Structuring appropriate and feasible evaluations of risk (safer)

The National Institute of Mental Health awarded Butler Hospital $165,987 on May 1, 2026, under the Mental Health Research Grants program (CFDA 93.242) to develop evidence-based suicide risk management protocols for research involving high-risk populations.

The SAFER (Structuring Appropriate and Feasible Evaluations of Risk) project will create and evaluate protocols that balance participant safety with scientific validity in suicide risk research. The study pursues three aims: examining stakeholder views on the acceptability of risk management protocols through semi-structured interviews with approximately 16 college students with lived experience of suicidal ideation and approximately 16 suicidologists; assessing the perceived acceptability and effectiveness of various risk response strategies among high-risk college students (N=30) and suicidologists (N=10); and testing how different levels of research personnel outreach affect reports of suicidal ideation and behaviors in a cohort of college students.

Butler Hospital, a tax-exempt psychiatric hospital and division of Care New England Health System based in Providence, Rhode Island, serves as the recipient. The award funds work performed in Providence, RI, with a period of performance from May 1, 2026, through April 30, 2028. The project addresses a gap in empirical validation of suicide risk management protocols currently used in research settings, particularly relevant given that suicide is the second leading cause of death among college-aged individuals, with 6.4 percent of students developing new-onset suicidal ideation.

Abstract

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.