Ethical Review Needed for Clinical Research in Developing Countries
Thu, 14 October 1999
PRESS RELEASE
14 October 1999
EMBARGO: TUESDAY 19 OCTOBER 1999
ETHICAL REVIEW NEEDED FOR CLINICAL RESEARCH
IN DEVELOPING COUNTRIES
The debate over ethical standards in health research in
developing countries is highlighted in a discussion paper
published today (19 October) by the Nuffield Council on
Bioethics. The paper, "The ethics of clinical research in
developing countries," sets the scene for a new working party
to examine these issues.
The paper is based on the discussion of 30 international
experts in clinical research in developing countries during a
workshop hosted by the Nuffield Council on Bioethics in
February this year. The workshop was sponsored by the
Department for International Development, the Medical
Research Council and the Wellcome Trust. The workshop's
steering group included representatives from these
organisations and from the London School of Hygiene and
Tropical Medicine.
"Research into diseases prevalent in developing countries is of
vital importance," said Professor Peter Smith from the London
School of Hygiene and Tropical Medicine and a member of the
steering group. "Rapid advances in biotechnology research
have greatly accelerated the rate of development of new
vaccines and other preventative and curative treatments which
may help disease control in developing countries. But it is also
very important to ensure that such research investigations are
subject to thorough ethical review."
There was particular concern in the paper about the statement
in the Declaration of Helsinki that trial participants 'should be
assured of the best proven diagnostic and therapeutic method.'
This statement is ambiguous as it could refer to the best
methods available in the sponsoring country, or in the
developing country where standards of care will differ
substantially.
The difficulties that may arise from ethical review of clinical
research in developing countries are highlighted. Even where
ethical committees are in place, members may lack the training
and resources to assess the ethical acceptability of the
research protocol. Misunderstandings can occur when those in
the country - or countries - sponsoring, designing and
conducting the research are unfamiliar with the cultural traditions
in the host country. For instance, a woman might be required to
seek permission from her husband before agreeing to take part
in a trial. Equally, in some societies, taking samples of blood or
hair is taboo.
The paper suggests that while the Declaration of Helsinki (1)
and international biomedical guidelines are both necessary and
useful, they have weaknesses that need to be addressed.
Furthermore, such guidance can only protect the interests of trial
participants and their communities if training and resources are
available for proper interpretation and implementation.
The paper emphasises that there is a lack of awareness of the
Helsinki Declaration and of the Council for International
Organizations of Medical Sciences (CIOMS) guidelines (2) in
developing countries and that they should be disseminated
more widely and effectively.
"The starting point for this discussion paper was the criticism in
1997(1) of the large-scale trials of treatment with zidovudine
(AZT) for HIV positive pregnant women to prevent transmission
of infection to the baby," said Dr Sandy Thomas, director of the
Nuffield Council on Bioethics. "These trials were considered by
some to be unethical because some of the participants
received no treatment (a placebo), rather than the care available in
many developed countries which would have been a costly
drug treatment based on AZT. This is, however, just one of a
wide range of important ethical and social issues raised by
those in developed countries undertaking or sponsoring clinical
research in developing countries."
The Nuffield Council on Bioethics is, therefore, convening a
working party to explore the issues raised by clinical research in
developing countries. The working party will be chaired by Sir
Kenneth Calman, vice chancellor and warden of the University of
Durham and former chief medical officer at the Department of
Health. It will review the role of clinical research supported by
those in developed countries and conducted in developing
countries. It will identify and consider the ethical and social
implications of such research including:
· who benefits from the research;
· what happens when the trial is over in terms of delivering
healthcare and of the follow up of participants;
· how genuine consent to participate in research should be
obtained;
· tensions arising from differences between standards of
healthcare locally and in developed countries;
· the relative roles of local and non-local ethics review bodies;
· the adequacy of existing ethical guidelines produced by
international bodies.
END
For further information contact
Elaine Snell, Public Relations Consultant
PO Box 10461, London SW11 6ZJ
Tel: +44 171 738 0424, Fax +44 171 978 4494, Email
elaine.snell@which.net
Notes to Editors
The Nuffield Council on Bioethics is an independent, non-profit
organisation that explores issues in biomedical ethics and is
chaired by Professor Ian Kennedy. The Council's Director is Dr
Sandy Thomas. The Nuffield Council on Bioethics is funded
jointly by the Medical Research Council, the Nuffield Foundation
and The Wellcome Trust. Previous reports have included:
Genetic Screening - Ethical Issues, Human Tissue - Ethical
and Legal Issues and Animal-to-Human Transplants - the
Ethics of Xenotransplantation, Mental Disorders and Genetics:
The Ethical Context and, most recently, Genetically Modified
Crops - the Ethical and Social Issues.
The conclusions and recommendations of the first three reports
and the full text of the last two reports is available on the Nuffield
Council website at http://www.nuffield.org/bioethics/
The Ethics of Clinical Research in Developing Countries is
available from the Nuffield Council on Bioethics. Contact Communications & External Affairs Manager, tel+44 171 681 9619 fax +44 171 637 1712 or
bioethics@nuffieldfoundation.org
(1) Ethical acceptability of developed countries undertaking
research in developing countries is discussed by: Lurie and
Wolfe, New England Journal of Medicine, 337:853-6; Angell, New England Journal of Medicine, 337: 847-9
Members of the steering group:
Professor Peter Smith, London School of Hygiene and Tropical
Medicine
Ms Marion Kelly, Department for International Development
Dr Imogen Evans, Medical Research Council
Dr Richard Lane, The Wellcome Trust
1 The Declaration of Helsinki: Recommendations guiding
physicians in biomedical research involving human subjects
first. The Declaration was adopted by the 18th World Medical
Assembly, Helsinki, Finland in 1964 and has been amended
since that time, most recently in 1996.
2 The Council for International Organization of Medical
Sciences (CIOMS) in collaboration with the World Health
Organization (WHO) prepared a set of guidelines (1991) for
biomedical research on patients drawing on the Nuremberg
Code, the Declaration of Helsinki and the Universal Declaration
of Human Rights.
The Wellcome Trust is the world's largest medical research
charity with an annual spend of £400 million. The Wellcome
Trust supports more than 3,000 researchers at 300 locations in
30 different countries - laying the foundations for the
development of new and better treatment of diseases in the next
century and helping to maintain the UK's reputation as one of
the world's leading scientific nations. As we as funding major
initiatives in the public understanding of science, the Wellcome
Trust is the country's leading supporter of research into the
history of medicine.
The Medical Research Council (MRC) established in 1913,
aims to improve health by promoting research into all areas of
medical and related science. It is funded mainly by the
government, but is independent in its choice of which research
to support. About half of the MRC's expenditure of around £300
million is invested in over 40 of its Institutes and Units, where it
employs its own research staff. The remaining half goes in the
form of grant support and training awards to individuals and
teams in universities and medical schools.
The Dept for International Development (DFID) is the British
government department responsible for promoting development
and the reduction of poverty. The policy of the government was
set out in the White Paper on International Development
published in November 1997. The central focus of the policy is a
commitment to the internationally agreed target to halve the
proportion of people living in extreme poverty by 2015, together
with the associated targets including basic health care provision
and universal access to primary education by the same date.
DFID seeks to work in partnership with governments which are
committed to the international targets, and seeks to work with
business, civil society and the research community to
encourage progress which will reduce poverty. DFID also work
with multilateral institutions including the World Bank, UN
agencies and the European Commission.
Last Updated Fri, 14 January 2005