Biomedical Research in Developing Countries - UNICRI

In Africa, the scarcity of trained bioethicists and of the capacity for advanced
institutional training is hindering the development of a genuine leadership that can
direct in the creation of an African philosophy of research ethics, focused on
problems that affect Africa directly.
These general considerations are necessary to understand the complex background
against which the work of Research Ethics Committees (REC) in developing
countries is set. Previous review and approval of a research protocol by an
independent ethical committee is in fact a recognized international ethical standard
for research with human participants. A competent review of research is necessary
to address ethical concerns. Review of research proposals by an ethical committee
does not guarantee that the trial will be conducted in an ethical manner, especially
if no subsequent follow-up monitoring activities are carried out. However, it helps
to ensure that the substantive ethical concerns raised by the study protocol are
addressed within their peculiar context, at the same level of importance as that of
scientific considerations.
It is evident that the role of RECs is fundamental in ensuring the protection of the
dignity, the rights, the safety and well-being of participants to clinical research. For
this reason, more efforts should be put in ensuring their institutional creation and
establishment as well as in building their capacity for ethical review.
Only recently, globalisation of research has increased the need for more efforts in
building the capacity for ethical review in developing countries. A series of
initiatives, coordinated primarily by UNESCO 58 , WHO 59 and TDR 60 are aimed not
only to strengthen ethics curricula and to increase access to training for individual
members of RECs, but are also directed to assist in the creation and formal
establishment of national and institutional RECs.
At the European Union level, the activities of EDCTP in working in partnership with
developing countries has been notable for the variety of approaches and the amount
of funding devoted to raising the understanding of the value of ethics in clinical
research.
At the national level, the United States Government and US private foundations,
such as the Bill and Melinda Gates Foundation, have been very active in promoting
the ethical training of RECs, through University exchange programmes or internetbased
courses.
Africa, for its particular placement within the developing context, is the continent
that possibly raises the highest number of challenging issues in this field. Composed
of 53 States, Africa is home to 34 of the 49 least developed countries in the world.
58 UNESCO -United Nations Educational, Scientific and Cultural Organization, UNESCO – ABC Project “Assisting
Bioethics Committees”, 2006
59 See WHO – World Health Organization, Ethics and Health Department Unit
(http://www.who.int/ethics/about/en/index.html),
60 See SIDCER, the “Strategic Initiative for Developing Capacity in Ethical Review”
(http://www.sidcer.org/new_web/index.php)
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