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.
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.
Authors: Dilip V Jeste; Barton W Palmer; Paul S Appelbaum; Shahrokh Golshan; Danielle Glorioso; Laura B Dunn; Kathleen Kim; Thomas Meeks; Helena C Kraemer Journal: Arch Gen Psychiatry Date: 2007-08
Authors: Charles W Lidz; Paul S Appelbaum; Robert Arnold; Philip Candilis; William Gardner; Suzanne Myers; Lorna Simon Journal: Acad Med Date: 2012-07 Impact factor: 6.893
Authors: Martha L Bruce; Thomas R Ten Have; Charles F Reynolds; Ira I Katz; Herbert C Schulberg; Benoit H Mulsant; Gregory K Brown; Gail J McAvay; Jane L Pearson; George S Alexopoulos Journal: JAMA Date: 2004-03-03 Impact factor: 56.272
Authors: Kelly E Irwin; Beverly Moy; Lauren E Fields; Catherine A Callaway; Elyse R Park; Lori Wirth Journal: J Clin Oncol Date: 2019-04-15 Impact factor: 44.544
Authors: William Vaughn McCall; Ruth M Benca; Peter B Rosenquist; Mary Anne Riley; Chelsea Hodges; Brittany Gubosh; Laryssa McCloud; Jill C Newman; Doug Case; Meredith Rumble; Mark Mayo; Kaitlin Hanley White; Marjorie Phillips; Andrew D Krystal Journal: Clin Trials Date: 2015-03-01 Impact factor: 2.486
Authors: Caitlin Wolford-Clevenger; Mickeah J Hugley; James McNulty; Lawrence Christian Elledge; Karen Cropsey; Gregory L Stuart Journal: Account Res Date: 2019-11-21 Impact factor: 2.622
Authors: Erin D Solomon; Jessica Mozersky; Matthew P Wroblewski; Kari Baldwin; Meredith V Parsons; Melody Goodman; James M DuBois Journal: J Empir Res Hum Res Ethics Date: 2021-08-19 Impact factor: 1.742
Authors: Elizabeth J Kirkham; Catherine J Crompton; Matthew H Iveson; Iona Beange; Andrew M McIntosh; Sue Fletcher-Watson Journal: Front Psychiatry Date: 2021-06-10 Impact factor: 4.157