Biomedical Research in Developing Countries - UNICRI

health care become critical issues. The debate over the article by Lurie and Wolfe 9
that discusses the ethical acceptability of the trials on the prevention of HIV
perinatal transmission, 10 11 12 as well as the most recent debates on the trials of
13 14
surfactants in Latin America can be considered perfect examples of how
generalised principles can give way to opposite interpretations, when applied to
limited-resource settings.
In addition to that, as clinical research identifies more and more with international
multicentric trials, we are faced with the rising of a dangerous relativism that tends
to direct the consensus on the basic principles that characterized bioethical thinking
on human experimentation in the past, towards more utilitarian considerations (the
international consensus vs the international principles). The United States, for
example, announced, in 2004, that clinical research sponsored by US government
would be subject only to US rules and regulations, no matter where it was being
conducted. Apart from the critical issues raised by the legitimacy of applying
national regulations trans-nationally 15 , it is important to stress out that these
regulations, that are still rooted in international principles, do not apply to private
companies, which are currently the biggest investors in global health R&D and are
mostly concentrated in the United States 16 .
Many examples of abuses of international ethical guidelines in the conduct of
biomedical research in developing countries, particularly in the most disadvantaged
ones, such as Sub-Saharan Africa, pose the urgent need for the development of
appropriate legislation and regulation. This legislative framework can provide clear
guidance on the role of Research Ethics Committees and on critical issues such as
standard of care, informed consent and what happens when research is over,
especially as more and more research is conducted by foreign sponsors, who may
rely on standards that have limited or no application in developing settings or who
are reluctant to consider even rudimentary local statutes and guidelines.
9 Lurie P., Wolfe S.M., Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency
virus in developing countries, New Engl. J. Med., 1997, Vol. 337, No. 12, Pages 853-856
10 Varmus H., Satcher D., Ethical complexities of conducting research in developing countries, New Engl. J. Med.,
1997, Vol. 337, No. 14, Pages 1003-1005
11 Angell M., The ethics of clinical research in the third world, New Engl. J. Med., 1997, Vol. 337, No. 12, Pages
847-849
12 Ijsselmuiden C.B., Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in
the Third World, N. Engl. J. Med., 1998, Vol. 338, No. 12, Pages 838-841
13 Robert J. Temple, Benefit to trials participants or benefit to the community? How far should the Surfaxin trial
investigators’ and sponsors’ obligations extend?, in: Lavery J.V., Grady C., Wahl E.R., Emanuel E.J.(Ed.), Ethical issues
in international biomedical research, Oxford University Press, 2007, Pages 155-159
14 Lurie P., Wolfe S.M., The developing world as the “answer” to the dreams of pharmaceutical companies: the Surfaxin
story, in: Lavery J.V., Grady C., Wahl E.R., Emanuel E.J.(Ed.), Ethical issues in international biomedical research,
Oxford University Press, 2007, Pages 159-170
15 Dubois W., New drug research, the extraterritorial application of FDA regulations and the need for international
cooperation, Vanderbilt J. of Transnational Law, 2003, Vol. 36, Pages 161-207
16 De Francisco, A. Matlin, S. (Eds.), Monitoring financial flows for health research 2006. The changing landscape of
health research for development, Global Forum for Health Research, 2006
138