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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.

ABSTRACTThis study obtained the perspectives of 11 providers employed in Veteran Affairs (VA) primary care clinics across 4 states regarding the factors that influence the assessment and management of suicide risk. Qualitative data was analyzed using a hybrid inductive-deductive thematic analysis approach. Themes highlighted the impact of a trusting patient–provider relationship, multidisciplinary team-based care, education about suicide prevention from integrated behavioral health providers, reliable access to mental health care, and VA system-wide suicide prevention efforts in supporting generalists' ability to effectively assess and manage veterans' suicide. Recommendations for enhancing evidence-based care for suicide risk in primary care are discussed.

Collateral information facilitates comprehensive mental health care and is consistent with recovery-oriented models of care. But providers are often faced with complex decisions about obtaining collateral information, particularly when patients do not consent to communication with third parties for information gathering. Such situations require a thoughtful balance of best clinical practices, legal and ethical responsibilities, and patient safety concerns. This column offers an overview of the clinical utility of collateral information as well as the ethical and legal regulations concerning confidentiality that guide the process of obtaining collateral information. The risk-benefit analysis process related to obtaining collateral information without patient permission is illustrated. Recommendations about clinical consultation and documentation that facilitate optimal and ethical patient care are offered.