C01 - [IN-PERSON/RECORDED] Assessment of Suicidality in SBER: Ethical Considerations vs. Regulatory Requirements IRBs MustNavigate When Protecting Participants in Research

This session will be offered in-person and recorded for on-demand access by in-person SBER23 registrants, and PRIMR23/SBER23 Virtual Meeting registrants.

Research studies that include direct assessment of suicidality carry added ethical and regulatory considerations important for IRBs to appropriately manage when conducting review of human subjects research. Many SBE researchers, in particular, require guidance on how to safely manage suicide risk throughout the entirety of the study to ensure respect for persons, but also to ensure appropriate data monitoring and supports are in place that are compliant with numerous nuanced federal/state/local laws. Using case studies, this session will explore nuances in research that include assessment of suicidality, and to exemplify best practices when reviewing applications to ensure criteria for approval are appropriately met (e.g., risks to subjects minimized, provisions for monitoring data are adequate, robust informed consent, etc.)