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Institutional Review Boards

Institutional Review Boards. Juliann Tenney, JD Director Institutional Ethics and Compliance Program D UKE U NIVERSITY. The Historical Perspective 1202: Assize of Bread 1848: Drug Importation Act 1901: Biological Control Act 1906: Food and Drugs Act

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Institutional Review Boards

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  1. Institutional Review Boards Juliann Tenney, JD Director Institutional Ethics and Compliance Program DUKE UNIVERSITY

  2. The Historical Perspective 1202: Assize of Bread 1848: Drug Importation Act 1901: Biological Control Act 1906: Food and Drugs Act 1931: Food and Drug Administration 1932: Tuskegee Syphilis Study 1938: Food, Drug, and Cosmetics Act 1947: Nuremberg Code 1962: Kefauver-Harris Amendment 1964: Declaration of Helsinki 1974: National Research Act

  3. 1976: Medical Device Amendments 1979: Belmont Report 1980/81: Belmont -> 21 CFR 50, 56 (IRBs) 1983: Orphan Drug Act 1988: FDA becomes agency of DHHS/President appoints Commissioner of F & D 1990: Safe Medical Devices Act Int. Conf. on Harmonization 1995: FDA: cigarettes = drug delivery devices 1999: Death of 18 y/o in gene therapy trial w/o fully informed consent; conflict of interest issues present 2000: OHRP -> (D)HHS from NIH

  4. Institutional Review Boards have come to be regarded as the conscience of the campus. Conscience: The faculty of recognizing the difference between right and wrong with regard to one’s conduct coupled with a sense that one should act accordingly. Webster’s II, New College Dictionary

  5. Convergence of concepts of security, integrity, and autonomy from protection of the physical health and safety of human subjects to protection of their financial well-being and privacy: • Sarbanes-Oxley (internal controls, prescribed reporting) • Deficit Reduction Act of 2006 (protection of employees reporting false claims) • HIPAA

  6. “~For every actionthere is an equal and opposite reaction” Isaac Newton's “Third Law” An Emerging Culture of Integrity

  7. The Challenge: Increasingly, institutions approach IRBs to “determine” their conscience in ways that have not been anticipated, resulting in Mission and Scope Creep, which Strains resources.

  8. Additionally … IRB members are held to standards that include disclosing conflicts of interest (similar, if not identical, to that of principal investigators), mastery of complex scientific concepts, and dedication of enormous amounts of time to understand the material.

  9. Relationship of the Compliance Program to the IRB: Collaborative and supporting Verify applicable laws and regulations adhered to Ensure appropriate oversight, including monitoring and auditing.

  10. That’s it for the Overview …and now for the “particulars” …. Thank you!

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