I found this interesting. Information access is restricted under privacy and private property laws on the corporate side, while public funded research is available to scrutiny and challenge. I have concerns over private 'ownership' of information arrising from human genome research. Who should own the patents to life on earth? While this article doesn't address this issue specifically one can see its connection.
from the NYTimes.." July 31, 1999
Law on Access to Research Data Pleases
Business, Alarms Science
By PHILIP J. HILTS
he proposition is simple enough: Public dollars pay for a lot of
scientific research, so data from that research should be available
to the public.
At the request of Senator Richard C. Shelby, Republican of Alabama, a
proposal saying just that passed quietly one evening last October, without
hearings or debate, as a one-sentence amendment to the
4,000-plus-page appropriations bill. Under the amendment, anyone can
write a request to the Government under the Freedom of Information Act
and get "all data produced" by a published study paid for with any public
dollars, and potentially receive everything from a summary of findings to a
scientist's notebooks or E-mail or, in some cases, information about
patients.
"Experience has shown that transparency in
government is a principle that has improved
decision-making and increased the public's
trust in government," Shelby stated in
explaining the law's premise.
For too long, he said, Americans "have
been unable to access federally funded
research data despite the significant impact of this data in the
policymaking process."
The law has the United States Chamber of Commerce delighted. "In the
regulatory reform arena there may never be a more important issue," its
Web site reads. It says that companies would be better able to scrutinize
the data that policy makers use when they issue regulations, and it adds,
"This would be the first time the business community has ever been
provided with the basis for the bureaucracy imposing $700 billion in
annual regulatory costs on us."
The conclusion: "If implemented properly, this rule will do more for
regulatory reform than all the legislation passed in the last 10 years!"
But scientists and university administrators, who took some time to notice
the law, are alarmed. They fear that corporate or political interests will
use the law to hamper research on controversial subjects, tie up scientists
in red tape, circumvent confidentiality agreements and thwart
Government regulations. While they agree with the general notion of
giving the public access to research data, they assert that data from any
study, no matter how rigorous, can be made to appear questionable if
examined by hostile experts and publicists.
"We have now concluded that the legislation constitutes a broad political
attack on both science and on the Federal regulatory apparatus," Nils
Hasselmo, president of the Association of American Universities, said in
a letter to Vice President Al Gore on Wednesday. He added that "we
are very concerned that such an effort could involve actions designed to
discredit scientists and discourage researchers from addressing
controversial topics."
At a hearing about the law before a House subcommittee on government
management and technology earlier this month, scientists recalled
previous clashes between science and industry and said they feared the
law would increase such cases.
In one example, Dr. Paul Fisher at the Medical College of Georgia
published a study in 1991 of what small children know about tobacco
brands. He found that Joe Camel was a figure known just as well as
Mickey Mouse by 6-year-olds, and that they knew the brands of
cigarettes in some detail.
The cigarette maker R.J. Reynolds decided it wanted to see Dr. Fisher's
data and do its own analysis. The company wanted not only all the raw
data, but the names and addresses of the children who were interviewed
so the company could go back to "re-interview" them. Dr. Fisher fought
the case in court, but ultimately the college's own president agreed that
the company should have access to the data. Dr. Fisher resigned from
the college, and Reynolds got most of the data it wanted, although it did
not contact the children. The litigation dragged on for years and made Dr.
Fisher decide not to do research on tobacco issues ever again.
Supporters of the law dismiss the possibility of harassment. But critics
point out that Senator Shelby started work on the amendment after
Harvard researchers, citing confidential patient information, declined to
give Congress their raw data in a two-decade-long pollution study. The
study, sponsored by the Environmental Protection Agency, was
instrumental in creating a 1997 Federal regulation that required stronger
controls on sources of small particle emissions, including cars and power
plants. Among the companies that opposed the regulation was Alabama
Power and Light.
Ultimately, Harvard compromised by giving the data to a bipartisan
group, funded by both the E.P.A. and the auto industry, which is auditing
the data and conclusions.
After that episode, Senator Shelby
recommended that businesses be able to get
the raw data themselves for analysis and
re-interpretation.
"I strongly believe that federally funded
research data that is used to drive public
policy should be available to the taxpayers
who paid for it," he said in a statement
today.
