Institutional Review Boards and the Freedom to Take Risks

Abstract

The regulation that IRBs shall determine, before approving research proposals, that risks to subjects be reasonable in relation to anticipated benefits is considered to be a hindrance to investigation in certain circumstances. A hypothetical case is presented in which a physicist, his graduate students, and colleagues chose to expose themselves to a microwave field, but the IRB had to make the risk-benefit decision. The author contends that, when obvious bodily harm is not threatened and where the expertise of the proposed research subjects allows them to be aware of the hazards, then the IRB should respect their judgment. (KIE abstract)