Competence of depressed patients for consent to research

Objective: The capacities of depressed patients to consent to research have been questioned by commentators who fear that the cognitive effects of a d isorder may impair subjects' abilities to protect their interests. This stu dy used a new instrument for assessing depressed patients' capacities to co nsent to research and examined their performance, including the relation be tween severity of depression and extent of impairment. Method: Twenty-six f emale outpatients with major depression (assessed with the Schedule of Affe ctive Disorders and Schizophrenia-Lifetime Version) enrolled in a study of maintenance psychotherapy were recruited for this project. Consent-related abilities were measured with the MacArthur Competence Assessment Tool-Clini cal Research (MacCAT-CR) 1 week after intake and again 8-10 weeks later. De pressive symptoms were measured by the Hamilton Depression Rating Scale. Re sults: Almost all subjects performed quite well on the capacity measures an d maintained that level of performance over time. There was no correlation between performance and degree of depressive symptoms and little relation t o prior research experience. Some subjects appeared confused about the exte nt to which decisions about assignment to treatment groups would be made on the basis of their clinical condition rather than randomly. Conclusions: T his outpatient group with major depression showed few impairments in their decision-making capacities related to research. As in other studies, some c oncerns were raised about subjects' appreciation that treatment assignments would not be individualized for their needs. Examination of hospitalized p atients and those with psychotic depression would help to determine whether they show greater degrees of impairment. The MacCAT-CR was easily adapted for use with this depressed group.