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  • China to release tougher rules for research ethics


[BEIJING] China is set to release detailed new rules to improve ethical standards in medical research on human subjects.

Liu Yanfei, director of the Ministry of Health's science and education department, announced the plans at the 8th World Bioethics Congress, which ran from 6 to 9 August in Beijing.

The rules are likely to be released in August and will take effect on 1 January 2007.

China already has ethical rules concerning clinical trials of new drugs, research using human stem cells and embryos, and reproduction research and therapy.

The 2003 regulation on clinical trials, for example, stipulate that all hospitals doing clinical research must set up institutional review boards whose approval is needed before trials can begin.

But the existing rules only cover some aspects of medical research, says health ministry official Wang Jinqing.

For instance, they do not cover preclinical research that uses cells derived from living people.

Liu said that, under the new rules, all of the Ministry of Health's central and regional departments across China would have to set up ethical review committees to regulate and monitor medical research in their jurisdiction.

Cong Yali, a professor of medical ethics at Peking University, told SciDev.Net that the new rules should lead to better ethical practices in medical research.

But she added that the authorities would need to work hard to implement the rules and to improve the capacity of regional health officials to conduct ethical reviews of planned studies.

Cong Yali acts as an advisor to SciDev.Net on ethics of research.

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