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Participants in clinical trials in developing countries need not always be offered the best known treatment available elsewhere in the world to make such trials ethically acceptable, according to Britain's leading advisory body on bioethics in a report published today (25 April).

"Wherever appropriate, participants should be offered the best standard of care available in the world for the disease being studied," says Ian Kennedy, chairman of the Nuffield Council on Bioethics, which produced the report. "But this is not always appropriate or possible."

For example, says Kennedy, sometimes the medical facilities to provide such treatment do not exist in developing countries. "In these situations, we recommend that — as a minimum — participants should be offered the best treatment available from the national public health system."

The report, The ethics of research related to healthcare in developing countries, also calls for strict safeguards to prevent exploitation of those in developing countries who take part in foreign-led medical research.

It recommends that all countries should establish effective research ethics committees that are independent of government and sponsors of research. And it says that the sponsors of clinical trials should fund the training of developing country scientists in the ethics of research.

"Capacity building is part of the cost of conducting research," says Peter Smith, a member of the international working party that produced the report, from the London School of Hygiene and Tropical Medicine. "This should be the responsibility of the sponsors, whether they are a pharmaceutical company or a medical research council."

The report also stresses that genuine consent to take part in trials must be obtained from all participants. "Too often consent is obtained more to protect the researcher against litigation rather than to protect the participants," says Smith.

Taking the cultural context into account is key, he says. For example, in some cases, consent may be required from community leaders before individuals are approached.

But the report states that genuine consent to participate in research must also be obtained from each participant. And it suggests that, where literacy levels are low, verbal consent could be taped, or witnesses could be called in to verify that consent has been given.

Kenneth Calman, chairman of the working party, recognises that it is impossible to formulate a robust set of guidelines for all situations, given the varying social, cultural and economic contexts of clinical trials.

But, he says: "Taken as a whole, we hope that these recommendations will allow research to be conducted so that it has the greatest chance of providing useful information, without risking exploitation of vulnerable people."

Link to full text of The ethics of research related to healthcare in developing countries (recommendations also available in French and Spanish)

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Nuffield Council on Bioethics
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