IRB: Ethics & Human Research

Institutional Not-for-Cause Compliance Review Programs

Use of routine, not-for-cause research study review programs to determine and mitigate risks to research participants has markedly increased in recent years, yet no guidance on the topic is currently available. In developing a compliance review program for the University of Michigan, the vice president of research requested that the university’s Office of Human Research Compliance Review contact peer institutions to see how they approach this type of review activity. We conducted telephone interviews with administrators or senior staff persons in the compliance review programs at 11 institutions. Information from the interviews revealed wide variation in review methods and the number of compliance reviews completed, though all institutions agreed that their review program was designed to be a mechanism for education and collaboration, rather than a punitive program. Of note, only one institution made any attempt to evaluate the effectiveness of review on decreasing the level of investigator noncompliance.

Key words/concepts: human subjects research, institutional review boards, human subjects regulations, regulatory compliance, not-for-cause review

Terry M. VandenBosch and Ronald F. Maio, “Institutional Not-for-Cause Compliance Review Programs,” IRB: Ethics & Human Research 33, no. 1 (2011): 15-17.