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The 40th Anniversary of the Belmont Report Le quarantième anniversaire du Belmont Report

The 40th Anniversary of the Belmont Report Le quarantième anniversaire du Belmont Report. Ivor Pritchard Office for Human Research Protections April 25, 2014. Why do REBs make questionable or varying decisions about research projects?. The local circumstances are peculiar.

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The 40th Anniversary of the Belmont Report Le quarantième anniversaire du Belmont Report

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  1. The 40th Anniversary of the Belmont ReportLe quarantième anniversairedu BelmontReport Ivor Pritchard Office for Human Research Protections April 25, 2014

  2. Why do REBs make questionable or varying decisions about research projects? • The local circumstances are peculiar. • The REB members don’t know the facts. • The REB members don’t understand and apply the rules. • REB members exhibit psychological behavior. • REB members are influenced by each other in the group’s decision-making processes. • The REB members hold different ethical perspectives.

  3. Oops! 2014 -1979 35

  4. National Research Act (1974) “The Commission shall … conduct a comprehensive investigation and study to identify the basic ethical principles which should underlie the conduct of biomedical and behavioral research involving human subjects…”

  5. National Research Act (1974) “…the Commission shall consider at least the following: • The boundaries between biomedical or behavioral research involving human subjects and the accepted and routine practice of medicine.” • The role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects…”

  6. National Research Act (1974) “(iii) Appropriate guidelines for the selection of human subjects for participation in biomedical and behavioral research. (iv) The nature and definition of informed consent in various research settings…”

  7. The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects in Research (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979))

  8. Principle: Respect for Persons Subjects as Autonomous Beings Protection of Subjects with Limited Autonomy Applications: Informed Consent as Informed, Competent, and Voluntary Subjects’ Assent and Third Party Consent Respect for Persons/Le Respect

  9. Principle: Beneficence Do No Harm Maximize Benefits and Minimize Possible Harms Applications: Favorable Risk/Benefit Assessment Systematic Analysis and Minimization of Acceptable Risks of Harm Beneficence/La Bienfaisance

  10. Principle: Justice Distribute Burdens and Benefits Equitably Don’t Exploit Vulnerable Populations Applications: Select Individuals and Classes of Subjects Equitably Link Burdens to Benefits Justice/La Justice Distributive

  11. How Old are the Belmont Report’s Ethical Principles? And Where Did They Come From?

  12. Respect for Persons (1785) Immanuel Kant, leading philosopher of Deontology and the categorical imperative of treating every rational being (person) as a end.

  13. Beneficence (1789) Jeremy Bentham, leading philosopher of Utilitarianism and the Principle of Utilityof the Greatest Happiness of the Greatest Number

  14. Justice (350 BCE) Aristotle, leading philosopher of Aristotelian Philosophy and of the principle of distributive justice according to what people deserve.

  15. Conflict Between Principles Beneficence vs. Justice (E.g. Rare Disease Research) Respect for Persons vs. Beneficence (E.g. Deception Research) Justice vs. Respect for Persons (E.g. Culturally Stigmatizing Research)

  16. An Ethical Dilemma

  17. A Second Ethical Dilemma:Take Me Out to the Ballgame?

  18. Practice/ResearchLa Pratique/La Recherche “Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. This need not cause any confusion regarding whether or not the activity requires review; the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.” (Belmont Report)

  19. Learning Health Care Systems “The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight” (Kass et. al., 2013) “An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics” (Faden et. al., 2013)

  20. A Third Ethical Dilemma

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