| Informed consent from cognitively impaired persons participating in research trials: comparative law observations. | |
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MedLine Citation:
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PMID: 22194069 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria. |
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Authors:
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Carlo Petrini |
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Publication Detail:
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Type: JOURNAL ARTICLE |
Journal Detail:
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Title: Annali dell'Istituto superiore di sanita Volume: 47 ISSN: 0021-2571 ISO Abbreviation: - Publication Date: 2011 |
Date Detail:
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Created Date: 2011-12-23 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7502520 Medline TA: Ann Ist Super Sanita Country: - |
Other Details:
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Languages: ENG Pagination: 353-362 Citation Subset: - |
Affiliation:
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Unità di Bioetica, Presidenza, Istituto Superiore di Sanità, Rome, Italy. E-mail: carlo.petrini@iss.it. |
Vernacular Title:
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Il consenso informato nel caso di soggetti con disabilità mentale che partecipano alla sperimentazione clinica: osservazioni di diritto comparato. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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