The SRA Symposium - College of Medicine

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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. 114 2005 Symposium Proceedings Book
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) 2005 Symposium Proceedings Book 115
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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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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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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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Page 138 and 139: Papers Conclusion Defense mechanism
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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 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 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 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 Mentoring and Motivating: Br
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Papers Appendix A Sample Feedback N
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Papers Introduction Certification p
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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 Lower, G. (2005, June 27). W
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Papers Institute of Ecosystem Studi
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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 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 areas of responsibilities. T
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Symposium Future Proposals
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