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Analysis And Comment Global medicine

Regulation of biomedical research in Africa

BMJ 2006; 332 doi: (Published 06 April 2006) Cite this as: BMJ 2006;332:848
  1. Sylvester C Chima, postgraduate research scholar ( (
  1. 1 Northumbria University, School of Law, Newcastle upon Tyne NE1 8ST
  1. Correspondence to: S C Chima, 384A Green Lanes, London N13 5PD
  • Accepted 31 January 2006

In view of major violations of international ethical codes during biomedical research in developing countries, local and regional regulation frameworks and legislation are needed to interpret international guidelines

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.312 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 1315 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.

The case for local statutory regulation

The current debate on research ethics in Africa and other developing countries has focused on informed consent,14 7 12 15 standards of care,810 17 18 ethical review, and distributive justice.412 15 To promote ethical research in Africa, appropriate legislative controls, increases in research capacity, new career structures, and appropriate allocation of resources may be needed. Although most developing countries adhere to international ethical codes, some research sponsors and regulatory agencies may ignore these codes to pursue national interests.5 19 Some foreign researchers have taken advantage of the lack of local legislation and have ignored rudimentary …

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