Associate director of IRB operations in the Office of Regulatory Affairs and Research Compliance at the Harvard T. H. Chan School of Public Health and an EdD candidate at Vanderbilt University.
Postdoctoral fellow and scholar at the Stanford Center for Biomedical Ethics at Stanford University.
Ethics Hum Res. 2022 Mar;44(2):26-32. doi: 10.1002/eahr.500121.
Institutional review boards (IRBs) are permitted by regulation to seek assistance from outside experts when reviewing research applications that are beyond the scope of expertise represented in their membership. There is insufficient understanding, however, of when, why, and how IRBs consult with outside experts, as this practice has not been the primary focus of any published literature or empirical study to date. These issues have important implications for IRB quality. The capacity IRBs have to fulfill their mission of protecting research participants without unduly hindering research is influenced by IRBs' access to and use of the right type of expertise to review challenging research ethics, regulatory, and scientific issues. Through a review of the regulations and standards permitting IRBs to draw on the competencies of outside experts and through examination of the needs, strategies, challenges, and concerns related to doing so, we identify critical gaps in the existing literature and set forth an agenda for future empirical research.
机构审查委员会（IRB）被法规允许在审查超出其成员专业知识范围内的研究申请时，寻求外部专家的协助。然而，对于 IRB 何时、为何以及如何咨询外部专家，人们的理解还不够充分，因为迄今为止，这一做法并不是任何已发表文献或实证研究的主要关注点。这些问题对 IRB 的质量有着重要的影响。IRB 保护研究参与者的能力，同时又不会过度阻碍研究，这取决于 IRB 获得和使用正确类型的专业知识的能力，以审查具有挑战性的研究伦理、监管和科学问题。通过审查允许 IRB 利用外部专家能力的法规和标准，并通过审查与之相关的需求、策略、挑战和关注点，我们发现现有文献中存在重大空白，并为未来的实证研究制定了议程。
