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 suicidality deserve safe and effective treatments, just as do other individuals with mental disorders who do not experience suicidality. Points for consideration regarding safety and monitoring procedures are offered to help researchers who conduct treatment trials with individuals who have mental disorders and investigators specifically interested in developing treatments to reduce suicidality. Issues such as study design, increased monitoring and supervision, research clinician competencies, and liability concerns are addressed. Points to consider in planning an intervention trial, a checklist of informed consent issues, and a list of relevant active federal regulations are provided.