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Trust unveils ethical guidelines

Clinical trials conducted in developing countries must benefit the health of the host country, new ethical guidelines suggest.

Clinical trials conducted in developing countries must benefit the health of the host country, new ethical guidelines published by the Wellcome Trust suggest.

The guidelines set out an ethical framework for conducting research projects involving patients living in developing countries, with the aim of providing guidance and practical advice for scientists.

Principles outlined in the document include ensuring that the interests of research participants are not sacrificed for the sake of a scientific goal and giving participants the opportunity to give or withhold consent to treatment.

The guidelines also suggest that any research outcomes, such as a new drug, should be made available in a sustainable way to those taking part in the study. Therefore, grant applications should consider how post-research access could be ensured after completion of a project.

Robert Terry, senior policy adviser at the Wellcome Trust, said: ìIt is essential that those people who have volunteered to take part in scientific studies ultimately benefit. This means thinking up-front how any new vaccine or drug will be delivered to that population in a sustainable way.î

The guidelines draw on recommendation outlined in the Nuffield Council's Bioethics 2002 report, The Ethics of Research Related to Healthcare in Developing Countries. The report, released by the Nuffield Council on Bioethics, provided a framework for any company conducting research in developing countries.

It suggested that all countries should set national priorities relating to their provision of healthcare, and that an effective system for the ethical review of research should be created, including the establishment and maintenance of research ethics committees that are independent from sponsors and governments.

The Medical Research Council, the World Medical Association, the European Group on Ethics in Science and New Technologies and the Council for International Organisations of Medical Sciences have also released similar guidelines.

Terry added: ìThere are lots of guidelines out there providing advice on best practice for research in the developing world. However, as a research funder we felt it important to set out the principles that need to be addressed before we agree to fund the project.î

Over the past five years, The Wellcome Trust has spent more than £130m on overseas research activities and initiatives.

30th September 2008

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