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PUBLIC ACCESS TO DATA FROM FEDERALLY FUNDED RESEARCH: OMB CIRCULAR A-110 AND ISSUES FOR CONGRESS
CRS Report for Congress
Public Access to Data From Federally Funded
Research: OMB Circular A-110 and Issues for
Eric A. Fischer and Genevieve J. Knezo
Resources, Science, and Industry Division
Congressional Research Service ˜ The Library of Congress
This analytical report examines issues associated with the provision known as the Shelby
amendment in P.L. 105-277 to make data from federally funded research available to the
public through the procedures established under the Freedom of Information Act. It discusses
the context of the legislation, including previous rules, the development by the Office of
Management and Budget of revisions to OMB Circular A-110 required by the statute; issues
that it raises for Congress; and related legislative activities, including H.R. 88. This report
will be updated in response to new developments.
Public Access to Data From Federally Funded Research:
OMB Circular A-110 and Issues for Congress
The results of scientific studies are often used in making government policy
decisions. While the studies are often published, traditional federal research funding
policies have not required the data on which they are based to be made available
publicly. Such policies generally require researchers to share data and physical
samples with other scientists after publication of the research. A rider, called the
Shelby amendment, that was attached to the Omnibus Appropriations Act for
FY1999, P.L. 105-277, mandated OMB to amend Circular A-110 to require federal
agencies to ensure that "all data produced under a [federally funded] award will be
made available to the public through the procedures established under the Freedom
of Information Act [FOIA]." The amendment authorizes user fees. OMB was
required to make changes and release a revised circular; subsequently agencies that
choose to do so will issue their own "conforming rules." OMB published proposed
revisions for comment in February and August; the final revision was issued
September 30, published in the Federal Register on October 8, 1999, and took effect
on November 8, 1999. The amendment originated from disputes about access to
research information used in a federal regulation. It is a significant change from
traditional practice, since, while permitted, federal agencies typically do not require
grantees to submit research data and, pursuant to a 1980 Supreme Court decision,
agencies did not have to give the public access under FOIA to research data they did
not possess as part of agency records.
To balance the need for public access while protecting the research process,
OMB's revision limits the kinds of data that will be made accessible (it excludes
personal and business-related confidential data) and limits applicability to federally
funded data produced under an award that has been published or cited by a federal
agency and used in developing an agency action that has the force and effect of law.
Opponents of the amendment say that FOIA is an inappropriate vehicle to allow wider
public access since it will harm the traditional process of scientific research; human
subjects will believe that the federal government might obtain access to confidential
information; researchers will have to spend additional time and money putting data
into a form required by the government, thereby interfering with ongoing research;
and private sector cooperation and funding for government/university/in-dustry
partnerships will be jeopardized.
Proponents of the amendment say that "accountability" and "transparency" are
paramount. The public should have a right to review scientific data underlying
research funded by government taxpayers. Some believe that the OMB revision
"narrows" the scope of public access to research data contrary to congressional intent
and might be challenged in court. Senator Shelby said the final revision, "while still
narrow in scope, is a good first step...." Some say that the OMB revision, not the
provision in the law directing OMB to amend the circular, will be the legal predicate
if there is a court challenge. Both Congress and OMB might seek continuing
oversight. Legislation to withhold funding for implementation of the amendment was
rejected. H.R. 88, a proposal to repeal the provision of the law, is pending.
Requirements of the Shelby Amendment ..............................2
Rationale For the Change in Law....................................3
Previous Federal Rules, Including FOIA ..............................6
Traditional Policies for Access to Data From Federally Funded Research..6
FOIA and Its Exemptions.....................................11
Relevant State Laws............................................12
OMB's Proposed and Final Revisions of Circular A-110.................13
Reaction to the Draft Revisions ...............................14
Issues ....................................................... 18
Will the Revision Make the Desired Information Available to the
Public? ................................................18
Do the Proposed Changes to Circular A-110 Meet the Legislative Intent of
the Amendment?.......................................18
What Data Will Be Made Available to the Public?................20
What Is Meant by "Data"?................................20
To What Activities Does the Provision Apply?.................21
What Is Meant by "Published"?............................22
How Quickly Should Access to the Data Be Provided?..........23
How Long Should the Data Be Kept, and Who Should Keep
Them? ..............................................24
How Will Public Access to Research Data Serve the Public Interest?..25
Will the Procedures Established Adequately Protect Proprietary Information and
the Privacy of Human Subjects?..............................27
Protection of Proprietary Information and Trade Secrets...........27
Protection of Personal Information about Volunteer Human Subjects..30
What Will Be the Financial Benefits and Costs of Implementation?......31
Potential Benefits.........................................31
Reimbursable Costs.......................................31
Nonreimbursable Costs....................................32
Costs of Litigation........................................33
How Might the Changes Affect Needed Research?..................33
Additional Issues for Congress.....................................35
Table 1. Percentage Shares of Federally Funded R&D and Research Awarded to
Selected Performers, Calculated According to Percentages of Federal
Obligations ................................................7
Amendment, Proposed Revisions, and Final Revision to OMB Circular A-110
(emphasis added) ..........................................17
Data From Federally Funded Research:
Revisions Made to OMB Circular A-110 and
Issues for Congress
The results of scientific studies are often used in making governmental policy
decisions. While the studies are often published, the data on which they are based
have seldom been publicly available, even for federally funded research, especially if
the study was performed by a nonfederal grantee. A provision in P.L. 105-277
changed that; it directed OMB to revise its Circular A-110 to make data from
federally funded research governed by the circular available to the public through the
Freedom of Information Act (FOIA, 5 U.S.C. 552; see also CRS Rept. 97-91).1
Popularly known as the Shelby or Shelby-Aderholt amendment, it is a significant
change from traditional practice. It is controversial and has raised several issues that
the 106th Congress has been addressing through oversight and legislative proposals.
The fundamental issue is how to reconcile different public interests. On the one
hand, the public interest requires that government-funded research is performed
efficiently and effectively and that the rights of individuals involved in that research
are protected. On the other hand, the public has an interest in examining the results
of government-funded research and in verifying the soundness of the science
underlying policy decisions. Those interests can conflict if, for example, public access
makes the research more difficult or more expensive to perform.
Supporters of the amendment say that the public has a right to review all data
produced from research supported by taxpayers, especially those used in developing
federal policies such as regulations. Most opponents say that using FOIA to provide
access to federally funded research will harm the process of scientific research by
imposing additional costs and other burdens on researchers and by making
participation in research less attractive to potential subjects and collaborators
concerned about confidentiality. OMB said its revisions to Circular A-110 attempt
to balance those interests.
1Congressional Record, 105th Cong., 2nd sess., 1998, 19 October 1998: 11178. The FOIA
may be found at 5 U.S.C. 552 (1994 and 1996 supp.). The provision was a rider attached to
the Treasury and Postal section of the Omnibus Consolidated and Emergency Supplemental
Appropriations Act for FY1999, P.L. 105-277, enacted on October 21, 1998. It requires that
OMB amend section __.36 (c) [intangible property] of OMB Circular A-110. Its principal
sponsors were Senator Richard C. Shelby and Representative Robert B. Aderholt. For
Circular A-110, see Office of Management and Budget, Circular A-110: Uniform
Administrative Requirements for Grants and Agreements With Institutions of Higher
Education, Hospitals, and Other Non-Profit Organizations, 29 August 1997,
[http://www.whitehouse.gov/OMB/circulars/A-110/A-110.html].
This report provides an analysis of the issues raised by the changes to Circular
A-110 mandated in P.L. 105-277. The first section describes the basis for the relevant
provision and how it and the proposed changes to Circular A-110 change access to
federally funded research data. This is followed by a discussion of the issues raised
by those changes and relevant activity in the 106th Congress.
Requirements of the Shelby Amendment
OMB circulars are applicable to the federal executive branch. OMB describes
the intent and authority of OMB circulars as "[i]nstructions or information issued by
OMB to Federal agencies. These are expected to have a continuing effect of two2
years or more." Furthermore, OMB requires all agencies to observe the provisions
of relevant circulars.3
Before passage of the Shelby amendment, Circular A-110 did not define data,
but it permits the federal government to "obtain, reproduce, publish or otherwise use
the data first produced under an award," and authorizes "others to receive, reproduce,
publish, or otherwise use such data for Federal purposes" (Section_.36. "Intangible
property"). Also, it does not define the word record, but pursuant to Section _.53,
"Retention and access requirements for records," requires that records related to an
award be kept for a minimum of three years from the date of submitting the
expenditure report or allows the government to request transfer of records to its
custody if it determines that records have "long term retention value." The same
section permits agencies, unless required by statute, to limit public access to recipient
records if the awarding agency can demonstrate that such records shall be kept
confidential and would have been exempted from disclosure by FOIA if the records
belonged to the federal awarding agency. Circular A-110 applies only to federal
"grants to and agreements with institutions of higher education, hospitals, and other
nonprofit organizations." It does not apply to grants and agreements with state and
local governments, but "[f]ederal agencies may apply [it] to [grants awarded to]
commercial organizations, foreign governments, organizations under the jurisdiction
of foreign governments, and international organizations."
The Shelby amendment mandated OMB to modify Circular A-110 "to require
Federal 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." Pursuant to the changes made to Circular A-110, if a request is
made under FOIA, agencies will be required to obtain certain types of research data
from grantees and provide the requester access to the data, if FOIA exemptions do
not apply, and (as permitted by FOIA), the agencies may collect research data in
anticipation of public requests for data. FOIA and the circular also provide for cost
reimbursement via fees charged to persons who request data under FOIA.
2At [http://www2.whitehouse.gov/OMB/circulars/index.html] .
3OMB Circular No. A-1, Revised, Subject: Bureau of the Budget's System of Circulars and
Bulletins to Executive Departments and Establishments, August 7, 1952.
Rationale For the Change in Law
Passage of the Shelby amendment is rooted in a two-year effort, begun in 1997
in House committee discussions, to make federally funded research data accessible to
the public.4 A key element contributing to the effort was debate over the scientific
basis of Environmental Protection Agency regulations to strengthen national ambient
air quality standards for ozone and particulate matter. In particular, dispute focused
on the unavailability of data underlying Harvard's Six Cities study, funded by the
National Institutes of Health, that found a link between particulate air pollution and5
health. Industry groups requested to review the data, but the researchers refused,
4According to Kathy Casey, Office of Senator Shelby: " In 1997, a similar effort was made
on the House side, in full committee. While it did not succeed, it was something that we were
aware of and certainly supported. In early 1998, the Senator [Shelby], joined by other
Members, Senators Lott, Campbell, and Faircloth, was interested in seeing some sort of effort
by OMB to review the current policies for making federally funded research subject to public
disclosure, and sought to include language in the Treasury and General Government
Appropriations bill" ("Origins of Congressional Action Regarding Public Access to Data,"
AAAS-Federal Focus Briefing on Data Access, February 16, 1999). The language calling
for OMB action evolved during 1998, from the first proposal, which called for a study of the
issue, to the final language in P.L. 105-277, which required specific changes in Circular A-
110. Specifically, S. 2312, the Treasury and Government Appropriations Act, 1999, required
that the "Director of OMB submit a report within 180 days of enactment to the Senate
Committee on Appropriations: (1) evaluating the implementation of specific government-wide
procedures for making federal funded research results (including all underlying data and
supplementary materials) available as appropriate to the public unless such research results
are currently protected from disclosure under current law...." The accompanying Senate
report 105-251 referred to language in OMB Circular A-110 that gave agencies the right to
obtain data produced under an award, but concluded that "...these policies [sic] directives are
not being implemented on a systematic basis. Although the National Aeronautics and Space
Administration, the Public Health Service, and the National Science Foundation currently
implement data sharing policies in order to permit wider assessment of the validity of the
research results and to facilitate broader public understanding, other Federal agencies do not.
