Clarification on Declaration of Helsinki

The World Medical Association has clarified one of its ethical guidelines to physicians on biomedical research to ensure that those people taking part in research would continue to have access to proven beneficial treatment following the research study.

The Declaration of Helsinki, regarded as the world’s most widely recognised source of ethical guidance on biomedical research on humans, was revised four years ago and one of its aims was to try to preclude double standards in research in industrialised and developing countries.

Its provision in paragraph 30 of the Declaration 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 therapeutic methods identified by the study’ met with various interpretations.

The aim of the paragraph was to ensure that research subjects would have access to treatment that had been proven to be beneficial. But it was claimed that this standard of care was unrealistic and could not be implemented. To maintain this requirement, it was argued, would deter sponsors from initiating needed research. Others, especially from developing countries, considered that the requirement could and should be met.

At its annual General Assembly in Tokyo last week, more than 400 WMA delegates from 40 countries decided to issue a note of clarification to paragraph 30 of the Declaration.

This states ‘The WMA hereby reaffirms its position that it is necessary during the study planning process to identify post-trial access by study participants to prophylactic, diagnostic and therapeutic procedures identified as beneficial in the study or access to other appropriate care.

‘Post-trial access arrangements or other care must be described in the study protocol so the ethical review committee may consider such arrangements during its review’.

Dr Yoram Blachar, chairman of the WMA, said: ‘The WMA’s primary considerations have always been that the best interests of patients be served and that no good ethical research should be restricted. The WMA is adamant not to compromise the ethical principles that the medical profession stands for.

‘We hope that this clarification will best achieve that aim’.