Background: Medical research involving human subjects must be evaluated by a research ethics committee (REC) before a study is initiated. However, knowledge of REC decision processes, particularly in relation to evaluating the risk-benefit balance in various study types, appears scant. Methods: The study protocols and records of a Finnish…

Institutional Review Boards (IRBs) and their federal overseers protect human subjects, but this vital work is often dysfunctional despite their conscientious efforts. A cardinal, but unrecognized, explanation is that IRBs are performing a specific function -- the management of risk -- using a flawed theoretical and practical approach. At the time…