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Better regulation is needed to ensure that research carried out in Africa and other developing countries is ethical, says an expert in this week’s BMJ.
Although most developing countries adhere to international ethical codes, some foreign researchers have taken advantage of the lack of local legislation and have ignored rudimentary local statutes, writes Sylvester Chima of Northumbria University.
He describes recent cases of unethical conduct and argues that local and regional regulatory frameworks and legislation are needed to protect research participants in Africa.
He suggests that regulations could provide guidance on forming local research ethics committees, informed consent procedures, standards of care, and distributive justice (such as post-trial benefits or compensation for injuries arising from research). Such regulations have already been introduced in Western countries.
But he dismisses the argument that such regulations would discourage drug trials in Africa.
The principles of respect for autonomy require that all people have the opportunity to determine what is done to their own body, in accordance with internationally recognised legal standards, he says. Research conducted contrary to these principles takes advantage of patients whose only fault is that they live in countries where research laws are lax and the quality of medical care is poor.
The suggested approach should not lead to an exodus of research sponsors from Africa. Instead it should encourage ethical conduct and provide a solid legal framework for future research in Africa, designed to safeguard researchers and participants, he writes.
“Experimental medicine and biomedical research will always be hazardous but should be encouraged within a framework of respect for autonomy, justice, and human rights. Ethical practice and new advances in biomedicine are not mutually exclusive, he concludes.”
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