Date: Wed, 15 May 2002 12:57:32 -0400
Subject: Harvard President Laments China Study_Globe

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
A Human Rights Organization
www.researchprotection.org

Contact: Vera Hassner Sharav

FYI

Harvard's genetic experiments in rural China have elicited much criticism. In December 2000, The Washington Post published a highly critical investigative report about the pervasive financial conflicts of interest that were undermining the safety of subjects in Harvard's research in China. Impoverished Chinese people were used in genetic experiments that disregarded their human rights to informed consent, and put them at risk of losing their livelihood by a regime that discriminates against people with a genetic disposition to illness.

In March 2002, the federal Office of Human Research Protections issued 3 letters of determination [See AHRP Infomail, March 31] finding multiple violations. In particular, failure to obtain institutional review board (IRB) approval for every study and for every change in the research; failure to minimize risks; and failure to fully disclose to the subjects their rights to refuse to participate without consequences--as required under the Code of Federal Regulations.

The Boston Globe reports today that Harvard's President, Lawrence Summers, said Harvard has since changed the way it handles studies of human illnesses. ''We have revised in a drastic way all our procedures for research at the public health school,'' he told the Chinese students. ''The interests of individual human beings should never be sacrificed to some concept of abstract scientific inquiry.''

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THE BOSTON GLOBE

THIS STORY HAS BEEN FORMATTED FOR EASY PRINTING

http://www.boston.com/dailyglobe2/135/nation/In_China_Harvard_head_laments_studyP.shtml

In China, Harvard head laments study

By Josh Gerstein, Globe Correspondent, 5/15/2002

BEIJING - Harvard's president, Lawrence Summers, in remarks to Chinese students yesterday, expressed deep regret that a dozen Harvard-run genetic studies in China failed to give test subjects adequate information about potential pitfalls.

''What happened was wrong and it was badly wrong,'' Summers said, answering a question following his speech at Peking University. ''It's the responsibility of the dean of the School of Public Health and, ultimately, it's my responsibility as president of the university to see to it that where wrong can be put right it is and, more importantly, to see to it that it never happens again.''

In March, the US Department of Health and Human Services faulted the Harvard School of Public Health, Brigham and Women's Hospital, and the Massachusetts Mental Health Research Corp. for their procedures involving research conducted in China. Officials at the federal Office for Human Research Protections found that participants risked not being treated for health problems that might be diagnosed in the studies, that they faced job discrimination if medical problems were discovered by the subjects' employers, and that some consent forms were too complex for rural Chinese.

In addition, significant changes to the studies were made without necessary approvals, federal investigators reported. The studies sought genetic and environmental causes for ailments that included asthma, obesity, miscarriage, and schizophrenia.

Summers said Harvard has since changed the way it handles studies of human illnesses. ''We have revised in a drastic way all our procedures for research at the public health school,'' he told the Chinese students. ''The interests of individual human beings should never be sacrificed to some concept of abstract scientific inquiry.''

During the federal investigation, Harvard suspended the studies and reprimanded the lead researcher on most of the projects, Dr. Xiping Xu, an associate professor of occupational epidemiology. In previous statements, university officials said they agreed with the thrust of the federal government's investigation, but stressed that no harm had been done to the people.

The Harvard studies have been the subject of numerous articles in China's state-run news media, which have generally portrayed the research as exploitative.

Summers wrapped up a five-day trip to China yesterday. On Sunday, he inaugurated a program to bring about 50 Chinese bureaucrats to Cambridge each year to study at the Kennedy School of Government. On Monday, the Harvard leader and former treasury secretary met briefly with China's president, Jiang Zemin.

In his first year as Harvard's president, Summers has declared it a priority to give the university a more global orientation. He has described the domestic focus of much of the faculty and students as ''a serious problem.'' He has endorsed efforts to make it easier for Harvard students to study abroad, and called on the university to admit more foreigners.

At a forum Sunday in Beijing, Summers was asked whether increases in enrollment from overseas would displace minority students or others, such as Massachusetts residents, who currently get a boost in the admissions process. He declined to answer, saying, ''I think we will be most likely to progress if we retain a sense of creative ambiguity.''

This story ran on page A12 of the Boston Globe on 5/15/2002.
© <http://www.boston.com/globe/search/copyright.html>Copyright 2002 Globe Newspaper Company.


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