-Caveat Lector-

http://www.boston.com/dailyglobe2/042/nation/Disclosure_law_worries_researc

hers+
>.shtml
>
>                                    Disclosure law worries researchers
>
>                                    By Aaron Zitner, Globe Staff,
02/11/99
>
>  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.
>                                    © Copyright 1999 Globe Newspaper
Company.
>

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