ABSTRACT
The congressional hearing marked one of the first public discussions of the issue of private, commercial review of research involving human subjects. Only recently has the phenomenon of commercial review attracted limited scholarly attention. This chapter points out why conflict-of-interest rules should be better developed and why they should prescribe more clearly what types of relationships are appropriate between institutional review boards (IRBs) or IRB members and research sponsors. The National Bioethics Advisory Council is also looking into the adequacy of the current system of human subjects protection, and it is hoped that they will deal with the phenomenon of private commercial review and problems associated with it in their final recommendations. Procedural rules dealing with the membership and composition of IRBs, including conflict-of-interest rules, are important in research ethics review precisely because there is so much reliance on the fairness of IRB members.
