Public Access to Data From Federally Funded Research: OMB Circular A-110 and Issues for Congress

Congressional research reportNov 18, 1999

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Order Code RL30376

CRS Report for Congress

Received through the CRS Web

Public Access to Data From Federally Funded

Research: OMB Circular A-110 and Issues for

Congress

November 18, 1999

(name redacted) and (name redacted)

Resources, Science, and Industry Division

Congressional Research Service ˜ The Library of Congress

ABSTRACT

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

Summary

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.

Contents

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

List of Tables

Table 1. Percentage Shares of Federally Funded R&D and Research Awarded to

Selected Performers, Calculated According to Percentages of Federal

Obligations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Table 2. Comparison of Language Relating to Data Availability in the Shelby

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.

Congressional 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].

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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 two

years or more.”2 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.

At [http://www2.whitehouse.gov/OMB/circulars/index.html] .

OMB Circular No. A-1, Revised, Subject: Bureau of the Budget’s System of Circulars and

Bulletins to Executive Departments and Establishments, August 7, 1952.

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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 and

health.5 Industry groups requested to review the data, but the researchers refused,

According 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 A110. 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,

105th Cong., 2nd 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,

105th Cong., 2nd sess., 1998, H. Rept. 105-789).

See, 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.

(continued...)

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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 are

well-supported scientifically and do not carry an undue burden.7

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

(...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,

Hearings, 105th Cong. lst sess., March 12 and May 7 and 21, 1997, 582-596.

“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].

See, 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.

See, 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.

445 U.S. 169, 179 (1980).

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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

“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.)

Ibid., at 186.

Ibid., at 180.

For 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 AEIBrookings 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.).

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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

Research

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,

extramural, especially academic, research by grants.15 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

universities.

Testimony 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.

See 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 (name redacted),

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-MSET-34, February 1986, pp. 14-15; and Daniel S. Greenberg, The Politics of Pure Science

(New York: The New American Library, 1967), Chap. vi.

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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 funded

activity

2. Performer

3. Percentage of activity in

column 1 performed by performer

in column 2

Research and development

(R&D)

Nonfederal performers, FY1999

preliminary16

76%

Research only

Nonfederal performers, FY1999

preliminary17

74%

Research only

Intramural performers, FY1999

preliminary

26%

Research only

Universities and colleges (39%)

and nonprofit institutions, (8%)

FY1999, preliminary18

47%

Research only

Universities and colleges, FY1999,

preliminary19

39%

1. Type of activity

2. Source of funds

3. Percentage of activity in

column 1 provided by the federal

government, as described in

column 2

All research performed by

universities and colleges

Federal government, FY1998,

preliminary20

59%

Calculated 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).

Calculated from Table C-18, Ibid., (NSF 99-333).

Ibid.

Excluding FFRDCs. Calculated from Table C-18, Ibid., (NSF 99-333).

Calculated 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).

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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 access

to research data via databases.23 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.

Adler, “Impact of FOIA,” 1-2.

See 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.

Excerpts 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].

CRS-9

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 PHSsupported 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

Section on “Publications” in Part 8, “Postaward Administration” in PHS Grants Policy

Statement, (PHS GPS 9505).

Ibid.

“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).

Interview, John C. Chester, NSF General Counsel office, September 13, 1999.

CRS-10

safeguard the rights of individuals and subjects, the validity of results, or the

integrity of collections or to accommodate legitimate interests of investigators.28

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

Document GC-1, October 1, 1998.

“Actions Are Needed to Promote Research Sharing,” Statement from Bruce M. Alberts,

Kenneth I. Shine, and William A. Wulf, September 8, 1998.

“Sociologists Take Note: Data Access and Proposed Use of FOIA,” Footnotes, February

1999.

Letter AAAS to Hon. Jim Kobe, chairman, Subcommittee on Treasury, Postal Services and

General Government, House Committee on Appropriations, May 3, 1999.

