May 9, 2005). City’s College-Bound Rate a Third Less than Thought, Chicago 

Tribune, A1 & 9. 

Heber, S., (2004). State Spending on Higher Education Up Slightly, a Reversal from Previous Year. 

The Chronicle of Higher Education. Volume Number. Pages. 

Illinois Board of Higher Education, (2005). Fiscal Year 2006 Higher Education Cooperation Act 

(HECA) Requests for Proposals (RFP) for New and Renewal Applications. 

Selingo, J., (2005). To Recruit Today’s Students, College Must be Agile Marketers, Officials are 

Told. The Chronicle of Higher Education, Volume 50. Pages. 

Special Report (July 21, 2005). Manna or Pork: Members of Congress earmarked more than 

$2- billion for charities this year, a Chronicle study finds. The Chronicle of Higher Education, 

Volume 27, Number 19, A6. 

Wake Forest University (2005). A Report on Research Activities at U.S. Research Universities, 1-8. 


Research Management in Southern African Higher Learning Institutions 

Prof Isaac N Mazonde, PhD 

Office of Research & Development 

University of Botswana 

Corner Nyerere/Notwani Road 


mazondei@mopipi.ub.bw 

Abstract: 

Contemporary Southern Africa is characterized by one thing, a lack of innovation system at the 

national level and a corresponding lack of research management in the national university. A consequence 

of this is that the region is not as yet positioned to harness science & technology for its 

economic development. This feature is at the bottom of the continuous lack of economic growth 

in the region, despite the prevalence of natural resources such as minerals, and other natural 

advantages like extensive coastlines. By contrast, the developed world has moved beyond science 

& technology development to innovation. The result of this is that these countries are increasing 

their national wealth through expanding their share of the global market for goods and services 

which derive from science & technology based innovation. Using the innovation success achieved 

in the western world, especially by universities, this paper attempts to point out where gaps exist in 

some countries of Southern Africa, and how the sub-continent can arrange itself through research 

management to meet development challenges of the time. The paper adopts a national perspective 

in its argument in view of the fact that research management brings together the entire national 

innovation system. 

Introduction 

Papers 

Contemporary Southern Africa is characterized by one thing, a lack of innovation system at the 

national level and a corresponding lack of research management in the national university. A consequence 

of this is that the region is not as yet positioned to harness science & technology for its 

economic development. This feature is at the bottom of the continuous lack of economic growth in 

the region, despite the prevalence of natural resources such as minerals, and other natural advantages 

like extensive coastlines. By contrast, the developed world has moved beyond science & technology 

development to innovation. The result of this is that these countries are increasing their 

national wealth through expanding their share of the global market for goods and services which 

derive from science & technology based innovation. The developed countries have come a long 

way with technology based development. They have satisfied the first pre-condition for technology 

transfer, which is to establish a strong science system. Next, technology development and technology 

transfer systems which are based on national economic needs and the global market are firmly 

in place. For technology development to occur, at least two things must come together, social and 

physical infrastructure or human resources and the machines. The developed world has all of that. 

However, a major requirement is the presence of a political will that should manifest itself through 

an overarching framework of a national research and an innovation strategy that largely works to 

implement the national science and technology policy. Again this is essentially what is obtaining 

in the developed world. The technology transfer system does have underlying dynamics which 

need to be understood if expectations from investment must be realistic. These underlying dynamics 

include the likely size of returns, time taken to generate a positive return, and the variability 

of outcome. Through successful harnessing of these, the developed world continues to increase 

its economic strength. 


Papers 

Using the innovation success achieved in the western world, especially by universities, this paper 

attempts to point out where gaps exist in some countries of Southern Africa, and how the subcontinent 

can arrange itself through research management to meet development challenges of 

the time. The paper adopts a national perspective in its argument in view of the fact that research 

management brings together the science system, the technological set up and the government, 

especially for funding innovation. Political will is necessary in order for the nation to mobilize 

adequate funding that is required to set up and implement a functional innovation system which 

would be the engine of economic growth. The paper goes to some length to explain the need 

for research and innovation management, which it argues is necessary to minimize risk, simply 

because technology development and technology transfer are both risky and expensive activities, 

especially within the context of developing countries generally, but more so over Southern Africa. 

The paper posits that research and innovation management can enhance efforts towards ensuring 

synergy and growth of value from the various science and technology activities, and further that 

without that, southern Africa, or SADC, does not stand a chance to experience any further growth 

in its economy within the globalizing world economy. However, a positive sign is that there is 

currently concerted effort within some African countries to attempt entry into the global market 

through indigenous technology, and also through efforts to lay a foundation for innovation based 

national development via strategic funding arrangements, as shown later in the paper. To some 

extent, this move has been initiated through SADC when in 2000, the Community encouraged its 

member states to create a Ministry of Science & Technology as the first major step towards increasing 

the growth and management of technology based innovation. However, the fact that the 

SADC secretariat does not have a desk officer for its Science & Technology portfolio, when it has 

an officer for every other portfolio, seems to underscore the Community’s lack of sufficient appreciation 

of the role of science & technology in the economic development of the Community. Only 

in 2004 did SADC produce its first Strategic Plan for Science & Technology. It became clear then, 

that this portfolio would move very slowly due to a lack of a desk officer. 

Research and Innovation Management in Southern Africa 

The positive linkage between research and development (R&D) on the one hand and economic 

development on the other, is no longer an issue for debate. What remains less appreciated is the 

critical role played by research management in facilitating economic growth through a nationally 

structured technology development, transfer and an innovation system. For example, while it is 

acknowledged that there exists a linkage between technology development, technology transfer, 

innovation and wealth creation, little do we realize that it is not merely R&D but well directed 

R&D that leads to new products and services. R&D must be well directed because of the high risk 

and the high rate of failure involved in the commercialization of research. In order to minimize 

that loss the risk needs to be managed. That is what research and innovation management attempts 

to achieve through maximising value from research and innovation activities and ensuring 

strategic alignment at a departmental, organisational and national level. Ideally, there should be 

complementarity between the entire research process in the tertiary institutions such as the universities, 

the government and private sector operations. That brings about the innovation system 

at the national level. Research and innovation management introduces processes for the identification 

and management of research risk; and it assists in the selection of the most attractive investment 

options from a multitude of possibilities (Walwyn 2004:1). Optimal investment in science 

& technology for innovation is especially essential in the less developed countries where there is 

an acute shortage of resources that are necessary for expanding the national economies through 

innovation. 

Economic development does not occur in a vacuum. The economies of developed countries such 

as Japan and the United States are backed by strong technological initiatives and successful innovation. 

The innovation as well as the technological development of these countries is based on 


Papers 

a strong science system, which is defined by the different research councils, while the innovation 

is largely based on the successful linkages between the outputs of technology or R&D institutes 

and the market. Such economies tend to be well diversified, through a well coordinated national 

innovation system. Knowledge management, especially through skilful use of the ICT and the cyberspace 

in general, is central to the structure and functioning of these economies. In them, there 

is continuous gathering and processing of all types of information which is necessary for meeting 

economic demands across the whole world. The economies use the information to re-position 

themselves as necessary in order to take advantage of changes in opportunities. For example, 

Heher states that in 2002, universities in the USA and Canada earned US$1.2b from the commercialization 

of research (Heher 2004:1). In addition, universities that participated in the survey 

conducted by the Association of University Technology Managers (AUTM) over a 10 year period 

reported 4,300 new companies formed and over 300,000 jobs created. Heher makes two more 

important observations. First, he notes that the indirect economic impact is estimated to be an 

order of magnitude higher. Secondly, he states that the success of university technology transfer is 

considered one of the key drivers of the sustained growth in the USA economy in the past 20 years 

(Heher 2004:1). In this case, technology transfer by these universities is able to re-direct R&D to 

produce new products and services that are essential to continue the innovation process. Indeed 

without continuous innovation, economies cannot expect to survive in a global and increasingly 

competitive business environment. Other countries have responded to this success by taking steps 

to put in place support programmes for technology transfer and commercialization, as I shall 

demonstrate for India, later. 

The success of North American universities in commercialization of research needs to be considered 

cautiously, because innovation or commercialization of research is often very risky. For example, 

Majewsky notes that the US$1.2b made by the US and the Canadian universities is mainly 

license fees and it represents only 3% of the research income of these universities. This means 

that the returns are minimal, hence the need for spin off companies. But forming spin off companies 

can also be problematic, because that requires venture capital, which is not readily available, 

especially in the developing countries. Majewsky notes that in Warwick University between 2000 

and 2003, researchers made 120 commercial opportunities and 20 spin off companies including 

4 inventions licensed. The spin off companies raised 2 million Euros but it took 1 Million pounds 

sterling to create 1 opportunity, and 1 million pounds sterling to bring about 1 spin off company 

(Majewsky 2003). The problem is complicated by the fact that most technologies from the universities 

never get licensed because they are too under-developed. Developing the technologies is not 

straight forward; it is risky, it requires careful NPV calculations to reduce the risk because usually, 

development costs can be 10 times the research cost. Above all, the support services are very 

strong in the developed world. CONNECT is one of the many companies used in the UK and the 

US to link university researchers with investors in technology development since 1985. 

Non cautionary comparisons across countries might lead to wrong conclusions regarding efficiencies. 

For example, UK universities produce 5 to 6 more start-up companies for every US$100m 

when compared with the US universities. From these figures, it might appear that the UK is more 

efficient than the US. The difference, however, is accounted for by the difference in policy. In the 

USA, emphasis is on licensing while in the UK emphasis is on start up company formation (Heher 

2004). The implication for developing countries is that have to clearly determine what their priorities 

are in science & technology based innovation and then make policies accordingly. This point is 

taken up later under the discussion on Botswana. 

By contrast, the history of education in Africa has indicated that before independence, the continent 

has focused more on liberal arts to the neglect of science education. Through its reforms, 

the World Bank tried to shift the focus towards science but the number of students in science in 

a number of tertiary institutions in Southern Africa continues to be lower than the number of 


Papers 

students in non-science subjects. Table 1 and Table 2 below reflect this situation in the University 

of Botswana. 

Table 1: Total Student Enrollment by Faculty 1997/98-2001/02 

Faculty/School/Centre 1997/98 1998/99 1999/00 2000/01 2001/02 

Business 541 589 685 820 819 

Continuing Education 1598 1691 1966 2203 2036 

Education 1394 1669 1879 2095 2255 

Engineering & Technology 808 904 998 1157 1272 

Graduate Studies 283 347 419 501 571 

Humanities 1271 1393 1629 2054 2147 

Science 1257 1289 1353 1337 1384 

Social Sciences 1132 1083 1231 1555 1802 

Total 8284 8965 10160 11722 12286 

Table 2: Graduation Rate (%) by Faculty (Full-Time) 1997/98-2000/01 

Faculty 1997/98 1998/99 1999/00 2000/01 

Business 85 76 57 81 

Education 96 111 97 98 

Engineering & Technology - - 89 78 

Humanities 97 90 95 94 

Science 39 32 34 33 

Social Sciences 91 70 81 83 

In this regard the region ranks lower than other parts of the developing world. In the first place, 

the science system as reflected in the formal education structures, including tertiary institutions, 

is weak. The weak science system translates into poor performance of students in science subjects 

in comparison with their performance in other subjects. African countries therefore have a weak 

base for doing basic research in the sciences, which is necessary for the development of technology. 

Hence, almost all countries in the region (with the exception of South Africa) are not able to 

calculate their R&D index. 

There is variation across the subcontinent with formerly European areas of pre 1994 South Africa 

coming at the top, while Botswana, Lesotho, Swaziland and Mozambique are at the bottom. 

Because the region was developed to provide a market for goods and services produced in South 

Africa, the R&D institutions remain very few. Failure to appreciate the value of science & technology 

by the post colonial governments has led to low funding levels for R&D, with the result that 

the few R&D institutions are weak. Furthermore, where they do exist, they usually act like silos, 

without any connectivity. They are usually not strategically aligned to form a functional national 

innovation system that is prevalent in the developed world. The weak science system perpetuates 

itself into a weaker innovation system. Partly because of this situation, southern African countries 

have so far not been able to take advantage of their natural endowment of a rich biodiversity by 

developing indigenous technology, as other parts of the developing world such as India and China 


have done. There is no sustained effort to develop indigenous knowledge, despite the availability 

of this advantage. This is a serious omission since indigenous knowledge is what should secure for 

Africa a niche in the globalizing world economy, as is the case with the developing countries of the 

east. 

Because of the continent’s low level of development of science & technology, 54 African countries 

are now poorer than they were in 1990 (Hewett 2004:10) despite the fact that some OECD countries 

have been moving their R&D operations to the developing world (mainly India, China and 

Singapore). Apart from the science and technology infrastructure that these countries have, they 

also have the advantage of much cheaper labour. For example, South Africa pays US$2.17 per hour 

in manufacturing against US 60 cents in India and US 50 cents in China (Mouton 2004:12). The 

challenge for Africa is for it to upgrade its technology intensive products. In fact, India is applying 

what it calls its 18th Century technology (meaning indigenous technology) as one of the means 

of attaining its planned economic growth of 7-8% of its GDP. India’s biotechnology industry is 

growing and is expected to compete with that of the West very soon. In view of India’s success, 

Kenyatta University in Kenya has set up a Faculty of Traditional Medicine. This paper argues that 

the development of indigenous technology is only possible through a well managed innovation 

system which is based on a strong science system, with adequate funding systems. It is recognized, 

however, that the region does not have sufficient resources to fund a sustained innovation system, 

given that in the US, Heher reports 1 invention disclosure for US$2.5m of research expenditure 

[or between 20 and 50 papers published] (Heher 2004:11). This paper will use as cases, South 

Africa, Zimbabwe, Lesotho and Botswana. 

South Africa 

Papers 

South Africa has historically been the economic hub of the region. It is much more developed than 

any of the SADC countries in all respects, especially in terms of the infrastructure for technology 

based innovation. The country has moved from a situation in the 1980s where its science and technology 

institutions were autonomous and unrelated to a position where the country now boasts 

the most elaborate S&T infrastructure and the best functional research management system in the 

region. In particular, South Africa has a fairly well developed and relatively well funded science 

system with tertiary institutions and research councils. It also has a technology and innovation 

system which is backed by scientific councils, R&D institutions and an S&T administrative structure 

that is championed by the Department (Ministry) of Science & Technology which oversees 

a number of advisory councils on research and innovation. In that country, research and innovation 

management is done at different levels of the science and technology systems, in the public as 

well as the private sector. For example, there is an overarching framework within which all public 

S&T endeavours operate, whether in the tertiary institutions, in the public sector or in the private 

sector. This is the National Research & Development Strategy which was adopted in 2002, and 

through which the government has re-defined the country’s science and technology system as a 

national system of innovation. 

Then there is an elaborate structure for promoting and funding innovation. The major funding 

body for the public tertiary institutions is the government, which gives these institutions a subvention 

to cover the greater part of their budgets. The government specifies that 10% of the subvention 

it gives is for research. In addition, there are many other ways in which the government funds 

not just the science system (i.e. tertiary institutions and research councils) but the technology development 

and transfer (or innovation) activities. Central to the government’s effort in this regard 

is the National Research Foundation (NRF) which, as an intermediary institution between policy 

and research providers, operates different funding schemes as a way of implementing the National 

Research & Development Strategy. NRF’s funding system is multi-pronged in that it aims to grow 

both the country’s science system as well as its innovation, through different funding programmes. 


Papers 

For example, to address innovation specifically, there are a number of funding programmes such 

as the Innovation Fund, the Research and Innovation Support Agency (RISA) and the Poverty Alleviation 

Programme. These programmes are administered by the NRF on behalf of the state. They 

award funds competitively to any applicant. For technikons and technical stations, South Africa 

runs the Tshumisano Fund which finances innovation projects in these institutions. The projects 

covered are mainly the small, medium and micro-economic enterprises (SMMEs). 

For the universities, the NRF administers research programmes for masters students who do their 

thesis in any field of innovation within the parameters set from time to time. In this case, the 

NRF advances the science system and the innovation system simultaneously. There is yet another 

government source of funding for research into South African tertiary institutions. This is through 

rebates on publications that have come out through the South African Publication Standard for 

journals (SAPSE). 

South Africa is very much aware of the crucial need for specialised manpower training and 

development in the country’s innovation chain. In addition to the training efforts indicate above, 

the country implements the Technology for Human Resources in Industry (THRIP) programme, 

which focuses specifically on manpower development in science & technology. 

And the public sector does not struggle alone. The private sector is also involved, mainly through 

funding research in tertiary institutions, in line with its needs. This is mainly in the form of scholarships 

and in consultancies that are done for the private sector by tertiary institutions. However, 

levels of private sector R&D have declined in the past few years. (RSA Government, 2000:2). Due 

to the S&T set up in South Africa, it is much easier to carry out research and innovation management 

in that country than it is the case in the rest of the region, as I show below. South Africa is 

able to calculate its R&D intensity. For instance, currently, it stands at 0.7% of Gross Domestic 

Product, after dropping from 1.1% at the onset of majority rule in 1994. 

Zimbabwe 

Zimbabwe set up its Ministry of Science & Technology in 2002. The Ministry is within the Office 

of the President in order to give it the power it needs to leverage resources necessary for a 

functional S&T system. With the Ministry of Science & Technology has come a national research 

council (Research Council of Zimbabwe). However, there also exist other science councils, centres 

and trusts with specific mandates e.g. Agricultural Research Council (ARC), Medical Research 

Council (MRC), Tobacco research Board (TRB), Pig Industry Board (PIB), BioSafety Board, 

Scientific and Industrial Development Centre (SIRDC), Agriculture Research Trust (ART - private 

sector) and 13 universities, all of them offering science and technology related subjects with varying 

strengths, and 5 polytechnics. 

In spite of that infrastructure, Zimbabwe does not have a single national S&T or innovation system. 

The new Ministry is meant to provide an impetus for setting up a functional national innovation 

system. Polytechnics function as a coordinated system but universities are virtually independent 

as far as innovation development is concerned. One of the major functions of Research 

Council of Zimbabwe (RCZ) is to coordinate research undertaken by sectoral research councils 

and institutes but this is often handicapped by lack of research funds from RCZ. In other words, 

the country lacks a well coordinated funding structure. 

Zimbabwe has an S&T Policy as well as the Intellectual Property legislation but only now is the 

Ministry of Science & Technology working on a national research strategy. The country is unable 

to estimate its R&D expenditure and neither is it able to relate any of its economic development 

directly to its R&D activities. 


Lesotho 

Lesotho has neither a Science & Technology policy nor a Research Council. The country’s only 

university has a Faculty of Science but it does not offer technical training in medicine or engineering. 

There are only three technical schools which are not even affiliated to the University. Specifically, 

there are no institutions that deal with technology development and technology transfer. The 

private sector is quite small and there is not much industrialization. It is therefore not meaningful 

to talk of the involvement of the private sector in the development of technology. 

Botswana 

Papers 

The situation in Botswana is relatively much better than in Lesotho, although the country remains 

behind Zimbabwe in a number of science & technology measures. The country has only in the 

past four years made a significant move towards establishing itself in science and technology. In 

1998, the Science & Technology policy was adopted through an Act of Parliament and a National 

Council on Science & Technology (NCST) set up, along with a National Research Council. Not 

much happened until the Ministry of Communication, Science and Technology was established 

in 2002. There now exists a Botswana Research Science & Technology Plan. The country’s one 

university does have the critical faculties of Science and Engineering & Technology, but it does not 

offer medicine. The country upgraded its only polytechnic into the Faculty of Engineering & Technology 

in a bid to position itself for providing technological education. The country is pushing its 

agenda for science & technology development quite fast. In 2004, it prepared tender documents 

for an inventory of researchers and physical faculties in Botswana, something comparable to the 

South African Research and Information Directory (SARID) that South Africa is busy with. The 

country has also appointed South Africa’s Council for Scientific and Industrial Research (CSIR) 

to develop the National Research Science & Technology Plan. Soon, the country will have clearly 

spelt out national priorities in research, to guide the research process at the national level. 

Botswana has three R&D institutions which are supposed to compliment each other in their 

mandate and operation. Although all of them are companies limited by guarantee, they are funded 

mainly by the government (95%) and they are not financially self-sufficient as yet. While it is recognized 

that the three R&D institutions are a contribution to the national S&T system, the problem 

is that they are not aligned in terms of their operations and functions. As such, they do not 

form a national innovation system through which an idea could be developed from conception 

to a marketable product. Because the R&D institutions do different things, that are not directly 

related, the overall synergy from their total output is not as strong as it might have been had there 

been strategic alignment across the institutions. In other words, what we see in Botswana currently 

is the level that South Africa was in around 1980. 

The first R&D institution is the Rural Industries Promotion Company (RIPCO), which was established 

in 1974, with the objective of undertaking R&D for industrial development and commercializing 

and disseminating research results. RIPCO operates through its technical company 

known as the Rural Industries Innovation Company (RIIC), to produce technologies and equipments 

that are required by rural industries. These include the dehuller which is an industrial 

machine used for sorghum milling, threshers, grain grinders, solar cookers, incinerators, hammer 

mills and bread ovens. 


Papers 

The second is the Botswana Technology Centre (BOTEC) established in 1979. Its mandate is to 

promote Science and Technology through 

• R & D 

• technology transfer, 

• industrial support, 

• policy development, and 

• specialized informational services and systems on technology solutions for industry, business, 

education. 

BOTEC manufactures hi-technology products such as the mini hearing aid, the photovoltaic 

charge controller and the remote sensing equipment for weather stations. Consistent with its mandate 

of policy development, it was also instrumental in drafting the Science and Technology Policy 

for Botswana. 

In terms of collaboration, BOTEC is the national focal point for a number of international S&T 

bodies including the Commonwealth, WAITRO, and the World Energy Council. 

The National Food Technology Research Centre (NFTRC) is the third R&D institute in Botswana. 

It developed from being the Botswana Food Laboratory in 1984 to become a NFTRC in 1999. Its 

role is limited to producing food technology, with the following objectives: 

• To initiate, conduct, and direct scientific and technological research and development work 

relating to food and nutrition to enhance national food security 

• To generate and disseminate food and nutritional data and information for use by farmers and 

researchers and professionals in nutrition, agriculture, public health, food safety, control and 

regulation, food processors, policy makers and other stakeholders. 

• To provide information and technical expertise needed to facilitate the development and sustainability 

of food based SMME’s and related enterprises by contributing to economic diversification, 

import substitution and job creation. 

Research Management, A Sine Qua Non For National Development 

Innovation can be both very expensive and risky. It is estimated that for every 100 ideas that look 

commercializable, only around 17 will be commercially exploitable, and that only 1 out of every 

10,000 chemical entities initially screened as drug candidates, will lead to a final product.(Walwyn 

2004:1). Thus, innovation is costly. Hence risk management becomes critical in innovation and 

technology development. Risk management is made possible by commercialization strategies that 

apply the right techniques which are used to minimize economic loss in the process of new product 

development. The technologically developed countries of the West have the techniques that 

enable them assess not only the chances of commercial success of innovation ideas, but also they 

have the techniques such as the risk adjusted net present value (rNPV) which is used to manage 

research risk, and R&D gain which is used to determine the required level of R&D expenditure. 

Such competence enables them to know at what stage of the commercialization process technology 

development must be licensed out to other companies, sold or whether it is optimal to develop 

it up to the final product stage, which is the market. 


The ability of an organization to license a new product at a certain level of its development (before 

it is commercialized) implies the participation of the private sector in the innovation process. This 

is the case in the developed countries; the private sector works in conjunction with the public sector 

and the knowledge intensive organizations (KITO) such as the tertiary institutions. 

By contrast, it has been demonstrated above that developing countries lack the key ingredients of 

what would constitute an effective research management-based knowledge economy. To start with, 

the national science systems are underdeveloped. This means that the technology institutes where 

R&D is carried out lack a firm foundation that is needed for facilitating a viable commercialization 

strategy. The human resource base is poorly prepared to discharge the mandate that the R&D 

institutes set for themselves. More specifically, the knowledge and skills for commercialization, as 

reflected in the previous paragraph, is lacking, thereby increasing the risk of failure in technology 

transfer. The risk of failure is increased by the fact that the key expertise in this area is not primarily 

technological or scientific, but rather commercial and business skills, a combination that most 

people working within technology transfer in the developing countries do not have. The absence 

of a linkage between the various segments of the research and innovation value chain from basic 

research to technology transfer and commercialization is normally referred to as an innovation 

chasm. 

As explained in the previous paragraph, commercialization of innovation requires very sophisticated 

techniques, without which new product development would be too expensive to be feasible, 

especially in the developing countries where there are not even adequate resources to meet basic 

human needs. The mandates of the research and technology institutes in these countries may 

purport to address national development but the lack of forward and backward linkages between 

them as well as the absence of an overall national strategy within which they operate, work to ensure 

that there is no synergy both between the science system and the innovation process, among 

the efforts of each, not to speak of an innovation system that would turn ideas and scientific discoveries 

into wealth through saleable goods and services. 

It is at this stage that the benefits of research management would be best felt. There is need, here, 

to re-define research and innovation management as the active intervention that aims to achieve 

an organisation’s strategic objectives including value creation. In this context, it is necessary to 

consider that the value of a product increases with its movement along the innovation value chain. 

But in order for that value to increase, risk must be well managed. And this is because an idea on 

its own has no value unless there has been some proof of concept study about it. It is only through 

the progression of the idea into a proven innovation that value is created. In the technologically 

developed economies of the West, this increase in value content through knowledge generation 

is frequently exploited by R&D organisations, which are able to trade intellectual assets prior to 

product launch (Walwyn 2004:7), but in the technologically undeveloped economies, this opportunity 

is lost, because of several factors, which include inappropriate science and technology 

climate and lack of participation of the private sector and tertiary institutions in the state-led innovation 

processes. 

Towards Analysing the Bottlenecks of Research Management in southern Africa 

Papers 

The level of S&T depicted in the cases used in this study is very low. Except for South Africa, the 

rest of the region is still in its infancy in terms of science and technology development. In particular, 

the infrastructure is very weak. The foundation for the teaching of science is yet to be strengthened 

in order for the countries to have a functional science system. The situation is even more 

desperate with respect to science and technology. Dedicated S&T institutions are not in place, 


Papers 

manpower is not trained, and the countries lack a framework that is necessary for implementing a 

well guided S&T policy. Such a framework would be provided by a National Research and Development 

Strategy, backed by a comprehensive funding system. Because of the lack of all these, there 

is no innovation chain that would lead to the growth of the economies of these countries. Hence, 

the foundation for an effective research and innovation management remains shaky. 

For purposes of focus, the conclusion will concentrate on Botswana, which is being taken to typify 

the region. There are several reasons why Botswana’s economy has not received a boost from the 

nation’s three R&D institutes. The first is that institutes in that country operate as silos, in vacuum 

or without an overarching framework that guides research and innovation in the way the National 

Research & Development Strategy in South Africa does in that country. The existence of a Science 

& Technology policy and a National Council on Science & Technology are necessary but not 

sufficient conditions for research that leads to innovation. Political leadership is a crucial factor for 

successful innovation. A look across the world suggests that a strong focus on Science and Technology 

is associated with high level of government steering. For example, the S&T portfolio is placed 

within the highest office in the land in those countries that are most successful in innovation. In 

Finland, the National Advisory Council on Science & Technology is chaired by the Head of State; 

in Korea, the Deputy Prime Minister has that responsibility. In the US, the Office of Science and 

Technology Policy resides within the Office of the President. A national research and innovation (or 

development) strategy, with clearly interlinked structures that bring together the national systems 

of science and technology, and also backed by well spelt out funding mechanism, is the basic minimum 

that is required for successful innovation that would lead to creation of wealth. 

Botswana is still in the process of establishing a funding mechanism known as the Botswana Research 

and Science & Technology Investment Agency (BRSTIA), through an Act of Parliament. It 

is still early to assess its effectiveness, because it is not yet in place. 

The country has decided to re-organise its S&T landscape by putting in place research councils 

which will operate in a more coordinated way, in line with the direction provided in the Research, 

S&T Plan. These proposed research councils are based in part on alternative providers of research 

such as the Botswana Institute of Development Policy Analysis (BIDPA), which is being proposed 

to become a broadened National Council for Social Sciences Research, and the Botswana Technology 

Centre (BOTEC), which will become the National Council for Industrial Research, after 

merging with the Rural Industries Promotion Company (RIPCO). 

All of this is at the planning stage; therefore it is too early to say how much value the restructuring 

will add to research, especially to innovation. Experience has shown that mere restructuring and 

investing in R&D may not always lead to improvements in innovation. South Korea increased its 

investment and is now reaping the benefits while Sweden, which spends 4% of its GDP on R&D, is 

not enjoying an economic growth that would be commensurate with that investment. For Botswana, 

the available information does not seem to put enough emphasis on the linkages of an innovation 

value chain. It is in this regard that one needs to introduce road mapping. This is an activity 

with different but related objectives. At one level, it is about raising the population’s awareness of 

the importance of science and technology. It is in the developing countries that this aspect is most 

important. At another level, road mapping is about linking S&T trends to market opportunities 

in the form of new products or services. And furthermore, it is also an effective communication 

tool within and between organizations that form the research and innovation value chain. When 

road mapping is done correctly, it becomes possible to provide, within an economy, a clear plan 

for science platform development, technology acquisition, and specific new product development 

projects so that the path towards commercialization emerges clearly. 


Because of its small population size, Botswana, with its 1.7 million people will not have as many 

S&T institutes as South Africa, which has some 40 million people. As the experience from a study 

done by the University of Nottingham’s business School suggests, ‘Universities that want to spin 

out more successful companies don’t need bigger technology transfer offices. They need better 

ones,’ ([Res-Man] Research Management Briefing - Issue 10). The same study, done on 110 of 

Britain’s top research universities, found that the experience and skills of technology transfer office 

staff are more important in creating wealth than the number of staff. “It is not so much the number 

of staff that is important but their experience,” ([Res-Man] Research Management Briefing 

- Issue 10). Human resource development is one thing that southern African countries are weak at. 

As indicated earlier, successful technology development and transfer is complex and requires high 

level skills. Otherwise R&D efforts will incur enormous loss. 

Conclusion 

This paper has attempted to argue the case for streamlining a country’s science and technology activities 

and arranging them in such a way as to complement one another, for purposes of creating 

an innovation system that is capable of expanding the national economy. For this arrangement to 

bring the desired results, there is need for an overarching framework of a national research and innovation 

strategy that largely works to implement the national science and technology policy. The 

paper went further to indicate that a strong science system is a pre-condition for an effective technology 

transfer system. In addition, it was emphasizes that adequate funding is required for the 

entire innovation system to function. And, since technology is both risky and expensive, the paper 

has demonstrated that research and innovation management is the single variable that will ensure 

synergy and growth of value from the various science and technology activities. It has been amply 

indicated that southern Africa lacks all these, but that without them, the region does not stand a 

chance to experience any further growth in its economy within the globalizing world economy. 

REFERENCES 

Heher, A (2004): Economic Modelling of Institutional Research and Innovation. 

SARIMA Project 3. Cape Town. 

Hewett, F. (2004): Technology Transfer and Economic Growth In The Twentieth Century. Paper 

Presented at a Workshop on The Overview Of The South African 

Research and Innovation System, Pretoria, 22-24 July, 2004 

Majewsky, I (2003): Good Practice in Spin Off Companies. EARMA 2003. 

Mouton, J (2004): Scientific Production: Knowledge Utilisation: Models of Research 

Utilisation. CREST, University of Stellenbosch, South Africa. 

RSA Government (2002): National Research and Development Strategy. Department of 

Science & Technology, Pretoria. 

Research Research (2004): Research Management Briefing Issue No. 10 

Papers 

Walwyn, D (2004): New Product Development and Commercialisation Strategy. Council 

for Scientific and Industrial Research, University of Pretoria, South Africa. 


Papers 

European and Federal Funding Comparison: 

Ever thought about getting research funding from Europe? 

Principal Author: 

Stuart McKissock CRA MCIPS 

Senior Manager of the Grants and Contracts Team 

Research & Enterprise, University of Glasgow 

Research & Enterprise 

No. 10 the Square 

University Avenue 

University of Glasgow 

Glasgow G12 8QQ, Scotland, U.K. 

Tel. No. 0044 141 330 3255 

Fax. No. 044 141 330 5611 

Email: s.mckissock@enterprise.gla.ac.uk 

Secondary Authors: 

Kathleen Sweeney FCCA 

Assistant Director of Finance – Research Admin 

Finance Department 


Martin Jamieson BA ACMA MBA 

Costing Manager 

Research & Enterprise 


Authors Note 

The authors would like to thank our “compadres”, Matt DeVol and Kathy Burke (La Jolla Institute 

for Allergy & Immunology); Mike Dollar, Jean Freiser and Antony Peake (The Burnham Institute); 

and Sandra Nordhal (San Diego State University Foundation). Without their gracious hospitality, 

professionalism, and ever enduring patience, none of this would have been possible. 

Abstract 

Do you have restricted funding? Ever thought about seeking funding from Europe? As the funding 

rules for the European Seventh Framework Program (FP7) get announced in September 2005, it 

is expected that the funding scheme will seek to encourage further US research collaboration with 

Europe. So, what are the major differences when seeking European research funding, as opposed 

to Federal funding? From September this year, the UK Treasury has imposed a new Activity Based 

Costing methodology on UK Universities, called Full Economic Costing (FEC). FEC has many 

similarities to the Federal cost accounting principals. The introduction of FEC will impact significantly 

on UK pre-award project costing, post-award project management, the cost ledger and UK 

billing systems. As FEC has many similarities to the Federal cost accounting principles, the University 

of Glasgow with the help of 3 US research Institutions is reviewing both our Federal and 

European pre and post- award financial processes. This review will give a comparison between the 

two funding schemes, and for the US Institution wishing to seek European collaborative funding, 

an invaluable insight into how the regulations significantly differ, where the gains can be made, 

and more importantly what to look out for. 


Relevance to Research Administrators 

Behind every successful academic and Institution lies a great research administrator. One definition 

of a great research administrator is an individual who has the ability to support the research 

academic when seeking research funding anywhere in the world. Is that you? 

Introduction 

As funding for research continues to be a major issue internationally, organisations are seeking 

new and more inventive ways of securing the necessary resources. This is creating an environment 

whereby more and more Universities and Non-profits are looking further afield, to funders that 

they have not considered previously. 

In the past, funding streams from the European Commission (EC) were exclusively for Europe, but 

under the Framework Programmes 6, and to a greater extent in 7, US collaboration is being actively 

encouraged. Likewise for UK Universities and Non-profits, as our accounting systems change, more 

and more collaborative funding opportunities are opening up to us in the United States. So, before 

launching ourselves into these new funding pots, what do we need to be aware of? 

In the UK we have extensive experience in the EC funding environment, but limited experience 

with Federal funding. So in May of this year, the University of Glasgow conducted a study tour of 

three US research active organisations in San Diego (the La Jolla Institute for Allergy & Immunology, 

the Burnham Institute and the San Diego State University Foundation), to learn more by 

comparing the differences between Federal and European funding, both pre and post award. 

This paper is a summary of that review, from the perspective of the European funding system, 

which we hope will be of value to our SRA colleagues. 

Background 

As part of a new UK Government initiative, UK Universities must adopt an amended Activity 

Based Costing (ABC) methodology called Transparent Approach to Costing (TRAC) to determine 

the Full Economic Cost (FEC) of their activities. In so doing, this aligns our accounting systems, 

processes and practices more closely with that of our US colleagues. It is worth bearing in mind 

that whilst the European Union (EU) has brought about some commonality within its Member 

States, the accounting standards, policies and processes are not uniform. Each member country 

has its own legislation (similar to State law compared with Federal law), Generally Accepted Accounting 

Principles (GAAP) and Accounting Standards. 

