WASHINGTONThe Office of Management and Budget (OMB) has issued
a final rule that defines what research data the public can demand to
see under the Freedom of Information Act (FOIA). To the relief of
many in the biomedical sciences, the White House agency did not
include data from research in progress or any information that could
be used to identify particular persons in a research study.
The new rule took effect Nov. 6. It requires that data from a
published study must be provided within a reasonable time
when the information is requested under the FOIA. To OMB, a published
study is one that has appeared in a peer-reviewed journal or one that
a federal agency has officially cited to support an action that
has the force and effect of law. [See below for definitions.]
Narrowing the FOIA Target
Scientific organizations expressed considerable concern about what
Research data is defined as the recorded factual material
Research data also does not include: trade secrets,
Published is defined as either when research findings are
Anyone who makes a request for research data can be charged a
reasonable fee to cover the costs incurred in providing
The new rule is a revision to OMB Circular A-110, which governs the
administration of federally funded research grants. OMB was required
to make the revision by a two-line amendment inserted into the 1999
Omnibus Appropriations Bill by Sen. Richard C. Shelby (R-Ala). His
amendment, which passed both houses of Congress, called on OMB
to require Federal awarding agencies to ensure that all data
produced under an award will be made available to the public
through FOIA procedures.
Sen. Shelby acted after researchers at the Harvard School of Public
Health refused to release data they had gathered and which the
Environmental Protection Agency relied upon to justify its decision
to create a standard for ultrafine ambient air particles. The Harvard
scientists said that releasing the data would violate the
confidentiality of people they studied.
When word of the Shelby amendment spread, the research community
responded with vigorous protests. For example, National Cancer
Institute director Richard D. Klausner, MD, said the Shelby amendment
has very disruptive, if not paralyzing implications for
research. And the National Cancer Advisory Board responded with
a letter strongly expressing its concerns.
When OMB published a first draft of its proposed revision, it
received more than 9,000 letters of comment. Its second draft drew
another 3,000 comments. In issuing its final rule, OMB said it
recognizes the importance of ensuring that the revised Circular
does not interfere with the traditional scientific progress. As
such, we have not construed the statute as requiring scientists
to make research data publicly available while the research is still ongoing.
OMB said it also agreed with the suggestion that all appropriate data
be protected. Thus, it changed its initial wording to replace the
word files in the phrase personal and medical
files with the word information so as to protect
such things as videotapes or audiotapes of research subjects.
OMB made clear that the responsibility for identifying requested
material remains with the researchers, and that staff of federal
funding agencies would not search investigators files. However,
the federal awarding agency would retain its right to ask the
recipient for additional information, if it believed the
recipients submission was not complete.
As for research data already available to the public through data
archives or other means, OMB agreed that researchers could answer an
FOIA request by providing information on how to obtain the sought
The cost of responding to an FOIA request concerned many in research.
In its rule, OMB said that when information is obtained solely in
response to an FOIA request, the federal agency could charge a fee to
cover the full incremental cost of obtaining the research data.
This fee should reflect cost incurred by the agency, the
recipient, and applicable subrecipients, the agency noted.
OMB also dealt with the situation in which a data request is made
after a federal grant or contract has expired. Under FOIA procedures,
a request for data would go to the funding agency, which would then
ask the grantee for an estimated cost of complying. With cost in
hand, the federal agency would then apply existing standards
for requesting appropriate prepayments from the requester. And
once the requested data are received, the federal awarding agency
will then seek reimbursement from the person or organization making
the FOIA request.