Council on Governmental Relations (COGR), “Policy Considerations: Access to and

Retention of Research Data,” Washington, D.C., 1996, 5.

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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

confidential,

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

wells.

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 make

discretionary disclosures of exempt information “as a matter of good public policy.”37

For 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 (n ame redacted), 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.

Exemption 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)).

Exemption 7 has 6 qualifying subparts.

In 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.”

U.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

(continued...)

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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 have

interpreted the exemptions narrowly, promoting disclosure.39

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

(...continued)

1993), [www.usdoj.gov/oip/foia_updates/Vol_XIV_3/page3.htm].

However, 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]).

Martin J. Silverman, “Administrative Law — Freedom of Information Act — Agency

Records — Forsham v. Harris,” New York Law School Law Review 27, no. 2 (1981): 643 –

644.

In 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.

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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 protect

sensitive data.44

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-day

comment period.45 After reviewing more than 9,000 comments, OMB published a

second proposed revision on August 11 and provided an additional 30-day comment

period.46 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 both

published and used in the development of policies or rules.47 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.).

Paul 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.

Center for Regulatory Effectiveness, “CRE Comments on Data Access Rule I.3.5 State

Legislation.”

California Government Code, sec. 6255.

Testimony 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.

Office 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.

Office 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-a110.html].

OMB, “Proposed Revision,” 5684-5685.

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The final revision was released on September 30, 1999 and published in the Federal

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

Office of Management and Budget, Final Revision, “OMB Circular A-110, ‘Uniform

Administrative Requirements for Grants and Agreements With Institutions of Higher

Education, Hospitals, and Other Non-profit Organizations,” [September 30, 1999], Federal

CRS-15

Administrations; and the Eagle Forum.49 Those groups argued for what the Senate

sponsors discussed relating to transparency and accountability — a broad, wideranging 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 American

Association for the Advancement of Science Council.51 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

“Strong Response for Proposed Circular Change,” Science and Technology In Congress,

June 1999, 2.

“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.

See 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].

“Opponents of New Data Release Law Maintain Blocking Strategy If Passed, House

Amendment Would Strengthen Research Argument,” Washington Fax, June 16, 1999.

Paul Guzzi, president, Greater Boston (MA) Chamber of Commerce, Letter to OMB

Regarding Proposed Revision to Circular A-11, April 5, 1999.

CRS-16

process, and (3) implement a public access process that will be workable in

practice.54

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.)

Ibid., OMB, Proposed Revision, [August 5, 1999], August 11, 1999, p. 43786, at

[http://www.whitehouse.gov/OMB/fedreg/2ndnotice-A-110.html].

Ibid., p. 43786 and Final Revision, p. 54927.

Proposed revision, p. 43787 and Final revision, p. 54928. These are similar to FOIA

exemptions 4 and 6.

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Table 2. Comparison of Language Relating to Data Availability in the Shelby Amendment, Proposed Revisions, and Final Revision to OMB

Circular A-110 (emphasis added)

Legislative 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

Information Act”

FIRST OMB

February 1999

Proposed Revision of

Circular A-110

SECOND OMB

August 1999 Proposed Revision of Circular A-110

FINAL OMB

September 30 , 1999 Final Revision of Circular A-110

“...in response to a

Freedom of

Information Act

(FOIA) request for

data relating to

published research

findings produced

under an award that

were used by the

Federal Government

in developing policy or

rules, the Federal

awarding agency shall,

within a reasonable

time, obtain the

requested data so that

they can be made

available to the public

through the procedures

established under the

FOIA.”

“...in response to a Freedom of Information Act (FOIA) request for

research data relating to published research findings produced under

an award that were used by the Federal Government in developing a

regulation, the Federal awarding agency shall request, and the recipient

shall provide, within a reasonable time, the research data so that they

can be made available to the public through the procedures established

under the FOIA....

