Framework for research involving people living in developing countries

Scientific research conducted in the developing world that involves the participation of local people must ultimately benefit the health of the host country.That is one principle put forward in new guidelines published today by the UK’s leading charitable research funder, the Wellcome Trust.

Today’s publication sets out an ethical framework that underlies the Trust’s decisions to fund research involving people in developing countries, and provides guidance and practical advice for scientists who approach the Trust for funds to conduct such research.

“The Trust is a significant supporter of research in developing countries and has been for nearly 60 years,” said Robert Terry, senior policy adviser at the Wellcome Trust.“We want the scientists we fund, who enlist the help of communities in these regions, to see good ethics as an integral part of good science.

“Equally important is the question of who benefits from the research.It 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.”

Over the past five years the Trust has spent more then £130 million on overseas research activities which aim to tackle the devastation caused by diseases such as malaria, HIV/AIDS and tuberculosis.

The Trust’s position statement on research involving people living in developing countries includes the following principles:

• Meeting healthcare needs: research must be relevant to the healthcare needs of the host country and the outcome of the research, for example a new drug, needs to be available in a sustainable way to people participating in the study;

• Selecting research participants: the interests of research participants should never be sacrificed for the sake of a scientific goal, and only appropriate individuals should be chosen to take part in research;

• Consent: volunteers should have an opportunity to give or with-hold their individual, informed consent.Researchers also need to be aware of cultural, legal or social considerations in the host country which may inform the consent process;

• Ethical review: this is the responsibility of ethical review committees.Review should be undertaken in those countries where the research is to take place;

• Collateral benefits: the Trust will support the provision of collateral benefits only if they do not have an adverse effect on the local research environment or could create an undue influence to participate in research;

• Standards of care for control groups: this should be at least equivalent to the best local, available and affordable standard of care.Placebos are only acceptable if there is no reasonably accessible, safe or clinically effective treatment for patients at that particular stage of the disease, or their use is needed to answer the research question;

• Post-research access to interventions demonstrated to be effective: the Trust does not fund the provision of healthcare so the provision of successful interventions on completion of a research project falls outside its remit.Therefore, grant applicants should consider how post-research access could be ensured.

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

The Trust’s guidelines have drawn upon the recommendations outlined in a number of reports on this issue.This includes the Nuffield Council on Bioethics 2002 report, the Ethics of Research Related to Healthcare in Developing Countries.

The Wellcome Trust position statement and the Nuffield Council on Bioethics follow-up discussion paper to their 2002 report will be launched today (17 March) at a joint event held at the Nuffield Foundation.

Media contact:

Noorece Ahmed

Wellcome Trust Media Office

Tel: 020 7611 8540

Mobile: 07801 526354

mailto:n.ahmed@wellcome.ac.uk

If you wish to attend the launch, contact:

Catherine Joynson

Nuffield Council on Bioethics

Tel: 020 7681 9619

mailto:cjoynson@nuffieldbioethics.org

Notes to editors:

The Wellcome Trust is an independent research-funding charity established in 1936 under the will of tropical medicine pioneer Sir Henry Wellcome. The Trust’s mission is to promote research with the aim of improving human and animal health and it currently spends more than £400m p.a.Website: www.wellcome.ac.uk