IRB and the Authentic Teaching Alliance

IRB and the Authentic Teaching Alliance Thursday, June 28, 2001 Teri Reed Rhoads teri.rhoads@ou.edu

University of Oklahoma-Norman Susan Wyatt Sedwick, Ph.D. Director, Office of Research Administration

Who must Apply? Any research which will result in publication involving human subjects or use of data on human subjects including survey research and use of existing data that will be conducted on this campus and/or conducted by OU staff, students or faculty must be reviewed.

RESEARCHA systematic investigation designed to produce generalizable knowledge, i.e. data.

REGULATIONProvides for prospective and continuing review by a group of diverse individuals collectively known as the IRB who ensure protection of the rights and welfare of human subjects involved in research.

Historical Perspective • Nuremberg Trials – 1946 • Tuskegee Syphilis Study 1953 – 1972 • Increase in federally funded research involving human subjects during the 1950s and 1960s • Jewish Chronic Disease Study – 1963 • Willowbrook Studies, 1963-1966 • Radiation Tests, 1946 - 1956

Nuremberg Trials and Code • Nazi War Crimes • 23 Nazi physicians went on trial • Nuremberg Code, as the first internationally recognized code of research ethics, required voluntary consent and a scientifically valid research protocol

Tuskegee Study • 400 black men with syphilis • No Informed Consent/Deception • Death Rate • No Penicillin • Compensation to Survivors/Families

Jewish Chronic Disease Study • Study of Transplant Rejection Process • Injected Active Cancer Cells • Oral, not written consent

Willowbrook Studies • Mentally Impaired Subjects • Hepatitis administered orally and with injections • Justification was that it was in a controlled environment • Coercion: Willowbrook admission contingent upon participation

Historical PerspectiveRegulations • Nuremberg Code – 1947 • Commission for the Protection of Human Subjects of Biomedical and Behavioral Research – 1974 • Belmont Report – 1978 • 45 CFR 46 Protection of Human Subjects – 1980s • NIH Required Training – 2000 • Responsible Conduct of Research (RCR) –Pending Draft

Role of the IRB RISK VERSUS BENEFIT

Protected Classes • Pregnant Women • Children/Minors • Cognitively/Mentally Impaired • Prisoners • Traumatized and Comatose Patients • Terminally Ill • Elderly/Aged • Other Vulnerable Groups

Required Elements of Informed Consent • Should be written in appropriate language • For projects involving minors, provide a Parental Consent Form and a Child Assent Form • Succinct description of the research • Risks Involved • Time Required for Participation • Assurance of Confidentiality

Required Elements of Informed Consent • Participation is Voluntary • Can Withdraw at Any Time, Without Penalty • Compensation • 18+ Statement, if appropriate • Research Contacts (Investigator for research questions/ORA for questions regarding rights as a participant) • No waiver of legal rights

IRB and the Authentic Teaching Alliance