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<TITLE>NOT-OD-04-042: NIH POLICY ON SHARING OF MODEL ORGANISMS FOR BIOMEDICAL RESEARCH</TITLE>
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<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: NIH POLICY ON SHARING OF MODEL ORGANISMS FOR BIOMEDICAL RESEARCH NOT-OD-04-042. NIH">
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<META NAME="Keywords" CONTENT="NOT-OD-04-042: NIH POLICY ON SHARING OF MODEL ORGANISMS FOR BIOMEDICAL RESEARCH">
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<pre>
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<pre>NIH POLICY ON SHARING OF MODEL ORGANISMS FOR BIOMEDICAL RESEARCH
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RELEASE DATE: May 7, 2004
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NOTICE: NOT-OD-04-042
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<b>Update:</b> The following update relating to this announcement has been issued:
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<a href="//grants.nih.gov/grants/guide/notice-files/NOT-HD-09-019.html">August 7, 2009</a> - See Notice NOT-HD-09-019 Revised Resource Sharing Plan Instructions.
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(also see <a href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-04-066.html">NOT-OD-04-066</a>)
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National Institutes of Health (NIH)
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As a public sponsor of biomedical research, NIH is committed to supporting
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national and international efforts that encourage the sharing and
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dissemination of important research resources. NIH is also cognizant of the
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need to support reasonable incentive structures that facilitate commercial
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development or translation of basic research findings. Restricted
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availability of unique research resources, upon which further studies are
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dependent, can impede the advancement of research. Conversely, sharing
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biomaterials, reagents and data in a timely manner has been an essential
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element in the rapid progress that has been made in research on many model
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organisms for biomedical research. The NIH is interested in continuing to
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ensure that the research resources developed with NIH funding are made
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readily available in a timely fashion to the research community for further
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research, development, and application, in the expectation that this will
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further the research enterprise and accelerate the development of products
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and knowledge of benefit to the public. At the same time, NIH recognizes
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the rights of grantees and contractors to elect and retain title to subject
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inventions developed with federal funding pursuant to the Bayh-Dole Act.
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This notice reaffirms NIH support for the concept of timely sharing and
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distribution of biomedical research resources [See NIH Grants Policy
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Statement (<A HREF="//grants.nih.gov/grants/policy/nihgps_2003/index.htm">http://grants.nih.gov/grants/policy/nihgps_2003/index.htm</A>); NIH
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Research Tools Policy, also referred to as Principles and Guidelines for
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Recipients of NIH Research Grants and Contracts on Obtaining and
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Disseminating Biomedical Research Resources: Final Notice
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(<a href="http://www.ott.nih.gov/policy/rt_guide_final.html">http://www.ott.nih.gov/policy/rt_guide_final.html</A>), December 1999], and
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provides further guidance with particular attention on model organisms for
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biomedical research. Model organisms include but are not restricted to
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mammalian models, such as the mouse and rat; and non-mammalian models, such
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as budding yeast, social amoebae, round worm, fruit fly, zebra fish, and
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frog. [See NIH Model Organism for Biomedical Research Website at
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<a href="http://www.nih.gov/science/models/">http://www.nih.gov/science/models/</A> for information about NIH activities
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related to these resources]. Research resources to be shared include
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genetically modified or mutant organisms, sperm, embryos, protocols for
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genetic and phenotypic screens, mutagenesis protocols, and genetic and
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phenotypic data for all mutant strains. Genetically modified organisms are
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those in which mutations have been induced by chemicals, irradiation,
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transposons or transgenesis (e.g., knockouts and injection of DNA into
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blastocysts) or those in which spontaneous mutations have occurred. By
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sharing of research resources and, thus, avoiding the duplication of very
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expensive efforts to generate model organism models, the NIH is able to
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support more investigators than if these useful models had to be generated
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in duplicate by more than one NIH funded investigator.
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This statement applies to extramural investigators funded by NIH grants,
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cooperative agreements, and contracts, including SBIR and STTR awards.
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Guidelines already in place for the intramural research program are
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consistent with those for the extramural community (for example, see
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<a href="http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/resources.htm">http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/resources.htm</A>).
