The SRA Symposium - College of Medicine

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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/ 104 2005 Symposium Proceedings Book
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 2005 Symposium Proceedings Book 105
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2005 Symposium Proceedings The SRA
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Dear Colleagues and Friends, Octobe
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Table of Contents Karen M. Wilson.
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Poster Abstracts
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Poster Abstracts Poster Abstract 20
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Poster Abstracts Contributed Poster
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Papers
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Papers The principles of respect fo
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Papers The narrative approach, on t
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Papers References Agre, P., Campbel
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Papers Potts, A., Grace, V., Gavey,
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Papers Introduction Day by day soci
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Papers Brent: Karl has been a great
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Papers Karl: During my time at the
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Papers Work Hard. Another very impo
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Papers External Resource Acquisitio
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Papers Generally speaking, fundrais
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Papers Organizations and websites t
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Papers Public HBCUs and smaller chu
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Papers There are key databases avai
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Page 68 and 69: Papers The Utility of Gender, Race,
Page 70 and 71: Papers As a three hospital health c
Page 72 and 73: Papers References Amdur, R., Banker
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Page 76 and 77: Papers • Cross Unit Collaboration
Page 78 and 79: Papers The Development, Implementat
Page 80 and 81: Papers Background: IRBs in AMCs hav
Page 82 and 83: Papers Institutional Quality Improv
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Page 86 and 87: Papers References: Burke, G.S. (200
Page 88 and 89: Papers Table 1 Total Number of Prot
Page 90 and 91: Papers Sunday, December 7, 2003. D
Page 92 and 93: Papers Similarly, the OGE audit ind
Page 94 and 95: Papers Changes to 5 C.F.R. §5501.1
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Page 98 and 99: Papers 4. Conclusion The NIH Februa
Page 100 and 101: Papers Within the context of a mana
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Page 104 and 105: Papers Figure 3. Recommendation lev
Page 106 and 107: Papers References Australian Vice-C
Page 108 and 109: Papers The Problem and Its Statemen
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Page 112 and 113: Papers Table 1: Survey Respondents
Page 114 and 115: Papers Conclusions With the creatio
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Page 132 and 133: Papers followed by 39 side effect b
Page 134 and 135: Papers References Chall, J.S. & Dal
Page 136 and 137: Papers Coping involves the effort t
Page 138 and 139: Papers Conclusion Defense mechanism
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Page 144 and 145: Papers Focusing on “Development
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Page 156 and 157: Papers Abstract “Best Practices
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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 254 2005 Symposium Proceedin
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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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The SRA Symposium - College of Medicine

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