(i) “Research data” is defined as the recorded factual material

commonly accepted in the scientific community as necessary to validate

research findings, but not any of the following: preliminary analyses,

drafts of scientific papers, plans for future research, peer reviews, or

communications with colleagues. This “recorded” material excludes

physical objects (e.g., laboratory samples). Research data also do not

include (A) trade secrets, commercial information, materials necessary

to be held confidential by a researcher until publication of their results

in a peer-reviewed journal, or information which may be copyrighted or

patented; and (B) personnel and medical files and similar files the

disclosure of which would constitute a clearly unwarranted invasion of

personal privacy, such as information that could be used to identify a

particular person in a research study.

(ii) “Published” is defined as either when (A) research findings are

published in a peer-reviewed scientific or technical journal, or (B) a

Federal agency publicly and officially cites to the research findings in

support of a regulation.

(iii) “Used by the Federal Government in developing a regulation” is

defined as when an agency publicly and officially cites the research

findings in support of a regulation (for which notice and comment is

required under 5 U.S.C. 553).

“...in response to a Freedom of Information Act (FOIA) request for

research data relating to 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, the Federal awarding

agency shall request, and the recipient shall provide, within a reasonable

time, the research data so that they can be made available to the public

through the procedures established under the FOIA.....

(i) “Research data” is defined as the recorded factual material

commonly accepted in the scientific community as necessary to validate

research findings, but not any of the following: preliminary analyses,

drafts of scientific papers, plans for future research, peer reviews, or

communications with colleagues. This “recorded” material excludes

physical objects (e.g., laboratory samples). Research data also do not

include (A) 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, and (B) personnel

and medical information and similar information the disclosure of

which would constitute a clearly unwarranted invasion of personal

privacy, such as information that could be used to identify a particular

person in a research study.

(ii) “Published” is defined as either when (A) research findings are

published in a peer-reviewed scientific or technical journal, or (B) a

Federal agency publicly and officially cites to the research findings in

support of an agency action that has the force and effect of law.

(iii) “Used by the Federal Government in developing an agency action

that has the force and effect of law” is defined as when an agency

publicly and officially cites the research findings in support of an

agency action that has the force and effect of law.

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Issues

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, federal

infrastructure, and case law for FOIA are well-established.57 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 are

released.59

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.

Will the Revision Make the Desired Information Available to the

Public?

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.

Do the Proposed Changes to Circular A-110 Meet the Legislative Intent of

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 A110 limits access to selected kinds of federally funded “research data relating to

Testimony of James T. O’Reilly, University of Cincinnati College of Law, Hearing on H.R.

88, 15 July 1999.

Testimony 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.

“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.)

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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 the

narrow approach of OMB:61

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

Congressional Record, daily ed., 9 October 1998, 144 (141): S12134.

“Strong Response for Proposed Circular Change,” op. cit., p. 2.

OMB, Final revision, [September 30, 1999], October 8, 1999, p. 54928.

Ibid., p. 54928.

Ibid., p. 54928-54929.

Testimony of James C. Miller, Citizens for a Sound Economy, Hearing on H.R. 88, 15 July

1999.

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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 of

data could be exempted by an agency via the FOIA exemption process,”67 OMB

retained them in the final revision (See table 2). One exclusion, related to Exemption

The 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).

“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.

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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 covers

is basic research.69 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.

OMB, Proposed revision, [August 5]. 11, 1999, p. 43786.

For 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.

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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 procuring

services,70 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, emails, 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

“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.

See, 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].

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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 in

developing the regulation.”73 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

Letter 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.

“Analysis of the Second OMB Proposal Extending FOIA to Federal Grantees, OMB Watch,

August 20, 1999, [http://ombwatch.org/npadv/a-110rev2.html].

“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].

and (name redacted),

“Intellectual Property Protection for Noncreative Databases,” CRS Report

98-902, 15 September 1999.

“Analysis of the Second OMB Proposal Extending FOIA to Federal Grantees, OMB Watch,

August 20, 1999, [http://ombwatch.org/npadv/a-110rev2.html].

