A question of ethics

Medical research in developing countries that is funded by organisations from developed countries must be subject to rigorous ethical standards, says Dr Sandy Thomas, director of the Nuffield Council on Bioethics.

This is the subject of a recent report published by the Nuffield Council on Bioethics - The Ethics of Research Related to Healthcare in Developing Countries. The report is the outcome of two years of consultation by an international working group of the Nuffield Council.It was in part a response to the recent international controversies surrounding HIV research in Thailand and Africa, but there has also been a significant rise in healthcare research in developing countries, supported by sponsors with significantly differing interests. These range from governments to voluntary organisations, international bodies and multinational pharmaceutical companies. While some forms of sponsorship have been altruistic, others have been driven by academic interests that do not necessarily reflect research priorities in the country concerned.

areas of concern

The Council's working party aimed to establish a framework for considering the ethical issues when externally sponsored research is undertaken. It identified four areas of primary concern: standards of care; consent; review of the ethics of research; and what happens once research is over.

• Standards of care: A particularly controversial issue when a new treatment or vaccine is being evaluated is the standard of care given to members of a control group during research. The report recommends that wherever appropriate, participants in the control group should be offered a universal standard of care, the best treatment available anywhere in the world, wherever the research is conducted, contrasted with non-universal standard of care, referring to treatment available in a defined region.

But there might be cases where provision of a universal standard is not appropriate. It may not always be deliverable - for example, if the infrastructure in developing countries is too limited to allow researchers to offer the treatment. Alternatively, the use of a universal standard of care may not give results that are relevant to the population in which the research is conducted. For example, it might not be appropriate to evaluate a new treatment against one that is too expensive to purchase and too complicated to deliver in a country, even if that is the universal standard.

The treatment being evaluated may be much more effective than the currently available treatment, but this might not be demonstrated by research using the universal standard. In these instances, the report states the minimum that should be offered is the best intervention currently available as part of the national public health system. In rare cases, exceptions to this recommendation may be justified; for example, where research attempts to establish the ineffectiveness of what currently is deemed to be the best treatment available through the host's country health system, by comparing it to a placebo.

• Consent: Misunderstandings can occur when research sponsors are unfamiliar with the cultural traditions of the country in which it is conducted. The report states that in some cultural contexts it may be appropriate to obtain agreement from the particular community or assent from a senior family member before approaching a prospective participant. However, it insists that genuine consent to participate in research must also always be obtained from participants individually.

• Once a research project is completed: The report says it is unacceptable for research to begin without a decision having been made about whether or not participants will be offered an intervention shown to be successful on completion of the trial. Researchers should address the question of post-trial access for the wider community at the outset.

• Reviewing the ethics of a research project: All coun tries should establish an effective system for the ethical review of research. Ethics committees that are independent of government and research sponsors must be established and maintained, with financial support and training from sponsors or organisations such as the WHO.