Biomedical Research in Developing Countries - UNICRI

not yet developed a uniform model for RECs 17 18 . Typologies of committees that
review the ethical aspects of biomedical research are different in terms of
composition, internal regulation and are influenced by the differences in the cultural
and historical heritage of the nations. A more in-depth research will be needed to
collect data on the type and functions of RECs within the various countries.
Two different approaches, based on the analysis of primary and secondary sources
of information were used to collect the information and data necessary to respond
to the three questions, based on the above established criteria.
Primary sources of information included:
1) Country information sheets were circulated randomly, mostly by email, to
individual experts, ministries of health, ministries of research, national research
foundations in the 53 African States.
2) Meetings were organized with the Council of Europe, the European Commission,
international experts, international organizations such as COHRED and WMA and
United Nations Agencies and Programmes, such as the UNESCO Division on Science
and Technology and the WHO Ethics and Health, Department of Ethics, Equity,
Trade and Human Rights, to gain information from those constituencies directly
involved in the issue of ethics in biomedical research.
3) Participation to international and regional conferences.
Secondary sources of information included:
1) Internet searches performed on the following databases:
the UNESCO GEOBs, the Harvard School of Public Health database and the
International Compilation of Human Subjects Research database of the Office for
Human Research Protection at the Dept. of Health and Human Services of the United
States of America, the “Survol de la législation en matière de recherche en santé dans
quelques pays d’Afrique” of the University of Neuchâtel.
2) Internet searches also regarded websites of NGOs, private foundations, scientific
databases (PloS, PUBMED, MEDLINE), specialised scientific journals websites and
governmental websites. The documents collected were organized, based on the type,
in Excel spreadsheets, in order to create the following databases: Legislation, 19
17 CASE STUDY - Choosing a Research Ethics Committee system amongst the existing models? Critical decision of a
middle income country (Chile), (http://www.mies.mf.vu.lt/gfbr/docs/1.doc) (accessed july 2008)
18 Doppelfeld E., Harmonization of research ethics committees – are there limits?, Japan Medical Association Journal,
2007, Vol. 50, No. 6, Pages 493-494 19 Laws, Decrees, National Constitutions, Codes, Internal Regulations of
Committees, Professional Ethics Regulation and Codes of Conduct, downloaded and collected from different sources:
Council of Europe, World Medical Association, European Commission, European Parliament, National Governments,
Departments and Ministries of Health, National Medical Syndicates and through emails sent by experts.
19 Laws, Decrees, National Constitutions, Codes, Internal Regulations of Committees, Professional Ethics Regulation
and Codes of Conduct, downloaded and collected from different sources: Council of Europe, World Medical
Association, European Commission, European Parliament, National Governments, Departments and Ministries of
Health, National Medical Syndicates and through emails sent by experts.
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