How Will Changes in the Common Rule Affect IRB Practices, Efficiency, and Effectiveness?

The National Institutes of Health (NIH) has sponsored the RAND Corporation, in cooperation with the Scripps Translational Sciences Institute, to conduct a survey of IRBs. This IRB survey will ask about IRB organization and staffing, the volume and timing of IRB reviews, IRB resources and procedures, and opinions about IRB efficiency and effectiveness. The resulting data may serve as a baseline for tracking results of changes that take place as the revised Common Rule is implemented and provide IRBs with a current snapshot of how other IRBs are organized and staffed and what procedures they are following.

We are also asking about expected impact of changes to the Common Rule on IRB efficiency and effectiveness, as well as challenges IRBs are currently facing.  This is an opportunity for the people most directly involved with and affected by changes in the Common Rule to answer questions about their expectations and concerns. The survey also provides an opportunity for participants to add comments and any other information they wish to include.

To develop the Internet questionnaire, we reviewed the Bell Report and recent peer-reviewed literature on IRB functioning and conducted semi-structured interviews with key informants who are familiar with IRBs from different perspectives.  We randomly selected IRBs based on information provided by the Office for Human Research Protections (OHRP) to include different types of IRBs, of different sizes, at different kinds of institutions.

The survey responses are confidential and will be seen only by RAND researchers working on this study. The decision to participate or not participate will not have any bearing on a person’s relationship with the IRB, NIH, ORHP, or any other organization involved in this survey.

The results of the study will be disseminated to participating IRBs first, and then in public reports and publications. We will summarize it for IRBs overall and for each of several types of IRBs. We will not identify any IRB or individual associated with an IRB and we will not make comparisons at the individual IRB level: for example, we will not compare and contrast information from investigators and IRB members for any particular IRB. Rather, we will report results for IRBs generally.  Separately, we will be conducting a survey of Principal Investigators funded by NIH asking about their experiences with IRBs, but this will not be linked to specific IRBs.

If you have questions about the survey please contact or call the toll-free line at (866) 442-6407.

The RAND Corporation is a private, non-partisan, nonprofit public policy research organization. The principal investigator for this study, Sandra H. Berry, is also the Chair of the RAND IRB (titled the Human Subjects Protection Committee) and also serves on the Secretary’s Advisory Committee on Human Research Protections (SACHRP) which provides expert advice and recommendations to the Secretary of HHS on issues pertaining to the protection of human subjects in research.