The SRA Symposium - College of Medicine

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Poster Abstracts Poster Abstract 2005 Symposium Annual Meeting of the Society of Research Administrators International 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
Poster Abstract 2005 Symposium Annual Meeting of the Society of Research Administrators International 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: Poster Abstracts 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. 2005 Symposium Proceedings Book 7
Page 1: 2005 Symposium Proceedings The SRA
Page 7: Dear Colleagues and Friends, Octobe
Page 10 and 11: Table of Contents Karen M. Wilson.
Page 13: Poster Abstracts
Page 16 and 17: Poster Abstracts Poster Abstract 20
Page 32 and 33: Poster Abstracts Contributed Poster
Page 37: Papers
Page 40 and 41: Papers The principles of respect fo
Page 42 and 43: Papers The narrative approach, on t
Page 44 and 45: Papers References Agre, P., Campbel
Page 46 and 47: Papers Potts, A., Grace, V., Gavey,
Page 48 and 49: Papers Introduction Day by day soci
Page 50 and 51: Papers Brent: Karl has been a great
Page 52 and 53: Papers Karl: During my time at the
Page 54 and 55: Papers Work Hard. Another very impo
Page 56 and 57: Papers External Resource Acquisitio
Page 58 and 59: Papers Generally speaking, fundrais
Page 60 and 61: Papers Organizations and websites t
Page 62 and 63: Papers Public HBCUs and smaller chu
Page 64 and 65: Papers There are key databases avai
Page 66 and 67: Papers 2. Basic Institutional Compo
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Papers The Utility of Gender, Race,
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Papers As a three hospital health c
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Papers References Amdur, R., Banker
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Papers • Dramatic Growth in Resea
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Papers • Cross Unit Collaboration
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Papers The Development, Implementat
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Papers Background: IRBs in AMCs hav
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Papers Institutional Quality Improv
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Papers Institutional Audit Findings
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Papers References: Burke, G.S. (200
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Papers Table 1 Total Number of Prot
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Papers Sunday, December 7, 2003. D
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Papers Similarly, the OGE audit ind
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Papers Changes to 5 C.F.R. §5501.1
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Papers * * * However, § 5501.106(c
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Papers 4. Conclusion The NIH Februa
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Papers Within the context of a mana
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Papers As illustrated (Figure 1) th
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Papers Figure 3. Recommendation lev
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Papers References Australian Vice-C
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Papers The Problem and Its Statemen
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Papers ated directly or indirectly
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Papers Table 1: Survey Respondents
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Papers Conclusions With the creatio
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Papers APPENDIX 2 I. Research Admin
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Papers facing patients being recrui
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Papers Even if prospective subjects
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Papers sponsors must have some idea
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Papers 4) Heuristics: Since the con
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Papers Hochhauser, M. Informed Cons
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Papers How “readable” are conse
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Papers of vowels per word, some on
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Papers followed by 39 side effect b
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Papers References Chall, J.S. & Dal
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Papers Coping involves the effort t
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Papers Conclusion Defense mechanism
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Papers of Pennsylvania in 2000. In
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Papers for board members, reviewing
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Papers Focusing on “Development
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Papers Figure 1: Total UB Internal
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Papers Figure 3: Academic staff vie
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Papers Respondents’ evaluations o
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Papers 140 2005 Symposium Proceedin
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Papers ing proposals, the greater t
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Papers Abstract “Best Practices
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Papers INSTITUTIONAL ERA PLANNING A
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Papers process than an end product;
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Papers realization of the benefits
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Papers State and private institutio
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Papers Institutions of higher educa
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Papers Typically, all interactions
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Papers Figure 2 There are nine pers
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Papers Questions that can be discus
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Papers Using the innovation success
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Papers students in non-science subj
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Papers For example, to address inno
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Papers The second is the Botswana T
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Papers manpower is not trained, and
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Papers European and Federal Funding
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Papers As the majority of US Univer
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Papers Integrated Project Duration
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Papers up to these terms (called
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Papers Collective responsibility -
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Papers • Revised implementation p
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Papers Conclusion SRA is an interna
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Papers Virgin Territory: The Role o
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Papers and in which disciplines. Th
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Papers a historically black univers
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Papers Benefits of Working with Jun
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Papers Human Subjects Research and
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Papers observational and could do v
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Papers ted on patients at l’Hopit
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Papers The pastor of the Bergen hos
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Papers it was at any rate an imposs
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Papers The Environmental Protection
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Papers of the restriction on the he
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Papers Mentoring and Motivating: Br
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Papers more importantly, individual
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Papers with little or no cash outla
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Papers better outcomes for areas th
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Papers attention of the research of
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Papers discussion of each prepropos
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Papers Appendix A Sample Feedback N
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Papers Introduction Certification p
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Papers The list of certified resear
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Papers Research Question 2 What is
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Papers 8. Twenty-nine percent (29%)
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Papers individuals outside their or
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Papers References Bratton, B. & Hil
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Papers Never let your sense of mora
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Papers Lakoff (2002) describes inte
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Papers place blame at the feet of i
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Papers Lower, G. (2005, June 27). W
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Papers Institute of Ecosystem Studi
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Papers • Collaborative research p
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Papers How Administrators Can Help
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Papers How to Develop a Centralized
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Papers The current trend of selecti
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Papers References Kaiser Daily Heal
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Papers Evaluation of Strategies for
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Papers on research activity; manage
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Papers 4. Introduction of encourage
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Papers Table 1 Research Attitudes -
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Papers Constraints When staff were
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Papers Houston, D. & Studman, C.J.,
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Papers to look at the technologies
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Papers areas of responsibilities. T
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Symposium Future Proposals
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Symposium Future Proposals Symposiu
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Symposium Future Proposals Symposiu
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