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NIH Guidance – Research with Persons at Suicidality Risk

National Institute of Mental Health

Issues to Consider in Intervention Research with Persons at High Risk for Suicidality

Jane L. Pearson, Ph.D.,

National Institute of Mental Health

Barbara Stanley, Ph.D.,

Columbia University

Cheryl King, Ph.D.,

University of Michigan

Celia Fisher, Ph.D.,

Fordham University

Prepared under NIMH Contract Numbers 263-MD 004930 (Dr. Stanley), 263-MD-004928 (Dr. King), 263-MD-004929 (Dr. Fisher). Jane Pearson, Project Officer. January 2001.







Relevant Policy Documents

Current Federal Initiatives

Consideration of Safety Efforts in Tandem with Research Evidence

Factors Associated with Increased Risk for Suicidal Behavior
Design Considerations
Treatment Comparison Conditions

Treatment commensurate with Study participant Risk Status

Points to Consider in Planning an Intervention Trial with Suicidal Study Participants
Monitoring and Risk Management Protocols
Risk Management Protocols

Increased Monitoring and Supervision

Research Clinician Competencies
Legal Risk to Investigators and Institutions Conducting Research with Persons at High Risk for Suicidal Behavior

Checklist of Informed Consent Issues



In 1997 approximately 30,000 people died by suicide in the United States, making suicide the 8th leading cause of death in the U.S. (Hoyert, Kochanek, & Murphy, 1999). There are an estimated 8 to 25 attempted suicides for every completion. Persons with mental disorders are at increased risk for suicidality and death by suicide. NIMH is providing this guidance for those investigators conducting research on interventions to reduce suicidality, as well as for investigators likely to encounter persons at risk for suicidality in intervention trials involving persons with mental disorders. This document focuses on issues most relevant to adult study participants. For study participants considered special populations, such as children and prisoners, see information about required additional safeguards and procedures at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

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