In order to seek European Commission (EC) funding, US Universities and Non-profits will need 

to collaborate with European organisations, as they cannot bid for this funding directly. Collaboration 

of this nature also requires adherence to the legal framework of the EC (Belgian or Luxembourg 

law) and an understanding of the different pre and post-award milestones when operating 

as a project partner in a European collaborative research project. 

Project Costing Methodology 

Papers 

Universities and Non-profits have three options under European funding rules when costing their 

participation in a European collaborative research project (such as an Integrated Project or a Specific 

Targeted Project). These costing options are Additional Cost with indirect flat rate costs (the 

AC model), Full Cost with indirect flat rate costs (the FCF model), and Full Cost (the FC model). 

Only Universities and Non-profits, which do not have an accounting system that allows the share of 

their direct and indirect costs relating to the project to be distinguished, may opt for the AC model. 


Papers 

As the majority of US Universities and Non-profits are able to distinguish their direct and indirect 

costs through their standard accounting systems, the only EC costing models likely to be available 

to them will be the FCF and FC models. 

Historically in the UK, Universities have used the AC model, as our financial systems could not 

identify all of our actual indirect costs. This is because, until recently, we have never had a need to 

do so. There has never been a requirement placed upon us to be able to identify our actual indirect 

cost base against a Government driven cost accounting process, guidelines, or set of standards 

(such as the Office of Management and Budget cost principals A-21, A-110, A-122 and A-133). 

With the introduction of Full Economic Costing (FEC) into the UK from September 2005, all UK 

Universities are now required to be able to financially account for both direct and indirect costs, in 

accordance with the Government driven TRAC methodology. Whilst the vast majority of Universities 

in the rest of Europe will still be eligible to use the AC costing model, UK Universities, like 

our US counterparts, will need to assess which of the FC models gives us the best financial net 

return. 

The European Commission (EC) has different funding levels based upon the type of activity being 

conducted on a project. For Integrated Projects they will pay 50% towards the cost of Research, 

35% towards the cost of Demonstration activities, 100% of the cost of Training, and 100% of the 

cost of Management (to a maximum of 7% of the total EC contribution). 

As the AC costing model is now not an option for the majority of UK and US Universities and 

Non-profits, we have applied the FCF and FC costing models to a typical EC Integrated Project 

(IP), by type of activity, to see how they stack up against each other and what one would expect to 

receive from a Federal research grant. 


Papers 

Integrated Project 

Duration – 4 years 

Typical costs under an EC FP6 project 

Full Cost with indirect Flat rate costs (FCF) Model 

Research Euros (€) Demonstration Activities Euros (€) 

Principal Principal 

Investigator 10% FTE 30,000 Investigator 1% FTE 3,000 

Research Research 

Assistant (3yrs) 90% FTE 117,450 Assistant 10% FTE 13,050 

Technician 50% FTE 69,000 

Consumables 50,000 Consumables 10,000 

Travel 18,000 

Equipment Purchase 6,000 

Equipment access 5,000 

Sub total 295,450a Sub total 26,050a 

Overheads Overheads 

(indirect costs/F&A) (indirect costs/F&A) 

@ 20% flat rate 59,090b @ 20% flat rate 5,210b 

Total Costs 354,540 Total Costs 31,260 

EC funds 50% for Research 177,270c EC funds 35% for Demonstration 10,941c 

Training activities Euros (€) Management Activities Euros (€) 


Investigator 5% FTE 15,000 Investigator 1%FTE 3,000 

External Examiners 5,000 Administration 6,000 

Audit Certification 8,000* 




@ 20% flat rate 4,000b @ 20% flat rate 1,800b 

[*8000 excluded as a subcontract cost] 

Total 24,000 Total 18,800 

EC funds 100% for Training 24,000c EC funds 100% for Management 18,800c 

Actual Total Direct Cost of the Project [total of a] (€) 358,500 

Actual Total Indirect Cost (F&A) is 90% of Actual Total Direct Cost (€) 322,650 

Actual Total Cost of the Project [Direct + Indirect/F&A] (€) 681,150 

Total Indirect Costs (F&A) that can be claimed under the 

FCF cost model (I.e. 20% of Eligible Costs) [total of b] (€) 70,100 

Total funds paid by the EC for activity type [total of c] (€) 231,011 

Match funding required [Actual Total Cost of Project – EC funding (c)] (€) 450,139 

Match funding required as a percentage of Actual Total Cost of Project 66% 


Papers 

Integrated Project 

Duration – 4 years 

Typical costs under an EC FP6 project 

Full Cost (FC) Model 

Research Euros (€) Demonstration Activities Euros (€) 


Investigator 10% FTE 30,000 Investigator 1% FTE 3,000 

Research Research 

Assistant (3yrs) 90% FTE 117,450 Assistant 10% FTE 13,050 

Technician 50% FTE 69,000 Consumables 50,000 

Consumables 10,000 

Travel 18,000 

Equipment Purchase 6,000 

Equipment access 5,000 




@ actual rate of 90% 265,905b @ actual rate of 90% 23,445b 

Total 561,355 Total 49,495 

EC funds 50% for Research 280,677.50c EC funds 35% for Demonstration 17,323.25c 

Training activities Euros (€) Management Activities Euros (€) 


Investigator 5% FTE 15,000 Investigator 1%FTE 3,000 

Examiners 5,000 Administration 6,000 

Audit Certification 8,000* 




@ actual rate of 90% 18,000b @ actual rate of 90% 8,100b 

[*8,000 excluded as a subcontract cost] 

Total 38,000 Total 25,100 

EC funds 100% for Training 38,000c EC funds 100% for Management 25,100c 

Actual Total Direct Cost of the Project [total of a] (€) 358,500 

Actual Total Indirect Cost (F&A) is 90% of Actual Total Direct Cost (€) 322,650 

Actual Total Cost of the Project (Direct + Indirect/F&A) (€) 681,150 

Total Indirect Costs (F&A) that can be claimed under the 

FC cost model (I.e. Actual Indirect Cost of 90% - Subcontract costs) [total of b] (€) 315,450 

Total funding paid by the EC for activity type [total of c] (€) 361,100.75 

Match funding required [Actual Total Cost of Project – EC Funding (c)] (€) 320,049.25 

Match funding required as a percentage of Actual Total Cost of Project 47% 

* please note that overheads (indirects/F&A) are not payable on subcontracts, including Audit 

Certificates. 

This comparison of EC costing models shows that the FC model is the one to favour, as it provides the 

higher net financial return between the two costing models. It is also the default model. Under the FC model 

you are able to negotiate your institutional cost rate (F&A) with the EC, as long as you are able to demonstrate 

and account for these costs in your financial accounting system by project. If you are unable to do so, 

you are only left with the FCF option, whereby your University or Non-profit will have to accept the arbitrary 

“indirect flat rate cost” of 20%, which will be significantly lower than your actual indirect cost rate base 

(F&A). A University and Non-profit that is using the FCF costing methodology can move to a FC model as 

soon as they are able to demonstrate the required financial accounting criteria. The rationale as to why the 

EC only pays 50% towards research is because the EC 


This comparison of EC costing models shows that the FC model is the one to favour, as it provides 

the higher net financial return between the two costing models. It is also the default model. Under 

the FC model you are able to negotiate your institutional cost rate (F&A) with the EC, as long as 

you are able to demonstrate and account for these costs in your financial accounting system by 

project. If you are unable to do so, you are only left with the FCF option, whereby your University 

or Non-profit will have to accept the arbitrary “indirect flat rate cost” of 20%, which will be significantly 

lower than your actual indirect cost rate base (F&A). A University and Non-profit that is using 

the FCF costing methodology can move to a FC model as soon as they are able to demonstrate 

the required financial accounting criteria. The rationale as to why the EC only pays 50% towards 

research is because the EC argues that the participants get to keep the results of the research. The 

shortfall in funding should therefore be made up by the participating University or Non-profit 

exploiting or using the results. 

Pre-Award Administration 

So what is the process for applying for European funding? 

European funding opportunities are published by thematic areas of research, and each work package 

has a published road map, which details when calls for proposals are being sought. 

Contract Negotiation Phase (The Main differences in Funding Terms) 

Papers 

How is the contract negotiation conducted, and what are the likely terms of funding you need to 

consider? 

The European Commission places the main EC contract terms upon the “Project Coordinator” 

(i.e. the lead coordinating project partner/prime contractor). These contract conditions are then 

flowed- down to each project partner by the “Project Coordinator” requesting each of them to sign 


Papers 

up to these terms (called “accession to contract form”). Under these terms the project partners are 

required to enter into a Consortium Agreement (a research collaboration contract) to determine 

what conditions will govern the management and delivery of the project. If there is any conflict between 

the terms and conditions of both agreements, the main EC contract terms take precedence. 

The EC is not a party to the Consortium Agreement. This is different from the Federal system, 

which generally works on the basis of the Federal award to the lead organisation (who submitted 

the original funding application), which then in turn raises a single subcontract to each participating 

partner in the research project. 

So what will you be asked to sign up to? 

Project Coordinator - Under the main EC contract terms the “Project Coordinator” is the lead organisation 

responsible for submitting the funding application, breaking down and identifying the 

project resources and activities associated with the project for the European Commission (EC). A 

legal obligation is also placed on the “Project Coordinator” on award of the funding to act as the 

project co-ordinating body, making it solely responsible for the overall management of the project, 

similar to a prime contractor. The “Project Coordinator” is therefore responsible for managing the 

Consortium; negotiating the terms of the Consortium Agreement; obtaining financial security 

statements (such as bank guarantees, when necessary); obtaining audit certificates on behalf of all 

of the project partners; managing the distribution of EC funding to the project partners; implementing 

competitive calls for the participation of new project partners; co-ordination of the technical 

activities; and legal, contractual, ethical, financial, patent and administrative management. 

The “Project Coordinator” also has the responsibility of ensuring that each project partner signs 

up to the main EC contract terms and the terms of the Consortium Agreement. It is extremely 

unlikely that a non-European University or Non-profit would be accepted by the EC in the role of 

a “Project Coordinator”. 

Force Majeure -Project partners under this clause are exempted from the legal provisions of the 

EC contract terms for events which cannot be foreseen or pre-planned for (i.e. outwith your reasonable 

control). Interestingly, anomalies in functionality or performance of products or services 

supplied under the project, labour disputes, strikes, or financial difficulties, do not constitute a 

“Force Majeure” event, under these terms. 

Project suspension or termination - The EC or the Consortium may request suspension or termination 

of the project where it is established that it will be excessively difficult to continue with 

all or part of the project due to technical, financial, economic, or scientific reasons making the 

project no longer viable. During a suspension no costs may be charged to the project. Any project 

partner can also request termination of their participation in the project with the agreement 

of the other project partners. This must be submitted to the EC through the “Project Coordinator”. 

The Consortium may also request the termination of a project partner from the project. The 

“Project Coordinator” on such a request needs to notify the EC how the terminated party’s work 

programme will be reallocated within the Consortium. In the event of a termination, the EC will 

pay all eligible costs up to the effective date of the termination and any legitimate, non cancellable 

commitments made prior to that date. 

Sub-contracting - Project partners may subcontract for minor services which do not represent 

core elements of the project. Project partners who subcontract are to ensure that best value for 

money is achieved for these services (demonstrated by the competitive tendering of these services) 

and that the subcontractor is bound by the same contract conditions. 


Papers 

Activity and Financial Reporting - Period activity reports describing progress toward agreed objectives, 

milestones and deliverables, periodic management reports (justifying resources allocated, 

plus a financial statement for the period of the report) and a final report (to include audit certificates), 

are to be submitted to the EC within 45 days of the respective period. EC budget allocations 

are made on an 18-month rolling grant basis. The EC undertakes to evaluate all activity reports 

within 45 days. If no comments or changes are received from the EC within 90 days after submission 

of the report, the activity report is deemed accepted by the EC. This automatic acceptance 

does not apply to any other type of report, such as financial reports. 

Confidentiality, Use of Confidential Information, and Publication - All information, documents, 

intellectual property or materials are to be kept confidential when the disclosing party cites it 

as being confidential. Without prejudice to this confidentiality provision, project partners are 

required to provide confidential information to the EC to enable the continuous and systematic 

review of the specific research programme, the sixth framework programme, and for the evaluation/impact 

assessment of EC activities. The EC will also make confidential information available 

to any Member State, including intellectual property generated from an EC project, only where 

it is relevant to public policy and when no reasoned case has been received by it from a project 

partner(s) not to do so. Any information supplied by the EC to a Member State will be on a confidential 

basis only. The project partners during the life of the project must also take appropriate 

measures to ensure suitable publicity in order to highlight the EC financial support given (similar 

to the Stevens Act). Any notice (verbal or written) or publication (in whatever medium), including 

seminars or conferences, must specify that the project has received EC financial support from the 

EC Framework Programme. The usual disclaimer statements are to be made also, similar to the 

requirements of the National Institutes for Health and the National Science Foundation. 

Liability and Indemnity - The EC cannot be held liable for acts or omissions committed by the 

project partners. The EC is also not to be held liable for any defaults of any products or services 

created by intellectual property resulting from the project. Each project partner is to indemnify 

the EC against any action, claim, or proceeding brought by a third party as a result of damage 

caused, by either act or omission committed by a project partner(s) in performing the project, or 

through any products or services created by intellectual property generated from the project. In 

the event that a claim is raised by a third party against a project partner(s), the EC may opt to assist 

the project partner(s) at the project partner(s) own expense. 

Assignation of rights - No project partner(s) may assign their rights and/or obligations arising 

from the contract without prior approval of the EC. 

Breach of contract terms - In the case of a breach, the Consortium has 30 days to come up with a 

solution, which needs to be accepted by the EC. Costs incurred by the Consortium after the date 

of such a breach will only be paid by the EC if they accept the remedial action suggested. If the EC 

fails to accept the remedial action proposed, the EC can terminate the contract or terminate the 

defaulting project partner if the project is still capable of being delivered. The EC is also able to immediately 

terminate the participation of a project partner in the event of a deliberate or negligent 

act or contravention of any fundamental ethical principle set by the EC. A defaulting project partner 

has 30 days from the effective date of termination to provide the EC with an activity report for 

the period of performance and a final audit certificate. Failure to provide either report will result 

in no remaining eligible payments being made by the EC to the defaulting party. The Consortium 

(within 30 days of termination) is also required to provide the EC with information on the share 

of the EC contribution paid to the defaulting partner up to the point of termination. The EC will 

then determine what sums are due to it from the defaulting partner’s share. 


Papers 

Collective responsibility - The Consortium partners are collectively responsible for the technical 

milestones, objectives and deliverables for the project. Should the Consortium have a defaulting 

partner, the remainder of the project partners are required to take on the defaulting party’s work 

package at no extra cost to the EC. If a defaulting partner does not return any debt due to the EC, 

the remaining project partners are liable for this cost, based on the percentage share of their EC 

contribution. The Consortium is not collectively responsible for any amount owed to the EC by 

the defaulting partner found after the end of the project, liquidated damages (as a result of a false 

expenditure statement post-award), or any other sanctions imposed by the EC on the defaulting 

partner. 

Intellectual Property Rights and Access - Intellectual Property Rights (IPR) are owned by the generating 

party. Jointly generated IPR is jointly owned. Transferring ownership in IPR is allowed, but 

prior approval is required from the EC. The EC may object to the transfer, in the interests of the 

European Commission. Other project partners may also object to such a transfer, if their access 

rights are adversely affected. The project partner who owns the IPR has to provide for its adequate 

protection. When an owner of IPR decides not to protect it, other project partners may have the 

right to step in (under the terms of the Consortium Agreement), or the EC may do so on its own 

behalf. IPR generated or obtained from the project has to be used either in further research activities 

and/or for commercial purposes (creating and marketing a product or process or providing a 

service). A plan outlining the dissemination/exploitation of IPR generated from the project is to 

be supplied to the EC, by the Consortium. Publications are allowed, so long as it does not affect 

the protection of IPR. Prior notification of publication is required to other project partners and 

the EC. Both may object under certain conditions. Each partner has access rights to all IPR necessary 

for the completion of their work package. The possibility of granting access rights to third 

parties is also recognised; the EC needs to be notified, however, when granting such rights. The 

EC can object to the granting of these rights in the interests of the European economy or if ethical 

principles are infringed. Pre-existing IPR brought to the project can be excluded from such access 

rights, by the project partner’s written agreement, and at specifically defined times. IPR owned 

or generated by a project partner prior to the project can also be excluded from the project. Such 

excluded IPR has to be communicated to the EC in the funding application and resultant Consortium 

Agreement. 

How should you approach the Consortium Agreement? 

As a project partner, when you enter the contract negotiation stage, the “Project Coordinator” 

(which could be a University, Non-profit or a commercial company), will seek to negotiate with 

you on your technical work package, the associated budget, and the terms of the Consortium 

Agreement. During the contract negotiation phase each Consortium has approximately three 

months to resolve these issues prior to the prime award being made by the EC to the “Project Coordinator”. 

On receipt of the prime award, the “Project Coordinator” needs to demonstrate to the 

EC that the Consortium terms have been agreed and signed by all the participating parties to the 

project within 90 days after receipt of the main EC contract terms. 

As each project can have anywhere between 5 to 50 partners throughout Europe and beyond (including 

both large and small companies, Universities, and Non-profits), agreeing on the contract 

terms within three months is extremely challenging. 

The “Project Coordinator” therefore may seek to agree a Heads of Terms with the project partners 

at the time the EC funding application is submitted (which will define the contract principles of 

the Consortium Agreement), such as project/ contract management, liability and indemnity provisions, 

ownership of intellectual property, access rights, commercial exploitation process, commercial 

terms for licensing, budgeting rules, and the distribution process of the EC funds to the 


project partners. This enables any contentious issues to be identified, discussed and agreed upon at 

an early stage of the application process, rather than leaving it all to the three-month period at the 

contract negotiation stage. 

Negotiating tactics? 

Your negotiating position with the “Project Coordinator” will vary depending on the value of your 

work-package or the proprietary nature of what you bring to the project. 

Taking account of the main EC contract terms already discussed, you need to be aware of a number 

of key issues when negotiating and/or agreeing the terms of the Consortium Agreement, such 

as: 

• How the project will be managed? Do you participate in the project’s management committee? 

Do you have voting rights? Can others in the Consortium make decisions on behalf of your 

Institution? (i.e. changes to your work programme and funding share). 

• Has your financial liability been restricted to the value of your agreed work package? 

• What is the likelihood of any of your project partners defaulting on the delivery of their work 

package? 

• What is the likelihood of any of your project partners going into liquidation, or filing for 

bankruptcy? 

• How do you share in any commercial exploitation of your intellectual property? 

• How do you define what intellectual property you are excluding from the access provisions 

of the main EC terms? In the UK we have adopted the practice of identifying (in a schedule 

of the Consortium Agreement) what pre-existing intellectual property (IP) we are bringing 

to the project. Therefore by definition, any pre-existing IP not listed is excluded from these 

terms. 

• Can you terminate your participation in the project unilaterally, and if so, what are your legal 

and financial liabilities? 

Post Award Administration 

What do you need to do and be aware of after an EC award? 

Reporting 

EC projects require the following periodic reports: 

Papers 

• Cost statement – a brief document that lists the direct costs and contribution to indirect costs 

giving the total financial contribution requested from the EC without provision of detailed 

cost breakdown. This is a simplified version of US form SF-269 or SF-269A, Financial Status 

Report. 

• Audit certificate – [see section on Audit]. 

• Management report – this is required to justify the use of resources on the project and must 

clearly show all of the inputs (i.e. the matched funding element of the project), and an estimate 

of the effort (expressed in person months). Also required in the management report is confirmation 

to the EC that the lead University/Non-profit (i.e. the “Project Coordinator”) has sent 

the other project partners their share of EC funding. This compares with US SF-272, Report of 

Federal Cash Transactions. 

• Activity Report – to inform the EC of the progress towards the specified deliverables including 

any problems encountered and remedial action taken. This is similar to the US requirement 

for performance reporting. 


Papers 

• Revised implementation plan – to inform the EC of any deviation from the original proposal. 

This must be completed before the deviation is made to avoid any abatement of future financial 

claims. 

• Revised Joint programmes of activity – to inform the EC of the redistribution of workload in 

production of the revised implementation plan. 

• Plan for using and disseminating the knowledge. 

• Science and society reporting questionnaire. 

• Reporting on the implementation of the gender action plan (only for Integrated Projects (IPs) 

and Networks of Excellence (NoEs)). 

• Questionnaire on workforce statistics (for all projects except IPs and NOEs). 

• Socio-economic reporting questionnaire. 

The frequency of these reports will be specified in the contract but will be a multiple of 6 months, 

most commonly at 12 or 18-month intervals. This is unlike US reports which will be required no 

more frequently than quarterly and at least annually. 

Financial Management 

The project Consortium management budget must be used to meet the cost of audit certification, 

the cost of calls for proposals, obtaining any financial security such as bank guarantees when 

requested by the EC, and any other management activities at the Consortium level not covered 

by any other activity (such as coordination of intellectual property management and promotion 

of gender equality within the project). This budget heading is limited to 7% of total budget for the 

project. Any of these management costs in excess of each of the participating partner’s negotiated 

share of the management budget will be regarded as non-eligible. 

The EC regards all identifiable indirect taxes, including sales tax or import duties, as non-eligible 

costs, so your systems must be able to separate out these elements of indirect taxes from the eligible 

expenditure items to which they relate. 

Timesheets 

The US effort-reporting requirement is to monitor the percentage level of activity and the percentage 

contribution of capped salary costs. The EC effort-reporting requirement is to monitor the 

whole-time hours of effort for individuals involved with the project. Percentages are not acceptable 

as these hours are then converted using a standard rate into person months. This evidence is 

required irrespective of whether or not the EC is requested to pay some or all of the salary costs 

relating to this involvement. 

Audit 

Within EC Framework 6, and it is likely Framework 7, more emphasis is being placed on the 

responsibility of the University or Non-profit to evidence the accuracy of the cost statements 

submitted than in previous funding rounds. The release of the next block of cash funds will not 

be made unless the necessary audit certification has been received. Unlike the US value threshold 

of $500k triggering the need for audit certification, in EC funding such certification is required to 

accompany the periodic cost statement submitted irrespective of the value of award. Only in cases 

where no cost statement is due within an annual reporting period, but the financial contribution 

is in excess of Euro 750k (with one certificate required per partner in receipt of amounts above 

this limit during the period), is the value of the award relevant. The audit certification is similar 

for both EC and US funding and is deemed to be an “independent” certification as the audit firm 

selected are independent of both the University/Non-profit and of the funder. A special Clause 

39 has been recently added to provide organisations in receipt of less than Euro150k exemption 


from the need for multiple audit statements. Now these organisations need only submit one audit 

certification at the end of the project. 

The cost of the independent audit is an eligible cost of an EC project (see Financial Management 

section) but is a limited amount. The cost of independent audit on a US funded project may be 

direct or an allocated indirect in accordance with the applicable statements of cost principles. 

Audit statements must be submitted to US funding agencies no later than 9 months after the end 

of the audit period, but for the EC the audit certificate must be submitted within 45 days of the 

period end (which can be extended by a further 45 days at the request of the project Consortium). 

An EC project funded under FP6 is likely to be audited by the funding body at least once during 

the active life of the project and up to 5 years after cessation of the project. This is clearly different 

from US funding streams where the funding body will audit a random sample of funded projects, 

unless accounting irregularities are suspected, in which case the University or Non-profit would 

automatically be audited. 

Currency 

If you are in a University or Non-profit funded primarily in US Dollars (USD) you may not have 

encountered the issue of currency gains and losses. All European programmes are funded in 

Euros. The Euro is a traded currency, which free floats against the dollar. This means that there is a 

risk element for participation in an EC funded programme that despite the principal investigator 

remaining on budget in terms of dollars, once this is converted to the funding currency, there is a 

resultant difference. This difference can be a loss or a gain and the European Commission will not 

be interested in either, even if you make a significant loss through such an exchange rate fluctuation. 

Under the European funding rules, you are also not allowed to build contingency funding into 

your budget proposal for this potential liability. However, if you make any gains from this exchange 

rate fluctuation, you are free to keep these costs. 

One further complication is that the floating rate of the USD against EURO is not the rate that can 

be submitted for cost statement purposes. The official exchange rate to be used in the determination 

of the amount of reimbursement due in Euros is published by the EC and it is only this rate 

they will accept. 

Summary 

Whilst European funding doesn’t cover all of your costs, may result in currency fluctuation, and has 

more problematic funding terms to contend with, don’t automatically discount this type of funding 

stream. It may provide an opportunity to collaborate in research areas, which compliment and/or 

improve your own, give you access to unique research/study populations, or facilitates the ability to 

be able to use research infrastructure unavailable to you within the United States. 

Recommendation 

Papers 

When entering into a European collaborative project, have a look at the Scientific and Technological 

Cooperation Agreement between the European Commission and the Federal Government. 

This agreement enables Federal agencies to fund US Universities and Non-profits engaged in 

European collaborative research, as though it were a Federal grant, where the aims and objectives 

of the research match those of the Federal Government. 


Papers 

Conclusion 

SRA is an international organisation. Use it to build links in Europe so you can use this expertise 

when assessing European funding opportunities, when seeking collaborative partners, and when 

negotiating budgets and contract terms. This interaction will significantly reduce your exposure to 

the associated risks, and will help you build your own expertise. 

PRE-AWARD (Quick Glance Comparison between US and EU funding rules) 

Pre Award US [NIH Grants] EU (FP6) [Grants for Integrated Projects] 

Rules Office of Management and Budget issues 

circulars that apply to all Federal funders and 

all recipients of such funding. 

EC rules change for each programme and vary 

by type of financial contribution. National 

bodies use different funding rules. 

Language English (US) The main EC terms are supplied in English. 

Legislative System US Code Belgian or Luxembourg law, i.e. not English or 

Scots law. 

Accounting Systems US GAAP UK GAAP, or European equivalent. 

Pre Award US [NIH Grants] EU (FP6) [Grants for Integrated Projects] 

Allowable and 

Eligible costs 

Costs should be: 

• Allocable 

• Reasonable 

• Due prudence 

• Consistent - Usual Accounting principles 

• Commencement & Convocation excluded 

Costs should be: 

• Actual 

• Economic 

• Necessary 

• Consistent - Usual Accounting principles 

• During the duration of the project 

“Eligible” cost categories are not defined 

instead the definition is based on exclusion of 

non-eligible costs. 

Cost Models Allocable costs plus negotiated F&A rate. Full Cost (FC) = 50% of All Eligible Direct and 

Indirect Costs. 

Full Cost Flat rate (FCF) = 50% of the Eligible 

Direct Costs + 20% contribution to Indirect 

Costs. 

Additional Cost (AC) = 100% Eligible Direct 

Costs + 20% contribution to Indirect Costs. 

Direct Costs Costs that can be identified specifically with 

a particular sponsored activity. Costs for the 

same purpose must be treated consistently as 

either direct or F&A. 

Direct additional 

costs 

F&A costs/ - 

Indirect costs 

Collective 

responsibility 

“Should require no significant changes in the 

generally accepted accounting practices of 

colleges.” 

Indirect cost rates for F&A are negotiated. 

Costs that are directly associated with the 

project. 

Eligible costs that are additional to the normal 

recurring costs of the contractor and are 

directly associated with the project. 

All eligible costs, caused by two or more cost 

objectives, determined by a contractor in accordance 

with its usual accounting practice. 

For Research under the AC model - these are 

paid at 20% of the eligible additional costs. 

Technical collective responsibility is shared 

between partners on a project. 

Sanctions Any amount unduly paid by the EC has to be 

reimbursed by the contractor. 

Overclaims may be penalised in proportion to 

the amount overpaid (liquidated damages). 


POST-AWARD (Quick Glance Comparison between US and EU funding rules) 

Post Award US EU 

Financial administration rules provided 

in full with each award 

Single set of rules apply commonly 

across all schemes 

Interest earned on project funds Initial $250 is not counted, but sums 

in excess of this are to be included in 

revenue streams 

Cash flow timing specified and fixed 

at time of funding 

N Y 

Y N 

Must be included in revenue streams, 

but ONLY if lead partner 

Y N 

Staff time / effort % Effort report Total hours worked on all activities 

converted to “person months” 

Financial Reporting Annual cost statement Annual cost statement 

Contract Framework Award made to lead University 

or Non-Profit who then 

subcontracts to each research 

partner 

Applicable contract law framework 

(country thereof) 

Award made to Project 

Coordinator, with each 

research partner joining Consortium 

Agreement 

US Belgium/Luxembourg 

Audit - local certification When above threshold Each cost statement 

Audit - by funder In exceptional circumstances or 

random sample 

Each programme will be audited once 

at any point during life and up to 5 

years after end 

Audit fees eligible costs? Yes but may be Direct or F&A Y, but capped 

Currency USD EURO 

Currency losses/gains N/A Will not be refunded/recovered 

Working Bibliography 

Guide to Financial Issues relating to Indirect Actions of the Sixth Framework Programmes (Version 

– April 2004). 

Sixth Framework Programme Checklist for a Consortium Agreement (reference MS/AS 2002/09 

revised 31/03/2003). 

European main contract terms (Approved by the Commission on 23 October 2003, decision C 

(2003) 3834 dated 31.10.03), plus Annex II General Conditions (Approved by the Commission on 

17 March 2003, decision COM (2003) 799/2 dated 17.03.03). 

Scientific and Technological cooperation between the European Community and the Government 

of the United States of America (Official Journal of the European Communities dated 22.10.98 EN 

L 284/37). 

Office of Management and Budget Circulars A-110, A122, A-133, & A-21. 

http://fp6.cordis.lu/fp6/home.cfm 

Useful Links 

http://www.eurunion.org/legislat/STE/EUUSS&TCoopAgree.htm 

Papers 


Papers 

Virgin Territory: The Role of Research Administrators in Mentoring Junior Faculty 

Rebbecca A. Moen, MBA 

Duke University 

Office of Research Administration 

Suite 11103 Hock Plaza 

Box 2722 

2424 Erwin Road 

Durham, NC 27705 

Tel: 919-668-2242 

E-mail: Rebbecca.Moen@duke.edu 

Patricia Byrns, MD 

University of North Carolina at Chapel Hill 

Office of Research and Faculty Development 

243 MacNider 

CB# 7000 

Chapel Hill, NC 27599 

Tel: 919-843-7232 

E-mail: Patricia_Byrns@med.unc.edu 

Contributor: Meghan Maloney, Duke University 

Authors Note: The authors would like to thank the junior faculty in our programs for providing 

the qualitative data and Meghan Maloney for her critical assistance in reviewing the mentoring 

literature 

Abstract 

Most newly appointed faculty members at academic medical centers are insufficiently prepared to 

succeed in their new role. They are required to publish research findings and compete for research 

funding, which may be an entirely new experience for them. In particular, the process of searching 

for, applying for, and managing extramural funding is new territory for these “grant virgins.” There 

is substantial overlap in the needs of junior faculty and the knowledge that research administrators 

possess. Experience at our two institutions has taught us that research administrators have a great 

deal of knowledge and experience to offer junior faculty, making the inclusion of a research administrator 

on a mentoring team a worthy endeavor. Networking, problem-solving, and obtaining 

research funding are examples of the skills research administrators can bring to the relationship. 

The success of research institutions relies on ensuring the success of its junior faculty in procuring 

research funding and in becoming independent investigators. Research administrators can play a 

significant role in helping junior faculty attain this goal. 

A Challenge for Junior Faculty 

Most newly appointed faculty members at academic medical centers are insufficiently prepared to 

succeed in their new role. Basic researchers have been trained in research methods and clinicians 

trained in patient care, but once an individual secures an academic faculty appointment, there 

are new requirements for gauging success. These individuals must now juggle their time between 

teaching, administration, research, and perhaps clinical duties. They are required to publish 

research findings and compete for research funding, which may be an entirely new experience for 

them. 


In particular, the process of searching for, applying for, and managing extramural funding is new 

territory for these “grant virgins.” Beyond coming up with interesting and novel science, they must 

learn the language of sponsored research, with its R01’s, F&A, Fastlane and Commons. They must 

also learn business practices, policies and processes for their institution and sponsoring agencies. 

Mentoring 

Mentoring is the standard method that academic medical centers use to teach junior faculty the 

skills they need to be an academic researcher. Mentoring has been much described in the literature, 

with many definitions and descriptions of responsibilities. While there is some disagreement 

about terminology, most of the research community agrees that mentoring should involve training 

and guidance on technical scientific skills as well as career development issues (Werner 2004, 

Connor 2000, Bauchner 2002). Table 1 highlights the most commonly identified responsibilities of 

mentoring. 

Table 1: Responsibilities of the Mentor 

• Developing research skills 

• Selecting and conducting research projects 

• Conducting research ethically 

• Presenting research findings 

• Completing and submitting manuscripts 

• Guidance on balancing work/home life 

• Promoting one’s career 

• Networking 

• Obtaining research funding 

• Listening and problem solving 

FN: Bauchner 2002; Pololi 2002, IOM 1997 Mott 2002, 

Greggs-McQuilkin 2004, Waugh 2002, Tobin 2004, 

Ramanan 2002, Connor 2000, Shea 1995, Mason 2003, 

Schrubbe 2004, Waugh 2002,Werner 2004 

Papers 

Most academic medical centers rely on a traditional mentoring system for junior faculty, where 

there is one mentor who trains and guides the mentee. One of the drawbacks of this model is 

inherent to the one-on-one model: the mentee only learns what the mentor knows. The mentor’s 

experience is based on a sample of one – his or her personal experience, which may not always 

match the mentee’s needs (Waugh 2002, IOM 1997). Another drawback of this model is that the 

best mentors are usually highly sought leaders, which means that they have less time to spend with 

individual mentees (Pololi 2002, Connor 2000, Bauchner 2002). A major criticism of the mentored 

learning experience is that the mentor does not have enough time to give adequate attention to the 

mentee (Mason 2003, Bauchner 2002, Waugh 2002). 

Research Administrators 

Research administrators in academic institutions are typically involved in supporting investigators 

in the procurement or management of research funding. This role may take various forms, from 

assisting in budget development to ensuring compliance with sponsor regulations to overseeing 

a departmental or institutional portfolio of sponsored research funding. There are a few areas 

of knowledge, however, that are common across many research administrators. These individuals 

typically have an in-depth familiarity with the various funding mechanisms and agencies that 

sponsor research. They know the project timelines and budgetary implications of the funding 

mechanisms and which sponsors are more likely to sponsor which kind of research. Research administrators 

also generally know how the review process works for various funding agencies. They 

frequently have access to information about who in the institution is doing what kinds of research 


Papers 

and in which disciplines. They know how the processes in the institution work and who to call for 

what information. This wealth of information is typically underutilized. 

An all-too-common interaction between junior faculty and research administrators comes when 

a new investigator submits his or her first grant application. The investigator then learns about 

grant submission and administration through trial and error, by being corrected on what he or she 

has done wrong. This initial interaction may make investigators feel like research administrators 

are simply putting up barriers or adding hoops through which one must jump. It may also make 

research administrators frustrated that the junior investigator has not been taught by his or her 

mentor what he/she needs to know about research administration. 

Overlap of Need and Expertise 

There is substantial overlap in the mentoring needs of junior faculty and the knowledge that research 

administrators possess. While research administrators may not be able to train a new investigator 

in specific research methods, there are a few areas where their expertise can be particularly 

helpful to the junior faculty member: 

Networking – One of the critical responsibilities of a mentor is introducing junior faculty members 

to research leaders in their field (Bauchner, 2002, Kaye 1996, Schrubbe 2004). But beyond this traditional 

concept of networking, mentors should also give junior faculty advice about access to resources 

within and outside of the institution. Because research administrators work with a number 

of faculty members, they can serve as “match-makers” for faculty with similar research interests. 

