The SRA Symposium - College of Medicine

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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. 112 2005 Symposium Proceedings Book
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. 2005 Symposium Proceedings Book 113
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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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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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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 120 and 121: Papers Even if prospective subjects
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Page 126 and 127: Papers Hochhauser, M. Informed Cons
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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
Page 146 and 147: Papers Figure 1: Total UB Internal
Page 148 and 149: Papers Figure 3: Academic staff vie
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Page 156 and 157: Papers Abstract “Best Practices
Page 158 and 159: Papers INSTITUTIONAL ERA PLANNING A
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Page 168 and 169: Papers Typically, all interactions
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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 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 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 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 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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