The ethics of clinical research in developing countries
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The debate over ethical standards in health research in developing
countries is highlighted in a discussion paper published by the Nuf-
field Council on Bioethics. The full text paper, "The ethics of
clinical research in developing countries" is available as a .PDF
file (560 Kb) at:
http://www.nuffield.org/bioethics/publication/download.html
For those without full internet connection a hard copy is available
on request from:
Yvonne Melia
Research Assistant
Nuffield Council on Bioethics
Tel: +44-171-681-9625
Fax: +44-171-637-1712
mailto:ymelia@nuffieldfoundation.org
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Executive summary
The ethical acceptability of developed countries' supporting or un-
dertaking research in developing countries has been debated for many
years. The ethical issues have recently been highlighted by contro-
versy surrounding large scale trials conducted in developing coun-
tries to see whether zidovudine (AZT) treatment for HIV-infected
women prevented perinatal transmission of HIV. The ensuing debate has
focused attention on the relatively narrow issue of standards of care
in clinical trials in developing countries. However, this paper,
based on discussions, which took place at an international Nuffield
Council on Bioethics workshop in February 1999, draws attention to
the fact that a much wider range of ethical and social issues that
need to be addressed. The duty to conduct scientifically sound re-
search, the need to act in the patient's best interests and the need
to respect the patient's autonomy are fundamental to all clinical re-
search but may be more difficult to achieve in poor countries where
basic healthcare is not widely available. Questions about justice are
also particularly relevant where limited resources mean that effec-
tive treatments may be unaffordable.
In view of the potential risk of harm in clinical research, sound
ethical standards must be observed, irrespective of the geographic
and economic setting in which such research is undertaken. Unfortu-
nately the mechanisms and procedures for ethical review in some de-
veloping countries are under-developed. This paper suggests that
while the Declaration of Helsinki and international biomedical guide-
lines are both necessary and useful, they have weaknesses which need
to be addressed. Furthermore, such guidance can only facilitate pro-
tection of the interests of trial participants if training and re-
sources are available for its interpretation and implementation.
A range of ethical and social issues is highlighted which need to be
addressed by research sponsors, intending collaborators and relevant
authorities in poor countries. These include the relevance of the re-
search to the country's health needs, the availability of effective
treatments after research is completed, the need to respect cultural
traditions when conducting research and issues relating to consent.
There is clearly a very considerable distance between the broadly
based principles outlined in international guidance and the practical
issues being considered by local research ethics committees reviewing
individual protocols. One way forward would be to produce 'intermedi-
ate' guidelines to link these two levels of ethical assessment. Those
international bodies undertaking inquiries on this topic have ac-
knowledged the importance of bringing their studies together to cre-
ate coherent guidance.
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