Ethical issues in a study of bipolar disorder and HIV risk among African-American men who have sex with men: case study in the ethics of mental health research.

African-American men who have sex with men (MSM) are at increased risk of HIV infection, as are individuals with severe mental illness. This study was conducted at the behest of members of the African-American MSM community in Cleveland, Ohio, to assess the co-occurrence of HIV risk and bipolar disorder among African-American MSM. A sample of 125 participants was recruited via flyers and word of mouth at venues used by members of this community. Individuals were assessed for HIV risk and severe mental illness. Various ethical issues were presented, including participant capacity and voluntariness and the risk-benefit ratio. Divergent perspectives of the local institutional review board and the community advisory group with respect to the risks and benefits of participation required reconciliation before the study could proceed. Solutions for the resolution of such conflicts are discussed.