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.''