Biomedical Research in Developing Countries - UNICRI

In order to calculate the percentage of countries for which data were obtained
(analyzed countries) and countries for which no data were obtained (not analyzed
countries) as well as the extent to which the three questions had been answered, the
country information sheets were counted and divided into three categories: fully
completed, partially completed and totally empty. This last category refers to those
countries for which no response was given to any of the three questions.
During the analysis, a problem was posed for those countries, which are currently
working on a national legislation on ethics in biomedicine. These countries have
been included in the list of analyzed countries if they already have some sort of
biomedical research framework or institutions. Otherwise they were included in the
list of not analyzed countries if they did not appear to have any regulations on
biomedical research or any reported ethical review activity. This was the case for
Malawi and Mauritius, which are currently working on the drafting of a national
legislation on ethics in biomedicine and in the setting up of a national research ethics
committee, but at very different levels and degrees of implementation.
The analysis of data aimed to calculate the prevalence of response to the three
questions on the country information sheets: 1) the existence of national specific
legislation on the protection of human participants in clinical research; 2) the
existence of national specific guidelines or standard operating procedures on ethics
in clinical trials; 3) the presence/absence of national or institutional ethics
committee reviewing biomedical research with human participants.
RESULTS
Information was received directly from 10 countries: Egypt, Malawi, Mauritius,
Morocco, Nigeria, Senegal, South Africa, Tanzania, Togo, Tunisia. All other country
information sheets were completed through the analysis of the documents collected,
from the responses of experts meetings and from databases queries.
Of the 53 African countries analyzed, information was obtained for 42 countries
(79,3%). The remaining 11 countries (20,7%) were left out of the analysis due to the
fact that not enough evidence was found to respond to the three questions on the
country information sheet.
Table 1. Number of analyzed and not analyzed countries
Analyzed
Not analyzed
Total
Number
of African countries
42
11
53
%
79,3
20,7
100 %
142