Harvard-affiliated gene studies in China face federal inquiry – Boston Globe.

August 1, 2000.

Harvard-affiliated gene studies in China face federal inquiry,
by Deborah Nelson.

Genetic research in China is booming. The biotech industry, in collaboration with scientists from America’s elite research centers & the U.S. government, is looking at China, with its1.2 billion human beings as a ready pool for conducting genetic research–without human rights strings attached.

The research is being conducted on illiterate Chinese people who do not have the luxury of free choice– just as they had no choice when their government enforced a decree allowing only one offspring per couple. The Chinese government, whose “eugenics policies could put individuals with genetically linked diseases at risk of sterilization” has giving American industry & its academic scientists the green light.

The Boston Globe & The Boston Herald report that a former Harvard Assistant Professor filed a 15 page complaint about three Harvard affiliated research institutions, accusing them of exploiting the social and political situation in China to conduct genetic research on Chinese people that fails to comply with US rules of human subject protections.

The Harvard researchers worked with Chinese collaborators, who carried out much of the work. Two studies were funded by Millennium Pharmaceuticals of Cambridge, and the remainder by the National Institutes of Health.

George Annas is right when said, ”It’s hard to believe there’s a firewall between public universities and the government.”

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<a href="http://www.boston.com/dailyglobe2/214/nation/Harvard_affiliated_gene_studies_in_China_face_federal_inquiry+.shtml"> http://www.boston.com/dailyglobe2/214/nation/Harvard_affiliated_gene_studies_in_China_face_federal_inquiry+.shtml </a>

The Boston Globe
August 1, 2000

Harvard-affiliated gene studies in China face federal inquiry
By Alice Dembner, Globe Staff, 8/1/2000 front page

For researchers hunting the genetic causes of disease, the 1.2 billion residents of China offer choice targets. Not only are they numerous, but many have lived in isolated villages for generations, making genetic defects easier to spot.

However, human research in China is also a minefield. It is extremely difficult to get true consent from some rural villagers, who bow to authority and cannot read. And the communist government's eugenics policies could put individuals with genetically linked diseases at risk of sterilization.

Now, three Harvard-affiliated institutions are caught in this bind. The federal government is investigating research initiatives at the Harvard School of Public Health, Brigham and Women's Hospital, and Massachusetts Mental Health Research Corp. following a complaint from a former colleague about their research practices and whether they put citizens at risk of genetic discrimination.

The Harvard-affiliated institutions – which are researching potential genetic links to conditions ranging from obesity to schizophrenia – say they have adhered to the same rules they use in the United States to protect study participants. But ethicists caution that human research in China requires special vigilance. ''We're all tied up in knots about the ethics of conducting cross-national research, particularly between rich and poor countries and those with poor human rights records,'' said Ruth Faden, executive director of the bioethics institute at Johns Hopkins University. ''Our current set of regulations governing research on human subjects is inadequate.''

A national commission is developing comprehensive rules for international human genetics research. The effort grows out of fears about exploitation arising as scientists scour nations from Iceland to India to collect genetic samples and medical records. Doctors and ethicists have raised questions about forced participation, privacy violations, and profiteering.

Despite the concerns, genetic research in China is booming. China has been developing its own industry, with numerous labs, gene sequencing centers, and a gene bank of about 50 ethnic groups. It has built sometimes-strained collaborations with foreign scientists and biotech companies.

In 1998, Chinese officials temporarily shut down a collaborative project on longevity with Duke University and a German research center after a Chinese worker questioned the consent process and others accused researchers of robbing the country's genetic legacy. The sampling of 4,100 elderly Chinese, partly supported by the US National Institute on Aging, was resumed when researchers and the government stipulated that no samples would leave the country and evidence was offered that the samples were given voluntarily.

No Chinese have joined in the recent complaint against Harvard, but there was an outcry in 1996 following a bad translation of an article about a new collaboration between six Chinese medical centers and the Harvard Program for Population Genetics in an area where about 200 million Chinese live.

Several members of the Chinese Academy of Sciences decried the foreigners' efforts, saying they were exploiting China's genetic resources, and one Harvard scientist was temporarily blocked from exporting genetic samples. China subsequently imposed rules requiring all foreigners to get approval before exporting genetic material and to share scientific or financial proceeds with the Chinese.

Two Chinese scientists at the academy, who declined to be identified, said last week that they remained concerned about foreign violation of their intellectual property rights. They said they were unaware of any problems with the current Harvard studies or any complaints about forced participation.

But Gwendolyn Zahner, a psychiatric epidemiologist, formerly an assistant professor at Harvard's school of public health, said that Harvard researchers did not comply with US rules and that they took advantage of the social and political situation in China.

''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,'' wrote Zahner, who filed a complaint against Harvard with the federal Office for Protection from Research Risks, which was recently reconfigured into the Office for Human Research Protection.

The 15-page complaint, obtained by the Globe, concerns nearly a dozen studies recently concluded or still underway in China that are overseen by Dr. Ming T. Tsuang of the Massachusetts Mental Health Research Corp. and Harvard Medical School or Dr. Xiping Xu of Brigham and Women's Hospital and the Program for Population Genetics at the Harvard School of Public Health. One study with no genetic component included in the complaint was conducted by Dr. David Christiani of the public health school.

