Inclusive, engaged, and accountable institutional review boards.

In February 2023, the U.S. Government Accountability Office (GAO) released another report acknowledging that we still lack meaningful, validated, widely-accepted measures for evaluating institutional review board (IRB) quality and effectiveness. This challenge is well known to the Consortium to Advance Effective Research Ethics Oversight (www.AEREO.org), a collaborative group of human research protection (HRP) professionals, researchers, and research ethicists founded in 2018 to do precisely what GAO recommends: examine approaches for measuring IRB effectiveness in protecting human subjects, and implement the approaches as appropriate. Two underlying tenets have been central to AEREO's as approach to thinking about IRB quality and effectiveness: (1) IRBs exist to protect participants and thus the participant perspective should be central to all IRBs do; and (2) because IRBs are tasked with applying subjective ethical and regulatory standards about which people may disagree, their approach and decisions should at least meet the basic standard of reasonableness in terms of accounting for relevant perspectives, considering key factors, and providing defensible justifications. Critical to each of these tenets, IRBs should include diverse perspectives in their deliberations, find ways to meaningfully engage with relevant communities about their views regarding ethical research and appropriate participant protections, and be accountable to the public.