July 9, 1982

Problems With Institutional Review Board Inconsistency

Author Affiliations

The Joseph and Rose Kennedy Institute of Ethics Georgetown University Center for Bioethics Washington, DC

JAMA. 1982;248(2):179-180. doi:10.1001/jama.1982.03330020023022

The study "Inconsistency and Institutional Review Boards" by Jerry Goldman, PhD, and Martin D. Katz, presented elsewhere in this issue (p 197), raises troubling and important questions for anyone concerned about the future of research involving human subjects. Presenting three research protocols purposefully modified to raise questions of methodology, consent, and other ethical issues to 22 institutional review boards (IRBs) in major academic medical research facilities, they found substantial inconsistencies in decisions to approve or disapprove the research, in reasons given for or against approval, and in the standards applied in review.

Research on IRBs is extremely difficult, as it requires permission from researchers to submit protocols to this process and from IRBs willing to expend valuable time to learn something about the nature of the review process. We have previous studies of IRBs that have hinted at the problem of inconsistency,1 but never before have we been able