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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

Institutional Review Boards

Juliann Tenney, JD

Director

Institutional Ethics and Compliance Program

DUKE UNIVERSITY

slide2

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

slide3
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

slide4
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

slide5
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
slide6
“~For every actionthere is an equal and opposite reaction”

Isaac Newton's “Third Law”

An Emerging Culture of Integrity

slide7
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.

slide8
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.

slide9
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.

slide10
That’s it for the Overview …and now for the “particulars” ….

Thank you!