Appendix D.3.


Investigators conducting biomedical research frequently develop unique research resources. Categories of these resources include synthetic compounds, organisms, cell lines, viruses, cell products, and cloned DNA as well as DNA sequences, mapping information, crystallographic coordinates, and spectroscopic data. Specific examples include specialized and/or genetically defined cells, including normal and diseased human cells; monoclonal antibodies; hybridoma cell lines; microbial cells and products; viruses and viral products; recombinant nucleic acid molecules; DNA probes; nucleic acid and protein sequences; certain types of animals such as transgenic mice; and intellectual property such as computer programs.

It is the policy of 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 the agencies under contract, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. This policy applies to grants, cooperative agreements, and contracts.

Investigators who believe that they will be unable to implement this policy should promptly contact the appropriate PHS Program Administrator to discuss the circumstances, obtain information that might facilitate compliance with the policy, and reach an understanding in advance of the subsequent award. 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 other 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 to include pertinent information on the nature, quality, or characterization of the materials.

Investigators must exercise great care to ensure that resources involving human cells or tissues do not identify original donors or subjects, directly or through identifiers such as codes linked to the donors or subjects.

The goal of some programs, e.g., the Human Genome Program, are such that applicants for certain projects may be required to discuss plans for the sharing of data and materials in their applications. These plans will undergo review by program staff and any applicable national advisory council prior to award.

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. Investigators should note, 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 and cooperative agreements, the income is governed by 45 CFR Parts 74 and 92 and must be reported on the FSR. Questions regarding these policies and the treatment of income should be directed to the awarding office GMO.

Inventions and Commercialization

Federal policy encourages the commercialization of the products of research developed as a consequence of Federal funding; therefore, the intent of this policy is not to discourage, impede, or prohibit the organization that develops unique research resources or intellectual property from commercializing the products. 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 . The terms for licensing of unpatented research products such as cell lines, monoclonal antibodies, and other materials and products should generally be no more restrictive than would have been the case had they been patented, for example, only if there is full public disclosure of the invention/discovery availability through a repository, and written agreement to end all fees and constraints after 17 years. When reporting is required, it should occur at the earliest possible time. (See Public Law 96-517, Public Law 98-620, and 37 CFR Part 401.)