Disclosure of suicidal ideation in non-psychiatric clinical research: Experience using a novel suicide risk management algorithm in a multi-center smoking cessation trial

Background Clinical trials involving pharmacologic or behavioral treatments often assess depression and suicidal ideation for purposes of screening, baseline assessment of potential moderators or mediators of treatment, or as a study outcome, even if the primary condition under study is not a mental health disorder. Suicide risk management in the context of clinical research poses significant clinical, ethical, and practical challenges, and the literature provides little guidance with respect to outcomes of suicide risk management protocols (SRMPs) or suicide risk assessment instruments deployed in the clinical research setting. Methods We report our experience using a novel SRMP in the Program for Lung Cancer Screening and Tobacco Cessation (PLUTO) trial through in-person and remote interactions. Results An SRMP was developed for non-clinical research staff to assess and respond to participants who express suicidal ideation. Between September 2016 and April 2021, the SRMP was used 61 times for 59 individuals. The SRMP was activated by explicit probing of suicidal ideation in 46 of 61 uses (75%). Subject risk was categorized as high-risk in 6 of 61 SRMP uses (10%). Conclusion Our findings demonstrate a useful tool for the management of suicidal ideation and behavior in a clinical trial. Suicidal ideation may be endorsed by only a small number of study participants, however participant safety dictates the need to develop and implement a practical SRMP. These findings may be of relevance to researchers collecting patient reported outcomes remotely. Researchers should consider available resources for SRMPs during design and start-up phases of research.