Proposals for minor revisions to the Declaration of Helsinki, including ideas for providing additional protection to research participants, have been sent out for comment to national medical associations by the umbrella World Medical Association (WMA).

This is the latest step in a process beginning with a recommendation by the WMA’s Medical Ethics Committee in May 2007 that a formal working group should be appointed to review the Declaration “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”. Representatives of national medical associations (NMAs) in Brazil, Germany, Japan, South Africa and Sweden were subsequently appointed as members of the working group.

Regarded by many as the foundation document for medical research ethics worldwide, the Declaration was first adopted in 1964 and has been amended five times since, most recently in 2000. Notes of clarification dealing with the acceptability of placebo-controlled trials and with arrangements for post-trial access to procedures identified as beneficial by the research were added to paragraph 29 and paragraph 30 of the Declaation respectively in 2002 and 2004.

In May to August 2007, NMAs and other stakeholders were asked to identify paragraphs in the Declaration that might need revising, to propose specific amendments and/or to identify new topics for inclusion. This initial consultation produced almost unanimous consent that the principles of the Declaration were sound, the WMA said. However, there was also a desire for clarification of how these principles should be applied and recognition that a number of new issues had arisen since the existing version of the Declaration of Helsinki was adopted seven years ago.

In addition to the proposals on giving extra protection to medical research participants, the initial draft of the revised text sent out by the WMA’s working group includes a new provision making it clear that the well-being of the individual should take precedence over the interests of research sponsors as well as those of science and society.

Other proposed changes relate to the treatment of participants who suffer injury as a result of research interventions; the ability of the general public to access a register of all clinical trials; and the need for populations previously under-represented in medical research, such as children and pregnant women, to have equitable access to research participation.

The deadline for comments on the initial draft changes is February 25, 2008. Owing to the large number of potential stakeholders involved, WMA secretary general Dr Otmar Kloiber has asked all NMA members of the association to conduct a consultation in their own country and combine the responses into one submission to the WMA. The request for comments also includes all the relevant international organisations, such as the World Health Organization (WHO).

A second draft of the revised Declaration will be considered by the WMA’s Medical Ethics Committee and Council at their May 2008 meetings and circulated for comment. The hope is that an amended Declaration may be ready for adoption by the WMA General Assembly in Seoul in October 2008.

Bigger than the WMA?
Writing in the November issue of CRfocus, the journal of the UK-based Institute of Clinical Research (ICR), editor Andrew Smith asks whether the WMA is still “the right body to set the standard for whether a proposed clinical study is ethical”.

Doctors have no monopoly on ethical practice, and the Research Ethics Committees referring to the Declaration to give opinions on individual studies “now comprise a far more diverse range of scientists and lay people than was the case in 1964”, Smith points out. In his view, a more inclusive drafting process – involving the WMA, but also patient representatives, regulators, industry and professional ethicists on an equal footing – is needed to achieve a document “that will be complied with by all and incorporated into legal documents”.

Representatives “should come from developed and developing regions, for open debate without deference or power-politics”, he adds. While acknowledging that completing such a process by October 2008 would be impractical, Smith suggests that the existing consultations should continue as planned, but the WMA should then “immediately set the scene for the creation of a successor to be drafted and adopted by a multi-disciplined body in 2010”.

With a new name and a broader mandate, he argues, “this document should be free from the Declaration’s ‘baggage’, and acceptable and workable for all, to protect patients while facilitating the development of new medicines”.