The studies, which involved thousands of Chinese participants, were seeking genetic and other causes for ailments including asthma, obesity, miscarriage, and schizophrenia, and in all but four cases included collection of blood samples for DNA analysis. None of the studies involved potential treatment. In each case, the Harvard researchers worked with Chinese collaborators, who carried out much of the work. Two studies were funded by Millennium Pharmaceuticals of Cambridge, and the remainder by the National Institutes of Health.

Zahner questions whether participants, some of whom were illiterate, willingly and knowingly consented or whether they were coerced by the involvement of local health officials or small payments offered as reimbursement for missed work. She asks whether DNA samples might have slipped into the hands of local officials, which could put participants at risk of discrimination or forced sterilization. She asks whether participants might have been harmed by the use of unsterilized needles to draw blood and whether the review boards at the Massachusetts institutions provided proper oversight.

As evidence to support the allegations, she cites published studies, knowledge gained while helping review studies at Harvard, and trips to China after she left Harvard in 1998 when her contract was not renewed.

The researchers and institutes rebutted the complaint item by item and vociferously defended their research practices.

''Any time that any research is done anywhere in the world sanctioned by the Harvard School of Public Health, it must meet the standards that apply to research in the United States,'' said James Ware, dean for academic affairs, in comments echoed by representatives of the other institutions. ''No research was done without obtaining informed consent, and no people were put in harm's way.''

However, the government is still reviewing the institutions' responses, months after they were submitted. And ethicists say the conditions in China may result in even the most protective measures being applied unevenly.

Brigham officials acknowledge that the hospital's oversight committee could have benefited from more knowledge of China and delegated too much authority early on to a parallel committee in China, which allowed work to begin before US approval. Faden, while not familiar with the Harvard case, said that in the United States ''most local institutional review boards are not well equipped'' to oversee international research.

Although there is growing knowledge and acceptance of Western notions of consent among prominent researchers in China, the concept is still foreign to average citizens in a nation where collective decision-making is the norm and coercive policies are common. ''It's a particular problem when you're dealing with illiterate populations and particularly complicated science, like genetics,'' said Sophia Gruskin, an assistant professor of health and human rights at Harvard.

Potential discrimination based on genetic testing is Zahner's and ethicists' greatest concern. Some provinces in China have policies requiring sterilization of individuals with certain genetic conditions, and a national law widely seen in the West as a eugenics policy is on the books, although reportedly it is not being enforced.

The Harvard researchers say they have been careful to use numerical codes, rather than names, to link genetic information with medical records and to limit access to the key codes. They say no one in the Chinese government has asked for access to those codes, although local public health officials and public universities are involved in some of the research.

Boston University medical ethicist George Annas said there is always a potential risk unless the code linking names to samples has been destroyed. ''It's hard to believe there's a firewall between public universities and the government,'' he said. ''If there's a code that someone can break, it's a problem. China does not have the best human rights record.''

However, in May, President Jiang Zemin of China told Science magazine that ''the prevention of gene-based discrimination'' and ''the protection of privacy'' were ''issues of concern.'' He also said collaborations with Harvard were proceeding smoothly.

This story ran on page A01 of the Boston Globe on 8/1/2000.
© Copyright 2000 Globe Newspaper Company

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http://www.bostonherald.com/news/local_regional/china08012000.htm

BostonHerald.com

Federal agency looking at research practices in China projects
Associated Press
Tuesday, August 1, 2000

The federal government is investigating medical research projects conducted by three Harvard-affiliated institutions in China following a complaint that researchers failed to protect study participants. The studies, which involved thousands of Chinese participants, seek genetic and other causes for conditions including asthma, obesity, miscarriage and schizophrenia.

The Harvard School of Public Health, Brigham and Women’s Hospital in Boston and Massachusetts Mental Health Research Corp. were named in the complaint.

Psychiatric epidemiologist Gwendolyn Zahner, formerly an assistant professor at Harvard’s school of public health, filed the complaint with the federal Office for Protection from Research Risks, which was recently revamped and renamed the Office for Human Research Protection.

“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.

The 15-page complaint concerns nearly a dozen studies recently concluded or still under way in China, according to reports. Blood samples for DNA analysis were collected in all but four of the studies. The government is looking into five of the studies, said Robin Herman, a spokeswoman for the Harvard school.

In each case, the Harvard researchers worked with Chinese collaborators, who carried out much of the work. Two studies were funded by Millennium Pharmaceuticals of Cambridge, and the remainder by the National Institutes of Health.

Zahner’s complaint says some of the participants were illiterate, and she questions whether they voluntarily consented, were coerced by Chinese health officials or paid to participate. The complaint also asks if DNA samples were obtained by local officials, which could put the participants at risk of discrimination or forced sterilization.

The researchers and institutions defended their research practices, saying participants were identified in the research by code numbers, not names. “No research was done without obtaining informed consent, and no people were put in harm’s way,” said James Ware, dean for academic affairs.

Participants were not paid, but they were reimbursed for lost wages, Herman said. “These are all observational studies, this is not any kind of treatment,” she added. “We’re looking at large populations. We can say nothing about the individual about what we’re learning.”

The government is still reviewing the institutions’ responses, months after they were submitted. “We’re all tied up in knots about the ethics of conducting cross-national research, particularly between rich and poor countries and those with poor human rights records,” said Ruth Faden, executive director of the bioethics institute at Johns Hopkins University. “Our current set of regulations governing research on human subjects is inadequate.”