China has a rapidly developing biomedical industry, whose growing pharmaceuticals market is attracting the attention of western researchers. But the country may not be paying as much attention to the ethical framework within which the growing body of clinical research is done.
Reporting from China, David Cyranoski says that researchers and medical professionals have little knowledge of regulations and procedures for obtaining informed consent from trial participants.
He adds that institutional review boards, from which researchers must seek approval for their trial's design, often consist of scientists with no training in bioethics. Not only that, but the regulations that do exist are rarely implemented fully and do not contain detailed guidelines for recruiting trial participants.
Cyranoski interviewed participants in an HIV drug trial who said they were not told of the potential risks of treatment. Those who suffered from side-effects from the trial drug had to pay for treatment themselves.
Participants also said that they had signed consent forms they did not understand, and were not explained to them. Nor were they informed of the trial's results.
Editors of scientific journals can provide an extra safeguard by refusing to publish the results of an unethical trial, but one editor told Cyranoski that Chinese journals pay no attention to such matters.
Cyranoski warns western researchers to be aware of these issues before embarking on clinical research in China.
Link to full article in Nature
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