Status of national research bioethics committees in the WHO African region.

Charles Wambebe,Joses M Kirigia,Amido Baba-Moussa

doi:10.1186/1472-6939-6-10

Abstract

BackgroundThe 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.MethodsThis 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 (χ2) for independence was undertaken to test the relationship between presence/absence of Research Ethics Committee (REC) and selected individual socioeconomic and health variables.ResultsThe 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.ConclusionIn 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.

Highlights

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
The questionnaire was deliberately kept short and simple in order to ensure quick response. It consisted of questions aimed at obtaining the following information: existence of a national ethics committee dealing with health issues; its composition and main functions; frequency of scheduled meetings and number of times the committee met last year; if a Research Ethics Committee (REC) did not exist, were there mechanisms for clearing ethical issues in research; and whether a national ethical approval was required for implementation of research proposals
Sixty-seven per cent (12/18) of the countries that did have an ethics committee had it named as national bioethics committee; the remaining 33% (6/18) had alternative names for their national entity that performed the functions of REC

Summary

Introduction

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. Biomedical research involves research on pharmaceuticals, medical devices, medical radiation and imaging, surgical procedures, medical records and biomedical samples, as well as epidemiological, social, and psychological investigations [2]. It often entails collection, analysis, and interpretation of information obtained from human beings. Since the end of World War II, ethical and scientific standards for conducting biomedical research on human subjects have been enshrined in international guidelines, including the Nuremberg Code [5], the Declaration of Geneva [6], the International Covenant on Civil and Political Rights [7], the International Code of Medical Ethics of the World Medical Association [8], the Declaration of Helsinki [9], the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects [3], the WHO Operational Guidelines for Ethics Committees that Review Biomedical Research [2] and the ICH Guidelines for Good Clinical Practice [10]

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