The Pathologies of Institutional Review Boards

Abstract:     
Federal regulations require all research funded by the federal government and involving human subjects to be overseen by an institutional review board (IRB) that evaluates whether the risks to subjects are minimized; whether those risks are reasonable in light of expected benefits; and whether subjects are selected in an equitable manner. IRBs have come under intense criticism since their creation, for obstructing legitimate, low-risk research and approving questionable, high-risk research. The important question to ask about IRBs is not whether they are perfect, but whether they are the "least worst" institutional response to the problem of balancing the marginal cost and marginal benefit of research and research oversight. Even judged by this modest standard, IRBs fall well short.

Keywords: the pathologies of instititional review boards, david a. hyman, federal regulations, IRB, institutional review boards, research, human subjects, federal funding, risks, benefits, criticism, marginal cost, marginal benefit, asymmetry, performance, judicial oversight

JEL Classifications: D71, H11, L59

Accepted Paper Series