UK’s Wellcome Trust issues ethics guidelines

A leading funder of research on HIV/AIDS, malaria and tuberculosis yesterday (17 March) issued its first ethical guidelines for studies it funds in developing countries.

The UK-based Wellcome Trust has spent more than US$250 million over the past five years, mostly on research in developing nations, but until now has not stated explicitly its stance on ethical aspects of medical research.

The trust’s senior policy advisor, Robert Terry, told SciDev.Net that the guidelines would provide advice to scientists applying for funding and would help researchers already being funded to "see good ethics as an integral part of good science".

The guidelines cover aspects of research such as obtaining consent from volunteers, providing care for them after the research is over, and ensuring that participants in scientific studies ultimately benefit.

"This means thinking up-front about how any new vaccine or drug will be delivered to that population in a sustainable way," said Terry.

Terry added that adherence to the guidelines would not be a condition on which the trust would award grants because creating guidelines that took into account different settings and local conditions would be nearly impossible.

The guidelines give prominence to the importance of local capacity. For research undertaken and run entirely in a developing country, the trust would accept ethical review done solely in that country to be sufficient.

This contrasts with the UK-based Medical Research Council’s requirement for research it funds to be assessed by ethics committees both in the United Kingdom and in the country where research will take place.

Focus group in Nane-Janania village where treated-bednet trials are underway Photo: WHO/TDR/Haaland

The Nuffield Council on Bioethics, which advises on ethical aspects of research, also recommends that all research is reviewed in both countries.

At the launch of the Wellcome Trust’s guidelines, the council presented a discussion paper based on a workshop it held last year in South Africa. The paper described a range of ethical issues specific to research in developing countries.

One is the need to understand local traditions, when seeking consent. Often consultation with the community is as important as gaining the consent of individual trial participants.

The council says that complicated consent forms can also be a barrier to obtaining ‘genuine’ consent, and suggests using innovative approaches — such as television, community participation or theatre — to convey information about research more effectively than written documents.

The Wellcome Trust and the Nuffield Council on Bioethics agree that strengthening local capacity to review research ethics is vital. The absence of local expertise could mean that ethical reviews of planned research lacks the local input needed to tailor research to the population in which it is undertaken.

Recognising the need to boost local ethics capacity, the UK Medical Research Council recently launched a joint African-European programme to understand ethical issues that arise in African countries, and to identify what capacity already exists (see Africa and Europe create ethics network).

Strict adherence with ethical guidelines can conflict with local needs, and is impossible in some settings, agree the Wellcome Trust and the Nuffield Council on Bioethics. In these situations, they encourage researchers and sponsors to adapt guidelines to be locally appropriate.

Standards of care and what happens once the trial is over are prickly issues discussed in detail by both organisations.

They say that burdening a funding body or researchers with onerous duties of care — such as providing drugs or treatments to participants long after the trial is over — could make trials costly enough to discourage funders from committing to projects, reducing the amount of research done in developing countries.

Nor is it always appropriate for participants to continue receive the treatment after the trial, and opinions differ on how effective a treatment needs to be before it is used in a wider setting.

It is crucial that these sorts of issues are discussed at an early stage by researchers, health authorities and governments, says the council’s paper.

The Wellcome Trust is quite clear, says Terry, about the fact it is not a healthcare provider and that after-trial care "falls outside its remit".

According to the trust’s ethical guidelines, the responsibility lies with those applying for funding, who need to determine how post-trial access to medicines could be ensured.

Terry said post-trial care that is supported entirely by a funding agency is clearly unsustainable, and thinks national governments could be more involved in providing this care.

Read more about research ethics in SciDev.Net’s ethics of research dossier.

Link to Nuffield Council of Bioethics’ discussion paper  

Link to Wellcome Trust position statement