Webinar: Suicidal Individuals in Research

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Overview

Including suicidal or potentially suicidal individuals in clinical research is a critical way to gain important data that can advance suicide prevention efforts. Researchers and IRBs may tend to exclude suicidal individuals from research studies to avoid potential risks; however, in order for the research to be scientifically and clinically valuable, it is important that suicidal individuals are not excluded from research unnecessarily. Implementing proper safety measures in the protocol can help mitigate potential risks and encourage safe and ethical participation of suicidal and potentially suicidal individuals in research.

This webinar will summarize the recently released National Institute of Mental Health (NIMH) guidance for conducting research with subjects at elevated risk of suicide*, focusing on the areas most relevant for IRBs, including considerations for informed consent, study design, safety monitoring and reporting, end of study participation, and the use of novel technologies in research. The webinar will also discuss practical applications to address these considerations, including the role of clinical care in mitigating risk. Potential negative consequences of excluding suicidal individuals in research will also be considered. The webinar will conclude with interactive case studies.

What will I learn?

After attending this webinar, you will be able to:

  • Support clinical researchers in including potentially suicidal individuals in their studies by directing them to resources that provide guidance on safe and ethical practice
  • Evaluate inclusion and exclusion criteria for suicidal individuals’ participation in research
  • Evaluate the appropriateness of risk assessment and mitigation strategies proposed in a study protocol

Who should attend?

This webinar will be beneficial for IRB staff and members who are involved in reviewing research and trials involving suicidal and potentially suicidal individuals.

Continuing Education

CIP Credit labelWebinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Learn More »

*No endorsement of PRIM&R, its programs, or services, by NIH is intended.

Speakers

Galia SiegelGalia Siegel, PhD has worked with the National Institute of Mental Health (NIMH) since 2009 and is currently a clinical trials program coordinator in the NIMH Office of Clinical Research. In her present role, she provides operational support focused on data and safety monitoring to clinical research studies funded by NIMH, many of which are suicide prevention studies. Her portfolio also includes work with pragmatic effectiveness trials and the development of a technology-enhanced mental health interventions portfolio analysis. Previous to her work with NIMH, Dr. Siegel was an attending psychologist at Montefiore Medical Center and assistant clinical professor of psychiatry and behavioral sciences at Montefiore Medical Center Department of Psychiatry, University Hospital for the Albert Einstein College of Medicine, in New York City. There she worked as a clinician in a psychiatry clinic for HIV+ adults. Also, in New York City she had a private practice primarily treating women and families dealing with the transition to parenthood and postpartum depression. Dr. Siegel is a graduate of Brown University in Providence, RI, completed her PhD at the University of Illinois at Urbana-Champaign, and subsequently took courses at New York University’s Postdoctoral Program in Psychotherapy and Psychoanalysis. In graduate school, Dr. Siegel was part of the Division of Clinical and Community Psychology in the Department of Psychology, where her research focused on the school-based domain identity development of African American elementary school students.

Barbara StanleyBarbara Stanley, PhD is director of the Center on Intervention for Prevention of Suicide and research scientist in the Department of Neuroscience at New York State Psychiatric Institute. She is also on the faculty of the Department of Psychiatry in the College of Physicians and Surgeons at Columbia University and City University of New York-John Jay College. Dr. Stanley has served as President of the New York Metropolitan Area Regional Chapter of the American Foundation for Suicide Prevention and is a former Chair of the Committee for the Protection of Human Participants in Research for the American Psychological Association. She has served on several IRBs and has been a consultant for the NIH Office of Protection from Research Risks. Dr. Stanley recently served as a consultant to NIMH in developing guidelines to investigators considering including suicidal patients in treatment trials. She has published over 70 articles on research ethics, suicidal behavior, self-injury, and borderline personality disorder and has been the recipient of several federal and private foundation grant awards. She is currently the principal investigator on two grants, one of which is a NIMH-funded psychosocial medication treatment trial for actively suicidal and self-injuring individuals. Dr. Stanley has been actively involved with PRIM&R as a past board member, and as founder and first president of Applied Research Ethics National Association (ARENA).

Additional Resources

A collection of relevant background reading, further reading, links, templates, checklists, and/or charts accompany each PRIM&R webinar. Groups that register for webinars receive a discussion guide containing thought-provoking questions and facilitation tips that may help in using the webinar as an educational tool for IRBs.

Background Reading:

Hogan, M.F., & Grumet, J.G. (2016). Suicide Prevention: An Emerging Priority For Health Care. Health Affairs, 35, p. 1084-1090.

Questions?

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