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

Introduction:  Building atop discussions from PRIM&R 2023 about whether the Belmont Report is still an adequate foundation for human subjects research regulations, the USC HRPP examined what it means to conduct Belmont-centric IRB reviews.

Methods:  The USC HRPP broke into small groups to apply the Belmont Report Principles to two case studies: one used photovoice methodology to examine the lived experiences of foster care youth in an international residential treatment facility; and the other explored whether ketamine could effectively mitigate treatment-resistant depression in teens. Our discussion questions focused on both the studies as a whole and their recruitment strategies in particular, to examine how the inclusion of underrepresented populations in research aligns with the Belmont Report Principles. We then divided up the 111 criteria into 8 individual statements and used Mentimeter polling to rank salience of the three Belmont Report Principles in each of the criteria (Figure 1). Finally, we discussed as a group what it means to do a Belmont-centric review, particularly when the regulations conflict with the principles.

Discussion:  Case Study 1 examined research with foster youth, emphasizing consent procedures that balance legal requirements with participant autonomy (Respect for Persons), psychological support (Beneficence), and justification for studying vulnerable populations (Justice). Case Study 2 explored a clinical trial involving teens with treatment-resistant depression, addressing parental consent disagreements (Respect for Persons), medication risks and post-study treatment access (Beneficence), and equitable representation across populations (Justice). The Mentimeter activity revealed that when considering the 111 approval criteria, the most salient Belmont Report Principle was usually tangible and self-evident. However, while reviewing criterion a.6, biomedical reviewers expected Beneficence to be most salient due to its connection with risk assessment, while social behavioral reviewers viewed Justice as most relevant, linking it to equal risk distribution through monitoring. For criterion a.2, while the group correctly predicted Beneficence would rank highest, they were surprised that Respect for Persons ranked second instead of Justice, which deals with fair distribution of risks and benefits. Finally, we examined tensions between Belmont Report Principles and regulations, including: protecting vulnerable participants vs. ensuring broad inclusion; randomized trials providing societal benefits vs. individual acceptability of risks; and whether applicability of consent waivers should take precedence over Respect for Persons.

Next Steps: We will develop a working group to strategize future guidance, revisions to protocol and consent templates, and to facilitate the creation of education for the research community on Belmont-centric study design considerations.