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Protection and March 31, 2002 Harvard research jeopardized the welfare of disadvantaged Chinese people while violating federal regulations. FYI Sadly, Harvard joins the list of prestigious academic research institutions that have jeopardized the rights, dignity, and welfare of human subjects in order to expedite highly lucrative biomedical research studies. The federal Office of Human Research Protections (OHRP), has issued three separate letters to Harvard University affiliated research centers -- School of Public Health (HSPH), Brigham and Women's Hospital (B&WH), and Mass. Mental Health Center (MMHC) as a result of "an ongoing investigation." The investigation follows a complaint filed in 1999 by Dr. Gwendolyn Zahner, an epidemiologist who had conducted on-site inspections of Harvard's research in China. Dr. Zahner raised serious concerns about the conduct and ethics of American sponsored genetic experiments which were performed on vulnerable Chinese people who were subject to coercion. Dr. Zahner raised concerns that the research jeopardized the welfare of disadvantaged Chinese people while violating federal regulations. First, is the issue of unsterilized needles that may have been used to draw blood, which may have led to spreading infectious diseases. Second, is the issue of confidentiality in genetic research--some involving reproduction, others involving diseases believed to have genetic predispositions. Dr. Zahner raised concerns about the handling of DNA samples with identifiable markers--inasmuch as the repressive regime in China discriminates against people with inherited medical problems. Similarly, concerns were raised about identifying information about those who--contrary to government edict, have more than one child. The issue of confidentiality has serious consequences in China and should not be taken lightly. OHRP's letters indicate that multiple violations were found: 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. Signatures on informed consent documents raised concerns that they were post dated: "OHRP is concerned that it appears that subjects did not date the informed consent documents...." The number of subjects recruited seemed to bear no relationship to the number approved by the IRB: For example, in one study, "Molecular Genetic Epidemiologic Study on Asthma", the B&WH IRB approved the enrollment of 2,000 subjects. However, the investigator enrolled 16,686. Changes were made in the informed consent documents without IRB approval: For example, the amount of blood drawn was changed from two teaspoons to six. In some cases, Harvard officials reported to OHRP that a given study had not been conducted, but OHRP cited recent publications in which the investigators described the findings of such a study. In another case, the HSPH IRB did not review an asthma study until three years after it had been submitted. 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 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. The following newspapers reported the news about the OHRP March 28 letters: Boston Globe: http://www.boston.com/dailyglobe2/089/nation/Harvard_studies_faulted+.shtml “Enrollment in the studies overseen by the Mental Health Center were halted because of the investigation, according to the federal letter. The studies overseen by Brigham and Women's were completed in 1999.” Dr. Zahner told The Globe: ''With no independent monitoring of what is happening on the ground in China, it's reckless endangerment.'' The Los Angeles Times: http://www.latimes.com/news/nationworld/nation/la-000022902mar30.story “In letters Friday to two Harvard units, the federal Office for Human Research Protections underscored the ethical pitfalls of working with impoverished people in developing countries. Particularly in authoritarian countries, these people might be easily coerced into volunteering for research and yet unable to afford the new treatments that result, the office said. The letters said that Harvard research supervisors failed in a variety of ways to make sure that the rights of research participants were protected.” The Washington Post: http://www.washingtonpost.com/ac2/wp-dyn/A38420-2002Mar29?language=printer “The forms in some Harvard-sponsored studies included complex language difficult for rural Chinese families to understand, the letter said. Other forms reportedly did not list the risks and discomfort associated with x-rays and lung function tests. "Continuing review of research by [the Harvard ethics committee] regularly failed to be substantive and meaningful," the investigation concluded.” |