Given the prevalent use of Government funded research data in developing regulations and
Federal policy, it is important that such data be made available to other interested Federal
agencies and to the public on a routine basis for independent scientific evaluation and
confirmation" (Section on "OMB. Data Access," in Senate Committee on Appropriations,
Treasury and General Government Appropriation Bill, 1999, Report to accompany S. 2312,thnd
105 Cong., 2 sess., 1998, S. Report. 105-251). This bill was incorporated into H.R. 4104
as an amendment. H.R. 4104 was passed in lieu of original S. 2312 (Sept. 3, 1998). H.R.
4104 as originally passed in the House did not contain language relating to data access (July
16, 1998). The conference report on H.R. 4104 (House Rept. 105-789) explained that the
conferees "included new language to amend Section XX.36 of OMB Circular A-110 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" (Section on "OMB. Salaries
and Expenses, in House Committee of Conference, Making Appropriations for the Treasury
Departments, ... for the Fiscal Year 1999..., Conference Report to Accompany H.R. 4104,thnd
105 Cong., 2 sess., 1998, H. Rept. 105-789).
5See, for example, Douglas W. Dockery and others, "An Association Between Air Pollution
and Mortality in Six U.S. Cities," New England Journal of Medicine 329 (1993): 1753-1759.
citing confidentiality agreements with the subjects. Subsequently, a procedure by
which an independent group of scientists could review the data was developed, but
the law's supporters believe that better access is needed.6
The amendment's supporters say two issues were raised by the EPA dispute.
One was the need for transparency — that the public should have access to data that
they paid for and that affects policy. The second related to accountability — that the
public, not only peer reviewers or scientists, should have a right to examine the data
on which agency regulations are based, since the data or interpretations of it might be
incorrect, and regulations can be very expensive to implement and to comply with.
Proponents have argued that data access is important to ensure that regulations are7
well-supported scientifically and do not carry an undue burden.
Those issues are not new,8 but they had been relatively quiet since the U.S.
Supreme Court ruled in 1980 that a grantee's data were not agency records within the
meaning of FOIA because the data had not been created or obtained by a federal
agency. The case was Forsham v. Harris.9 The legal issue presented was whether
records that were created and retained by nonagencies, but which are in some way
affiliated with an agency, may be classified as agency records. In Forsham, the Court
established the minimum requirements for determining agency record status in the
context of records created by nonagencies. In Forsham, a private organization of
physicians sought to obtain the data underlying the report of a Department of Health,
Education, and Welfare (HEW) grantee funded to conduct a study of diabetes
treatment regimens. The plaintiffs alleged that the data they sought were agency
records because 1) they were records of the grantee which received its funds from a
federal agency and were subject to some supervision in the use of those funds; 2) the
federal agency had authority under its grant agreement to have obtained the data had
it chosen to do so; and 3) they formed the basis of the grantee's reports which were
relied upon by the agency. The court found that Congress had purposely excluded
federal grantees from the FOIA, and held that the private grantee was not an agency
subject to the FOIA. The court also concluded that the required data were not agency
5 (...continued)
See also, House Committee on Science, Subcommittee on Energy and Environment, The
Science Behind the Environmental Protection Agency's (EPA's) Proposed Revisions to the
National Ambient Air Quality Standards for Ozone and Particulate Matter, Parts I-III,th
Hearings, 105 Cong. lst sess., March 12 and May 7 and 21, 1997, 582-596.
6"Disclosure Law Worries Researchers," By Aaron Zitner, Boston Globe Staff, February 11,
1999. See also Roger O. McClellan, "An Industry perspective on the Proposed Revision"
presented at AAAS-Federal Focus Briefing on Data Access, February 26, 1999
[http://www.aaas.org/spp/dspp/sfrl/projects/omb.htm].
7See, for example, the statement of William L. Kovacs, U.S. Chamber of Commerce, before
the House Subcommittee on Government Management, Information, and Technology, House
Committee on Government Reform, Hearing on H.R. 88, Regarding Data Available Under
the Freedom of Information Act, 15 July 1999, pp. 2-3.
8See, for example, Judith Lowitz Adler, "The Impact of FOIA on Scientific Research
Grantees," Columbia Journal of Law and Social Problems 17, no. 1 (1981): 1-44.
9445 U.S. 169, 179 (1980).
records within the meaning of FOIA because the data had not been created or
obtained by a federal agency;10 and "[t]he FOIA applies to records which have in fact
been obtained and not to records which merely could have been obtained."11 The
Court suggested that the grantee's data could become agency records if it could be
shown that the agency directly controlled the grantee's day-to-day activities.12
The legislative history of the amendment is sparse because no hearings were held
on it before passage. The major indication of legislative intent, other than the
language in the provision itself and the report language, is from Senate floor
statements made at the time the amendment was adopted. However, on July 15,
1999, the Subcommittee on Government Management, Information, and Technology
of the House Committee on Government Reform held a hearing on H.R. 88, a bill that
would repeal the amendment. That hearing provided additional background.
Proponents of the amendment cited the costs of compliance with federal regulations
coupled with the lack of public review of the data used by agencies in developing
regulations. They also cited concerns about the adequacy of peer and agency review
mechanisms to validate scientific data for setting regulations.13 Opponents cited
concerns about possible violation of the privacy of human subjects, risks to
10"Written data generated, owned, and possessed by a privately controlled organization
receiving federal study grants are not 'agency records' within the meaning of the Act when
copies of those data have not been obtained by a federal agency subject to the FOIA. Federal
participation in the generation of the data by means of a grant from the Department of Health,
Education, and Welfare (HEW) does not make the private organization a federal 'agency'
within the terms of the Act. Nor does this federal funding in combination with a federal right
of access render the data 'agency records' of HEW, which is a federal 'agency' under the
terms of the Act." (Ibid., at 171.)
11Ibid., at 186.
13For instance, an official of the U.S. Chamber of Commerce testified in support of the Shelby
amendment and in opposition to H.R. 88, saying that the excessive cost of compliance with
federal regulations — cited as $737 billion annually — coupled with the lack of public review
of the data used by agencies in developing regulations, justifies support for more access
(William L. Kovacs, statement of the U.S. Chamber of Commerce, before the House
Subcommittee on Government Management, Information, and Technology, House Committee
on Government Reform, Hearings on H.R. 88, Regarding Data Available Under the Freedom
of Information Act, 15 July 1999, pp. 2-3). Another witness, Robert W. Hahn, of the AEI-
Brookings Joint Center for Regulatory Studies, testified, "At present, analyses used in policy
making are rarely checked carefully before big regulations are put in place." He also said, "the
peer-review process...is frequently not adequate for major public policy decisions, such as
those involved in regulation." He recommended "allowing greater access to information that
pertains to the formulation of such regulations..." (Testimony, Robert W. Hahn, p. 2, at
Hearing, Ibid.) At the same hearing, Michael Gough, of the Cato Institute, claimed that a
study ultimately supporting a regulation was published in a refereed journal, but that upon
replication it yielded different nonsupporting results. ("The Importance of Data Access for
Science and Governance," at Hearing, Ibid.).
confidential proprietary information, misinterpretation of data, inhibitory effects on
the research enterprise, and costs of compliance.14
Previous Federal Rules, Including FOIA
This section discusses traditional policies for access to data derived from
federally funded research, relevant provisions of FOIA, and exemptions of FOIA.
Traditional Policies for Access to Data From Federally Funded
Traditionally, research performers funded by federal grants have been required
to provide the agency with a grant completion report and a copy of the publication
that resulted from their research, if there was one. As is discussed in this section,
agencies have developed policies to encourage researchers to share their data with
other researchers. However, agencies have not generally required researchers to
provide the data used or collected to the federal agency that sponsored their research.
Therefore while data may be available to other researchers, they have not been
available to the public.
Those practices are based on principles and policies about governmental support
of science. Many of the principles about federal support for science were discussed
first in Science, the Endless Frontier, by Vannevar Bush, a science adviser to
Presidents Franklin Roosevelt and Harry Truman, considered to be the document that
established the basis of policy for governmental support of, and accountability for,15
extramural, especially academic, research by grants. After World War II, Congress
initiated large programs to fund scientific research because of its perceived immediate
or future value to the nation. Post-World War II enactments (creating the National
Science Foundation, the National Institutes of Health, and so forth) led to the
development of programs of governmental grants for research and for education and
training of scientists in U.S. colleges and universities. Scientists were largely given
responsibility through the research funding agencies to select research grantees by
means of peer and merit review procedures; many of the responsibilities for
administrative and financial accountability for grants research were shifted to
14Testimony of Gary D. Bass, Executive Director, OMB Watch; Robert N. Shelton, Vice
Provost for Research, University of California; and Harold E. Varmus, Director, National
Institutes of Health, at Hearing, Ibid.
15See Vannevar Bush, Science—the Endless Frontier, a report to the President on a Program
for Postwar Scientific Research, U.S. Govt. Print. Off., 1945, passim. For additional
information, see Richard E. Rowberg, Federal R&D Funding: A Concise History, August.
14, 1998, 15 p. , CRS report 95-1209 STM; U.S. Congress, Office of Technology
Assessment, The Regulatory Environment for Science, A Technical Memorandum, OTA-M-
SET-34, February 1986, pp. 14-15; and Daniel S. Greenberg, The Politics of Pure Science
(New York: The New American Library, 1967), Chap. vi.
Also in the postwar period, additional federal intramural laboratories were
established to enable the conduct of applied or mission-relevant research, and private
companies, funded mostly by government contracts, began research and development
for the federal government. As a result, today, 76% of federally funded research and
development (R&D) and 74% of federally funded research is performed extramurally,
with universities being the single largest performer of federally funded research,
usually by means of grants. The federal government is, in fact, the largest single
supporter of research in universities. See Table 1. In summary, Congress, "in some
instances, made a conscious decision to finance this research in the private sector [that
is, in academic institutions, other nonprofit institutions, and industry], rather than to
Table 1. Percentage Shares of Federally Funded R&D and Research
Awarded to Selected Performers,
Calculated According to Percentages of Federal Obligations
1. Type of federally funded2. Performer 3. Percentage of activity in
activitycolumn 1 performed by performer
in column 2
Research and developmentNonfederal performers, FY19991676%
(R&D) preliminary
Research onlyNonfederal performers, FY19991774%
Research onlyIntramural performers, FY199926%
Research onlyUniversities and colleges (39%)47%
and nonprofit institutions, (8%)18
FY1999, preliminary
Research onlyUniversities and colleges, FY1999,1939%
1. Type of activity2. Source of funds3. Percentage of activity in
column 1 provided by the federal
government, as described in
All research performed byFederal government, FY1998,2059%
universities and colleges preliminary
16Calculated from Table C-10, U.S. National Science Foundation, Federal Funds for
Research and Development, Fiscal Years 1997, 1998, 1999, Vol. 47, 1998, (NSF 99-333).
17Calculated from Table C-18, Ibid., (NSF 99-333).
19Excluding FFRDCs. Calculated from Table C-18, Ibid., (NSF 99-333).
20Calculated from Table B-2A and B-2B, U.S. National Science Foundation, National
Patterns of R&D Resources: 1998. An SRS Special Report, 1999, (NSF 99-335).
create an alternative state system of research. In so doing it has attempted to preserve
value peculiar to private systems...," including grantee autonomy, while incorporating
federal interests.21 A legal interpretation of these private interests relevant to grant
research was discussed in Forsham v. Harris, including "the values of competitive
priority and peer recognition..." and the preservation of "grantee autonomy."22
The system of federal grants to support scientific research reflects principles that
scientists consider important to the conduct of research. Those include scientific peer
review of data and findings, replication of research results, use of publications to
award credit for discovery and interpretation of data, and protection of the process
of scientific inquiry. Especially important to scientists is public discussion of
preliminary findings and research data without the potential for interference by
political interests that might act to oppose the research during the research process.
Even before passage of the Shelby amendment, Circular A-110 allowed agencies
to obtain and use the data produced under an award and authorized others to use
"such data for federal purposes" (OMB Circular A-110, __.36(c)). However, neither
Circular A-110 nor other instruments set overall Federal policy about ownership of
data produced under grant awards. In general researchers have acted as owners, and
agencies have permitted them to act as owners, of data in that they retain them and
control access to them.
