The responsibility of scientists to make research data accessible to
peers or the public continues as a topic of concern in Washington, most
recently in a March 12 forum at the National Academy of Sciences (NAS).
The discussion focused on Senator Richard Shelby's (R-Ala.) 1998 legislative
provision requiring that data generated under federal research grants to
universities and other non-profit organizations be made available to the
public under the Freedom of Information Act. Representatives of industry
who back the Shelby law and new legislation on "data quality"
were featured speakers at the NAS meeting.
In the meeting's first panel, moderated by David Korn, M.D., AAMC Vice
President for Biomedical and Health Sciences Research, Dr. Steven Goodman
of Johns Hopkins University provided an overview of the types and variety
of data employed in the scientific process. Dr. Goodman objected to the
notion, perhaps underlying the layman's view, that all data fall into three
categories: true, false, and unproven. Rather, the truth validity of data
may lie at varying levels of certainty between false and true. Dr. Goodman
recounted the ways the scientific community improves the reliability of
its findings, by re-examination, replication, and further research.
Dr. Douglas Dockery of Harvard University then reviewed the "Six
Cities Study," an epidemiologic study of particulate air pollutants.
Industry, objecting to Environmental Protection Agency regulations based
in part on the study, tried to obtain the Six Cities data for separate
examination but was declined because of confidentiality agreements accorded
to participants in the study. The case purportedly motivated Sen. Shelby
to pass the law requiring access to such data through FOIA.
Although the Six Cities findings have been extensively re-examined (and
supported) by the independent Health Effects Institute, William Kovacs
of the U.S. Chamber of Commerce insisted that the Chamber and other groups
should have the right to examine the data for themselves. "This is
[a matter of] civics," he stated. But David G. Hawkins of the National
Resources Defense Council argued that industry's intent is to obstruct
and undermine the authority of federal agencies to effect environmental
or other regulations, comparing industry's questioning of research data
as an "O.J. Simpson defense" of its practices.
Wendy Baldwin, M.D., NIH Deputy Director for Extramural Research, said
that NIH promotes and continues to seek better ways to ensure access to
research data. The Shelby statute, by its reliance on FOIA, she noted,
is not an effective mechanism for data access. FOIA does not provide for
structure or documentation of the records released. It is difficult for
agencies to know how thoroughly to redact data to protect the privacy of
individuals, nor do the provisions of FOIA protect the confidentiality
of individual clinics, schools, or other organizations. And, as others
noted, data access under Shelby/FOIA is strictly one-sided, requiring release
of university data to anyone for any intent, but does not correspondingly
require sharing of data from private firms or individuals with the scientific
community. Moreover, because the Shelby statute amends Office of Management
and Budget (OMB) Circular A-21, which governs the management of federal
grants and cooperative agreements to academic and non-profit institutions
only, the law does not apply to for-profit institutions, even when they
receive federal funds.
Although the Office of Management and Budget (OMB) and federal agencies
recognized university concerns in implementing the statute , which became
effective last year, the U.S. Chamber of Commerce made
clear that it intends to sue the federal government to overturn the OMB's
restrictive interpretation of the statute. No suit has been filed at this
time. William Kovacs believes that industry may concede to confining the
reach of the statute to data used to support federal policies and regulations
(the Shelby statute does not explicitly make such distinction).
Jim Tozzi representing the Center
for Regulatory Effectiveness (CRE), supporting the Shelby provision,
also supports the "daughter of Shelby," a provision in last year's
appropriations bill that requires OMB to implement procedures for ensuring
"data quality" [see Washington
Highlights, Jan. 19]. OMB must implement the data quality regulation
by Sept. 30, 2001.
The forum, "Seeking Access to Research Data in the 21st Century:
An Ongoing Dialogue Among Interested Parties" was moderated by Donald
Kennedy M.D., editor of Science and co-chair of the Science, Technology,
and Law Program of the National Academies.
Information: Steve Heinig, AAMC
Division of Biomedical and Health Sciences Research, 202-828-0488.
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