• IRB: ETHICS & HUMAN RESEARCH

Bipolar Mania and Capacity to Consent: Recommendations for Investigators and IRBs

There is little guidance to help investigators and institutional review boards determine what safeguards should be in place to ensure that individuals with bipolar disorder have adequate capacity to consent to participate in research. Of particular concern is the capacity for consent when individuals are experiencing bipolar mania. We recently demonstrated that individuals who are in a manic state have impaired understanding and appreciation of important research concepts, as well as difficulty differentiating research participation from clinical care. Nonetheless, we also demonstrated that educational interventions can remediate some of these deficits. Thus, if protocols are properly designed and special safeguards are in place to guard against undue influence, individuals with mania may have the decisional capacity to provide valid consent to participate in research.

Key words/concepts: informed consent, decision-making capacity, bipolar disorder, mania, human subjects research

Sahana Misra, Donald Rosenstein, Robert Socherman, and Linda Ganzini, “Bipolar Mania and Capacity to Consent: Recommendations for Investigators and IRBs,” IRB: Ethics and Human Research 32, no. 1 (2010): 7-15.