NIH Seeks Comments on Data
Sharing Policy
March 8, 2002 - The National Institutes of Health
(NIH) March 1 requested
comments from the research community on its proposed data
sharing guidance. NIH policy will require all applicants for
research awards to submit a data-sharing plan with their applications,
or to state explicitly why data sharing is not possible. The
proposed statement is consistent with long standing NIH policies
promoting open communication and sharing of research data
and tools, to the maximum extent possible and consistent with
protection of the confidentiality of human subjects, intellectual
property, or other. The agency notes that such policy ensures
openness in science, strengthens scientific inquiry and criticism,
promotes new research or alternative approaches, and even
improves efficiency in spending limited research funds (e.g.,
by eliminating duplication of effort in data collection).
NIH also intends its statement to be consistent with guidelines
and requirements established by major journals for research
publications, sharing of research tools, and intellectual
property practices.
The issue of data sharing within federally sponsored research
has been raised several times outside of the scientific community
and particularly in Congress, for example, in 1998 legislation
amending the Office of Management and Budget (OMB) Circular
A-110 (the so-called Shelby Amendment). That legislation sought
to make data from federally funded academic research available
to the public under the Freedom of Information Act. The amendment's
implementation has been primarily narrowed to published data
specifically cited in the promulgation of federal regulations.
More recently, OMB encouraged dissemination of research data
in guidelines for ensuring the quality of information disseminated
by federal agencies [67 Federal Register 369,
revised 8451]
[see Washington Highlights,
Jan. 11]. Those guidelines, which also were required by
legislation, reflected concerns similar to the Shelby amendment
for the reliability of research data used to develop federal
regulations. Action by the scientific community was effective
in refining both OMB's Circular A-110 and its recent data
quality guidelines.
The NIH notes that data sharing is an issue well addressed
within individual research project proposals, allowing investigators
to identify appropriate procedures and formats and to ensure
that other regulations and obligations, such as protecting
the confidentiality of research participants, are observed.
This proposed mechanism would further allow applicants to
seek reimbursement for at least some of the costs for archiving
and communication of data to be supported by the research
grant. Public comments on NIH's data sharing statement must
be received no later than June 1, 2002.
Information:
Stephen Heinig, Senior Research Fellow
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
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