In The Lancet this week, the 2000 revision of the Declaration of Helsinki (available on www.wma.net) is critically analysed by Heidi Forster and colleagues from the National Institutes of Health, Bethesda, USA.
The Declaration is accepted by most researchers and approval committees as defining ethical rules for research on patients. It is revised from time to time by assemblies of the World Medical Association. Before the extensive revisions made in the year 2000, the Declaration was last amended in 1996.
The authors note major changes in the Declaration’s tone and structure, as well as specific improvements and problems with this revision. One of the reasons, they comment, that the revision process was inadequate is that, “only 2 weeks were made available for comment and critique between the final proposed version and the assembly vote”; a procedure that the authors call, “secretive and rushed”.
Another criticism is that the four-strong committee that drew up proposals for the revisions were all from more-developed countries, and none had any recognised expertise in the conduct of clinical research and bioethics.
The authors recognise several key changes in the Declaration of Helsinki 2000 that are clear improvements over previous versions, including guidance on monitoring and oversight, recognition of financial conflicts of interest, and assuring access of participants to interventions proven effective.
Among the particular deficiencies in the 2000 revision that the authors discuss is the provision that research on patients should not be done unless the risks have been adequately assessed. Adherence to this rule would, they say, make preliminary trials of a new treatment, designed to assess the risks involved, impossible.
Noting some of Helsinki’s ambiguous wording and controversy about application, the authors conclude by quoting S Senn, “those who draft guidelines which are meant to legislate for the behaviour of others ought to pay more than a little care to the wording.”
Contact: Dr Christine Grady, National Institutes of Health, Department of Clinical Bioethics, National Institutes of Health, Department of Clinical Bioethics, Building 10, Room 1c118, Bethesda, MD 20892, USA. T) +301-496-2429, E) cgrady@nih.gov
Journal
The Lancet