BOSTON--Government investigators last week took Harvard University and two other U.S. institutions to task for their handling of research studies involving rural Chinese subjects. University officials insist they have already tightened their procedures, but the U.S. Department of Health and Human Services has asked for more information on whether researchers failed to obtain informed consent in advance, backdated documents, and misled investigators about the number of people involved in the studies.
The department's Office for Human Research Protections (OHRP) began its inquiry in 1999 after a Harvard School of Public Health researcher filed a complaint alleging that two occupational epidemiologists at the school, Xiping Xu and David Christiani, had taken advantage of Chinese subjects in rural Anhui Province, where they conducted a variety of genetic and environmental studies. The department's first public comment about its continuing probe appeared in the form of letters to Harvard, Brigham and Women's Hospital, and Massachusetts Mental Health Center, dated 28 March, that outline the government's concerns and ask for more information.
The letter to Harvard does not draw any conclusions but questions whether some subjects were enrolled in investigations before they signed informed consent documents. It also notes that "the handwriting for the dates next to the subject's signatures appear to be identical," indicating that either the subjects--even those who could write--did not do the dating or that the documents may have been backdated. The letter also cites a large discrepancy between a report to OHRP and a journal article on the number of women enrolled in one particular study. Harvard has until 10 May to respond.
A Harvard statement points to the "complex and difficult ... ethical and cross-cultural issues" in international research, adding that the university has beefed up its monitoring staff. It has also formally reprimanded Xu and Christiani and placed their work under greater scrutiny. Harvard officials insist that OHRP has accepted its action plan and that the matter is largely laid to rest. But OHRP officials say the case remains open. Former Harvard researcher Gwendolyn Zahner, who brought the original complaint, says she is happy that OHRP has taken her concerns seriously but chides the office for not looking "beyond [the] paper work." Investigators need to visit China, she says, to find out what really happened.