Perelman School of Medicine at the University of Pennsylvania

AEREO: The Consortium to Advance Effective Research Ethics Oversight

The Problem

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.

At present, we lack valid and reliable outcome measures to assess the effectiveness of IRB and HRPP review and oversight of research with human participants. That means we can't properly evaluate IRB/HRPP effectiveness, which in turn means that we can't clearly demonstrate that the impact of the human subjects research oversight system is justified by its effectiveness or evaluate the effectiveness of new approaches. This has to change. We practice evidence-based medicine -- it's time to practice evidence-based human subjects protection.