Do IRBs “work”? What does that mean – and how would we know?
Launched in May 2018, AEREO is a consortium of leaders in human subjects research oversight, research ethics, and empirical methods. We have come together to advance the shared mission of evaluating and improving the effectiveness of Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs). Consortium members work collaboratively to advance an empirical research agenda to support evidence-based approaches to research ethics review, oversight, and policy.
What have we learned so far?
In March 2023, we had the opportunity to share our findings and future plans with the Secretary's Advisory Committee for Human Research Protections (SACHRP) in response to the GAO report on IRB effectiveness. Watch the video below (starting at the 25:21 mark) and take a look at AEREO's publication list.
Work so far has led to the following recommendations for HRPPs and IRBs aiming to improve quality and effectiveness:
- Attend to compliance but minimize “audit culture” that focuses on achieving metrics for their own sake over attention to substantive goals
- Prioritize assessments directly related to participant protection outcomes (e.g., quality of the informed consent process and understanding, robust review of adverse events and whether they could have been avoided, and overall participant experience in research)
- Emphasize assessment of processes and standards likely to promote participant protection through identification of risks and implementation of safeguards (e.g., how systematically IRBs evaluate research risks and benefits, data monitoring plans, and plans to provide care and compensation for participant injury)
- Make sure reviewers are fully informed about relevant details of proposed and ongoing research and that they have adequate time to review materials and deliberate
- Examine the extent of meaningful discussion and debate about key ethical and regulatory issues during board meetings
- Promote diversity, expertise, and independence among board members to ensure consideration of a variety of relevant perspectives
- Appreciate and utilize the expertise of unaffiliated and non-scientist IRB members
- Periodically inventory content area expertise represented amongst IRB members and adjust as needed
- Consult external expert(s) to fill gaps in member expertise, e.g., in the context of novel study designs or research methods, inclusion of unique participant communities, or distinct challenges relevant to data security and information technology
- Encourage reliance on prior decisions to promote consistency, where appropriate, and efficiency, as well as to clarify the meaning of ambiguous ethical and regulatory standards
- Include attention to whether and how the HRPP monitors the conduct of research beyond protocol review (i.e., what happens after IRB approval)
- Adopt assorted quality assessments that incorporate feedback from and about a variety of stakeholders (e.g., board members, HRPP staff, research teams, study participants and others) obtained through a variety of methods (e.g., checklists, site visits, record review, interviews, and surveys)