The history and current status of competence and informed consent in psychiatric research. 2000

D A Pinals, and P S Appelbaum
Department of Psychiatry, University of Massachusetts Medical School, Worcester 01655, USA. debra.pinals@DMH.state.ma.us

Informed consent to research has recently become a focus of public attention as questions have been raised about the adequacy of information disclosed to potential research subjects and about the competence of psychiatric research subjects to provide valid informed consent to participate in potentially high risk studies. Around the world, policies and position statements have been written to address these concerns and to offer suggestions to protect potentially vulnerable research subjects, such as persons with neuropsychiatric disorders. Relevant literature has demonstrated that a subset of persons with such disorders have significant competence-related deficits, and thus may require specific means of protection with regard to informed consent to research. Recent guidelines offered to improve the informed consent process include review of potential studies for scientific merit and potential risk, assessment of subject competence to consent to research, and the use of proxy decision-makers when subjects are deemed incompetent.

UI MeSH Term Description Entries
D007258 Informed Consent Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment. Consent, Informed
D008605 Mental Health Services Organized services to provide mental health care. Mental Hygiene Services,Health Services, Mental,Services, Mental Health,Services, Mental Hygiene,Health Service, Mental,Hygiene Service, Mental,Hygiene Services, Mental,Mental Health Service,Mental Hygiene Service,Service, Mental Health,Service, Mental Hygiene
D011570 Psychiatry The medical science that deals with the origin, diagnosis, prevention, and treatment of mental disorders.
D005544 Forecasting The prediction or projection of the nature of future problems or existing conditions based upon the extrapolation or interpretation of existing scientific data or by the application of scientific methodology. Futurology,Projections and Predictions,Future,Predictions and Projections
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D016743 Mental Competency The ability to understand the nature and effect of the act in which the individual is engaged. (From Black's Law Dictionary, 6th ed). Competency, Mental,Incompetency, Mental,Competence,Incompetence, Mental,Mental Competence,Competence, Mental,Mental Incompetence,Mental Incompetency

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