This may involve a simple introduction via e-mail that points out the similar interests or a meeting 

to introduce individuals face-to-face. Research administrators also generally know the institution 

well enough to know who to call for what (e.g., access to the General Clinical Research Center or 

Department of Lab Animal Resources, etc.). This access to resources can be of significant benefit 

to junior faculty. Simply giving a junior faculty member the name of a contact person instead of a 

general office number is well-received. 

Listening and problem solving –Most junior faculty appreciate having someone with whom they 

can talk and work through issues (Pololi 2002, Mott 2002, Connor 2000, Tobin 2004, Kaye 1996). 

These issues may involve political situations in the institution or simply questions about the city, 

if the faculty member is new to the area. Research in the area of mentoring has identified a lack of 

time with the mentor as the biggest obstacle to the success of the experience (Waugh 2002, Mason 

2003, Andrews 1999). Research administrators can help fill this gap and provide mentoring to 

junior faculty through problem solving, particularly related to research administration. Questions 

about application deadlines or institutional business practices are common among junior faculty 

and don’t require a response from a senior faculty member. In addition, sometimes the junior faculty 

member just needs someone with whom he/she can brainstorm. This access to a listening ear 

is extremely helpful to junior faculty. 

Obtaining research funding – For many junior investigators, the most intimidating activity faced 

is obtaining research funding. It entails identifying the appropriate sponsor for research (e.g., 

foundation, federal, industry, etc.), identifying the appropriate mechanism of support (e.g., fellowship, 

pilot or seed funding, or research grant), and writing the proposal itself. Each of these tasks 

requires knowledge of an extensive amount of information. Research administrators can greatly 

assist junior faculty with the tasks involved in obtaining research funding. 

• First, whether through tacit knowledge or a computerized system, administrators know how 

to find out which agencies are sponsoring research. This may involve doing on-line searches, 

through Community of Science, for example, or searching the listing of Requests for Application 

on the National Institutes of Health (NIH) website. 


Papers 

• Second, research administrators can help junior investigators identify appropriate funding 

mechanisms. For example, a junior faculty member who has no history of NIH funding and 

is looking for $25,000 in a fairly short timeframe should be looking for foundation funding, as 

opposed to submitting an R01 grant. 

• Third, by virtue of having seen many research proposals, research administrators may be able 

to assist junior investigators in actual grant writing. Typically, they would not be able to assist 

with the science, but good grantsmanship requires more than good science. Administrators 

can work with junior faculty to help them articulate their research ideas and develop specific 

goals for their research. They can assist with the structure and organization of grants and may 

be able to contribute to standardized sections (e.g., descriptions of resources or other boilerplate 

information). Good grantsmanship requires that the proposal should be understandable 

by a layperson, therefore, even if a research administrator does not have a scientific background, 

he/she should be able to understand what the research project is, why it is important, 

and how the investigator is going to carry it out. 

Experience at Duke and UNC 

Experience at our two institutions (Duke University and the University of North Carolina at Chapel 

Hill) has taught us that research administrators have a great deal of knowledge and experience 

to offer junior faculty, making the inclusion of a research administrator on a mentoring team a 

worthy endeavor. 

Both UNC and Duke have considerable experience in the training of new investigators in the art 

and science of research. Our combined totals for the following categories of training awards include: 

forty-five F32s, twenty-six K01s, thirty-six K08s, fifty-three K23s, and seven K12 awards. 

K30 Program: Both Duke and UNC are recipients of the NIH-funded K30 Clinical Research 

Training Programs. These grants offer formalized academic programs in the quantitative and 

methodological techniques of clinical research. At both UNC and Duke, the K30 trainees include 

fellows and junior faculty from a variety of health professions. 

Mentored Clinical Research Scholar Program (MCRSP): The MCRSP is funded by the National 

Center for Research Resources at both Duke and UNC and is a prototype for the K12 awards. 

It involves a structured didactic and applied research curriculum designed to foster training in 

patient-oriented clinical research. Faculty members selected for their expertise, experience, and 

commitment to training provide oversight of the program and/or serve as research mentors. Each 

trainee participates in a formal multidisciplinary didactic program that can lead to a master’s 

degree. The various components of the program include mentored research, professional skills development, 

and formal training in responsible conduct of research. At Duke, MCRSP participants 

include both post-doctoral physicians pursuing subspecialty or primary care training and junior 

faculty members. At UNC, all MCRSP participants are junior faculty physicians from the School 

of Medicine and junior faculty dentists from the School of Dentistry. 

Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) Program: The BIRC- 

WH is funded by the National Institute of Child Health and Human Development at both UNC 

and Duke. The primary goal of this program is to expand an institution’s activities in women’s 

health research. Most of the elements of the program are quite similar to the MCRSP described 

above. UNC was funded in 2000 with the initial cohort of BIRCWH Programs and has to date 

enrolled seventeen (17) junior faculty members across three of the Schools on our Health Affairs 

campus. To date, UNC’s BIRCWH Scholars have included: 1 PharmD; 6 PhDs; 1 MD-PhD; and 

9 physicians. Disciplines and departments are quite diverse as is the spectrum of research activity 

that ranges from basic to translational and patient-oriented to population sciences. The Duke 

BIRCWH was funded in 2002 and collaborates in training with North Carolina Central University, 


Papers 

a historically black university. 

Table 2: Mentoring for Grant Funding - Examples of Specific Activities 

• Information about grant opportunities 

• Finding and providing copies of successful grants 

• Planning or strategy meetings 

• Providing written information about the institution and/or institutional 

resources 

• Nuts and bolts of grants: biosketches, other support, letters of support 

• Assistance with budget preparation 

• Review, comments, editing 

These programs have provided a nidus for junior investigators in translational and patient-oriented 

research and a forum within which mentoring by research administrators is taking place 

through a variety of activities including seminars, formal presentations, and one-on-one mentoring. 

Table 2 lists some of the specific one-on-one mentoring activities that take place between 

research administrators and junior faculty that facilitate obtaining grant funding. 

To evaluate the benefits of these services, we have conducted two assessments. The first was a 

qualitative evaluation in which we asked junior faculty open-ended questions about the “benefits 

of collaborative efforts between research administrators and junior faculty.” The second evaluation 

consisted of a survey that asked junior faculty to score the importance of listed services for preparing 

a grant. 

Qualitative Evaluation of the Role of Research Administrators in Mentoring Junior Faculty 

Written responses to an open-ended question identified many of the activities listed in Table 2 but 

each individual respondent focused on just a subset. 

“Working with [the Research Administrator] was fundamental in that she has a deep understanding 

of several aspects of grantsmanship that are not frequently communicated by my research 

peers and mentors. First, she provided me with information on funding opportunities that would 

be most appropriate for my research interests and phase of my career. A second factor was her 

knowledge on how I should structure the grant text to meet reviewers’ expectations. Above all, 

she was able to simplify the concepts I was trying to explain in my proposal. And last, our weekly 

meetings determined the pace at which I progressed towards completion. Having deadlines makes 

all the difference and gives you a sense of accomplishment.” – RP 

“When talking about mentoring, most people think automatically about the professional and 

scientific guidance a new faculty person needs in order to get started on the right track. But my 

academic mentor, [Dr X], knew that in addition, I needed to learn more about the process of how 

to write grants. She encouraged me to seek guidance from our budget and grants office, where I 

was fortunate to wind up working with [Ms Y]. [She] provided access to a wealth of information I 

had previously been unaware of, and also suggested other people on campus and at the NIH who 

could be helpful to me. She helped me to organize and prioritize tasks that needed to be completed 

prior to grants submission, provided some gentle accountability for the most onerous tasks, and 

even read the grant and provided feedback prior to submission. I still remember the first time I 

met with [Ms Y]. My comment was, ‘the next deadline is June 1 and I’m not sure I can make it.’ 

[Ms Y’s] comment was, “Of course you can, and here’s how.” Leaving her office after our initial 

meeting, I was convinced for the first time that I really would be able to get it done. 


Papers 

Another thing that has been extremely helpful to me personally is the mentoring I’ve received 

from our budget office in the Center where I work. Preparing an R01 budget for the first time can 

be intimidating, and our staff are outstanding, rigorous in their review, but also very supportive. I 

feel fortunate as a young investigator to have had their administrative mentoring, and without it, I 

don’t think I would yet have a grant submitted. 

One thing I heard [a Program Officer] from the NIH say over and over again at a recent seminar 

was, ‘No matter how good your science is, you can’t get a grant if you don’t submit one.’ For me, 

getting the grants submitted required that I receive not only one-on-one academic and scientific 

mentoring, but also mentoring from administrators, budget staff, and colleagues who were willing 

to share their knowledge and experience.” - JP 

“I think that the addition of the Mentoring team that consists of administrative representatives of 

the institution who are knowledgeable about pathways to success for junior faculty, and who have 

been selected because of their familiarity and broad view and knowledge of institutional dynamics 

and resources is a wonderful addition to the scholar and the individual mentor. 

As junior faculty writing a K08, my research mentor was involved in my research plan but not 

able/willing/interested in helping with the other components of my grant application. Working 

with [Ms Y] was extremely helpful; she helped me to understand what is expected/appropriate in 

the supporting documentation for this type of grant. Through interactions with grant administrators 

like [Ms Y], I am able to learn how to write a successful grant. I did not have to guess about 

what type/detail of information to include and do not have to “re-invent the wheel” when writing 

the administrative, institutional, and career portions of my K08. With her prior experience in 

reviewing these types of grants, [Ms Y] is able to critically review my grant and help me improve 

and focus my application before submission to the NIH.” - PM 

Survey of Importance of Services Provided by an Office of Research 

Self-administered surveys were sent to investigators that the Office of Research had assisted 

between 2002 and 2005. Services provided for grants were listed and the survey asked investigators 

to rate whether a service was crucial, very important in that it would be difficult to write the 

grant without the service, important because it facilitates grant preparation, or not needed by the 

investigator for grant preparation. The responses were not identified in any way other than having 

the investigators indicate the general type of grant(s) for which they had received assistance. The 

initial response rate was 26%; a reminder was sent and additional responses were obtained for an 

overall response rate of 40%. Thirty of the respondents were faculty who themselves or their mentees 

had applied for a career development award. 

There was a great deal of heterogeneity at the service level and an analysis at the respondent level 

revealed that this heterogeneity occurred even for two investigators who had the identical aggregate 

score (i.e., two investigators might have the same score but one would say a particular service 

was not needed while the other would report it as very important). There was no one service that 

was felt to be needed by every investigator. However, services ranked highly by >75% of investigators 

included providing copies of successful grants, sections on institutional resources, and helping 

them write administrative letters of support with almost 50% rating such services as “crucial”. 

Other mentoring activities rated as crucial by at least 25% of the investigators were planning and 

strategy meetings and grant review. 

These two evaluative efforts illustrate two points: that the perception that a single mentor may not 

be able to satisfy all of the mentee’s needs is likely correct, and that research administrator activities 

to mentor new investigators can help fill these gaps. 


Papers 

Benefits of Working with Junior Faculty to Research Administrators 

The development of relationships between junior faculty and research administrators is mutually 

beneficial. First, it allows the research administrator better insight into and knowledge of the 

research being conducted in the institution, which, for many, is the reason for their career choice. 

Second, it gives administrators a broad perspective on the faculty researching specific areas, which 

allows for improved research “matchmaking” when needed. Third, it allows administrators to 

train junior faculty in developing good habits early on related to grant preparation (e.g., rules of 

research administration and creation of timelines to minimize procrastination and last-minute crises). 

Finally, it results in a collegial relationship between faculty and research administration and 

the satisfaction of watching these young investigators succeed. 

Conclusion 

The success of research institutions relies on ensuring the success of its junior faculty in procuring 

research funding and in becoming independent investigators. Research administrators can play a 

significant role in helping junior faculty attain this goal. Institutions should recognize this valuable 

resource and should provide protected time for administrators to serve as part of a mentoring 

team for junior faculty. 

References 

Andrews M., Wallis M. (1999). Mentorship in nursing: a literature review. Journal of Advanced 

Nursing. 29(1), 201-7. 

Bauchner H. (2002). Mentoring clinical researchers. Archives of Disease in Childhood. 87(1), 82-4. 

Connor M.P., Bynoe A.G., Redfern N., Pokora J., Clarke J. (2000). Developing senior doctors as 

mentors: a form of continuing professional development. Report of an initiative to develop a 

network of senior doctors as mentors: 1994-99. Medical Education. 34(9), 747-53. 

Greggs-McQuilkin D. (2004). Mentoring really matters: motivate and mentor a colleague. 

MEDSURG Nursing. 13(4), 209, 266. 

Institutes of Medicine. (1997). Adviser, teacher, role model, friend: on being a mentor to students 

in science and engineering. Washington, DC: National Academy of Sciences, National 

Academy of Engineering, Institutes of Medicine. 

Kaye B., Jacobson B. (1996). Reframing mentoring. Training & Development. 50(8), 44-8. 

Mason C., Bailey E. (2003). Benefits and pitfalls of mentoring. Retrieved June 2, 2005, from 

Society for Technical Communicators Web Site: www.stc.org/ConfProceed/2003/PDFs/ 

STC50-003.pdf 

Mott V.W. (2002). Emerging perspectives on mentoring: Fostering adult learning and development. 

In C.A. Hansman (Series Ed.), Critical perspectives on mentoring: Trends and issues: 

Information Series No. 338. (pp.5-13). Columbus, OH: ERIC. 

Pololi L.H., Knight S.M., Dennis K., Frankel R.M. (2002). Helping medical school faculty realize 

their dreams: an innovative, collaborative mentoring program. Academic Medicine. 77(5), 

377-84. 

Ramanan R.A., Phillips R.S., Davis R.B., Silen W., Reede J.Y. (2002). Mentoring in medicine: keys 

to satisfaction. American Journal of Medicine. 112(4), 336-41. 


Shea G. (1995). Can a supervisor mentor? Journal of Supervision. 56, 3-5. 

Schrubbe K.F. (2004). Mentorship: a critical component for professional growth and academic 

success. Journal of Dental Education. 68(3), 324-8. 

Tobin M.J. (2004). Mentoring: seven roles and some specifics. American Journal of Respiratory & 

Critical Care Medicine. 170(2), 114-7. 

Waugh J. (2002). Faculty Mentoring Guide: VCU School of Medicine. Richmond, VA: VCU 

Werner W. (2004). The importance of mentoring. Law Practice Today. 

Papers 


Papers 

Human Subjects Research and Protections: A Brief History 

Elsa G. Nadler, EdD, Department of Community Medicine, 

West Virginia University School of Medicine 

1 Medical Center Drive, PO Box 9190 

Morgantown, WV 26506-9190 

304.293.3546; enadler@hsc.wvu.edu 

Author’s Note: The author thanks Alan M. Ducatman, Chair of the WVU Department of Community 

Medicine, for his insightful comments and suggestions that greatly improved the original 

version. This paper is essentially a review of print and electronic sources and does not represent 

original research. 

Abstract: The Nuremberg Code is nearly sixty years old. The National Research Act (Pub. L. 93- 

348), which created the National Commission for the Protection of Human Subjects of Biomedical 

and Behavioral Research, is now thirty. Most of us take for granted the existence of Institutional 

Review Boards, consent forms, and protocols without giving much consideration to the principles 

underlying those requirements or the history behind them. This paper will explore the history of 

research with human subjects in advancing medical and social knowledge and will examine the 

development of laws and restrictions pertaining to that research. Many are familiar with the Hippocratic 

Oath and the stricture that physicians should do no harm. However, many are not equally 

familiar with the history of research on children, ancient Jewish and Islamic medical laws, and 

Russian and German regulations both before and during World War II. The National Institutes 

of Health requirement for human research ethics education and training is one attempt to make 

researchers aware of potential problem areas. An understanding of how human subject issues have 

changed over the centuries will enhance efforts to sensitize researchers to the specialized concerns 

of research with humans now and into the future. 

Introduction and Generalities 

The Nuremberg Code has been called “perhaps the most influential document in bioethics” (Kious, 

2001). But it is not the first document whose intent was to protect the safety and health of 

humans used in medical experiments, nor is it the first document to express concern about ethical 

aspects of research with human subjects. While much current research is conducted on attitudes 

and practices in many non-medical fields (agriculture, public administration, education, history, 

to name a few), the origins of human subjects research are to be found in medicine. Medicine is 

the natural home of substantial human subject dilemmas and errors of clinical judgment. This 

paper is not intended to offer solutions or provide prescriptions for the future of human subject research. 

However, an understanding of the past contributes to understanding present practice and 

can lead us into the future with greater appreciation of the origins and limitations of our attitudes 

and actions. As Santayana said, “Those who do not know the past are doomed to repeat it.” 

Disease and pain are universal human conditions. From the beginning of human existence, people 

have tried to cure disease and alleviate pain. The archaeological record indicates clearly that early 

peoples had a cornucopia of herbal remedies, often coupled with ritual, magic, religion and mysticism, 

as well as primitive surgical techniques (von Engelhardt, 2004). Skulls in the archaeological 

record from several cultures show evidence of early trepanation and long bones show evidence of 

primitive surgical intervention following a break. The Code of Hammurabi (ca. 1700 B.C.E.) lists 

surgical fees and penalties for a failed surgical procedure. Observant early Egyptians categorized 

diseases according to parts of the body. Von Engelhardt notes that early Greek and Roman sources 

stressed public health and health maintenance. Medical treatments were designed to heal injuries 

and improve an individual’s health status. It is natural to ask how and when diagnostic processes 

and medical treatments were developed. At what point did practicing physicians, who were the 


Papers 

early medical researchers (even if they did not recognize their work as research), recognize that 

their work was experimental research and begin to consider ethics? The archaeological record cannot, 

of course, answer this question. Written records going back to the fifth century B.C.E, however, 

can provide some insight into both practice and ethics. 

Medical ethics has been an essential element of physician-patient relationships for at least two 

millennia. Hippocrates (5th century B.C.E.), known to us today as the father of medicine, was 

concerned with the physician’s behavior and his treatment of the patient. His “first do no harm” 

has become a standard dictate and the basis for all subsequent ethical and legal considerations. 

Plato was likely the first to put considerations of ethics of the patient into writing. For Plato and 

then Aristotle (4th century B.C.E.), medicine and philosophy were paired, and the connection was 

ethics (Wildes, 2002). 

In his capacity as physician to gladiators, Galen (2nd century B.C.E.) developed treatments for 

broken bones (for example, traction), suturing methods, and surgical instruments. He viewed 

health as a harmony and correct relationship between elements of the body; disease was a disproportionate 

mix. His theories were adhered to through the Renaissance and into the seventeenth 

century. It is this mechanistic view of health (overlaid with religious viewpoints) that formed the 

relationship of physician and patient as well as medical treatments themselves through the eighteenth 

century. 

Jewish and Islamic medieval scholars and physicians (tenth through thirteenth centuries) wrote 

treatises on proper conduct and the ethical treatment of patients, largely basing their commentary 

on Hippocrates and Galen. According to these treatises, the professional needed to study the great 

men of the past (doing the right thing meant emulating the ancients) and have a store of knowledge 

from many disciplines at his fingertips. Of particular note, perhaps, is the medieval whine 

that may reflect the sad state of current affairs. At least one Islamic physician advocated explaining 

to patients only as much as they could understand, (Chipman, 2002); a paternalistic attitude that 

still has followers in the 21st century. 

The Renaissance artist Andreas Vesaluis (1514-1564) is worthy of special notice. Called the “father 

of anatomy,” Vesalius created detailed paintings of human anatomy, all drawn from human cadavers. 

Michelangelo (1475-1564) and da Vinci (1452-1519), studied anatomy using mostly executed 

criminals, even though the Church at the time prohibited human dissection (through misinterpretation 

of a bull promulgated by Pope Boniface VIII in 1300 that forbade cutting up bodies and 

boiling them to separate flesh from bone prior to transporting the deceased to his home country). 

These artists were, in essence, doing research, even though they did not call it such. They were 

greatly expanding knowledge of human anatomy and beginning the work that would eventually 

replace the 1500-year-old medical texts in use at the time. 

Until quite recently, medical advances and discoveries required direct experimentation on human 

patients, cadavers, or animals that did not necessarily replicate the human body and organs 

and were very imperfect models. The prohibition of human dissection was also the case in ancient 

Greece and Rome because it was considered disrespectful, which is why Aristotle’s anatomies were 

inaccurate—he had only animals to dissect. Stark is of the opinion that “Christian theology was essential 

for the rise of science” because it posited the separation of soul and physical body and that 

possession of a soul was unique to humans. Thus, when a person died, the physical remains were 

only a shell and so “dissection of the human body had no theological implications.” (Stark, 2004) 

The Enlightenment, however, saw the beginnings of a true medical science and the joining of 

clinic and laboratory (Wildes, 2002). With increasing scientific and technological developments 

and successes, medicine came to be viewed as curative. Before this time, medicine itself was largely 


Papers 

observational and could do very little to really help patients. Now, however, medical science had 

created situations requiring decision making. The patient becomes more involved; and medical 

ethics, rather than focusing on the physician’s thoughts and actions, now must focus on the 

patient’s wishes. Let us note that before the era of scientific research, medical ethics was really 

healthcare ethics, which is quite distinct from research ethics; although, as we shall see, the distinction 

easily becomes blurred. 

Early Human Subjects Research 

Possibly the first documented experiment with human subjects appears in the Book of Daniel 

(1:3-15). In this chapter, whose historical setting is about 650 B.C.E., Daniel and his friends are 

prisoners of Nebuchadnezzar, who wants to educate them to become advisors and orders a court 

official to provide fare from his table: “8 Daniel resolved not to defile himself with the king’s food 

or the wine he drank, so he sought permission of the chief officer not to defile himself.” The official 

is worried the king will have his head, but he is kind and he and Daniel strike a deal: “12 ‘Please 

test your servants for ten days, giving us legumes to eat and water to drink. 13 Then compare our 

appearance with that of the youths who eat of the king’s food, and do with your servants as you see 

fit.’ 14 He agreed to this plan of theirs, and tested them for ten days. 15 When the ten days were 

over, they looked better and healthier than all the youths who were eating of the king’s food” (JPS 

translation, 1985). 

In the 3rd century B.C.E. the Alexandrian physicians, Herophilus of Chalcedon and Erasistratus, 

performed systematic dissections of human cadavers and experimental vivisection on criminals. 

Herophilus and Erasistratus accurately described the heart and heart valves, the liver, the female 

reproductive organs, the eye, and the vascular system, among other discoveries. The Greek cultural 

taboo against cutting the body effectively prohibited further such practices. Von Staden 

offers a thorough explanation of how Greek concepts of death and pollution (extending even to 

the house), skin, and cutting prevented medical experimentation. He suggests that the unique 

confluence of Ptolemaic tyrants who offered generous patronage to intellectuals, Greek Stoicism 

that placed the dead body into an “indifferent” moral category, and Aristotle’s rather crass attitude 

concerning the human corpse combined to allow, for a brief period, contravention of traditional 

Greek beliefs and practices. Systematic dissection would not occur again until the development of 

early schools of medicine in the 12th and 13th centuries (von Staden, 1992). 

The Babylonian Talmud (Niddah (30b)), begun about the year 550, reports what may be an 

apocryphal story about Cleopatra, to settle an argument between two rabbis about the amount of 

time it takes for a male and a female fetus to fully develop. Supposedly, Cleopatra had slave girls 

impregnated, operated on at specified times, and killed to examine the development of the fetuses. 

She was told that boys did indeed develop in the 40 days and girls took the full 80 days. Is this the 

first instance of manipulating data to suit the sponsor? 

Human experiments are mentioned at least two other times in the Talmud. In one instance, students 

dissected a condemned prostitute to determine the number of joints in a human body (Berachot 

(45)). In another instance, a rabbi used two handmaids to determine the validity of a test 

for virginity (Ketubot (10b)). Interestingly enough, in the virginity experiment, which required 

the test subject to sit on an open cask of wine, the rabbi did not think it appropriate to experiment 

with Jewish women and so used non-Jewish handmaidens for the test. 

The Talmud does not comment on the propriety of using these data to settle an argument. Nor 

does it comment on the ethics of using people in experiments. Later commentaries (responsa) do 

comment on human subject research and informed consent as well as on the ethics of using what 

might be “tainted” data (in particular, data resulting from Nazi experiments). 


Papers 

Galen experimented on his patients (mostly gladiators, who were essentially slaves) in the course 

of treating them to repair injuries. Galen was a Persian dentist, physician, and inventor who designed 

many medical and dental instruments that have changed little over the centuries. Several 

centuries later, physicians conducting research have frequently used patients, children, the elderly, 

prisoners and the mentally ill. These populations were considered available, if not expendable. 

Later physicians began to question the ethics of experimenting with these populations, but as 

Saunders noted, “In the setting of high mortality and morbidity from infectious diseases, some experiments 

with children subjects provided an alternative to an otherwise lethal infection, notably 

Jenner’s smallpox vaccination and Pasteur’s rabies vaccine. Successful development of an antitoxin 

for the treatment of diphtheria can be credited to the testing of children in Paris orphanages at 

the turn of the 19th century. However, the history of children as subjects in human experimentation 

is also clouded with research failures and exploitation, particularly involving non-therapeutic 

research,” (Saunders, 1996). It was not until the Helsinki Declaration that an ethical method was 

created for the research with children.. 

One of the first “modern” instances of documented research with a human subject was Edward 

Jenner’s 1796 smallpox experiment on James Phipps, an eight-year-old boy. The practice of inoculation 

had been brought to England by Mary Wortley Montagu (1689-1762), wife of the British 

ambassador to Turkey in the second decade of the eighteenth century. A letter to a friend in 1717 

outlined the inoculation against smallpox common in Turkey at the time. The problem with this 

method (called “engrafting” at the time), which introduces the live and unattenuated smallpox 

virus directly into an open sore, was that some patients contracted the full-blown smallpox and 

many subsequently died (Internet Modern History Sourcebook. Retrieved March 26, 2005 from 

http://www.fordham.edu/halsall/mod/montagu-smallpox.html). 

During a smallpox epidemic in 1796, Edward Jenner’s careful observations and clinical documentation 

led him to conclude that those who had already contracted cowpox (a mild version of 

smallpox that affects the teats of cows and the hands of milkers) did not even get mild symptoms 

of smallpox. Jenner, knowing of the engrafting procedure, used it to vaccinate (from vacca, cow) 

Phipps, who then developed the mild symptoms of cowpox. Three months later, Jenner challenged 

the boy with smallpox. (Note: Pasteur adopted the terms vaccine and vaccination to honor Jenner.) 

Subsequent to this experiment, Jenner inoculated his own son. His colleague in the United States, 

Benjamin Waterhouse, also used his own children as subjects. 

Horace Wells, a dentist, first used nitrous oxide to anesthetize himself to have a wisdom tooth 

extracted in 1844. He subsequently experimented on 12 patients, using the gas for tooth extractions. 

He began experimenting with chloroform and ether, became addicted to chloroform, and 

ultimately committed suicide. 

Between 1845 and 1849, J. Marion Sims conducted a series of experiments on slave women, supposedly 

without getting their consent (Sartin, 2004). Sims has been called the “father of gynecology,” 

yet some have excoriated his experiments and his practice. He devised a crude speculum to 

examine women and experimented with surgical methods of repairing vesicovaginal fistulas. He 

finally succeeded in repairing the fistula of one slave on the thirtieth attempt. Sims documented 

his experiments in the Journal of the American Medical Sciences in 1852. It is noteworthy that 

Sims was brought before the New York Academy of Medicine on ethics charges of using paid advertising 

and revealing patient secrets (Sartin, 2004). There was not, at the time, any castigation of 

his practice of using slaves and poor Irish immigrants in his studies and experimental surgeries. 

At about the same time, physicians in France were inoculating patients in hospitals to determine if 

secondary syphilis pustules were contagious and debating the ethical nature of these experiments. 

Permission to test the contagion theory on prostitutes had been denied in 1852, but later permit- 


Papers 

ted on patients at l’Hopital St.-Louis in 1859 (Dracobly, 2003). 

Louis Pasteur is perhaps more renowned for his discovery of the process of pasteurization, anaerobic 

life, the process of fermentation, and development of the scientific method. He also discovered 

a method to attenuate virulent microorganisms. In 1885, he successfully inoculated a nine-year 

old boy named Joseph Meister, who was bitten multiple times by a rabid dog, with rabies vaccine 

and in so doing, saved his life. He also developed treatments for chicken cholera and anthrax in 

cattle. 

Some of the above research continues to be controversial, as is the use of data collected from them. 

Significantly, research that was instrumental in developing successful treatments for a human 

disease has received little adverse press. 

Human Subjects Protections 

Pre-World War II 

So far there has been little distinction between medical ethics and research ethics. It is a fine line, 

one profiled in Bernard’s comment about hospitals as the place where physicians (and researchers) 

make their observations. As mentioned earlier, medical advances (especially before the early days 

of the scientific revolution in the late eighteenth century) depended on observations of human 

diseases and experiments with patients. Evans and Beck note that each generation views life—and 

medicine and research—through a different lens. What is commonplace in one century is frequently 

decadent, indecent, or immoral in another. It is also worth noting that many experiments 

were and remain controversial. 

The distinction between therapeutic and nontherapeutic research merits distinction. Even though 

they used children and slaves, Jenner, Pasteur, and Sims were conducting therapeutic research; 

Cleopatra and Hansen were not. In therapeutic research, the patient might realistically benefit 

from the experimental intervention. Prior to World War II, nontherapeutic research was not extensive 

and there was consequently little concern over the ethical aspects of research with humans. 

It is important to recognize that social and behavioral research was essentially nonexistent until 

the middle years of the nineteenth century. Thus human subject research almost always dealt with 

treating an injury or a disease. 

Although early research with humans was almost invariably clinical in nature, Davies suggests that 

Mary Shelley’s Frankenstein is an early research ethics text. He contends that Shelley was familiar 

with electricity experiments and wrote the novel for its shock value. In her narrative, however, she 

discusses how the scientist can become so thrilled with his work, so caught up by the science, so 

excited by success, that he loses his moral perspective. Davies notes that future ethicists have “recognized 

that the researcher’s ethical standards are probably the research subject’s most important 

protection against harm.” 

The basic principles of the Belmont Report are, according to Aksoy and Tenik, embodied in the 

work of a thirteenth century Sufi scholar named Mawlana Jalaladdin Rumi (1207-1253). His writings 

discuss the ways to a more harmonious life: autonomy, beneficence, non-maleficence, and 

justice. Although Mawlana’s attention is not directed at research (or by extension human subjects 

of medical experimentation), his writings presage the universal concerns of modern bioethical 

concerns. 

The earliest “modern” comment specifically about research ethics appears in Wilcock’s 1830 Laws 

Relating to the Medical Profession: “When an experiment is performed with the consent of the 

party subjected to it after he has been informed that it is an experiment, the practitioner is answer- 


Papers 

able neither in damages nor on an original proceeding. But if the practitioner performs his experiment 

without giving such information and obtaining consent he is liable to compensate in damages 

any injury,” (Lock 1995). Lock calls this statement “surprisingly perceptive about the need 

for informed consent.” A second instance of consent occurred when physician William Beaumont 

wanted to conduct experiments on Alexis St Martin, in whom a gunshot wound had created a 

gastric fistula. Beaumont and the patient agreed on a contract in which St Martin could withdraw 

if he was “distressed or dissatisfied,” thereby codifying two of the primary criteria for the subject to 

continue or discontinue with the research project (Lock, 1995). 

Max Simon wrote a medical monograph in 1845 in which he noted that experimentation was 

necessary to advance science, but under no circumstances could a physician “sacrifice the interests 

of the individual to those of society” or to “scientific speculation.” He did grant that certain experiments 

were permissible for diagnosis or clarification as long as they posed no threat to the patient. 

A physician at the Val-de-Grace military hospital echoed this sentiment when he wrote about 

syphilis experiments: “Up to what point does morality allow such experiments, since they can have 

such disastrous consequences for those who undergo them?” and broaches the topic of consent: 

“Would it not still be necessary to warn the person who submits to such an experiment that he 

is taking serious risks?” Ricord, a French physician interested in determining whether secondary 

syphilis was contagious, replied that experimental inoculation was therapeutic and beneficial. 

The whole issue became public when a Paris newspaper printed a front-page editorial condemning 

“these experiments (which) offend the moral instincts when performed on humans. … Never 

does the medical ministry call for transforming a human into an experimental subject” (Dracobly, 

2003). 

Claude Bernard (1813-1878) was a French physician, physiologist, teacher, and researcher who 

was forthright in his belief in the necessity of experimental research and in the absolute prohibition 

of doing harm. He considered the “hospital the antechamber of medicine, it is the first place 

where the physician makes his observations. But the laboratory is the temple of the science of 

medicine.” Although known for his opinion that doctors and scientists are ethically bound to do 

experiments in order to advance medicine, Bernard stated in his 1865 treatise (An Introduction to 

the Study of Experimental Medicine), “Among the experiments that may be tried on man, those 

that can only harm are forbidden, those that are innocent are permissible, and those that may do 

good are obligatory.... If it is immoral, then, to make an experiment on man when it is dangerous 

to him, even though the result may be useful to others, it is essentially moral to make experiments 

on an animal, even though painful and dangerous to him, if they may be useful to man.” This succinct 

statement presages some of the major ethical concerns that were ultimately codified in the 

Nuremberg Code: harm, benefit, animal experimentation. 

Interestingly enough, John Harris, professor of bioethics at the Institute of Medicine, Law, and 

Bioethics at the University of Manchester, England, comments in a recent article that research is 

under attack and urges his readers: “We should not, however, forget the powerful obligation there 

is to undertake, support, and participate in scientific research, particularly biomedical research, 

and the powerful moral imperative that underpins these obligations.” He reprises Bernard’s refrain 

of the moral obligation to conduct research but then shifts emphasis and responsibility from the 

researcher to the participant. He contends that it is our moral duty to participate as subjects in scientific 

research, that doing so is the “duty of beneficence, our basic moral obligation to help other 

people in need.” 

Armauer Hansen, after extensive studies, discovered in 1874 (to 1879, depending on which document 

you read) that leprosy was caused by a bacterium. Because the bacillus would not grow 

in laboratory mice, Hansen inoculated leprous material into nurses and patients, one of whom 

brought charges. Hansen provided no explanation nor did he obtain consent from his subjects. 


Papers 

The pastor of the Bergen hospital complained to the authorities who eventually held a criminal 

hearing and found Hansen “guilty of trespass against a patient, ordering him to forfeit his hospital 

post and to pay costs,” (Lock 1995). Of course, there is a bit more to this story than outlined here, 

but this is nevertheless an example of what is possibly the first expression of true public (rather 

than professional practitioner’s) concern for humans who are research subjects—a concern that 

would ultimately lead to the federal regulations we follow today. 

The issue of patient consent received attention from the Prussian government at the turn of the 

nineteenth century. In 1891, prisoners could not be treated with tuberculin for tuberculosis 

without their consent. A few years later (1898), Dr. Albert Neisser, a professor of dermatology and 

venereology at the University of Breslau, failed to obtain consent from prostitutes admitted to the 

hospital for other ailments for experiments with a syphilis vaccination.. The Royal Disciplinary 

Court fined Neisser for failing to obtain consent from the women. (Vollmann and Winau, 1996) 

This incident contributed directly to the Minister for Religious, Educational and Medical Affairs’ 

1900 directive that patients in clinics and hospitals receive “proper explanation of the possible 

negative consequences” and give “unambiguous consent” for any medical intervention that was 

not specifically for diagnosis, treatment or immunization (Evans and Beck 2002). This was the first 

regulation to deal with nontherapeutic research on living humans (Vollmann and Winau, 1996). 

