| Clinical trials with mentally disabled subjects: ethical issues in national and international documents. | |
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MedLine Citation:
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PMID: 20931162 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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This article summarises the key ethical considerations involved in performing clinical trials involving persons who cannot conscious, free and informed consensus. Criteria are considered, which are drawn from ethical codes, declarations, treaties, conventions, regulations and other documents and published by national, international, and supranational institutions and authorities. The article focuses on the evolution of attitudes regarding the evolution of participation of incapacitate people in clinical research--from their almost complete exclusion in the mid-twentieth century, partly because of serious historical violations of human rights, to a gradually acceptance that these "vulnerable" people could be involved in trials, provided that certain conditions were met. In particular, the problem of including incapacitated people in clinical trials during emergencies is also addressed. |
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Authors:
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C Petrini |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: La Clinica terapeutica Volume: 161 ISSN: 1972-6007 ISO Abbreviation: Clin Ter Publication Date: 2010 Jul-Aug |
Date Detail:
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Created Date: 2010-10-08 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0372604 Medline TA: Clin Ter Country: Italy |
Other Details:
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Languages: eng Pagination: 365-73 Citation Subset: IM |
Affiliation:
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Bioethics Unit, Office of the President, National Institute of Health (Istituto Superiore di Sanità), Rome, Italy. carlo.petrini@iss.it |
Export Citation:
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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