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<!-- From DocTemplateOld.txt -->
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<TITLE>NOT-OD-03-032: FINAL NIH 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: FINAL NIH STATEMENT ON SHARING RESEARCH DATA NOT-OD-03-032. NIH">
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<pre>
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FINAL NIH STATEMENT ON SHARING RESEARCH DATA
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RELEASE DATE: February 26, 2003
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NOTICE: NOT-OD-03-032
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National Institutes of Health ((NIH)
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As part of NIH's long-standing policy to share and make available to
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the public the results and accomplishments of the activities that it
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funds, NIH announced and invited comments on a draft statement about
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the sharing of final research data on March 1, 2002. Since that time,
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NIH has received and reviewed many thoughtful comments from a range of
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scientific organizations and over 150 individuals. Additionally, during
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the comment period, HHS published final modifications for the STANDARDS
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FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION, the
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"Privacy Rule," of the Health Insurance Portability and Accountability
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Act (HIPAA), available at <a href="https://www.hhs.gov/ocr/">http://www.hhs.gov/ocr/</a>. The Privacy Rule is
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a federal regulation that governs how certain health care providers,
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health care clearinghouses, and health plans, known as "covered
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entities," use and disclose identifiable health information. NIH has
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carefully considered the comments and the Privacy Rule, and issues the
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following statement on data sharing:
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NIH reaffirms its support for the concept of data sharing. We believe
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that data sharing is essential for expedited translation of research
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results into knowledge, products, and procedures to improve human
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health. The NIH endorses the sharing of final research data to serve
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these and other important scientific goals. The NIH expects and
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supports the timely release and sharing of final research data from
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NIH-supported studies for use by other researchers. Starting with the
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October 1, 2003 receipt date, investigators submitting an NIH
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application seeking $500,000 or more in direct costs in any single year
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are expected to include a plan for data sharing or state why data
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sharing is not possible.
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As indicated above, all investigator-initiated applications with direct
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costs greater than $500,000 in any single year will be expected to
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address data sharing in their application. Applicants are encouraged to
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discuss their data sharing plan with their program contact at the time
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they negotiate an agreement with the Institute/Center (IC) staff to
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accept assignment of their application as described at
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<a href="http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html">http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html</a>.
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Applicants are reminded that agreement to accept assignment of
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applications over $500,000 must be obtained at least six weeks in
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advance of the anticipated submission date. Instructions related to the
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data sharing policy as it is applied to applications and proposals
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responding to a specific Request for Application (RFA) or Request for
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Proposals (RFP) will be described in the specific solicitation. In
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some cases, Program Announcements (PA) may request data sharing plans
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for applications that are less than $500,000 direct costs in any single
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year. Reviewers will not factor the proposed data-sharing plan into
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the determination of scientific merit or priority score. Program staff
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will be responsible for overseeing the data sharing policy and for
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assessing the appropriateness and adequacy of the proposed data-sharing
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plan.
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NIH recognizes that data sharing may be complicated or limited, in some
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cases, by institutional policies, local IRB rules, as well as local,
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state and Federal laws and regulations, including the Privacy Rule. As
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NIH stated in the March 1, 2002 draft data sharing statement
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(<a href="http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-035.html">http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-035.html</a>),
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the rights and privacy of people who participate in NIH-sponsored
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research must be protected at all times. Thus, data intended for
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broader use should be free of identifiers that would permit linkages to
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individual research participants and variables that could lead to
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deductive disclosure of the identity of individual subjects. When data
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sharing is limited, applicants should explain such limitations in their
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data sharing plans.
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The final NIH statement on data sharing is largely the same as stated
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in the March 1, 2002 draft with the following exceptions:
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o The effective start date has been changed from January 1, 2003 to
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October 1, 2003 receipt date.
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o This policy applies to applicants seeking $500,000 or more in direct
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costs in any year of the project period. Such applicants are expected
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to contact IC program staff prior to submission and are also expected
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to include a data-sharing plan in their application stating how they
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will share the data or, if they cannot share the data, why not.
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Applicants responding to an RFA or RFP will find instructions related
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to data sharing in the specific announcement.
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o Several groups and individuals objected to sharing of research data
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prior to publication. As noted earlier, NIH recognizes that the
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investigators who collect the data have a legitimate interest in
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benefiting from their investment of time and effort. We have therefore
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revised our definition of "the timely release and sharing" to be no
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later than the acceptance for publication of the main findings from the
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final data set. NIH continues to expect that the initial investigators
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may benefit from first and continuing use but not from prolonged
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exclusive use.
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For more information on data sharing, please see our website at
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<a href="http://grants.nih.gov/grants/policy/data_sharing/">http://grants.nih.gov/grants/policy/data_sharing/</a>.
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</pre>
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<P><HR><P>
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<A HREF="/grants/guide/WeeklyIndex.cfm?WeekEnding=02-28-03">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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