Invitation to review the Declaration of Helsinki

Expert Conference to Discuss Revising Declaration of Helsinki

The meeting of the World Medical Association hosted by the South African Medical Association (SAMA) ends today. SAMA hosted experts at the conference to discuss Revision of Declaration of Helsinki. The conference started on the 5th of December and continued to the 7th of December at the Westin Hotel, Cape Town.

The Declaration of Helsinki is described as one of the most important international ethical regulations of biomedical research - and also one of the core documents of the WMA. The Declaration has been revised several times since its adoption in Helsinki in 1964 as a statement of ethical principles for medical research involving human subjects. This includes research on identifiable human material and data. The objective of the work-group is to gain the approval of the General Assembly for the revised version by October 2014, to coincide with the 50th anniversary of the Declaration of Helsinki.
The conference provides a platform for the international biomedical ethics community to air diverse viewpoints on the Declaration of Helsinki in order to identify the points in need of revision and facilitate the drafting of a revised version. This will ensure that the revised Declaration will not only be in line with new developments and challenges in biomedical research, but will also take a broad range of international perspectives into consideration.

In October 2011, the Council of the World Medical Association decided to embark on a process of revising the internationally accepted benchmark document in human medical research, the Declaration of Helsinki (DoH).

At meeting today however, Prof Dominique Sprumont of the Institute of Health Law, University of Neuchâtel, Switzerland made a case that the DoH does not need any review. He clearly points out the research ethics is not limited to code of ethics such as the DoH or professional standards such as the ICH – GCP and that the value of the DoH is in the fact it is reflecting the applicable ethical principles in the field. The DoH may therefore considered as the Constitution of research ethics. It however requires more detailed rules to be implemented. Those rules of implementation do not belong to the DoH as they are not principles.

Once again, Prof Sprumont reminded the group that the DoH is not merely an academic document but a product of history, lobbying from various stakeholders. The document therefore presents a structure for engaging stakeholder involved in the ethical conduct of research. It is the expression of a careful consensus within the medical profession and also the research community, the RECs and the competent authorities worldwide.

In effect, the fact that a principle requires more detailed instruction to be implemented does not mean the principle should be revised. What is needed is the development of rules for the implementation of the principles. For emerging issues or issues requiring more detailed rules, the WMA should adopt guidance documents separated from the DoH but that should be implemented in the light of the DoH. And for the principle on placebo control trials, this should not be revised simply because the placebo rule hurts the interests of those wanting research to go faster. Its review will contradict the Council of Europe and EU principle of the primacy of the interests of the participants versus the sole interests of science or society.

The community voices have asked that (i) If there is no urgency for the revision of a law, it is urgent not to revise it (ii) If specific issues deserve more detailed guidances, they should be convered in a separate set of documents (iii) The placebo rule must be maintained (and even strenghtened) (iv) The consultation process should be open to non-English speaking stakeholders, with special attention to interested parties in developing world.

Please note that your contributions to this discussion are welcome. It will be complied and send to the WMA.