alexa Regulation of biomedical research in Africa
Clinical Research

Clinical Research

Journal of Clinical Research & Bioethics

Author(s): Sylvester C Chima

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Debate on biomedical research in Africa has focused on international ethical codes, such as the Declaration of Helsinki,1 2 and recent abuses of major international ethical guidelines.3–12 The declaration has been criticised for not fully protecting local populations—it requires only that researchers need be “aware of” other ethical and legal requirements; procedures for enforcement and penalties for breach of the declaration are absent; and the declaration, like all international ethical codes, does not have the force of law.8 13–15 Biomedical research in Africa would benefit from regulations that provide guidance on the role of local research ethics committees, informed consent procedures, standards of care, and compensation for injuries arising from sponsored research. The African Union should consider legislation and directives on biomedical research, similar to directives developed by the European Union,16 which are binding on but adaptable to the laws of individual states. These could enhance and simplify the regulatory and administrative provisions that govern biomedical research in Africa.

This article was published in BMJ and referenced in Journal of Clinical Research & Bioethics

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