Biomedical Research in Developing Countries - UNICRI

with South Africa and Egypt accounting for more than half of the continent’s
whole percentage 55 . Recently, editors from the most prestigious scientific journals
have launched The “African Medical Journal Partnership Project” 56 organized by the
US Fogarty International Centre and the National Library of Medicine (NLM), to
foster capacity building in medical publishing in Africa and to assist African Journal
develop their capacity to attract scientific research reporting by matching their
journals with African journals.
THE CAPACITY FOR THE ETHICAL REVIEW OF RESEARCH IN AFRICA
Closely interrelated to the necessity to strengthen education and research within
developing countries health systems is the necessity to foster and sharpen the
ethical capacity for evaluating health research, in view of the recent and massive
increase in pharmaceutical research globally. High quality capacity for biomedical
research review is a key component of health development that should always keep
into account the cultural, social and economic context of the country where
research is conducted. Unethical research leads to failure in delivering useful
interventions and decreases public trust in research.
As pointed out in an Editorial in the NEJM published in 2001, there is also a
growing need for transparency in the sponsorships of clinical trials, especially in
countries with poor regulatory infrastructure, and in the ability to evaluate such
sponsorships in ethical terms 57 . Still, to date, against the growth in international
research, there has been no commensurate investment in the development of ethics
review capacity and infrastructure in the developing world.
Research inspections based on the international guidelines and on good clinical
practice (GCP inspections) assure clinical trial data reliability and guarantee the
patient’s rights. These requirements are necessary for the scientific and ethical
assessment of the research protocol and for the subsequent medicinal marketing
authorisation. The reliability of research protocols and investigational sites also
derives from many factors, the most important being a regular and systematic
inspection, analysis and evaluation by Research Ethics Committees (REC). Data
resulting from multinational clinical trials performed in many countries are utilised
for the purpose of marketing authorisation. Clinical data obtained from Countries
with high qualitative level of GCP inspection systems are considered by National
Regulatory Authorities more reliable.
55 Hassan, M.H.A., Collaboration requires a strong home base, 14 May 2008 (http://www.scidev.net/en/scienceand-innovation-policy/south-south-cooperation/opinions/collaboration-requires-a-strong-home-base.html,
accessed September 2008)
56 Tillet T., Global collaboration gives greater voice to African journals, Environmental Health Perspectives, 2005,
Vol. 113, No. 7, Pages A452-A454
57 Sponsorship, authorship and accountability, Editorial, NEJM, 2001, Vol. 345, No. 11, Pages 825-827
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