by Charles Walter and Edward P. Richards, III, 19 IEEE Engineering In Medicine And Biology Magazine #4 121-125.
a two-sentence provision in the Omnibus 1999 Appropriations Bill [Public Law
105-277] directing the Office of Management and Budget (OMB) to amend OMB Circular
A-110 to extend the Freedom of Information Act (FOIA) to "require Federal
awarding agencies to ensure that all data produced under an award will be made
available to the public under the FOIA." The Circular applies to grants
and other financial assistance provided to institutions of higher education,
hospitals, and non-profit institutions from all Federal agencies. Therefore,
the final revision will affect the full range of research activities funded
by the Federal Government.
to congressional floor statements made in support of the provision in P.L. 105-277,
its aim is to "provide the public with access to federally funded research
data" that are "used by the Federal Government in developing policy
and rules"  (Statement of Sen. Lott). The provision "represents
a first step in ensuring that the public has access to all studies used by the
Federal Government to develop Federal policy"  (Statement of Sen. Shelby).
The congressional proponents further explained that the provision requires OMB
"to amend OMB Circular A-110 to require Federal awarding agencies to ensure
that all research results, including underlying research data, funded by the
Federal Government are made available to the public through the procedures established
under the Freedom of Information Act"  (Statement of Sen. Lott). The
proponents of the legislation stated that "the amended Circular shall apply
to all Federally funded research, regardless of the level of funding or whether
the award recipient is also using non-Federal funds"  (Statement of
Sen. Campbell). They also noted that "[t]he Conferees recognize that this
language covers research data not currently covered by the Freedom of Information
Act. The provision applies to all Federally funded research data regardless
of whether the awarding agency has the data at the time the request is made"
under the FOIA .
to the provision contained in P.L. 105-277, OMB published a Notice of Proposed
Revision to the Circular on February 4, 1999 . This initial proposed revision
(c) The Federal Government has the right to (1) obtain, reproduce, publish or
otherwise use the data first produced under an award, and (2) authorize others
to receive, reproduce, publish, or otherwise use such data for Federal purposes.
In addition, in response to a Freedom of Information Act (FOIA) request for
data relating to published research findings produced under an award that were
used by the Federal Government in developing policy or rules, the Federal awarding
agency shall, within a reasonable time, obtain the requested data so that they
can be made available to the public through the procedures established under
the FOIA. If the Federal awarding agency obtains the data solely in response
to a FOIA request, the agency may charge the requester a reasonable fee equaling
the full incremental cost of obtaining the data. This fee should reflect costs
incurred by the agency, the recipient, and applicable subrecipients. This fee
is in addition to any fees the agency may assess under the FOIA (5 U.S.C. 552(a)(4)(A))."
first proposed revision interpreted the provision in P.L. 105-277 to apply only
to published data. This is surely a reasonable limitation in that premature
distribution of raw research data can lead to misunderstandings amongst the
public and thereby do more harm than good. Moreover, OMB recognized that the
provision should not require scientists to make research data publicly available
while the research is still ongoing . To do so would force scientists to
"operate in a fishbowl" and to release information prematurely .
proposed revision also limited FOIA access to data used in developing policy
or rules. Whether this limitation conforms to Congressional intent would depend
on the interpretation of "used" and "policy or rules." A
broad interpretation may conform whereas a narrow interpretation would exclude
access to data that the provision intended to make available. Within these limits,
the first proposed revision implemented the language and intent of the provision
in P.L. 105-277 that "all research results, including underlying research
data, funded by the Federal Government are made available to the public through
the procedures established under the Freedom of Information Act."  (Statement
of Sen. Lott).
this revision, OMB recognized that agencies would be able to withhold personal
privacy and confidential business information pursuant to existing FOIA exemptions
. As noted in the FOIA exemptions, federal statute prohibits the release
of certain information related to technology transfer such as pending patent
applications. Under FOIA exemption 6, an agency is not required to release "personnel
and medical files and similar files the disclosure of which would constitute
a clearly unwarranted invasion of personal privacy." The U.S. Supreme Court
explained in U.S. Dep't of Justice v. Reporters Committee of the Freedom of
the Press that certain types of privacy information can be protected as a categorical
matter, without regard to individual circumstances . The FOIA exceptions
for protecting the privacy of medical and personal records were strengthen by
the Privacy Act , which severely limits the discretion to release records
that is provided by the exceptions to the FOIA. In addition, courts have held
that, although the redaction of names or other individual identifiers may be
sufficient in some cases to protect privacy, an entire record may be withheld
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) .
approximately 8,350 comments on the proposed revision during the 60-day period
during which comments were timely. 55 percent of the comments received were
submitted by individual members of the public, without any organizational identification.
