The SRA Symposium - College of Medicine

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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. 110 2005 Symposium Proceedings Book
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. 2005 Symposium Proceedings Book 111
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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
Page 72 and 73: Papers References Amdur, R., Banker
Page 74 and 75: Papers • Dramatic Growth in Resea
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
Page 84 and 85: Papers Institutional Audit Findings
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
Page 96 and 97: Papers * * * However, § 5501.106(c
Page 98 and 99: Papers 4. Conclusion The NIH Februa
Page 100 and 101: Papers Within the context of a mana
Page 102 and 103: Papers As illustrated (Figure 1) th
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
Page 116 and 117: Papers APPENDIX 2 I. Research Admin
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Page 120 and 121: Papers Even if prospective subjects
Page 124 and 125: Papers 4) Heuristics: Since the con
Page 126 and 127: Papers Hochhauser, M. Informed Cons
Page 128 and 129: Papers How “readable” are conse
Page 130 and 131: Papers of vowels per word, some on
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
Page 140 and 141: Papers of Pennsylvania in 2000. In
Page 142 and 143: Papers for board members, reviewing
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
Page 150 and 151: Papers Respondents’ evaluations o
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Page 156 and 157: Papers Abstract “Best Practices
Page 158 and 159: Papers INSTITUTIONAL ERA PLANNING A
Page 160 and 161: Papers process than an end product;
Page 162 and 163: Papers realization of the benefits
Page 164 and 165: Papers State and private institutio
Page 166 and 167: Papers Institutions of higher educa
Page 168 and 169: Papers Typically, all interactions
Page 170 and 171: 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 256 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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