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NIH has implemented a policy on "Sharing
of Model Organisms for Biomedical Research." This policy
requires investigators to include a plan for organism sharing
as a component of certain grant applications.
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Who needs to write a plan?
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All NIH R, P, K, STTR, or SBIR applications
that plan to produce new, genetically modified variants
of model organisms and related resources are expected
to include a sharing plan.
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What should the plan cover?
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The plan should describe how the
investigator will share those organisms in a timely
manner with colleagues from non-profit and for-profit
organizations who request them. If such sharing is
restricted or not possible, the plan should state
why.
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What must be shared?
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Depending upon accepted practice,
new, genetically modified organisms may be shared
as mature organisms, sperm, eggs, embryos, or, in
some cases, vectors used to generate transgenic or
knockout organisms.
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How do I share?
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Organisms can be shared either by
distributing them from your own lab, or depositing
the organism in a repository such as Jackson Labs
or ATCC. Note that you may request funding in the
grant to support anticipated sharing expenses.
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How will this affect my grant
review?
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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, except for some
special initiatives, will not include their assessment
in the overall priority score.
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Where can I obtain additional information?
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The NIH Policy on Sharing Model
Organisms for Biomedical Research:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html
NIH Organism Sharing home page, with sample
plans:
http://grants.nih.gov/grants/policy/model_organism/
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SAMPLE PLAN
A generic plan is provided below in order to assist investigators
in developing a plan to include in their grant. If this
project will involve the use of any material received from
a company or another institution under an MTA, or will use
additional funds provided by a company under a sponsored
research agreement, please consult with your Dean's office
regarding special provisions that may apply.
________________________
Following the characterization and peer-reviewed
publication of [ORGANISM], [ORGANISM] will be freely distributed
to investigators at academic institutions wanting [ORGANISM]
for non-commercial research.
[If organism is covered by AAALAC, insert the following
paragraph:]
Individual requests for shipment of [ORGANISM]
generated by this program project funding to AAALAC (Association
for Assessment and Accreditation of Laboratory Animal
Care International)-accredited institutions will be honored.
The recipient investigators would provide written assurance
and evidence that the animals will be used solely in accord
with their local IACAC review; [ORGANISM] will not be
further distributed by the recipient without consent of
the PI; and [ORGANISM] will not be used for commercial
purposes.
Requests for [ORGANISM] from for-profit corporations
to use [ORGANISM] commercially may be negotiated by the
University's patent management organization, the Wisconsin
Alumni Research Foundation. All royalty income shall
be subject to distribution pursuant to the University's
policies and procedures on royalty income. The University
will report any invention disclosure submitted to it to
the appropriate federal agency.
[If the organism is a mouse, and if the PI wishes
to work through a repository, add the following paragraph:]
In addition, all of the transgenic mice generated
will be deposited in at an NIH supported mouse repository
[see http://www.nih.gov/science/models/mouse/sharing/4.html
for a partial list of mouse repositories and databases.
NIH supported repositories cryopreserve embryos or sperm
and distribute the frozen embryos or mice to biomedical
researchers.] For the mice I generate I will
use standard nomenclature and receive approval from the
Mouse Genome Informatic (MGI) nomenclature committee
(http://www.informatics.jax.org/mgihome).
"Other Research Resources" generated with funds
from this grant may include DNA constructs, etc. These resources,
as available, would also be freely distributed upon request
to qualified academic investigators for non-commercial research.
My institution and I will adhere to the NIH Grants
Policy on Sharing of Unique Research Resources including
the "Sharing of Biomedical Research Resources: Principles
and Guidelines for Recipients of NIH Grants and Contracts"
issued in December, 1999. http://ott.od.nih.gov/NewPages/Rtguide_final.html.
Specifically, material transfers to non-profit institutions
would be made with no more restrictive terms than in the
Simple Letter Agreement or the UBMTA and without reach through
requirements. Should any intellectual property arise
which requires a patent, we would ensure that the technology
remains widely available to the research community in accordance
with the NIH Principles and Guidelines document.
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