title: Addressing risks to advance mental health research.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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
  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.affiliation: Center for Bioethics, Health, and Society and Department of Philosophy, Wake Forest University, Winston-Salem, North Carolina.
authors.forename: Ana S
authors.initials: AS
authors.lastname: Iltis
authors.forename: Sahana
authors.initials: S
authors.lastname: Misra
authors.forename: Laura B
authors.initials: LB
authors.lastname: Dunn
authors.forename: Gregory K
authors.initials: GK
authors.lastname: Brown
authors.forename: Amy
authors.initials: A
authors.lastname: Campbell
authors.forename: Sarah A
authors.initials: SA
authors.lastname: Earll
authors.forename: Anne
authors.initials: A
authors.lastname: Glowinski
authors.forename: Whitney B
authors.initials: WB
authors.lastname: Hadley
authors.forename: Ronald
authors.initials: R
authors.lastname: Pies
authors.forename: James M
authors.initials: JM
authors.lastname: Dubois
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D028744:Ethics Committees, Research / Q000592:standards; D017408:Guidelines as Topic / Q000592:standards; D006801:Humans; D007258:Informed Consent / Q000592:standards; D008603:Mental Health / Q000592:standards*; D009315:National Institute of Mental Health (U.S.) / Q000592:standards; D018570:Risk Assessment / Q000592:standards*; D014481:United States