NIH issues "Principles and Guidelines" for Research Tools

by Joyce Brinton

On December 23, 1999, NIH released a new policy addressing concerns about the exchange and availability of a wide variety of research tools and materials. Of particular concern were materials being exchanged using Material Transfer Agreements (MTAs) - whether those changes were between two non-profit institutions or between a non-profit and a for-profit institution.

The Council on Governmental Relations (COGR)  has prepared a summary of this document along with points for institutions to consider. Visit the COGR Web iste to read more. 

NIH's purpose in issuing these Principles and Guidelines was to improve access to unique research tools, to help grantee institutions ensure that the terms of MTAs they either accept or issue will not hinder future research, and to ensure that patenting and licensing of these tools and materials will not inhibit their availability to the research community.

As licensing professionals, this means we must be sensitive to these Principles and Guidelines as we grant licenses to the for-profit sector for patents on technology as well as for unpatented materials or other resources which have a significant utility as research tools.

NIH expresses a strong preference for licensing these tools on a non-exclusive basis on terms that are designed to encourage widespread use by both the for-profit and non-profit sectors. At a minimum, NIH expects us to reserve sufficient rights so that, even if the technology is licensed exclusively, we can provide access to the technology to the academic/non-profit/governmental research community for its research use.

When this technology has utility both as a research tool and as a therapeutic or diagnostic, NIH strongly encourages that exclusive licenses be field limited to the therapeutic/diagnostic fields. Fortunately, NIH recognizes that some research tools require development to be maximally useful to the research community and in those cases, it is appropriate to license exclusively to a company that will develop and then distribute the tools widely (preferably by sale rather than by licensing with significant "reach-through" provisions).

In accepting research tools and materials from third parties for use in research at academic, research or non-profit institutions, NIH strongly encourages the institutions to avoid accepting terms and conditions that will limit traditional academic freedoms (long delays in publication, controls on collaboration, etc.). There are occasions, when it may be wise to "Just Say No" rather than accept terms that will compromise future research and scholarly activity.

NIH is especially concerned that exchanging materials among non-profit and governmental institutions be simple with agreements that include as few restrictions as possible. A "Simple Letter Agreement" is included which NIH strongly recommends we use for such non-profit to non-profit exchanges. If there are prior obligations made by a provider that require "reach-through" provisions or other types of restrictions, NIH states that the provider should seek to re-negotiate them so the Simple Letter Agreement can be used.

Download a Simple Letter Agreement for the transfer for materials. (Word Document - 36 KB)