IRB: Ethics & Human Research

Reining in IRB Review in the Revised Common Rule

Abstract: The revised Common Rule contains several changes designed to reduce the time institutional review boards (IRBs) spend on overseeing low-risk studies, including an expansion of the categories of research that are exempt from the regulations and a list of specific activities that do not satisfy the regulatory definition of “research.”   While these changes go a long way toward the goal of reducing unnecessarily regulatory burden, they leave several important questions about IRB jurisdiction unresolved.  The most significant omission is the failure to address when IRB review is necessary for quality assurance activities.  In addition, the revised Common Rule’s distinction between “research” and “public health surveillance” may prove to be unworkable as applied to some types of public health activities.  Many of these interpretive questions stem from the inherent ambiguities in the regulatory definition of research, which turns on whether an activity is “designed to develop or contribute to generalizable knowledge.”  Because the revised Common Rule does not alter this basic definition, difficult questions about the circumstances in which IRB review is required are likely to remain.

Key words: IRB exemptions, definition of research, generalizable knowledge, public health surveillance, quality improvement, quality assurance