Throughout the world, research ethics committees are relied on to prevent unethical research and protect research subjects. Given that reliance, the composition of committees and the manner in which decisions are arrived at by committee members is of critical importance. There have been Instances in which an inadequate review process has resulted in serious harm to research subjects. Deficient committee review was identified as one of the factors In a study in New Zealand which resulted in the suffering and death (...) of many women diagnosed with carcinoma in situ. (shrink)

The institutional review board Is charged with assessing the risks and benefits of research projects Involving human subjects. Ethical considerations and federal regulations require that an IRB, in part, must find that the potential risks of participation are proportional to the potential benefits and to the Importance of the knowledge that may be learned before the IRB can approve the voluntary assumption of risk by a research participant. Adequate assessment of the risks and benefits requires careful scrutiny of the study (...) design In relation to the study objectives. (shrink)

I have been a member of the Loyola University of Chicago, Medical Center Institutional Review Board for 12 years and Chair for the last 4 years. The Medical Center Campus is a full-service academic medical center, providing tertiary and primary care to Chicago and its western suburbs. The campus houses a 520bed hospital, outpatient facilities, a cancer center, the graduate medical sciences, a nursing school, and the Loyola University Stritch School of Medicine.