WASHINGTON - With rising alarm, universities and hospitals are moving
to repeal a new and little-noticed federal law that requires them to
release details of their research to the public, possibly including
confidential interviews and trade secrets, if the work is backed by
federal funds.
The law was included with little debate in a 4,000-page appropriations
bill that Congress approved as one of its final actions last year. It
says that ''all data'' produced by researchers receiving federal
grants can be obtained through the Freedom of Information Act, a
federal law that gives citizens access to government documents.
Supporters of the law, who include Senate Majority Leader Trent Lott,
say its intent is to provide the public access to all research used by
federal agencies in setting policies and regulations. The measure
arose from a complaint by industry groups that the Harvard School of
Public Health refused to release data that federal regulators relied
on when they proposed tougher air-quality standards two years ago.
But as news of the law trickles through the research community,
universities and hospitals are reacting with apprehension. They say
the law could result in much broader releases of information, putting
notes, confidential material, and incomplete or misleading data in the
hands of those who want to use it for profit or who oppose the
research for political reasons.
''I see nothing positive in this,'' said Dr. Eugene Braunwald, who
oversees 2,000 researchers at Partners Health Care, the parent of
Massachusetts General Hospital and Brigham & Women's Hospital in
Boston. ''It's mischievous. It was not discussed. It was buried in a
huge bill without a full airing. This is nothing you just slip in to
suddenly change the life of lots and lots of scientists.''
''We have grave concerns,'' said Kevin Casey, spokesman for Harvard
University. ''This is a large problem, and the more we look into it,
the more sirens go off.''
A wide range of other research organizations expressed concern about
how the law will be applied. They include the National Academy of
Sciences, the Massachusetts Institute of Technology, Boston University
Medical Center, and the American Association of University Professors.
''There is no way to implement this law that is tolerable,'' said Dr.
David Korn of the Association of American Medical Colleges.
Representative George Brown Jr., Democrat of California, has filed a
bill to repeal the law, and 21 lawmakers echoed the research
community's concerns in a letter to the federal agency charged with
implementing the new measure.
The Freedom of Information Act is a 32-year-old law that compels
government agencies to release a wide variety of documents on request.
The law, however, allows the government to withhold information for a
variety of reasons, such as national security and ''unwarranted''
invasion of privacy.
Those exemptions will prevent the government from releasing sensitive
information gathered by researchers, such as confidential medical
records or proprietary material, said Andrea Andrews, spokeswoman for
Senator Richard Shelby, the Alabama Republican who wrote the law.
Andrews said the law arose from a dispute over Harvard's Six Cities
study, which tracked the health of about 8,000 people for close to 20
years and found a link between air pollution and health. When the EPA
cited the study in proposing tougher air standards, lawmakers and
industry groups demanded that Harvard release more details of its
work. The researchers refused, saying that the habits, death records,
and medical histories of their subjects were obtained under
confidentiality agreements.
The researchers allowed independent scientists to review the data, but
Shelby believes better access is needed.
''If the public pays for a study, then we should be able to examine
that study,'' Andrews said. ''And agencies such as the EPA should not
be allowed to propose regulations without releasing the study on which
they are basing the regulations.''
But researchers say that the language in Shelby's measure is so broad
that confidential information might not be protected.
Moreover, depending on how it is interpreted, the law could give
anyone access to research data before it is published, violating a
long-held tradition that those who gather the data get to interpret it
first. Researchers also worry that the law might force them to
disclose new research that could be patented and turned into
profitable products.
''We do a lot of industrially supported research,'' said David
Litster, vice president for research at MIT. ''Sometimes a company
will provide us with confidential information - the source code for
software or something else - that they do not want public. This law
just seems to cast a very broad net, and nobody knows quite what could
be scooped up.''
Researchers say that the scientific process, by its very nature,
already requires that all pertinent data be made public. Scientific
results are not valid unless they can be reproduced, and prominent
journals will not publish papers unless they contain enough data to
satisfy independent reviewers. ''If scientists don't put their work in
the pubic eye, it's not worth anything to their careers,'' said Ruth
Flower of the American Association of University Professors.
Some academic groups also say they fear the law will be used by
industry groups to harass researchers whose work might lead to tougher
regulations.
They cite the case of Dr. Paul M. Fischer of the Medical College of
Georgia. In 1991, Fischer and others released a study showing that Joe
Camel, the cigarette cartoon symbol, was as well known to 6-year-olds
as Mickey Mouse.
Tobacco giant R.J. Reynolds sought the details of Fischer's work,
including the names and telephone numbers of all children who
participated in the study and the addresses, phone numbers, and
background information of the people who interviewed them. The company
argued that Fischer, as a public employee, had to release this and
other information under Georgia's open records law. The tobacco
company won, though the state law was quickly amended so the
children's names remained confidential.
''What happened to me was very clearly not an attempt to understand
the science. This was an attempt to shut down my research operation,''
said Fischer, who has since left the medical school. The new federal
law, he said, ''will be used by companies to harass researchers. This
is going to be a mess.''
Scott Williams, a spokesman for the five largest US tobacco companies,
said it was ''blatantly unfair'' to say the industry would use the new
law to harass researchers.
Williams said that if researchers ''try to drive public policy, then
they should be prepared to have their data face rigorous public
review.''
This story ran on page A01 of the Boston Globe on 02/11/99.
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