Harvard Project in China Violates Farmers' Rights

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Last updated at: (Beijing Time) Thursday, May 02, 2002

Harvard Project in China Violates Farmers' Rights

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After two years of investigation, the Office for Human Research Protections under the US Department of Health & Human Services Office of Public Health and Science announced in late March that 15 Harvard-affiliated genetic studies on diseases ranging from asthma to schizophrenia were faulty because the rights of thousands of Chinese farmer-participants were ignored and violated by the American researchers.

Since the Harvard genetic projects were launched in the mid-1990s, Chinese farmers in remote mountainous areas in East China's Anhui Province were asked to give DNA blood samples in turn for free physical checkups and medical treatment. They were not told why they were chosen or the purpose of the collection of blood samples.

The US Department of Health & Human Services issued a letter of determination about the investigation which described the massive blood collection in terms of "the breadth and seriousness of violations" of human rights. The United States is one of the few countries in the world to have enacted laws requiring doctors and researchers to inform individuals and participants about the treatment or research goals of a research project.

While applauding the long-awaited investigation and conclusions on the faulty research projects, we in China are shocked to see that for nearly a decade, researchers from such renowned institutions as Harvard University have been engaged in projects that turned out to be problematic as far as bioethical practices..

How could this be allowed to happen in the first place?

According to the conclusion letters addressed to the related institutions, many of the projects were carried out on sites in China before they had been reviewed by the US Institutional Review Board for approval. The so-called consent from Chinese participants was not considered a fully informed consent. It is hard to imagine that these Harvard-affiliated projects could operate in the same manner in the United States.

However, the conclusion letters focused the blame on individual researchers who failed to honour bioethical principles in their search for genetic resources, but ignored the responsibility of those who provided the money to these researchers. Without their financial support, "the breadth and seriousness of violations" would have been impossible.

Noticeably absent from the list of those to be held responsible is the Millennium Pharmaceutical Corporation in Massachusetts in the United States, which put in the seed money to start up the Harvard genetic projects in the mid-1990s. The very first project of genetic studies on asthma funded by Millennium with US$3 million reportedly incurred US$53 million more investment to the corporation in 1995.

Why is it that the Millennium company is not held responsible for the ethical breaches involved in the research?

Also left out of the determination letters is the renowned National Institutes of Health (NIH), which had given permission for nine of the 15 problematic Harvard projects headed by Dr. Xu Xiping of the Harvard School of Public Health in fiscal 2000.

This is abnormal for NIH, which is known for its rigorous review process for research grants. As many scientists are proud of obtaining just one NIH grant, why did a US governmental institute give nine grants to one person? Moreover, all the nine projects involved human blood collection in remote areas in China where per capita annual income averaged 1,400 yuan (US$170) last year?

As the determination letters stated, farmers in those areas are indeed "vulnerable individuals" and "economically or educationally disadvantaged persons." Then why did the NIH lower its acceptance standards to grant support for projects based on this vulnerable population?

Some are trying to shirk the US institutions' responsibility for the faulty research by putting the blame on the Chinese, saying it was Xu Xiping's Chinese partners who failed to implement the protocols to the letter.

Yet it is not the Chinese who initiated and funded the blood collection projects. They had been US-funded projects, on the list of US governmental institutions' grants. Those Chinese colleagues were just used or abused in order to help ship the Chinese blood samples to Harvard.

The question is not whether these Chinese are to blame. The question is why the American funding institutions allowed such unqualified partners to be engaged in human subject studies.

The author is a senior editor of China Features of the Xinhua News Agency.

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