In Russia at the same time, Dr. D. V. Dmitriev created a comprehensive informed consent document 

for a volunteer donating a portion of his thyroid for transplantation. This document has all 

the elements required today: explanation, risks, benefit, voluntariness, cost, procedures. It was evidently 

commonplace for individuals to sell body parts and tissue for transplantation and experimentation. 

Kubar comments that Dmitriev’s statement indicates that the issue of clear explanation 

of procedures and their consequences had been raised in Russia and also that medical experiments 

were considered in the context of criminal and civil law. Other issues of human experimentation 

were considered under public morality. 

First in the U.S. and then in England in 1907, William Osler advocated what we now call informed 

consent and was of the opinion that any experiments with possible “ill-result” was “always immoral 

without a definite specific statement from the individual himself, with a full knowledge of 

the circumstance,.” (Evans and Beck, 2002). 

Russia required patient consent for surgery by a law passed in December 1924. Taking its lead 

from this statute, in 1936 the Scientific Medical Council of the People’s Commissariat of Health 

Care of the RSFSR adopted regulations governing the development of new drugs and procedures 

with human research subjects. This was the first law regulating biomedical research in Russia. 

Although it did consider several concerns present in modern regulations (risk, harm, consent and 

assent, prior animal studies), it did not encompass the idea of independent ethics boards (Kubar, 

2001). 

The Health Department of the German Reich, in 1931, passed a regulation prohibiting experiments 

with humans unless thorough animal tests had been completed and unless the human 

subjects had given “clear and undebatable” consent. Vollman and Winau note particularly that this 

regulation was based on the principles of beneficence, nonmaleficence, patient autonomy, and a legal 

doctrine of informed consent. Moreover, it made specific distinction between therapeutic and 

nontherapeutic research. This regulation remained in effect throughout World War II, although 

the German definition of “human” underwent a change. Ironically, almost concurrently, a 1933 

Reich law prohibited the use of animals for medical experimentation. 


Papers 

Post-World War II 

As of 2001, according to Kubar, there were in excess of 250 guidelines, declarations, codes and other 

documents concerning bioethics. Between 1947 and 1998, 17 European countries and 15 Latin 

American countries adopted more than 74 codes or guidelines concerning medical ethics. These 

are clearly outgrowths of the Nuremberg Trials and the medical experiments those trials exposed. 

Knowledge of experiments conducted by Nazi doctors on children, the mentally or physically 

handicapped, the elderly, and inmates of concentration camps caused horror and revulsion around 

the world. As a result of these atrocities and the Nuremberg trials, at which 23 Nazi doctors were 

tried for their medical experiments on concentration camp victims, the American doctors who 

had presided at the trials developed a ten-point code in 1947. The first, most basic and most discussed 

tenet of the code requires explicit consent from human subjects prior to participation. Risk 

and benefit are the subjects of the other nine items in the document. The Nuremberg Code is the 

basis for a majority of the subsequent ethical guidelines. 

Kious notes that, even with imperfections, this code provided guidelines where nothing had previously 

existed, certainly there was no international consensus on the ethics of human experimentation. 

But other issues require comment. Some populations that cannot give legal informed consent 

are unique and have research needs that can only be studied in individuals belonging to that 

group (children, the emotionally or psychologically impaired, the elderly). This code also requires 

experiments with significant risk (“death or disabling injury”) to be first tried on the experimenter. 

The requirement for animal experiments cannot work for conditions that have no animal model. 

Kious also points out that this code does not provide a definition of human experimentation, nor 

does it address the difference between therapeutic and nontherapeutic research. 

Evans and Beck note that this code had little impact at the time. In fact, most American and British 

researchers were of the opinion that it was not necessary, that the high motives and responsible 

nature of researchers obviated the need for such safeguards. The possibility of Nazi-type experiments 

occurring in a civilized society was dismissed out of hand. In 1953 the British Medical Research 

Council was the first to promulgate a statement on medical research ethics. This memorandum 

called for a signed informed consent statement and an oversight body to guide researchers. 

Parliament engaged the issue in 1955 after an experiment on the effects of two different penicillin 

concentrations in infants was performed without parental consent. Nothing came of the Parliamentary 

debate as the ministers did not consider it their duty to interfere with professionals in the 

conduct of their responsibilities (Evans and Beck, 2002). 

Russia conducted its own version of the Nuremberg Trials in 1949 in Khabarovsk in which members 

of the Japanese military were indicted for “criminal and inhuman experimentation on live 

human beings, participated in the villainous killing of people by conducting cruel experiments on 

them, and were developing biological weapons for the mass destruction of peaceful populations” 

(Kubar, 2001). 

Public discussion on ethical standards occurred in Great Britain in 1964, concerned largely with 

treatments of direct benefit to the patient and procedures having no direct benefit to the subject. 

The use of controlled clinical trials also came in for comment, with general agreement that if the 

trial included two procedures, participants should be asked for their “cooperation.” It was also 

agreed that true consent was necessary if an experiment involved procedures of no direct benefit 

to the participants. Physician researchers, however, still resisted the concept of informed consent. 

The Royal college of Physicians published a 1967 report that questioned the advisability of giving 

patients a complete explanation of the experiment or even asking their consent. Physicians in the 

United States (in a 1975 report from the Department of Health and Social Security), clearly felt 

that requiring informed consent of everyone would hinder or prevent research and thought that 


Papers 

it was at any rate an impossibility. However, the report echoed Bernard’s stricture that researchers 

are morally prohibited from performing experiments that could be harmful to the subject, even if 

the results could benefit others. 

The Declaration of Helsinki (1964) was an attempt to overcome some of the shortcomings of the 

Nuremberg Code and extend human subjects protections. It was the first attempt by the international 

medical community to regulate itself. Unlike the Nuremberg Code, the declaration makes 

a distinction between therapeutic and nontherapeutic research and was likely a response to the 

growing pharmaceutical industry and drug testing. In its original draft form the declaration prohibited 

research on vulnerable populations (children, prisoners, the elderly, the mentally handicapped, 

students and employees). The Helsinki representatives were divided on the use of children 

and prisoners—institutionalized children and prisoners had been a continuing source of experimental 

subjects in the U.S.— the document ultimately omitted all mention of children and prisoners. 

The most controversial condition concerns the use of placebos—some interpretations allow 

the use of placebos while others insist that a placebo should never be used if effective therapy for 

the condition exists. The declaration has been revised five times, most recently in October 2000. 

The National Institutes of Health created the Office of Protection from Research Risks (OPRR) in 

1966. The guidelines set out by OPRR called for independent review bodies, later called Institutional 

Review Boards (IRBs). 

These review bodies have become an established element in higher education and are required for 

an institution to be eligible to receive federal funding. IRBs effectively control the use of humans 

in research of any nature. 

France passed “la Loi Huriet” (the Huriet Law) in December 1988 explicitly for the protection 

of healthy human research subjects. This legislation had its origins in the development of pharmaceuticals 

for worldwide distribution and the medical community’s concerns for the safety of 

human test subjects and the safety and efficacy of the drugs themselves. The law makes a clear 

distinction between clinical and nonclinical research, between care of patient and research, and 

emphasizes individual benevolence while acknowledging the essentially emergent nature of ethical 

norms (Lechopier 2004). 

After the Tuskegee syphilis study finally received public attention and notoriety, Congress reacted 

by passing the National Research Act (Pub. L. 93-348) in 1974. This act created the National 

Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which 

subsequently composed the Belmont Report (April 18, 1979). Recognizing the prescriptive rules 

“are inadequate to cover complex situations; at times they come into conflict, and they are frequently 

difficult to interpret or apply,” it collapsed the Nuremberg Code and the Declaration of 

Helsinki into a set of three basic principles that “are particularly relevant to the ethics of research 

involving human subjects: the principles of respect of persons, beneficence and justice.” It is the 

first document to make a distinction between biomedical and behavioral research and takes into 

consideration “risks of psychological harm, physical harm, legal harm, social harm and economic 

harm and the corresponding benefits.” The third section of the report lists applications of the three 

basic principles and extends definitions to practice. 

International biomedical research has come under increased scrutiny in the past few decades. In 

1993 the Council for International Organizations of Medical Sciences (CIOMS) published guidelines 

“designed to be of use to countries in defining national policies on the ethics of biomedical 

research involving human subjects, applying ethical standards in local circumstances, and establishing 

or improving ethical review mechanisms. A particular aim is to reflect the conditions 

and the needs of low-resource countries, and the implications for multinational or transnational 

research in which they may be partners.” The 2002 revision addressed concerns over genetic and 


commercial research and research in developing countries. 

Papers 

With the passage of time, the federal regulations continue to be tweaked, often in response to 

specific ethical issues. The office originally established to oversee human research, the Office of 

Protection from Research Risks in the National Institutes of Health, became the Office of Human 

Research Protection in June 2000. It moved administratively to report directly to the Director 

of Health and Human Services. Most recently, on 25 March 2005, the Department of Heath 

and Human Services (DHHS) published in the Federal Register a request for public comment on 

the proposed five steps to ensure equivalent protections to the 45 CFR 46 guidelines for research 

conducted in foreign countries: (1) articulate the specific protections of 45 CFR 46 subpart A, (2) 

assess protections provided by the institution’s procedures, (3) compare the protections provided 

by the institution’s procedures and determine if they are “at least equivalent” to U.S. protections, 

(4) approve substitution of the foreign institution’s procedures for those of 45 CFR 46, (5) assure 

that substituted procedures will be followed (from institution). 

Some Post-World War II Transgressions 

Despite the publicity of the Nuremberg Trials and the promulgation of many ethical codes and 

guidelines, questionable and unethical practices continue to occur. Because scientific advances 

bring new issues in their wake, it is unlikely that the need for evolving ethical standards will ever 

cease. 

The long-term study of black males conducted at Tuskegee by the United States Public Health 

Service began in the 1930s as an examination of the natural history of untreated syphilis and 

continued until 1972 when it came to public attention. More than 400 black men with syphilis participated, 

and about 200 men without syphilis served as controls. The men were recruited without 

informed consent; additionally, they were persuaded that some research procedures (e.g., spinal 

taps) were actually “special free treatment.” In the 1940s, penicillin was found to be effective in the 

treatment of syphilis; but the study was not halted, nor were the men informed or treated with the 

antibiotic. 

Between 1953 and 1957 eleven patients at Massachusetts General Hospital were injected with 

uranium to see if the substance would localize in malignant brain tumors. None of the patients 

were informed of the study procedures or goals. Even though all of the subjects were terminally 

ill and some comatose, the U.S. Department of Energy report states: “That people are not likely to 

live long enough to be harmed does not justify failing to respect them as people.” Even though the 

researchers entertained a naïve hope for a cure, they sidestepped the basic dictate of respect for 

persons and the need for informed consent. 

In 1963, at New York’s Jewish Chronic Disease Hospital, patients hospitalized with various debilitating 

diseases were injected with live cancer cells to study the body’s ability to reject cancer cells. 

Previous studies had indicated that healthy persons reject cancer cells promptly. The researchers 

allegedly believed that the debilitated patients would also reject the cancers but at a substantially 

slower rate when compared to healthy participants. Consent had been given orally, but did not 

include a discussion on the injection of cancer cells. 

From 1963 through 1966, children admitted to the Willowbrook State School in New York for 

“mentally defective” children were infected with the hepatitis virus. Researchers rationalized their 

actions by stating that “the vast majority of them would acquire the infection anyway while at Willowbrook, 

given the crowded and unsanitary conditions, and because only children whose parents 

had given consent were included.” Because of crowding, the school was closed to new students; 

but in a clear case of coercion, those children whose parents consented to the study were allowed 

admittance to the space occupied by the hepatitis study. 


Papers 

The Environmental Protection Agency recently halted a Florida study of the effect of pesticides 

on children under the age of 12 months (Kirkpatrick 2005). Partially sponsored by the American 

Chemistry Council, the study received a great deal of press and a large level of misrepresentation. 

The New York Times was correct in saying that the study represents a conflict of interest: it is 

generally unacceptable for an organization to sponsor research on a topic in which it has a vested 

interest. 

A host of other transgressions exist, but without independent and disinterested and dispassionate 

corroboration, I will not enumerate them here. For the curious reader, please see the Sharav Web 

page. (Sharav VH. Human Experiments: A chronology of human research. Alliance for Human 

Research Protection. http://www.researchprotection.org/history/chronology.html.Accessed 22 

October 2004.) 

The following two tables provide an overview of the history of research with humans and a timeline 

of the protections for human subjects. 

Table I: Timeline of Use of Human Subjects 

Date Researcher/Sponsor Topic 

650 B.C.E. Daniel Nutrition 

200 B.C.E. Herophilus of Chalcedon Human anatomy 

48 B.C.E. Cleopatra Male and female gestation 

200 C.E. Galen Surgery/orthopedics 

500 C.E. (?) Israeli medical students Number of joints in body 

500 C.E. (?) Rabban Gamaliel Test for virginity 

15th-16th centuries Renaissance artists Human anatomy 

1796 Edward Jenner Smallpox 

1822 William Beaumont Digestion 

1844 Horace Wells Anesthetics 

1845-59 J. Marion Sims Gynecological surgery 

1859 Camille Gibert Contagiousness of syphilis 

1874 Armauer Hansen Contagiousness of leprosy 

1885 Pasteur Rabies treatment 

1900 Walter Reed Yellow fever 

1930s US Public Health Service Tuskegee syphilis study 

1941-44 Nazi physicians Various topics 

1953 US Department of Energy Mass General uranium study 

1963 Willowbrook State Mental Hospital Hepatitis 

1963 Stanley Milgram Obedience to authority 


Table II: Timeline of Human Subjects Protections 

Date Person, Organization or Country Ethical Concept or Topic 

400 B.C.E. Hippocrates (Greece) Beneficence 

1207-53 Mawlani Rumi (Persia) Autonomy, beneficence, justice 

1830 John Wilcock (Australia) Laws Relating to the Medical Profession 

1822 William Beaumont (United States) Informed consent 

1845 Max Simon (France) Risk 

1891 Prussian government Protection of prisoners 

1898 Royal Disciplinary Court of Germany Informed consent 

1900 German Minister for Religious, Educational 

and Medical Affairs 

Informed consent 

1900 D. V. Dmitriev (Russia) Informed consent 

1907 William Osler (United States and 

England) 

Informed consent 

1924 Russian law Regulation of new drugs and procedures 

1931 German Reich Experiments on humans prohibited 

1933 German Reich Animal experimentation prohibited 

1947 Nuremberg Code (international) General guidelines 

1953 British Medical Research Council Statement on research ethics 

1964 Great Britain Nontherapeutic research, clinical trials, 

informed consent 

1964 Declaration of Helsinki (international) Autonomy, beneficence, justice 

1966 OPRR formed by NIH (United States) Respect for persons, beneficence, justice 

1974 National Research Act (United 

States)—Belmont Report 

Respect for persons, beneficence, justice 

1988 France: La Loi Huriet Clinical trials, autonomy 

1993 Council for International Organizations 

of Medical Sciences 

2000 Office of Human Research Protection 

replaces OPRR 

Autonomy, beneficence, justice 

Papers 

Respect for persons, beneficence, justice 

Conclusion 

Belkin comments that it is easier to set out rules governing what is ethical or unethical than to 

define what it is. We must ask if increasing particular formulation and regulation will solve our 

ethical problems and dilemmas. Perhaps we should turn our focus to analyzing how to develop appropriate 

and ethical decision making. It is thus necessary to lay the groundwork and give everyone 

the tools necessary to make decisions. In some way, Belkin seems to suggest, we have failed to 

understand that “ethics” involves real people in real situations, that it is not an abstract construct 

that can be regulated from afar. He recommends what he calls a “medical humanism” by “deepening 

and enriching the self-understanding and perspective brought to bear when people confront 

choices and each other.” 

Another issue we might consider is the role of curiosity and the desire for forbidden knowledge, 

which engenders a tension between the search for knowledge and the ability (or inability) to 

handle that knowledge. Guinan notes that this has been a recurring theme: Adam and Eve and the 

fruit of the tree of knowledge, Lot’s wife’s “need” to see the destruction of her home, Icarus’s testing 


Papers 

of the restriction on the height of his flight, Pandora and her box of mysteries, Dr. Frankenstein 

and his creation. He suggests that researchers should hold in abeyance seeking knowledge we do 

not have the skills to handle, but “given human experience… humans will, given the choice, seek 

the forbidden fruit.” 

But we seek new knowledge, and, for the most part, it is done with honesty, compassion, consideration 

and humility. Of the hundreds of research studies undertaken each year, a limited number of 

reprimands are handed out and even fewer studies closed for noncompliance with federal regulations. 

At one state university, an average of about 300-400 full or expedited protocols are submitted 

and 1,300 open in any given year (the number of exemption applications is much higher). 

During the past 15 years, fewer than five studies have been closed and 10-15 suspended for 

noncompliance with federal and institutional regulations. High-profile cases cause public outcry, 

contaminate public trust in human subjects research, and generally cause more specific regulations 

and stricter guidelines. (This is also true of biomedical laboratory research when misconduct creates 

public distrust in science.) 

Since people are not perfect, and laws, guidelines and regulations are made by people, we will 

always find the need to adjust and modify. Let us go forward with the knowledge that we can improve 

the way we manage our work. Let us keep in mind the examples of the past and work toward 

the goal that those who follow will not fault our intentions. 

References 

Aksoy, S. and Tenik A. (8 October 2002).The ‘four principles of bioethics’ as found in 13th century 

Muslim scholar Mawlana’s teachings. BMC Medical Ethics. Retrieved February 23, 2005 from 

http://www.pubmedcentral.gov/articlerender.fcgi?tool=pubmed&pubmedid=12370082. 

Belkin, G. S. (Summer 2004). Moving beyond bioethics: history and the search for medical 

humanism. Perspectives in Biology and Medicine. 47(3), 372-385. 

Chipman, L. N. (2002). The professional ethics of medieval pharmacists in the Islamic world. 

Medicine and Law. 21(2), 321-338. 

Davies, H. (2004). Can Mary Shelley’s Frankenstein be read as an early research ethics text? Journal 

of Medical Ethics; Medical Humanities. 30, 32-35. 

Dracobly, A. (Summer 2003). Ethics and experimentation on human subjects in mid-nineteenthcentury 

France: the story of the 1859 syphilis experiments. Bulletin of the History of Medicine. 

77(2), 332-366. 

Evans, G. E. and Beck, P. (May/June 2002). Informed consent in medical research. Clinical Medicine. 

2(3), 267-272. 

Finder, S. G. (1995). Lessons from History: Horace Wells and the Moral Features of Clinical 

Contexts. Anesthesia Progress. 42, 1-6. 

Guinan, P. (Summer 2002). Bioterrorism, embryonic stem cells, and Frankenstein. Journal of 

Religion and Health. 41(2), 305-309. 

Harris, J. 2005. Scientific Research Is a Moral Duty. Journal of Medical Ethics. 31,242-248. 

(Internet Modern History Sourcebook. Retrieved March 26, 2005 from http://www.fordham. 

edu/halsall/mod/montagu-smallpox.html) 


Papers 

Kirkpatrick, D. D. (9 April 2005). E.P.A. Halts Florida Test on Pesticides. New York Times. 

Kious, M. K. (Spring 2001). The Nuremberg Code: Its History and Implications. The Princeton 

Journal of Bioethics. 4, 7-19. 

Kubar, O. (October 2001). Research involving human subjects: ethics and law in early 20th century 

Russia. Bulletin of Medical Ethics. 172, 13-17. 

Lechopier, N. (2004). L’émergence de norms pour la recherche biomedicale: A l’origine de la loi 

Huriet (1975-1988). Médecine/Sciences. 20,377-81. 

Lederer, SE. (2003). Children as Guinea Pigs: Historical Perspectives. Accountability in Research. 

10,1-16. 

Loewy, E. (Fall 2002). Bioethics: past, present, and an open future. Cambridge Quarterly of 

Healthcare Ethics. 11(4), 388-97. 

Lock, S. (December 1995). Research ethics—a brief historical review to 1965. Journal of Internal 

Medicine. 238(6), 513-520. 

Saunders, C. (March/April 1996). The Vulnerable Among Us: Protection of Children in Medical 

Research. Research Nurse. 2(2). 

Smallwood, R. (5 April 1993). Medical ethics—past and future. Medical Journal of Australia. 

158(7), 444-445. 

Stark, R. (9/2004). Catholicism and Science. Retrieved Marach 14, 2005 from http://www. 

catholicleague.org/research/catholicism_and_science.htm. 

Vollmann, J. and Winau, R. (7 December 1996). Informed consent in human experimentation 

before the Nuremberg code. BMJ 313, 1445-1447. 

von Engelhardt, D. (2004). Patient vs. disease in medicine: Historical perspectives and contemporary 

concerns. Journal of Nephrology. 17, 611-618. 

von Staden, H. (1992). The Discovery of the Body: Human Dissection and Its Cultural Contexts in 

Ancient Greece. Yale Journal of Biology and Medicine. 65, 223-241. 


Papers 

Mentoring and Motivating: Bring Your Staff Along 

Sandra M. Nordahl, CRA 

Sponsored Research Administration 

San Diego State University Research Foundation 

5250 Campanile Drive 

San Diego, CA 92182-1934, USA 

Phone: 619.594.4172 

Fax: 619.582.9164 

snordahl@foundation.sdsu.edu 

Author’s Notes 

This paper was developed from the session (same title) that was presented at the 2004 Western 

Section meeting held at La Quinta, California. The style of mentoring and motivation presented 

herein is used daily by the author, which has and continues to evolve. The author greatly acknowledges 

the mentors that have been motivational to her throughout the life of her career: Georgia 

Simpson, Arizona State University (retired), Mark Elder, North Texas State University (retired), 

Lee Hanna, Arizona State University (retired), Frank DiSanto, The Ohio State University Research 

Foundation, Paul Nacon, Department of Health and Human Services, David Mineo, National 

Institutes of Health and Michèle Goetz, San Diego State University Research Foundation. 

Abstract 

More often than not, as managers and supervisors, our world becomes full of complex issues, 

meetings and events that fill days endlessly. Frequently, mid-level and upper management can be 

out of touch with their immediate workforce. One of the primary challenges that face managers 

and supervisors is creating the time and opportunity to develop, mentor and excite staff about the 

tasks involved in their workday. This paper will address taking time for one’s self and rejuvenating 

for work. The ability to learn to develop a fine line between work and personal life with the hopeful 

outcome being a happier, more productive employee is considered. The objective is to achieve a 

balanced life, resulting in employees who enjoy their jobs. Having staff members who feel motivated 

and successful is one of the primary keys to reducing turnover and developing individuals for 

promotional opportunities within an organization. The ability to mentor and motivate successfully 

leads to satisfied employees, who in turn are more productive in the work place. Motivated and 

productive employees greatly enhance the opportunities and possibilities to achieve the organization 

mission goals. The author explores ideas and suggestions that have been utilized to motivate 

and mentor staff in the workforce. 

Introduction 

What motivates one to come to work? Is it just a paycheck? Is it the interaction that occurs between 

an individual and others throughout the workday? Is it the field of work that entices people 

to jump out of bed? Job satisfaction is one of the necessary keys to achieve success in mentoring 

and motivating the workforce. Many organizations in the field of research administration have 

limited resources to provide salary increases as a motivational incentive. The quandary becomes 

how do managers and supervisors motivate and mentor employees without the benefit of additional 

compensation or limited monetary resources? 


Mentoring and Motivating: A Personal Reflection 

Papers 

As managers and supervisors, we need to recognize that employees often spend more waking 

hours at work, on the job than at home and/or with their loved ones or pursuing activities outside 

of the workplace. It is imperative to create a work environment that is productive, comfortable, 

and one in which the employee feels fulfilled as a part of the organization. Most individuals do not 

work for an organization solely for a paycheck. There are other tangible factors involved, such as 

benefit packages, location, and more importantly, job satisfaction. There must be other means of 

contentment, in addition to salary, benefits, and other “perks” obtained in order to retain employees. 

Employees want to feel that their work is satisfying, stimulating, engaging and/or thought 

provoking. 

If an individual isn’t happy with their work environment, it will be VERY evident to most people 

that come into contact with the person at work, including staff and clientele (faculty, staff, etc.) 

that there is a job dissatisfaction issue. Similarly, if managers and supervisors aren’t satisfied with 

the workplace, staff will become aware of the negativity and discontentment will begin to percolate 

throughout the organization. Unfortunately, negativity permeates quickly and the informal communication 

grapevine works overtime. Leadership needs to be acutely aware of their non-verbal 

expressions and body language. The workforce recognizes the underlying temperament of the 

upper hierarchy of an organization and follows suit. Generally speaking, happy employees lead 

to happy clients. This is not to say that every moment of work must be happy and cheerful. There 

are situations in the work force that are unable to be painted in a positive light. Hopefully, these 

situations are few and far between and tempered to the best extent possible. Situations that are not 

favorable need to be discussed honestly and openly with staff. Resolutions for favorable outcomes 

need to be explored and the best possible solution implemented. 

What can you, as a supervisor, do to motivate your staff? Many small, cost free gestures can be 

incorporated into a managers work style. Remember to pay compliments when appropriate. This 

cannot be done enough. Compliments must be sincere and well deserved, but it is important not 

to overlook any opportunity to let a staff member know that they are doing a good job. Try to be 

positive during tough times. It is difficult, but staff look to their supervisor to provide leadership 

and optimism during periods of budget shortfalls or other difficulties. If the leadership doesn’t 

have a positive outlook, why shouldn’t the employee begin to search for other alternative employment 

and a work environment that is more conducive to a happier life? If supervisors are having 

a difficult time remaining positive, they should explore resources that will help to motivate them 

and maintain an upbeat outlook. Many resources are available including monthly publications 

such as “Bits & Pieces,” “Leadership” and “Managing People at Work.” In addition, inspirational 

readings from other resources can also bolster sagging attitudes. Often motivational materials are 

not directly related to the work at hand, nor does it need be. Motivational material is anything that 

provides an opportunity to think and possibly realize a different angle to a difficult situation or 

provide a spark of encouragement. 

Staff need to know that management cares about them as individuals in addition to being employees. 

Take time to get to know the staff. Listen and learn about each person under your supervision. 

Luncheons are a perfect opportunity to share funny stories about life outside of the workplace. 

These times provide management insight into the staff, what their lives are like and what motivates 

them or what issues might provide a barrier to accomplishing work in the most productive manner 

possible. When a staff member is going through difficult times, sharing like experiences may 

help the employee. This is an area that must be handled with extreme care. Individuals must be 

open to discussing personal situations and management needs to be respectful of an individual’s 

privacy. Some individuals need to discuss situations in great detail, others choose to not to talk 

at all about personal events. The key is to be genuinely interested in their lives and activities. But 


Papers 

more importantly, individuals need to know that management is willing to listen and truly cares 

about them. 

Recognize that each person brings strengths to the work group. Focus and develop those positive 

attributes in employees. When large group projects are at hand, try to ensure that each individual 

is assigned to a task that will develop and strengthen their strengths further. The majority of the 

times, when positive qualities are built upon, less desired behaviors are minimized. Whenever possible, 

be a cheerleader for staff, promoting their good work to others as appropriate! This type of 

recognition is cost free, yet provides a feeling of accomplishment to the individual that is recognized. 

Simple thoughtfulness is another element that can boost an employee’s morale. Remember to recognize 

birthdays and holidays. Most staff truly look forward to being remembered by management 

on their birthday or another special occasion. Respect the privacy of staff who may not be thrilled 

with the idea of the recognition of their significant birthday or event. Workgroups can convene for 

a Dutch luncheon with all staff sharing in the expense that treats the birthday employee. A simple 

gesture, such as sending grocery store, inexpensive, decorated cookies to workgroups for a holiday 

such as St. Patrick’s Day is a morale booster, especially when the cookies are totally unexpected! 

Try this sometime and reap the benefits of the goodwill that this simple act of thoughtfulness 

provides. 

Another example of thoughtfulness is to remember employees when traveling. Magnets, pens or 

another small token of appreciation can be purchased from the city of the meeting and brought 

back for each employee. It is important to realize and recognize that these individuals are continuing 

to “hold down the fort” and support the mission, while the supervisor is away from the 

workplace. 

Other ideas for building team spirit might be to institute an activity such as the “End of the Month 

Brunch.” One group of employees established that the last Friday of each month a potluck brunch 

would be held. Each employee shared in the cost of the event by bringing an item that was suitable 

for brunch, including juice, bagels, eggs, bacon, potatoes, etc. This event allowed the employees to 

gather in an informal setting without a planned agenda. While some management might see this 

as a waste of work time, often it became a forum to discuss issues that were viewed as obstructions 

to a productive work environment. Possible solutions were discussed. Not only was this gathering 

productive, the group became one of the most cohesive teams in the department. The team would 

meet to discuss upcoming activities and issues facing the department. They presented ideas for 

constructive resolution to issues facing the department without being prompted. The objective of 

these informal gatherings from a supervisory point of view is to gain the “pulse” of the workforce. 

To be effective, management must acknowledge the climate of workforce environment and take 

action when necessary. The cohesiveness that was built around these activities made managing this 

workgroup interesting and fun. 

Formal recognition of staff is essential. Staff needs to receive praise for their contributions and 

accomplishments in a peer setting. This can be accomplished by several means, recognizing 

outstanding performances for single events or over a period of time. Have staff submit nominations 

for employees of the month or quarter to an individual that does not have direct supervisory 

responsibility. When recognizing the staff, read the comments that were submitted by their peers. 

Small tokens of appreciation can be given out at the time of recognition. It is important to recognize 

employees as soon as possible. Delayed recognition does not have the same morale boosting 

effect and can be viewed by the individual as an afterthought by management. Never take credit 

for a staff member’s work. Give recognition and credit where due. It is important that individuals 

be given the recognition for their work contributions. There is not a quicker way to demoralize an 


Papers 

individual than having someone else receives recognition and praise for their work. 

It is also essential to acknowledge personal events, goals and achievements of staff. While these 

events may not be a part of the work environment, they often have a “spill over” into the morale of 

an employee. Individuals who have completed their college education, whether or not it is related 

to the research management field, have labored long and hard to obtain the degree. It is an accomplishment 

worthy of recognition. 

If management takes the opportunity to treat people like stars, they will make management shine. 

Most employees will perform relative to how they are treated by their immediate supervisor. It is 

important to offer constructive feedback often, as well as when necessary. Install the concept of 

“pride in your work.” Employees may need to be reminded that their work is a direct reflection 

upon them as an individual, not only as an employee. This philosophy creates an atmosphere of 

ownership of work. 

Management should take the opportunity to assist staff in achieving their career goals with them 

as they progress in the workplace. Not only is it selfish to try to prevent staff from growing in their 

careers, it also fosters an atmosphere of resentment and discontent amongst the employees. Staffs 

who are encouraged to grow and learn realize that new opportunities will be available for them 

to improve in their jobs as well. It is far easier to advance in one’s own career with the support of 

well-trained knowledgeable staff, who are willing to assist in new endeavors. 

It is also important to acknowledge that we as managers don’t know everything there is to know 

about research administration. Be honest with your staff. Let them know when you need to research 

an issue and get answers to their questions. Acknowledgement of your shortcomings fosters 

a team approach in problem solving as well as an open learning environment. Staff who feel that 

management is approachable will bring issues and concerns forward for proactive problem solving. 

This is far more desirable than waiting until the problem has developed into the proverbial 

nightmare. 

There is an anonymous saying that says, “Once upon a time there was a lot of time…” Most research 

administrators recognize that time crunches are never ending. Staff look to management 

for assistance in resolving issues that arise in the course of their work. While the problems they 

present may not be management’s top priority, the concerns are not able to be resolved by staff, 

which are preventing them from feeling productive and providing resolution to the subject at 

hand. Try to assist staff in a timely fashion with either an answer or a timeline of when the issue 

might be reviewed. This communication acknowledges that management is aware of the issue and 

has not been forgotten. 

Management should acknowledge the individuals who have mentored and motivated them during 

the course of their own careers. Create reference “banks” of individuals with knowledge in various 

areas. Share these resources with staff, especially when there is a difficult topic at hand. It is important 

to empower staff to look outside the home institution to resolve complex issues. Knowledge 

gained from other sources can then be summarized and discussed with management to determine 

a solution based on best practices and institutional policy. 

Learning is the key to success. Always encourage staff to take advantage of the variety of opportunities 

available to enhance their knowledge of research administration and the skills associated 

with the profession. Low cost or no cost computer classes are often readily available to staff at 

their own institutions. Local meetings and workshops for a modest fee, as well as teleconferences, 

provide excellent opportunities for enhancing the skill sets of many staff with a relatively low cost 

per person. Encourage staff to become involved in organizations related to research administration. 

Staff should be prompted to bring back knowledge to the institution that can be implemented 


Papers 

with little or no cash outlay. Internal sharing of new ideas and concepts are key for organizations 

with limited resources. Staff who attend meetings should be prepared to share the highlights of the 

sessions that are relevant with colleagues and management. 

Staff should be mentored in building relationships, both internally and externally of the immediate 

work groups and organization. Have staff explore “where their jobs take them.” Who are they 

interacting with throughout the course of their work assignments? Internal relationships within an 

organization are just as critical and can be more crucial to develop. Many organizations experience 

in-fighting or finger-pointing between work groups or departments. Team building and relationships 

can help to resolve issues quicker than if no relationship existed. Case in point, recently an 

agency’s outstanding final report website indicated an overdue report for a project which had 

ended in 1999. The project director stated that he had provided the report, prior to the implementation 

of electronic submission. An email to the agency staff was to no avail. A follow up email 

with a contact at the agency, which a relationship has been established through several interactions, 

was critical in resolving the issue. Share similar experiences of the importance of developing 

relationships with staff. These contacts are invaluable. 

Relationships need to be give and take. Demonstrate assisting others with problems that may not 

directly relate to current workload. Foster an environment of “what can I do to make this happen”, 

instead of creating roadblocks to success. Share the knowledge that has been gained over the life of 

your career. 

Don’t be afraid to “get into the trenches.” Be more than willing to assist staff during crunch times if 

copying, filing or other “menial” tasks need to be performed. Be willing to take on a portion of an 

individual’s work to assist during particularly difficult times. This willingness serves two purposes: 

staff will view management as being a part of the team that does what it takes to get the job done 

and a refresher course for management is taking place! It is amazing how quickly daily routines 

and processes change. Don’t become a manager who “doesn’t know what they are talking about” 

when it comes to being able to perform what it takes to get a proposal out the door or submit 

various reports on-line. Managers who fail to participate in the work of their staff are performing 

a major disservice to their organization by not keeping up to date with current practices of the 

profession. 

Leading a balanced life between professional and personal can be difficult to do. There is nothing 

worse than one’s child saying “You think too much about work.” A staff member who is overburdened 

either at work or home will not perform optimally in either situation. Staff should be 

encouraged to take vacation time without the guilt of leaving work behind. Time away from work 

re-energizes most individuals who return to the workforce refreshed and renewed. 

Management also needs to take time to relax and reinvigorate. Everyone in the workforce experiences 

difficult times, including management. If possible, leave personal difficulties outside of 

the workplace. Unfortunately, some of life’s events are so serious that this is not possible. When a 

personal situation is at a magnitude where it may affect one’s ability to focus at work, share. The 

amount of details discussed is the decision of the individual. Staff will often rally to assist individuals 

through a difficult time. 

