wg_doh_jan2004

5 January 2004 Original: English
THE WORLD MEDICAL ASSOCIATION, INC.
WORKGROUP REPORT ON THE REVISION OF PARAGRAPH 30 OF
THE DECLARATION OF HELSINKI
Contents:
1. Background
2. Considerations
3. Recommendations
1. Background
Following the adoption by the World Medical Association Assembly in October 2000 of a
substantially revised version of the Declaration of Helsinki (DoH), concerns were voiced about a
few of its provisions, especially paragraph 29 dealing with the use of placebos in clinical trials
and paragraph 30 on continuing care of research subjects. Para. 29 was addressed in a note of
clarification adopted by the Assembly in October 2002. This report deals with para. 30.
At its October 2001 meeting, the WMA Council established a workgroup to determine whether,
in addition to the note of clarification on para. 29 of the Declaration of Helsinki, further notes of
clarification were warranted, in particular on paras. 6, 19 and 30. The report of the workgroup to
the May 2002 Council meeting recommended that no note of clarification was needed for para. 6
and that para. 19 required further study. It suggested a note of clarification for para. 30, but
Council rejected that draft note of clarification, at least partly because of the perception that, as
formulated, it would compromise para. 19. It was agreed not to change para. 19 and the
workgroup was asked to continue its work on para. 30.
The workgroup provided progress reports at Council meetings in October 2002 and May 2003. At
the latter meeting it was asked to draft, after appropriate consultation, either an amendment or a
note of clarification to para. 30.
In August 2003 the workgroup produced its report, which was distributed to NMAs and other
stakeholders for comment. The report included background considerations regarding the
perceived need for a change to para. 30 and both a proposed note of clarification and a proposed
amended version of para. 30.
Many comments were received in reaction to this report. Immediately prior to the Helsinki
Assembly meetings, the WMA Secretariat compiled these comments and prepared a new report
for Assembly participants outlining the options for dealing with para. 30, including two
alternative notes of clarification and two alternative amended versions
(www.wma.net/e/ethicsunit/pdf/secretariat_report_rev_paragraph30.pdf). After considerable
discussion at the Medical Ethics Committee and Council meetings, Council chose not to change
para. 30 or add a note of clarification at this time but to continue and expand discussion of this
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paragraph among NMAs and other interested parties. Council formed a new workgroup,
consisting of Drs. Sir David Carter (U.K.), Dirceu Greco (Brazil), Otmar Kloiber (Germany),
Kgosi Letlape (South Africa) and John Nelson (U.S.A.), to oversee this work.
The workgroup communicated electronically during November and December 2003 and has
prepared this report for consultation with NMAs and other interested parties. In March 2004 the
workgroup will review the comments received and prepare a report for the WMA Medical Ethics
Committee and Council when they meet in May.
2. Considerations
The discussion of para. 30 has generated considerable interest and concern in many quarters.
Council’s decision at Helsinki to continue the discussion was reported and commented on in
numerous journals, including editorials in the Lancet and the Canadian Medical Association
Journal. Many individuals and groups are waiting anxiously for the WMA to come to a definitive
resolution of this matter.
It was evident before and during the Helsinki meetings that there are widely differing views, both
within the WMA and outside, as to how to deal with para. 30. These views can be summarized as
follows:
• Para. 30 should not be changed – the ethical principle it states is correct, and all those
responsible for medical research should strive to overcome the practical obstacles to its
implementation.
• Para. 30 should be left unchanged, but a note of clarification should be added that would
specify one or more of the following items: the conditions required for implementing the
principle stated in the paragraph; the need for informing the research subject about
provisions for continuing care; the role of the ethics committee in determining the
appropriateness of any continuing care provisions. Two alternative proposed notes of
clarification were included in the secretariat report to the Helsinki meetings.
• Para. 30 should be amended – suggestions for amendment range from a relatively minor
clarification of the ethical principle stated there to a qualification/limitation of the
principle to a deletion of the principle and its replacement by another principle and/or
operating procedure(s). Two alternative proposals were included in the secretariat report
to the Helsinki meetings.
The workgroup acknowledges that the current wording of para. 30 is not perfect. It is convinced,
however, that there are overriding reasons for not proposing an amended version of the
paragraph. These include:
• agreement with the spirit, if not the exact wording, of the paragraph;
• the difficulty of achieving the required 75% approval for any change;
• the need for stability (the DoH should be amended only when absolutely necessary).
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The workgroup has considered several alternative, but not mutually exclusive, approaches for
resolving the disagreements about para. 30:
• Add the following preamble explaining that the Declaration is a set of ethical guidelines,
not laws or regulations. “As a statement of principles, the Declaration of Helsinki is
intended to establish high ethical standards that guide physicians and other participants in
medical research involving human subjects. These ethical principles provide the basis of
moral reflection on the means and goals of research involving human subjects, distinct
from national legal and regulatory requirements. Interpreting the provisions of the
Declaration regarding the design, conduct or completion of the research requires careful
balancing of all of the Declaration’s ethical principles. Differences in interpretation
should be resolved by physicians and other participants involved in the research who are
most familiar with all relevant factors, including the needs of research participants and of
the host population.”
• Add a note of clarification that reaffirms the intention of para. 30 but avoids the
possibility of misinterpretation. The note would emphasise the ethical obligation on
those conducting studies to explain to potential research subjects what is being proposed
and its rationale, to provide a comprehensive explanation of potential risks and benefits,
and to give a detailed explanation of what will and will not be available in terms of
prevention, diagnosis and treatment for the individual concerned.
• Do not make any changes or additions to the Declaration of Helsinki. If it is felt that the
WMA should expand its treatment of equitable access to health care, in the research
context as elsewhere, this should be done in a separate document apart from the
Declaration of Helsinki.
3. Conclusions
1. The workgroup recommends that para. 30 not be amended.
2. The workgroup has not yet achieved consensus on an alternative approach to para. 30.
Before making its report to the WMA Medical Ethics Committee and Council, the
workgroup requests comments and suggestions from NMAs and interested parties on the
three alternatives described above or any other.