Over time, federal agencies have developed their own separate policies that
generally endorse sharing by the researchers of recorded information following
publication of research results, with access limited to other researchers and with
adequate safeguards for protection of confidential information relating to human
subjects or confidential commercial information. Some agencies allow public access23
to research data via databases. Several major research funding agencies (such as the
National Science Foundation (NSF), the National Institutes of Health (NIH), the Food
and Drug Administration (FDA) and the National Aeronautics and Space
Administration (NASA) ) encourage or require researchers to share raw data, slides,
or physical samples with other researchers, usually, but not in all cases, after
publication of research results. Agencies stipulate a variety of time periods for
researchers to retain data, ranging from three to seven years; some require researchers
to provide data automatically to other researchers, others do not.
21Adler, "Impact of FOIA," 1-2.
22See also Adler, "Impact of FOIA," 1-3 and Alvin J. Lorman, Esq., Daniel R. Johnson, Esq.,
and Daniel F. O'Keefe, Jr., Esq., "Tilting the Balance in Favor of Disclosure: The Scope of
the Medical Records Exemption to the Federal Freedom of Information Act," Food Drug
Cosmetic Law Journal 43, (January 1988): 17-32.
23Excerpts of the various policies for the Food and Drug Administration, the National Science
Foundation, the Public Health Service, the National Institutes of Health, the National Center
for Health Statistics of the Centers for Disease Control and Prevention, the National
Aeronautics and Space Administration, and the National Institute of Justice in the Department
of Justice were reproduced by the Center for Regulatory Effectiveness in "I.3.1. U.S.
Government Executive Branch Policies," at [http://www.thecre.com/access/comments/
1-3-1.html].
For instance, the policy governing the National Institutes of Health, the federal
agency that provides the largest amount of federal research funds (predominately in
the life sciences) to universities and colleges, says "it is incumbent" upon supported
researchers "to make results and accomplishments of their activities available to the
public."24 Results and accomplishments may or may not encompass data. The Public
Health Service (PHS), which includes NIH, defines data developed in a PHS-
supported project as "writings, films, sound recordings, pictorial reproductions,
drawings, designs, or other graphic representations, procedural manuals, forms,
diagrams, work flow charts, equipment descriptions, data files, data processing or
computer programs, statistical records, and other research data."25 Also, to expedite
the process of biomedical research, PHS requires NIH grantees and contractors to
make "unique research resources," including physical samples such as specific cell
lines and cloned DNA, available to other researchers following publication or
fulfillment of a contract. In certain cases researchers are expected to deposit data in
data banks to permit efficient access to the scientific community.26
NSF is the second largest federal funder of research at universities and colleges.
It supports research in all areas of science. From its inception in 1950 until 1989, NSF
had no written policy on data sharing (except relating to Automated Data Processing
(ADP), software and large databases, which were written beginning in 1969). Its
early policies allowed nongovernmental scientist/grantees to use their own
professional procedures and incentives to promote sharing of information. It expected
grantees to share data consonant with the principles of scientific exchange and
replication in scientific research. In 1984, the National Science Board of the National
Science Foundation adopted a data sharing policy. In 1989, the findings of an NSF
committee were incorporated into a written NSF data sharing policy that appears in
NSF's grant and management documents. As a result, NSF grantees are not required,
but are encouraged, to follow condition 37 of Grant General Conditions, dealing with
"Sharing of Findings, Data, and Other Research Products." Peer/merit reviewers are
asked to consider whether a researcher's previous data sharing practices are
consistent with NSF policies when selecting new award winners.27 NSF's policy on
"Sharing of Findings, Data, and Other Research Products" reads
a. NSF expects significant findings from research and education activities it
supports to be promptly submitted for publication, with authorship that accurately
reflects the contributions of those involved. It expects investigators to share with
other researchers, at no more than incremental cost and within a reasonable time,
the data, samples, physical collections and other supporting materials created or
gathered in the course of the work. It also encourages awardees to share software
and inventions or otherwise act to make the innovations they embody widely useful
and usable. b. Adjustments and, where essential, exceptions may be allowed to
24Section on "Publications" in Part 8, "Postaward Administration" in PHS Grants Policy
Statement, (PHS GPS 9505).
26"PHS Policy Relating to Distribution of Unique Research Resources Produced with PHS
Funding," from Part 8, "Postaward Administration" in PHS Grants Policy Statement, (PHS
GPS 9505).
27Interview, John C. Chester, NSF General Counsel office, September 13, 1999.
safeguard the rights of individuals and subjects, the validity of results, or the28
integrity of collections or to accommodate legitimate interests of investigators.
Some prominent nongovernmental science policy groups have long advocated
the disclosure of research data, but generally only after publication, usually only to
other researchers, and only if disclosure is balanced by protections for privacy and
intellectual property rights. In 1985, the National Academy of Sciences report,
Sharing Research Data, said, "Data relevant to public policy should be shared as
quickly and widely as possible, in time with public release and following appropriate
review." It recommended against using FOIA for that purpose. The Academy also
published Bits of Power: Issues in Global Access Scientific Data (1997), which called
for open exchange of data from research funded with tax dollars, without severe
restrictions by intellectual property rights law. A recent statement of the Academy
presidents urges professional societies, academic leaders, and industry to develop
clear and workable standards of open communication in scientific research.29 Various
professional groups, such as the American Sociological Association, the American
Economic Association, and other scientific associations, have developed policies
encouraging or requiring sharing of data cited in articles published in their journals.30
The American Association for the Advancement of Science (AAAS) Council, in early
1999, adopted a resolution stating that "it supports the public disclosure of scientific
findings and regulatory decisions, at the appropriate time and with appropriate
safeguards...."31 Reflecting foresight and the reality of the public pressures that would
come shortly, the Council on Governmental Relations (COGR), a prominent
association of research universities, issued a paper in 1996 urging senior university
officials to develop polices to respond to increasing pressures for public access to
data from federally sponsored research. Noting that the tradition of FOIA exemptions
might weaken, it stated, "Scientists may not be able to defend their 'rights' in the
public's view, unless they can argue convincingly that reasonable limitations of release
are actually in the public's interest."32
28Document GC-1, October 1, 1998.
29"Actions Are Needed to Promote Research Sharing," Statement from Bruce M. Alberts,
Kenneth I. Shine, and William A. Wulf, September 8, 1998.
30 "Sociologists Take Note: Data Access and Proposed Use of FOIA," Footnotes, February
31Letter AAAS to Hon. Jim Kobe, chairman, Subcommittee on Treasury, Postal Services and
General Government, House Committee on Appropriations, May 3, 1999.
32Council on Governmental Relations (COGR), "Policy Considerations: Access to and
Retention of Research Data," Washington, D.C., 1996, 5.
FOIA and Its Exemptions
The Freedom of Information Act provides a procedure for any individual to
obtain access to information in records held by federal executive agencies.33 FOIA
does not require the requester of information to give a reason for the request. It
presumes that the public has a right to information held by government agencies, and
allows access for any purpose, with the following exemptions (5 U.S.C. 552b):
1. information that is properly classified to be kept secret in the interests of
national defense or foreign policy,
2. information on internal personnel issues,
3. information that is exempted from disclosure by other statutes,34
4. trade secrets and commercial or financial information that is privileged or
5. internal agency memos available only by litigation,
6. personnel, medical, or similar files, whose release would constitute an
unwarranted invasion of privacy,
7. records or information compiled for law enforcement and whose release
would compromise impartial adjudication or disclose information about law
enforcement processes and related issues, 35
8. information related to the supervision of financial institutions, and
9. geological and geophysical information and data, including maps, concerning
The law allows, but does not require, the agencies to withhold or redact agency
records pursuant to these exemptions.36 In many cases, agencies may make37
discretionary disclosures of exempt information "as a matter of good public policy."
33For an explanation of FOIA procedures, see House Committee on Government Reform and
Oversight, A Citizen's Guide on Using the Freedom of Information Act and the Privacy Act
of 1974 to Request Government Records, 106th Cong., 1st sess., 1999, H. Rept. 106–50
(available from CRS in Congressional Research Service, Freedom of Information Act/Privacy
Act: a Guide to Their Use, CRS InfoPack IP047F, n.d.). For a discussion of FOIA provisions
and legislative history, see Ronald C. Moe, Coordinator, General Management Laws: A
Selective Compendium, CRS Report RL30267, 28 July 1999, 35-39. FOIA does not apply
to elected officials, to the judicial branch, or to the legislative branch.
34Exemption 3 applies if the statute "(A) requires that the matters be withheld from the public
in such a manner as to leave no discretion on the issue, or (B) establishes particular criteria
for withholding or refers to particular types of matters to be withheld" (5 U.S.C. 552 (b) (3)).
35Exemption 7 has 6 qualifying subparts.
36In Chrysler Corp. v. Brown (441 U.S. 281) (1979), the Supreme Court held that "The FOIA
is exclusively a disclosure statute and affords petitioner no private right of action to enjoin
agency disclosure. The language, logic, and history of the FOIA show that its provisions
exempting specified material from disclosure were only meant to permit the agency to
withhold certain information, and were not meant to mandate non-disclosure."
37U.S. Attorney General to Heads of Departments and Agencies, 4 October 1993,
memorandum, reprinted in Department of Justice, FOIA Update 14, no. 3 (Summer/Fall
The exemptions do not include any specific "public interest" provision,38 and the Act
"does not authorize withholding of information or limit the availability of records to
the public, except as specifically stated." Also, some say that the courts have39
interpreted the exemptions narrowly, promoting disclosure.
FOIA also permits agencies to charge requesters for the cost of complying,
although agencies do not retain the reimbursements, which go to the Treasury. Only
direct costs can be reimbursed, and they are limited at most to search, duplication, and
review. Lower charges apply to certain classes of requesters, such as educational
institutions and the media.
Before passage of the Shelby amendment, private performers of federally funded
research were not required to provide federal agencies with raw data and related
information in response to FOIA requests. However, if the funding agency obtained
the data for "federal purposes,"40 such as to investigate possible scientific misconduct,
the data became agency records subject to FOIA. In addition, intramural research,
performed directly by federal agencies, is accessible to the public, provided that none
of the FOIA exemptions apply. About 26% of all federally funded research is
intramural, See Table 1.
Relevant State Laws
Many states have enacted "right-to-know" laws. In some cases, those laws
provide broader access to information from nongovernmental researchers than the
changes to Circular A-110 would allow, but some are more restrictive. Some
observers have cited experience with those laws in commenting on the changes. For
instance, Georgia's open records law allowed R.J. Reynolds Tobacco Company to try
to obtain the data records of a Georgia researcher's study showing that children
between the ages of 3 and 8 identified the company's cartoon camel and linked it to
cigarettes. The researcher refused to allow the children to be identified and
interviewed as the company wanted. The case involved litigation and a conflict
between the university administration and the researcher regarding the applicability
of the state law. Subsequently the State passed a law to prohibit invasion of the
37 (...continued)
1993), [www.usdoj.gov/oip/foia_updates/Vol_XIV_3/page3.htm].
38However, the courts have interpreted Exemption 6 to require that any viable privacy interests
outweigh the public interest in "shed[ding] light on an agency's performance of its statutory
duties..." (U.S. Department of Justice v. Reporters Committee, 489 U.S. 749 [1989]).
39Martin J. Silverman, "Administrative Law — Freedom of Information Act — Agency
Records — Forsham v. Harris," New York Law School Law Review 27, no. 2 (1981): 643 –
40In Forsham v. Harris (445 U.S. 169), the U.S. Supreme Court reaffirmed lower court
rulings that denied access to information generated and retained by private grantees (see
Silverman, "Administrative Law — the Freedom of Information Act," 635-662.
children's privacy, but the researcher resigned his position and abandoned the line of
research he had been pursuing.41
Some state laws allow the release of specific kinds of scientific research data.
California, Massachusetts, and Michigan have laws permitting the release of
epidemiological data.42 The laws vary and some are more restrictive than the changes
permitted by the language of Shelby amendment. For example, the California Public
Records Act, unlike FOIA, permits an agency to withhold a record if "on the facts of
the particular case the public interest served by not making the record public clearly
outweighs the public interest served by disclosure of the record."43 The law also
apparently allows researchers to negotiate directly with the requesting party to protect44
sensitive data.
