Applying international guidance on healthcare-related research in developing countries in practice is often fraught with difficulty, according to a Discussion Paper published today by the Nuffield Council on Bioethics. The ethics of research related to healthcare in developing countries: a follow-up Discussion Paper reports that existing guidelines are often inconsistent and inappropriate for the developing country setting.

Research in developing countries is crucial for improving healthcare by providing appropriate treatments and preventing disease. However, lack of resources and weak infrastructure mean that researchers in developing countries are often unable to conduct their own clinical research. As they increasingly establish partnerships with groups from developed countries, a sound ethical framework is a crucial safeguard to avoid possible exploitation of research participants in these circumstances.

The Council published a report on the ethics of research related to healthcare in developing countries in 2002. Since then, a number of international organisations have revised existing guidelines or prepared new ones. As a follow-up to its 2002 report, the Council held a Workshop, co-hosted with the Medical Research Council of South Africa, in February 2004 to give researchers from around the world the opportunity to exchange experiences and consider how the new guidance is implemented in practice. The discussions that took place at the Workshop are presented in the Discussion Paper.

“When the guidelines were compared, we found that they are markedly inconsistent in some areas,” said Professor Peter Smith, Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine and a Member of the Workshop Steering Committee. “In addition, faithful adherence to some of the provisions within the guidelines is often unachievable.”

The guidelines disagree about:
  • the kind of information that should be provided to participants when seeking their consent;

  • whether new medicines should be compared with the universal standard of care (best available alternative) in trials in developing countries as they are in developed countries;

  • whether a placebo (an inactive substance) should be used in research, as a comparison for the medicine being tested, when an effective treatment is available;

  • the extent to which research participants are owed access to medicines after the research is complete; and

  • the degree of involvement of the developing country in the ethical review process.

“Delegates at the Workshop provided a number of case studies that demonstrate the difficulties of adhering to the new guidance,” continued Professor Smith. “For example, when obtaining informed consent in emergency settings and securing guarantees from sponsors or physicians that access to medicines will be provided to participants once a trial is over.”

Local needs should be taken into account when conducting research in developing countries and the delegates emphasised the role of research ethics committees in this respect. Initiating early discussion of the issues with national authorities as well as the local communities concerned can help researchers to overcome the difficulties of adhering to conflicting international guidance.

Delegates concluded that researchers, sponsors and members of ethical review committees should judge for themselves how to approach some of these complex issues. In accordance with this, the Wellcome Trust launched today a position statement and guidance notes on the research that it funds involving people living in developing countries. The Medical Research Council published their own ethical guidelines on research involving human participants in developing societies for MRC-sponsored studies in 2004.

For further information contact:

Catherine Joynson
Communications & External Affairs Manager
Nuffield Council on Bioethics
28 Bedford Square
London WC1B 3JS
Tel: +44 (0)20 7681 9619
Fax: +44 (0)20 7637 1712

Notes to editors

1. Copies of the full Discussion Paper will be available to download on 17th March from the Council website.

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.

3. The Council is very grateful for the financial support provided specifically for this project by The Nuffield Foundation, the Medical Research Council and The Wellcome Trust, The Rockefeller Foundation and the Department for International Development.

4. Members of the Steering Committee

Professor Zulfiqar Bhutta
Professor of Paediatrics, Aga Khan University, Pakistan

Professor Sir Kenneth Calman KCB FRSE
Vice-Chancellor and Warden, University of Durham, member of the Nuffield Council on Bioethics, and former Chairman of the Working Party on the ethics of research related to healthcare in developing countries

Dr Soledad Diaz
Consultorio De Plantification Familiar, Institute Chileno de Medicina Reproductiva, Santiago, Chile

Dr Imogen Evans
Research Strategy Manager, Medical Research Council, London

Dr Richard Lane
Former Head of International Programmes, The Wellcome Trust, London, currently Director of Science at the Natural History Museum

Dr Alwyn Mwinga
Medical epidemiologist with the CDC Global AIDS Program (GAP), Lusaka, Zambia
Professor Catherine Peckham CBE
Centre for Paediatric Epidemiology and Biostatistics, Institute of Child Health, and Great Ormond Street Hospital, Deputy Chairman of the Nuffield Council on Bioethics, and former member of the Working Party on the ethics of research related to healthcare in developing countries

Professor Prescilla Reddy
Director of Health Promotion Research and Development, South African MRC

Professor Peter Smith CBE
Head of Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, and former member of the Working Party on the ethics of research related to healthcare in developing countries

Dr Bella Starling
Senior Project Manager, History of Medicine and Biomedical Ethics, The Wellcome Trust

5. Guidance considered in the Discussion Paper

World Medical Association (WMA): Declaration of Helsinki as last revised in Oct 2000; Note of Clarification on Paragraph 29, Dec 2002; Workgroup Report on the revision of Paragraph 30, Sep 2003; and Note of Clarification on Paragraph 30, October 2004.

The Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO): International Ethical Guidelines for Biomedical Research Involving Human Subjects, as last revised in Sep 2002.

Council of Europe (CoE): Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, prepared by the Steering Committee on Bioethics (CDBI) of the Council of Europe adopted by the Committee of Ministers, June 2004. (A draft Protocol, approved by the CDBI in June 2003, was discussed during the Workshop in February.)

European Council and European Parliament (EU): Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, April 2001, adopted by Member States by May 2003 brought into force May 2004.

The European Group on Ethics in Science and New Technologies (EGE): Opinion Nr 17 on the ethical aspects of clinical research in developing countries, published in Jan 2003.

Nuffield Council on Bioethics: The ethics of research related to healthcare in developing countries, April 2002.