Ethical Concerns Re: U.S. Sponsored Genetic Experiments in China

Commentary by Vera Hassner Sharav

February 18, 2002 

FYI
United States Government Sponsored Genetic Research in Rural China Raises Troubling Ethical Concerns

A January 2002 report in China Daily, byXiong Lei, the senior journalist with China Features, Xinhua News Agency(below), raises troubling ethical concerns about U.S. government-sponsoredgenetic research in rural China.

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

But Chinese critics have pointed out that these conditionsdo not affect poor populations in rural China, but rather are disease thatconcern affluent societies. Written complaints have been made by farmers whoseblood 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 areapplying a lesser ethical standard when conducting genetic research on people inThird World countries, such as China?

Were the Chinese subjects in Anhui afforded the respectrequired 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 wasfiled with the federal Office of Protection from Research Risks (now the Officeof Human Research Protections) on September 12, 1999.

The China Daily points out that”science, while important to the advancement of people and health, is notan autonomous entity independent from society. Scientific research must respecthuman dignity.”

The two federal agencies that are authorized toinvestigate ethical violations in human research are both headed byadministrators who are on leave from Harvard. This raises questions about apotential conflict of interest.

In August 2000, The Boston Globe reportedthat human research in China is “a minefield” because it is”extremely difficult to get true consent from some rural villagers, who bowto authority and cannot read. And the communist government’s eugenics policiescould put individuals with genetically linked diseases at risk ofsterilization.”

In Dec. 2000, The Washington Post publishedan investigative series reporting that villagers of Anhui who gave their bloodsaid, “We were told there would be free medical care, So of courseeverybody came out.” The Post further reported that Harvard researchers hadexploited the repressive Communist regime’s persuasion tactics to get”volunteers”: “If they don’t want to participate,” said onedoctor, “officials go down to the villages and do thought work and movethem to participate.” This assured the American researchers 95%volunteerism!

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China Daily

Farmers not well-informed about gene probe (XIONG LEI)01/10/2002 http://www1.chinadaily.com.cn/cndy/2002-01-10/51325.html
Chu Mianzhai, a farmer from Toutuo Town in Yuexi County, Anhui Province,disclosed in a letter that genetic studies conducted by Harvard University didnot conform to standard ethics codes. The genetic studies, using blood collectedfrom many farmers in China, aroused grave concern from the public after mediaexposure early last year (See China Daily report: Health is notenough, Page 9, April 9, 2001).

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

In fact, the United States, Australia and India haveenacted laws requiring doctors and researchers to inform individuals of theirtreatment or research.

In his letter to me dated December 31, 2001, Chu recalledhow he signed the so-called “informed consent form” that someinvestigators have claimed he signed in October 1997.

“At the time the Toutuo Hospital issued a documentpaper, on which were some tiny characters,” he wrote. “What thesewords meant were not discernible to me (as I did not bring my reading glasseswith me). Nor did they (referring to the people from the hospital) tell me whatit was for. I was just asked to sign it. Perhaps it was the “informedconsent form.”

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

Some villagers declined to go the second time, herecalled, “but I was willing to do it because I wished to get some medicaltreatment for my daughters, especially the eldest one. She wheezes ratherseverely in spring time.”

But he said the expected treatment never came.

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

The media’s coverage of the issue, Chu wrote in hisletter, “is out of responsibility for the collaboration project on geneticstudies as well as for the ordinary Chinese people and the Chinese nation.”

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

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

By contrast, the number of collaborative projects approvedby the Chinese Government up to January 2001 was only three, which did notinclude the asthma project.

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

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

Even the Chinese authorities’ investigation on the Harvardprojects in Anhui, first conducted in late March of 2001, “have yet toreach any official conclusion,” he said.

Medical people and journalists in China are continuing toinvestigate the case, to make sure that Chinese people’s rights and bioethicalprinciples were not violated in cross-border genetic research.

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