OMB's Proposed and Final Revisions of Circular A-110
The Shelby amendment required OMB to revise Circular A-110 by September
30, 1999. OMB published a proposed revision on February 4 and provided a 60-day45
comment period. After reviewing more than 9,000 comments, OMB published a
second proposed revision on August 11 and provided an additional 30-day comment46
period. Language in both OMB draft revisions and the final revision arguably
restrict the application of the term data more narrowly than in the Shelby amendment,
which included "all data produced under an award." (The language of the law and
OMB's three versions are summarized in Table 2.) The first, that is, February,
proposed revision, would have applied only to data from research that had been both47
published and used in the development of policies or rules. The second, or August,
proposed revision, was somewhat more restrictive, in that it would have applied only
to research that is used in the development of regulations, for which notice and
comment is required under the Administrative Procedure Act (5 U.S.C. 553, et. seq.).
41Paul M. Fischer, "Fischer v. The Medical College of Georgia and the R.J. Reynolds
Tobacco Company: A Case Study of Constraints on Research, New Directions for Higher
Education, 88 (Winter 1994): 33-43.
42Center for Regulatory Effectiveness, "CRE Comments on Data Access Rule I.3.5 State
Legislation."
43California Government Code, sec. 6255.
44Testimony of Robert N. Shelton, Vice Provost for Research, University of California, before
the Subcommittee on Government Management, Information, and Technology, House
Committee on Government Reform, 15 July 1999.
45Office of Management and Budget, Notice, "Proposed Revision to OMB Circular A-110,
'Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher
Education, Hospitals, and Non-Profit Organizations'," Federal Register, 64, no. 23 (4
February 1999): 5684-5685.
46Office of Management and Budget, Notice, "Request for Comments on Clarifying Changes
to Proposed Revision to OMB Circular A-110," Federal Register, 64, no. 154 (11 August
1999): 43786-43791. Available at: [http://www.whitehouse.gov/OMB/fedreg/2ndnotice-a-
110.html].
47OMB, "Proposed Revision," 5684-5685.
The final revision was released on September 30, 1999 and published in the Federal
Register on October 8, 1999.48 It was effective on November 8, 1999. It broadened
the applicability of the provision from "regulations" to research that has been
published and used in "developing an agency action that has the force and effect of
law...." The second proposed revision defined the terms published and research data
and sought comments on whether the revision should apply only to regulations with
impacts of $100 million or more. The final revision defined the term published as in
the second proposed revision, but defined research data slightly more restrictively,
replacing the term files with information , to prevent the release of video or audio
tapes of research subjects. The implications of these differences in language are
discussed below in the section on issues.
The Shelby amendment provides specifically for cost reimbursement via "a
reasonable user fee equaling the incremental cost of obtaining the data" "if the agency
obtaining the data does so solely at the request of a private party." The OMB
language pertaining to this issue, which did not change through the three versions of
the revisions, allows an agency to obtain reimbursement of the "full incremental cost
of obtaining the research data," including the costs incurred by "the agency, the
recipient [of the research funding], and applicable subrecipients," provided that the
agency obtains the data "solely in response to a FOIA request." The supplementary
information attached to the second proposed revision said agencies would be allowed
to retain that fee "to reimburse themselves, recipients, and applicable subrecipients,
for the costs they incur." OMB also requested comments on estimates of such
incremental costs and on the ways that grant recipients might charge such costs to
their awards. The supplemental information attached to the final revision explained
a procedure agencies could use to obtain reimbursements for grantees but contained
the same cost-reimbursement provisions as in the first and second proposed revisions.
Although the final revised circular became effective thirty days after publication
in the Federal Register, federal agencies that issue conforming agency regulations will
allow the public and interested parties to comment before they issue their own
conforming rules, as governed by the Administrative Procedure Act.
Reaction to the Draft Revisions
OMB received over 9,000 public comments on the first draft revision, 55%
supporting it, 45% opposing it. Over 3,000 comments on the second revision
proposal were received.
Supporters of broad public access included the United States Chamber of
Commerce; the National Rifle Association; the Association of Equipment
Distributors; a group of Former Administrators of the Office of Information and
Regulatory Affairs, Office of Management and Budget during the Bush and Reagan
48Office of Management and Budget, Final Revision, "OMB Circular A-110, 'Uniform
Education, Hospitals, and Other Non-profit Organizations," [September 30, 1999], Federal
Register, 64, no. 195 (8 October 1999): 54926-54030.
Administrations; and the Eagle Forum.49 Those groups argued for what the Senate
sponsors discussed relating to transparency and accountability — a broad, wide-
ranging provision that would provide the greatest degree of access to all types of
research data and allow citizens and interest groups to examine the data supporting
new government rules. Among other supporters, the Wall Street Journal stated in an
editorial that "if scientists want to take taxpayer money to conduct research, they
should know that one of their main obligations is to make certain the public has full
confidence in the ways those results are used. The Shelby law is a reasonable
compromise that will help ensure just that."50
Objections to widening access to research data via FOIA — focusing especially
on the potential burdens to the scientific research community or costs to a federal
agency — were raised by the directors of the National Science Foundation and the
National Institutes of Health, the President of the National Academy of Sciences, and
such groups as the American Association of Universities, and the American51
Association for the Advancement of Science Council. Opposition has been reported
also from the Pharmaceutical Research and Manufacturers of American (PhRMA),
and the Semiconductor Industry Association.52 There was opposition also from the
Boston Chamber of Commerce.53
OMB responded to such concerns in the supplementary explanatory information
attached to the second proposed and final revisions of Circular A-110. For instance,
the supplementary information attached to the second proposed revision said,
[In preparing the proposed revision,] OMB has used its discretion to balance the
need for public access to research data with protections of the research process.
Specifically, OMB seeks to (1) further the interest of the public in obtaining the
information needed to validate Federally-funded research findings, (2) ensure that
research can continue to be conducted in accordance with the traditional scientific
49"Strong Response for Proposed Circular Change," Science and Technology In Congress,
June 1999, 2.
50"Science's Belated Complaint," The Wall Street Journal, June 7, 1999, editorial. See also:
"Opponents of New Data Release Law Maintain Blocking Strategy if Passed, House
Amendment Would Strengthen Research Argument," Washington Fax, June 16, 1999; "Secret
Science," Washington Times, Feb. 11, 1999; Angela Antonelli, "Preserve the Public's Right
to Know About Federally Funded Research, The Heritage Foundation Executive
Memorandum, June 8, 1999.
51See for instance, "Will FOIA Hold Science Hostage?" Psychological Science Agenda,
May/June 1999, 1-3. Additional information and hot links to other websites on both sides of
the issue may be found at: [http://photon.mit.edu/A-110/index.html]. See also proceedings
of the AAAS-Federal Focus, Inc. Briefing on OMB Revisions to Circular A-110, February
16, 1999 at [http://www.aaas.org/spp/dspp/sfrl/projects/omb.htm].
52"Opponents of New Data Release Law Maintain Blocking Strategy If Passed, House
Amendment Would Strengthen Research Argument," Washington Fax, June 16, 1999.
53Paul Guzzi, president, Greater Boston (MA) Chamber of Commerce, Letter to OMB
Regarding Proposed Revision to Circular A-11, April 5, 1999.
process, and (3) implement a public access process that will be workable in54
practice.
Similar language appeared in the supplementary information attached to the final
revision.
OMB also said that it "does not construe the statute as requiring scientists to
make research data publicly available while the research is still ongoing, because that
would force scientists to 'operate in fishbowl' and to release information
prematurely."55 The desire for scientists to do research using the traditional scientific
process also led OMB to allow grantees to withhold from agencies confidential
business information and private personal information.56 (See Table 2.)
54Ibid., OMB, Proposed Revision, [August 5, 1999], August 11, 1999, p. 43786, at
[http://www.whitehouse.gov/OMB/fedreg/2ndnotice-A-110.html].
55 Ibid., p. 43786 and Final Revision, p. 54927.
56Proposed revision, p. 43787 and Final revision, p. 54928. These are similar to FOIA
exemptions 4 and 6.
CRS-17
Circular A-110 (emphasis added)
Provision in P.L. 105-277: "...all data produced under an award will be made available to the public through the procedures established under the Freedom of
SECOND OMB FINAL OMB
August 1999 Proposed Revision of Circular A-110September 30 , 1999 Final Revision of Circular A-110
"...in response to a Freedom of Information Act (FOIA) request for"...in response to a Freedom of Information Act (FOIA) request for
research data relating to published research findings produced underresearch data relating to published research findings produced under an
an award that were used by the Federal Government in developing aaward that were used by the Federal Government in developing an
regulation, the Federal awarding agency shall request, and the recipientagency action that has the force and effect of law, the Federal awarding
iki/CRS-RL30376shall provide, within a reasonable time, the research data so that theycan be made available to the public through the procedures establishedagency shall request, and the recipient shall provide, within a reasonabletime, the research data so that they can be made available to the public
g/w producedunder the FOIA.... through the procedures established under the FOIA.....
s.orthat(i) "Research data" is defined as the recorded factual material(i) "Research data" is defined as the recorded factual material
leakcommonly accepted in the scientific community as necessary to validatecommonly accepted in the scientific community as necessary to validate
research findings, but not any of the following: preliminary analyses,research findings, but not any of the following: preliminary analyses,
://wikidrafts of scientific papers, plans for future research, peer reviews, ordrafts of scientific papers, plans for future research, peer reviews, or
http the Federalcommunications with colleagues. This "recorded" material excludesphysical objects (e.g., laboratory samples). Research data also do notcommunications with colleagues. This "recorded" material excludesphysical objects (e.g., laboratory samples). Research data also do not
include (A) trade secrets, commercial information, materials necessaryinclude (A) trade secrets, commercial information, materials necessary
to be held confidential by a researcher until publication of their resultsto be held confidential by a researcher until they are published, or
in a peer-reviewed journal, or information which may be copyrighted orsimilar information which is protected under law, and (B) personnel
patented; and (B) personnel and medical files and similar files theand medical information and similar information the disclosure of
disclosure of which would constitute a clearly unwarranted invasion of which would constitute a clearly unwarranted invasion of personal
personal privacy, such as information that could be used to identify aprivacy, such as information that could be used to identify a particular
particular person in a research study.person in a research study.
(ii) "Published" is defined as either when (A) research findings are(ii) "Published" is defined as either when (A) research findings are
published in a peer-reviewed scientific or technical journal, or (B) apublished in a peer-reviewed scientific or technical journal, or (B) a
Federal agency publicly and officially cites to the research findings inFederal agency publicly and officially cites to the research findings in
support of a regulation.support of an agency action that has the force and effect of law.
(iii) "Used by the Federal Government in developing a regulation" is(iii) "Used by the Federal Government in developing an agency action
defined as when an agency publicly and officially cites the researchthat has the force and effect of law" is defined as when an agency
findings in support of a regulation (for which notice and comment ispublicly and officially cites the research findings in support of an
required under 5 U.S.C. 553).agency action that has the force and effect of law.
The use of the Freedom of Information Act to provide access to data from
federally funded research has produced arguments for both potential benefits and
potential disadvantages. A frequently cited benefit is that the mechanisms, federal57
infrastructure, and case law for FOIA are well-established. Opposition focuses on
such issues as timing of access, need for access, the cost of administration, possible
inadequacy of the protections provided by FOIA's exemptions, and potential for
abuse.58 Some suggest that requests should meet a public interest test before data are59
The issues raised by the amendment and the OMB revisions to Circular A-110
can be divided into four categories:
!whether the revision of Circular A-110 will make the desired
information available to the public,
!whether the procedures established will adequately protect proprietary
information and the privacy of human subjects,
!what the benefits and costs of fulfilling the provisions will be, and
!how the changes may affect the research process.
Those issues are discussed in more depth below, followed by a discussion of
issues for Congress.
