30 - Post Revised Common Rule Implementation: Risks of Maintaining an Institutional Review Board

Background:  “Decreasing administrative burden, delay, and ambiguity for investigators, institutions, and IRBs” is the intent of the revised Common Rule by:
o Expanding Exempt Categories,
o Removing requirement for continuing review for less than greater than minimal risk (GTMR) research, and
o Adding the requirement for single IRB.

Methods:  Five (5) IRBs post Common Rule implementation were evaluated by the regulatory oversight authority. IRB workload metrics for expedited and GTMR research reviews were assessed. The regulatory requirement for convened meetings, the IRB meeting minutes, IRB member training and attendance were also assessed. The overall nonexempt research portfolio for each institution was discussed with leadership to determine the likelihood for changes in volume for nonexempt research.

Conclusion:  Given the revisions to the Common Rule, the reallocation of burden from the IRB to the human research protection program (HRPP) is occurring. The requirement for convening an IRB meeting is clear in the Federal Regulations. There is no requirement for every organization with a Federal Assurance to maintain its own IRB. Since the implementation of the revised Common Rule, the oversight organization facilitated the disestablishment of two (2) IRBs. The primary reason was for the lack of need to review nonexempt research. The resulting findings included: IRBs convening meetings when there was no regulatory determination to be made. IRB meeting minutes reflected non-regulatorily required discussions. While IRB members understood their ethical role, there was little opportunity to apply their understanding of the criteria for IRB approval due to lack of exposure.
Our experience shows that not every institution should maintain an IRB. Institutions should be considering the risk of maintaining an IRB. The risk to subjects could lie with the operation of an under-utilized IRB. IRBs that do not have ongoing exposure to reviewing GTMR studies should be critically evaluated. The time commitment for the HRPP to maintain IRB SoPs, the skill set needed to accurately create IRB meeting minutes, and the IRB members time commitment to participate in ongoing training without the exposure to active participation in convened meetings should also be assessed. Additionally, institutions could also consider the cost effectiveness or simply the added value for maintaining its own IRB.

Limitations: After a critical evaluation, institutions may discover that they do not need to maintain an IRB, yet IRB services might still be needed on rare occasions. In the two scenarios where two (2) IRBs were disestablished, reliance on other IRBs was easily established. Institutions might conclude that while maintaining an IRB is not effective, there may be limits to disestablishing an IRB, for example, due to the cost of IRB reliance.

Discussion:  The continued effectiveness of every individual IRB should be critically evaluated. The Government Accounting Office (GAO) was asked to examine independent IRBs, processes used to protect human subjects, and standards of IRB quality. The same should be done for University, Academic, and Federal Agency IRBs. IRBs that do not maintain a level of nonexempt review exposure, particularly for GTMR research, potentially impacts their effectiveness and/or expertise in the ethical and regulatory evaluation of human subjects research and should be disestablished.