 |
AAAS Policy Brief: Access to Data
Issue Summary | Resources
Contents
Introduction
In the late 1990's, proponents of government transparency made several
attempts to increase public access to federally-funded scientific data.
The impetus for this movement arose largely from the private sector's
frustration over the inaccessibility of data used to support regulations,
best exemplified by the controversy surrounding the 1997 Environmental
Protection Agency (EPA) air pollution standards.1
Sympathetic policy makers claimed that, considering the financial burden
they were often asked to impose on businesses, they deserved a chance
to inspect the data underlying controversial regulations. Scientists and
academic institutions warned that while increasing openness was a valid
aim, the privacy of research subjects and the preservation of scientific
autonomy should be paramount.
The Shelby Amendment
Inserted in the Treasury, General Government, and Civil section of Fiscal
Year (FY) 1999's Omnibus Appropriations Bill (Public Law 105-277) was
a provision to change a federal regulation in order to allow broader access
to federally-funded research data. The provision, called the Shelby Amendment
after its sponsor, tasks the Office of Management and Budget (OMB) to
change OMB Circular A-110 so that all federally-funded research data can
be accessed through the mechanisms set forth in the Freedom of Information
Act (FOIA).
The provision reads:
"Provided further, That the Director of OMB amends Section
__.36 of OMB Circular A-110 to require Federal awarding agencies to
ensure that all data produced under an award will be made available
to the public through the procedures established under the Freedom of
Information Act."
The bill was passed by Congress and signed by the President, but many groups
complained about the lack of debate on the measure and the secrecy under
which it was proposed.2 The office of Senator
Richard Shelby (R-AL), however, pointed to the related colloquies that had
been held on the Senate floor, and noted that similar legislation had been
proposed several times before.3 Still, many
opponents of the Amendment bemoaned the lack of substantive debate on such
an important topic, and launched a fight to overturn the provision, among
them Rep. George Brown, Jr. (D-CA) who unsuccessfully tried to repeal the
provision.4
Proposed Revision of A-110
OMB subsequently filed a proposed
revision in the Federal Register on February 4, 1999 and allowed for a 60-day public comment
period before taking further action. OMB's proposed revision focused exclusively
on published research used to support federal regulations. It read:
"Pursuant to the direction of Pub. L. 105-277,
OMB hereby proposes to amend Section __.36 of OMB Circular A-110 to read
as follows: (c) The Federal Government has the right to (1) obtain, reproduce,
publish, or otherwise use the data first produced under an award, and
(2) authorize others to receive, reproduce, publish, or otherwise use
such data for Federal purposes. In addition, in response to a Freedom
of Information Act (FOIA) request for data relating to published research
findings produced under an award that were used by the Federal Government
in developing policy or rules, the Federal awarding agency shall, within
a reasonable time, obtain the requested data so that they can be made
available to the public through the procedures established under the FOIA.
If the Federal awarding agency obtains the data solely in response to
a FOIA request, the agency may charge the requester a reasonable fee equaling
the full incremental cost of obtaining the data."
Public Response to the
Proposed Revision
OMB received over 9,000 comments on its proposed revision, with 55 percent
of the respondents favoring the changes.5
Some heralded the move as a boon to the economy, claiming that it would
help to "avoid situations in which data that cannot withstand vigorous
scrutiny is used to support new regulation."6
According to the U.S. Chamber of Commerce, a pro-business group, the new
provision would provide "a basis for the bureaucracy imposing $700 billion
in annual regulatory costs..."7
Many supporters outside of industry praised the revision for allowing
taxpayers to view directly the research they themselves subsidize.8
Some comments even included stories of past frustrations over the inaccessibility
of data. The Salt Institute, for example, described a hard-fought battle
over the accuracy of a government-funded study on nutrition.9
Still, many of the supporters complained about the narrow scope of the
provision, favoring applicability to all government-funded research, not
just published regulatory data.10
Scientific and academic organizations took a strong stance against the
new rules. While for the most part, they appreciated the restriction of
the changes to published regulatory data,11
they raised a number of concerns both about the Shelby Amendment and the
vague language in the A-110 revision. They felt that by not effectively
defining the terms "data" and "published" OMB had opened the door to a
number of potential problems.
