Determining when impairment constitutes incapacity for informed consent in schizophrenia research.

Determining when impairment constitutes incapacity for informed consent in schizophrenia research. Research Abstract Details 

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Determining when impairment constitutes incapacity for informed consent in schizophrenia research. Abstract Text:

Scott Y H Kim,Paul S Appelbaum,Jeffrey Swan,T Scott Stroup,Joseph P McEvoy,Donald C Goff,Dilip V Jeste,J Steven Lamberti,Adrian Leibovici,Eric D Caine,Scott Y H Kim,Paul S Appelbaum,Jeffrey Swan,T Scott Stroup,Joseph P McEvoy,Donald C Goff,Dilip V Jeste,J Steven Lamberti,Adrian Leibovici,Eric D Caine,

BACKGROUND: Although people with schizophrenia display impaired abilities for consent, it is not known how much impairment constitutes incapacity. AIMS: To assess a method for determining the categorical capacity status of potential participants in schizophrenia research. METHOD: Expert-judgement validation of capacity thresholds on the sub-scales of the MacArthur Competence Assessment Tool-Clinical Research (MacCAT-CR) was evaluated using receiver operating characteristic (ROC) analysis in 91 people with severe mental illness and 40 controls. RESULTS: The ROC areas under the curve for the understanding, appreciation and reasoning sub-scales of the MacCAT-CR were 0.94 (95% CI 0.88-0.99), 0.85 (95% CI 0.76-0.94) and 0.80 (95% CI 0.70-0.90). These findings yielded negative and positive predictive values of incapacity that can guide the practice of investigators and research ethics committees. CONCLUSIONS: By performing such validation studies for a few categories of research with varying risks and benefits, it might be possible to create evidence-based capacity determination guidelines for most schizophrenia research.

Determining when impairment constitutes incapacity for informed consent in schizophrenia research. Publishing Authors By Initials

SY Kim,PS Appelbaum,J Swan,TS Stroup,JP McEvoy,DC Goff,DV Jeste,JS Lamberti,A Leibovici,ED Caine,SY Kim,PS Appelbaum,J Swan,TS Stroup,JP McEvoy,DC Goff,DV Jeste,JS Lamberti,A Leibovici,ED Caine,

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Determining when impairment constitutes incapacity for informed consent in schizophrenia research. Journal Published:

PUBLICATION TYPE: Validation Studies

Journal: The British journal of psychiatry : the journal of

VOLUME: 191

Page Numbers: 38-43

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ISSN: 0007-1250

DAY: 2

MONTH: Jul

YEAR: 2007

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LANGUAGE: eng

NlmUniqueID: 342367

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AFFILIATION: Department of Psychiatry, Bioethics Program, and Center for Behavioral and Decision Sciences in Medicine, University of Michigan, 300 North Ingalls, Ann Arbor, MI 48109-0429, and Massachusetts General Hospital, Boston, USA. scottkim@umich.edu

Country: England

AGENCY: United States NIMH

GRANT: N01 MH90001

ACRONYM: MH

MEDLINETA: Br J Psychiatry

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