PHS Policy Relating to Distribution of Unique Research Resources Produced with PHS Funding
National Institutes of Health
Investigators conducting biomedical research frequently develop unique research resources. Categories of these resources include organisms, cells, viruses, cell products, cloned DNA, as well as DNA sequences, mapping information, and crystallographic coordinates. Some specific examples are specialized and/or genetically defined cells, including normal and diseased human cells; monoclonal cell lines; hybridoma cell lines; microbial cells and products; viruses and viral products; recombinant nucleic acid molecules; DNA probes; nucleic acid and protein sequences; and transgenic mice. The Public Health Service (PHS) provides the following statement of policy concerning unique research resources developed through its awards.
A. PHS Policy on Distribution of Research Resources
It is the policy of the PHS to make available to the public the results and accomplishments of the activities that it funds. Restricted availability of unique resources upon which further studies are dependent can impede the advancement of research and the delivery of medical care. Therefore, when these resources are developed with PHS funds and the associated research findings have been published or after they have been provided to NIH under contract, they should be made readily available for research purposes to the scientific community. This policy applies to NIH intramural research as well as extramural research funded by grants, and cooperative agreements, and contracts.
Investigators who have such resources are encouraged to consult the appropriate PHS program administrators who may be of assistance
Reprinted from NIH Guide for Contracts and Grants 17(29):1, September 16, 1988.
in determining a suitable distribution mechanism. For research and development contracts, approval should be obtained from the NIH Contracting Officer before distribution of unique resources, unless the terms of the contract permit distribution without prior clearance of the Contracting Officer. In order to facilitate the availability of unique or novel biological materials and resources developed with PHS funds, investigators may distribute the materials through their own laboratory or institution or submit them, if appropriate, to entities such as the American Type Culture Collection or similar repositories. In the case of unique biological information such as DNA sequences or crystallographic coordinates, investigators are expected to submit them to the appropriate data banks because they otherwise are not truly accessible to the scientific community. When distributing unique resources, investigators are encouraged to include pertinent information on the nature, or quality, or characterization of the materials.
Investigators must exercise great care to ensure that resources do not identify original donors or subjects, directly or through identifiers, such as codes linked to the donors or subjects.
B. Distribution Costs
Institutions and investigators may charge the requester, if necessary, for the reasonable cost of production of unique biological materials, and for packaging and shipping. Such costs may include personnel, supplies, and other directly related expenses. It should be noted, however, that such a charge accrues as general program income. This should not be an impediment to the distribution of materials, but investigators and institutions are advised that:
for grants, the income is governed by 45 CFR Part 74 and it must be reported on the Financial Status Report. Questions regarding these policies and the treatment of income should be directed to the Grants Management Officer.
for contracts, the income is governed by Federal Acquisition Regulations (FAR) 45.610-3. Contracting Officers must be contacted before generating any revenues from the distribution of materials. Any contract under which research resources would be sold requires specific contract instructions. Existing contracts may require an amendment and specific approval of the Contracting Officer to render them allowable.
C. Inventions and Commercialization
This policy does not discourage, impede, or prohibit the organization that develops unique biologic materials or intellectual property from commercializing the materials or licensing them for commercial purposes. Investigators may make their materials available to others with appropriate restrictions and licensing terms as they and their institutions deem necessary.
Institutions are reminded that some of these products may be inventions subject to the various laws and regulations applicable to patents and need to be reported. When reporting is required, it should occur at the earliest possible time. (See P.L. 96-517, P.L. 98-620, and 37 CFR 401.)