McGill University.
Advarra IRB.
Am J Bioeth. 2023 Sep;23(9):W1-W8. doi: 10.1080/15265161.2023.2237762.
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.
我们感谢每一位抽出时间就研究监督中的保护-纳入困境提出深刻见解的人。几乎所有的回复者都认为，这种困境是机构审查委员会（IRB）以及研究生态系统中的其他参与者所面临的一个真实而具有挑战性的问题。许多回复详细描述了这一困境在他们特定的医学研究领域中的具体表现。在阅读这些例子时，我们深表认同，因为它们非常好地强调了 IRB 理解脆弱性的复杂性、对这种复杂性做出适当回应的重要性，以及考虑与不同群体、不同地理位置和不同研究方案相关的保护和纳入义务的具体方式的重要性。一些回复者还就如何最好地努力解决这一困境提出了建议，特别是通过包容倡议，而另一些回复者则描述了在努力实现保护和纳入之间平衡的过程中可能存在的障碍。我们非常感谢大家对我们的稿件的广泛参与和扩展。由于许多公开同行评议（OPC）在不同的研究领域阐述了保护-纳入困境，在这里，我们将这些例子中的几个与我们的建议联系起来。然后，我们考虑了一些提出的建议，并回应了评论中的一些批评意见。
