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

descriptionPublicationkeyboard_double_arrow_right Article 01 Oct 2001 English Publisher:Elsevier BVJournal:The Lancet, volume 358, pages 1,449-1,453 (issn: 0140-6736,

Authors: Forster, Heidi P.; Emanuel, Ezekiel; Grady, Christine;

doi: 10.1016/s0140-6736(01)06534-5

pmid: 11705513

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

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Abstract

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; 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.

Related Organizations

National Institutes of Health
United States
National Institute of Health
Pakistan

Keywords

Informed Consent, Internationality, Research, Humans, Physician's Role, Vulnerable Populations, Ethics, Research, Helsinki Declaration

Impact byBIP!

	citations This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).	79
	popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.	Top 10%
	influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).	Top 1%
	impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.	Top 10%