What IRBs Could Learn from Corporate Boards

Abstract:     
Institutional review boards (IRBs) serve as the centerpiece in the regulatory system for protecting research subjects. Although many studies conclude that IRBs are weak and deficient, insufficient attention has been paid to how IRBs perform relative to other oversight bodies. The corporate board of directors provides an interesting comparison point for better understanding IRBs' institutional limitations, as well as for recognizing IRBs' considerable strengths. This Article details the many monitoring problems that IRBs share with corporate boards, including a high degree of insularity and the risk of groupthink bias. The corporate board experience suggests that proposed IRB reforms that attempt to change the composition of IRBs, such as adding more community members, will likely have only a subtle and attenuated impact. More serious changes, such as altering the appointment process and limiting the tenure of service for members, are needed to truly affect IRB performance. The corporate board experience teaches that an IRB's ultimate success is dependent upon organizational ability, neutrality, expertise, culture, and training. IRB reform proposals that simply assign more tasks when IRB members run the risk of work overload, potential bias, conformity pressures, or gaps in expertise will likely disappoint.

Number of Pages in PDF File: 6

Keywords: medical research, experimentation, research subjects, medicine, corporate board, IRB

Accepted Paper Series