Author(s): Kirigia JM, Wambebe C, BabaMoussa A
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Abstract BACKGROUND: The Regional Committee for Africa of the World Health Organization (WHO) in 2001 expressed concern that some health-related studies undertaken in the Region were not subjected to any form of ethics review. In 2003, the study reported in this paper was conducted to determine which Member country did not have a national research ethics committee (REC) with a view to guiding the WHO Regional Office in developing practical strategies for supporting those countries. METHODS: This is a descriptive study. The questionnaire was prepared and sent by diplomatic pouch to all the 46 Member States in the WHO African Region, through the WHO country representatives, for facilitation and follow up. The data were entered in Excel spreadsheet and subsequently exported to STATA for analysis. A Chi-Squared test (chi2) for independence was undertaken to test the relationship between presence/absence of Research Ethics Committee (REC) and selected individual socioeconomic and health variables. RESULTS: The main findings were as follows: the response rate was 61\% (28/46); 64\% (18/28) confirmed the existence of RECs; 36\% (10/28) of the respondent countries did not have a REC (although 80\% of them reported that they had in place an ad hoc ethical review mechanism); 85\% (22/26) of the countries that responded to this question indicated that ethical approval of research proposals was, in principle, required; and although 59\% of the countries that had a REC expected it to meet every month, only 44\% of them reported that the REC actually met on a monthly basis. In the Chi-Squared test, only the average population in the group of countries with a REC was statistically different (at 5\% level of significance) from that of the group of countries without a REC. CONCLUSION: In the current era of globalized biomedical research, good ethics stewardship demands that every country, irrespective of its level of economic development, should have in place a functional research ethics review system in order to protect the dignity, integrity and safety of its citizens who participate in research.
This article was published in BMC Med Ethics
and referenced in Journal of Clinical Research & Bioethics