Bipolar Mania and Capacity to Consent: Recommendations for Investigators and Irbs (Insight) (Report‪)‬

In 1998 the National Bioethics Advisory Commission (NBAC) released a report entitled Research Involving Persons with Mental Disorders That May Affect Decision-Making Capacity. (1) The Commission expressed concern that certain mental disorders--including schizophrenia, dementia, and mania--increased the likelihood that an individual would not have the decisional capacity to provide voluntary, informed consent to participate in research involving a mental disorder. The report noted that although there was a need for continued research to identify safe and effective treatments for mental disorders, federal regulations governing research with humans were not sufficient to protect research participants in these types of studies. The Commission identified six areas of concern: 1) review bodies such as institutional review boards (IRBs); 2) research design; 3) protocol risk level; 4) informed consent and decisional capacity; 5) surrogate decision-making; and 6) education of and support for investigators and research participants. Although federal regulators have not issued new regulations or guidance that reflect any of NBAC's 21 recommendations, the report increased awareness of the need for rigorous review of researchers' plans to protect individuals with mental disorders who participate in their studies. Indeed, the body of literature examining the decision-making capacity of individuals with mental disorders has grown substantially in the decade since NBAC issued its report, revealing that decisional capacity varies according to the type and severity of the mental disorder. Until recently, however, there has been a paucity of information about the decisional capacity of individuals with bipolar mania. The purpose of this article is to 1) provide a brief review of the research on decisional capacity related to mental disorders, particularly studies involving schizophrenia, depression, and dementia; 2) theorize about the unique aspects of mania that may affect research participation; 3) summarize our recent published findings regarding the decisional capacity of individuals who are manic; and 4) provide provisional recommendations for investigators and IRBs regarding research with individuals who have bipolar mania.