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To further extant NIH resource sharing policies, all investigators
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submitting an NIH application or contract proposal beginning with the
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October1, 2004 receipt date, are expected to include in the
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application/proposal a description of a specific plan for sharing and
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distributing unique model organism research resources generated using NIH
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funding so that other researchers can benefit from these resources, OR
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state appropriate reasons for why such sharing is restricted or not
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possible. Unlike the NIH Data Sharing Policy, the submission of a model
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organism sharing plan is NOT subject to a cost threshold of $500,000 or
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more in direct costs in any one year, and is expected to be included in all
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applications where the development of model organisms is anticipated. (The
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NIH Final Statement on Data Sharing is available at
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<A HREF="//grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html">http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html</A>)
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The adequacy of plans for sharing model organisms will be considered by
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reviewers when a competing application is evaluated. Reviewers will be
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asked to describe their assessment of the sharing plan in an administrative
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note and, normally, will not include their assessment in the overall
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priority score. For some special initiatives, such as Request for
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Applications (RFA) and Request for Proposals (RFP) specifically directed to
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the development of model organisms, reviewers may be asked to integrate
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their evaluation of the plan for sharing with other review criteria and
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factor their assessment into the overall evaluation of scientific merit.
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As the expectations and tools available to facilitate model organism
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sharing continue to evolve, maximum flexibility is encouraged to allow for
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renegotiations during the project period at the request of either the
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Institute/Center (IC) or the funded institution in response to materially
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new and/or unforeseen information or developments. Applicants/Offerors
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responding to a RFA or RFP may find additional requirements related to
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resource or data sharing in the specific announcement. Applicants/Offerors
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are encouraged to discuss their sharing plans with their NIH program
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contact, who also can direct them to existing repositories or national
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coordinating centers. A reasonable time frame for periodic deposition of
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material and associated data should be specified in the application.
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Applicants/Offerors are also expected to address as part of the sharing
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plan if, or how, they will exercise their intellectual property rights
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while making model organisms and research resources available to the
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broader scientific community. At a minimum, the plan should address the
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following questions in a clear and concise manner:
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o Will material transfers be made with no more restrictive terms than in a
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Simple Letter Agreement (SLA)(<a href="http://www.ott.nih.gov/policy/rt_guide_final.html#sla">http://www.ott.nih.gov/policy/rt_guide_final.html#sla</A>)
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for the transfer of materials or the Uniform Biological Material Transfer
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Agreement (UBMTA)( <a href="http://ott.od.nih.gov/NewPages/UBMTA.pdf">http://ott.od.nih.gov/NewPages/UBMTA.pdf</A>)?
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o How would inappropriate reach-through requirements (as discussed in
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the NIH Research Tools Policy) on materials transferred be addressed?
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o How will technologies remain widely available and accessible to the
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research community, for example, if any intellectual property rights arise
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for which a patent application may be filed?
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Applicants/Offerors are encouraged to inform and/or confer with their
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institutional offices of technology transfer and other relevant
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institutional offices to develop plans for addressing these requirements.
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Applicants/Offerors are reminded that the research institution is required
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to submit a report of each subject invention to NIH within two months after
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the inventor discloses it in writing to institutional personnel responsible
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for invention matters.
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In their evaluation of non-competing continuation applications, NIH program
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staff may consider, as part of the criteria for continued funding, adequate
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progress in model organism sharing as well as a demonstrated willingness to
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make research resources developed during the project widely available to
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the research community. Failure to comply with NIH research resource
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sharing policies, guidelines, and the accepted plan may also be carefully
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considered by NIH staff in future funding decisions for the investigator
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and the investigator’s institution.
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Investigators may request funds in their application/proposal to defray
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reasonable costs associated with sharing materials or data or transfer of
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model organisms and associated data to appropriate repositories.
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Investigators are encouraged to confer with their technology transfer
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office and/or office of sponsored programs for guidance.</pre>
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</pre>
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<P><HR><P>
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<A HREF="/grants/guide/WeeklyIndex.cfm?WeekEnding=05-07-04">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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