Day_7_101816_PHI+015+Presentation+B

Day_7_101816_PHI+015+Presentation+B - Dr Rulli PHI 015...

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October 18, 2016 Dr. Rulli PHI 015: Introduction to Bioethics 1
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Today’s Agenda Essays due October 20 th , in-class, beginning of class Human Subjects Research, cont. Randomized Control Trials Placebo Control Trials 2
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The Belmont Report Came out of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Commissioned to review Tuskegee 3
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The Belmont Report Part A: Distinction Between Research and Practice Easily confused: some research has therapeutic benefits; some clinical practice is experimental Practice: interventions designed solely to enhance the well-being of an individual patient, with reasonable chance of success Research: activity designed to test a hypothesis, draw conclusions, and develop or contribute to generalizable knowledge If any element of research in an activity, it should go through review to protect human subjects 4
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The Belmont Report Part B: Ethical Principles Respect for Persons Individuals should be treated as autonomous Those that are not deserve protection Beneficence Obligation to do no harm Obligation to maximize benefits and to minimize harm Justice Just distribution of benefits and burdens of research Treat equal people equally 5
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The Belmont Report Part C: Applications Informed consent requirement Information Comprehension Voluntariness Risk benefit assessment Includes determination of whether it is necessary to include humans Subject selection Fair procedures in subject selection Fair distribution of benefits and burdens Attention to vulnerable populations 6
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The Belmont Report An ethical code, not a regulatory one Provides a moral framework for ethical research in the U.S. Provides the moral basis for regulatory codes 45 CFR 46, The Common Rule, that governs all HHS research 7
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45 CFR 46; & The Common Rule Health and Human Services regulatory requirements Four subparts: Subpart A, the “Common Rule” (agreed to by 15 other US agencies/departments, 1991) Subpart B, additional protections for pregnant women, human fetuses, and neonates; Subpart C, additional protections for prisoners Subpart D, additional protections for children 8
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The Common Rule/IRBs Among other things, it provides requirements for Institutional Review Boards (IRBs) Must approve all non-exempt research on human subjects (federally funded research) Each institution conducting research has them 5 members Diversity of gender, profession Representation for relevant vulnerable groups 1 scientist; 1 non-scientist 1 community member 9
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IRBs Give initial approval of research and conduct periodic reviews Primary goal is to protect human subjects Informed consent review Risk/benefit assessment 10
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Onto clinical research . . .
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