IRBOverviewPresentation.pptVIP

Human Subjects Protection Committeeat Cal Poly Pomona The Institutional Review Board Bruce W. Kennedy, MS RLATG CMAR Compliance Associate IRB Administrator Office of Research and Graduate Studies  - Agenda Purpose of the IRB Development of Research Ethics Scope of Authority Regulations re Human Subjects Review Elements of Informed Consent Forms and Procedures Human Subjects Training and Education Wrap-up  - Purpose Protect the welfare of human research subjects (or participants). Assure compliance with both federal law and ethical standards for the conduct of human subjects research. Review protocols Establish policy for the campus a medical school IRB would be different than a program of behavioral sciences Respond to non-compliance  - Purpose The Cal Poly Pomona IRB The committee faculty representing various disciplines outside, unaffiliated members administrator Meets once per month generally Chair is Dr. David Adams, a professor of philosophy and ethics Respect for Persons Voluntary participation Informed consent Privacy and confidentiality - Development of Research Ethics Milestones: 1940s - Nuremberg Code 1950s-60s - Controversial studies 1964 - Declaration of Helsinki 1970s - “Common Rule” 1970s - Belmont Report 1990s - 2000s - IRBs and protections - Research Ethics Nuremberg Code … At the end of World War II, 23 Nazi doctors and scientists were put on trial for the murder of concentration camp inmates who were used as research subjects. That led to: Informed consent is essential. Risks must be justified by anticipated benefits. Research must be conducted by qualified researchers. Physical and mental suffering must be minimized. - Research Ethics Controversial studies, examples, historical perspective… Milgram study, ‘60s The purpose of this study was to determine response to authority in normal humans. The researchers told recruited volunteers that the purpose was to study learning and memory. Each subject was told to teach a stude