NIH Guidance – Research with Persons at Suicidality RiskNational 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.,
Cheryl King, Ph.D.,
University of Michigan
Celia Fisher, Ph.D.,
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 InitiativesDesign Considerations
Treatment Comparison ConditionsMonitoring and Risk Management Protocols
Risk Management ProtocolsLegal Risk to Investigators and Institutions Conducting Research with Persons at High Risk for Suicidal Behavior
Checklist of Informed Consent Issues
Purpose: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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