You are invited to submit comments and suggestions for the review of the Declaration of Helsinki (DoH). The 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 in Berlin, the WMA Council accepted the recommendation of the WMA Medical Ethics Committee that a review of the DoH be undertaken immediately and that proposed amendments be presented to the WMA General Assembly in Seoul, South Korea in October 2008. Council approved the following timetable for the review process:

• June-August 2007 - invitation to National Medical Associations (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.

For this initial consultation, we will need to receive your comments and suggestions by August 21, 2007 in order to translate and collate them for consideration by members of the WMA Medical Ethics Committee and Council in advance of their October meetings.

Please send your comments and suggestions in one of two formats:

• an electronic version to wma@wma.net;
• if you do not have access to email, you can send a faxed copy to the WMA offices at fax number +33 450 40 59 37.

The WMA Secretariat will confirm receipt of your comments within 48 hours (during weekdays) of receiving your comments. If you have not received this confirmation, please call Mrs. Dudu at the WMA offices (+33 450 40 75 75).

The literature on the DoH is vast. The following list is not meant to be exhaustive or even representative but may be useful to those who wish to participate in this review process:

• 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
• Schmidt U, Frewer A, eds. History and Theory of Human Experimentation: The Declaration of Helsinki and Modern Medical Ethics, Stuttgart: Franz Steiner, 2007

Thank you in advance for your contribution to this important task.
With all best wishes,
WMA Secretariat