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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 are

used in a rulemaking process.77

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

Letter from Senators Richard Shelby, Ben Nighthorse Campbell, and Trent Lott to Jacob

J. Lew, Director, Office of Management and Budget, April 5, 1999, p. 2.

Available at [http://grants.nih.gov/grants/policy/A-110/A-110_nihresponsetoomb0999.

htm].

The 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).

FOIA (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.”

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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

OMB, Final revision, p. 54929.

The 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.”

Council on Governmental Relations (COGR), “Policy Considerations: Access to And

Retention of Research Data,” 1996.

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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

See for instance, Harris Cooper and Larry V. Hedges, eds., The Handbook of Research

Synthesis (New York: Russell Sage Foundation, 1994), 573 pp.

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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 A110, 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

CRE, “Enhancements to the Scientific Enterprise,” [http://www.thecre.com/access/

comments/1-2-4.html]/

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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. Commercially

sensitive data in pending patents are also protected from disclosure by other statutes.87

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 nonFederal funds.”89 There is also the view that some partnerships that include federally

funded researchers “make strict requirements on the researcher not to share data

OMB, Final revision, p. 54928.

See, for example CRE, “Intellectual Property Protection,” [http://www.thecre.com/

access/comments/2-2-2.html].

The 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 Request

Government Records. First Report. 105th Cong., 1st 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).

OMB, Proposed revision, [August 5, 1999] August 11, 1999, p. 43787, citing statement of

Senator Campbell, Congressional Record, v. 144, October 9, 1998, p. S12134.

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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,

1999:

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 the

actual project sponsors, who are their competitors.91

He also said foreign governments would obtain data from federally funded basic

research for use in their own R&D.92 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 wellunderstood 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, have

already been addressed in specific substantive laws.”96

Statement of Director Varmus, 15 July 1999, p. 4.

Statement of Dr. Alberts, 15 July 1999, pp. 4-5.

Ibid.

Mark S. Frankel, “Public Access to Data,” Science 284 (19 February 1998), 1114.

Specifically 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.)

Ibid.

Testimony before the Subcommittee on Government Management, Information, and

Technology, House Committee on Government Reform, July 15, 1999.

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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 of

related information and the rapid pace of discoveries about human genetics.98 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 such

concerns.99 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,

CRE, “Intellectual Property Protection,” [http://www/thecre/com/access/comments/

2-2-2.html].

See, for example, B.P. Fuller and others, “Privacy in Genetics Research,” Science 285 (27

August 1999): 1359–1361.

See (name redacted) and Gina Marie Stevens,

Issue Brief IB98002, 15 September 1999.

100

Medical Records Confidentiality, CRS

The 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]).

CRS-31

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, including

personal medical information, to the requestor.101

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 of

dollars annually.102 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

101

Statement 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.

102

See 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.

CRS-32

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’ nor

with the very substantial financial and administrative burdens of doing so.”105 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 custommade 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

103

OMB, 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].

105

Letter 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.

CRS-33

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, “Cost

Principles for Educational Institutions.”108 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

108

Letter from David Johnston to F. James Charney, OMB, September 1, 1999.

See archived CRS IB91095, “Indirect Costs at Academic Institutions: Background and

Controversy; archived issue brief.”

CRS-34

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 and

inconsistent decisionmaking....109

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].

110

Views 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.

CRS-35

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 utilize

limited resources and staff time in fulfilling these mandated requests.112

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

next.

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,

1999.113 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

112

Shelton, 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.

CRS-36

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 assumed

leadership on H.R. 88, following Representative Brown’s death.115

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 the

American people access to the research and science used in federal policies....”116

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.

114

Extension 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.

115

See, 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.

117

Kenneth 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.

118

OMB, Final revision, [September 30, 1999] October 8, 1999, p. 54927.

CRS-37

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 the

$100 million threshold of cost or impact; 119

! 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

119

For 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].

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