The 2000 revision of the Declaration of Helsinki: a step forward or more confusion?

At a time when there was great attention and intense public controversy surrounding clinical (especially multinational) research, the 52nd general assembly of the World Medical Association (WMA) adopted the 5th revision of the Declaration of Helsinki (in October, 2000)—available at www.wma.net. Thes...

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Published in:The Lancet (British edition) 2001-10, Vol.358 (9291), p.1449-1453
Main Authors: Forster, Heidi P, Emanuel, Ezekiel, Grady, Christine
Format: Article
Language:English
Subjects:
Adaptation
Bioethics
Biological and medical sciences
Clinical trials
Committees
Ethical standards
Ethics
Ethics, Research
Helsinki Declaration
Humans
Informed Consent
Internationality
Medical equipment
Medical ethics
Medical research
Medical sciences
Physician's Role
Research - standards
Research ethics
Vulnerable Populations
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description At a time when there was great attention and intense public controversy surrounding clinical (especially multinational) research, the 52nd general assembly of the World Medical Association (WMA) adopted the 5th revision of the Declaration of Helsinki (in October, 2000)—available at www.wma.net. These revisions are the most substantial adaptations since those adopted by the 29th WMA assembly in October, 1975. The commitment to revision of the declaration acknowledged that deficiencies and disagreements in interpretation needed to be corrected and that ethical standards evolve. Nevertheless, this revision process resulted in a controversial version of the declaration. Reports on the revisions have focused mainly on clinical trials that use placebos;1,2 but because of the role of the Declaration of Helsinki in the ethics of research, a more thorough examination is needed. Here, we analyse the process of revision and the major changes made to the declaration.
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subjects Adaptation
Bioethics
Biological and medical sciences
Clinical trials
Committees
Ethical standards
Ethics
Ethics, Research
Helsinki Declaration
Humans
Informed Consent
Internationality
Medical equipment
Medical ethics
Medical research
Medical sciences
Physician's Role
Research - standards
Research ethics
Vulnerable Populations
title The 2000 revision of the Declaration of Helsinki: a step forward or more confusion?
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