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ETHICAL REVIEW NEEDED FOR CLINICAL RESEARCH IN DEVELOPING COUNTRIES - download the paper

The debate over ethical standards in health research in developing countries is highlighted in a discussion paper published today (19 October) by the Nuffield Council on Bioethics. The paper, "The ethics of clinical research in developing countries," sets the scene for a new working party to examine these issues.

The paper is based on the discussion of 30 international experts in clinical research in developing countries during a workshop hosted by the Nuffield Council on Bioethics in February this year. The workshop was sponsored by the Department for International Development, the Medical Research Council and the Wellcome Trust. The workshop's steering group included representatives from these organisations and from the London School of Hygiene and Tropical Medicine.

"Research into diseases prevalent in developing countries is of vital importance," said Professor Peter Smith from the London School of Hygiene and Tropical Medicine and a member of the steering group. "Rapid advances in biotechnology research have greatly accelerated the rate of development of new vaccines and other preventative and curative treatments which may help disease control in developing countries. But it is also very important to ensure that such research investigations are subject to thorough ethical review."

There was particular concern in the paper about the statement in the Declaration of Helsinki that trial participants 'should be assured of the best proven diagnostic and therapeutic method.' This statement is ambiguous as it could refer to the best methods available in the sponsoring country, or in the developing country where standards of care will differ substantially.

The difficulties that may arise from ethical review of clinical research in developing countries are highlighted. Even where ethical committees are in place, members may lack the training and resources to assess the ethical acceptability of the research protocol. Misunderstandings can occur when those in the country - or countries - sponsoring, designing and conducting the research are unfamiliar with the cultural traditions in the host country. For instance, a woman might be required to seek permission from her husband before agreeing to take part in a trial. Equally, in some societies, taking samples of blood or hair is taboo.

The paper suggests that while the Declaration of Helsinki (1) and international biomedical guidelines are both necessary and useful, they have weaknesses that need to be addressed. Furthermore, such guidance can only protect the interests of trial participants and their communities if training and resources are available for proper interpretation and implementation.

The paper emphasises that there is a lack of awareness of the Helsinki Declaration and of the Council for International Organizations of Medical Sciences (CIOMS) guidelines (2) in developing countries and that they should be disseminated more widely and effectively.

"The starting point for this discussion paper was the criticism in 1997(1) of the large-scale trials of treatment with zidovudine (AZT) for HIV positive pregnant women to prevent transmission of infection to the baby," said Dr Sandy Thomas, director of the Nuffield Council on Bioethics. "These trials were considered by some to be unethical because some of the participants received no treatment (a placebo), rather than the care available in many developed countries which would have been a costly drug treatment based on AZT. This is, however, just one of a wide range of important ethical and social issues raised by those in developed countries undertaking or sponsoring clinical research in developing countries."

The Nuffield Council on Bioethics is, therefore, convening a working party to explore the issues raised by clinical research in developing countries. The working party will be chaired by Sir Kenneth Calman, vice chancellor and warden of the University of Durham and former chief medical officer at the Department of Health. It will review the role of clinical research supported by those in developed countries and conducted in developing countries. It will identify and consider the ethical and social implications of such research including:
· who benefits from the research;
· what happens when the trial is over in terms of delivering healthcare and of the follow up of participants;
· how genuine consent to participate in research should be obtained;
· tensions arising from differences between standards of healthcare locally and in developed countries;
· the relative roles of local and non-local ethics review bodies;
· the adequacy of existing ethical guidelines produced by international bodies.

For further information contact:

Elaine Snell, Public Relations Consultant
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