Dear all,

The Nuffield Council on Bioethics launched a public consultation as part of
its Working Party on the ethics of healthcare-related research in
developing countries in July.  

A copy of the invitation to comment is reproduced below for list members as
the consultation period is due to close on 30 November.   We would very
much welcome members input on this. In particular, your comments on the
conduct, assessment and regulation of healthcare-related research in
developing countries and your views on the way in which ethical issues
raised by such research are addressed. 

If you would still like to receive a copy of the consultation document by
email please contact me at [log in to unmask]  Further
information about the Working Party is available on the Council's web site
at www.nuffieldfoundation.org/bioethics/ 

Yvonne Melia





THE ETHICS OF HEALTHCARE-RELATED RESEARCH IN DEVELOPING COUNTRIES

EXPERTS SEEK VIEWS ON HEALTHCARE-RELATED RESEARCH IN DEVELOPING COUNTRIES 

Many developed countries sponsor healthcare-related research involving
populations and patients in developing countries. But questions remain over
the moral implications of this kind of             research. A Working
Party of the Nuffield Council on Bioethics is considering the ethical and
social issues raised by healthcare-related research in developing
countries. In a consultation              exercise launched today, the
Working Party is seeking the views of the public and relevant organisations
about these issues.

New vaccines and drugs which could be useful in the developing world are
being devised at an increasing rate. This is likely to lead to the funding
of an increasing amount of research in countries where basic healthcare is
not widely available and research ethics committees are often
underdeveloped or absent. Should such research be undertaken in a
developing country when it could also be done in a developed country? Is it
acceptable to undertake research in a community which cannot afford the
treatment being tested? Should trial participants be offered the same
standard of care during trials as would be enjoyed by participants in
Europe and the USA? Is it acceptable to compare new therapies with no
therapy when alternative treatments are not available to patients in
developing countries, even though they may be available in developed
countries? Is there a moral obligation to provide treatment free of charge
or at low cost to people who have              participated in clinical
trials once the trial is over?

Misunderstandings can occur when financial sponsors of research are
unfamiliar with the cultural traditions in the host country. Should
cultural practices (such as a husband giving consent on behalf of a wife)
be respected in developing countries when they would be unacceptable in
developed countries?

Individuals or organisations wishing to comment can obtain an information
pack which gives details about the Working Party and sets out the main
issues at http://www.nuffield.org/bioethics. All              responses
will be considered carefully by the Working Party which includes experts in
medical research, health policy, ethics, political theory, regulatory
issues, and anthropology. The Working Party will produce a report in
mid-2001 which will aim to help healthcare workers, regulators and
policy-makers to develop professional guidance and public policy, and to
promote public debate.

NOTE TO EDITORS

The Council's discussion paper entitled The ethics of clinical research in
developing countries can be downloaded at
http://www.nuffieldfoundation.org/bioethics/publication/download.html

Membership of the Working Party

Professor Sir Kenneth Calman (Chairman), 
Vice-Chancellor and Warden, University of Durham and member of Nuffield
Council on Bioethics
  
Dr Fred Binka, 
Navrongo Health Research Centre and Ghana School of Public Health
             
Professor Michael Elves,
Former Director, Office of Scientific and Educational Affairs, Glaxo
Wellcome plc

Professor V I Mathan, 
Division Director for Laboratory Sciences Division, International Centre
for Diarrhoeal Disease Research, Dhaka
             
Professor Keith McAdam, 
Director, MRC Laboratories, Fajara, The Gambia

Dr Anne McLaren, 
Wellcome/CRC Institute, Cambridge

Professor Bhiku Parekh, 
Professor of Political Theory, University of Hull

Professor David Parkin, 
Professor of Social Anthropology, All Souls College, Oxford

Professor Catherine Peckham CBE,
Professor of Epidemiology, Institute of Child Health, University College
London and member of Nuffield Council on Bioethics
             
Professor Povl Riis, 
Copenhagan Ministry of Science

Professor Nelson Sewankambo,
Dean, Faculty of Medicine, Makerere University, Kampala, Uganda

Mrs Shahwar Sadeque, 
Educational & ICT Consultant
  
Professor Peter Smith, 
Head of Department of Infectious and Tropical Diseases, London School of
Hygiene & Tropical Medicine
             
Dr Fabio Zicker, 
Coordinator, Research Capacity Strengthening and Tropical Diseases Research
Programme, World Health Organization

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.

 Terms of Reference 

1 To review the importance of healthcare-related research in humans,
supported by those in more affluent countries and conducted, at least
partly, in developing countries. 
 2 To identify and consider the ethical and social implications of
conducting such research including:
             a) who benefits from the research;
             b) consent;
             c) differences in cultural values; 
             d) differences in levels of healthcare between countries; 
             e) compatability of ethical guidelines produced by international
             bodies;
             f) the respective responsibilities of local and non-local
ethics review
             bodies, and mechanisms for review and monitoring; 
             g) follow-up, including the possible implementation of
findings, after
             the completion of research.
3 To make recommendations.

The Council has issued the following reports and discussion papers:

Reports

Genetic Screening: Ethical issues (1993)
Human Tissue: Ethical and legal issues (1995)
Animal-to-Human Transplants: The ethics of xenotransplantation (1996)
Mental Disorders and Genetics: The ethical context (1998)
Genetically Modified Crops: The ethical and social issues (1999)

Discussion papers

The ethics of clinical research in developing countries (1999)
Stem cell therapy: the ethical issues (2000)

        

        
Yvonne Melia
Research Assistant
Nuffield Council on Bioethics
28 Bedford Square
London
WC1B 3JS

Tel:  + 44 (0) 20 7681 9625
Fax:  +44 (0) 20 7637 1712
Email:  [log in to unmask]
Web site:  http://www.nuffieldfoundation.org/bioethics/



%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%