Clear the mind and work space of distractions when meeting with staff. The ability to focus solely 

on the staff ’s topic at hand gives the message that the issues being brought forward and being 

discussed are important to all. While these issues might be readily resolved, in a quick and efficient 

manner, staff would not bring them to management’s attention if they knew how to effectively and 

correctly deal with the topic. Extend the courtesy of full attention; minimize the email program 

and place the telephone on divert, if possible. These small gestures are extremely important in 

building a team. Staff need to be courteous of one another, when meeting with management. It is 


Papers 

extremely distracting to have others pacing back and forth outside an office or meeting room for a 

minor question that could be addressed at a later time. Interrupting a scheduled meeting for such 

an occurrence sends the message to the individual who arranged a specific meeting that they or 

their topic might not be as valuable or important, as another individual. Staff should be informed 

not to interrupt scheduled meetings, unless there is a critical need or an emergency situation that 

cannot be dealt with later. Having an “open door” policy is more than lip service. Staff must know 

that management is approachable with any issue that arises. While interruptions to one’s own 

work may not always be timely; if possible ask the staff member to take a seat, and then let the 

staff know that you need to complete the immediate thought or action. Individuals should be able 

to bring complex issues and problems forward to management without the concern of repercussion. 

If the situation requires additional research, either provide the necessary information to the 

individual or let them know that further investigation will be needed. Timely updates on the status 

of the problem to staff is important. Remember, it was important enough for the individual to 

bring the issue forward; follow through on the part of management is essential. Staff need to feel as 

though management is ready and willing to assist with their concerns. 

Brainstorming also builds a sense of team atmosphere. Involve staff whenever possible in organizational 

problem resolution. Staff feel a sense of ownership when they are part of the discussion 

and solution. More often than not, staff have the day-to-day working knowledge of the issue at 

hand. Homework can be assigned to staff with direct knowledge of the topic at hand, with scheduled 

time to reconvene for a resolution. Discussions can be held through email or small groups as 

needed. There is nothing more detrimental than changing a policy or procedure without including 

the input of all key players, who are responsible for the results. Having individuals with direct 

knowledge participate in the brainstorming process can streamline the end result with a positive 

outcome and acceptance of the change at hand. Encourage staff to explore ideas and concepts to 

continually improve processes. Small monetary amounts or other tokens of appreciation, such as 

gift cards, golf balls, or flowers picked from a home garden can be used to reward creativity and 

innovation. 

Unfortunately, technology has created an environment of performing tasks quicker and faster, 

creating a “real time” environment for many in the research administration field. Learning and 

teaching an acceptable form of “ADD” is almost a necessity in the field of research administration. 

Management and staff need to be able to move from task to task and between tasks effectively. 

Developing an organizational system for various ongoing issues that can refresh the memory easily 

is key, whether one uses notes stored in the computer system, a manual filing system or a combination 

of any organizational tools. Teaching staff good organizational skills will help aid in issues 

of desk coverage and timely responses, in addition to good work habits. 

Performance evaluations are a critical tool for motivating staff. Evaluations should be performed 

frequently, but not less than every 12-18 months. Staff deserves to know how management perceives 

their contribution to the work environment. Don’t wait until formal appraisals to give 

feedback on performance. It is important to address concerns immediately with constructive 

critiquing. Exemplary performance should be recognized immediately, whether in a face-to-face 

discussion or through another means of recognition. Emails are often sent praising accomplishments 

or tasks. These should be sincere and copy other management staff that should be aware 

of the outstanding service the individual is providing for the organization. Instant recognition 

is a motivational tool that is not used frequently enough. Likewise, addressing areas of concern 

quickly may help to eliminate a larger problem in the future. Formal evaluations should include 

documentation of instances that could be improved upon, as well as “praise” emails. Set goals for 

each member of the staff that is reasonable and achievable during the next review cycle. Individuals 

that have shortcomings need to be provided with firm and consistent feedback. Give concrete 

examples of areas and issues that require improvement. Discuss in written form ways to achieve 


Papers 

better outcomes for areas that require change. Resources should be provided, such as web sites, 

additional one-on-one training and discussion time, as well as professional meeting opportunities. 

Staff should be encouraged to participate in the review process, by completing a self-evaluation 

and/or a response to the formal evaluation. Participation by all in the evaluation process fosters 

the team environment. Expect the best – if management anticipates mediocre outcomes, the result 

will be mediocre. 

“You get what you give…” The amount of effort spent mentoring, developing and participating 

with staff will be a direct reflection of the quality of each individual’s performance and work product. 

Encourage staff to ask questions. At the beginning of each training session, staff should be reminded 

that “there are no stupid questions.” If someone is slightly unclear on a topic or procedure, 

it is management’s responsibility to guide in the right direction to obtain the appropriate assistance 

or train staff. Pay attention to facial expressions when conducting trainings. Seek out individuals 

who appear to be confused or not understanding the topic at hand. Recognize that individuals do 

not learn the same way. Staff may learn better through lecture, others with handouts, and some 

employees may require direct hands-on training to be successful. Struggling staff should be asked 

which learning style best suits their needs. 

Conclusion 

The following are two important points to remember when working with others regardless of the 

venue: 

Too often management feels a sense of entitlement. It is important to recognize the importance 

of each position within an organization, but respect for the individual filling the position is not 

achieved automatically. Respect from staff must be earned; it doesn’t come with the title. 

Two of the best words that can be used in the workplace and throughout society are “please” and 

“thank you.” They can never be overused, if the words are extended with sincerity. It is common 

courtesy to ask in a polite manner and thank someone at the conclusion of an assignment or task. 

This is one of the best “cost free” means of recognizing staff. 

Suggested Reading 

Bizarro, Dan Piraro, King Features, San Diego Union-Tribune 

Bits & Pieces, Ragan’s Motivational Resources 

Leadership, Ragan’s Motivational Resources 

Leading for Results, Lawrence Regan Communications, Inc. 

Motivational Manager, Lawrence Regan Communications, Inc. 

People @ Work (formerly Practical Supervision), Professional Training Associates, Inc. 

Positive Thinking, Guideposts 

Johnson, Spencer (1998). Who Moved My Cheese? New York: G.P. Putnam’s Sons. 


Helpful Gatekeepers: 

Positive Management of the Limited Submission Process 

Robert Porter, PhD 

Program Development Manager 

Research Division 

Virginia Tech 

340 Burruss Hall 

Blacksburg VA 24061 

Ph: (540) 231-6747 

E-mail: reporter@vt.edu. 

Abstract 

Limited submission grant programs force a sensitive gatekeeper role squarely on research administration. 

By limiting the number of proposals that an institution may submit in response to a 

program announcement, sponsors (both governmental and private) are, in effect, pushing down to 

the universities the initial triage of competitive vs. non-competitive grant proposals, thus reducing 

their own workloads to a considerable degree. At the other end, research administrators can view 

this role either as an onerous but necessary task, or they can seize opportunities for constructive 

communications, proposal improvements, and faculty development. This paper describes a process 

at Virginia Tech that aims at the latter approach, using ten rules for managing limited submission 

programs. 

Introduction 

With sponsor budgets flattening as universities ramp up their research agendas, intensified competition 

has become the norm. In 2003 NSF underwent a near budget freeze, while the number of 

proposals increased 14 per cent, thus lowering their average success rate from 25 to 20 percent in 

one year (NSF 2004). Similarly, universities are witnessing an increasing number of limited submission 

grant programs with more internal candidates competing for each opportunity. In January 

of 2005, for example, the research office at Virginia Tech posted twelve programs on its limited 

submission calendar for the month, one of which had eleven research teams vying for a single 

slot! In this environment, research administration is under heightened pressure to manage limited 

submissions in a manner that is perceived as fair by all constituencies. The following are ten rules 

for implementing a positive management philosophy in this sensitive arena. 

Ten rules for positive management 

As a grounding principle, the entire limited submission process should mirror, as closely as possible, 

the best qualities of the peer review system now in place with most major sponsors, a system 

that continues to get high marks from most researchers (NIH 2001). 

Rule 1: Cast a broad net 

Papers 

Limited submissions have always presented management challenges, the first being the difficulty 

in flagging them accurately and in a timely fashion. Recurring programs such as NSF’s Major 

Research Instrumentation (MRI) or American Honda’s Grants in Scientific Education, present 

few difficulties. But, like wayward meteorites, new limited submissions can swoop into view with 

precious little warning. Online database services such as Community of Science and InfoED can 

be programmed to issue alerts, but their performance with new programs can be spotty. Likewise, 

researchers who become aware of a new limited submission may or may not choose bring it to the 


Papers 

attention of the research office until they’re ready to deliver the final proposal. (Why invite competition?) 

To cast as broad a net as possible, grants specialists and all pre-award staff should report 

any new program to a single coordinator who is responsible for immediate communications to 

researchers. 

Rule 2: Communicate in multiple channels 

Researchers who belatedly find themselves excluded from the limited submission process often 

complain they weren’t aware of it. To fight this, it is well to recall an old rule of organizational 

communications: Send important information through at least three channels. For limited submissions, 

the big three are: a) web site calendars with internal deadlines going forward several 

months, b) individual e-mail alerts to researchers, department heads and deans; and 3) periodic 

postings in hard copy newsletters. 

Rule 3: Set workable deadlines 

Maintaining workable deadlines while trying to balance the conflicting needs of researchers, sponsors, 

the university and the research office can often seem like mission impossible. It helps to stay 

focused on the primary goal: To assure the selected investigator(s) has sufficient time to prepare 

a high quality proposal, a task that requires at least five weeks after a project has been selected for 

submission. Working backward from the sponsor’s deadline, the initial program posting should 

go out about 12 weeks ahead. Internal notices of intent should be required nine weeks before the 

sponsor deadline, with preproposals (if necessary) due about two weeks after that. Of course, all 

the timelines suggested below must be adjusted to fit the academic calendar, as well as the sponsors’ 

choices in setting dates for the initial program announcement and the submission deadline. 

Finally, it should go without saying that granting exceptions to any of these deadlines is a dangerous 

practice and will almost always be regretted. 

Table 1. 

A Typical Limited Submission Calendar 

Limited 

Submission 

Announced 

12 weeks 

ahead 

Internal Notices 

of Intent 

Due 

Selection 

Committee 

Identified 

Preproposals 

Due 

Winning 

Preproposal(s) 

Selected 

9 weeks ahead 8 weeks ahead 7 weeks ahead 5 weeks ahead 

Rule 4: Provide a concise policy statement to investigators 

Sponsor 

Deadline 

Even with the best of communications, some researchers will remain unaware of the institution’s 

need to systematically manage the limited submission process. A concise policy and procedure 

statement, posted on the web site and repeated periodically through other communication channels, 

should reduce the number of uninformed. The statement should include the key steps to be 

followed, as well as the respective responsibilities of the PI, research administration, and leaders of 

the academic units involved. 

Rule 5: Require notices of intent and structured preproposals 

As the sole purpose of written notices of intent is to determine whether an internal competition 

will be necessary, they need only include a brief statement of the project title, a sentence or two 

about its scope, and the names of investigators. Should the notices of intent exceed the limit, an 

internal competition is called for, and the next communication is critical. Each PI should receive a 


list of all notices that have been received, together with explicit instructions for preparing and submitting 

their preproposal. Full disclosure to all of the investigators involved and their project titles 

can have beneficial results, as it signals the candidates of the level of internal competition, and on 

occasion it can trigger collaborations and/or early withdrawals. 

Requirements for preproposals should be clearly spelled out, and they should be tailored to the 

needs of each specific grant program. Preproposals are just that: concise project summaries that 

give reviewers enough details to judge their relative merits. A maximum of three pages is sufficient 

for most programs, and PI’s should be instructed to reference the program announcement in two 

important ways: (a) show specifically how the project will meet the sponsor’s program goals and 

objectives; and (b) use the sponsor’s instructions for proposal preparation to outline the preproposal. 

This forces investigators to scrutinize the sponsor’s requirements in greater detail, and it 

assures a solid head start for the PI who is selected to write the full proposal. It is well to remind 

PI’s at the outset that the selection committee consists of their own hard working colleagues who 

do not appreciate small fonts, crowded margins, lack of subject headings or documents that exceed 

page limits. In other words, when it comes to writing preproposals (or full proposals for that matter) 

more is not more. 

Rule 6: Choose selection committees carefully 

Selection committees are the foundation of the whole process. Functioning as internal grant 

review panels, each group must include the appropriate range of scholarly expertise, and their 

deliberations must result in the best possible outcomes for the university, i. e., they must consistently 

select those proposals with the best chances for success. Any evidence of bias or inability to 

properly evaluate the merit of proposed projects would seriously undermine the integrity of the 

entire enterprise. Deans and department heads should take the lead in putting the panel together; 

they are the best judges of who should or should not serve on any given committee, and they have 

a vested interest in maintaining quality and fairness over the long run. Selecting the right panel 

members can be challenging even in large universities, as faculty with the appropriate expertise 

often have conflicts of interest. Moreover, as sponsors increasingly stress interdisciplinarity, some 

proposals can have a breadth of scope that stretches beyond the abilities of a small group of reviewers 

to evaluate fairly. 

Rule 7: Nurture the selection committee 

The research administrator serves in a classic staffing role to the selection committee. This means 

taking every opportunity to inform, assist, and simplify life for every member. Among the helping 

steps that make this assignment less onerous to committee members are: (a) sending an initial 

note thanking them for offering to serve and instructing them as to the committee’s working 

procedures and probable calendar; (b) delivering a package with hard copy of all preproposals 

together with the program announcement to their offices (saves them time from downloading, 

printing and compiling the correct stack of documents); and (c) assuring that their meeting room 

is as convenient and comfortable as possible. When it comes to amenities, morning coffee or box 

lunches are always wise investments. 

Rule 8: Be a catalyst, not a participant in the selection process 

Papers 

During the committee meeting, the research administrator should be a facilitator, not a voter. This 

means guiding the discussion in a nondirective, yet structured manner aimed at achieving a consensus 

ranking of the preproposals. Always start by reviewing the essential features of each grant 

program, with special emphasis on program goals and review criteria. It is important to resist any 

group’s tendency to move too quickly to a voting mode. This can be done by encouraging general 


Papers 

discussion of each preproposal beforehand. Here is a sequence of facilitator prompts that can help 

move the committee toward consensus: 

Round one: General discussion of each proposal. Facilitator prompt: 

Our work today really has two goals. Of course we want to agree on which proposal(s) 

should be submitted based on their likelihood for success, but we also have an obligation 

to provide feedback to all the PI’s who submitted preproposals. There’s a great opportunity 

here to help improve their future proposals, whether they were selected or not. So let’s list 

the overall strengths and weaknesses we see in each preproposal, plus our recommendations 

for improvement, before we start narrowing down. 

During the discussion that follows, the facilitator should take notes on a flipchart or 

greaseboard to make sure key points are recorded and are clearly visible to the committee. 

Round two: Pick the extremes. Facilitator’s prompt: 

Based on our discussion, and looking at the notes, do we see any preproposals that stand 

out, either as being quite strong, or conversely, quite weak? Let’s try to justify our choices 

based on the points we’ve already discussed. 

This instruction goes a long way in building consensus, and the ensuing discussion rarely 

ends with more than two closely ranked preproposals still open for discussion as to which 

one should go forward. 

Round three: Review and test for consensus. (In this example, two submissions are allowed.) 

Facilitator’s prompt: 

Let’s review our choices. First we eliminated (name proposals and reasons for elimination). 

Then we decided the strongest proposal was (name proposal and strong points). That 

will be the first submission. For the second submission, we had some difficulty choosing 

between (name proposals), but we finally decided that (PI’s name) proposal was stronger 

because (reason). So that will be the second submission. Are we all still agreed on these 

choices?” 

Such a summary may seem like needless repetition of the obvious, but it has a powerful 

effect on the group, as it reaffirms the rationale for their choices and cements their ownership 

of same. Prior to adjourning, be sure to collect any written comments committee 

members made for individual proposals, as these will help in writing summary notes to 

the PI’s. Finally, a warm thank you note is in order. 

Rule 9: Provide written feedback to investigators 

The most important step in positive management of limited submissions, and the one most easily 

overlooked, is providing feedback to PI’s. Whether their proposal was selected or not, PI’s invariably 

benefit from constructive feedback, and the research administrator has an excellent opportunity 

to be seen as a helper and a coach and not just a traffic cop who signals stop or go. 

Setting up meetings with selected PI’s is relatively easy, as they are usually on the lookout for tips 

to improve their chances. Getting an audience with rejected PI’s is often more difficult. Some will 

want to argue the committee’s decision, some will ignore the invitation for a meeting, and some 

will ask that you simply send the notes by e-mail. Whenever possible, try to set up a face to face 


meeting, as this has far more impact and provides an excellent opportunity to discuss other possible 

funding sources. Always provide the PI with neatly written notes, as this lends weight to the 

discussion that cannot be achieved by an informal chat alone (see sample notes, Appendix A). 

Do a funding search beforehand and take along a sheaf of grant summaries—there is a strong possibility 

that among them are one or two potential sponsors the researcher was not aware of, and 

this can change the tone of the whole session. Finally, you can draw upon your broader knowledge 

of faculty expertise and award history to suggest possible collaborators or mentors, and this is too 

is greatly appreciated, especially by younger faculty. 

Rule 10: Be prepared to swing into contingency mode 

Expect snags to crop up. Consider this scenario: a new limited submission program has slipped 

under the radar screen, and never appears on the research office’s posted list. Shortly before the 

sponsor’s deadline, a PI appears in your pre-award office with a sketchy draft proposal. Being first 

in line and with the deadline approaching, she’s given the go ahead. The next day, a more polished 

proposal comes in, with a second PI anxious to submit. What to do? In this situation, the best 

course is to seek shared decision making. Convene a quick meeting of the principals (PI’s plus 

department heads or deans), and start the discussion by (a) acknowledging the lapse in communications, 

and (b) reminding the group that the ultimate purpose of the limited submission policy 

is to assure the best proposal goes forward while being fair as possible to all participants. Then ask 

them which proposal they think should be submitted (the documents having been distributed to 

all before the meeting). Given that both PI’s were lax in communicating their intent, the tentative 

approval given the first PI becomes moot, and you have at least a reasonable chance that the group 

will agree to send the better proposal. There are many variations to this scenario, but the point is 

to act quickly, and to take responsibility immediately for any shortcoming(s) on the part of the 

research office. 

Summary 

The expanding gatekeeper role forced by more limited submission programs provides rich opportunities 

for research administration to be seen, not as a reluctant enforcer, but as a conscientious 

supporter of the university’s—and the faculty’s—best interests. To do this effectively, a positive 

management philosophy must be articulated, backed by systematic procedures that assure fairness 

and consistent benefit to the principal stakeholders. Above all, constructive feedback to all PI’s can 

turn a difficult process into a powerful tool for faculty development. 

References 

Papers 

National Institutes of Health, Center for Scientific Review. (2001). Study section member satisfaction 

survey final report: Executive summary. Retrieved 15 February 2005 from http://www.csr. 

nih.gov/events/ExecSumm.pdf 

National Science Foundation. (2004). NSB-04-43: Report to the National Science Board on the National 

Science Foundation’s merit review process, Fiscal Year 2003. Retrieved 15 February 2005 

from http://www.nsf.gov/nsb/documents/2004/MRreport_2003_final.pdf 


Papers 

Appendix A 

Sample Feedback Notes to PI 

Limited Submission Program: NSF, Major Research Instrumentation 

Selection Committee Notes, December 8, 2004 

Project Title: “Acquisition of Advanced Mass Spectroscopy Instrumentation 

to Support Bio/Nanotechnology Laboratory” 

Overall Strengths of the Preproposal: 

• A well conceived and well written document; the logic is easy to follow 

• Proposed project supports the university’s strategic plan and research priorities 

• Co-PI’s are well qualified, with a strong research record 

• Instruments requested could be used to support a variety of interdisciplinary projects (though 

only 2 researchers are mentioned in proposal) 

• Some components of the proposed Bio/Nanotech laboratory are already in place 

Areas needing improvement: 

(Note: Some of the following comments may be due to the abbreviated nature of the preproposal as 

reviewed by the Committee) 

• It is not clear how other users would be able to access the equipment. This could cost points in 

an NSF review, as a multidisciplinary need is not demonstrated. More Co-PI’s and their lines 

of research should be mentioned 

• The “broader impacts” statement is not convincing. Similarly, the education/outreach components 

are not well developed. These criteria are becoming increasingly important as competition 

heats up at NSF 

• In general, the narrative is well written, but the budget appears to be a hasty, last minute effort 

• The small font and narrow margins make the document hard for reviewers to read. Enlarge the 

font or use a two column format 

Committee recommendation: 

Proposal not approved for submission to NSF. There are strong qualities in this proposal, as it 

ranked fourth out of the nine submitted, coming just behind the three that were approved. But the 

weaknesses cited above lowered the committee’s overall score. Given the importance of this research 

to the university’s current priorities, and the existing infrastructure to support the requested 

equipment, the PI’s are encouraged to pursue funding. If future proposals to NSF are anticipated, 

they should seek assistance with the education/outreach components. (Note: A workshop on this 

subject is being offered by the research office next month.) 


Perceptions of Research Administrators on the Value of Certification 

Thomas J. Roberts 

Assistant Vice President for Research 

Florida Gulf Coast University 

Office of Research and Sponsored Programs 

10501 FGCU Blvd., South 

Fort Myers, FL 33965-6565 

239-590-7021 

troberts@fgcu.edu 

Author Note 

This paper was developed by the author based on his doctoral dissertation research in the Department 

of Educational Research, Technology, and Leadership in the College of Education at the University 

of Central Florida. Sincere appreciation is extended to Dr. Jess House who was the Chair of 

the dissertation committee and who provided a great deal of support, encouragement, and guidance 

to the author in regard to this study. Sincere thanks are also extended to Florida Gulf Coast 

University for awarding the author a grant in partial support of this research. 

Abstract 

The professional field of research administration faces critical challenges in maintaining and 

cultivating a talented group of skilled administrators in the new millennium. Universities have 

created increasingly complex bureaucracies to manage the dramatic rise in research funding and 

the complicated legal and regulatory requirements associated with receiving funding for research 

(Hanson & Moreland, 2004). As a result, the number of people employed in the field of research 

administration has increased. The value of certification in the field of research administration is not 

known. This study sought to determine whether those who have attained the Certificate in Research 

Administration (CRA) perceive a benefit to their careers and why most research administrators do 

not attempt certification. The primary research question studied is concerned with the relationship 

between perceived value of the CRA to research administration professionals and demographic 

characteristics. No research is available concerning the value of research administrators becoming 

certified through the Research Administrators Certification Council (RACC). This study will help 

to determine to what degree research administration professionals value certification, and will help 

in determining the perceived value of certification to different groups of research administrators. 

An analysis of the data will be provided and implications for future practice will discussed. 

Delimitations and Limitations 

Papers 

The study is delimited to research administrators based in the Southeastern region of the United 

States as defined by the National Council of University Research Administrators (NCURA). This 

sample population was selected because the author is well known in this region due to previously 

held leadership positions attained as a result of membership voting, presentations made at various 

meetings, and participation in numerous other activities involving regional membership. It 

was anticipated that response rate to the survey administered would likely yield the best results if 

the aforementioned population was utilized. An additional delimitation pertains to the half of the 

sample population that has achieved certification because in order to be included in the study the 

Certified Research Administrator (CRA) must have achieved certification prior to February 1, 2005. 

This study is limited since it is assumed respondents will answer the survey questions honestly. 

Furthermore, the accuracy and currency of the records obtained from the NCURA, SRA, and 

RACC could not be controlled. 


Papers 

Introduction 

Certification programs are designed to confirm that individuals in a given profession possess the 

fundamental knowledge necessary to serve their employer and profession in the best possible 

manner. Gilley and Galbraith (1986) define certification as the process by which a professional 

organization or an independent external agency recognizes the competence of individual practitioners. 

There is often a great deal of confusion associated with the term certification. For example, Bratton 

and Hildebrand (1980) emphasize that professional certification should not be confused with 

teacher education certification because the term teacher certification is a misnomer. Instead, it 

is a licensing mechanism regulated by a local body. Since teachers are required to hold a valid 

certificate in order to teach in the public school system, the teacher education certification is, in 

reality, a license to teach. Parker and Smith (2004) report that processes established for certifying 

and licensing practitioners share important credentialing related commonalities, but the primary 

difference often misunderstood is that licensure is mandatory and certification is voluntary. Galbraith 

and Gilley (1985) contend this confusion biases many educators regarding the certification 

issue and narrows the examination and discussion of professional certification. Penland (1982) 

asserts that this confusion has resulted in misunderstanding and frustration on the part of those 

concerned with the topic of professional certification and has impeded communication. Galbraith 

and Gilley (1985) maintain that certification, licensure, and accreditation each attempt to regulate 

the measurement of competencies, however; the methodology, population, and purposes of 

regulations differ. For example, in McCue (2003), Schoon and Smith indicated that licensure is the 

granting of a license by a governmental body to practice a profession, while certification is thought 

of as a means of promoting achievement within a discipline. Certification is not a property right to 

practice a profession; instead, it is a voluntary achieved standard of excellence for an individual. 

According to Bratton and Hildebrand (1980) certification is often perceived as being the same as 

accreditation and licensure. Distinctions between certification, accreditation, and licensure need 

to be recognized in order to place professional certification in correct context and avoid confusion 

in use of terminology. The following table provided by Bratton and Hildebrand (1980) offers a succinct 

comparison of accreditation, licensure, and certification. 

Table 1 

Comparison of Accreditation, Licensure, and Certification 

Type of Credential Recipient of Credential Credentialing Body Required or Voluntary 

Accreditation Programs Association/Agency Voluntary 

Licensure Individuals Political Body Required 

Certification Individuals Association/Agency Voluntary 

Bratton and Hildebrand (1980) offer the following definitions to help clarify the distinctions between 

certification, accreditation, and licensure. 

Certification – the process by which a professional organization or an independent external 

agency recognizes the competence of individual practitioners. 

Accreditation – the process whereby an agency or an association grants public recognition to 

a school, college, or university, or specialized study program that meets certain predetermined 

qualifications or standards. 


Licensure – a mandatory legal requirement for certain professions in order to protect the public 

from incompetent practitioners. Licensing procedures are generally established or implemented by 

a political governing body that prescribes practice without a license. 

According to various authors (Bratton & Hildebrand, 1980; Mason, 1984; Galbraith & Gilley, 1986; 

McCue, 2003) certification is a voluntary achieved standard of excellence for an individual practitioner 

recognized by a peer group. The focus of this study falls under this category of credentialing 

identified in the literature as professional certification. 

The Research Administrators Certification Council (RACC) was formed in conjunction with the 

Society of Research Administrators International (SRA) in 1993 with the primary purpose of certifying 

that an individual, through experience and testing, has the fundamental knowledge necessary 

to be a professional research or sponsored programs administrator (Research Administrators 

Certification Council, 2004). Since the RACC was formed in 1993, 501 research administration 

professionals have achieved certification (Research Administrators Certification Council). 

This study sought to determine whether those who have attained the Certificate in Research Administration 

(CRA) perceive a benefit to their careers and why most research administrators do 

not attempt certification. The primary research question studied is concerned with the relationship 

between perceived value of the CRA to research administration professionals and demographic 

characteristics. Five research questions guided the investigation. 

Statement of the Problem 

The value of certification in the field of research administration is not known. Research administration 

professionals do not know whether certification has benefited the careers of those who 

have achieved it, or why most research administrators do not attempt certification. The primary 

focus of the study was concerned with the relationship between perceived value of the Certificate 

in Research Administration (CRA) to research administration professionals and demographic 

characteristics. 

Methodology 

An Internet-based survey instrument was developed to collect data from certified research administrators 

(CRAs) and non-certified research administrators. The survey collected demographic 

information to help describe the relationship between the demographic characteristics of the population 

and perception of value. A pilot study was conducted to determine the survey instrument’s 

work under realistic conditions. The survey instrument was then distributed via an electronic mail 

notification and included a link to an Internet site where the survey could be completed online. 

Three electronic mail requests followed by personal telephone calls to those who did not respond 

to the electronic mail requests resulted in a return of 230 usable surveys or an 83% rate of return. 

Population and Sample 

Papers 

The population of respondents for this study included research administrators based in the Southeastern 

region of the National Council of University Research Administrators (NCURA). According 

to the NCURA (2005), 1,101 members are based in the Southeastern region. 

A list of 501 research administrators who have achieved certification was obtained from the Research 

Administrators Certification Council (RACC), and the list revealed that 147 of the research 

administrators who have achieved certification are from the Southeastern region of the NCURA. 

These 147 individuals were selected to represent half of the overall sample population for this 

study. The other half of the sample population was randomly selected from a list of non-certified 

members based in the Southeastern region. 


Papers 

The list of certified research administrators provided by the RACC only included the names, affiliation, 

and city of the individuals. In order to obtain complete contact information for the certified 

research administrators, further research was necessary as RACC did not readily provide complete 

contact information upon request. NCURA and SRA membership databases were utilized in an 

attempt to find complete contact information for the 147 certified research administrators based 

in the Southeast region of the NCURA. A search of these two sources revealed contact information 

for 84 of the 147 certified research administrators based in the Southeast region of NCURA. 

A search of university Web sites provided the necessary contact information for 34 additional 

individuals. Contact information for the remaining 29 individuals was obtained through Internet 

searches, telephone calls, and through contacting individuals known to the researcher who were 

affiliated with the same organization as the CRA. Contact information was verified, edited, and 

resulted in a final count of 134 certified research administrators based in the Southeast region of 

NCURA. 

The list of 1,101 research administrators based in the Southeast region of NCURA was used to 

draw a random sample of 147 non-certified research administrators. Sixty-eight (68) of the individuals 

included in the list of 1,101 were deleted since they were already included in the certified 

research administrator sample population. The author of this paper was also deleted from the list 

of 1,101, leaving a total 1,032 non-certified research administrators based in the Southeast region 

of the NCURA from which a random sample of 147 was drawn. This resulted in 126 verified and 

willing participants. 

Since there were more non-certified research administrators based in the Southeast region of 

NCURA to draw a random sample from, a second random sample of 21 was drawn in an effort 

to identify more respondents. The list the second random sample of 21 was drawn from was 

narrowed to 885 after the 147 from the first random sample were eliminated from the list. The 

second random sample resulted in 17 additional potential respondents that could be verified. Of 

the remaining 4 individuals identified in the second random sample, 2 could not be located, and 2 

were unresponsive. Contact information was verified, edited, and resulted in a final count of 143 

non-certified research administrators based in the Southeast region of NCURA. 

A total of 277 potential respondents comprised the overall sample population for this study. 

134 were identified as certified research administrators, and 143 were identified as non-certified 

research administrators. Each potential respondent was contacted by telephone or e-mail and notified 

that this study was in progress. Confirmation of contact information for all potential respondents 

was checked for accuracy and edited as necessary. 

A third random sample of 5 was drawn from the list of non-certified research administrators after 

a situation arose subsequent to the initial distribution of the survey instrument. One of the potential 

respondents indicated it was the policy of that particular institution to receive Institutional 

Review Board approval for any study involving students or employees of that institution. Despite 

already having obtained the appropriate Institutional Review Board approval, the researcher 

was asked to refrain from sending additional surveys to students or employees of that particular 

institution unless Institutional Review Board approval from that particular institution was obtained 

for this study. Considering this circumstance the researcher elected to draw a third random 

sample of 5 since all the potential respondents from this institution were non-certified research 

administrators who could be replaced. One individual from this particular institution had already 

freely responded to the initial survey invitation, so their response was maintained. The researcher 

complied with the request from this institution by not resending the survey to any potential 

respondent from that institution. Contact information for all 5 of the potential respondents from 

the third random sample were verified, notified of the study, and identified themselves as willing 

participants in the study after being contacted by the researcher. 


In summary, the population of respondents for this study included 277 research administrators 

based in the Southeastern region of the National Council of University Research Administrators 

(NCURA). 

Summary and Discussion of the Findings 

The summary findings and discussion of the data collected for the five research questions of this 

study are presented below: 

Research Question 1 

Papers 

What is the perception of certified research administrators compared to non-certified research 

administrators in regard to the value of certification? 

The relationship between the demographic characteristics of research administrators and the level 

of agreement in regard to the perceived value of the Certificate in Research Administration (CRA) 

was analyzed to determine if perceptions of value were different between CRAs and non-certified 

research administrators. There was a statistically significant difference (

Papers 


What is the relationship of demographic characteristics to the attainment of certification? 

Age, educational level, salary, and length of employment in the field of research administration 

were the demographic characteristics selected to compare the perceived value of certification between 

CRAs and non-certified research administrators. 

In regard to the demographic characteristic of age, there was a statistically significant relationship 

(

Papers 

The summary findings and discussion of the data collected for the eight characteristics are presented 

below: 

1. Eighty-five percent (85%) of the certified research administrators (CRAs) agreed or strongly 

agreed that others more fully recognize their ability to perform their job compared to 50% of the 

non-certified research administrators. This perception is consistent with the perceived value of 

certification being greater for CRAs than non-certified research administrators. Although there is 

a significant difference in perception between CRAs and non-certified research administrators, the 

majority of non-certified research administrators still agreed or strongly agreed that others would 

more fully recognize their ability to perform their job. 

2. Seventy-nine percent (79%) of the CRAs agreed or strongly agreed that their prestige among 

individuals within their organization increased as a result of becoming certified compared to 43% 

of non-certified research administrators. This perception is consistent with the perceived value of 

certification being greater for CRAs than non-certified research administrators. The majority of 

non-certified research administrators did not perceive certification making a difference in terms of 

increased prestige among individuals within their organization. 

3. Seventy percent (70%) of the CRAs agreed or strongly agreed that their prestige among individuals 

outside their organization increased as a result of becoming certified compared to 61% of 

the non-certified research administrators. Although there was a small difference in perception between 

CRAs and non-certified research administrators in regard to this characteristic, the majority 

of non-certified research administrators positively perceived the value of certification in terms of 

prestige among individuals outside their organization. 

4. Sixty-seven percent (67%) of the CRAs agreed or strongly agreed that their prestige among 

superiors within their organization was greater as a result of becoming certified compared to 45% 

of the non-certified research administrators. This perception is consistent with the perceived value 

of certification being greater for CRAs than non-certified research administrators. The majority 

of non-certified research administrators did not think certification made a difference in terms of 

prestige among superiors within their organization. 

5. Fifty-percent (50%) of the CRAs indicated no difference in regard to certification being beneficial 

in terms of increased professional opportunities for contributions compared to 46% of the 

non-certified research administrators. Forty-eight (48%) of the non-certified research administrators 

agreed or strongly agreed that they perceived a benefit. The perceptions of both CRAs and 

non-certified research administrators were similar in regard to certification being beneficial in 

terms of increased professional opportunities for contributions, but slightly more non-certified 

research administrators agreed or strongly agreed that there was a perceived a benefit. 

6. Fifty-seven percent (57%) of the CRAs indicated no difference in regard to certification leading 

to increased job responsibilities as a result of certification compared to 61% of the non-certified 

research administrators. The perceptions of both CRAs and non-certified research administrators 

were similar in regard to certification leading to increased job responsibilities. 

7. Thirty-nine percent (39%) of the CRAs agreed or strongly agreed that their salary increased as a 

result of becoming certified compared to 30% of the non-certified research administrators. Fiftyfive 

percent (55%) of the CRAs indicated no difference that their salary increased as a result of 

becoming certified compared to 56% of the non-certified research administrators. The perceptions 

of both CRAs and non-certified research administrators were similar in regard to certification 

leading to an increase in salary. 


Papers 

8. Twenty-nine percent (29%) of CRAs agreed or strongly agreed that they would receive a promotion 

as a result of becoming certified compared to 31% of non-certified research administrators. 

