Members of the World Medical Association are being advised against amending a controversial part of the Declaration of Helsinki that seeks to protect the continuing health care of patients who have been involved in research studies.

The Declaration, regarded as the world’s most widely recognised source of ethical guidance for biomedical research, was revised by the WMA three years ago, but ran into immediate controversy. One of its new paragraphs (paragraph 30) declared that ‘At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutical methods identified by the study’.

But the paragraph attracted criticism on the grounds that the ‘best proven’ care was unrealistic and could not be implemented. Clinical trials sponsors said they could not guarantee the provision of treatment at the end of a clinical trial and critics argued that as a result the new provision would deter sponsors from initiating badly needed research.

The wording ‘identified by the study’ was also criticised as misleading because it suggested that a single study might provide conclusive proof, which, critics argued, was unlikely.

For the past two years, the WMA has been debating whether in response to this criticism, the new paragraph needed clarification or amendment. Now a WMA work group has concluded that the Declaration should not be amended. However the work group says it has not yet achieved consensus on an alternative approach to a new paragraph 30. It has therefore suggested three alternatives:

1. to add a preamble explaining that the Declaration of Helsinki is a set of ethical guidelines, not laws or regulations;
2. to add a note of clarification that reaffirms the intention of paragraph 30 but avoids the possibility of misinterpretation;
3. to make no changes or additions to the Declaration.

Dr Delon Human, secretary general of the WMA, said: ‘The aim of this paragraph is to guarantee that research participants are not worse off after a study than they are during the study.

‘The WMA’s primary consideration has always been that the best interests of patients be served, but also that no good ethical research should be restricted. At the same time, the WMA is adamant not to compromise the ethical principles that the medical profession stands for.’

The work group, whose latest report has been circulated to all the WMA’s 80 national medical association members, acknowledges that the current wording of paragraph 30 is not perfect. However, it is convinced that there are overriding reasons for not proposing an amended version. It believes there is general agreement with the spirit, if not the exact wording, of the paragraph and that there would be difficulty in achieving the required 75 per cent approval for any change.

It has also concluded that there is the need for stability and that the Declaration of Helsinki should be amended only when absolutely necessary.

The work group’s report and the comments received from national medical associations and other interested individuals and groups will be debated at the WMA’s next meeting in Divonne, France in May.

Members of the work group are: Sir David Carter (UK), Dr Dirceu Greco (Brazil), Dr Otmar Kloiber (Germany), Dr Kgosi Letlape (South Africa) and Dr John Nelson (USA).

The work group’s full report can be found on the WMA’s website:
http://www.wma.net/e/ethicsunit/pdf/wg_doh_jan2004.pdf