13 Pages Posted: 14 Dec 2006
Institutional Review Boards (IRBs) are committees that review research studies involving human subjects to assure that they will be conducted in compliance with federal regulations designed to protect those subjects. Recently, claims have been made that this system of IRB review-particularly insofar as it is applied to social and behavioral research-constitutes censorship that violates the First Amendment.
Taking a look at the actual regulations that govern IRBs provides a useful way to evaluate these claims. Doing so demonstrates that in fact many social and behavioral research studies are not even subject to IRB review. Another very large group of such studies falls into an exempt category, and receives very cursory review. Admittedly, the current system is imperfect and a variety of improvements can and should be made to eliminate those review requirements that do little to protect subjects. But even with these problems, getting IRB approval of social and behavioral research studies should in the great majority of cases be a relatively non-burdensome task that is a minimal hindrance to the conduct of the research. That burden should rarely if ever rise to the level of triggering constitutional protections against censorship.
Critics of the system would be better served by trying to improve the functioning of the IRB at their own institutions, and by working to enact appropriate changes to the regulations, than by throwing up the red flag of censorship.
Keywords: institutional review boards, IRBs, human subjects research, health law, research ethics, human experimentation
Suggested Citation: Suggested Citation
Menikoff, Jerry, Where's the Law? Uncovering the Truth About IRBs and Censorship. Northwestern University Law Review, Vol. 101, 2006. Available at SSRN: https://ssrn.com/abstract=951533