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News Stories on Human ResearchProtection and April 29, 2002 China Daily: Harvard Project ViolatesFarmers’ Rights FYI American experiments on impoverished populations inunderdeveloped countries needs much more oversight than seems to have beenprovided. XIONG LEI, the senior editor of China Featuresof the Xinhua News Agency, raises legitimate questions about the focus of afederal investigation by the U.S. Office of Human Research Protection (OHRP). The genetic research was conducted for almost a decade inChina by Harvard University researchers. It was funded by NIMH and MillenniumPharmaceutical. A complaint was filed by Dr. Gwendolyn Zahner whose concern wasthat the experiments were performed on vulnerable Chinese people who weresubject to coercion, and that the research jeopardized their welfare whileviolating federal informed consent regulations. On March 2, 2002, OHRP issued 3 letters of determination(See url below, See also, AHRP Infomail, March 31) "we in China are shocked to see that for nearly adecade, researchers from such renowned institutions as Harvard University havebeen engaged in projects that turned out to be problematic as far as bioethicalpractices.." XIONG LEI notes that OHRP’s letters "focused theblame on individual researchers" "but ignored the responsibility ofthose who provided the money to these researchers and who had oversightresponsibilities in accordance with federal regulations. She notes, withouttheir financial support, "the breadth and seriousness of violations"would have been impossible." After two years of investigation, the Office for HumanResearch Protections under the US Department of Health & Human ServicesOffice of Public Health and Science announced in late March that 15Harvard-affiliated genetic studies on diseases ranging from asthma toschizophrenia were faulty because the rights of thousands of Chinesefarmer-participants were ignored and violated by the American researchers. Since the Harvard genetic projects were launched in themid-1990s, Chinese farmers in remote mountainous areas in East China’s AnhuiProvince were asked to give DNA blood samples in turn for free physical checkupsand medical treatment. They were not told why they were chosen or the purpose ofthe collection of blood samples. (See China Daily reports: "Health is notenough," Page 9, April 9, 2001; and "Farmers not well-informed aboutgene probe," Page 10, January 10, 2002) The US Department of Health & Human Services issued aletter of determination about the investigation which described the massiveblood collection in terms of "the breadth and seriousness ofviolations" of human rights. The United States is one of the few countriesin the world to have enacted laws requiring doctors and researchers to informindividuals and participants about the treatment or research goals of a researchproject. While applauding the long-awaited investigation andconclusions on the faulty research projects, we in China are shocked to see thatfor nearly a decade, researchers from such renowned institutions as HarvardUniversity have been engaged in projects that turned out to be problematic asfar as bioethical practices.. How could this be allowed to happen in the first place? According to the conclusion letters addressed to therelated institutions, many of the projects were carried out on sites in Chinabefore they had been reviewed by the US Institutional Review Board for approval.The so-called consent from Chinese participants was not considered a fullyinformed consent. It is hard to imagine that these Harvard-affiliated projectscould operate in the same manner in the United States. However, the conclusion letters focused the blame onindividual researchers who failed to honor bioethical principles in their searchfor genetic resources, but ignored the responsibility of those who provided themoney to these researchers. Without their financial support, "the breadthand seriousness of violations" would have been impossible. Noticeably absent from the list of those to be heldresponsible is the Millennium Pharmaceutical Corporation in Massachusetts in theUnited States, which put in the seed money to start up the Harvard geneticprojects in the mid-1990s. The very first project of genetic studies on asthmafunded by Millennium with US$3 million reportedly incurred US$53 million moreinvestment to the corporation in 1995. Why is it that the Millennium company is not heldresponsible for the ethical breaches involved in the research? Also left out of the determination letters is the renownedNational Institutes of Health (NIH), which had given permission for nine of the15 problematic Harvard projects headed by Dr. Xu Xiping of the Harvard School ofPublic Health in fiscal 2000. This is abnormal for NIH, which is known for its rigorousreview process for research grants. As many scientists are proud of obtainingjust one NIH grant, why did a US governmental institute give nine grants to oneperson? Moreover, all the nine projects involved human blood collection inremote areas in China where per capita annual income averaged 1,400 yuan(US$170) last year? As the determination letters stated, farmers in thoseareas are indeed "vulnerable individuals" and "economically oreducationally disadvantaged persons." Then why did the NIH lower itsacceptance standards to grant support for projects based on this vulnerablepopulation? 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 protocolsto the letter. Yet it is not the Chinese who initiated and funded theblood collection projects. They had been US-funded projects, on the list of USgovernmental institutions’ grants. Those Chinese colleagues were just used orabused 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 unqualifiedpartners to be engaged in human subject studies. The author is a senior editor of China Features of theXinhua News Agency. Copyright 2002 by chinadaily.com.cn. all rights reserved. http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/mar02a.pdf http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/mar02b.pdf http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/mar02c.pdf FAIR USE NOTICE: This may contain copyrighted (© )material the use of which has not always been specifically authorized by thecopyright owner. Such material is made available to advance understanding ofecological, political, human rights, economic, democracy, scientific, moral,ethical, and social justice issues, etc. It is believed that this constitutes a’fair use’ of any such copyrighted material as provided for in section 107 ofthe US Copyright Law. In accordance with Title 17 U.S.C. Section 107, thismaterial is distributed without profit to those who have expressed a priorgeneral interest in receiving similar information for research and educationalpurposes. 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