Several groups worried about the premature release of data and its potentially
harmful consequences. In controversial studies, data released too early
could allow interested parties to thwart potential regulation by harassing and
intimidating scientists.12
The revision left some respondents concerned about collaborative research
between federally-funded institutions and the private sector. They worried
about unintended consequences on the Bayh-Dole Act, which awards patent
rights to universities and businesses over federally-funded research.
Release of data might jeopardize intellectual property protection and
thus hamper public-private collaboration.13
Other criticisms of the revision focused on human research subject confidentiality.14
Some groups felt that "…compulsory premature disclosure of data could
discourage the participation, or alter the behavior, of study participants,
thereby jeopardizing important research…"15
Critics feared that if people suspected their personal medical information
could be accessed by the public, they might not participate in the first
place.
Another pragmatic complaint concerned the lack of specifics with regard
to reimbursement mechanisms. The American Lung Association expressed anxiety
that "much of the burden related to FOIA requests will be passed on to
grantees, who have no ability to recoup the costs."16
Finally, a theme that appeared in many comments was the assertion that
the FOIA procedure was an inappropriate mechanism to share research data.
According to Rep. George Brown, "OMB's revision would eliminate the distinction
between a grant and a contract. A grant is provided to support an activity
we deem to be in the public interest; a contract is used for procurement."17
Second Revision to A-110
OMB released its second
proposal on August 11, 1999 in the Federal Register. The proposal
addressed the concerns of vagueness raised in many of the comments and
attempted to improve the definitions of key terms.
"Research Data" was limited to recorded material and made to exclude preliminary
analyses, trade secrets, copyrighted or patented material, and drafts
of scientific papers. In addition, the FOIA exemption used to protect
personal medical files was added to the provision.
The term "Published" was redefined so as to include material published
in a peer-reviewed journal or cited by a Federal agency. The scope of
the revision was limited to citations that actually supported federal
regulations; guidelines and memos were excluded.
OMB also sought comments on a plan to restrict the proposal to regulations
costing over $100 million. Finally, the proposal called for estimates
on reimbursement costs and ideas for potential reimbursement mechanisms.
Final Revision to A-110
After receiving more than 3000 comments,
OMB posted the final
revision of Circular A-110 in the Federal Register on October 8, 1999.
OMB offered additional modifications to some key terms in order to address
issues such as intellectual property rights. A three year data retention
requirement for federally-funded scientists was set, but the concept of
a $100 million impact threshold was removed.
After reviewing several suggestions, OMB detailed a reimbursement plan
in which a Federal agency would serve as the middleman between the FOIA
requester and the data provider.
The revised A-110 Circular became effective November 6, 1999.
1 For a discussion of this topic, see the report prepared by Linda R. Cohen
and Robert W. Hahn of the AEI-Brookings Joint Center for Regulatory Studies entitled
"Should Researchers be Required to Share Data Used in Supporting Regulatory Decisions?"
2 Memo from University of Pennsylvania President Judith Rodin
3 From a statement given by Kathy Casey,
Legislative Director in the Office of Senator Richard Shelby. The statement was part of a briefing on the
OMB revision to Circular A-110 hosted by the American Association for the Advancement of Science (AAAS).
4 The text of the bill can be found here.
5 See the Summary Section here
6 Comments from the U.S. Chamber of Commerce
7 March 23, 1999 memo from the Grassroots Action Information Network of the U.S.
Chamber of Commerce titled "In the Regulatory Reform Arena, There May Never Be a More Important Issue!"
8 Memo from Gun Owners of America (GOA)
9 Comments from the Salt Institute
10 Comments from the National Rifle Association (NRA), April 2, 1999.
11 Comments from the American Association for the Advancement of Science (AAAS)
12 Comments from the Association of American Universities (AAU)
13 Comments from the Pharmaceutical Research and Manufacturers of America (PhRMA)
14 Comments from the Environmental Protection Agency (EPA)
15 Comments from the Association of American Universities (AAU)
16 Comments from the American Lung Association
17 Comments from Representative George Brown, Jr. (D-CA)
Updated February 10, 2005
|
|
