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SCHENECTADY — Volunteers
in a clinical trial in Poland
believed doctors there were testing a new flu vaccine. Some were homeless
and took numerous shots to earn the $4 stipend. The vaccine, however, was
for bird flu and some of the volunteers may have died, according to
newspaper reports in July.
The truth of the scandal is still unknown, but it raises questions of
whether the volunteers were lied to and whether they knew the full risk of
the experiment. Few people can answer those questions in developing
countries like Poland, Estonia, Georgia,
Romania and Belarus.
"There is a concern that the ethical standards that are followed in
the West may not be followed in the underdeveloped countries," said
Martin Strosberg, a bioethics professor at Union Graduate
College.
That's where Union comes in. The
school's bioethics program was the first in the nation to receive a grant
from the National Institutes of Health to educate people from developing
countries about Western standards of medical research. The idea is the
students can become bioethics leaders in their own countries.
Since receiving a $1 million grant in 2004, Union
has trained 26 people and the NIH has funded similar programs at Johns
Hopkins, Case Western Reserve and Vanderbilt universities. The Union
program focuses on Central and Eastern Europe.
NIH's Fogarty International Center
recently awarded Union an additional $1
million to continue the program for four more years.
Roughly 40 percent of all clinical trials of American and European Union
pharmaceutical companies are conducted in developing countries, Strosberg
said. It is cheaper to recruit patients and to pay doctors, and the
governments do not enforce the same level of protections for human testing,
he said.
"There are ethical questions, questions about conflict of interest,
questions about whether the subjects are being adequately informed,"
Strosberg said. "There needs to be people who are skilled in reviewing
scientific protocols."
Joanna Rozynska, 30, an instructor at a university
of Warsaw, Poland,
went through the Union program, which is a combination of online and
on-site education. Students and faculty meet face-to-face twice during the
16 month program when they gather at Lithuania's
Vilnius University.
"It was an absolutely amazing experience," Rozynska said.
Rozynska, 30, has advanced degrees in law, philosophy and sociology. She
teaches ethics and medical law to students the University of Physical
Education.
Poland
has about 60 Research Ethics Committees that are affiliated with the
nation's medical society or attached to a hospital or medical school. The
committees are supposed to review medical research, but they are secretive
and have no established protocols to guide them, Rozynska said in a
telephone interview from her home.
"There is a lack of knowledge and sensitivity in some cases,"
she said. Some physicians "prefer to do something faster and cheaper
than follow the rules."
Rozynska and fellow student wrote a manual on informed consent and
distributed it to the committees.
"It's the very first literature about informed consent in the
Polish language," she said.
The Union students are young and up-and-coming scientists, academics,
social scientists and philosophers, Strosberg said. Graduates have written
legislation to guide pediatric research in Russia,
created a National Center for Bioethics in Poland, published book chapters in Lithuania, and attained bioethics positions
in government in Moldova.
Others have created bioethics courses in their own schools.
"We are training them to be change agents," Strosberg said,
"changing the culture of the scientists themselves."
Cathleen F. Crowley can be reached at 454-5348 and
ccrowley@timesunion.com.
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