Intervention Research With Persons at High Risk for Suicidality: Safety and Ethical Considerations

There is a critical need for studies designed to reduce suicidality. Individuals at high risk for suicidalitydeserve safe and effective treatments, just as do other individuals with mental disorders whodo not experience suicidality. Points for consideration regarding safety and monitoring procedures areoffered to help researchers who conduct treatment trials with individuals who have mental disordersand investigators specifically interested in developing treatments to reduce suicidality. Issues such asstudy design, increased monitoring and supervision, research clinician competencies, and liabilityconcerns are addressed. Points to consider in planning an intervention trial, a checklist of informedconsent issues, and a list of relevant active federal regulations are provided.