Review cites risks to Chinese studied
By Alice Dembner, Globe Staff, 3/30/2002
Chinese citizens who participated in 15 Harvard-affiliated genetic studies on diseases ranging from asthma to schizophrenia may have been put at risk because they weren't properly informed of possible drawbacks to participating, according to documents released yesterday by federal investigators.
The federal Office for Human Research Protections sent letters detailing their complaints to the Harvard School of Public Health, Brigham and Women's Hospital, and Massachusetts Mental Health Research Corp. They found 38 specific problems, mostly related to weak oversight.
The violations included misleading consent forms and failure to determine whether the risks to Chinese participants outweighed the benefits. Participants risked not being treated for health problems that might be diagnosed in the studies, as well as job discrimination if medical problems were discovered by the subjects' employers.
In response to the investigation, which was launched in 1999 and is continuing, the Harvard School of Public Health has reprimanded two researchers, Dr. Xiping Xu and Dr. David Christiani; suspended its China studies; and changed its procedures for reviewing research. It has also commissioned a separate review of its other international genetic studies by PriceWaterhouseCoopers, said spokeswoman Robin Herman.
Officials at both Brigham and Women's and the Mental Health Center said they were working to address the federal concerns. 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.
The federal research office did not find any actual harm to research subjects and did not impose sanctions on the institutions. The letters demanded changes in how the institutions oversee research.
The government reviewed federally funded studies that sought genetic and environmental causes of ailments, including asthma, obesity, miscarriage, and schizophrenia, but offered no treatment. In addition to Xu and Christiani, the research was conducted by Dr. Ming Tsuang, a Harvard psychiatry professor.
Tsuang's office said he wasn't available for comment, and Christiani couldn't be reached. Xu, however, released a statement, saying, ''We have improved our protection of human subjects in China through the experience of the Office of Human Research Protection investigation.''
The former Harvard researcher who filed a complaint that launched the investigation said yesterday she didn't think federal investigators went far enough. Gwendolyn Zahner had questioned whether Chinese citizens might have been harmed by the use of unsterilized needles to draw blood and whether DNA samples might have slipped into the hands of local officials who could discriminate against those with medical problems.
''With no independent monitoring of what is happening on the ground in China, it's reckless endangerment,'' said Zahner, an epidemiologist who works at a research institute in North Carolina.
In a statement, Harvard spokeswoman Robin Herman said the school ''agreed with the thrust'' of the report and is ''vigorously committed to protection of the people who volunteer to participate in our studies.''
Alice Dembner can be reached at dembner@globe.com
This story ran on page A5 of the Boston Globe on 3/30/2002.