Office of Research and Project Administration

May 14, 2004

To: NIH Investigators and Department Administrators

From: Gunta J. Liders
Associate Vice President for Research Administration

Re: NIH Policy on Sharing of Model Organisms for Biomedical Research

NIH published a new policy on the sharing of model organisms in the NIH Guide: NIH POLICY ON SHARING OF MODEL ORGANISMS FOR BIOMEDICAL RESEARCH dated May 7th, 2004. While NIH has always supported timely sharing and distribution of biomedical resources developed with NIH funding, this policy now requires that investigators anticipating the development of model organisms include a plan for sharing and distributing such resources in applications beginning with the October 1, 2004 deadline. Highlights of the new policy include the following:

1. 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;

2. 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;

3. Adequacy of plans will be considered by reviewers when a competing application is evaluated, however, reviewers will not include their assessment in the overall priority score;

4. At a minimum, the plan should address the following:
· Will material transfers be made with no more restrictive terms than in a Simple Letter Agreement or Uniform Biological Materials Transfer Agreement;
· How would inappropriate “reach through” requirements on materials transferred be addressed;
· 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?

5. Investigators may request funds in their applications/proposals to defray reasonable costs associated with sharing materials or data or transfer of model organisms and associated data to appropriate repositories.

Investigators should contact the Offices of Technology Transfer (University Office x5-3998, Medical Center Office 784-8850) for advise on sharing plans. In addition, investigators are encouraged to confer with NIH program contacts. It is anticipated that a Frequently Asked Questions document on this policy will be posted on ORPA and OTT web sites in the next few months.

pc: M. Coburn
M. Hunter
H. Federoff
P. Slattery