China must address the issue of using executed convicts' organs for transplantation if it is to compete in medical research, says Stephen Wigmore

British universities have flocked to China in recent months, and with good reason. The steady stream of Chinese students to British universities has become a valuable source of income and contributes to cultural diversity. Moreover, China is at the forefront of developments in almost every sphere of academic endeavour. Its genuine thirst for technology, powerful manufacturing base and market economy make it a good target for research collaboration. For medical researchers, its advanced techniques and huge patient base are ideal for clinical research.

There are many mutual benefits to such partnerships. But there is one big drawback: China's record on medical ethics. Last month, the British Transplantation Society issued a press release drawing attention to China's use of executed prisoners' organs in transplant operations and their sale to British patients seeking transplants overseas. This comes amid suggestions that the speed with which donors and patients are matched could mean that prisoners are being executed to order. British academics seeking to collaborate in clinical research with China have grave concerns.

In Britain, every grant funding application and every submission of a paper to a medical journal demands that the ethical considerations of any research have been considered and approved. This does not mean a simple statement nodding to the notion that the proposed research conforms to the general principles of the Declaration of Helsinki. Modern research requires a thorough peer review that evaluates every aspect of the study and the welfare, safety, choices and information given to patients. Similarly, clinical trials sponsored by the pharmaceutical industry require ethical approval and documentation of written informed consent from patients involved.

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The British Transplantation Society is concerned that the use of executed prisoners' organs in transplants flouts the issue of consent. The question of consent has also been raised by US congressmen, 28 of whom sent an open letter to Hu Jintao, the Chinese President, criticising the use of executed prisoners' organs.

The Chinese argue that the number of prisoners involved is small and that they give consent to the use of their organs. But it is hard to imagine how the power gradient between a condemned man or woman and any agent of the state could be conducive to an act of free will.

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The consequences of the question mark that hangs over medical ethics in China are clear. The majority of publications in transplantation research originating in China and cited by Pubmed, the US National Library of Medicine's search service, are either in Chinese-language journals or in low impact-factor English-language journals. This publication bias is in stark contrast with Chinese research on basic science subjects, much of which is published in the best English-language journals. Most journals require peer reviewers grading the quality of research to fill in a form that asks whether a study has been granted ethical permission.

But the message that research quality is immaterial unless the ethics are right seems not to have hit home in China. Moreover, the breach of ethical principles in one area of clinical practice casts doubt on ethical practices in other areas of medicine. What is needed to clear China's name is complete transparency. There is no doubt that China is at the top of its game in transplantation, but no one is interested in its results because they are tainted by the country's use of executed prisoners' organs. To become one of the acknowledged leaders in transplantation research, China needs to convince the world that it is "clean" and to consign the use of, and trade in, executed prisoners' organs to history.

The Chinese authorities are taking steps to get their house in order: on March 28 they issued an interim regulation prohibiting the trade in organs.

Legislation banning this practice comes into effect on July 1. Despite this, websites originating in China continue to advertise transplants to foreign nationals. In addition, the Beijing International Medical Support Network Centre website, which represents five hospitals including the Beijing University Hospital and is headed by Shen Zongyang, China's transplant pioneer, still states that it uses organs from executed prisoners.

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If such regulations are flouted in the capital, it is little wonder that people are uneasy about their enforcement in the provinces. China does not need to rely on executed prisoners' organs to meet its transplantation needs: it could meet these by establishing an accepted definition of brainstem death and expanding its living donor programmes. The implementation of such initiatives, alongside the new legislation on the trade of organs, might also help to prevent it from going underground.

A number of British universities have established strong links with China.

They include Oxford University, which has a long-standing association with China and has begun a collaborative research project through its clinical trials unit. To date, this has not thrown up any issues related to medical ethics. Other universities are also exploring closer collaborations with China. It is likely that at some point these links will involve clinical research directly or indirectly related to transplantation. In the long term, it can only be to China's benefit to resolve the issues that many countries have with its objectionable practice of using executed prisoners'

organs for transplantation. A transparently clean image in transplantation would reassure academic investors about the moral quality and integrity of the whole of China's medical research programme. Ethical reform would improve China's research infrastructure and its academic relations with universities worldwide and must surely far exceed the revenue generated from the unethical sale of human organs.@Details = Stephen Wigmore is chairman of the British Transplantation Society's ethics committee and professor of transplantation surgery in the liver unit of Queen Elizabeth Hospital, University of Birmingham.

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