The capacity of individuals to provide informed consent to participate in neuropsychiatric research studies is an important and controversial issue. We are currently conducting a series of studies to answer the following questions:

• Are people with psychiatric, medical, and social problems able to understand research studies well enough to provide informed consent to participate? If not, what interferes with this ability?
• How does capacity for informed consent change when various psychoactive medications are started or discontinued?
• Can capacity for informed consent be improved in subjects who are initially "incompetent?" Are there better ways to present research-related material that will facilitate the subject’s understanding of what he or she is getting into?

Findings thus far suggest that most individuals with significant psychiatric, medical, or social problems are able to provide consent to participate in research, but mental illness does decrease the ease with which a given subject can understand research consent forms and come to a reasoned decision about whether or not to participate. Level of cognitive functioning seems to influence decisional capacity more so than severity of psychiatric symptoms. We have not found any evidence that subjects are coerced into participating in research, despite the fact that many view the prison setting as an inherently coercive environment.