WMA says trial participants must have access to best treatment when a trial endsBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7471.876-a (Published 14 October 2004) Cite this as: BMJ 2004;329:876
The World Medical Association (WMA) has sought to clarify controversial ethical guidance that seeks to ensure that people who take part in a research trial benefit by getting the best available treatment when the trial ends.
Its annual general assembly held in Tokyo this week decided to issue a note of clarification to paragraph 30 of the Declaration of Helsinki, which is regarded as the world's most widely recognised source of ethical guidance on medical research involving human participants.
The WMA amended the Declaration four years ago in a move that was widely seen as protecting the interests of people in the developing world who take part in medical research. It stated that they should get access to the “best proven prophylactic, diagnostic and therapeutic methods identified by the study” at the end of a trial (BMJ 2000;321:913).
Pharmaceutical companies and research organisations complained, however, that the guidance was unrealistic in placing an obligation on them to guarantee a particular standard of care when a trial ended. They warned that this could threaten the future of much needed research projects that could benefit developing countries (BMJ 2001;323:531).
The WMA has responded by issuing the clarification. It 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.”
This is not seen as any weakening of the amended declaration but an attempt to place responsibility on those who conduct trials to state clearly what is to happen once the study is finished. That would then be used to judge if the trial should be approved.
David Carter, a WMA council member said the issue of access to best treatment was not confined to the developing world but affected the developed world as well. People need clarity about the implications of taking part in research. “The WMA has really looked at this thoroughly. The issue has been debated on a number of occasions, and we have arrived at a consensus that is acceptable and workable,” he said.
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.”