Biomedical Research in Developing Countries - UNICRI

appropriate guidance in order to deal with critical issues and to deliver their
functions appropriately 26 .
CONCLUSIONS AND RECOMMENDATIONS
As we have discussed throughout this book, training, organizational funding and
independence are the key factors for the development of RECs in Africa. However, a
strong political commitment is also needed to create the necessary research
governance mechanism, such as specific laws and legislation, guidelines and
common standards, as well as monitoring mechanisms for external auditing of
RECs functioning.
The current and future increase of international clinical trials in Africa, for diseases
that rank low in its health priorities and that may take advantage of weak
regulatory systems and lower costs, necessitates measures to increase the African
pool of expert bioethicists, who can develop original guidelines, to respond
appropriately to the implementation of the research projects and make a real impact
on the decision making, that is still mostly done in the sponsor countries.
The creation of a genuine ethical working environment at the level of researchers
and reviewers is urgent to ensure that corruption and lack of transparency and
accountability towards violations are identified and institutionally approached.
To this purpose, it would be also important to reinforce the culture of ethics and
legality of biomedical research with human participants among policy makers and
judges, in order to strengthen the knowledge base and decision making powers on
these themes and to ultimately reinforce the national normative capacity, the rule
of law and the prevention and control of criminal offences.
The sensitization of policy makers would facilitate the inclusion of the ethical and
legal issues of biomedical research with humans in a sustainable political agenda
and promote the issuing of specific legislation in this field, based on the development
needs of the countries.
The increase on the awareness by judges and magistrates on the themes of ethics
and legality of biomedical research with human participants would integrate these
issues in the everyday legal and judicial practice and increase the institutional
capacity to respond and tackle the issues that can arise in clinical trials with human
participants, with particular regard to vulnerable population, including women and
minors.
26 Chima, S.J., Regulation of Biomedical Research in Africa, British Medical Journal, 2006, Vol. 332, Pages 848-851
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