26 - What It Means to Conduct Belmont-Centric IRB Reviews

Background:  Building atop discussions at the 2023 PRIM&R Annual Conference about whether the Belmont Report is still an adequate foundation for human subjects research regulations, a university HRPP examined what it means to conduct Belmont-centric IRB reviews, and conceptualized ways to encourage researchers to incorporate the principles into their study designs.

Methods:  We conducted focus groups with the universities HRPP staff analysts to learn how they incorporate the Belmont Principles into their reviews of expedited research, areas where they feel their reviews could benefit from stronger consideration of the Belmont Principles, and common gaps they have identified between principle ideals and study design proposals submitted to the IRB.

Conclusion:  We presented the focus group findings to the staff and co-developed staff review guidance grounded in the Belmont Principles. We also created a workgroup devoted to educating the research community on the Belmont Principles and creating guidance about IRB expectations for how researchers should incorporate the principles into their research submissions.

Limitations: Though staff noted that the 111 criteria for approving research are grounded in the Belmont Principles, the staff focus groups revealed that there are areas where staff reviews could and should demonstrate more robust consideration of the principles. These gaps have informed the development of a staff review guidance document, which will be utilized internally, and also made available to the larger PRIM&R community.

Discussion:  Though we have formed a Belmont workgroup, the group has not yet had the opportunity to engage with the research community about their knowledge of the Belmont Principles, or to have a discussion with the research community about the HRPP’s expectations for how the principles should be integrated into study design; though this will be the focus and purview of the workgroup going forward. We also would like to share our co-developed guidance document for conducting Belmont-centric reviews with the PRIM&R community.