Sixty-six percent (66%) of the CRAs indicated no difference that they would receive a promotion 

as a result of becoming certified compared to 55% of the non-certified research administrators. 

The perceptions of both CRAs and non-certified research administrators were similar in regard to 

certification leading to a promotion. 

The summary findings and discussion of the data collected for enhanced knowledge and confidence 

are presented below: 

In terms of enhanced knowledge, 74% of the CRAs indicated they do feel more knowledgeable as 

a research administrator as a result of becoming certified compared to 40% of the non-certified 

research administrators. Although there is a significant difference of perception between CRAs 

and non-certified research administrators, the majority of non-certified research administrators 

still indicated they would feel more knowledgeable as a result of certification. 

In terms of confidence, 74% of the CRAs indicated they felt more confident in their ability to do 

their work as a result of becoming certified compared to 36% of the non-certified research administrators. 

Thirty-eight percent (38%) of non-certified research administrators indicated they would 

not feel more confident in their ability to do their work as a result of certification. 


What reasons, if any, do non-certified research administration professionals give for not attempting 

certification? 

Eighty-two percent (82%), or 96 of 117, of the non-certified research administrators provided a 

reason for not attempting certification, with 40%, or 38 of 96, indicating they did not believe there 

was any benefit to becoming certified. There was a tie for the second most popular reason for not 

attempting certification, with not having enough time and not being aware of the opportunity to 

become a CRA each garnering 11%, or 11 of 96, of the responses of reasons for not attempting certification. 

Despite the perception of the majority of non-certified research administrators doubting 

the value of certification, some of the reasons provided by non-certified research administrators 

suggest they are not opposed to the concept of becoming a CRA. As examples of this, none of the 

following are individual objections to the concept of certification: (1) a current employer does not 

support a research administrator’s effort to become certified, (2) a research administrator is not 

eligible to sit for the exam, and (3) a research administrator takes the exam but does not pass. 

Overall, the majority of non-certified research administrators do not believe there is benefit to becoming 

certified. However, when all the other reasons for not attempting certification are closely 

examined, the responses taken as a whole indicate that as many non-certified research administrators 

may perceive a benefit to becoming certified as those who do not perceive a benefit. These 

data indicate that non-certified research administrators perceive some benefit to certification. 



What relationship, if any, exists between the value placed by certified and non-certified research 

administrators in a supervisory role when they evaluate the qualifications of applicants for positions 

in research administration? 

The relationship between the value placed by certified and non-certified research administrators 

in a supervisory role when they evaluate the qualifications of applicants for positions in research 

administration and the perceived value of the Certificate in Research Administration (CRA) were 

analyzed. These data revealed that there is a statistically significant difference (

Papers 

individuals outside their organization increasing as a result of becoming certified and others 

more fully recognizing their ability to perform their jobs. These findings lead to the conclusion 

that research administrators did not believe that their organizations internally value certification, 

whereas research administrators did perceive value external to their own organizations. 

In terms of feeling more knowledgeable as a result of certification, 83% of CRAs and 45% of 

non-certified research administrators’ believed they would feel more knowledgeable as a result of 

certification. Despite this significant difference in perception, the majority of both CRAs and noncertified 

research administrators perception was that becoming certified would, or did, enhance 

their knowledge as research administrators. 

The research revealed some differences in the perception of value of the CRA in terms of research 

administrators feeling that their prestige among individuals within their organizations would 

increase and their prestige among superiors within their organization would increase as a result 

of becoming certified. CRAs overwhelmingly agreed or strongly agreed that their prestige was 

enhanced within their organizations, and non-certified research administrators perceived there 

would be no difference in their prestige. This leads to the conclusion that CRA’s perception of 

value is greater than that of non-certified research administrators’ perception of value in prestige 

among individuals and superiors within their organizations. 

The research revealed two additional subtle differences in the perception of value in terms of 

increased professional opportunities to contribute and increased confidence in their ability to 

perform their work as a result of certification. Slightly more non-certified research administrators 

agreed or strongly agreed that certification would increase their professional opportunities for 

contributions, whereas CRAs perception was that there would be no difference in their opportunities 

for professional contributions. There was also a minor difference in feeling more confident in 

ability to do their work as a research administrator, with slightly more non-certified research administrators’ 

perceiving they would not feel more confident compared to CRAs dominant perception 

that they did feel more confident in their ability to do their work as a research administrator. 

Implications and Recommendations for Professional Organizations 

The National Council of University Research Administrators (NCURA) and the Society for 

Research Administrators International (SRA) are the two primary professional organizations 

dedicated exclusively to the field of research administration. Research administrators’ perceptions 

of NCURA and SRA professional development opportunities are extremely positive with 90% of 

respondents reporting positive or extremely positive experiences with professional development 

opportunities offered through these organizations. The Research Administration Certification 

Council (RACC) was established in conjunction with the SRA; however, there is no association 

with NCURA, and since the establishment of RACC in 1993 there has not been a strong coordinated 

effort between RACC and SRA that has been recognized by research administrators as being 

of vital importance to them personally or the profession in general. Professional organizations 

could potentially benefit from offering certification programs to research administrators through 

financial gain and being recognized as positively serving their membership (Knapp and Gallery, 

2003). 

There are many perceived positive implications of certification among research administrators, 

including enhanced prestige among individuals outside one’s own organization and enhanced personal 

knowledge. If RACC is to be widely recognized as a value to individuals and their respective 

institutions, it needs to be more closely aligned with the professional organizations that research 

administrators report having positive professional development experiences. Since the professional 

field of research administration emerged, it has consistently grown larger, and universities 


have been forced to pay close attention to the administration of research dollars and the fostering 

of the research enterprise in general. It is reasonable to assume hiring the most knowledgeable 

research administrators would be a high priority to universities. Since the vast majority of research 

administrators enter the profession with little or no experience in the field, it should be extremely 

important to employers to have high quality and comprehensive professional development opportunities 

readily available for newcomers to the field. 

Even though both CRAs and non-certified research administrators doubt the value of certification 

in terms of increased job responsibility, promotions, and salary, CRAs report earning more money 

on an annual basis than do their non-certified counterparts. The only exception is those earning 

more than $80,000 annually. The majority of those earning more than $80,000 annually are not 

certified, and it is concluded that those individuals do not feel they need to become certified. 

In summary, a comprehensive certification program in the professional field of research administration 

has strong potential to serve individuals, organizations, and sponsors of research in an 

effective and positive way. In order to accomplish this, a comprehensive certification program 

should be closely aligned with the two major professional organizations dedicated exclusively to 

the professional field of research administration. 

Recommendations for Future Research 

Further research is suggested in the following areas: 

Papers 

1. It is recommended that a replication of this study be done in another region of the United 

States to further validate the results. 

2. It is recommended that a replication of this study be done on an international scale to further 

validate the results. 

3. It is recommended that research be conducted to determine if curriculum at the university 

level should be developed in research administration management. 

4. It is recommended that the primary professional organizations in support of research administration 

engage in research to determine how many people are involved in the profession of 

research administration to help make decisions in regard to continuing adult education. 

5. It is recommended that research be conducted focusing on the employers of research administration 

professionals to determine if they would value being served by a Certified Research 

Administrator (CRA) through the Research Administrators Certification Council (RACC). 

6. It is recommended that the primary professional organizations in support of research administration 

engage in research about specific needs and preferences of their membership. 


Papers 

References 

Bratton, B. & Hildebrand, M. (1980). Plain talk about professional certification. Instructional 

Innovator, 25(9). 

Galbraith, M. W. & Gilley, J. W. (1986). Professional Certification: Implications for adult education 

and HRD. Clearinghouse on Adult, Career and Vocational Education, National Center Publications, 

National Center for Research in Vocational Education, Columbus, Ohio. 

Galbraith, M. W. & Gilley, J. W. (1985). An examination of professional certification. Lifelong 

Learning, 9(2). 

Gilley, J. W. & Galbraith, M. W. (1986). Examining professional certification. Training and Development 

Journal, 40(6). 

Hansen, S. & Moreland, K. (2004). The Janus face of research administration. Research Management 

Review, 14(1). 

Mason, I. W. (1984). Influence of the certificate in data processing on career development (Doctoral 

dissertation, Arizona State University, 1984). Dissertation Abstracts International, 45, 3685. 

McCue, D. L. (2003). The National Association of Industrial Technology Certification exam: 

Quality control assessment using item response theory and classical test theory methodologies 

(Doctoral dissertation, Iowa State University, 2003). Dissertation Abstracts International, 64, 

3224. 

National Council of University Research Administrators (2005). National Council of University 

Research Administrators Database, Accessed February 9, 2005, One Dupont Circle NW, Suite 

220, Washington, DC. 

Parker, W. & Smith, G. (2004, November). Certification as a predictor of quality performance. 

Paper presented at the National Organization for Competency Assurance, Miami, FL. 

Penland, P. R. (1982). Certification of school media specialists. Journal of Research and Development 

in Education, 16(1). 

Research Administrators Certification Council (2005). Retrieved February 26, 2005, from the 

World Wide Web: http://cra-cert.org/Default.htm 

Research Administrators Certification Council (2004). Retrieved November 16, 2004, from the 

World Wide Web: http://cra-cert.org/activecra.htm 

Research Administrators Certification Council (2004). Retrieved March 27, 2004, from the World 

Wide Web: http://cra-cert.org/Default.htm 


Why do ethical scientists make unethical decisions? 

Debra S. Schaller-Demers, BA 

Education Coordinator, Research Integrity 

Weill Medical College of Cornell University 

Research Compliance Division 

425 East 61 Street, Suite 301 

New York, New York 10021 

212 821-0675 

des2010@med.cornell.edu 

Author’s Note: 

I would like to acknowledge Sheila C. Zimmet, BSN, JD, Associate Dean (Research Compliance) at 

Weill Medical College of Cornell University for providing me with confidence, support and sharing 

her keen legal insights into the puzzling web of scientific misconduct. Additionally, I would 

like to acknowledge Jeffrey Cohen, PhD for introducing me to SRA and getting me “hooked” 

on RCR education in the first place, and Michael Zigmond and Beth Fisher of the University of 

Pittsburgh and all the participants at the 2005 Teaching Survival Skills and Ethics conference for 

showing me that there are many educators, administrators and scientists world-wide dedicated to 

the cause. 

Abstract 

Papers 

In light of the ever-increasing number of cases of research misconduct being highlighted in the 

media, this paper looks to consider what conditions exist that cause supposedly ethical scientists 

to make blatantly unethical decisions. Looking to understand the ethical breaches illustrated in 

some of the more publicized cases, three things become apparent. One is the need to explore basic 

core values, second is to agree on common definitions and concepts, and third is to recognize the 

many outside forces that may have influence on ethical conduct and decision-making. Can common 

moral ground among ideology, pedagogy and reality be found through mandatory ethics 

training? Free will and choice are part of the human condition - what are the forces that impact 

the ethics of those choices and how do we as a societal collective react when our revered scientific 

role models fall short? 


Papers 

Never let your sense of morals get in the way of doing what’s right. 

~ Isaac Asimov 

In December of 2002, the Office of Science and Technology Policy defined research misconduct 

as “fabrication, falsification, or plagiarism (FFP)—the “high crimes”—in proposing, performing 

or in reviewing research results (OSTP.gov). However, as discussed below some commentators 

suggest there is a much wider—and grayer—area of misbehaviors and faulty decisions that are not 

captured in this limited definition. If these troubling practices are allowed to continue unchecked 

they will eventually erode any attempt to establish a solid foundation of responsible conduct of 

research. 

Martinson, Anderson, and de Vries (2005) state that serious misbehavior in research is important 

for various reasons, not least because it damages the reputation of, and undermines public support 

of, science. They suggest that, in light of the public’s penchant for headline grabbing cases 

of scientific and medical misconduct, the research community can no longer afford to ignore the 

ever-widening array of integrity issues. 

The question always is: “Why?” 

Martinson, Anderson, and de Vries (2005) surveyed several thousand early- and mid-career US 

scientists funded by the National Institutes of Health (NIH) and asked them to report their own 

behaviors. Although the survey did not attempt to link specific behaviors to specific incidents, the 

results yielded a range of questionable practices, which forces one to examine more closely the 

“negative aspects of the research environment.” 

The modern scientist faces intense competition for limited research grants, which can create many 

scenarios for compromise that, extend well beyond FFP (Martinson, Anderson, and de Vries, 

2005). The survey authors state: “In ongoing analysis, not yet published, we find significant associations 

between scientific misbehavior and perceptions of inequities in the resource distribution 

processes in science.” These behaviors undermine the scientific process, could lead to “misuse of 

public monies,” and generally foster an environment that lacks integrity (Mitchell, 2005). Lower 

(2005) is more blunt: “Corporate America provides a research environment that is not particularly 

conducive to good scientists or good science.” 

I suggest that there is more to the issue than a simple succumbing to the pressures of “publish or 

perish” or the demand “show me the money.” One needs to consider from where core belief systems 

come and how they may be affected by outside influences. 

Values, beliefs, moral, ethics and integrity are intricately interwoven concepts and are consistently—albeit 

mistakenly—used synonymously. Benefiel (n.d.) says that values are learned from 

childhood. These are the beliefs that children absorb from those who raise them and from their 

immediate surroundings. Benefiel (n.d.) goes further to say that morals are the intrinsic beliefs developed 

from the value systems of how one “should” behave in any given situation and that ethics 

are how one actually does behave in the face of difficult situations that test one’s moral fiber. 

Kidder (2005) talks about moral courage as, simply, the courage to be moral. To be considered 

moral, he says our moral fiber must adhere to one of five core moral values: honesty, respect, 

responsibility, fairness and compassion. As one attempts to examine past incidences of scientific 

misconduct, the inherent breaches of research integrity, and the prevailing conditions that cause 

ethical scientists to make unethical decisions, one needs to understand these basic or core values, 

agree on some common definitions, and recognize the influence of outside forces. 


Papers 

Kidder (1995) notes four basic paradigms of ethical decisions: 1) justice versus mercy – fairness, 

equity and even-handed application of the law often conflict with compassion, empathy and love; 

2) short-term versus long-term – difficulties arise when immediate needs or desires run counter to 

future goals or prospects; 3) individual versus community – this can be restated as us versus them, 

self versus others, or the smaller group versus the larger; and 4) truth versus loyalty – honesty or 

integrity versus commitment, responsibility, or promise-keeping. 

Certainly any of these paradigms, if not several, can be applied when examining the motivation of 

those who commit unethical scientific acts. In the case of the University of Vermont and researcher 

Dr. Eric Poehlman, it was determined by federal prosecutors that Dr. Poehlman committed 

scientific misconduct by falsifying and fabricating research data in numerous federal grant applications 

and in academic articles from 1992 to 2002. According to a Boston Globe article (Goldberg 

and Allen, 2005), this was “the worst case of scientific fakery” to come to light in two decades. Colleagues 

of Dr. Poehlman, a top obesity researcher, speculate that either he buckled to an exaggerated 

perception of the pressure to publish papers and win grants to keep his laboratory going, or 

he was just so sure that he knew the right answers that he cut corners to get them. 

According to a Boston Globe article (Goldberg and Allen, 2005) one of Dr. Poehlman’s lab technicians 

offered that he could not be sure what Dr. Poehlman was thinking, but that the benefits were 

clear – the fabricated data made his grant proposals more appealing and his papers more publishable, 

thus enabling him to be one of the better-funded researchers at the University of Vermont. If, 

in fact, Dr. Poehlman manipulated the system to maintain his lab, his determination to preserve 

what he had created overrode the necessity to learn and publish the truth. 

Karcher (2004) contends that integrity is choosing ethics above personal benefit. The fact that “everybody 

does it” or “no one will ever know” is irrelevant. Actions should be based on values rather 

than personal gain. The question becomes muddled—and perhaps more than slightly rhetorical—if 

one’s value system puts personal gain above all else. Hymes (n.d.) states that people breach 

or ignore their respective code of ethics for the very base reason of greed. Greed, whether viewed 

as lusting after financial gain, material goods, knowledge, fame or power can be a major motivating 

factor for breaking or overlooking ethical boundaries. 

I suggest that lusting for scientific fame (e.g., a Nobel Prize) was the motivation in both the 1984 

case of Dr. Robert Gallo, famed NIH researcher who claimed to have discovered the AIDS virus, 

and the more recent case surrounding the death of 18-year-old Jesse Gelsinger, who died in a gene 

therapy experiment led by Dr. James Wilson of the University of Pennsylvania. 

In both of these instances the motivation to achieve that-which-had-yet-to-be-done was a driving 

force for breaking the rules. 

Those involved in the thick of the Gallo debacle felt powerless to reverse the course of events. The 

prevailing political climate of ignorance and denial created a scenario in which many in the US 

and abroad were forced to watch in horror as the number of AIDS related deaths began to climb, 

while scientists on both sides battled for scientific superiority. How many died needlessly while 

patent issues were being fought in the courts? 

Luc Montagnier of the Pasteur Institute of Paris, whose lab many now acknowledge discovered 

the virus, is quoted as saying, “Scientists in the US are forced to produce results, which sometimes 

warps their sense of ethics” (Caton, 1995). This is consistent with the Martinson, Anderson, and 

de Vries survey results – that intense competition forces otherwise respectable scientists to act 

unethically to widely varying degrees. 


Papers 

Lakoff (2002) describes integrity as the virtue of being morally whole. In his view someone with 

integrity has consistent moral principles, and suggests that it is the overall unity of moral principle 

that makes someone with integrity strong. 

Yet how strong does a young scientist have to be to stand up to and blow the whistle on a worldrenowned 

figure such as Gallo? Or stand up to one’s graduate advisor, mentor or lab director in 

a school setting? The power imbalance can be crushing—and it can destroy a career before it has 

begun. Is such strength too much to ask when society is unwilling to take such a stand? 

Harris (1998) adds the genetics element into the morality mix. She claims that the long-held 

notion that a child’s personality or “character” is shaped or modified by his or her parents is not 

completely valid. Alternatively she claims there are two far more overpowering influences: one 

being genetics and the other being the influences experienced outside of the home. She contends 

that parents do not socialize children, that children socialize children and therefore outside peer 

groups have a more powerful influence than parents. 

Perhaps an argument can be made here about the influence of adult peer groups as well. If the scientific 

community as a whole is not willing to take a dramatic stand against breaches of scientific 

integrity—as illustrated by the dearth of peers in the scientific community willing to testify against 

Robert Gallo or the US government agency that was supporting the work—then what message is 

being sent? Is it that we as scientists know what we are doing and it is for a nobler purpose, therefore 

it is not necessary or warranted to punish those who cross the line in the name of the greater 

good of furthering science? This might be argued under a Utilitarian approach, doing the best for 

the greatest number, but certainly not from the perspective of moral rights. How many innocent 

subjects and patients were trampled in the race to be “first”? 

Lower (2005) argues that it is time for the people to demand honesty and integrity in science. He 

faults what he calls “religious capitalism” for creating an unethical abyss into which many have 

fallen. He is not surprised that this seeming eruption of corruption in American science has come 

to surface under the George W. Bush administration. Lower suggests that there is plenty of evidence 

that the Bush administration appears to be on a mission to systematically eliminate honest 

scientists. Sweet (2002) feels that this is particularly true for scientists with the courage to disagree 

with policies set forth by an administration with an agenda—hidden or otherwise. Sweet offers as 

examples that two existing scientific committees were purged for opposition to the White House 

political and/or religious points of view: one studying federal protections for human research subjects 

is said to have angered Bush’s radical religious supporters and the other committee—charged 

with helping to protect public health—was jettisoned because it recommended that the FDA 

expand its regulation of the genetic testing industry, which had been previously free of oversight 

(Sweet, 2002). 

In light of the building instances of “political interference” in scientific research, how can we expect 

to change behaviors that positively impact ethical decision-making? What are the rewards for 

“doing the right thing” when government has a slanted view of what is the right thing? 

The messages are mixed at best. Many institutions (such as my own) mandate ethics training for 

trainees and/or specialized human subjects training for anyone submitting a protocol to the IRB. 

We compel student scientists to attend a fixed number of sessions and complete a specific number 

of online assignments on various topics relating to the responsible conduct of research (RCR). This 

is very fine. We can state with a clear conscience that X-number of trainees completed some sort of 

ethics instruction in a given year. 


Papers 

The more troubling question is what impact, if any, does such mandatory training have on future 

behaviors and decision-making? Do our trainees make more ethical choices? Are we creating and 

supporting an institutional culture that encourages, nurtures and enables ethical science? Or is it 

an illusion? 

I like to think that we work hard to create educational and professional venues, which support “doing 

the right thing because it is simply the right thing to do.” Yet sometimes perception and reality 

are two separate things. 

As Fuchs and Macrina (2005) suggest, once we enter the realm of moral reasoning, we base judgments 

on what we ought to do and we assume that this is the right thing. Yet, acting morally is not 

always akin to acting legally. History is filled with indiscretions that, at the time, were legal but today 

would be considered highly unethical—if not outright unlawful. Fuchs and Macrina state that, 

in order to avoid repeating these historical breaches, scientists must strive to carefully examine the 

moral dimensions of current research practices. It is no longer a matter of abiding by the regulations. 

The regulations do not always cover every nuance, and—in the opinion of some—regulators 

are suspect at best because of questionable political and/or religious affiliations (Lower, 2005, 

Sweet, 2002, Crewdson, 1995). This is illustrated not only by the Gallo case orchestrated under the 

Reagan administration’s watch, but most certainly by the ongoing interference of the current Bush 

administration as well. 

The public trust is fragile. Once shattered it is difficult to repair. Perception is the key—sometimes 

it is the mere hint of a possibility of wrongdoing that can be the catalyst for disaster. Hoey (2003) 

cites that the problem in the Gelsinger case was not one of uninformed consent, misleading protocols, 

publication gag clauses, or the like. Rather, the issue became one of public perception. Once 

the family filed a suit against the University of Pennsylvania (UPenn), it was learned that James 

Wilson, the lead investigator, was also the president and major shareholder of the private company 

that held patents for the procedure in question and funded the research. It also was discovered 

that the university and some members of the board of governors also owned stock in the firm. 

Although, Hoey (2003) asserts that these factors had no direct bearing on Jesse Gelsinger’s death, 

UPenn quickly settled the suit and Wilson resigned his university post. UPenn went a step further 

by instituting strict guidelines for clinical research that would prohibit faculty from participating 

if they or close family members have a material financial interest in a private company whose 

product(s) they are evaluating. Many other institutions have followed with similar guidelines. 

Conflict of interest and commitment become a slippery slope for many researchers in search of 

funding. Guterman (2005) reports that over the past twenty years the proportion of research studies 

funded publicly has decreased significantly, while those supported privately have increased. 

This seems especially true in occupational and environmental health, where the field is dedicated 

to studying dangers to the public’s health and safety from the workplace and/or environment. 

Academic scientists in this field know that business interests increasingly drive research agendas 

(Guterman, 2005). The government seems to give this work low priority, and, so, scientists are 

forced to look to the private sector for research funding. How does the responsible scientist balance 

the paycheck with the findings that their sponsor’s product is actually a menace to public 

health and welfare? Guterman quotes Daniel T. Teitelbaum, a Denver doctor specializing in medical 

toxicology and occupational epidemiology, who says, “Industry doesn’t give you money to do 

research. Industry gives you money to do research that favors them.” 

Therefore are corporate sponsors the villains? The money has to come from somewhere, but at 

what price to the public trust? Many feel journal editors are equally culpable. Guterman argues 

that some journals in occupational and environmental health do not require authors to reveal 

their funding source or any other possible conflicts of interest. Shuchman and Wilkes (1997) also 


Papers 

place blame at the feet of irresponsible journalists who at best are careless in their reporting, if not 

deliberately misleading. Shuchman and Wilkes recommend that members of the research community 

take an active role in ensuring honest reporting. They suggest that scientists check institutional 

press releases for accuracy and clarity; medical journals and sponsors of medical meeting 

should seek expert advice to place new information in the proper context; the scientific community 

must inform journalists of any potential conflict of interest; and finally, industry sponsorship 

of research and persons who speak or write about a research should be identified as such. 

I agree that research integrity issues are multi-faceted. There are many stakeholders, and these are 

not problems for researchers to tackle alone. All of us in the research community have a voice and 

an important role to play. As Martinson remarked at the conclusion of his survey, “We should be 

asking what kind of aspects in science are fostering [these questionable practices] and are there 

ways of addressing them to make them better” (Mitchell, 2005). 

As citizens in a democratic society, we have a duty to hold issues of integrity—in science, business, 

politics, education, or elsewhere—to a very bright light. If we fail to do so, those who suffered and 

perished as result of the Nazi WW-II experiments, were deceived in the Tuskegee Study of untreated 

Syphilis, or fell victim to research delays in the early—or present—days of the AIDS epidemic, 

did so in vain. To have learned these lessons, only to discard them for the sake of corporate greed, 

Nobel-Prize-blind-sightedness, journalistic sensationalism or religious dogma is unacceptable. 

Programs like the University of Pittsburgh’s “Survival Skills and Ethics” course have sought to address 

these issues for twenty years. They attempt to integrate ethics and the responsible conduct 

of research into every topic. The Department of Health and Human Services’ Office of Research 

Integrity offers institutions grant money to develop pilot programs to teach graduate students 

responsible conduct of research. The assumption is that if we make greater efforts to educate 

students about integrity issues, then the incidents of misconduct will be reduced. However, ethics 

education is not a one shot deal. 

My trainees in the Tri-institutional Responsible Conduct of Research Program (co-sponsored by 

Weill Medical College, Memorial Sloan-Kettering Cancer Center, The Rockefeller University since 

the early 1990’s) lament: You can’t force-feed someone ethics. You cannot transform someone into 

an ethical being in every instance by mandating course attendance and completion. 

Rather, ethics education is an ongoing life-long process that individuals must choose as a way of 

life and that peers, mentors and colleagues must model. Regulations change from administration 

to administration, but good science must remain unspoiled by the political flavor of the month. 

Can we find common moral ground among ideology, pedagogy and reality through mandatory 

ethics training? There is power in numbers and unity. For a single university to tackle this dilemma 

alone is as foolish as waiting for something to go drastically—and publicly—wrong. RCR 

training should not be viewed as “punishment.” Martinson cautions that it would be dangerous 

for a single institution to try and address research misconduct in isolation, because this could put 

them at a “distinct disadvantage” regarding competition for grants and other resources from other 

universities (Mitchell, 2005). As sad a commentary as that is, it is a reality that needs to be acknowledged 

and addressed in a way that does not dilute the importance of doing what is right for 

its own sake. 

To date there is no extant empirical data of which I am aware to support whether mandatory training 

affects ethical behavior and decision-making in a positive way. Of course, if I reach retirement 

without seeing my institution or one of my trainees in the headlines for scientific misconduct, that 

would be a victory of sorts. More over, I would be satisfied when I stop seeing cynical evaluation 


comments from trainees upon being “forced” to attend my RCR program. I strive for the day when 

the unanimous response will be – “Ethics – wow, this is great stuff – I couldn’t possibly imagine 

my life as a scientist (or a person) without it!” 

References: 

Benefiel, Z. (n.d.) Be the dream. Personal ethics and life. Organizational Ethics. University of 

Phoenix. Retrieved on June 28, 2005 from: http://www.bethedream.net/ethics.htm 

Caton, H. (1995). The AIDS Mirage. Junk sciences goes belly-up. Retrieved on June 27, 2005 from: 

http://www.ourcivilisation.com/aids/chap6.htm 

Crewdson, J. (1995, January 1). In Gallo case, truth termed a casualty. Report: Science subverted 

in AIDS dispute. Chicago Tribune. Retrieved on June 27, 2005 from: http://www/virusmth. 

net/aids/data/jcgallocase.htm 

Federal Policy on Research Misconduct. Office of Science and Technology Policy (OSTP). Retrieved 

on June 27, 2005 from: http://www.ostp.gov/html/001207_3.html 

Goldberg, C. and Allen, S. Researcher admits fraud in grant data. The Boston Globe. Retrieved on 

June 28, 2005 from: http://www.boston.com/news/nation/articles/2005/03/18/researcher_admits_fraud_in_grant_data/ 

Guterman, L. (2005, June 25). Occupational hazards. The Chronicle of Higher Education. Volume 

LI, Number 42. 

Harris, J. R. (1998) The Nurture Assumption. New York. Simon and Schuster. 

Hoey, J. (2003, August). Profits, pressure, and perception: Expensive research collides with medicine. 

The Journal of Rheumatology. Retrieved on June 28, 2005 from: http://www.jrheum. 

com/subscribers/03/08/1661.html 

Hymes, S. (n.d.) But whose ethics? Reading your ethical roadmap. Retrieved on January 20, 2005 

from: pmcoe.gsa.gov/.../But%20Whose%20Ethics_ Reading%20Your%20Ethical%20Roadmap. 

pdf 

Karcher, C. (2004, February). Following your moral compass in the workplace. Retrieved on June 

28, 2005 from: http://www.mrotoday.com/mro/archives/exclusives/MoralCompass.htm 

Kidder, R. M. (1995) How Good People Make Tough Choices. Resolving the Dilemmas of Ethical 

Living. Chapter One. Overview. The Ethics of Right Versus Right. New York. William Morrow 

and Company. Retrieved on June 27, 2005 from: http://www.globalethics.org/pub/toughchoices.html 

Kidder, R. M. (2005). Moral Courage. Chapter One. Standing up for principle. New York. William 

Morrow and Company. Retrieved on June 28, 2005 from: 

http://www.moral-courage.org/mc_chapter_one.html 

Lakoff, G. (2002). Moral Politics. How Liberals and Conservatives Think. 2nd Edition. 

The University of Chicago Press. 

Papers 


Papers 

Lower, G. (2005, June 27). When science lies, our nation dies: What can’t religious capitalism make 

meaningless? Science/Nature. Axis of Logic. Retrieved on June 28, 2005 from: http://www. 

axisoflogic.com/artman/publish/article_18818.shtml 

Macrina, F.L. (2005). Scientific Integrity, Third Edition. Fuchs, B. A. and Macrina, F. L. 

Chapter 2, Ethics and the Scientist. Washington, DC. ASM Press. 

Martinson, B. C., Anderson, M. S. and de Vries, R. (2005, June 9). Scientists behaving 

badly. Nature. 435. 

Mitchell, S. (2005, June 8). Research misbehavior may be widespread. Retrieved on June 

9, 2005 from: http://www.sciencedaily.com/upi/index.php?feed=Science&article=UPI-1- 

20050608-13433000-bc-us-badscientists.xml 

Shuchman, M. and Wilkes, M. S. (1997, June 15). Medical scientists and health news 

reporting. A case of miscommunication. Annals of Internal Medicine. Volume 

126. Issue 12. 

Sweet, F. (2002, October 10). The Purge of Bush science. Intervention Magazine. 

Retrieved on June 28, 2005 from: http://www.interventionmag.com/cms/modules.php?op=mo 

dload&name=News&file=article&sid=207 


The Ups and Downs of Collaborative Ventures: 

A Case Study on Being a Collaborator 

Marie F. Smith, CRA 

Institute of Ecosystem Studies (IES) 

PO Box AB, Millbrook, NY 12545. 

Telephone: 845-677-7600 x202. 

Fax: 845-677-5976. 

E-Mail: Smithm@ecostudies.org. 

Abstract 

Successful scientists work in teams, with their productivity relying on effective teamwork among 

collaborators. When everything goes well, collaborations result in higher quality research than could 

have been accomplished by scientists working alone (Kotok, 2004). 

As Research Administrators, we seek to facilitate collaborative ventures while protecting the interests 

of the institution and the institutional research investigator. Collaborative relationships are 

often very complex and may involve new relationships between both investigators and institutions. 

As with any new relationship, trust and familiarity are not yet been firmly established. Understanding 

the nature of collaborations is an essential tool for the effective Research Administrator. 

In order to gain insight into collaborative relationships and to better understand the process, first 

hand knowledge of the intricacies of collaboration can be invaluable. This is why being part of a 

collaborative relationship can be edifying, can give a greater appreciation of the rewards and pitfalls 

of collaborations, and can provide greater insights to enhance the former and avoid the latter. 

The goal of this paper is to share with other administrators the lessons learned and insight gleaned 

as I became a collaborative insider, including a: 

• Better awareness of the complexities of collaboration of ideas, authorship issues, personality 

differences, power relationships; 

• Better understanding of what I am trying to facilitate in the agreements that I write and manage, 

and 

• New empathy for those whose collaborations are made possible by the agreements that I write. 

Introduction 

Background 

Papers 

Fishbough, 1997 defines a collaboration as a formal body established by two or more autonomous 

partners, none of whom are, as a rule, under personal contract to another but whose aim is to attain 

substantive or symbolic goals that no other partner could achieve independently. Spurred on 

by the Patent and Trademarks Laws of 1980 (PL 96-517), commonly referred to as Bayh Dole, and 

the funding criteria change implemented by federal agencies, such as the National Science Foundation, 

multi-organizational research is on the rise (Murphy et al., 2004) and is becoming more 

complex as it becomes more diverse and increasing in size (Likens, 2001). 

The increase in collaborative ventures is responsible for a steadily growing number of agreements 

that lay the institutional groundwork for these collaborations. Therefore, the need to understand 

the intricacies of the collaborative mechanism is an important component of research administration 

because it will enable the administrator to structure agreements that facilitate rather than 

hamper these relationship by not overshadowing the function it is designed to accommodate 

(Smith, 2004). 


Papers 

Institute of Ecosystem Studies 

Founded in 1983, the Institute of Ecosystem Studies (IES) combines research and education in fulfillment 

of its scientific mission and is one of the largest ecological programs in the world. Roughly 

it is the size of an academic department in a large university, but it functions independently. Being 

this size offers opportunities that would be more difficult to attain in a large university setting. 

Nonetheless, this experience opened my eyes to the complexities involved in collaborative ventures. 

Not unlike many research organizations, IES is experiencing a rise in collaborative ventures, 

although collaboration among the faculty at IES has always been encouraged and is part of the 

culture of IES. The faculty at IES is part of many collaborative projects, which include: 

• Hudson River research projects, 

• Lyme Disease and the Ecology of Infectious Diseases, 

• Ecosystem Engineering, Invasive Species, 

• Synthesis, and Prediction in Understanding Ecosystems, and the 

• Baltimore Ecosystem Study Long -Term Ecological Research (LTER) project sponsored by the 

National Science Foundation (NSF). 

The Founder, Director and President of IES, Dr. Gene E. Likens, with Dr. F. Herman Bormann and 

colleagues, initiated the Hubbard Brook Ecosystem Study (currently an NSF LTER site) in 1963. 

He has been involved in numerous collaborative ventures, and has written extensively on the subject 

(see Likens 2004 in a recent summary published in Ecology). 

Inside the Collaborative Process 

The Nature of the Collaboration 

In 2004 I initiated a discussion group at IES on the Responsible Conduct in Research (http://www. 

ecostudies.org/responsible_conduct.html). This brought me together with our research scientists 

in a new and different context. The collaboration took the form of working with faculty and other 

staff members to write some of the case studies for discussion. Later, we decided to author a paper 

to share our experience. 

Being a neophyte in the area of collaborative relationships, I learned many valuable lessons, giving 

me a better understanding of the complexities (e.g. authorship, ownership of ideas, power relationships, 

personality differences), motivations, protocols and dynamics that each of these relationships 

entails. This insight has been useful in structuring the contractual agreements that protect 

the interests of the organization and the investigators, while maintaining a positive relationship 

among the parties involved. It is imperative that neither the negotiating process nor the agreement 

results in an adversarial association that strains the collaborative relationship. The agreement 

needs to be a well-structured document that serves the best interests of all parties, including the 

funding agency and recipient of the support. 


