Original Investigation |

Addressing Risks to Advance Mental Health Research

Ana S. Iltis, PhD1; Sahana Misra, MD2,3; Laura B. Dunn, MD4; Gregory K. Brown, PhD5; Amy Campbell, JD, MBE6; Sarah A. Earll7; Anne Glowinski, MD, MPE8; Whitney B. Hadley, MA9; Ronald Pies, MD10; James M. DuBois, PhD, DSc11,12
[+] Author Affiliations
1Center for Bioethics, Health, and Society and Department of Philosophy, Wake Forest University, Winston-Salem, North Carolina
2Mental Health and Clinical Neurosciences Division, Portland VA Medical Center, Portland, Oregon
3Department of Psychiatry, Oregon Health and Science University, Portland
4Departments of Psychiatry and Psycho-Oncology, UCSF Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco
5Clinical Psychology in Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia
6Center for Bioethics and Humanities, SUNY Upstate Medical University, Syracuse, New York
7St Louis Empowerment, St Louis, Missouri
8Department of Psychiatry (Child), Washington University School of Medicine, St Louis, Missouri
9Falk College for Sports and Human Dynamics, Syracuse University, Syracuse, New York
10Department of Psychiatry, SUNY Upstate Medical University, Syracuse, New York
11Department of Medicine, Washington University School of Medicine, St Louis, Missouri
12Center for Health Care Ethics, Saint Louis University, St Louis, Missouri
JAMA Psychiatry. 2013;70(12):1363-1371. doi:10.1001/jamapsychiatry.2013.2105.
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Importance  Risk communication and management are essential to the ethical conduct of research, yet addressing risks may be time consuming for investigators and institutional review boards may reject study designs that seem too risky. This can discourage needed research, particularly in higher-risk protocols or those enrolling potentially vulnerable individuals, such as those with some level of suicidality. Improved mechanisms for addressing research risks may facilitate much needed psychiatric research.

Objective  To provide mental health researchers with practical approaches to (1) identify and define various intrinsic research risks, (2) communicate these risks to others (eg, potential participants, regulatory bodies, and society), (3) manage these risks during the course of a study, and (4) justify the risks.

Evidence Review  As part of a National Institute of Mental Health–funded scientific meeting series, a public conference and a closed-session expert panel meeting were held on managing and disclosing risks in mental health clinical trials. The expert panel reviewed the literature with a focus on empirical studies and developed recommendations for best practices and further research on managing and disclosing risks in mental health clinical trials. No institutional review board–review was required because there were no human subjects.

Findings  Challenges, current data, practical strategies, and topics for future research are addressed for each of 4 key areas pertaining to management and disclosure of risks in clinical trials: identifying and defining risks, communicating risks, managing risks during studies, and justifying research risks.

Conclusions and Relevance  Empirical data on risk communication, managing risks, and the benefits of research can support the ethical conduct of mental health research and may help investigators better conceptualize and confront risks and to gain institutional review board–approval.

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