Participants in mental health research frequently differ from participants in other types of medical research in significant ways including: stigma, institutionalization, cognitive deficits, and poverty. Research methods in clinical psychiatric research also routinely involve procedures that are rarer in other research including washout periods and placebo controls. The result is that mental health research presents unique ethical problems. While ethical principles like respect for persons, beneficence, and justice may provide a framework for ethical discourse (National Commission, 1979),empirical research on research ethics is necessary to determine effective and creative ways to protect and respect human participants (Sieber, 2004; B. Stanley et al, 1987). Although a significant amount of research in this area has been funded, the results have not been systematically reviewed to make recommendations for best practices or develop a comprehensive research agenda. This application proposes a unique 5-year conference series on """"""""Best Practices in Mental Health Research Ethics"""""""" that will provide an opportunity for researchers working on these issues to share their findings and develop future plans as a community of scientists. Each conference will consist of: 1) a public conference with 3 plenary speakers, respondents, and a panel discussion, followed by 2) a closed-session expert panel meeting which will review the empirical literature on the conference theme and develop recommendations for best practices and further research. Conference series objectives include: 1) Expert panel session objective (primary objective): Convene an expert panel to develop recommendations for ethical best practices in mental health research based on a critical review of existing data and to make recommendations for future research on research ethics. The reviews and recommendations from each conference will be published as a peer-reviewed article; 2) Public plenary session objective (secondary objective): Educate mental health researchers via public conference sessions that provide continuing education credit. Each conference will have an expert panel with 12-13 members (Program Director, 4 Steering Committee members, 2 plenary speakers, 3 standing expert panelists, and 2-3 other members who have conducted relevant research). Key participants were selected to ensure a presence of diverse stakeholders and experts, including ethicists, leading mental health researchers, IRB members, a mental health consumer, a mental health advocate, and a diversity and cultural-competence researcher. All conferences will be held in St. Louis, MO, on the campus of St. Louis University. Conference topics include: """"""""Informed Consent: Assessing Decision-Making Capacity and Enhancing Understanding"""""""" (year 1); """"""""Engaging the Stakeholders in Mental Health Research"""""""" (year 2, tentative); """"""""Managing and Disclosing Risks in Clinical Trials"""""""" (year 3, tentative); """"""""Recruitment: Incentives, Voluntariness, and the Role of the Community"""""""" (year 4, tentative); and """"""""Recent Trends and Future Directions"""""""" (year 5, specifics to be determined). Relevance Mental health research is necessary in order to discover the causes of and effective treatments for mental disorders, but this research must be conducted in an ethical manner. Empirical research is needed to determine how best to accomplish the aims of protecting and respecting participants while facilitating potentially beneficial research. The proposed conference series will review empirical studies that address the ethical aspects of mental health research to identify best practices and areas requiring further investigation. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Conference (R13)
Project #
5R13MH079690-02
Application #
7454245
Study Section
Special Emphasis Panel (ZMH1-CNF-C (01))
Program Officer
Muehrer, Peter R
Project Start
2007-07-01
Project End
2011-04-30
Budget Start
2008-05-01
Budget End
2009-04-30
Support Year
2
Fiscal Year
2008
Total Cost
$47,222
Indirect Cost
Name
Saint Louis University
Department
Type
DUNS #
050220722
City
Saint Louis
State
MO
Country
United States
Zip Code
63103
Iltis, Ana S; Misra, Sahana; Dunn, Laura B et al. (2013) Addressing risks to advance mental health research. JAMA Psychiatry 70:1363-71
DuBois, James M; Beskow, Laura; Campbell, Jean et al. (2012) Restoring balance: a consensus statement on the protection of vulnerable research participants. Am J Public Health 102:2220-5
Anderson, Emily E; Solomon, Stephanie; Heitman, Elizabeth et al. (2012) Research ethics education for community-engaged research: a review and research agenda. J Empir Res Hum Res Ethics 7:3-19
Dubois, James M; Bailey-Burch, Brendolyn; Bustillos, Dan et al. (2011) Ethical issues in mental health research: the case for community engagement. Curr Opin Psychiatry 24:208-14
Dubois, James; Bante, Holly; Hadley, Whitney B (2011) Ethics in Psychiatric Research: A Review of 25 Years of NIH-funded Empirical Research Projects. AJOB Prim Res 2:5-17