Several factors could affect the degree to which the intended goals of the Shelby
amendment are achieved. They include
!the degree to which the proposed revisions to Circular A-110 fulfill the
legislative intent of the amendment,
!what data will actually be made available, and
!how public access to data serve the public interest.
the Amendment? The language in the final revision to Circular A-110 clearly is
narrower than that in the legislative provision (Table 2). While the amendment called
for access to all data produced under a federal award, the final revision to Circular A-
110 limits access to selected kinds of federally funded "research data relating to
57Testimony of James T. O'Reilly, University of Cincinnati College of Law, Hearing on H.R.
88, 15 July 1999.
58Testimony of Robert N. Shelton, University of California, and Bruce Alberts, President of
the National Academy of Sciences, Hearing on H.R. 88, 15 July, 1999.
59"FOIA is fundamentally flawed as the mechanism here, because it fails to require evidence
from the data requestor that the disclosure of the data in question is in the public interest.
Congress needs to do more investigation of this concern" (Statement of Alberts, Ibid.)
published research findings produced under an award that were used by the Federal
Government in developing an agency action that has the force and effect of law."
This version is more restrictive than the proposed language of the first revision, which
would have limited release to federally funded research data relating to published
research findings that were used in developing federal policy or rules, but less
restrictive than the proposed language of the second revision, which would have
limited applicability to published research findings that were cited in or used by the
government in developing a regulation. OMB said that it based its first proposed
revision on its interpretation of floor statements in support of the provision made by
Senators Shelby, Trent Lott, and Ben Nighthorse Campbell.60 However, those
Senators cosigned a letter of April 5, 1999, to OMB Director Lew criticizing the61
narrow approach of OMB:
We believe that the clear intent of the statutory language, the accompanying report
language and floor debate was to make "all" federally funded research data subject
to FOIA, not just ... data which are used to support a federal rule or policy.
Additionally, OMB cited parts of a comment letter to the second revision
submitted by Senators Shelby, Lott, Campbell, and Gramm "that the revision should
not be limited to regulations, but should apply generally to 'federal actions that can
dramatically impact the public'."62
In response to comments that application only to data directly related to
regulations narrowed access contrary to congressional intent,63 OMB in the final
revision to Circular A-110 broadened applicability to when "a Federal agency publicly
and officially cites the research findings in support of an agency action that has the
force and effect of law." OMB said that would include actions in the form of
administrative orders, but added "we think that agencies rarely rely on Federally
funded research in the context of their administrative orders."64 OMB said it "decided
not to extend the scope of the revision to agency guidance documents and other
issuances that do not have the "force and effect of law" because that would be
difficult to implement.
It is possible that the OMB final rule will be subject to court challenges, since it
limits public access to research data and is more restrictive than Congress apparently
intended in passing the law. Some say that is a moot point since the OMB circular
— not the provision in the law directing OMB to amend it — will be the legal
predicate if there is a court challenge.65
60Congressional Record, daily ed., 9 October 1998, 144 (141): S12134.
61"Strong Response for Proposed Circular Change," op. cit., p. 2.
62OMB, Final revision, [September 30, 1999], October 8, 1999, p. 54928.
63Ibid., p. 54928.
64Ibid., p. 54928-54929.
65Testimony of James C. Miller, Citizens for a Sound Economy, Hearing on H.R. 88, 15 July
What Data Will Be Made Available to the Public? The amendment said that
FOIA would apply to "all data produced under an award," but did not define data.
The first and second proposed OMB revisions were more restrictive than the language
of the amendment (See Table 2). The first version used, but did not define, data.
The second and final revisions did so.
What Is Meant by "Data"? Many in the scientific community expressed
concern about how data should be interpreted — it might include not only final data,
but also preliminary results, as well as e-mails, physical specimens, notes of
researchers, and so forth. As discussed above, many federal agencies encourage or
require researchers to share physical specimens, as well as data, with other researchers
after the completion of a research project. Federal agency definitions such as those
used by the NSF, NIH, and NASA define data as recorded information, regardless of
form or medium. That can include computer software and copyrightable materials.
The definitions of data, however, do not include physical specimens.66
In their April 5, 1999 letter to OMB Director Jacob Lew, Senators Shelby, Lott,
and Campbell stated,
At a minimum, data should include all information necessary to replicate and
verify the original results and assure that the results are consistent with the data
collected and evaluated under the award. This would include all tangible
information or materials, including but not limited to measurements, surveys and
experimental details, and subsequent data treatments, including statistical analyses,
obtained, performed and compiled by researchers under an award and used as the
basis for reasoning, calculations, or conclusions (p. 3).
The second and the final revisions of Circular A-110 used the term research data
defining it as stated in Table 2. The definition focused on recorded factual material
needed to validate research findings, and specifically excluded several other kinds of
information and materials, including physical samples about which commenters on the
February proposed revision had expressed concern. However, arguably the second
version would have permitted access to a film or video of interviews with subjects,
which are both recorded data and samples. The final version seems to permit
researchers to withhold access to such records.
The second proposed and the final revisions also excluded from the definition of
research data, materials similar to two FOIA exemptions. Despite the objections of
many, including sponsoring Senators, that exclusions "at the
outset...[are]...inconsistent with the plain meaning of the law, and that these kinds of67
data could be exempted by an agency via the FOIA exemption process," OMB
retained them in the final revision (See table 2). One exclusion, related to Exemption
66The NIH definition can be found in the NIH Grants Policy Statement at
[http://grants.nih.gov/grants/policy/nihgps/fnpart_ii.htm]. The NASA definition can be found
at 14 C.F.R. 1260.29(a)(1). See also the Federal Acquisition Regulations (FAR)(48 CFR
27.401).
67"Comments to OMB on Proposed Clarifying Changes to Circular A-110," Letter of Senators
Campbell, Lott, Gramm, and Shelby to OMB Director Lew, September 10, 1999.
4, is for "trade secrets, commercial information, materials necessary to be held
confidential…until they are published, or similar information which is protected under
law." The second revision had excluded "information which may be copyrighted or
patented" (which commenters thought was too broad). The other exclusion is for
"information" that "would constitute a clearly unwarranted invasion of personal
privacy." The second revision had excluded "files" rather than "information," but
OMB explained in the supplementary information attached to the final revision notice
that many commenters said they feared that video or audio tapes of research subjects
might not be considered to be in the form of a file and could be subject to disclosure,
but that the word "information" covers such materials.
Thus, a grantee would not be required to submit excluded records to the funding
agency. In addition, the agency would presumably subject the records that were
submitted to further screening under the exemptions. OMB also noted that the courts
have allowed agencies to withhold an "entire record...if necessary to ensure privacy
(e.g., in a case where, notwithstanding the redaction of names or other personal
identifiers, an individual's identity could still be inferred from other information....)."68
To What Activities Does the Provision Apply? The final OMB revision limits
public access to research data consisting of "recorded" factual materials necessary to
validate research findings, excluding preliminary analyses, drafts of scientific papers,
plans for future research, peer reviews and communications. It also excludes physical
objects such as laboratory samples, trade secrets and information required to be held
confidential until publishing or similar information protected under law, and personnel
and medical information that would constitute an unwarranted invasion of personal
privacy. Furthermore, the materials have to have been published in a peer-reviewed
journal or cited by an agency in support of an action that has the force and effect of
law. (See Table 2 for a complete definition.)
Examination of funding sources indicates that about 47% of federally funded
extramural research is potentially covered by Circular A-110 (see Table 1). It
consists of federally funded research to universities and colleges and nonprofit
performers, most of which is funded by grants. However, the data that would actually
be made accessible to the public will likely come from a small proportion of federally
funded research activities. Much of the scientific activity that Circular A-110 covers69
is basic research. It is arguably likely that, under OMB's final revision, most basic
research would not be accessible to the public under FOIA because of exemptions,
the way data is defined, and the fact that most academic basic research is unlikely to
produce results used in developing "an agency action that has the force and effect of
law." However, much basic research is aimed at developing scientific principles that
can lay the groundwork for applied research that is targeted at specific policies,
actions, or regulatory issues.
68OMB, Proposed revision, [August 5]. 11, 1999, p. 43786.
69For FY1998, universities and colleges received approximately $13.7 billion in federal funds
for research and development, a large part of it for basic research. (Intersociety Working
Group, Research and Development FY2000, AAAS Report XXIV, (Washington DC: American
Association for the Advancement of Science, 1999) 65–66.
OMB also said in the supplementary information attached to the second revision
that it might narrow data access only to regulations that meet a $100 million threshold
level of impact, and it sought public comments on this suggestion. The supplementary
material attached to the final revision said OMB would not limit the applicability only
to agency actions that have an impact over $100 million, because it received
comments of both strong support for and opposition to the $100 million threshold.
Some believe that much research used in developing "agency actions that have
the force and effect of law" will still not be accessible to the public. That is because
Circular A-110 does not cover contracts, which agencies must use if procuring70
services, such as data which an agency knew from the outset would be used in
developing specific agency actions, including regulations. Federal agencies would not
be required under the amendment to obtain data from contracted research. Thus, such
data would not be available to the public under FOIA unless the contract required that
the data be provided to the agency. The circular also does not covers grants to state
and local governments, so data from such awards would not be available under the
amendment. In light of such considerations, some observers have proposed that
OMB extend the revisions of Circular A-110 to both the Federal Acquisition
Regulations (48 C.F.R. 1ff), which cover contracts, and Circular A-102, which covers
grants and cooperative agreements with state and local governments.71
What Is Meant by "Published"? The first OMB revision limited applicability
of the amendment to "data relating to published research findings...." It did not define
published, which could be interpreted narrowly or broadly, as commenters noted. For
example, it could apply only to papers published in scientific journals or to discussions
of preliminary findings at meetings, data cited in papers sent out for peer review, e-
mails, and so forth.
In their April 5 letter, Senators Shelby, Campbell, and Lott said that, while data
from published research (defined "to include publication in a journal or the
presentation of those findings to the media") should be released, "[i]f federally funded
70"An executive agency shall use a procurement contract as the legal instrument reflecting a
relationship between the United States Government and a State, a local government, or other
recipient when — (1) the principal purpose of the instrument is to acquire (by purchase, lease,
or barter) property or services for the direct benefit or use of the United States Government;
or (2) the agency decides in a specific instance that the use of a procurement contract is
appropriate" (31 U.S.C. 6303). For example, in a case involving a proposed study by the
National Academy of Sciences "to provide information on risks and benefits of certain
pesticides to help federal regulatory agencies, such as EPA, in analyzing prospective
regulations," the Comptroller General ruled, "The proper funding mechanism should be a
procurement contract,...since the primary purpose of the study is to acquire information for
the direct benefit or use of the Federal Government" (Comptroller General, "Federal Grant
and Cooperative Agreement Act of 1977 — Compliance — Cooperative Agreements —
Procurement v. Cooperative Agreement — Criteria for Determining," Decisions of the
Comptroller General of the United States 65 [1986]: 605.
71See, for example, "Analysis of the Second OMB Proposal Extending FOIA to Federal
Grantees," OMB Watch, August 20, 1999 [http://ombwatch.org/npadv/a-110rev2.html].
prepublished data or findings are used by a federal agency to support a federal rule or
policy, then...such data would also be made publically available under FOIA."72
In response, the second and final OMB revisions defined published research
findings as those appearing in a "peer-reviewed scientific or technical journal" or
publicly and officially cited in support of an agency action that has the force of law (or
in the case of the second revision, cited in a regulation). Some critics have said that
language would not resolve several problems. For instance, OMB Watch said "...the
trigger should not be based solely on whether the agency simply cites the research in
its support of the regulation. Rather, the trigger should be based on whether data from
the cited research was part of the underlying assumptions or assessments used in73
developing the regulation." NIH proposed narrowing access to "significant
scientific findings":
When a regulatory agency cites research in the regulatory process, that research
may be critically or marginally applicable to that regulation. A brief review of
regulations revealed that some cite hundreds of research studies, all of which
would be subject to FOIA under this amendment. It would greatly reduce the
burden of this legislation if access were afforded to data from only those studies
that were critical in the formulation of the regulation.74
Another question still troubling to some, despite the language of the final
revision, is what impacts public access will have on the ability of the researchers who
develop a data set to benefit appropriately from the effort they have invested.
