Assessment of psychiatric patients' competency to give informed consent: legal safeguard of civil right to autonomous decision-making.

Amendment of the Mental Health and Welfare Law in Japan will limit admission for medical care and protection only for those individuals who are incapable of giving consent to admission. This is a first in the history of the Japanese mental health legislation. By reviewing the law and psychiatric literature, it is argued that: (i) informed consent is a legal transaction that embodies the idea of an individual's right to autonomous decision-making in medical settings; (ii) health professionals have a duty to protect those individuals who cannot decide medical matters because of lack of capacity to do so; (iii) some patients are marginally incompetent so assessment of their competency is essential in protecting patients' civil rights; (iv) in order for a competency assessment to be reliable (and hence fair) the method should be psychometrically sound; (v) at the same time, in order for a competency assessment to be valid, the structure of a competency assessment should match the patient's psychological, cultural, and social background; and (vi) because informed consent is a process rather than a cross-sectional event, a competency assessment should be performed in everyday practice. The use of a brief and semistructured interview to assess patients' competency to give informed consent may meet all of the requirements described.