Benefits of Collaboration 

Loan-Clarke & Preston, 2002 describe the benefits of collaboration as including: 

• More effective use of individual talents. A collaborative relationship helps ensure the availability 

of a wide-range of complex skills, techniques and knowledge necessary to complete a 

project and/or solve a particular problem. 

• Knowledge and skill transfer. Collaboration facilitates the transfer of tacit knowledge while 

honing the participant’s social and management skills. Teamwork is hard to teach in a classroom 

but is best learned by participating and engaging in team activities, (although I would 

add, that exposure to both venues provides the best teaching tool). 

• Stimulation and Creativity. Collaboration is synergistic. New insights and perspectives often 

result from the exchange and/or clash of views and ideas. 

• Networking. Collaborations offer opportunities to make new contacts, broaden one’s knowledge 

base, give differing perspectives and increase productivity. 

• Intellectual Companionship – Collaborations can help participants overcome the isolation 

that is sometimes associated with research. 

• Enhanced Dissemination of ideas – Presentations and publications that result from collaborations 

usually increases in number, which leads to the findings being disseminated to a wider 

audience. Increased distribution leads to the likelihood of the findings having a greater impact. 

To this list, I would add necessity. Often the need for expertise to complete a project brings people 

of varying fields and disciplines together. 

Although my experience is not broad enough to comment on all of the benefits cited by Loan- 

Clarke & Preston, I concur that the collaborative efforts add a dimension and depth to our writings 

that would have not been present otherwise. The interaction among the members of the collaborating 

team proved to be stimulating and enhanced the creative flow of ideas. The case studies and paper 

that are produced benefited from the team brainstorming and exchange of ideas and are much 

improved as a result. However, the greatest benefit to IES was the empathy that I gained for the 

process and the strengthening of a positive relationship between the faculty and the grants office. 

Challenges Faced 

Papers 

Functioning as part of a group has its own set of challenges and drawbacks, especially when most 

of the members are researches working off-campus, traveling, teaching and/or managing large 

research projects. Getting responses and comments from each of the co-authors was not always 

instantaneous nor was it always gratifying. 

Forming and nurturing an effective, efficient, and collegial team is a continual challenge, which 

increases as the collaboration becomes larger more diverse; and often very little formal planning is 

given to this critical task (Likens, 2001). Collaborations, both large and small, face a wide variety 

of challenges, some of which are listed below (McGrath, 2004; Government-University-Industry 

Research Roundtable, 1999). 


Papers 

• Collaborative research projects provide cost savings to the funding agencies but can result in 

additional organizational costs. These increased costs are due to greater travel expenditures 

and material costs, if materials or equipment need to be transported to various locations. 

• Higher administrative costs. Negotiating, implementing and managing agreements for collaborative 

ventures require increased staff effort. 

• Collaborations place higher demands on time. More time is needed to prepare the proposal, to 

keep partners informed and to reach a consensus on data findings. 

• Challenges can arise from diverse organizational cultures. Each organization may place 

higher/lower priority on the project and disagree on associated commercial or ethical implications. 

The challenges that I faced in undertaking my collaborative venture were due to time and priority 

restraints. Although each of my collaborators felt the ideas we were communicating were important, 

there were times when the writing needed to be set aside to accommodate research projects, 

field work, scientific publications, travel schedules, proposal deadlines and a myriad of work-related 

demands. 

Despite the fact that electronic mail has made communicating across distances much easier and 

faster than in past years, networks go down, power goes out and then there are those electronic 

notes that mysteriously disappear in the black hole of cyberspace. I am not entirely sure if electronic 

communication is unreliable or if collaborators who fail to respond use this as a convenient 

scapegoat. In any event, it is important not to rely on only one form of communication. 

One of the biggest challenges I faced, however, was in writing and editing a paper that had the 

approval of all the collaborators. Disagreements and discussions were not limited to content or 

scope. Some of the lengthiest discussions centered on punctuation, grammar, topic headings, sentence 

structure and word placement. The hardest disagreements to resolve often centered on the 

small issues not the broader concepts, and the main difficulties that need to be resolved centered 

on the concern the authors had for getting the appropriate credit for their ideas and contributions. 

These concerns were complicated by differential power relationships among the participants, 

which was a revealing experience for me because it helped me gain insight into what goes on 

inside the collaborative grants that I manage. 

Lessons Learned 

The job of the Research Administrator is management for research not of research. Research 

should have as its goal the advancement of knowledge, and those institutions concerned with the 

“advancement of knowledge” need to have a truly nourishing climate for research. The institutional 

officers who are Research Administrators need to believe strongly in research and to argue for 

its existence. To do this, they must understand the process by which research is done (Woodrow, 

1978). 

Collaborations are part of the research process, and collaborations are hard work! Like all relationships, 

from marriages to business partnerships, they have their rewards and their drawbacks but 

the parties involved need to invest the time and effort necessary into making them work. Each 

member needs be a contributor. 


Papers 

Loucks-Horsley, et al (1998) wrote that successful collaborations share common implementation 

requirements: 

• Clear Focus of Activity. Every collaboration needs to have a focus and a purpose, a clear 

understanding, openly stated, of why they are there and what they are doing. Although the 

purpose can be fine-tuned along the way, the initial focus should be retained. 

• Size and Logistical Requirements. Cost and complexity have a definite relationship to the 

strength, longevity and effectiveness of a collaborative venture. As the number of partners 

increases so does the potential difficulty in reaching consensus and obtaining feedback. 

• Communication Mechanisms. An effective communication network must be established, 

whether it takes the form of local, regional or electronic meetings or a combination, the network 

must be setup and maintained. 

• Monitoring Progress and Impact. Effective collaborations take into consideration the needs of 

the partners and their contributions to the project. Someone must take the lead and the other 

partners need to contribute according to their assigned tasks and skill levels. This arrangement 

needs to be monitored and, in some cases, may need to be readjusted. 

Likens (1998, 2001) listed some fundamental characteristics desirable for successful team members, 

which includes: 

• Ability to trust and be trustworthy (trust), 

• Abundant common (or good) sense, 

• Creativity and willingness to share with the team, 

• Collective ability to make up deficiencies – Shared experiences, 

• Willingness to give the team time, 

• Personality – listens, enjoys working with others, is curious and interested, is open to new 

ideas and approaches, and 

• Serendipity – kismet and karma. 

To this list I would add respect and truthfulness. 

These characteristics along with team building strategies are the necessary ingredients to building 

successful teams. Some important team building strategies include training team leaders; mentoring 

by experienced team members; face to face communication outlining team and individual 

expectations; developing effective and efficient time management strategies; clear communication 

on team and individual expectations about responsibilities, priorities, openness and trust; 

clear understanding of roles and authorship order; using experience and commitment to fine tune 

common sense (a necessary ingredient for serendipity); and good administrative help in order to 

facilitate team function and accountability (Likens, 2001). 

It became apparent in the very early stages of our collaborative venture that, in order to be successful, 

the paper needed to be something that we all felt was important, that needed to be written 

and that we were willing to make the necessary contributions to see this project completed. Trust 

must be present among the partners. Well-defined roles and responsibilities help build that trust. 

Understanding and respect are also necessary ingredients. Collaborative partners need to know 

their strengths and weaknesses, their points of compatibility and disagreement. At times, you may 

agree to disagree, but it is essential to establish who takes the lead and who makes the decisions 

when divergent ideas prevail. 

Our collaborative writing venture was complicated by the fact that this was not a “normal” collaborative 

venture, in which the participants bring a particular expertise to the table. The fact that 

none of the participants had a “particular expertise” in this area tended to make the relationships 

somewhat more complicated. 


Papers 

How Administrators Can Help the Process and How the Process Helped Me 

Understanding the process makes facilitating the process easier. Participating in the process 

increases insight. Understanding and insight are useful tools to possess when tasked with writing 

research agreements, preparing proposals and managing subcontracts. Being part of the process 

has helped me step back and reevaluate some of the preconceptions I have had. 

Not all collaborators are the same; not all institutions are the same. Some institutions, just like 

some individuals, respond more quickly than others. Collaborators are not always friends nor do 

they always like each other personally but they may respect each other professionally. Sometimes it 

is a “marriage” driven by necessity rather than desire. 

It may not be a startling revelation but not everyone agrees and not everyone works at the same 

pace, but it is a fact that is easily forgotten. Waiting for input from one or more of my collaborators 

has made me aware of how frustrating it can be for a researcher in another institution to be 

waiting for my office to issue a subcontract so that they can begin their work. The prompt issuance 

of a subcontract can be very helpful to maintaining cordial collaborative relationships. Since 

these relationships can be new, tenuous, starting the relationship on a note of discord can be very 

counterproductive. As my esteemed colleague, Dr. Peter M. Groffman, often reminds me, ”A little 

kindness really helps the wheels of the world spin more smoothly!” 

As Research Administrators, we need to do our part to ensure that we facilitate the process, not 

impede the process. Negotiating a subcontract, for example, is not a competition where one 

administrator or institution wins and another loses. If it is not a win/win situation in which the 

rights of all parties, including the funding agency, are protected, then it may become a lose/lose 

situation for everyone. 

No time is wasted when administrators take the initiative to step out of their role to gain insight 

into the problems and to understand the complexities of colleagues. The rewards outweigh the 

effort and the insight gained is priceless. However, it takes individual initiative to do this – to reach 

beyond a “process the paper” approach in order to attain a feeling of ownership in the outcome. 

Conclusion 

Of course, collaborations among people can be done without institutional involvement. All that 

is needed is the desire, the need and the trust. However, when a transfer of money is involved, 

especially federal money, an institutional framework is necessary because institutions have multiple 

responsibilities. The challenge is to provide a helpful and supportive framework that does not 

impede progress or insert unnecessary burdens. A good Research Administrator rises to this challenge 

and accepts it as a routine part of the job! 

Collaborations can be a frequent source of problems (Magnus, Kalichman, 2002; Likens, 2001) 

due to their varying forms and complex nature. Misunderstandings, unproductive collaborators, 

authorship issues, data analysis disagreements can singly or collectively taint the relationship. 

While communication and understanding are key ingredients, a Research Administrator who is 

attuned to the process can be invaluable. Being part of a collaborative group helps one to appreciate 

the importance of flexibility, a key ingredient in any collaboration as well as a desirable quality 

in a good administrator. Constructing a good agreement, making sure that the statement of work 

received in the proposal stage is clear and is agreed to by the parties involved, expediting paperwork 

as quickly as possible and maintaining a cordial relationship with collaborating institutions 

can help strengthen the relationship. Collaborations do not stop with the researchers involved in 

the project; they include the institutional administrators that manage for them. 


Working collaboratively with members of the research staff is a good way to hone your working 

relationship and bring it to a new level of understanding and respect. Think about collaborating 

on writing a paper on how your roles interact, work with the research staff to plan a workshop 

aimed at helping each other to understand how your roles interrelate, write a proposal for funding 

for a Responsible Conduct in Research Project. The rewards will be worth the effort. According to 

the U.S. Department of Energy National Collaboratories, “One does not deploy a collaboratory, 

one builds a collaboratory,” and in the process can build a better working relationship and mutual 

understanding that will serve the institution, the faculty and sponsored projects staff well. 

References 

Papers 

Fishbough, M.S.E. (1997), Models of Collaboration. Needham Heights, MA: Allyn & Bacon. 

Kotock, Alan (2004), Collaboratories: Encouraging Remote Scientific Collaborations, Science 

– The Next Wave, U.S.: AAAS. 

Likens, Gene E. (1998), Limitations to Intellectual Progress in Ecosystem Science. In Successes, 

limitations, and Frontiers in ecosystem science, edited by M.L. Pace and P. M. Groffman, New 

York: Springer-Verlag. 

Likens, Gene E. (2001), Ecosystems: Energetics and Biogeocehmistry. A New Century of Biology, 

edited by W. J. Kress and G.W. Barrett, Smithsonian Press, Washington, pp.53-88. 

Loan-Clark, J., & Preston, D. (2002), Tensions and Benefits in Collaborative Research Involving a 

University and Another Organization. Studies in Higher Education 27(2), 169-185. 

Loucks-Horsley, S., Hoewson, P.W., Love, N., & Stiles, K.E. (1998). Designing Professional 

Development for Teachers of Science and Mathematics. Thousand Oaks, CA: Sage Publications. 

Magnus, P.D., Kalichman, M. (2002). Collaboration. From RCR Education Consortium – Online 

Resource for RCR Instructors - http://rcrec.org/r/index.php?module=ContentExpress&func= 

display&meid=79&ceid=45 

McGrath, Diane (2004). Strengthening collaborative work. Learning and Leading with Technology 

31, no. 530-33, Fall 2004. 

Murphy, K. Cifuentes, L. & Shih, Y (2004). Online collaborative documents for research and 

coursework, Tech Trends. 49 (3), 40-44, May/July 2004. 

Smith, Marie F. (2004). Subcontracting Primer: The ABCs of Agreements Between Collaborators, 

The Journal of the Society of Research Administrators, Arlington, VA, Volume XXXV, Number 

1, pp 25-31. 

U.S. Department of Energy National Collaboratories, http://www.doecollaboratory.org/overview. 

html 

U.S. General Accounting Office (1998). Technology Transfer: Administration of the Bayh-Dole 

Act by Research Universities, CAO/RCED-98-126, Washington, D.C. 

Woodrow, Raymond (1978). Management for Research in U.S. Universities, National Association 

of College and University Business Officers, Washington, D.C. 


Papers 

How to Develop a Centralized Pre-award Infrastructure Successfully Within a Climate Where 

the Number of Clinical Trials Sponsored by Pharmaceutical Industry Has Decreased Since 

2001 – A Large Multi-Specialty Academic Medical Center Perspective 

Theresa Ann Strakos, BSHSc., CCRP, CRCPA 

Felicia Ann Riney, MBA, CRCPA 

Research & Education Division - Grants Administration Department 

Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation 

2401 South 31st Street 

Temple, Texas 76508 USA 

254.724.5818 

tstrakos@swmail.sw.org 

friney@swmail.sw.org 

Edited by: Julia Blackwell, BS; 

her efforts were tireless and her contributions immeasurable. 

ABSTRACT 

In today’s research arena, protracted contract and budget negotiations are leading to pharmaceutical 

and device companies seeking sites and services abroad. Our presentation focuses on a 

successful pre-award infrastructure based on the ‘Circle of Support’ model. A contract administration 

component is the central point of contact for activities relating to pharmaceutical and device 

studies. Implementation of this model allows for decreased timelines, increased productivity, 

improved customer satisfaction, and successful budget negotiation. One cannot have management 

without measurement, thus institutional benchmarking is imperative. Utilizing the suggested 

pre-award model shows more dollars, more contracts and higher indirect cost recovery establishing 

a decreased timeline for critical path resolution due to the centralized infrastructure. Implementation 

of the ‘Circle of Support’ model and contracts administration component to decrease 

fragmentation among resources within an organization can achieve optimal results. Organizations 

tend to be either a square or a circle. Squares limit the number and flow of resources, which leads 

to fragmentation. Circular institutions are all-inclusive, never-ending and provide for unlimited 

flow of resources. Customers and stakeholders are thus surrounded by a fluid support system. The 

flexibility of this model allows it to be applicable to any organization. What Shape Are You? 

INTRODUCTION 

The landscape of research is constantly changing, and by its very nature is characterized by changing 

systems, procedures and new technology (Murray, McAdam, Burke 2004). Investigative sites 

and investigators must have foresight and flexibility to participate competitively. Industry-funded 

research is a multi-billion dollar business. Pharmaceutical and device companies are extending 

boundaries into peri- and post-approval activities. More and more companies are going abroad 

for clinical trial sites because drug developers try to decrease costs by decreasing pre-clinical costs. 

By going abroad, pharmaceutical companies can look for sites that will accept lower payment for 

research in order to secure a study at their site. Fewer regulations because of the absence of regulatory 

oversight agencies such as the Food and Drug Administration (FDA) simplify conduct of the 

research. Sites abroad also have larger potential subject pools (Shah, 2003). 


Papers 

In a business where every day’s delay in bringing a drug to market can cost as much as $1.3 million, 

according to industry estimates, finding a ready source of trial patients is an advantage (Rowland, 

2004). This atmosphere demands that research sites develop and showcase their increased 

success rates in patient recruitment and retention, accurate timely data, diverse patient population 

and institutional resources; thus ensuring their identity as a niche provider among competing 

research sites. Sites in the United States (U.S.) defend their patient costs by providing quality 

centered around what is referred to as the “Iron Triangle” of research. The “Iron Triangle” (Figure 

1) of research is composed of three points: Good, Fast, and Cheap. When conducting research one 

can manage any two of these, but one can never get all three. In the U.S., one can get data “Good 

and Fast,” but not “Cheap.” Abroad, one can get data that is “Fast and Cheap,” but not “Good,” or 

“Good and Cheap,” but not “Fast.” Data obtained in this manner will jeopardize the integrity of the 

study results, because information would be inaccurate or not provided expeditiously. 

In order to become a successful niche provider, sites must think “outside the box” of historical site 

management infrastructures. The focus of our presentation is the sharing of a successful model for 

pre-award within a large multi-specialty academic medical center involved in multipartite research 

activities ranging from bench research and animal studies to human trials. This model allows for 

abbreviated timelines on contract and budget negotiation and execution, enabling viability within 

a highly competitive marketplace. A ‘Circle of Support’ (Figure 2) is a strategic plan focusing on 

customer service and satisfaction, which provides resources necessary for expeditious pre-award 

processes. Beginning with an entry portal, this dynamic schema illustrates a fluid representation of 

resources such as feasibility, biostatistics, information systems, budget development and negotiation, 

and legal review. Additional institutional resources can be pulled into the circle as necessary. 

Outside of pre-award, examples of institutional resources utilized are regulatory review board (Internal 

Review Board) and post-award. With increased scrutiny (Congressional and otherwise) of 

research ethics, financial management and conflict of interest, the centralization of the pre-award 

infrastructure allows for establishment of controls to address these issues. In an industry fraught 

with opportunities for improvement, “Don’t Try to Fit a Square Peg in a Round Hole!” (Figure 3) 

According to information provided in the May 4, 2005, Kaiser Daily Health Policy Report, the 

number of clinical trials sponsored by the pharmaceutical industry has decreased “significantly” 

since 2001 and the number of principal investigators for trials in the United States has “declined 

even more steeply.” These results are reflected in a study conducted by the Tufts Center for the 

Study of Drug Development and reported in the Washington Post (Kaiser Daily Health Policy 

Report, 2005). Using information collected by the FDA, researchers at Tufts found that after a 

major expansion during the 1990s, the number of drug industry-sponsored clinical trials leveled 

off in 2000 and began to drop after 2002. The number of principal investigators for trials in the 

Unites States decreased by 11% between 2001 and 2003, and the number of trials abroad increased 

by 8%. Discontinuation of trials before they reach their final phase has contributed greatly to the 

decrease. In addition, trials are becoming less lucrative for doctors and researchers, thus more trials 

are being conducted at cheaper sites abroad. Researchers interested in participating in research 

are frustrated by increased costs, poor communication and fragmented organizational infrastructures. 

The work of Kenneth Getz (2005) reflects that new clinical trials are increasingly being done 

abroad. Statistics show that the number of American sites where clinical trials were underway 

declined from about 51,000 in 2001 to 48,000 in 2003. During that same period, the number of 

FDA-approved investigational drug studies in all phases of research rose from about 3,900 to 4,500 

but with less research being done at U.S. sites (Kaiser Daily Health Policy Report, 2005). Although 

ongoing clinical trials in the United States are generally not being moved overseas, the lower costs 

abroad and the often greater professional and public interest are leading many companies to set up 

new trials in Eastern Europe, South America and India. (Kaiser Daily Health Policy Report) 


Papers 

The current trend of selecting sites overseas does not significantly affect ongoing trials, because 

pharmaceutical and device companies realize the cost-effectiveness of letting a study continue to 

completion at a site where everything is already in place. However, studies indicate that industry 

looks at locating Phase I studies overseas for several reasons: increased potential subject pool, 

cheaper overall costs and less governmental regulation. Overseas, there is a larger pool of potential 

subjects, many of which are medication naïve (Shah, 2003.). Populations in countries with underdeveloped 

economies cannot afford to see physicians or afford medications they may need. Trials 

in the U.S. are highly regulated – experiments on Americans must undergo painstaking, lengthy 

reviews by government-regulated review boards (i.e. Institutional Review Board or Central Review 

Board) and are becoming more and more scrutinized to protect subject participants. When a 

study has been conducted overseas and then moved to the U.S., the only requirement of the FDA 

is that foreign trials conform to the World Medical Association’s Declaration of Helsinki, which is 

a series of recommendations that critics call rudimentary, nonbinding, and ambiguous. There is no 

oversight or auditing of whether or not these have indeed been followed prior to moving the trial 

to the U.S (Shah, 2003). 

To position an institution competitively within the market and meet institutional mandates, 

departmental objectives should include establishing an internal infrastructure that will streamline 

and ensure quality processes, as well as, determine current and future productivity needs. Our 

presentation discusses the evaluation and identification of opportunities for improvement within 

an active infrastructure of a grants administration office; specifically contracts administration. 

Reorganization took place within a large multi-specialty academic medical center involved in 

multipartite research activities ranging from bench research and animal studies to human trials. 

Changes were proposed in processes and infrastructure to facilitate flow and timelines for Clinical 

Trial Agreement processing, budget development and negotiation, monitoring and oversight, as 

well as, timeline tracking for duration of project administrative set-up. 

The ‘Circle of Support’ (Figure 2) lends itself to the creation of a separate contracts and budgets office 

within the grants administration office, which utilizes a contracts manager working in tandem 

with a budgeting manager. The suggested staff model (Figure 4) was to move contracts manager 

from Clinical Research Projects Office to Grants Administration, as well as moving a senior 

financial analyst from Research & Education (R&E) Fiscal to Grants Administration in capacity of 

Budgeting Manager. The previous model had a Contracts Manager interacting with the R&E Fiscal 

Senior Financial Analyst. Differences in departments and inconvenient physical locations caused 

fragmentation of processes resulting in increased processing timelines. The suggested model was 

implemented in March 2004. (Figure 4) This restructuring has allowed for an abbreviated timeline 

on contract and budget negotiation and preparation, enabling the institution to be considered a 

viable site for an increased number of highly competitive studies. 


The following data supports our contention that the restructuring was successful in increasing the 

number of clinical trials and increasing revenues for the institution: 

Table 1 

Annual Results: March 2003 – February 2004 and March 2004 – February 2005 

Annual Totals 

2003-2004 2004-2005 Increase 

Number Executed Contracts 47 51 4 (4%) 

Total Funding $3,247,203 $4,468,953 $1,221,750 (12%) 

Average Funding Per Contract $69,089 $87,627 $18,537 (12%) 

‘See charts 1 and 2 for details’ 

As indicated in Table I above, the numbers did increase significantly while utilizing the Contracts 

Administration model (Figure 4), within the ‘Circle of Support’ (Figure 2). Noted was a 12% 

increase in total funding and average funding per contract using the reconfigured model. The 

flexibility of this configuration facilitates effective communication among the critical path components 

of contracting, budgeting and institutional regulatory approval. As illustrated in Chart 1 

and Chart 2, there was significant increase in overall dollars and the number of studies which is 

credited to the restructuring. 

A speaker at a recent conference summed it up nicely, “There’s two farmers and one bear in the 

woods. Farmer One put on tennis shoes and Farmer Two says ‘You can’t outrun the Bear.’ 

Farmer One replies, ‘I only have to outrun YOU.’ We think the ‘Circle of Support’ (Figure 2) is the 

‘tennis shoes’ sites need to outrun the competition. 

In conclusion, utilizing the pre-award model shows more dollars, more contracts and higher indirect 

cost recovery, establishing a decreased timeline due to a centralized infrastructure. Organizations 

tend to be either a square or a circle. Squares limit the number and flow of resources, leading 

to fragmentation and inefficient use of resources. Circles are all-inclusive, never-ending and 

provide for unlimited flow of resources. 

What Shape Are You? 

Papers 


Papers 

References 

Kaiser Daily Health Policy Report (May 04, 2005) Number of Clinical Trials Sponsored by the Pharmaceutical 

Industry Decreased Since 2001, Study Finds 

Murray, E., McAdam, R., Burke, M. (2004) A critique of emerging European legislation in the 

pharmaceutical industry: a clinical trials analysis (International Journal of Health Care Quality 

Assurance, Volume 17 – Number 7 – 2004, Pages 389-393) 

Rowland, C. (2004) Clinical Trials Seen Shifting Overseas (International Journal of Health Services, 

Volume 34, Number 3, Pages 555-556) 

Shah, S. (2003). Globalization Of Clinical Research By The Pharmaceutical Industry (Volume 33, 

Number 1, Pages 29-36). 

Figure 1 

THE IRON TRIANGLE OF RESEARCH 

Good Fast 

Cheap 

The “Iron Triangle” of research is composed of three points: Good, Fast, and Cheap. When conducting 

research you can get any two of these, but you can never get all three. 


Papers 


Papers 


Papers 


Papers 


Papers 


Papers 

Evaluation of Strategies for Building a Research Culture – 

an Empirical Case Study at an African University 

Professor Cliff Studman, PhD, Dip Ed, BSc 

Pie Squared Consultants Pty, Box 45371, Gaborone, Botswana 

Phone (+267) 71793225 Email Studman@Botsnet.bw, or Pie2Research@hotmail.com 

and Dr G. Nnunu Tsheko, PhD, BEd 

Department of Educational Foundations, 

University of Botswana, Box 00022, Gaborone, Botswana 

Phone (+267) 3552419 Email: tshekogn@mopipi.ub.bw 

Author’s note 

Part of this study was made possible through a grant from the 

University of Botswana Research Advisory Committee. 

Abstract 

The impact of change strategies for developing research at an African Primarily Undergraduate 

Institution are considered using a case study of the University of Botswana. After an analysis of 

the existing situation, a short research policy written in understandable terms was developed. The 

policy was structured so that it could be used for subsequent compliance assessment. A lengthy 

approval process involving consultation with all faculties increased institutional buy-in to the 

policy. 

A new Office of Research and Development managed the implementation. Motivators such as 

research awards and recognition were introduced to encourage staff to develop research programmes, 

and simplified but transparent internal funding mechanisms were introduced. Staff 

attitude surveys were undertaken just after the policy was introduced, and again approximately 18 

months later. An indication of the impact of the changes was also undertaken through a compliance 

assessment exercise. 

The survey showed a positive change in staff attitude to research, despite a significant increase in 

teaching workload during the period. There was also a sustained increase in competition for available 

internal research funds. Compliance with the policy was increasing, although the University 

was fully compliant in only a few areas. Other results from the survey are presented. 

Introduction 

In an earlier paper, Studman (2003a) described the background that resulted in the development 

of a new Office of Research and Development at the University of Botswana. Although in a 

developing country, the University has received relatively strong financial support from government 

since its establishment in 1982. Botswana remains as a largely undeveloped country, consisting 

mainly of the Kalahari Desert, although the combination of a stable society, the discovery of 

diamonds in 1970, a democratic and peaceful electoral system, and generally good, benevolent 

governance with low corruption, has resulted in dramatic growth both in the number of students 

eligible for tertiary education, and the demands on government funding for the civil service, education 

and services. Thus by 2005 there were approximately 15,000 equivalent full-time students, 

but the government was concerned to hold or reduce the level of support for the University, while 

still increasing the numbers of students. Between 1997 and 2003 the overall student-staff ratio 

deteriorated from 12:1 to 16:1, and due to staff vacancies was often around to 19:1 in practice. As 

a University with a vision for academic excellence (University of Botswana, 2003), the University 


Papers 

recognised and acknowledged the principles of research led teaching (Hattie and Marsh, 1996; 

Geiger, 1993; Lipset, 1994; Pratt, 1997; and Zubrick, 2000), despite its predominantly undergraduate 

teaching history. The role of research in national development was also recognised (Studman, 

2003b). However in the late 1990’s the University also recognised that its research activity was not 

satisfactory, and set about improving the situation. It shared the problems of many other predominantly 

undergraduate institutions as described by Hazelkorn (2002). 

Studman (2003a) outlined some changes that were introduced in order to develop the research 

culture at the University. An analysis of the strengths, weaknesses, opportunities and threats 

(SWOT) of a given situation analysis was conducted. SWOT analysis is a commonly strategy used 

to understand any situation. Through this, it was found that the key areas of challenge were: (a) no 

strategic planning or alignment of research with University goals and strategies; (b) poor use of 

internal funds; (c) an absence of accountability for resources; (d) no management of the quality of 

outputs; (e) no structure for commercialisation of research; (f) limited postgraduate research; (g) 

insufficient motivation for some staff; (h) administratively complex research procedures, but no 

effective research support structure; (i) increasing teaching workloads; (j) insufficient training in 

research management, methodology, and communication; (k) no database of research capabilities, 

and few reported research outputs; and (l) lack of funding source information. In addition some 

staff preferred private consultancy to research for financial reasons, sometimes at the expense of 

their teaching responsibilities. Clearly, major changes were required. After prioritisation, and after 

assessing the available capability of the Office of Research and Development staff, strategic changes 

introduced initially included: 

1. Development of research policy 

2. Recovery and utilisation of internal funding through simplified, transparent procedures 

3. Introduction of a quality and accountability management programme 

4. Introduction of encouragements to undertake research 

5. Training in research proposal writing 

As recommended by Drummond (2003), we developed a plan to evaluate the effectiveness of 

changes. While a measure of success in growing research is ultimately the changes in the number 

of research outputs (i.e., research papers, books, presentations, patents) it is too early for the 

changes described in this paper to take effect. Moreover, Ramsden (1994) has pointed out that 

many factors affect this measure, and current international measures such as the Frascati system. 

The Frascati system is an international standard practice for assessing performance surveys on 

research and experimental development. This was developed by the Organisation for Economic 

Co-operation and Development at a meeting in Frascati, Italy. The system remains largely inappropriate 

at the current level of development of the University (OECD, 2002). Another factor is that 

the data is not yet available due to the challenges listed later. Instead it was decided to undertake a 

longitudinal study of attitudes of staff to research, since this would give a clearer indication of the 

impact of changes introduced by the research office. 

Intellectual challenges exist with the assessment of some of these goals. For example it is recognised 

that the perception of quality management in a university context is still a challenging concept, 

and misunderstood by academics and management alike (e.g., Houston and Studman, 2001). 

Internationally the Frascati manual has been largely adopted as a measure of research activity and 

development (OECD, 2002). The association of commonwealth Universities has also developed 

benchmarking procedures for evaluating research offices (Waugaman, 2004; Kirkland and Day, 

2005). 

Limited support was also provided to enable staff to identify external research funding opportunities. 

Other desirable changes, such as the development of postgraduate research studies; publicity 


Papers 

on research activity; management of consultancies; and policies on intellectual property, ethics 

and research centres were developed but delayed for various reasons until 2005. 

1. Development of research policy 

A research policy was developed and approved in 2002 (University of Botswana 2002, Studman, 

2004). This was written in a format that enabled an evaluation of compliance to be undertaken. 

This was given high priority and was developed in harmony with the University’s overall strategic 

goals, as recommended by Drummond (2003). 

The policy was designed to be straight-forward and relatively short. It established the basic aims 

of the university with regard to research, and emphasized those areas where growth was desired. 

The policy was then circulated by e-mail throughout the whole university, and went through the 

normal university procedures for approval of policies. At the University of Botswana this was a 

lengthy process involving several committees, from departmental level to senate. Finally policies 

were sent to the university council for approval. This process typically takes around two years for 

completion. The research policy was no exception. Therefore it was necessary to utilize the policy 

as a working document for decision-making even before approval. The policy included a paragraph, 

which indicated that the Office of Research and Development will be responsible for policy 

implementation, and that the guidelines will be placed in the university handbook. In this way the 

practical aspects of policy implementation could be undertaken simply by using a document that 

could be changed relatively easily, without seeking faculty, senate and council approval. 

Once approved, attempts were made to familiarise staff with the content. Few academics can be 

expected to find time to read a research policy, and it was therefore decided to remind staff continually 

about the conditions and aims of the policy. Electronic media, meetings with faculty boards 

and faculty executives, individual consultations, and reports to senior management all served the 

purpose. It was essential to refer to the research policy frequently in discussions with staff, so that 

gradually they became familiar with the terms of the policy. 

2. Recovery and utilisation of internal funding through simplified, transparent procedures 

The majority of research funds were being allocated to faculties on a per capita basis. Faculties 

were using their own procedures for approval and allocation of funds, and in many cases these 

were obscure, poorly advertised, and often excessively bureaucratic and complex. As a result most 

faculties were stockpiling research funds in internal accounts. With the agreement of deans, early 

in 2001 all unused research funds were returned from faculties to a central funding pool. In addition 

a review of all existing research projects was initiated, and funds in inactive accounts were 

also returned to the central funding pool. In this way almost P3 million (US$800,000) was recovered, 

or roughly four years annual internal funding. The per-capita system was abandoned. Some 

funds were then re-distributed to faculties: each received approximately 30% more than the total 

funding they had allocated in the previous year, making a total of P600 000. The clear message was 

given to faculties to use their resources or lose it. Subsequently Faculty funds were allocated first 

on the basis of their allocations, but later the allocation was based on reported research outputs, 

both moves proving to be unpopular with some deans. 

The remainder of the available money was allocated through a series of university wide funding 

rounds. In complete contrast to the previous system, deadlines were set for applications for funds, 

a simplified application form was drawn up, and the funding rounds were advertised throughout 

the university. Initially several funding rounds were advertised, including rounds which focused 

on specific topics such as HIV/AIDS, or were limited to specific areas (e.g., new staff, or large projects). 

The initial response was moderate. After 12 months trial, this was changed to two rounds 


per year in February and September. As a result interest in making proposals increased dramatically. 

By 2005 applications for funds were typically around P4 to P5 million per annum, with up 

to 50 applications each year. This represented a quadrupling of the number of research proposals, 

compared to the previous system. The university financial administration responded by doubling 

the internal research funding allocation to 1.6MP per year. 

The process of selecting projects was also made transparent. Initially projects proposals were sent 

to faculty research committees for an assessment of the quality of the proposal. Faculties were 

asked to comment on the proposals, and to rank the proposals from their faculty. However they 

were not allowed to reject proposals at this stage. All proposals were then returned to the central 

administration. At the second stage representatives of the faculties were asked to assess all proposals 

on their strategic merit. To enable this to happen a series of strategic criteria were drawn up, 

which were important to the university (e.g., to specific aims mentioned in the research policy), 

and were also intended to be independent of disciplinary area. Examples of such criteria included 

potential for external funding, evidence of collaboration between different departments, faculties 

and external researchers, or involvement of postgraduate students. Finally proposals had to 

explain the relevance of the proposals to the strategic goals and vision statements of the university 

and the country. 

After various trials with different versions, the University eventually settled on a system in which 

new staff were given priority for funding up to a fixed limit. In this way each staff member was 

given the opportunity to access funds when they first arrived at the university, and they were able 

to undertake some research. 

An important aspect of the internal funding system was its transparency. Full details of the procedure 

were publicized, and before each round a workshop was held for intending applicants. At 

this workshop the procedures were discussed, and the guidelines were explained, with the intent of 

aiding staff to complete application forms. The internal round was also seen as an opportunity to 

provide practical training on writing research proposals for external funding. 

3. Introduction of a quality and accountability management programme 

Papers 

There was no recognizable mechanism for ensuring staff accounted for research funds provided. 

In some cases there was no evidence of research activity, suggesting that staff were simply pocketing 

the money. Accountability checks were introduced, including the requirement for an annual 

report on the financial situation, and a closing report giving a full financial summary of the use of 

funds. Failure to provide this data meant that the funds would be recovered from staff salaries. 