Individual researchers working at institutions of higher education accounted
for 36 percent of the comments. The remainder of the comments came from other
non-profit research organizations (three percent), professional associations
(two percent), commercial research organizations (one percent), and official
comments from institutions of higher education (one percent). OMB also received
comments from Members of Congress, Federal agencies, employees of State governments,
and law firms.
commenters stated that they support the concept of full disclosure and open
access to information. Even commenters who opposed the provision contained in
P.L. 105-277 admitted that the traditional scientific process operates by requiring
researchers to subject their findings to the scrutiny of the scientific community
and the general public, so that those findings may be validated, corrected,
commenters offered strongly differing views on the provision contained in P.L.
105-277. Of those comments received, 55 percent supported implementation of
P.L. 105-277 in the form of the proposed revision. These commenters stated that
the public has a right to obtain research data that have been funded with tax
dollars, particularly when the research findings were used by the Federal Government
in developing policy or rules. They also expressed the view that making this
data available for public review and validation would improve the scientific
of the commenters suggested modifications of the proposed revision, and 37 percent
opposed P.L. 105-277 and the proposed revision implementing it. Commenters
who opposed the provision contained in P.L. 105-277 expressed concern that the
approach required by P.L. 105-277 would significantly impair scientific research.
In their view, individuals and businesses would be reluctant to agree to participate
in research, since the participants' personal privacy and proprietary information
could not be assured of confidential treatment.
some commenters from the scientific community expressed concerns about the impact
P.L. 105-277 would have on their research activities. In part, these concerns
arose from questions as to how expansively or narrowly the statute and the proposed
revision would be interpreted and applied.
these questions, commenters on both sides of the debate sought clarification
of three concepts. The first concept, "data," originated in the provision
in P.L. 105-277. The other two concepts, "published," and "used
by the Federal Government in developing policy or rules" originated in
OMB's proposed revision.
some commenters asked how the "reasonable fee" agencies may charge
pursuant to the provision contained in P.L. 105-277 would reach those who actually
incurred the expense of making the data available in response to the FOIA request.
This question was addressed fully by OMB when it pointed out that the "reasonable
fee" is intended to cover the cost of obtaining the requested data, and
is therefore separate from the FOIA fee an agency could assess under 5 U.S.C.
552(a)(4)(A). In light of the congressional intent that Federal agencies and
researchers be reimbursed by the requester for the costs that they incur in
responding to the request, OMB concluded that agencies may retain this new fee,
in order to reimburse themselves, recipients, and applicable subrecipients,
for the costs they incur . While passing on the fee can pay for clerical
costs, it does not solve the problem of smaller labs or specialized data where
the scientists themselves will have to take time away from their research to
prepare requested data.
Institutes of Health (NIH) response to the legislation was that the FOIA is
fundamentally inappropriate as a vehicle for sharing research data held by grantees.
However, this did not prevent NIH from recommending solutions for a litany of
horrors it envisions should OMB do as directed by P.L. 105-277 . First, the
NIH comment "strongly" recommended that "any new rule clarify
that only those projects for which 51 percent or more of the funds were from
Federal sources should be subject to the requirement." This would clearly
be contrary to the legislative intent expressed by Senator Campbell that there
be FOIA access to data even if the award recipient is also using non-Federal
funds . In addition, the NIH comment proposed that the access be limited
to data used to develop formal agency regulations that go through the rulemaking
process, or other actions of equivalent impact. Since NIH is not a regulatory
agency, its proposal would arguably exclude it from making most of the research
data generated under NIH grants available pursuant to the provision in P.L.
105-277. Obviously, the NIH comment is contrary to the legislative intent expressed
by Senator Lott that there be FIOA access to data used by the Federal government
to develop "policy or rules" .
