Guidance on the NIH Model Organism Sharing Policy

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.

Who needs to write a plan?
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.

What should the plan cover?
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.

What must be shared?
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.

How do I share?
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.

How will this affect my grant review?
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.

Where can I obtain additional information?
The NIH Model Organism Sharing Policy

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.