Assessment of mental capacity in patients recruited in clinical trials in psychiatry and its relationship to informed consent.

ABSTRACT

Insufficient attention is paid to the need for assessing the mental capacity of participants in clinical trials, particularly those in psychiatry. Assessment of mental capacity is paramount especially in patients suffering from certain brain disorders and psychiatric illnesses, as lack of capacity can invalidate the consent given. Suggested below is a framework for assessing mental capacity in a systematic way with the hope that those writing on the subject of clinical research give it due importance.