The current system of research ethics review and oversight developed over the past several decades to serve as an intermediary between researchers and research participants, intending to address 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 the prevention of harms or wrongs associated with research participation, as opposed to documenting when these occur. Systematic efforts to measure the 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 learning health care systems more generally, provide a strong current impetus for this long overdue work.
In addition, several members of Congress have recently stated concerns about IRB quality, in June 2020 calling for the Government Accountability Office 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?
It is our hope that AEREO's work can help inform these efforts.