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<TITLE>NOT-OD-02-035: NIH ANNOUNCES DRAFT STATEMENT ON SHARING RESEARCH DATA</TITLE>
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<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: NIH ANNOUNCES DRAFT STATEMENT ON SHARING RESEARCH DATA NOT-OD-02-035. NIH">
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<pre>
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NIH ANNOUNCES DRAFT STATEMENT ON SHARING RESEARCH DATA
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Release Date: March 1, 2002
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NOTICE: NOT-OD-02-035 (See <a href="/grants/guide/notice-files/NOT-OD-03-032.html">NOT-OD-03-032</a> for Update)
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National Institutes of Health
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Data sharing promotes many goals of the National Institutes of Health's
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(NIH) research endeavor. It is particularly important for unique data
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that cannot be readily replicated. Data sharing allows scientists to
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expedite the translation of research results into knowledge, products,
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and procedures to improve human health. THE NIH IS DEVELOPING A
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STATEMENT ON DATA SHARING THAT EXPECTS AND SUPPORTS THE TIMELY RELEASE
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AND SHARING OF FINAL RESEARCH DATA FROM NIH-SUPPORTED STUDIES FOR USE
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BY OTHER RESEARCHERS. INVESTIGATORS SUBMITTING AN NIH APPLICATION WILL
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BE REQUIRED TO INCLUDE A PLAN FOR DATA SHARING OR TO STATE WHY DATA
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SHARING IS NOT POSSIBLE. This statement will apply to extramural
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scientists seeking grants, cooperative agreements, and contracts as
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well as intramural investigators.
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Institutions and individuals are invited to comment on the draft
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policy. Additional information is available online on the NIH web site
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at: <a href="/grants/policy/data_sharing/index.htm">http://grants.nih.gov/grants/policy/data_sharing/index.htm</a>
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Comments must be received no later than June 1, 2002. They should be
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sent to the Office of Extramural Research, 1 Center Drive, MSC 0152,
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Building 1, Room 150, Bethesda, MD 20817 or by email to <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="462222233406282f2e68212930">[email protected]</a>
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Following consideration of public comments and appropriate revisions,
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it is expected that the new policy will be announced on August 1, 2002
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with a proposed effective date of January 1, 2003.
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Background Information
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There are many reasons to share data from NIH-supported studies.
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Sharing data reinforces open scientific inquiry, encourages diversity
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of analysis and opinion, promotes new research, makes possible the
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testing of new or alternative hypotheses and methods of analysis,
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supports studies on data collection methods and measurement,
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facilitates the education of new researchers, enables the exploration
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of topics not envisioned by the initial investigators, and permits the
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creation of new data sets when data from multiple sources are combined.
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By avoiding the duplication of expensive data collection activities,
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the NIH is able to support more investigators than it could if similar
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data had to be collected de novo by each applicant.
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NIH-supported basic research, clinical studies, surveys, and other
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types of research produce data that may be shared. However, NIH
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recognizes that sharing data about human research subjects presents
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special challenges. The rights and privacy of people who participate
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in NIH-sponsored research must be protected at all times. Thus, data
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intended for broader use should be free of identifiers that would
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permit linkages to individual research participants and variables that
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could lead to deductive disclosure of individual subjects. Similarly,
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NIH recognizes the need to protect patentable and other proprietary
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data and the restriction on data sharing that may be imposed by
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agreements with third parties. It is not the intent of this statement
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to discourage, impede, or prohibit the development of commercial
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products from federally funded research.
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There are many ways to share data. Sometimes data are included in
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publications. Investigators may distribute data under their own
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auspices. Some investigators have placed data sets in public archives
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while others have put data on a web site, building in protections for
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privacy through the software while allowing analysis of the data.
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Restricted access data centers or data enclaves facilitate analyses of
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data too sensitive to share through other means. All of these options
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achieve the goals of data sharing.
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However, the NIH also recognizes that in some particular instances
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sharing data may not be feasible. For example, studies with very small
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samples or those collecting particularly sensitive data should be
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shared only if stringent safeguards exist to ensure confidentiality and
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protect the identity of subjects.
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The NIH will expect investigators supported by NIH funding to make
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their research data available to the scientific community for
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subsequent analyses. Consequently, the NIH will require that data
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sharing be addressed in grant applications (e.g., in sections related
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to significance, budget, and the end of the research plan) and in the
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review of applications. Funds for sharing or archiving data may be
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requested in the original grant application or as a supplement to an
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existing grant. Investigators who incorporate data sharing in the
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initial design of the study can more readily and economically establish
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adequate procedures for protecting the identities of participants and
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provide a useful data set with appropriate documentation. Applicants
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whose research will produce data that are not amenable to sharing
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should include in the application reasons for not making the data
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available. NIH encourages investigators to consult with an NIH Program
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Administrator prior to submitting an application to determine the
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appropriateness of data sharing and a suitable mechanism to disseminate
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the data.
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This statement on data sharing is an extension of NIH policy regarding
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sharing research resources, which expects that recipients of NIH
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support will provide prompt and effective access to research tools.
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(See NIH Grants Policy, Part II Subpart A, Availability of Research
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Results: Publications, Intellectual Property Rights, and Sharing
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Biomedical Research Resources
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(<a href="http://grants.nih.gov/grants/policy/nihgps_2001/nihgps_2001.pdf">http://grants.nih.gov/grants/policy/nihgps_2001/nihgps_2001.pdf</a>)
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This statement is also an extension of the PHS policy relating to the
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distribution of unique research resources produced with PHS funding
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(see <a href="http://grants.nih.gov/grants/guide/notice-files/not96-184.html">http://grants.nih.gov/grants/guide/notice-files/not96-184.html</a>)
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Principles and guidelines for sharing biomedical research resources can
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be found in online NIH reports at
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<a href="http://www.nih.gov/science/models/sharing.html">http://www.nih.gov/science/models/sharing.html</a>
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and <a href="http://www.nih.gov/news/researchtools/index.htm">http://www.nih.gov/news/researchtools/index.htm</a>. Moreover, this
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statement on data sharing is consistent with the policies of many
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scientific journals publishing the findings of NIH-supported research.
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</pre>
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<P><HR><P>
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<A HREF="/grants/guide/WeeklyIndex.cfm?WeekEnding=03-01-02">Weekly TOC for this Announcement</A><br>
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<A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A>
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