A large number
of comments addressed the fact that "data" is not defined in either
P.L. 105-277 or in the proposed revision to Circular A-110. Some commenters
from the scientific community expressed concern that "data" might
be interpreted expansively to include such things as lab specimens, a researcher's
lab notebooks, working papers, phone logs and electronic mail, or a researcher's
from the scientific community also raised the concern that requiring public
access to research "data" would result in the public disclosure of
private information such as the medical condition or treatment of research subjects
and proprietary business information of their research partners. These commenters
were not reassured by the fact that the Federal awarding agency would be able
to withhold information that falls within the existing FOIA exemptions discussed
supporting the provision contained in P.L. 105-277 agreed that the term "data"
needs to be defined. Even commenters who argued for a broad interpretation of
"data" agree that financial records and other personal data of individual
researchers should be excluded from disclosure. A comment letter from Senators
Shelby, Lott, and Campbell made the common sense point that "research data"
should be defined:
on how the term is commonly used in the scientific community and the ultimate
goal of this provision. 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."
OMB proposed a definition of "research data" that is much narrower
than even the minimum scope suggested by Senators Shelby, Lott, and Campbell.
Rather than including at least "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," the definition proposed
by OMB is limited to "recorded factual material commonly accepted in the
scientific community as necessary to validate researching findings" but
necessary to be held confidential until publication in a peer-reviewed journal,
which may be copyrighted or patented, or
medical or similar files the disclosure of which would constitute a clearly
unwarranted invasion of personal privacy.
definition of "data" would exclude a substantial amount of "all
data produced under an award." As with other applications of the FOIA to
agency held information, the courts will determine if information is being improperly
characterized to prevent release under the FOIA. In doing so the courts will
uphold a definition of "data" restricting release only if it is consistent
with the statutory language in PL 105-277 requiring Federal awarding agencies
"to ensure that all data produced under an award will be made available
to the public under the FOIA." If the courts determine that "under
the FOIA" places substantive limits on what comprises "all data produced
under an award," a restrictive definition, perhaps based on other applications
of the FOIA to agency held information, might be upheld. On the other hand,
if the courts determine that "under the FOIA" merely sets forth the
procedure for disclosing "all data produced under an award," a less
restrictive definition will apply.
generally supported OMB's clarification that public access pertains to "published"
research findings. For example, a comment letter from Senators Shelby, Lott,
and Campbell stated that "the OMB reference to published findings is not
inconsistent with the underlying statute" and that "this limitation
to data related to published research findings will ensure that the provision
does not disrupt the research process by forcing the premature release of data
before the study is completed."
the general support for this publication requirement, a significant number of
commenters raised questions regarding when research findings have been "published."
Apparently, the usual, common sense meaning of "published research data"
(data that the researcher has elected to disclose publicly) was objectionable.
However, the reasoning offered to support these objections was generally not
some commenters claimed that defining "published" expansively could
lead to premature release of data as well as misunderstandings and false claims
about what research proves. It is not clear how this would take place. By definition,
publication of any sort makes information available to the public. Unless the
researcher publishes his or her results prematurely, there is no chance the
results will be considered to be "published" for purposes of FOIA
disclosure and released prematurely. If the researcher does publish prematurely,
whatever damage would be done by premature release is done. The provision in
P.L. 105-277 is therefore irrelevant to these comments.
Some of these
commenters also noted that requiring researchers to make their data publicly
available prematurely could also prevent future publication in some peer-reviewed
journals, and may limit a researcher's patent rights. But, as described above,
the disclosure required under the provision in P.L. 105-277 could happen only
if the researcher has already published the data--a process that may have already
jeopardized publication in peer-reviewed journals or limited patent rights.
some of these commenters argued that the willingness of private sector organizations
to enter into partnerships would be reduced unless their proprietary data can
be protected. Other researchers feared harassment from groups that do not support
certain scientific methods or those that do not support certain areas of research.
