Research involving people in developing countries raises challenging issues, particularly when the researchers or sponsors are from the developed world. The biggest problems usually arise from the great disparity in access to medical care. But different social structures, as well as health and political infrastructures, can also trap the unwary.

Good practice is documented in several sources. However, the meeting was characterised by an undercurrent of tension – crudely put, between 'purists' and 'pragmatists'. And at the risk of oversimplifying a complex debate, this often pits the professional ethicists against the practising researchers.

The tension highlights a terrible dilemma. The purist is striving to protect the interests of a vulnerable and disenfranchised population. But, the pragmatist suggests, doing so may create disincentives that impede research projects that could help those communities. So what were the key issues discussed?

Post-trial access: Everyone agrees that researchers have an obligation to a trial population. But for how long and who should bear the cost? And what about members of the population who did not take part in the trial?

Standards of care: The medical services in a study area may be well below those seen in the developed world. If researchers work within the existing system then their subjects will suffer – or die – from preventable causes. But if developed world standards are adopted, this can be seen as an undue inducement to take part, and, again, what happens at the end of the research?

Consent: In one area at least, almost complete agreement is possible. Informed consent, from individuals, is absolutely essential. In many developing countries, decisions are often made at community level, but community assent should be in addition to, not instead of, individual informed consent.

Methodology: One of the most dynamic – and contentious – areas is study design. Researchers may have a research question that they want to answer (e.g. whether a vaccine prevents disease) but they need to think very hard about how a trial should be set up. Observational studies, randomised controlled trials and use of placebos are deeply problematic: they may all lead to illness or death that could easily have been prevented.

Consultation: One consistent theme was the need to consult locally. This encompasses study participants and their representatives, as well as policy makers and politicians, to promote local use of research findings.

Governance: The role of ethical review committees is increasingly important. But who 'reviews the reviewer' to ensure that ethics committees are working satisfactorily?

Communication: Researchers hurry to communicate with their peers, but rarely take the time to explain their findings to their study groups in ways that are understandable to them.

Research fatigue: Can a research community become 'over-researched'? There may be good reasons to stick with a population, but also good reasons not to.

Pharma legacy: The activities of the pharmaceutical industry have left a feeling of deep mistrust in the developing world. One danger is that attempts to protect against exploitation may deter philanthropically minded researchers.

Issues of this complexity are not going to be resolved in two and a half days. Yet participants from a variety of backgrounds, cultures and continents found much common ground – and a platform on which to discuss disagreements.

Ethical conduct is becoming a critical element of biomedical research. It is not an add-on that a researcher considers at the end but an integral part of the planning process. The Global Forum on Bioethics in Research may have been entitled 'What happens when the research is over?' but in reality the question is, 'What should be done before the research begins?'

The Sixth Global Forum on Bioethics in Research: 'What Happens When Research is Over? Post-Trial Obligations of Researchers and Sponsors', took place in Blantyre, Malawi from 17–19 March 2005.

Image copyright: C Penn

See also

• Global Forum on Bioethics in Research (News: 7 March 2005)
• Guidelines for research involving people living in developing countries (News: 18 March 2005)