NIH POLICY ON SHARING OF MODEL ORGANISMS FOR BIOMEDICAL RESEARCH

RELEASE DATE:  May 7, 2004

NOTICE:  NOT-OD-04-042 

Update: The following update relating to this announcement has been issued: 

August 7, 2009 - See Notice NOT-HD-09-019 Revised Resource Sharing Plan Instructions.
(also see NOT-OD-04-066)

National Institutes of Health (NIH)

As a public sponsor of biomedical research, NIH is committed to supporting 
national and international efforts that encourage the sharing and 
dissemination of important research resources. NIH is also cognizant of the 
need to support reasonable incentive structures that facilitate commercial 
development or translation of basic research findings. Restricted 
availability of unique research resources, upon which further studies are 
dependent, can impede the advancement of research. Conversely, sharing 
biomaterials, reagents and data in a timely manner has been an essential 
element in the rapid progress that has been made in research on many model 
organisms for biomedical research. The NIH is interested in continuing to 
ensure that the research resources developed with NIH funding are made 
readily available in a timely fashion to the research community for further 
research, development, and application, in the expectation that this will 
further the research enterprise and accelerate the development of products 
and knowledge of benefit to the public. At the same time, NIH recognizes 
the rights of grantees and contractors to elect and retain title to subject 
inventions developed with federal funding pursuant to the Bayh-Dole Act. 

This notice reaffirms NIH support for the concept of timely sharing and 
distribution of biomedical research resources [See NIH Grants Policy 
Statement (http://grants.nih.gov/grants/policy/nihgps_2003/index.htm); NIH 
Research Tools Policy, also referred to as Principles and Guidelines for 
Recipients of NIH Research Grants and Contracts on Obtaining and 
Disseminating Biomedical Research Resources: Final Notice 
(http://www.ott.nih.gov/policy/rt_guide_final.html), December 1999], and 
provides further guidance with particular attention on model organisms for 
biomedical research. Model organisms include but are not restricted to 
mammalian models, such as the mouse and rat; and non-mammalian models, such 
as budding yeast, social amoebae, round worm, fruit fly, zebra fish, and 
frog. [See NIH Model Organism for Biomedical Research Website at 
http://www.nih.gov/science/models/ for information about NIH activities 
related to these resources]. Research resources to be shared include 
genetically modified or mutant organisms, sperm, embryos, protocols for 
genetic and phenotypic screens, mutagenesis protocols, and genetic and 
phenotypic data for all mutant strains. Genetically modified organisms are 
those in which mutations have been induced by chemicals, irradiation, 
transposons or transgenesis (e.g., knockouts and injection of DNA into 
blastocysts) or those in which spontaneous mutations have occurred. By 
sharing of research resources and, thus, avoiding the duplication of very 
expensive efforts to generate model organism models, the NIH is able to 
support more investigators than if these useful models had to be generated 
in duplicate by more than one NIH funded investigator.

This statement applies to extramural investigators funded by NIH grants, 
cooperative agreements, and contracts, including SBIR and STTR awards. 
Guidelines already in place for the intramural research program are 
consistent with those for the extramural community (for example, see 
http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/resources.htm). 

To further extant NIH resource sharing policies, all investigators 
submitting an NIH application or contract proposal beginning with the 
October1, 2004 receipt date, are expected to include in the 
application/proposal a description of a specific plan for sharing and 
distributing unique model organism research resources generated using NIH 
funding so that other researchers can benefit from these resources, OR 
state appropriate reasons for why such sharing is restricted or not 
possible. Unlike the NIH Data Sharing Policy, the submission of a model 
organism sharing plan is NOT subject to a cost threshold of $500,000 or 
more in direct costs in any one year, and is expected to be included in all 
applications where the development of model organisms is anticipated. (The 
NIH Final Statement on Data Sharing is available at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html)

The adequacy of plans for sharing model organisms will be considered by 
reviewers when a competing application is evaluated.  Reviewers will be 
asked to describe their assessment of the sharing plan in an administrative 
note and, normally, will not include their assessment in the overall 
priority score.  For some special initiatives, such as Request for 
Applications (RFA) and Request for Proposals (RFP) specifically directed to 
the development of model organisms, reviewers may be asked to integrate 
their evaluation of the plan for sharing with other review criteria and 
factor their assessment into the overall evaluation of scientific merit. 

As the expectations and tools available to facilitate model organism 
sharing continue to evolve, maximum flexibility is encouraged to allow for 
renegotiations during the project period at the request of either the 
Institute/Center (IC) or the funded institution in response to materially 
new and/or unforeseen information or developments. Applicants/Offerors 
responding to a RFA or RFP may find additional requirements related to 
resource or data sharing in the specific announcement. Applicants/Offerors 
are encouraged to discuss their sharing plans with their NIH program 
contact, who also can direct them to existing repositories or national 
coordinating centers. A reasonable time frame for periodic deposition of 
material and associated data should be specified in the application. 

Applicants/Offerors are also expected to address as part of the sharing 
plan if, or how, they will exercise their intellectual property rights 
while making model organisms and research resources available to the 
broader scientific community. At a minimum, the plan should address the 
following questions in a clear and concise manner:
o Will material transfers be made with no more restrictive terms than in a 
Simple Letter Agreement (SLA)(http://www.ott.nih.gov/policy/rt_guide_final.html#sla) 
for the transfer of materials or the Uniform Biological Material Transfer 
Agreement (UBMTA)( http://ott.od.nih.gov/NewPages/UBMTA.pdf)?
o How would inappropriate   reach-through  requirements (as discussed in 
the NIH Research Tools Policy) on materials transferred be addressed? 
o How will technologies remain widely available and accessible to the 
research community, for example, if any intellectual property rights arise 
for which a patent application may be filed?

Applicants/Offerors are encouraged to inform and/or confer with their 
institutional offices of technology transfer and other relevant 
institutional offices to develop plans for addressing these requirements. 
Applicants/Offerors are reminded that the research institution is required 
to submit a report of each subject invention to NIH within two months after 
the inventor discloses it in writing to institutional personnel responsible 
for invention matters.  

In their evaluation of non-competing continuation applications, NIH program 
staff may consider, as part of the criteria for continued funding, adequate 
progress in model organism sharing as well as a demonstrated willingness to 
make research resources developed during the project widely available to 
the research community. Failure to comply with NIH research resource 
sharing policies, guidelines, and the accepted plan may also be carefully 
considered by NIH staff in future funding decisions for the investigator 
and the investigator’s institution.

Investigators may request funds in their application/proposal to defray 
reasonable costs associated with sharing materials or data or transfer of 
model organisms and associated data to appropriate repositories. 
Investigators are encouraged to confer with their technology transfer 
office and/or office of sponsored programs for guidance.

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