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China's new bioethics regulations will protect human subjects while allowing biomedicine and biotechnologies to develop, argues Qiu Renzong.

China is fast becoming an energetic laboratory for economic growth, scientific research, social development and globalisation. A long economic boom, combined with a new economic system and social structure resulting from the changing role of the state, has made innovation essential to every area of life.

In particular, the country's rich genetic resources and biodiversity, together with the growing health needs of a large population, provide foreign and domestic pharmaceutical companies with one of the biggest markets in the world for exploring drug research and development. Indeed, national institutes and industry have become a pervasive and formidable global power in medicine and research.

But, until recently, there has been little control of ethical review in these sectors. In January this year — following around nine years of debate among Chinese scientists, bioethicists and policymakers — China's Ministry of Health finally approved the country's first general regulations on ethical review of biomedical research involving human subjects.

Tackling the key questions

The ministry has had to grapple with two principal questions. Is regulation in China necessary — or even desirable? And if it is, should guidelines be based on Chinese cultural characteristics like Confucian principles, or on the international guidelines that have been mostly developed by western ethicists?

Some scientists have advocated the development of biomedical research and biotechnology without constraint — arguing that such freedom will allow China to more rapidly catch up with efforts in developed nations.

But such advice is both wrong and dangerous.

It is wrong because it assumes that abiding by the ethical norms for protecting patients' rights and welfare would impede scientific progress. Research efforts in China — for example, the cooperative project between Beijing Medical University and the US Centers for Disease Control using folic acid to prevent neural tube defects — clearly demonstrate that the two are not mutually exclusive.


And it is dangerous because Chinese science and technology could lose its essential integrity and public support both at home and abroad, never mind halting its development. The scandals over Hwang Woo-suk in Korea and Chen Jin in China convincingly illustrate this point.

As to incorporating Chinese values into ethical regulations — respecting a unique cultural context is no excuse for rejecting the general applicability of international ethical guidelines. Such guidelines are a result of communication and debate among experts from different countries and cultures across the world, including China. As Confucius said, "human nature is similar, practice made them apart". Basic values, such as respect, non-maleficence and justice are shared by western and eastern cultures alike.

The new Chinese regulations successfully fit ethical review within the country's own laws and regulations while also abiding by international bioethical principles. They clearly state that the process of ethical review should be independent, objective, just and transparent.

The regulations encompass a three-tier infrastructure made up of national, provincial and institutional ethical committees. They outline the wider principles of ethical review, the requirements for obtaining informed consent or establishing a research protocol, and the penalties that will be applied for violating the rules. The new regulations prioritise individuals' health and safety over scientific and societal interests.

Where next?

But drafting the regulation is only the first step in making human subject protection sustainable. Implementing it, and ensuring its widespread adoption will be a far more demanding and formidable task — but one that, if successful, will give much-needed impetus to building Chinese capacity in research ethics.

Much should — and is — being done to help China succeed. The Ministry for Health's ethics committee is busy drafting key documents such as the constitutions of the proposed ethics committees and application forms for principal investigators to use when seeking ethical approval that can be used nationwide. Existing institutional ethics committees are also being monitored by the ministry and provincial healthcare administrations to assess how and if they work, and to consider where they need re-organising or re-establishing.

Great efforts are also being made to train researchers, ethics committee members and healthcare administrators responsible for governing ethical review.

National and foreign institutes — including the Peking Union Medical College, Huazhong University of Science and Technology and Fudan University in China and the US-based universities of Harvard, California, Chicago and Yale, among others — have been collaborating since 2004 to provide such training. They have organised research ethics workshops for Chinese stakeholders across the country.

Such efforts have created a favourable atmosphere for the implemention and spread of the newly approved regulations. This will help us take the protection of human subjects' rights and welfare to a new stage in China.

Qiu Renzong is honorary director of the Centre for Applied Ethics at the Chinese Academy of Social Sciences in Beijing, China.

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