Researchers often publish more than one paper from a set of data. Data cannot be
copyrighted75 and scientists have traditionally been reluctant to make data public until
they have had an opportunity to analyze them fully and publish the results. Once data
become publicly available, others might use them to publish analyses before the
original researchers have the opportunity to do so.76
72Letter from Senators Richard Shelby, Ben Nighthorse Campbell, and Trent Lott to Jacob
J. Lew, Director, Office of Management and Budget, April 5, 1999. For additional analysis
of the Senators' views, see: Angela Antonelli, "Preserve the Public's Right to Know About
Federally Funded Research," The Heritage Foundation Executive Memorandum, June 8,
1999, 2.
73"Analysis of the Second OMB Proposal Extending FOIA to Federal Grantees, OMB Watch,
August 20, 1999, [http://ombwatch.org/npadv/a-110rev2.html].
74"A-110: NIH Response to OMB, Memo to John Callahan, Assistant Secretary for
Management and Budget from Director NIH, [August 1999] Available at: [http://grants.
nih.gov/grants/policy/A-110/A-110_nihresponsetoomb0999.htm].
75Copyright law does not protect facts or discoveries. See, for example, Dorothy A. Schrader
and Robin Jeweler, "Intellectual Property Protection for Noncreative Databases," CRS Report
98-902, 15 September 1999.
How Quickly Should Access to the Data Be Provided? Senators Shelby, Lott,
and Campbell recommended to OMB that the public should have access in sufficient
time to review underlying data before a rule or policy is issued.
OMB should encourage agencies to: (1) notify the public of which studies will be
used as early as is feasible in the rulemaking or policy development process; and
(2) process all timely and relevant data requests before the public comment period
on a proposed rule or policy closes. In addition,...clarification that risk
assessments and other federal reports or surveys are covered independently under
the proposed revision will also help by providing the public with a chance to
review the underlying data supporting these government findings before they are77
used in a rulemaking process.
The first, second, and final versions of the revisions to the circular proposed a
"reasonable time" standard for the response to a request for research data. Some say
that those who use FOIA to obtain data to comment on a proposed regulation may
not obtain the data quickly enough to do so.78 Typical comment periods for
regulations are 30, 60, or 90 working days, although longer periods may be provided
for complex rules.79 In most cases, an agency would be required under FOIA to
notify the requester within 30 working days (six weeks) whether it would comply with
a request.80 If it grants the request, it must comply "promptly" or it may be subject
to legal action. Once the data are obtained, requesters must examine and possibly
reanalyze them to develop comments. In defense of the "reasonable time" standard,
OMB explained, in the supplementary information attached to the final revision,
"Since OMB and the agencies do not yet have experience with implementing the
public access process, we believe the 'reasonable time' standard, which allows
consideration of the circumstances of a particular case, is appropriate. As OMB and
J. Lew, Director, Office of Management and Budget, April 5, 1999, p. 2.
78Available at [http://grants.nih.gov/grants/policy/A-110/A-110_nihresponsetoomb0999.
htm].
79The Administrative Procedure Act stipulates that an agency provide "interested persons an
opportunity to participate in the rule making through submission of written data, views, or
arguments..." (5 U.S.C. 553 [c]). There is no uniform statutory requirement for the length of
a comment period, although statutes may stipulate periods in specific cases. A 1993 executive
order provides the following guidance: "[E]ach agency should afford the public a meaningful
opportunity to comment on any proposed regulation, which in most cases should include a
comment period of not less than 60 days" (President [Clinton], "Regulatory Planning and
Review," Executive Order 12866, Federal Register 58, no. 190 [4 October 1993]: 51735).
80FOIA (5 U.S.C. 552 [a][6]) states that an agency must "determine within 20 days (excepting
Saturdays, Sundays, and legal public holidays) after the receipt of [a] request whether to
comply...and shall immediately notify the person making [the] request..." In "unusual
circumstances," such as "the need to search for and collect the requested records from field
facilities or other establishments that are separate from the office processing the request," the
agency is permitted an extension of up to "ten working days."
the agencies gain experience with the public access process, we may be able to
develop further clarification on this point."81
How Long Should the Data Be Kept, and Who Should Keep Them?
Section_53 of Circular A-110 requires that papers or records pertinent to an award
(there is no specific requirement about data, but it is implied) must be retained for
three years from the date of submission of the final expenditure report, and, that if the
grantee holds it longer the federal government can still access it.82 Thus, if the
researcher kept records subject to the new circular for more than three years, the
funding agency would be able to seek that information to respond to a FOIA request.
If eligible research were officially cited or used in support of an agency action that has
the force and effect of law, but more than three years after an award had ended, the
data might no longer be available. However, in practice, scientists would seem
unlikely to so quickly discard data from such important research.
Questions remain about who — whether the university or the researcher —
should be the custodian of the data. That is important because the researchers who
collected the data may leave the institutions where the research was conducted.
According to the Council on Governmental Relations (COGR), various custodial
arrangements could be considered:
Custody could theoretically be placed at: a central facility; the department; the
laboratory or with the individual principal investigator. At least one university
(Harvard) has made the originating laboratory the custodian of research data....
Alternatively, universities may wish to assign custody of data to faculty and
researchers, whether those individual reside at the home university or move to
another institution. If so,...arrangements should specify that the custodian is
responsible for providing access to the data as well as for providing adequate data
storage. Such custodial arrangements should recognize ownership right and
require the custodian to keep the data in trust, not moving or destroying it without
appropriate advance notice and permission from the legal owner."83
How Will Public Access to Research Data Serve the Public Interest? The
debate before and after passage of the Shelby amendment and the hearings held on
H.R. 88 produced numerous reasons for widening public access to data from federally
funded research. One is the "transparency" argument — that the public should have
access to the data, since it was funded with taxpayer dollars. Other reasons are more
81OMB, Final revision, p. 54929.
82The circular requires retention of "[f]inancial records, supporting documents, statistical
records, and all other records pertinent to an award..." for three years. It also gives
government representatives "the right of timely and unrestricted access to any books,
documents, papers, or other records of recipients that are pertinent to the awards..." for "as
long as records are retained" (Section __.53 [e]). Section __.36(c) states that the government
can "[o]btain, reproduce, publish or otherwise use the data first produced under an award"
unless the awarding agency waives that right and allows the government to authorize others
to "receive, reproduce, publish, or otherwise use such data for Federal purposes."
Retention of Research Data," 1996.
directly related to accountability and the processes and politics of U.S. policymaking
that rely on scientific and technical information or judgments. As more, and more
costly, public policy decisions are based on scientific and technical information, there
will likely be more public scrutiny of the rationale for those decisions. That is
especially true in controversial issues where different scientists might interpret
research data and their policy implications differently or when opposing interest
groups might bring conflicting scientific data to bear on decisionmaking. Some
contend that public understanding of science and public financial support for science
might be enhanced with more access to research data. Others say that more access
would ensure confidence in the legitimacy of governmental actions.
Some say that peer review by other scientists may not be adequate to validate
research, especially when findings affect important public policy decisions. That is
crucial when research findings are based on "metaanalysis" or "research synthesis" —
when a researcher develops a new policy-relevant research finding based on
synthesizing the findings of many different research studies relating to the same
topic.84 Those research methods are increasingly used in policy analysis. Others
question not only the techniques used in metaanalysis, but also the validity of the
original research and findings. In addition, some segments of the public are skeptical
of the government's ability to correctly represent, interpret, or present all relevant
scientific findings, especially given recent disclosures about federal agency
misrepresentation of medical experimentation, such as the Tuskegee experiments,
relating to treatment of syphilis, and of radiation exposure levels around some nuclear
research laboratories. There is also skepticism about federal agency findings and
policies relating to research or research evaluations of subsidy or intervention
programs in such diverse areas as science education and genetic engineering of crop
seeds and other farm products. Advocates of public access say that, in cases like
those, they should be given access to research data to replicate the analyses, to verify
or refute the findings, or to evaluate methods used in conducting the research and
interpreting the data. Interested members of the public seek the same kinds of access
as other researchers often have to data, physical samples, specimens, and other
records from federally funded research.
For most research, however, scientists find that independent evaluation of the
raw data from a study is not necessary to evaluate the validity of the research.
Federal agencies and the scientific community use several methods during the research
process, with public involvement usually limited to later stages. Those evaluations
usually do not involve examination by others of the raw data produced by the
researchers. Before a grant for a scientific study is awarded, the granting agency
generally performs a merit review of the proposed study, including an evaluation of
the proposed methods of research and analysis. That review often involves evaluation
of the proposal by independent scientists. As a study progresses, scientists usually
report on progress, including preliminary findings, to their colleagues. Those findings
may become public at that time if reported at scientific conferences attended by
members of the press. Researchers may adjust methodologies or perform additional
research based on the feedback they receive from colleagues. Once a study, or a
84See for instance, Harris Cooper and Larry V. Hedges, eds., The Handbook of Research
Synthesis (New York: Russell Sage Foundation, 1994), 573 pp.
particular stage, is completed, researchers usually prepare the results for publication.
As part of that process, drafts of articles reporting the findings are usually evaluated
by other scientists, who examine the methodology, analysis, and other elements. Once
a paper is published, other segments of the scientific community and the public may
respond to it, and they might challenge the premises, methodology, analyses, or
conclusions. Such challenges might include other research aimed at testing the
validity of the findings. The potential for such testing is one of the fundamental
checks on validity provided by the scientific method. If independent researchers
obtain the same results, that greatly strengthens the conclusions. If the results cannot
be replicated, then the original conclusions were probably not correct.
However, replication can be difficult or even impossible for large-scale studies
or those using unique sets of information, such as the Harvard Six Cities study cited
earlier. Also, in some instances, regulatory or other decisions might need to be made
before confirming experiments could be performed. It is for such cases that
evaluation of the data by others can be especially important in judging the validity of
the research.
Public access to such data may lead to several alternative evaluations being
produced by interested parties. That should help validate conclusions and increase the
likelihood that errors will be detected. According to some, it could lead to a "higher
standard of review....[and] the end result of this approach will be a body of scientific
work more rigorously tested and reliable."85 However, evaluation of data is itself an
area of expertise requiring skill and training. For example, statistical analysis can be
done in many ways, and use of an inappropriate procedure can easily lead to spurious
conclusions. Therefore, public assessment of the original and alternative evaluations
may be difficult.
Will the Procedures Established Adequately Protect Proprietary
Information and the Privacy of Human Subjects?
Some opponents of the amendment say that FOIA is an inappropriate vehicle
because its exemptions would not provide adequate protections for research data that
should not be made public. As is specified in the final revision to OMB Circular A-
110, in responding to a FOIA request, a researcher or research institution may
withhold from an agency data that consists of trade secrets, confidential information,
or information that is protected by law, or personnel and medical information whose
disclosure would be an unwarranted invasion of personal privacy. Those definitions
are similar to FOIA Exemptions 4 and 6, but these data will not be sent to the agency
for consideration for redaction. As will be discussed next, despite those protections,
some researchers believe that human subjects data and proprietary data will not be
adequately protected.
Protection of Proprietary Information and Trade Secrets. The final revision
to the circular, like the second proposed revision, included language that excluded
proprietary information and trade secrets from the research data that would have to
85CRE, "Enhancements to the Scientific Enterprise," [http://www.thecre.com/access/
comments/1-2-4.html]/
be sent to an agency to comply with a FOIA request. Specifically excluded are "trade
secrets, commercial information, materials necessary to be held confidential by a
researcher until they are published, or similar information which is protected under
law." All of the language after the word "until" was modified in the final revision in
response to comments that too much information might be excluded by the second
revision, which read "until results are published in a peer-reviewed journal, or
information which may be copyrighted or patented." OMB explained in the
supplementary information published with the revision that "to avoid unintended
consequences, and to avoid having to sort out the complexities of copyright law (and
how it might apply in various areas of Federally funded research)," the substitute
language "is intended to ensure that the public access process will not upset
intellectual property rights that are elsewhere recognized and protected under the
law." 86
In addition, the exemptions and other precedents associated with FOIA would
seem to prevent public access under the Shelby amendment to trade secrets and
confidential business information. Exemption 3 exempts from mandatory disclosure
matters exempted from disclosure by other statutes. Exemption 4 specifically protects
trade secrets and privileged or confidential business information. Commercially87
sensitive data in pending patents are also protected from disclosure by other statutes.
