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The Declaration of Helsinki
(DoH) is the WMA's best-known policy statement. It was first
adopted in 1964 and has been amended five times since, most recently
in 2000. Notes of clarification were added to para. 29 in 2002
and to para. 30 in 2004. The current (2004) version is the only
official one; all previous versions have been replaced and should
not be used or cited except for historical purposes.
At its May 2007 meeting, the Medical Ethics Committee recommended,
subsequently approved by the Council, "That a formal working
group (3-5 NMAs) be appointed to review the Declaration of Helsinki…with
the goals of a) identifying gaps in the content but avoiding a
complete re-opening of the document and b) using the review process
to promote the Declaration of Helsinki." Following the meeting,
the following NMAs (National Medical Associations) were appointed
as members of the working group: Brazil, Germany, Japan, South
Africa, and Sweden.
Council approved the following timetable for the review process:
- May-August 2007 - invitation to NMAs and other stakeholders
to identify paragraphs of the DoH that might require revision,
to propose specific amendments, and/or to identify new topics
for inclusion;
- October 3-6, 2007 - discussion of consultation feedback
at the WMA Medical Ethics Committee and Council meetings; preliminary
choice of paragraphs for amendment and topics for addition;
progress report to WMA General Assembly;
- October 10-31, 2007 - preparation of initial draft
of revised text (including alternative wording for controversial
paragraphs);
- November 2007- February 2008 - distribution of initial
draft to National Medical Associations and other stakeholders
for comment;
- March 2008 (first half) - stakeholders conference (tentative);
- March 2008 (second half) - preparation of second draft
of revised text;
- May 2008 - consideration of second draft by the Medical
Ethics Committee and Council;
- May 2008 - distribution of second draft, as amended
by the Medical Ethics Committee and Council, to National Medical
Associations and other stakeholders for comment;
- August 21-31, 2008 - collation of responses for consideration
by the Medical Ethics Committee;
- October 2008 - approval, with or without further amendments,
by the Medical Ethics Committee and Council; transmission to
the General Assembly for adoption.
The WMA thanks all those who submitted comments and suggestions
this summer. They were collated and reviewed by the Working Group
and the Medical Ethics Committee at their October 2007 meetings.
The Working Group has prepared a set of suggested amendments to
the Declaration; these are being distributed to National Medical
Associations and other stakeholders for comment.
Some useful references:
- Human D, Fluss SS. The
World Medical Association's Declaration of Helsinki: Historical
and Contemporary Perspectives (References)
- The
International Response to Helsinki VI - The WMA's Declaration
of Helsinki on Ethical Principles for Medical Research Involving
Human Subjects, as adopted by the 52nd WMA General Assembly,
Edinburgh, October 2000
- De Roy PG. Helsinki and the Declaration of Helsinki. World
Med J 2004; 50/1: 9-11
- Benatar SR. Linking Moral Progress to Medical Progress: New
opportunities for the Declaration of Helsinki. World
Med J 2004; 50/1: 11-13
- Williams JR. The Promise and Limits of International Bioethics:
Lessons from the Recent Revision of the Declaration of Helsinki.
Int J Bioethics 2004; 15: 31-42
- Carlson RV, Boyd KM, Webb DJ. The revision of the Declaration
of Helsinki: past, present and future. Br J Clin Pharmacol
2004; 57: 695-713
- Nuffield Council on Bioethics: The
ethics of research related to healthcare in developing countries
- a follow-up Discussion Paper, London, Nuffield Council,
2005
- Williams JR. The Physician's Role in the Protection of Human
Research Subjects. Science and Engineering Ethics 2006;
12: 5-12
- Carlson RV, van Ginneken NH, Pettigrew LM, Davies A, Boyd
KM, Webb DJ. The three official language versions of the Declaration
of Helsinki: what's lost in translation? J Med Ethics
2007; 33: 545-548
- Schmidt U, Frewer A, eds. History and Theory of Human Experimentation:
The Declaration of Helsinki and Modern Medical Ethics, Stuttgart:
Franz Steiner, 2007
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