But Kevin Casey, who as senior director of Federal and state relations at
Harvard University was involved in the dispute over the pollution study,
called the Shelby amendment a backdoor attack on regulations like the
emissions rule.
"This is not about getting the public information," he said. "It is about
attacking regulations on pollution and other areas."
Through the new regulation, Casey asserts, the Republicans are able to
attack environmental laws under the guise of sunshine laws and not lose
public support, as they have for their more open challenges in recent
years.
"The Shelby amendment is a backdoor way to achieve the same goal,"
Casey said. "It allows company lawyers to harass scientists collecting
data on the most sensitive and controversial issues -- such as
environmental health and pollution -- to slow down the research used to
make policy."
The real impact of the amendment will not be known until it goes into
effect later this year; it is now being formulated into regulations by the
Office of Management and Budget. Among the questions facing the office
is how to define "data" -- does it mean blood samples and archeological
finds as well as written work? Under a draft of the regulations, those who
want data must ask for it under the Freedom of Information Act, by
submitting a request to the agency that gave the grant to the scientist. The
scientist then would turn over all data -- including names and addresses
of patients and other private and commercially secret information -- to
the agency. Then, the F.O.I.A. office of that funding agency would
determine what must be given to the requester and what must be
withheld.
The information act carries protections against giving out some kinds of
information, including commercial trade secrets or financial data, and
private information such as medical records.
Administrators at the National Institutes of Health, the agency that
finances the largest percentage of biomedical research, said they were
concerned about the cost of collecting and storing all the raw data. As it
is, in fiscal year 1998, N.I.H.'s F.O.I.A. office had 20 full-time
employees answering 1,200 requests at a cost of $500,000. And despite
the legal protections, administrators say they worry, too, about the
confidentiality of patient records.
"Even if they redact the name and address, there are other ways to
identify the patients -- if it was a female patient at a certain hospital with a
particular diagnosis, that might be enough to identify them," said Wendy
Baldwin, the institutes' deputy director for extramural affairs.
Members of Senator Shelby's staff said that while they understood the
worries of scientists, they believe that the F.O.I.A. rules will prevent
disclosure of private or trade secret information. And, if problems do
occur after the rule is in place, "we can address those. We will be alert to
those."
In most areas of science, the way to test the mettle of a study is not to
examine data, but to do another study, said Carol Scheman, vice
president for governmental affairs at the University of Pennsylvania, but
for some kinds of studies, she said, "Senator Shelby is right. There are
real issues of how to share data."
For example, in the pollution studies by Harvard's School of Public
health, thousands of subjects were followed for more than two decades.
That kind of work is unlikely to be copied. So some other method must
be used to review the data behind the scientists' final conclusions, she
said.
Industry is not uniformly in favor of the new rule. Pharmaceutical and
biotechnology companies, for example, fear that the rule will jeopardize
university-industry agreements. If a scientist's data can be fetched through
F.O.I.A., so can information they have shared with the scientist. This
means, potentially, that competitors could learn much about the progress
of their commercial work through the new rule.
The Washington watchdog group OMB Watch also points out that the
rule is aimed at nonprofit groups while leaving the corporations who
work with government funds untouched. The amendment applies to
hospitals and other nonprofit groups that get grants from the government,
but excludes other groups that get contracts from the Government. "Thus,
it applies to a Y.M.C.A. that receives a Federal grant, but not to Boeing
that is doing a range of research through contracts," Gary D. Bass, a
spokesman for the group, said in a July 15 statement.
But other business and advocacy groups are enthusiastic. Those on the
record in favor of the Shelby amendment include Gun Owners of
America, which has complained about research that shows guns in the
home are several times more likely to kill family members by accident
than intruders on purpose. In Washington, several dedicated
anti-regulatory groups have lined up in favor of the Shelby rule, including
the Competitive Enterprise Institute and Citizens for a Sound Economy.
In its Web site, the Chamber of Commerce, notes that huge masses of
data can be fetched from scientists -- data to challenge E.P.A.
regulations on clean air and water, data supporting the global warming
agreement called the Kyoto Protocol. "This list is virtually limitless and
can be extended into areas other than health and safety," it says.
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