None of these arguments address the question of when publication of research
who support the provision contained in P.L. 105-277 were generally sympathetic
to concerns about premature disclosure of preliminary research data. However,
many expressed the concern that, if "published" meant only publication
in a peer-reviewed journal, Federal agencies would be able to rely on research
findings that have been released to the agency (while not having yet been published
in a peer-review journal), but interested members of the public would not be
able to obtain the data that are necessary to validate these findings. This
concern was also raised in the comment letter from Senators Shelby, Lott, and
Campbell, which stated that
federally-funded pre-published data or findings are used to support a federal
policy or rule, then the final revision should ensure that such data would also
be made publicly available under FOIA. If the data are sufficiently sound to
support a federal policy or rule, then they should be able to bear public scrutiny
and disclosure...This point is critical to ensuring that our federal rules and
policies are based on good science and research findings." 
OMB proposed that "published" data be limited to either data published
in a peer-reviewed scientific or technical journal, or public and official citations
of data by a Federal agency in support of a regulation.
definition of "published" would exclude a substantial amount of "data
produced under an award" that is published elsewhere. According to the
above proposed restrictive definition of "data" and this proposed
restrictive definition of "published," you would not have to disclose
data if you can characterize it as one of the exceptions listed above, if it
falls under one of the exceptions in the FOIA, or if it is not published in
a peer-reviewed scientific or technical journal. Read on for more.
confuse "publication" for purposes of requiring FOIA disclosure under
P.L. 105-277 with "publication" for purposes of public disclosure
of a discovery you want to patent. You do not have to have published your discovery
in a peer-reviewed article in a scientific or technical journal for disclosure
of your discovery to be "published" for purposes of your patent rights.
Your discovery is still published when you distribute a description of it publicly.
requested clarification on what is meant by "used by the Federal Government
in developing policy or rules." Commenters who oppose the provision contained
in P.L. 105-277 argued for an interpretation under which "policy or rules"
would refer to agency regulations, and "used" would refer to the agency's
public and official citation of the research findings in support of the agency
who support the provision contained in P.L. 105-277 argued for a more literal
interpretation, under which "policy or rules" would mean "policy
or rules," including such things as agency guidance, surveys, risk assessments
and reports, and "used" would refer to when the agency first relies
internally on the findings.
OMB took the position that the provision contained in P.L. 105-277 should be
implemented in the manner that is most easily workable in practice. In this
regard, OMB felt that the operating principles in Circular A-110 should be relatively
easy to administer, should rely on existing processes whenever possible, and
should not result in uncertainties and disagreements when they are applied to
the facts in individual cases .
It was not
clear to OMB how the provision in P.L. 105-277 would operate in practice outside
the regulatory context. OMB observed that when agencies undertake "less
formal agency action" they often do not prepare and issue accompanying
explanatory preambles that outline the basis and underlying factual support
for the action. OMB felt that, in the absence of a formal record that explains
the agency's action, it would be too difficult for the public and the agencies
to determine whether particular research findings were "used" by the
agency in developing the agency action. For example, an agency might be viewed
as having "used" research findings if those findings:
(1) were relied
upon in an internal agency memorandum sent to a decision maker;
(2) were discussed
in an agency staff level communication, such as an email message; or
(3) were simply
available for the agency staff to read, regardless of whether there was any
evidence that the staff relied upon the findings in carrying out their work.
identifying agency reliance in the regulatory context, OMB felt that criteria
could not be applied readily and easily by members of the public and the agency
for determining whether research data should be publicly available under the
provision contained in P.L. 105-277. Instead of being able to rely on the public
record, these criteria would require a fact-intensive inquiry into the agency's
internal deliberations. OMB felt that such an inquiry could be burdensome and
time-consuming, and might intrude into the agency's deliberative process.
that "considerable implementation problems" would arise if the FOIA
access provision in P.L. 105-277 extended to such agency actions as guidance,
surveys, assessments, and reports. In fact, OMB concluded that such implementation
problems would arise unless the provision in P.L. 105-277 was implemented only
in the context of the agencies' promulgation of regulations. This is clearly
not what this legislation was intended to do. For example, there are numerous
non-regulatory Federal agencies (e.g., NIH) that develop Federal policy. The
legislation was clearly intended to require release of research data used by
non-regulatory Federal agencies in developing policies (e.g., NIH policies for
awarding research grants).
