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For the last several months, the federal government has been investigating complaints regarding medical research conducted on thousands of people in China by Harvard's School of Public Health (SPH).
In September 1999, Gwendolyn Zahner, a psychiatric epidemiologist and former assistant professor at SPH, filed a complaint with the Office for Protection from Research Risks in Washington, D.C. questioning medical research conducted by the University.
In the 15-page complaint recently obtained by The Boston Globe, Zahner--who according to SPH officials was denied tenure in 1998--questioned whether illiterate study participants actually consented to genetic research and whether their identities were kept confidential from Chinese government officials.
Brigham and Women's Hospital in Boston and Massachusetts Mental Health Research Corp.--both Harvard-affiliated institutions--were also named in the complaint, which focused on nearly a dozen studies into the causes of conditions ranging from schizophrenia to obesity. Most of the studies are funded by the National Institutes of Health, placing them under the jurisdiction of the federal government.
SPH officials denied the claims, saying that Harvard follows the same research practices overseas that it does in the United States.
"There is nothing being done [in China] to create any anxiety," said SPH spokesperson Robin Herman. "We care deeply about the safety, privacy and confidentiality of our participants, and we always have."
Herman said that most of the studies conducted by SPH in China are observational, only requiring participants to fill out questionnaires, take blood pressure tests or give blood samples for DNA analysis.
She said concerns about consent from illiterate participants are unfounded.
"All consent forms are read to participants, regardless of their education," said Herman, who added that all participants are identified by numerical code instead of by name.
But Zahner's complaint argued that Harvard was taking advantage of Chinese participants.
"Cheaper, larger and faster genetics studies are possible in China only because the country has not yet established the legal, environmental, workplace and medical protections afforded to American citizens," Zahner wrote.
Herman countered this critique by saying that research in other countries--not just China--is needed to make any breakthroughs in the medical field.
"The only way to understand these conditions is by studying large populations and finding patterns," Herman said. "We're looking for the best way to prevent diseases."
Zahner, who has since left SPH, could not be reached for comment.
SPH Professor David C. Christiani, who has conducted studies in China for over 20 years, said that any complaints against his work have "no foundation at all."
Christiani said that conducting research in foreign countries can be difficult, but that SPH takes proper steps to monitor studies.
"It presents some challenges, but not anything that's too difficult to overcome," he said.
Christiani said he and several other faculty members visited China in March 1999--months before Zahner's complaint was filed--for a site evaluation of the research to make sure procedures were being followed correctly.
Herman said Dr. Xiping Xu of Brigham and Women's Hospital and the Program for Population Genetics at SPH spends "a good deal of time" in China overseeing the studies.
And according to Herman, all research conducted by SPH has to receive approval from the school's Human Subjects Committee to make sure federal regulations are followed.
"The general questions raised by the complaint about protection and confidentiality of participants are questions we raise ourselves and monitor closely," Herman said.
Officials from the government's newly renamed Office for Human Research Protections (OHRP) would not comment on Harvard's case specifically but said that routine procedures are followed in making a final report on all complaints filed with the agency.
"We can ask for further explanation, make a finding or do a site visit," said Paul W. Goebel from OHRP.
Dr. Melody Lin, the acting director of the OHRP, said that most complaints are handled without doing visits to the locations of research.
Herman said that Harvard was contacted by OHRP in the fall and answered questions related to Zahner's complaints in December.
"We haven't heard anything since," Herman said.
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