Heroin prescription involves the medical provision of heroin in the treatment of heroin addiction. Rudimentary clinical trials on that treatment modality have been carried out and others are currently underway or in development. However, it is questionable whether subjects considered for such trials are mentally competent to consent to them. The problem has not been sufficiently appreciated in ethical and clinical discussions of the topic. The challenges involved throw new light on the role of value and accountability in contemporary discussions (...) of mental competence. (shrink)

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. (shrink)