Acknowledging Complexity and Reimagining IRBs: A Reply to Discussions of the Protection-Inclusion Dilemma.

We are grateful to everyone who took the time to offer such insightful comments with regard to the protection-inclusion dilemma in research oversight. Nearly all respondents agreed that this dilemma is a real and challenging one faced by Institutional Review Boards (IRBs), as well as other players in the research ecosystem. A number of the responses detailed the shape of this dilemma in their particular area of medical research. While reading these examples, we found ourselves in agreement, as they so nicely underscore the importance of IRBs understanding the complex nature of vulnerability, responding appropriately to that complexity, and considering the specific way in which obligations related to protecting and including differ across groups, across geographies, and across research protocols. Some respondents also offered recommendations for how to best work towards a resolution to this dilemma, particularly through inclusion initiatives, and others described barriers that will stand in the way of working towards a balance between protection and inclusion. We are thankful for the extent of engagement with and expansion of our manuscript. Since many of the Open Peer Commentaries (OPCs) illustrated the protection-inclusion dilemma in different realms of research, here we connect several of these examples with our recommendations. We then consider some of the suggestions made and respond to some of the critical comments offered within commentaries.