The Problem
The current system of research ethics review and oversight places IRBs in the role of intermediaries between researchers and research participants, addressing the inherent conflicts that may arise between advancing science and protecting and promoting participant interests. Although the burdens and inefficiencies of this system are well-studied, there has been little research on the system's benefits and effectiveness. This one-sidedness is due in part to the difficulty associated with evaluating whether and how IRBs and HRPPs prevent harm to research participants, as opposed to documenting when harms occur. Efforts to measure the oversight system's impact on ethical behavior, knowledge, and institutional culture can also be challenging.
Nonetheless, it is important to rigorously evaluate features relevant to the benefits and effectiveness of research ethics review and oversight in order to identify areas that can be improved and to assess the impact of different approaches. Recent policy changes, such as the revised federal Common Rule and NIH single IRB policy, combined with increasing attention to evidence-based policy and practice and support for learning health care systems more generally, provide a strong impetus for this long overdue work.
In June 2020, several members of Congress expressed concerns about IRB quality and called for the Government Accountability Office (GAO) to investigate a number of questions, including the following:
Do existing standards of quality, efficiency, and effectiveness provide adequate protection for participants in IRB-approved clinical trials? How can IRBs, the FDA, and the Department of Health and Human Services address any shortcomings in the current system to improve quality and patient outcomes?
In February 2023, GAO published its report, "Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness." The report concluded that "OHRP and FDA have not assessed IRB effectiveness in large part because the agencies have not overcome the challenge of determining the best approach or approaches for doing so." As a result, one of the report's four recommendations was as follows:
The Secretary of Health and Human Services should ensure that OHRP and FDA convene stakeholders to examine approaches for measuring IRB effectiveness in protecting human subjects, and implement the approaches as appropriate. These could include effectiveness measures; peer audits of IRB meetings and decisions; mock protocols; surveys of IRB members, investigators, and human research participants; or other approaches.