In Reply: As a long-time IRB advocate and member, I concur with Dr Feldman's assertion that “IRBs should be strengthened, knowledgeable, and independent.” I reaffirm, however, that to strengthen IRBs, evidence of their effectiveness is needed, along with criteria to measure how strong and effective they are. Without evidence, it is not known how well IRBs fulfill their mission of protecting research participants and promoting ethical research. Nor is it known the extent to which “ . . . inappropriate or ineffective IRB review [leads] to preventable, unnecessary, or inappropriate research risks. . . . ” It is not clear what part the adequacy or failure of IRB review played in the complex set of facts and events that preceded the tragic death of Jesse Gelsinger.
Grady C. Institutional Review Boards and Protecting Human Research Participants—Reply. JAMA. 2010;304(23):2591-2592. doi:10.1001/jama.2010.1823