Chinese Farmers Not Well-Informed about Genetic Probe

Alliance for Human Research Protection, 18 February 2002

A January 2002 report in China Daily, by Xiong Lei, the senior journalist with China Features, Xinhua News (below), raises troubling ethical concerns about U.S. government sponsored genetic research in rural China.

The research under question involved thousands of peasants in one of China's poorest rural provinces, Anhui, where basic medical care is lacking. It was sponsored jointly by the National Institutes of Health and Harvard University, School of Public Health. A Harvard research team conducted the research involving blood draws for genetic screening purposes. Nine projects sought to find hereditary links to diseases such as hypertension, obesity, asthma and osteoporosis, among others.

But Chinese critics have pointed out that these conditions do not affect poor populations in rural China, but rather are disease that concern affluent societies. Written complaints have been made by farmers whose blood was taken that they were not informed about the nature of the research, but were told to sign consent. Questions are being raised in the Chinese press, whether a group of American scientists from elite academic institutions are applying a lesser ethical standard when conducting genetic research on people in Third World countries, such as China?

Were the Chinese subjects in Anhui afforded the respect required under national and international ethical standards of voluntary, informed consent? Were adequate measures taken to ensure the subjects' confidentiality was protected from intrusive government surveillance?

Two and a half years have passed since a complaint was filed with the federal Office of Protection from Research Risks (now the Office of Human Research Protections) on September 12, 1999.

The China Daily points out that science, while important to the advancement of people and health, is not an autonomous entity independent from society. Scientific research must respect human dignity.

The two federal agencies that are authorized to investigate ethical violations in human research are both headed by administrators who are on leave from Harvard. This raises questions about a potential conflict of interest.

In August 2000, The Boston Globe reported that human research in China is a minefield because it is extremely difficult to get true consent from some rural villagers, who bow to authority and cannot read. And the communist government's eugenics policies could put individuals with genetically linked diseases at risk of sterilization. *[link below]

In Dec. 2000, The Washington Post published an investigative series reporting that villagers of Anhui who gave their blood said, We were told there would be free medical care, So of course everybody came out. The Post further reported that Harvard researchers had exploited the repressive Communist regime's persuasion tactics to get volunteers: If they don't want to participate, said one doctor, officials go down to the villages and do thought work and move them to participate. This assured the American researchers 95% volunteerism! **[link below]

Farmers not well-informed about gene probe

By XIONG Lei, China Daily,,
http://www1.chinadaily.com.cn/cndy/2002-01-10/51325.html
10 January 2002

Chu Mianzhai, a farmer from Toutuo Town in Yuexi County, Anhui Province, disclosed in a letter that genetic studies conducted by Harvard University did not conform to standard ethics codes.

The genetic studies, using blood collected from many farmers in China, aroused grave concern from the public after media exposure early last year (See China Daily report: Health is not enough, Page 9, April 9, 2001).

Some people point out that science, while important to the advancement of people and health, is not an autonomous entity independent from society. Scientific research must respect human dignity.

In fact, the United States, Australia and India have enacted laws requiring doctors and researchers to inform individuals of their treatment or research.

In his letter to me dated December 31, 2001, Chu recalled how he signed the so-called informed consent form that some investigators have claimed he signed in October 1997.

At the time the Toutuo Hospital issued a document paper, on which were some tiny characters, he wrote. What these words meant were not discernible to me (as I did not bring my reading glasses with me). Nor did they (referring to the people from the hospital) tell me what it was for. I was just asked to sign it. Perhaps it was the informed consent form.

Chu, 61, and his wife and two daughters gave blood twice to the Harvard genetic study, without knowing which specific projects they were participating in. In my interview with him at his home a year ago, Chu said he first gave blood in November 1996. He and his family members were asked to give blood again in March 1997, but there were not as many villagers the first time, he said.

Some villagers declined to go the second time, he recalled, but I was willing to do it because I wished to get some medical treatment for my daughters, especially the eldest one. She wheezes rather severely in spring time.

But he said the expected treatment never came.

Toutuo was one of the sites for the Harvard genetic study of asthma between 1994 and 1998, with Dr Xu Xiping of Harvard School of Public Health as the principal investigator. But Chu Mianzhai said he had no idea about it, let alone that the project was funded by the National Institute of Health of the United States (NIH).

The media's coverage of the issue, Chu wrote in his letter, is out of responsibility for the collaboration project on genetic studies as well as for the ordinary Chinese people and the Chinese nation.

A sample informed consent form offered to me last January by a local doctor who was involved in the blood collection for the Harvard projects, indicates that the blood taken is part of a genetic study co-sponsored by Harvard University and some Chinese medical institutions.

In the fiscal year of 2000, Xu Xiping headed nine projects funded with NIH grants amounting to nearly US$ 4.2 million. All of these projects involved blood collection in poor areas in Anhui. Xu claimed in earlier media interviews that his projects would involve screening 200,000 Chinese. Some American physicians were impressed that so many people could be screened at such a low cost.

By contrast, the number of collaborative projects approved by the Chinese Government up to January 2001 was only three, which did not include the asthma project.

Amidst the controversy over the bioethics of Harvard projects in Anhui, the Washington Post ran a report last June, saying two Chinese officials told the US Embassy in Beijing that the Chinese probes showed up no evidence against the projects.

However, Wang Yu, deputy director of the State Administration of Human Genetic Resources, said in a conference on August 8, 2001 that no official from the administration was authorized to meet US Embassy officials in Beijing and no official was authorized to make that statement.

Even the Chinese authorities' investigation on the Harvard projects in Anhui, first conducted in late March of 2001, have yet to reach any official conclusion, he said.

Medical people and journalists in China are continuing to investigate the case, to make sure that Chinese people's rights and bioethical principles were not violated in cross-border genetic research.

The author is a senior journalist with China Features, Xinhua News Agency.

[*See, Alice Dembner, The Boston Globe, Harvard-affiliated gene studies in China face federal inquiry, Aug. 1, 2000. front page http://www.boston.com/dailyglobe2/214/nation/Harvard_affiliated_gene_studies _in_China_face_federal_inquiry+.shtml ]

[**See, John Pomfret and Deborah Nelson, An Isolated Region's Genetic Mother Lode.

Chinese Human Genome Project Millenium Pharmaceuticals Harvard School of Public Health The Washington Post, Dec. 20, 2000. Front page. http://www.washingtonpost.com/wp-dyn/articles/A26797-2000Dec19.html ]

[See also, John Pomfret, Harvard Rebukes Head of China Gene Study. Thursday, August 9, 2001; Page A14 http://www.washingtonpost.com/wp-dyn/articles/A49656-2001Aug8.html ]