There is no
doubt that an agency's citation to research findings in support of a regulation
allows the data disclosure provision in P.L. 105-277 to be administered most
readily and easily. But the provision in P.L. 105-277 anticipates that, when
data is generated by research funded by the Federal taxpayers, the public should
have access to it when it is used in non-regulatory agency actions, including
agency guidance, surveys, assessments, reports, and the like.
does not appear that the provision contained in P.L. 105-277 can be readily
and easily implemented outside of the regulatory context. Given the considerable
implementation difficulties, and the lesser public interest in obtaining the
underlying research data when the agency is not taking action that has the force
and effect of law, OMB does not believe that the public interest would be served
by extending the provision contained in P.L. 105-277 beyond the regulatory context
OMB disregarded the plain language of the provision in P.L. 105-277 directing
OMB to "ensure that all data produced under an award will be available
to the public" through FOIA. OMB also disregarded statements by Senators
Lott and Shelby that the purpose of the data disclosure provision in P.L. 105-277
includes a guarantee that the public have access to "all studies used by
the Federal Government to develop Federal policy" . Replacing this mandate
with access merely to information used to develop a "regulation" may
avoid real and imagined "problems" created by public access to data
generated by public funding, but it also substantially limited public access
to most of the data the provision in P.L. 105-277 was intended to make available
to the public under the FIOA.
its "easy to implement" reasoning, OMB restricted "used"
in "used by the Federal Government in developing policy or rules"
to mean "a public and official citation to research data used in support"
and restricted "policy or rules" to mean "a regulation."
In addition, OMB requested comment on whether limiting the scope of the proposed
revision to regulations that meet a $100 million impact threshold would be appropriate.
definition of "used" and "policy or rules" would exclude
a substantial amount of "data produced under an award" that is used
in other ways. According to the above proposed restricted definitions of "data"
and "published," and this proposed restricted definition of "used"
and "policy and rules," you would not have to disclose data if you
can characterize it as one of the exceptions listed above, if it falls under
one of the exceptions in the FOIA, if it is not published in a peer-reviewed
scientific or technical journal, or if is not used publicly and officially by
an agency in support of a regulation, or some other action that has the force
and effect of law.
Notice to Implement P.L. 105-277
As a result
of this first round of comments, OMB changed its proposed amendment to Circular
A-110 as described above. The new proposed amendment was:
(c) The Federal
Government has the right to (1) obtain, reproduce, publish or otherwise use
the data first produced under an award, and (2) authorize others to receive,
reproduce, publish, or otherwise use such data for Federal purposes.
addition, 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. If the Federal awarding agency obtains
the research data solely in response to a FOIA request, the agency may charge
the requester a reasonable fee equaling the full incremental cost of obtaining
the research data. This fee should reflect costs incurred by the agency, the
recipient, and applicable subrecipients. This fee is in addition to any fees
the agency may assess under the FOIA (5 U.S.C. 552(a)(4)(A)).
(2) The following
definitions are to be used for purposes of subsection (d):
data" is defined as the recorded factual material commonly accepted in
the scientific community as necessary to validate researching 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
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.
by the Federal Government in developing a regulation" is defined as when
an agency publicly and officially cites to the research findings in support
of a regulation (for which notice and comment is required under 5 U.S.C. 553).
of the second round of comments and what OMB did about them appears in our next
1. 144 Cong.
Rec. S12134 (October 9, 1998).
Fed. Reg. 5684-5.
3. OMB Request
for Comments on Clarifying Changes to Proposed Revision on Public Access to
Research Data at
heading "Grants Management."
4. Wolfe v.
Department of Health and Human Services, 839 F.2d 768, 773 (D.C. Cir. 1988)
(en banc); Montrose Chemical Corp. of Calif. v. Train, 491 F.2d 63, 66 (D.C.
5. 5 U.S.C.
6. U.S. Dep't
of Justice v. Reporters Committee of the Freedom of the Press, 489 U.S. 749,
7. 5 U.S.C.
v. NLRB, 676 F.2d 423, 428 (10th Cir. 1982); Whitehouse v. U.S. Dep't of Labor,
997 F. Supp. 172, 175 (D. Mass. 1998).
9. NIH Response
from T.J. Tychan to OMB.
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