Also, the submitter of information may challenge its release through a reverse FOIA
lawsuit. 88
Some have complained that opportunities to compromise commercially relevant
information could arise in the context of joint university/government/industry
partnerships (even if the federal share of support is only 10%), since public access will
not depend on "the level of funding or whether the award recipient is also using non-89
Federal funds." There is also the view that some partnerships that include federally
funded researchers "make strict requirements on the researcher not to share data
87See, for example CRE, "Intellectual Property Protection," [http://www.thecre.com/
access/comments/2-2-2.html].
88The House Committee on Government Reform and Oversight explained that "Although there
is no formal requirement under the FOIA, many agencies will notify a submitter of business
information that disclosure of the information is being considered (See Predisclosure
Notification Procedures for Confidential Commercial Information, Executive Order 12600,
3 C.F.R. 235[1988]). The submitter then has an opportunity to convince the agency that the
information qualifies for withholding. A submitter can also file suit to block disclosure under
the FOIA. Such lawsuits are generally referred to as "reverse" FOIA lawsuits because the
FOIA is being used in an attempt to prevent rather than to require the disclosure of
information" (House Committee on Government Reform and Oversight, A Citizen's Guide
on Using the Freedom of Information Act and the Privacy Act of 1974 to Requestthst
Government Records. First Report. 105 Cong., 1 sess., 1997, H. Rept. 105-37, 16–17).
However, the basis for such lawsuits is not FOIA, since agencies are not required to withhold
information under the exemptions, but the Administrative Procedure Act and other relevant
statutes (Department of Justice, Freedom of Information Act Guide, September 1998).
89OMB, Proposed revision, [August 5, 1999] August 11, 1999, p. 43787, citing statement of
Senator Campbell, Congressional Record, v. 144, October 9, 1998, p. S12134.
further. Without such agreements, private researchers would not participate in these
partnerships."90 NAS President Alberts testified on this subject at hearings on July 15,
For example, commercial interests that have a strong competitive interest in
particular areas of research will now be able to use FOIA requests to obtain
university-based research data for their own use and competitive advantage in an
effort to dominate or control that area of research, ultimately discouraging
independent university research in these areas. Where universities have industry
partners for jointly sponsored research projects, commercial concerns can use
FOIA requests to obtain research data from these projects to the detriment of the91
actual project sponsors, who are their competitors.
He also said foreign governments would obtain data from federally funded basic92
research for use in their own R&D. There is also concern about timing: "Under
U.S. law, scientists have a year from the date of publication to file a patent
application. Will allowing data to be publicly available through FOIA threaten a
scientist's foreign patent rights?"93
According to the Council on Governmental Relations (COGR), considerable
case law has grown around use and challenges under FOIA and indicates that
"Exemption 4 has been effective in protecting university data."94 "..[T]here are well-
understood exemptions that serve to protect data that are important to universities for
scientific or commercial reasons," according to COGR.95 In fact, according to
testimony of James T. O'Reilly, Visiting Professor of Law, University of Cincinnati
College of Law, and author of Federal Information Disclosure, the protections
afforded by the exemptions to FOIA and court and case law, together with agency
rules and policies, have been viable in protecting privacy and commercial interests.
In addition, he said, there are about 100 special exempting statutes. "The conflicts
over specific research interests in medical device testing data, for example, have96
already been addressed in specific substantive laws."
90Statement of Director Varmus, 15 July 1999, p. 4.
91Statement of Dr. Alberts, 15 July 1999, pp. 4-5.
93Mark S. Frankel, "Public Access to Data," Science 284 (19 February 1998), 1114.
94Specifically according to COGR,"Case law regarding use of Exemption 4 shows that two
major tests are being used. Decisions regarding release of data are based on whether the
provider is likely to experience 'competitive harm' as a result of the release. If universities
desire to shield scientific raw data, protection may well hinge on the broad interpretation of
'competitive harm.' The second criterion traditionally used is the 'government impairment'
test. Release is usually granted when courts find no danger that the Government would be
unable to obtain information in the future or that release would cause substantial competitive
injury." (COGR, "Legislation to Amend OMB Circular A-110....", p. 4.)
96Testimony before the Subcommittee on Government Management, Information, and
Technology, House Committee on Government Reform, July 15, 1999.
Nevertheless, others have recommended that OMB "require agencies to allow
private sector participants in federally funded projects, who either contributed parts
of the database to the project or participated in developing the database, an
opportunity to make recommendations to the federal agency regarding which data
should be withheld from disclosure pursuant to the FOIA exemptions."97
Protection of Personal Information About Volunteer Human Subjects.
Many scientific studies involve volunteer human subjects. Concerns about protecting
the privacy of those subjects has increased in recent years in conjunction with the
increasing capabilities of information technology to integrate separate pieces of98
related information and the rapid pace of discoveries about human genetics. Many
observers believe that current protections for personal medical and health information
(collected during medical treatment as well as during scientific research) are
inadequate generally, and Congress has considered legislation to address such99
concerns. Some analysts suggest that the potential for increased public access to
health research data provided by the revision of Circular A-110 may increase those
concerns.
The exclusion of certain personal information in the circular's definition of
research data (Table 2) is intended to protect against unwarranted invasions of
privacy. FOIA Exemption 6 provides additional protection, as does the Public Health
Service Act.100 However, FOIA permits, but does not require, agencies to withhold
information covered by the exemptions, and courts have ruled that public interest in
disclosure may outweigh privacy interests (see section on FOIA above). Therefore,
some fear that information that a human research subject was told was confidential
might become public. In addition, courts might reject the exclusions that OMB wrote
into the definition of research data and require researchers to submit all data to the
agency, which would then determine what personal information can be withheld.
Some have expressed concern that the sorting and analytical capabilities of
information technology might permit human subjects to be identified even if personal
identifiers were removed. According to NIH Director Varmus,
97CRE, "Intellectual Property Protection," [http://www/thecre/com/access/comments/
98See, for example, B.P. Fuller and others, "Privacy in Genetics Research," Science 285 (27
August 1999): 1359–1361.
99See C. Stephen Redhead and Gina Marie Stevens, Medical Records Confidentiality, CRS
Issue Brief IB98002, 15 September 1999.
100The act permits but does not require the researcher to protect a subject's privacy. "The
Secretary [of Health and Human Services] may authorize persons engaged in biomedical,
behavioral, clinical, or other research...to protect the privacy of individuals who are the
subject of such research by withholding from all persons not connected with the conduct of
such research the names or other identifying characteristics of such individuals. Persons so
authorized to protect the privacy of such individuals may not be compelled in any Federal,
State, or local civil, criminal, administrative, legislative, or other proceedings to identify such
individuals" (42 U.S.C. 241 [d]).
FOIA would allow the government agency to remove obvious identifiers such as
name, Social Security number, telephone number, but in a given data set it is quite
feasible to identify subjects using other information. If the requestor knew a few
items about an individual's history, such as place of birth, education occupation,
marital history, or other general information, an individual could be identified.
Such identification would then open up the whole research record, including101
personal medical information, to the requestor.
A related concern of researchers is that potential volunteer human subjects,
fearing that personal private information will not be protected, will be reluctant to
participate in research projects. Experience over time will indicate whether the
exclusions embodied in the term research data will resolve concerns about privacy
and proprietary information.
What Will Be the Financial Benefits and Costs of Implementation?
Potential financial benefits associated with the Shelby amendment could result
from savings from actions not required. Three kinds of costs are potentially
associated with implementation: reimbursable costs, nonreimbursable costs, and costs
associated with the litigation that could follow implementation. Each of them is
discussed below.
Potential Benefits. The potential financial benefits of the amendment would be
reflected in any net savings to the public and the private sector that could occur if
implementation pursuant to Circular A-110 prevented agency actions having the force
and effect of law if the benefits of the actions were determined incorrectly, or if the
benefits did not justify the expense. This might include the net savings accruing from
postponing or not imposing regulations or other standard setting requirements. These
kinds of actions could result, according to some observers, in savings of billions of102
dollars annually. It is also possible that wider public access to research data used
in federal actions having the force and effect of law could facilitate public scrutiny and
identification of errors, which, if corrected, might lead to improved federal actions and
regulations. However, it is difficult to speculate about a range of cost savings in the
absence of information about which actions might be subject to provisions of the law.
Reimbursable Costs. FOIA allows the federal government to recover
reasonable costs of fulfilling requests, although reimbursements go to the Treasury,
not to the agency that incurred the costs. The Shelby amendment and revision to
Circular A-110 provided specifically for cost recovery, in addition to the normal
reimbursement fees imposed upon the requestor for a FOIA request.
The February proposed revision to Circular A-110 did not indicate whether
researchers and their universities or the federal agency would be reimbursed, or
101Statement of Harold Varmus, M.D., Director, NIH, before the Subcommittee on
Government Management, Information, and Technology Committee on Government Reform,
15 July 1999, p. 4.
102See footnote 13 above, statement of William Kovacs at hearings on H.R. 88, Regarding
Data Available Under the Freedom of Information Act, 15 July 1999, pp. 2-3.
whether fees collected would go to the U.S. Treasury, as with reimbursements
covered directly by FOIA. The second and final revisions said that agencies "may
charge the requester a reasonable fee equaling the full incremental cost of obtaining
the research data. This fee should reflect costs incurred by the agency, the recipient,
and applicable subrecipients. This fee is an addition to any fees the agency may assess
under the FOIA (5 U.S.C. 552(a)(4)(5))." The amendment itself is silent on whether
the agency can retain the fee or whether it should go to the Treasury. However, the
supplementary information attached to the second revision and the final revision
explained that agencies may seek reimbursement from data requesters to reimburse
the recipient and the agency for the costs of providing the data.103
Several objections were raised to the reimbursement provisions. OMB Watch
said the proposed revision does not explain how reimbursement would occur if the
agency fulfilling the FOIA request were not the grant-making agency or how to deal
with reimbursement for the costs of providing data after a grant period was finished104
and all funds had been expended.
Nonreimbursable Costs. Even though researchers may be reimbursed for
maintaining and preparing data to satisfy FOIA requests, scientists have complained
that FOIA access would substantially encumber researchers and universities with new
responsibilities. According to the president of the National Academy of Sciences,
"...federal research grantees are generally not well-equipped by inclination, training
or experience to deal with the legal and definitional subtleties of 'data' and the
bureaucratic responsibilities that go with being custodians of 'agency records' nor105
with the very substantial financial and administrative burdens of doing so." In
addition, some say that researchers who are likely to receive a request for information
from an agency pursuant to FOIA would be forced to store and maintain their data
in a form that could be understood. At the July 15 hearing on H.R. 88, NIH Director
Varmus also testified that costs of centralizing and maintaining data could be
staggering. In a letter to OMB commenting on the second proposed revision, he said,
"The costs associated with providing data under this amendment are likely to be
substantially greater than costs incurred to fulfill current FOIA requests" because of
the expense of importing and exporting data sets, especially if software were custom-
made for the research, and the costs of training agency FOIA officials to assess
materials for exemptions, including "training in the substantive area covered by the
research data as well as epidemiology and biostatistics."106
Some say that the provision will result in expansion of the federal bureaucracy
because agencies are likely to have to create a new office to decide how to collect and
103OMB, Proposed Revision, [August 5, 1999] August 11, 1999, p. 43791 and Final revision,
[September 30, 1999] October 8, 1999, p. 54929.
104 OMB Watch, "Analysis of the Second OMB Proposal Extending FOIA to Federal
Grantees," August 20, 1999. Available at: [http://ombwatch.org/npadv/910comment.html].
105Letter from Bruce Alberts, President, National Academy of Sciences to the Honorable
Jacob J. Lew, Director, OMB, January 16, 1999.
