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The Ethics of Clinical Research in Developing Countries
  1. A P Bacon

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    Nuffield Council on Bioethics. Nuffield Council on Bioethics, 1999, free, pp 24. ISBN 0952270153

    The discussion paper produced and published by the Nuffield Council on Bioethics about the ethics of clinical research in developing countries is a timely, useful and (for such a concise publication) comprehensive document. It will prove useful for those planning research in developing countries, as well as for those already working in the developing world and planning research. The sponsors of research should also read the paper, whether they are pharmaceutical companies or a host country's statutory bodies, reviewing research proposals.

    The topic has most recently been discussed in the context of the controversy surrounding trials of zidovudine (AZT), but the authors rightly point to a much wider agenda. They also convincingly highlight the differences and difficulties that are particular to research by developed countries in developing countries (rather than those inherent in all research). They also touch, however, on the issue of self generated research in the developing world.

    Perhaps the general issue can most easily be summarised in terms of the competing arguments for universality in the ethics covering research (which can be seen as arrogant paternalism from the developed world), and for acknowledging the need for local self determination (which can be seen as condoning unethical behaviour). Taken to the extreme the “Universal School” may result in no potentially useful research being done in the developed world because of the fear of any harm. The local self determination group can, however, fall into the dangers inherent in having varying standards and therefore lead to the developing world being exploited by the richer and more powerful North.

    More broadly, it is possible to see this branch of ethics as a subset of the overall ethics associated with development, underdevelopment and poverty. Many of the special dilemmas of consent and of appropriate standards of care arise directly from poverty and inequality. For example, those who argue for developed world standards of care for all trial participants, will need to ask if this medical care should continue to be provided, even when the underlying cause of the condition is malnutrition. Should one then provide developed world standards of food, then hygiene, then infrastructure and so on?

    The paper covers the existing guidance and the dilemmas, contradictions, and problems they pose in their application. It also covers the issues of non-therapeutic research, consent and concern for those who remain after a trial is over.

    Not surprisingly in such a paper, there are more questions than answers. The authors do, however, point to one very good example of practical assistance that the guidelines can provide. This is where pro-active guidance (unfortunately provisional and therefore un-referenced) is being provided in the form of a document on ethical considerations in international trials of HIV preventive vaccines by the Joint United Nations Programme on HIV/AIDS (UNAIDS). Perhaps the future lies in the production of appropriate intermediate guidance and training, in a minimum set of ethical issues and practical considerations that should be addressed before research is started. This may enable a compromise to be reached between some of the impracticalities and difficulties in applying developed world standards and developing universal standards. This paper is a very useful start in identifying the issues and indicating a way forward.

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