Document Detail


Meta-consent in research on decisional capacity: a "Catch-22"?
MedLine Citation:
PMID:  16254061     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Empirical studies of ethical issues, which have increased in number and scope in recent years, may themselves raise both practical and ethical issues. One example of such an issue is the question of who may be legitimately enrolled in studies of decision-making capacity; must all participants in studies of consent capacity have capacity to consent? This question may pose a "Catch-22": For example, if some of the participants in a study of consent capacity are deemed by a particular standard to be incapable of consent. In weighing the risks and benefits of studies of consent capacity, how should reviewers consider the context of actual versus hypothetical trials for which the participant's consent is being sought? Here, we explore these "meta-consent" issues by describing the dimensions of the issue and potential solutions, centering around the concept of "active assent" (requiring expressed understanding of the purpose of the study and its voluntary nature, as well as expression of a choice to participate).
Authors:
Elyn R Saks; Laura B Dunn; Barton W Palmer
Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2005-10-27
Journal Detail:
Title:  Schizophrenia bulletin     Volume:  32     ISSN:  0586-7614     ISO Abbreviation:  Schizophr Bull     Publication Date:  2006 Jan 
Date Detail:
Created Date:  2005-12-27     Completed Date:  2006-03-07     Revised Date:  2009-11-18    
Medline Journal Info:
Nlm Unique ID:  0236760     Medline TA:  Schizophr Bull     Country:  United States    
Other Details:
Languages:  eng     Pagination:  42-6     Citation Subset:  IM    
Affiliation:
University of Southern California Law School, USA. esaks@law.usc.edu
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MeSH Terms
Descriptor/Qualifier:
Biomedical Research / ethics,  legislation & jurisprudence*
Decision Making*
Empiricism
Humans
Informed Consent*
United States
Grant Support
ID/Acronym/Agency:
MH64722/MH/NIMH NIH HHS; MH66062/MH/NIMH NIH HHS
Comments/Corrections

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