106"A-110: NIH Response to OMB," Memo to John Callahan, Assistant Secretary for
Management and Budget from Director NIH, [August 1999], op. cit.
maintain research data and reimburse researchers. There may also be a need to create
a central office at research universities to deal with FOIA requests forwarded by an
agency.
Some have commented that much administrative work and researcher time will
be needed to prepare data and any accompanying explanations for disclosure. The
Federation of Behavioral, Psychological and Cognitive Sciences suggested that, to
alleviate the costs associated with this possibility, federal agencies could "notify
investigators whose work has been officially and publicly cited that their data meet the
threshold for being subject to a FOIA request."107 Then the institution could recover
costs for the period during which data could be subject to FOIA. A similar suggestion
of notifying researchers who need to retain data was made by NAS President Alberts
in his letter to OMB on April 5. Some observers have said that the expenses to
universities are likely to exceed the 26% cap on administrative costs as part of the
indirect cost rate universities may charge as defined in OMB Circular A-21, "Cost108
Principles for Educational Institutions." Therefore, universities would have to
absorb the costs unless Circular A-21 were revised. In its second revision, OMB
stated that it would consider such a revision and invited comments on costs.
Supplementary information in the final revision said comments received on this issue
focused on the need for a separate agreement between the awarding agency and the
recipient to ensure reimbursement for the full incremental cost of responding. It
explained a process that agencies might use and said that OMB would consider
revising Circular A-21 if the process did not work.
Costs of Litigation. Another issue of concern focuses on the potentially large
costs of litigation about implementation of the new rules as researchers, the
government, the public, and interest groups seek to clarify the meanings of ambiguous
terms and to determine whether agencies and funding recipients are complying
appropriately, especially in those cases where requests are denied. Some complain
that large amounts of money may be spent on lawsuits to deal with interpretations of
specific cases.
How Might the Changes Affect Needed Research?
It is possible that the changes will have little impact on research. Agencies may
determine that only a few actions having the force and effect of law cited or used
grantee-generated research data that would be open to public access via the revisions
to Circular A-110. In a September 10 letter to OMB, Senators Shelby, Campbell, Phil
Gramm, and Lott said that although OMB's exclusion of business and personal
information from its definition of research data that is maintained in the final revision
...may seem an innocent restatement of the FOIA exemptions, it creates a troubling
outcome by allowing researchers and agency officials broad discretion to interpret
these new exceptions outside of FOIA and the case law that has evolved under
FOIA. Given that terms such as privacy and confidential business information are
107 Letter from David Johnston to F. James Charney, OMB, September 1, 1999.
108See archived CRS IB91095, "Indirect Costs at Academic Institutions: Background and
Controversy; archived issue brief."
highly subjective, the results could be disastrous for the public's ability to access
important information. For instance, the main reason provided by research
institutions for not releasing the raw data supporting the particulate matter
epidemiology studies is the need to protect the privacy of the research subjects
despite the fact that personal identifiers could be redacted. The OMB proposed
revision should rely on the FOIA exemptions and the case law which have evolved
over time in applying these exemptions rather than allowing ad-hoc and109
inconsistent decisionmaking....
If there were only a few public requests for such data, neither researchers nor
their institutions might experience any major changes resulting from the amendment.
However, the amendment might stimulate more independent reanalysis of data, or
methods used to evaluate data, from covered research. It may also inspire more
efforts by researchers to explain the bases of their findings to the public. Or it may
generate more public scrutiny of the content and quality of scientific and technical
data used in making federal policies.
But some observers worry that costs, concerns about protection of personal and
proprietary information, and the potential for abuse could inhibit scientists from
performing needed research. As noted above, concerns have been raised that
subjecting research data to FOIA will make human subjects reluctant to participate
in studies (or, if they do, to provide sensitive medical and other information to the
researchers), and will make some scientists reluctant to engage in research likely to
be subject to FOIA requests. Some researchers say that study participants might
refuse to participate if they know that the federal government would see personal data
about them. There is also the view that despite privacy protections and the constraints
on obtaining human subjects data that are in the final revision to Circular A-110,
research would be compromised, since researchers would be obligated to inform study
participants that the information they provide might not remain confidential and could
be sent to the government.110 According to NIH Director Varmus,
Such intrusions could stop promising scientific research in its tracks, and the mere
threat of such intrusions could impede the Nation's efforts to recruit its most
talented students into publicly-supported research. For example, imagine what
would happen if HIV-infected patients thought their condition might be revealed
by someone using the new requirements to examine raw experimental data.
Patients would not participate in clinical trials if they believed there was an
opportunity for their infected status to be revealed. Progress toward treatment of
the disease would be stymied.111
109"Comments to OMB on Proposed Clarifying Changes to Circular A-110 Revision," Letter
to Jacob Lew, Director, OMB, September 10, 1999, from Senators Sen Nighthorse-Campbell,
Senator Richard Shelby, Senator Trent Lott, and Senator Phil Gramm,
[http://www.senate.gov/~Shelby/press/prsrs283.htm].
110Views of Bruce Alberts, April 5, 1999 letter to OMB, pp. 13–14 . Similar views were
expressed by Gary D. Bass, OMB Watch, in testimony before the House Committee on
Government Reform, Subcommittee on Government Management Information and
Technology, July 15, 1999, p 3.
111 Ibid.
Some observers fear that the effort required to respond to FOIA requests and
uncertainties about how the data would be used might inhibit the conduct of research
likely to be subject to the provision. Some even fear harassment — that groups
opposed to particular types of research will impose excessive data reporting
requirements on them:
[I]f FOIA is extended to research data, special interest groups could make data
requests solely for the purpose [of] creating the costs and disruptions that are
inherent in gathering extensive amounts of raw research data. Under FOIA, the
requestor would be the agency, not the group leading the campaign. The University
would be obligated to undertake extensive work and involve the time of the
targeted researchers, which would be the intention of the action, as well as utilize112
limited resources and staff time in fulfilling these mandated requests.
A third area of concern is that the various costs associated with implementation
could inhibit research. Time spent by researchers on complying with FOIA requests
could not be spent on research, and researchers might decide not to pursue a
particular line of research if they fear that it is likely to lead to burdensome FOIA
requests, or to involvement in litigation associated with such requests. If research
institutions find the financial burdens associated with compliance too great, they might
discourage scientists from pursuing research likely to generate FOIA requests. Also,
if agencies fear that compliance with FOIA requests will be too burdensome, they
might cite less research in developing regulations or support less research that would
be likely to generate requests.
Additional Issues for Congress
Attempts have been made in the 106th Congress to modify or repeal the
amendment. In addition, it is possible that Congress and OMB may exercise oversight
of implementation of the law by the federal agencies. These activities are discussed
Representatives James T. Walsh and David E. Price offered an amendment to the
Treasury Appropriations Bill for FY2000 to deny funds to implement the law pending
further study, possibly by the National Academy of Public Administration. The
amendment was defeated 25-33 in an Appropriations Committee vote on July 14,113
1999. Hearings were held by the Subcommittee on Government Management,
Information and Technology of the House Committee on Government Reform on July
15, 1999, on a bill introduced by the late Representative George E. Brown, Jr., to
repeal the law. Representative Brown's efforts began in December 1998, when 23
House members, including six Republicans, wrote a letter to OMB Director Jack Lew
warning about "a number of negative unintended consequences." Among the
cosigners were the chairmen of the House appropriations subcommittees for NIH and
112Shelton, Hearing on H.R. 88, 15 July 1999.
113"Effort to Block Access to Research Findings Under FOIA Fails. Administration to Release
Revised Regulation Soon," Washington Fax, July 15, 1999. See also: "Opponents of New
Data Release Law Maintain Blocking Strategy If Passed, House Amendment Would
Strengthen Research Argument," Washington Fax, June 16, 1999.
NSF, as well as Members from the House Science Committee. Representative Brown
subsequently introduced H.R. 88, a bill to repeal the provision of the law on data
access.114 No further action has occurred. Representative Rush Holt has assumed115
leadership on H.R. 88, following Representative Brown's death.
In a press release commenting on the final revision to Circular A-110, Senator
Shelby described it as "still narrow in scope" but as a "good first step to giving the116
American people access to the research and science used in federal policies...."
Reportedly, a spokeswoman for the Senator commented that he "may look at the
issue again in the future, depending on how federal agencies put the new rules into
effect."117 Similarly, the supplementary information attached to the final revision said,
"As OMB and the agencies develop experience with the revised Circular, changes to
the data access process may be considered. These could range from technical and
clarifying changes to substantive revision or rescission. OMB also endeavors to
review each of its Circulars every three years." 118
Oversight activities could focus on such issues as
!whether or not the objectives of the law are being met, or whether, by
virtue of the definition of research data, published, and so forth, and
other limitations in the revision of the circular, the public is being
denied access to research data cited or used in important agency actions
that have the force and effect of law;
!whether or not the research process is being helped or hampered by
implementation of the law;
!whether or not the formulation of public policy involving science and
technology is being helped or hampered by implementation of the law;
!whether or not industrial funding of research in universities for
cooperative government/university/industry projects is suffering
because of fears that public access to federally funded data might
release confidential industrial information;
!whether or not the conduct of research involving human subjects is
suffering because of fears that human subjects' privacy and
confidentiality is being compromised; and
!whether or not the reimbursable and nonreimbursable costs of
compliance are excessive or burdensome to requesters, researchers,
universities, and federal agencies.
114Extension of Remarks of Hon. George E. Brown, Jr., Congressional Record, January 7,
1999, E32-E33. See also, Bruce Agnew, "Freedom of Information: Scientific Leaders Balk
at Broad Data Release," Science, January 15, 1999, pp. 307-309.
115See, for example, "Rep. Holt Leads Bipartisan Attack on Science Regulations," News from
Congressman Rush Holt, October 8, 1999, 2 p.
116"Sen. Shelby Comments on OMB Final Revision to Circular A-110," Press Release, Office
of Richard Shelby, October 8, 1999.
117Kenneth Skilling, "OMB's Final Version of A-110 Changes Includes Wide Definition of
'Research Data,' " Daily Report for Executives 195, October 8, 1999, p. A-34.
118OMB, Final revision, [September 30, 1999] October 8, 1999, p. 54927.
While some scientists seek to make more data available to the public, they say
that FOIA is not appropriate and that other mechanisms should be used to make data
available to other researchers and the public. There also are suggestions to modify
the way data is stored and to fund more accessible data-collection storage and
retrieval databases for scientists and for the public. NIH Director Varmus cited a
number of those data repositories in his letter to OMB, commenting on the August
version of OMB's proposed revision to Circular A-110, including the Inter-University
Consortium for Political and Social Research and the National Center for Health
Statistics. Proposals could be introduced to provide funds for developing additional
databases of this sort.
Calls to modify Circular A-110 may continue, involving such issues as
!limiting access even more — such as to agency actions that meet the119
$100 million threshold of cost or impact;
!determining whether the applicability of the policy espoused in the
Shelby amendment should be extended to both the Federal Acquisition
Regulations (48 C.F.R. 1ff), which cover contracts, and Circular A-102,
which covers grants and cooperative agreements with state and local
governments; and
!requiring recipients to prepare a list of withheld data so that a requester
can challenge the propriety of the recipient's decision to withhold data
or to develop a way to appeal if a requester believed data were withheld
inappropriately. 120
119For instance, "Robert Hahn, director of the joint Center for Regulatory Studies, and Linda
Cohen, an economics professor at the University of California at Irvine, suggest tailoring
access to the documents. They believe there should be access to the information that results
in regulations that have significant economic impact—such as the EPA's 1997 ozone and
particulate matter standard, which would make current air-pollution rules more stringent —
and an independent agency should be created to replicate the results of research before any
standard becomes final." (Cindy Skrzycki, "The Regulators; Data Disclosure; Business Wants
to Breach a Stonewall," Washington Post, June 11, 1999, E01.) Dr. Hahn testified on these
points at the July 15, 1999 hearing.
120"CRE Comments to OMB on its August 11, 1999 Reproposal," letter to OMB Sept. 10,
1999 [http://www.thecre.com/access/cretoomb.html].