Structuring Appropriate and Feasible Evaluations of Risk (SAFER)

Suicide remains a leading public health crisis, claiming over 49,000 lives in 2022. Among college-aged individuals, suicide is the second leading cause of death, with studies indicating that 6.4% of students develop new-onset suicidal ideation, exceeding rates seen in the general population. To address this, researchers increasingly utilize technological tools for real-time suicide risk assessment. While these tools enhance risk detection, they also introduce ethical challenges, particularly in balancing participant safety with scientific validity. Existing protocols for managing suicide risk in research lack empirical validation, creating inconsistencies that delay studies and hinder progress. The proposed study, Structuring Appropriate and Feasible Evaluations of Risk (SAFER), aims to address this gap by developing evidence-based suicide risk management protocols. SAFER will incorporate perspectives from students with lived experience and suicidologists to create and evaluate risk assessment and intervention protocols. The project has three primary aims: (1) examining stakeholder views on the acceptability of suicide risk management protocols, (2) evaluating the effects of different protocols on participant safety, and (3) assessing their impact on data validity. Aim 1 will develop a stakeholder panel consisting of ~16 students with lived experience and ~16 suicidologists. Semi-structured interviews will be conducted until saturation is reached. Aim 2 will assess the perceived acceptability and effectiveness of various suicide risk management protocols among high-risk college students (n=30) and suicidologists (n=10). Participants will evaluate different risk response strategies, including variations in outreach, safety measures, and resource provision. Aim 3 will test the impact of different levels of research personnel outreach on reports of suicidal ideation and behaviors. A cohort of 50 students at risk for suicide will complete daily assessments. Responses will trigger stratified interventions, ranging from automated resource reminders to direct outreach by research staff. Participants will evaluate the acceptability of these interventions at the study’s conclusion. This project will generate empirical data to refine ethical guidelines for suicide risk management, ensuring they are both protective and conducive to research integrity. By balancing participant safety with scientific feasibility, SAFER will provide scalable, evidence-based risk management strategies applicable to diverse research settings. These findings will contribute to national efforts in bioethics, aligning with the Belmont Report principles while addressing critical gaps in suicide research methodologies. Project Number: 1R03MH143127-01 | Fiscal Year: 2026 | NIH Institute/Center: National Institute of Mental Health (NIMH) | Principal Investigator: Sarah Arias | Institution: BUTLER HOSPITAL (PROVIDENCE, RI), PROVIDENCE, RI | Award Amount: $165,987 | Activity Code: R03 | Study Section: Special Emphasis Panel[ZRG1 SEIR-B (80)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11286891