Medical research in developing countries that is funded by organisations in wealthy countries is crucial but it must be subject to rigorous ethical safeguards, according to a report published today by the Nuffield Council on Bioethics.
While acknowledging that some externally-funded research has been controversial in the past, the report, The ethics of research related to healthcare in developing countries, highlights the need to continue to support future research, provided it is appropriately planned and effectively reviewed on scientific and ethical grounds.
The need for research
The report comes at a time when the world’s attention has been drawn to the huge gap in health between rich and poor countries. Each year £35-40 billion is spent on healthcare research worldwide. But only 10% of this is devoted to the health problems of 90% of the world’s population. Developing countries urgently need research to help relieve the enormous burden of disease they carry, including diseases such as TB and malaria. But many countries have limited funds and a lack of trained staff to conduct their own research. It is vital therefore that the public and private sectors in developed countries should sponsor research to help bridge this gap.
“Our recommendations provide a framework for anyone who is designing or conducting research in developing countries. We want to ensure that there is no exploitation of those who take part,” says Professor Sir Kenneth Calman, Chairman of the multinational Working Party which included specialists in medicine and healthcare, anthropology, philosophy and public policy.
The Working Party recognised that it would be impossible to formulate a robust set of guidelines for all situations. “It is critically important that the local social, cultural and economic context is taken into account when research is designed,” says Dr Fred Binka, a member of the Working Party. One priority that the report identifies is the need for sponsors to assist developing countries to strengthen expertise in designing and conducting relevant research. Effective mechanisms for protecting research participants must be developed, including ethical review of any proposed research. Recognising that it can be difficult to determine how current international guidance on the ethics of research should be applied, the Working Party recommends that developing countries produce their own national guidance to promote ethically sound research. “Taken as a whole, we hope 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,” Sir Kenneth commented.
Specific recommendations in the report focus on three main areas:
Consent to participate in research
Researchers are often faced with difficult choices when considering who should make decisions about taking part in research. For example, in some communities it is customary for senior members of the family to make decisions on behalf of wives and children. “Misunderstandings can occur when sponsors of research are unfamiliar with the cultural traditions of the country in which it is conducted,” says Professor Peter Smith, a member of the Working Party. “We conclude that it is crucial that genuine consent to participate in research is obtained from each person. However, we also recommend that it may sometimes be appropriate to obtain agreement from the community or assent from a senior family member before approaching a prospective participant.”
Standards of care
A particularly controversial issue when a new treatment or vaccine is being evaluated is the standard of care that is provided to participants in a comparison group during research. Should participants in developing countries receive the same standard of care that participants in wealthier countries would receive if the research was conducted there? This issue was highlighted during an international debate sparked by US-sponsored research to prevent mother-to-child transmission of HIV in Thailand. “After much discussion, we concluded that wherever appropriate, participants should be offered the best standard of care available in the world for the disease being studied,” says Sir Kenneth. “But this is not always appropriate or possible. For example, sometimes the medical facilities to provide such treatment just don’t 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.”
What happens once the research is over?
Is it ethically acceptable to conduct research into a form of treatment in a country that may not be able to afford to provide it? “There are concerns that people in poorer countries will sometimes bear the risks of research while those in wealthier countries will receive the benefits.” says Dr Binka. “However this is not a straightforward issue. For example, sometimes the price of treatments can drop dramatically after research, or an agreement may be reached with a pharmaceutical company that the treatment will be provided for free for a certain period”. The Report concludes it is not ethically acceptable for research to begin without consideration having been given to what will be provided once the research is completed.
Notes to editors
1. For a printed copy or CD-ROM containing the report please e-mail: email@example.com. French and Spanish translations of the recommendations and conclusions are also available.
2. The Nuffield Council on Bioethics is an independent body which examines the ethical issues raised by developments in medicine and biology. Established in 1991, it is funded by The Nuffield Foundation, the Medical Research Council and The Wellcome Trust. www.nuffieldbioethics.org
3. Members of the Working Party
Professor Sir Kenneth Calman (Chairman) is Vice-Chancellor and Warden, University of Durham
Dr Fred Binka is Associate Professor of Epidemiology, School of Public Health, University of Ghana
Professor Michael Elves is a former Director, Office of Scientific and Educational Affairs, Glaxo Wellcome plc
Professor V I Mathan is a Senior Consultant for Health Research, Indian Council of Medical Research, National Institute of Epidemiology, Chennai, India.
Professor Keith McAdam is Director, MRC Laboratories, Fajara, The Gambia
Dr Anne McLaren is at the Wellcome/CRC Institute, Cambridge
Professor Bhikhu Parekh is Centennial Professor, the Centre for the Study of Global Governance, London School of Economics
Professor David Parkin is Professor of Social Anthropology, All Souls College, Oxford
Professor Catherine Peckham CBE is Professor of Epidemiology, Institute of Child Health, University College London
Professor Povl Riis is at Copenhagan Ministry of Science
Professor Nelson Sewankambo is Dean, Faculty of Medicine, Makerere University, Kampala, Uganda
Mrs Shahwar Sadeque is an educational & ICT Consultant
Professor Peter Smith is Head of Department of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine
Dr Fabio Zicker is Coordinator, Research Capacity Strengthening and Tropical Diseases Research Programme, World Health Organization
4. Seminar: Thursday April 25, 2.00 – 5.00 pm
An in-depth seminar providing an opportunity for professionals, researchers and interested members of the public to discuss the Report’s recommendations with members of the Working Party. Admission is free, but places must be reserved in advance.
5. In February 1999 the Council held an international Workshop, and a Discussion Paper, ‘The ethics of clinical research in developing countries’, was published in October 1999, based on the deliberations of this meeting. Following the Workshop, the Council determined that this was a matter of such importance that it established a Working Party in January 2000 to consider the topic in more detail.