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Studies using humans must be registered

By Shan Juan (China Daily)

11:06, July 17, 2013

Medical studies that use human volunteers as test subjects must be registered at the sponsoring institution before research begins to ensure ethical practices are followed.

The new regulation, from the National Health and Family Planning Commission, is open to public comments and suggestions on the commission's website.

The regulation aims to prevent health and ethical problems related to volunteers, particularly in clinical trials involving surgery technology and food safety, it said.

Possible risks and medical ethics issues must be examined by the sponsoring institution before the study can begin, it said.

The mainland's drug authority already oversees clinical trials of drugs, medical appliances and biochemical products.

Zhai Xiaomei, a member of the health commission's medical ethics committee, welcomed the initiative. "It helps regulate the procedures in many medical studies involving human trials," Zhai said.

An official of the commission's science and technology division who declined to be named said some medical clinical trials have problems. The irregularities pose health risks to participants and might violate their rights, the official said.

Zhai referred to a human trial-related scandal reported last year as a reason behind the new regulation.

In the 2008 study, 25 children aged 6 to 8 in Hunan province were fed genetically modified "golden rice" to see if the beta-carotene contained in the rice could provide them enough vitamin A, previous reports said.

The children's parents were not told the rice was genetically modified when they signed the consent papers.

"Such practices are unethical and could be averted with the new regulation in place," Zhai said.

Medical ethics issues should be a priority during such studies, even if a given study involves little risk to the volunteers, she added.

Meanwhile, to improve openness and facilitate public supervision, the commission is constructing a nationwide computerized registry of such trials.

Regarding studies on GM food, Zhai suggested other related government agencies like the Ministry of Agriculture work with the commission to ensure participants' rights are protected and that procedures are correct.

But "a balance should be struck between protecting the rights of trial volunteers and the long-term goal of advancing science and technology", she said.

Any trial can be halted immediately if serious adverse reactions are found in test subjects, the regulation said.

Proven unethical practices in violation of trial participants' due rights can also halt tests, it said.

In addition, charging trial participants fees is prohibited.

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