Biomedical Research in Developing Countries - UNICRI

there can be considerable differences in the effectiveness in which local ethics
committees deliver their functions. Consequently, even where national standards
and guidelines exist to assess the quality of RECs, their influence on the actual
quality of clinical trials remains yet to be clearly determined.
To conclude, there is testimony of a flourishing of RECs in Africa, not sustained,
however, by the necessary legislative framework. All stakeholders and the
international community at large need to strengthen their role in promoting the
importance of ethical review of biomedical research in a number of ways: by
promoting GCP guidelines application, by promoting training activities for both
investigators and RECs and by promoting ethical and human rights sensitisation
among policy makers, judges and governmental officials, in order to facilitate the
inclusion of these themes in the legislative agenda.
This is essentially a descriptive study, mostly based on indirect information. Because
only a small group of national governments and country experts responded directly
to the questionnaire, most of the country information sheets were completed by
collecting and analyzing information retrieved from the internet and from
specialized databases. Due to these reasons, it is difficult to establish whether the
high number of countries that resulted in lacking specific legislation or guidelines
on ethics of human experimentation, were actually so or whether this is due to a
lack of updated information in their institutional websites.
Another issue that was not possible to verify in our research study is represented by
the type and structure of RECs within the countries. Due to the initial choice to
restrict the country information sheet to three questions, limitation of data
collection has not allowed to establish whether ethical review of biomedical research
is conducted by local, national or institutional committees, such as universities and
hospitals committees or by both.
It would be important to investigate this aspect more deeply, as another important
debate regards the type and structure an ethical review system should have within
a developing setting. 25 Institutional Review Boards have been set up in various
countries in Africa, but their functioning and sustainability is constantly challenged
by financial restrictions as well as considerations related to their independence,
limited scope and real effectiveness. Ad hoc Institutional Review Boards may not be
able to deliver their functions properly, when reviewing research that is done within
the same institutions. According to S.J. Chima, the African Union could have a role
in establishing legislation and directives on biomedical research similar to those
developed by the European Union, which are binding for all Member States but can
be adapted to the laws and internal exigencies of each country. Specific national and
regional policies on research, reflecting local exigencies and realities, could be
subsequently developed by each State to assist local ethics committees to find the
25 Coleman C. H., Bouësseau M.C., Strengthening Local Review of Research in Africa: Is the IRB Model Relevant?, BMC
Med Ethics, 2006, Vol. 1, No. 2, Pages 39-58
146