Staff were also expected to demonstrate that they were using the research funds allocated, by providing 

a brief one page report every six months, with a more detailed report each year. In these reports, 

staff were expected to show some evidence of progress. If reports were not produced, funds 

were frozen and subsequently returned to the central pool for reallocation. In addition, faculty 

research committees were required to distribute funds allocated to them during the financial year. 

Any remaining funds at the end of the year were returned to the central pool. 


Papers 

4. Introduction of encouragements to undertake research 

Several mechanisms were introduced to encourage research growth. These are the outlined briefly 

below: 

(a) Research Awards 

A system of recognizing and rewarding top researchers was introduced. This included a cash prize 

as well as recognition of the individual researcher. The awards were made to top researchers, the 

best emerging staff, and the best team leader. Separate awards were made for Sciences and for Arts. 

(b) Key Accounts 

New accounts were introduced so that staff members could receive part of the overhead or administration 

income generated by the university from research activities. The policy specified that 40% 

of the overhead charge would be made available to the staff member for research related activities, 

while 20% of the overhead would go to the department concerned. In this way both the researcher 

and the head of department were encouraged to seek externally funded projects with significant 

overheads included. In practice the university set a minimum level of 15% for the overhead charge. 

Even so it was often difficult to encourage researchers to include the overhead charge as part of the 

overall cost of their project proposals. Researchers almost never sought more than the minimum 

15% overhead specified. In 2005 the concept of any form of full cost recovery for research projects 

had yet to be introduced to the university culture. 

(c) Community of Science Databases 

The university subscribed to this database of research funding information, giving weekly email 

alerts of research opportunities and enabling all registered staff to search for research funding in 

their particular area of interest. 

(d) Database of Research Outputs 

Staff outputs were recorded in a database, and this database was made available on the university 

website. This represented the beginnings of a marketing tool to demonstrate to the country the 

research activity of the university. We experienced great difficulty in obtaining details of research 

outputs from staff. There were glaring inconsistencies between information reported in annual 

appraisals and research funding proposals, and the information reported to the database. Attempts 

to establish the database as the only record of research outputs, to be used by the entire university 

for promotion and appraisal purposes, were unsuccessful. 

(e) Appointment of Assistant Directors 

Additional staff positions were created in Research and Development. The two key areas identified 

for priority were quality management and research funding. After many delays, including the 

appointment of a staff member who resigned after three months, good appointments were made to 

these positions late in 2004. 

5. Training in research proposal writing 

Courses were run in conjunction with the internal funding rounds as outlined above. 

Experimental Study 

The target population for the study was the teaching staff in the seven faculties at the University of 

Botswana (about 700). The university internal telephone directory was used to identify teaching 

staff. A questionnaire was developed and trial tested by interviewing 18 randomly selected staff 

representing all the faculties of the university. The results of the pilot study were used to revise 


the questionnaire. The final questionnaire asked for demographic information, research activity, 

research funding, reasons for doing research, knowledge of university research policy, research 

awards and overall attitudes in doing research. It was then mailed with a numbered return envelope. 

The numbers were used identify those who had not responded so that they could be followed 

up. A double-blind system was used to ensure that the researchers could not link questionnaire responses 

to individuals, but at the same time the list of respondents was available to secretarial staff. 

After two weeks, reminders were sent using the university e-mail, with the questionnaire as an attachment. 

The secretarial staff received any electronic responses and printed them out to preserve 

anonymity. A small token of appreciation (a R and D pen) was sent to respondents. Approximately 

12 months later a repeat questionnaire was sent out to the entire university teaching staff, with a 

similar email follow up. A numbering system was again used so that the numbers of staff who had 

responded to both questionnaires was known. However it was not possible to compare responses 

from the same person directly. 

A mini-survey of Research Office staff was undertaken to determine whether the university was 

complying with the research policy, by surveying selected staff with a questionnaire, which listed 

the 40 research policy statements, and asked respondents to assess compliance on a 0 – 5 point 

scale. The objective was to test the principle, so that this pilot exercise could be extended to a 

wider selection of staff. 

Results 

Demographics 

The demographics of the two sets of data were very similar. In the first survey 199 responses were 

received, and 170 responses in the second, while of these 75 people responded to both questionnaires. 

Full details of the results are given in the appendix. In the second survey 75% were male, 

(73% in the first survey). Figures for the first survey are given in brackets hereafter. In both 

surveys 36% of respondents had the rank of senior lecturers, 18% (19%) were professors, and 44% 

(46%) were lecturers. There were slightly more respondents with PhDs in the second survey (72% 

(67%)), while the remainder mostly had masters degrees (27% (31%). 

Overall attitude to research 

Papers 

For this discussion the responses were grouped into three groups: those who agreed or strongly 

agreed with a statement, those who were neutral, and those who disagreed or strongly disagreed. 

There were some changes between the two surveys in response to the questions about attitude to 

research at the University of Botswana (Table 1). Thus, 80% of the respondents agreed or strongly 

agreed with the statement that research is encouraged at UB, compared to 69% in the first survey. 

Only 9% (16%) disagreed with the statement. 


Papers 

Table 1 

Research Attitudes – Comparison of results from both surveys (%) results 

Figures for the first survey are given in brackets 

First 

survey 

Agree Neutral Disagree 

Second 

Survey 

First 

survey 

Second 

Survey 

First 

survey 

Research is encouraged at U.B. 69 80 15 10 16 9 

The U.B. research administration assists 

me to do research 

U.B. financial services assists me to do 

research 

In my department, research activities are 

encouraged and supported 

Consultancies should be discouraged for 

the good of U.B. as a whole 

To meet its obligations to society, U.B. 

should do more research 

There has been a positive change in attitude 

amongst my colleagues in favour 

of doing more research in the past 12 

months 

Personally I am more enthusiastic now 

about doing research than I was 12 

months ago 

Second 

Survey 

35 44 29 36 36 21 

38 33 33 42 29 25 

68 74 16 21 16 7 

13 15 16 17 71 68 

91 96 7 3 3 2 

39 46 42 37 19 17 

37 44 38 32 25 26 

Number of respondents 199 170 199 170 199 170 

Similarly in the later survey more people agreed with the statement that “the UB research administration 

assists me to do research” with 44% (35%) in agreement and 21% (36%) in disagreement. 

On the other hand Financial Services appeared to be viewed slightly less favourably than before: 

33% (38%) agreed that “UB financial services assist me to do research” while 25% (29%) disagreed. 

There was general support for the statement that “In my department research activities are encouraged 

and supported” 74% (69%) agreed or strongly agreed and only 7% (15%) disagreed. Most 

people felt that consultancies should not be discouraged. The statement “Consultancies should be 

discouraged for the good of UB as a whole” was only supported by 15% (13%) while 68% disagreed 

(71%). Nearly all respondents felt that to meet its obligation to society UB should do more 

research; 96% (90%) in favour and only 2% (3%) against. 

There were slightly more people in the second survey who felt that there has been a positive 

change in attitude amongst colleagues in favour of doing more research in the past 12 months; 

46% (39%) agreed and 17% (19%) disagreed. At a personal level there was also a slight increase 

in enthusiasm. “I am more enthusiastic now about doing research than I was 12 months ago” was 

supported by 44% (37%), while 26% (19% disagreed). 


Papers 

Sources of Information about Research Activities 

In a separate question introduced in survey 2, respondents were asked to indicate their main 

sources of information on research matters. The survey showed that 72% of respondents strongly 

agreed or agreed that the UB email group was where they had learnt a great deal about UB research 

activities. Only 12% disagreed. In order of priority the other sources of information favoured 

by the respondents were research seminars (58% agreed, 13% disagreed): from other staff 

members (49% agreed, 21% disagreed); research mail group (46% for and 19% against): presentations 

and research meeting (45% for and 29% against). In all 34% found the Community of 

Science database very helpful in identifying possible sources of funds while 13% disagreed with 

the statement. It is therefore clear that the Office of Research and Development should continue to 

provide information through all these different outlets, and that more effort should go into alerting 

staff about the research funding databases. 

Knowledge of Research Policy and Awards 

There was a significant increase in the number of staff who were aware of the existence of the 

research policy as 82% (60%) were now aware, and only 18% (40%) were not aware in the second 

survey. Respondents were also more aware of research awards to individual researchers: 71% 

(45%) knew of their existence. 

Reasons for undertaking research 

The results were generally similar for the two surveys: 89% of staff always or almost always did research 

because it helped their career and 86% enjoyed doing research. There were slight differences 

in the other responses: doing research to be known as a good researcher always or almost always 

applied to 68% of respondents (58%). 

Interestingly, financial incentives were not seen as a main reason for doing research; only 13% 

(14%) always or almost always did research for financial incentives whereas 56% (63%) rarely or 

never did research for this reason. Similarly the requirement of the department on the staff member 

to do research was not a major factor: only 23% (16%) always or almost always did research 

for this reason, whereas 60% (65%) rarely or never did research for this reason. 

Demand for funding 

Just under half of the respondents planned to seek internal research funding in the next 12 

months: 49% (48%) would seek support, while 15% (21%) were not sure. The remainder (36% 

(30%)) would not. Of these the reasons given were already having funds (46% (37%)), or funds 

not needed (37% (27%). Only 3% (7%) were not interested. Seeking external research funding was 

envisioned by 47% (43%) of respondents and 22% (31%) were unsure, while 31% (26%) would 

not. Of the latter only 3% (7%) were not interested, while 17% (34%) already had funds and 42% 

(25%) did not need external funds for their research. In the second survey we asked whether: (a) 

lack of experience in writing proposals stopped them (17% indicated this was a reason), (b) fear of 

rejection (3%), (c) lack of success previously (3%), (d) did not know where to get information on 

funding (9%). 

Interestingly 59% (52%) of respondents indicated they were doing research that did not require 

funding; 44% (42%) were undertaking research funded by the University, while 29% (29%) were 

undertaking externally funded research. Only 8% (15%) indicated they were not undertaking 

research. 

Incentives to do research 

In both surveys, most staff reported that being given time to do research would be an incentive 

(79% (85%)). Promotion was second (61% in both surveys). Cash came low at 32% (34%) and 

special commendations motivated only 29% (47%) of respondents surveyed. Receiving training in 

research management was an incentive for 32% (listed as an option in survey 2 only). 


Papers 

Constraints 

When staff were conducting research, several factors were identified as being constraints or difficulties. 

Financial limitations was the most often reported problem with 38% (46%) identifying 

this as always or almost always a constraint, and only 18% (16%) saying this was rarely or never a 

constraint. In the first survey other factors (availability of personnel, financial administration, support 

and encouragement, or equipment) were all evenly divided between those who felt they were 

almost always a constraint and those who felt they were not (32 to 37% of respondents indicating 

one way and the same range the other way. In the second survey slightly fewer staff indicated that 

availability of personnel (26% (35%)), administration (23% (32%)), and equipment (28% (37%)) 

were constraints. Support and encouragement was a constraint for 33% (35%), and not a constraint 

for 38% (37%), suggesting little change between the two surveys. 

When staff were not undertaking research, lack of time was identified by as always or almost 

always a reason (65% (61%)) while only 8% (11%) felt this was rarely a constraint. Lack of incentives 

constrained 32% (36%), but was not a problem for 42% (40%). Only 4% (13%) of staff felt 

constrained because their head of department was not supportive, while 84% (76%) felt this was 

not a constraint. No one indicated they were not interested in survey 2 (7% in survey 1). In additional 

questions in survey 2, 69% of staff felt too much teaching was a constraint, 49% identified 

too many meetings, and 42% indicated that not having research assistants available was always or 

almost always a constraint. 

Not all respondents answered every question on constraints. However each question identifying a 

possible restraint was answered by between 50% and 90% of the respondents in both surveys with 

time being the most often answered, and lack of interest the least. 

The study of compliance with research policy showed that only a very small number of policy 

statements had been fully implemented, but equally only a small number had not been started in 

some way. The mean score was 40% compliance. 

Discussion of Results 

The results show that there was a steady improvement in the opinions of staff about research support, 

and that, despite the pressures due to increased teaching loads and financial constraints, their 

was an improvement in the attitude of staff towards doing research. 

The increased number of internal research proposals shows that the new system has encouraged 

staff to engage in seeking these research funds. However there has been only a small increase over 

the study period in the intention to seek internal or external funding. It is also worth noting that 

despite the high level of intention reported in both surveys, with almost half the respondents planning 

to seek funding, only around 50 to 60 applications were received. Thus the intention did not 

always translate into action. 

Given that there was little change between the two surveys in response to the question as to 

whether there were sufficient incentives to do research, this suggests that the current incentives are 

not yet attracting currently inactive staff to do research. On the other hand staff were clearly more 

aware of the research policies and incentives, indicating that the methods used to promote these 

were having an effect. 

The reasons given for engaging in research should perhaps be treated with caution. Although the 

results would suggest that financial incentives are not a significant factor, this may or may not be 

accurate; in internal meetings it has been suggested that the result was largely due to a sense that 

this would be an “inappropriate” response to the question. Alternatively the high level of the nega- 


tive response suggests that financial rewards could be less important to staff than is assumed by 

both management and academics in general conversation. 

The high level of unfunded research reported suggests that financial indicators should not be 

taken as the only indicator of research activity. This may be related to the disciplinary area of the 

research. However it is also possible that staff could be undertaking both funded and unfunded 

projects at the same time, or that the unfunded projects could be minor studies undertaken on an 

irregular basis. However it is clear that unfounded research activity should not be ignored altogether. 

It is also clear that there is a strong feeling that time is a major constraint on research activity. Staff 

believe that they would be able to undertake more research if they had fewer teaching responsibilities. 

The pilot study on compliance with the research policy showed that the method had potential to 

enable the university to benchmark performance against its policy documents, by repeating the 

exercise at regular intervals. 

Conclusions 

There has been a steady improvement in staff attitude towards research over the period of the 

study. 

The most effective factor has been the simplification of the internal funding system, coupled with 

its transparency and fairness. 

Other incentives have not yet made a significant impact in overall attitudes. However staff have 

only recently become more aware of the new policies and incentives. 

Staff at the University of Botswana identified time constraints as the major restriction on their 

research activity. 

Unfunded research may be a component of the overall research activity. 

The university has a long way to go to achieve full compliance with its own Research policy, but it 

has made an encouraging start. 

References 

Papers 

Drummond, C.N., (2003). Strategic Plan for Research Administration. The Journal of Research 

Administration, XXXIV, (II), 4 – 10. 

Geiger, R. L., (1993). Research and relevant knowledge: American research universities since World 

War II. Oxford: Oxford University Press. 

Hattie, J. & Marsh, H.W., (1996). The relationship between research and teaching: A meta- 

analysis. Review of Educational Research, 66(4). 507-542. 

Hazelkorn, E., (2003). Challenges of growing research at new and emerging HEIs. In G. Williams 

(Ed.), The enterprising university: reform, excellence and equity (pp.69-82). London: Society for 

Research in Higher Education/Open University. 


Papers 

Houston, D. & Studman, C.J., (2001). Quality management and the university: a deafening clash of 

metaphors? Assessment and evaluation in higher education, 26(5), 475 – 487. 

Kirkland, J. & Day, R., (2005). Common problems, novel solutions: an international benchmarking 

group. Research Global, 9, Association of Commonwealth Universities, February 2005, 14-16. 

Lipset, S. M., (1994). In defense of the research university. In J. R. Cole, E. G. Barber, & S. R. 

Graubard (Eds.), The research university in a time of discontent (pp. 219-224). Baltimore: 

John Hopkins University Press. 

OECD., (2002). Frascati Manual: proposed standard practice for surveys on research and experimental 

development. Organisation for Economic Co-operation and Development, Paris: OECD 

Publications Service. 

Pratt, J., (1997). The polytechnic experiment: 1965-1992. London: Society for Research in Higher 

Education/Open University Press. 

Ramsden, P., (1994). Describing and explaining research productivity. Higher Education, 28, 

207-226. 

Studman, C.J., (2003a). Growing a Research Culture. The Journal of Research Administration, 

34(1), 19-27. 

Studman, C.J., (2003b). Research Utilisation and Sustainable Development. Keynote paper, 9th 

BOLESWA International Educational Research Symposium, Conference Proceedings, 

Lightfoot:Gaborone. 

Studman, C.J., (2004). Developing a Research Policy. Research Opportunities, Association of Commonwealth 

Universities, Issue 7, 8-9. 

University of Botswana, (2002). Policy for Research and Development at the University of Botswana. 

Gaborone; University of Botswana. University Website http://www.ub.bw/about/plandocuments.cfm. 

Also Association of Commonwealth Universities website http://www.acu.ac.uk. 

University of Botswana, (2003). Vision and Mission Statements. Gaborone; University of 

Botswana. Website http://www.ub.bw/about/plandocuments.cfm. 

Waugaman, P.G., (2004). Benchmarking research management – the US experience. Research 

Opportunities, Association of Commonwealth Universities, issue 7 May 2004, 12-13. 

Zubrick, A., (2000). Strengthening the nexus between teaching and research. In G. S. Fraser (Ed.), 

Vice-chancellor’s Symposium: The Research Teaching Nexus, Symposium Readings, Palmerston 

North, New Zealand: Massey University 1-4. 


Author’s Note: 

Peer-to-Peer Discovery: Beyond Knowledge Management 

Michael Whitecar 

mikewhitecar@hotmail.com 

This paper is an ongoing evolution of gaining an understanding of human interaction with technology 

beyond knowledge management. Presented through a case study approach, the historical 

references referred to within are based on my own experiences over 18 years. 

Abstract: 

There are many similar situations where organizations have claimed to tackle knowledge management 

through the installation of an enterprise software solution providing the capability to capture 

and transfer knowledge using a web browser enabling “water cooler” effects of centralizing casual 

office conversation. A centralized and one size fits all approach limits the ability and capacity to 

capture and share knowledge instantaneously at the point of creation. Time, fluidity, and human 

flow are of the essence in an era that no longer requires a physical presence of communication. 

Virtual employment, ease of travel, and the multitude of electronic capturing devices create new 

challenges that prohibit a single point of execution and force a new discipline of searching techniques. 

This paper introduces a concept called Peer-to-Peer Discovery that engages forthcoming 

contributors in discovering new knowledge, promoting collaboration, and reaching out to existing 

information collection points. The concept circulates a flow of conversation or document establishment 

from a multitude of existing interfaces, weighs and learns the context, and automatically 

seeks others with similar interests or objectives. Exponentially, just-in-time knowledge is created 

from these newly established relationships, and is routinely circulated attaching new members to 

its core and spinning off other topics of interests. 

Introduction 

Papers 

There are many similar situations where organizations have claimed to tackle knowledge management 

through the installation of an enterprise software solution providing the capability to capture 

and transfer knowledge using a web browser enabling “water cooler” effects of centralizing casual 

office conversation. Increasing numbers of newly appointed Chief Information Officers (CIOs), or 

in some cases Chief Knowledge Officers (CKOs), are tasked by their senior management with creating 

knowledge workers or initiating a knowledge management programs. A common approach 

to responding to management is to first seek technology that will address the requirements. 

Aware of many of those seeking knowledge management programs, an increasing number of 

software vendors are ever so present just when you need them with their products full of so called 

proven technical solutions. The vendors understand who the new CIOs/CKOs are and understand 

how they spend money. They present a variety of pricing models, a selection of menu items, and 

if a requirement is not currently developed, they can have it built. Anxiously waiting to secure 

an early win, stories are told over and over of CIOs/CKOs pursing this routine and often traveled 

path. The one thing that is always missing from every business case and presentation is the human 

element. How have humans interacted with technology? How have they interacted with transferring 

knowledge when at one time, and often still is, knowledge is power. 

Every new software installation starts with a level of excitement as the “techies” are eager to try 

something new, the CIOs are hoping to secure a win, and management, well, if they are behind the 

new initiative, are on the side lines just hoping all goes well with the rest of the organization. Once 

the excitement wares off, the solution may begin to dwindle. The most common reactive steps are 


Papers 

to look at the technologies deployed and try to replace them. Funding is already short and looking 

for new dollars is not always the easiest thing to do. Hence, usually before even starting, the 

program already has more things going against its launch. 

What is clearly evident in organizations are the vertical units of conducting business and within 

these units the silos of cultures, politics, and the “good ole boys” network. It simply becomes impossible 

to pass information at the right time, right place, and to the right person, unless there is 

an established association. 

Case Study and Summary 

The following case study looks at a similar story of where human interaction was initially taken 

into consideration. The setting is a military command with a mission to provide program management 

and acquisition strategies for medical information technology requirements. The organization 

is staffed with approximately 300 employees divided into three distinct groups: those in 

uniform, government service, and contractors. 

Like any other organization in today’s information age, standing up a web site is a de-facto standard 

for doing business electronically. Behind the scenes of a web site are the web masters who 

ensure content is up to date, design attractive pages, and liaison between customer’s electronically 

submitted questions and internal employees who can answer them. This is where the first challenge 

begins to surface. It is usually the web master’s total responsibility to answer incoming questions 

or route them accordingly. Between posting documents and making the site attractive, this 

can become a daunting task. What is critical for web master’s success to answering questions is the 

fact that the web master must know someone who may know the answer. In this situation, the “association” 

is much more valuable than the actual answer because the new knowledge may be difficult 

to capture, provide in the future, and validate later. History demonstrates that in some cases 

web masters are outsourced and do not have a good understanding of the organizational structure. 

As stated earlier, leadership did not formally request a knowledge management system. The 

indirect pain point was the fact that too many questions were coming into the web site and going 

directly to the web master. Because of this leadership did take notice and they wanted an electronic 

means to search for personnel by skill sets or position, provide 365/24/7 World Wide Web 

(WWW) model to automatically reply to questions, route questions (via email) throughout the 

organization until questions are answered, and store questions and responses in a searchable repository. 

What they didn’t see at the time were opportunities to capture corporate knowledge and 

determine educational requirements of organizational personnel. 

From a technical standpoint, originally leadership just wanted yet another web application or 

something electronic to handle all the requests. However, some of the more visionary talent within 

the IT department new that they couldn’t add another application to personnel’s working portfolio, 

but needed to take advantage of aligning the initiative with flow based architectures that would 

travel seamlessly along the path of each individual human interaction. What this means is how 

most things are conducted in life would prefer if each transaction would flow naturally with individual 

human interactions. Even though computers have made life much easier, screen to screen 

jumps are still required, logging in with multiple accounts, and often times repeat data entry of 

information. This lead to an opportunity to using a common user interface that their users are 

already accustomed within the framework of Microsoft Outlook and the web browser. 


Thus the new program seeks out to answer the following questions: 

• Do we have the right skill sets onboard? 

• Are we providing the right amount of training to our employees? 

• Do our employees understand the organization? 

• Do our employees feel comfortable sharing what they know or who they know? 

Papers 

The first determination was to discover and locate a primary source of personnel peer-to-peer 

information along with a location to store additional information such as demographics, and associations. 

Using the backend of MS Outlook, MS Exchange, became the source along with adding 

an additional data storage elements using an Oracle database. The Oracle database was already 

being used by other applications; therefore, it made sense to repurpose the data for other uses. Instead 

of asking users to go to both applications to update their information, the user interface was 

morphed into one. It appeared as one application, but behind the scenes it was updating multiple 

repositories of authoritative source data. 

The second process was to develop a database that would automatically collect information relative 

to a question and how it was answered. The process worked like this: A potential or current customer 

would submit a question via the web browser to the organization. In stead of the web master 

receiving the question to answer, the question would be routed to a business engine that would 

parse the contents of the message and submit the data pieces to search an authoritative source of 

data. The data searched would be people, who were able to answer the question before, personnel 

demographic information, and answers from the previously submitted questions. 

The next step, and probably the most challenging, was to inform the organization that the engagement 

of a new program that automatically tracks requested questions from customers. It will be 

critical that support from each member in the form of providing their primary and secondary 

areas of responsibilities. Though this may seem to be an easy task to ask the element of human 

interjection began to sink in. Since obviously military pretty much do what they are told, there 

was no problem with them contributing to the bank of new knowledge. The government on the 

other hand felt a level of insecurity as they did not see this new program as a state of knowledge 

management, but a state of inquiring what exactly they do. Contractors did not add their personal 

level of knowledge but only what they were hired to do based on the Statement of Work (SOW) 

they were employed under. So from the start, the new knowledge base was partially validated as 

the majority of the input was taken directly from employees’ personnel descriptions (PDs) which 

often times did not adequately describe what that employee performs or really “knew” within the 

organization. 

With the new knowledge management repository in place, keeping in mind that this repository 

will grow as new knowledge is added; the flow or decision path is needed to determine where the 

question will get routed to based on the heaviest level of knowledge. 

When the customer enters the question, as described above, the results are displayed via easy to 

use tabs that would allow the customer to shift through various bits of information including 

phone numbers or email addresses of knowledge workers within the organization who knew of or 

maybe had an association of the requested information. If the customer decided that the information 

provided was not enough, they were able to click on a button that would initiate an inquiry 

and submit the question to the beginning of the decision path. 

The business rules engine receives the question and determines the weight or emphasis of what is 

being requested. Based on the findings with the assumption that “someone” is initially capable of 

answering the question would be forwarded to that person based on their primary or secondary 


Papers 

areas of responsibilities. The knowledge worker would receive an email with the contents of the 

question and a link to the actual web application that would carry them through the process. With 

the first person, they have options on how to handle the question which was very important to the 

overall level of using existing knowledge, acquiring new knowledge, and seeking new. The initial 

employee has the ability to answer the question first based on their areas of responsibility and 

they should know the answer. If this is true, they simply type in the answer and submit. The rules 

engine would acknowledge the fact that the employee knew the answer, store the answer in the 

knowledge repository, and forward the answer to the customer. 

On the other hand, if the employee should know the answer but cannot provide it, he/she will 

forward to someone who they may think know the answer or to the next person in the chain based 

on the weighted average of the there area of responsibilities. The next person in the chain goes 

through the same process until the customer’s question is answered. If a weighted average cannot 

be provided initially, the question would go to the Public Affairs Officer (PAO) who, based on 

their knowledge of associations, would forward the question to someone with the organization 

and the process would start all over. 

The expectations to be gained from this initiative was for the organization to measure the amount 

of knowledge each responsible person possessed, the understanding of the organization’s structure, 

and if employees had the right amount of training. As the question would flow through each stop, 

the measurement process would pick up the following: 

• The question was answered by the employee who should have known the answer 

• The question was answered by the employee who knew the answer but was not part of their 

area of responsibility 

• The question could not be answered by the employee even though it was their area of 

responsibility 

• The question could be answer by the employee nor was their area of responsibility 

The program ran into its second hurdle when it came to the PAO (a contractor in this case) who 

would forward the question to their associations. The other groups of employees refused to take a 

question from a contractor as they believed that they didn’t have to take orders from a contractor. 

This caused a huge problem and slowed down customer service. Furthermore, most employees 

saw this task as a tedious process because it interfered with their daily routines. They believed 

that it was the responsibility of the “web master” to answer these questions. Even though the web 

master was from a technical background it was obvious that customer service expectations were 

minimal throughout the organization. 

Because of the unexpected hurdles it was difficult to truly measure the organization’s level of 

knowledge, skill sets, and associations. From a technical stand point, it was truly believed that 

developing a flow-based architecture where employees’ daily interactions with web-based programs 

would not be disruptive but would make it very easy to successfully create a peer-to-peer 

knowledge work center. The unexpected hurdle was a culture that needs to be addressed from the 

very beginning. This is often the problem with most knowledge management programs and other 

technology driven programs. In many cases too, when programs don’t work, the technology is 

replaced assuming this will be the fix. 

Understanding how people think, interact, and work together is very crucial to the success of any 

program. What was found after the month long pilot that it was too hard for leadership to accept 

the fact that their organization did not want to share or participate. Leadership wanted to blame 

the technology and therefore demanded that the program be terminated. After this decision was 

made, a ripple affect occurred. Not addressing the culture caused every other program based on 


Papers 

web-based technology to never leave the ground. Thousands of dollars were spent on technology 

by other departments with the same results and to this day shelves are full of more software than 

knowledge. 


Symposium 

Future Proposals

Symposium Futures 

Abstract for Future Symposium Paper 



Milwaukee, WI 

October 16-19, 2005 

Principal Author: Jennifer Conway 

Author Affiliation: St. George’s University School of Medicine 

Author Email: conjen@sgu.edu 

Author Address: St. George’s University School of Medicine 

c/o 26 S. Baker Drive 

Jackson, NJ 08527, USA 

Secondary Authors: Kathy Aligene, St. George’s University, Grenada 

Gita Patel, St. George’s University, Grenada 

Shante Aris-Williams, UMDNJ-Newark 

Title: Humanism in Medicine: A Case Study in Mentor/Trainee Responsibilities 

Proposal Summary: 

Symposium Future Proposals 

To secure best practices and fiscal responsibility, American healthcare and research institutions 

have adopted an industry or business model for operations and development. Sometimes, this 

has led to an uncritical assimilation of a productivity-benefits or quantitative-metrics paradigm. 

Resultantly, institutions are criticized for obscuring the human face of healthcare and research. 

A different approach is needed especially for the education of new healthcare providers and 

researchers. In December 2000, the DHHS Office of Research Integrity issued standards for the responsible 

conduct of research. These standards included responsibilities for the mentoring of new 

professionals. Under the leadership of the Arnold P. Gold Foundation for Humanism in Medicine, 

the New Jersey Department of Health and Senior Services piloted a Summer 2005 mentoring 

initiative. Four first year medical students were engaged in a ten week internship in Humanism in 

Medicine to explore and articulate core humanistic values for healthcare practice and biomedical 

research. In case study fashion, this paper will describe the Summer 2005 initiative with its various 

components of didactic information lectures, personal formation process groups, supervised field 

experiences, and academic requirements. The paper will discuss this initiative as a viable mentoring 

program for implementation by research administrators in their institutions. 




Abstract for Future Symposium Paper or Poster 



Milwaukee, WI 

October 16-19, 2005 

Principal Author: Dr. Edward Gabriele 

Author Affiliation: Research Ethicist and Theologian 

Author Email: efgabriele@comcast.net 

Author Address: 20460 Afternoon Lane 

Germantown, MD 20874, USA 

Secondary Authors: CAPT Joseph L. Malone, MC, USN, Mr. Stephen Gubenia, 

Ms. Jennifer Rubenstein, DoD-GEIS, Silver Spring, MD 

Title: The Invisible Cartology of Culture: The Challenge of 

Cultural Paradigms in the Development of International 

Medical Research and Healthcare Policy 


In the last ten years, research administrators have become part of leadership efforts in the formulation 

of policy and strategic planning for the types of research various institutions perform. One 

important means by which research administrators enrich institutions in this regard is providing 

clarity to the way that human beings process the information and experience about the human 

condition which research is meant to assist. Research administrators make an enormous impact 

when they assist institutions in understanding the forces of change that require new solutions for 

the quality of human life. This future paper will begin with a discussion on the “knowledge-matrix” 

that humans form by which to create a reference-grid for processing experience in culture. 

The paper will then discuss paradigmatic shifts as essential to successful, ongoing policy development. 

The paper will shift to a case study of policy analysis assistance for the Department of 

Defense Global Emerging Infections Systems Response Program. The paper will conclude with a 

final section elaborating upon the need for agencies to collaborate with one another in regular and 

intense fashion so as to share with each other aspects of research/healthcare policy analysis that 

transcend paradigms and make for more effective human services. The principal author welcomes 

comment and insight from research administration colleagues. 






Milwaukee, WI 

October 16-19, 2005 

Principal Author: Cindy Kiel, J.D., CRA 

Author Affiliation: Director, Office of Sponsored Projects 

University of Nevada, Reno 

Author Email: ckiel@unr.edu 

Author Address: Office of Sponsored Projects 

University of Nevada, Reno 

204 Ross Hall MS/325 

Reno, NV 89557 

Secondary Authors: None. 

Title: FOIA and the FAR: Fear or Freedom 

Abstract: 


The Federal Open Information Act “FOIA” was passed to provide the people of the United States 

with the knowledge and information to govern themselves and to prevent government abuses. 

FOIA excepted from disclosure information that had the potential to harm national security. 

The chosen method to protect national security was via the classification system. However, since 

September 2001, passage of the Patriot Act, promulgation of Homeland Security regulations and 

simultaneous transitions in funding opportunities and funding priorities at the federal level, many 

sponsoring agencies have been including data, publication, and foreign national restrictions in 

their contract clauses and guidelines. These restrictions seem, on their face, to be in conflict with 

the spirit and language of FOIA classification requirements. A paper is under development for 

submission in 2006 that will discuss the conflict of freedom versus national security and delves 

into the nature of security provisions for “unfoiable” information, the hierarchy of federal requirements, 

and finally, the impact of these additional security provisions on research institutions and 

academic freedom. 







Milwaukee, WI 

October 16-19, 2005 


Director of Database Development 

Master in Software Engineering 

Author Affiliation: Research and Development 



Author Address: ERA Software Systems, Inc. 

100 W.Broadway 

Long Beach, CA 90802 

Title: Reporting for Electronic Research Administration 

The Measures That Matter 

Abstract: 

The automation of grant management with Electronic Research Administration (ERA) offers clear 

opportunities for improved process efficiency, accountability, and integrity. That said, the most 

exciting benefits of ERA may well be the potential of placing a wealth of meaningful information 

within easy reach of key users – in the form of a dynamic and accessible ERA reporting system. 

This paper is intended to provide a practical introduction to understanding, evaluating, and planning 

electronice reporting systems for funded research. Three main topics are addressed: first, 

what are the key user requirements, and expected benefits, of ERA reporting. Second, what are the 

essential business analyses that can be answered most effectively with ERA reporting. Finally, what 

are the critical first steps required to plan for an implementation of ERA reporting. The paper will 

use several real world example of ERA reports which highlight effective analysis in the areas of 

funding forecasts, cost share and salary cap, certification of time and effort, and other areas. These 

reports will be examined both for their information content (the user perspective) as well for the 

way they were generated (the system perspective). The paper will conclude with a brief ‘plan of action’ 

for those interested in exploiting the power of ERA reporting. 



Abstract for Future Symposium Paper or Poster 



Milwaukee, WI 

October 16-19, 2005 

Principal Author: David F. Steele, Ph.D 

Author Affiliation: Faculty Grants Office 

University of St. Thomas 

Author Email: dfsteele@stthomas.edu 

Author Address: Director, Faculty Grants Office 

University of St. Thomas 

2115 Summit Avenue 

St. Paul, MN 55105 

Title: “Unwitting Human Subjects: Living in the Shadow of 

the Bomb in [town to be determined]” 



Even as the United States and the international community were developing a framework for the 

protection of human subjects in research in the 1960s and 1970s, the United States government 

was conducting regular tests of its nuclear arsenal at its Nevada Test Site. Many of the supposedly 

safe, underground tests following the Nuclear Test Ban Treaty of 1963 exposed Americans to 

radiactive fallout – most heavily across Nevada and southern Utah. This paper will look in detail 

at a single small town in Nevada or southern Utah and examine 1) what citizens were told about 

these tests throughout the 1960s and 1970s by the U.S. Atomic Energy Commission and, by extension, 

their local newspaper, 2) what the citizens believed about the testing program, 3) what their 

recollections are of that period when they lived in the shadow of these tests, and 4) if possible, the 

likely health effects of radioactive fallout on this community. In conducting this research, I hope 

to construct a case study in which hundreds or thousands of individuals in a small town unwittingly 

served as human subjects in America’s nuclear weapons program even as the federal government 

publicly supported the development of an ethos which mandated that individuals should be 

exposed to risk only when they have the capacity to acknowledge that risk and consent to it.

The SRA Symposium - College of Medicine

Create successful ePaper yourself

Delete template?

Save as template?