Office of Technology Transfer-NIH July 1994 Notice

Public Health Service Policy Relating to Distribution of Unique Research Resources Produced with PHS Funding

NIH GUIDE, Volume 23, Number 26, July 15, 1994

This announcement by the Public Health Service (PHS) is a republication of the one last appearing in the NIH Guide for Grants and Contracts, Vol. 21, No. 33, September 11,1992.

Introduction
Policy on Distribution of Research Resources
Distribution Costs
Inventions and Commercialization

Investigators conducting biomedical research frequently develop unique research resources. Categories of these resources include: synthetic compounds, organisms, cell lines, viruses, cell products, cloned DNA, as well as DNA sequences, mapping information, crystallographic coordinates, and spectroscopic data. Some specific examples are: specialized and/or genetically defined cell lines, 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. The PHS provides the following statement of policy concerning unique research resources developed through PHS awards.

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A. Policy on Distribution of Research Resources

The policy of the PHS is 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 PHS intramural investigators as well as extramural scientists funded by PHS grants, cooperative agreements, and contracts.

Because of concern that some crystallographers are not making their coordinates available promptly (see Science, Vol. 245, p. 1179), one of the national advisory councils of the NIH and the executive committee of another institute recently adopted resolutions affirming the policy of the International Union of Crystallographers (IUCr) (Acta Cryst., A45: 658, 1989). The PHS has now adopted the IUCr policy that includes data from publications based on spectroscopic data such as nuclear magnetic resonance as well as crystallographic coordinates.

The PHS encourages investigators who have such resources to consult the appropriate Program Administrators who may be of assistance in determining a suitable distribution mechanism. Such a mechanism should take into consideration all applicable Federal regulations including, but not limited to: those regarding human subjects, animal welfare, and use and handling of hazardous materials, where applicable. Investigators requesting materials should provide evidence of having the proper training, experience, and facilities to make use of the items they request. Program staff of the agencies will be available to assist in verification of credentials of requesters where such concern exists on the part of suppliers.

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. For research and development contracts, approval should be obtained from the PHS 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 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 goals of some programs, (e.g., the Human Genome Program) are such that applicants for certain projects may be required to provide plans for the sharing of data and materials. These plans will undergo review by program staff and the national advisory council prior to award.

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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 labor, 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:

C. 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 to not 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 for commercial purposes with appropriate restrictions and licensing terms as they and their institution deem necessary.

Institutions are reminded that some of these products may be inventions subject to the various laws and regulations applicable to patents and must be reported to the Extramural Inventions Reports Office of the NIH. 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 37 CFR 401 and NIH Guide for Grants and Contracts, Vol. 19, No. 6, February 9, 1990.)


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	Public Health Service Policy Relating to Distribution of Unique Research Resources Produced with PHS Funding NIH GUIDE, Volume 23, Number 26, July 15, 1994 This announcement by the Public Health Service (PHS) is a republication of the one last appearing in the NIH Guide for Grants and Contracts, Vol. 21, No. 33, September 11,1992. Introduction Policy on Distribution of Research Resources Distribution Costs Inventions and Commercialization Introduction Investigators conducting biomedical research frequently develop unique research resources. Categories of these resources include: synthetic compounds, organisms, cell lines, viruses, cell products, cloned DNA, as well as DNA sequences, mapping information, crystallographic coordinates, and spectroscopic data. Some specific examples are: specialized and/or genetically defined cell lines, 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. The PHS provides the following statement of policy concerning unique research resources developed through PHS awards. Return to Top A. Policy on Distribution of Research Resources The policy of the PHS is 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 PHS intramural investigators as well as extramural scientists funded by PHS grants, cooperative agreements, and contracts. Because of concern that some crystallographers are not making their coordinates available promptly (see Science, Vol. 245, p. 1179), one of the national advisory councils of the NIH and the executive committee of another institute recently adopted resolutions affirming the policy of the International Union of Crystallographers (IUCr) (Acta Cryst., A45: 658, 1989). The PHS has now adopted the IUCr policy that includes data from publications based on spectroscopic data such as nuclear magnetic resonance as well as crystallographic coordinates. The PHS encourages investigators who have such resources to consult the appropriate Program Administrators who may be of assistance in determining a suitable distribution mechanism. Such a mechanism should take into consideration all applicable Federal regulations including, but not limited to: those regarding human subjects, animal welfare, and use and handling of hazardous materials, where applicable. Investigators requesting materials should provide evidence of having the proper training, experience, and facilities to make use of the items they request. Program staff of the agencies will be available to assist in verification of credentials of requesters where such concern exists on the part of suppliers. 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. For research and development contracts, approval should be obtained from the PHS 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 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 goals of some programs, (e.g., the Human Genome Program) are such that applicants for certain projects may be required to provide plans for the sharing of data and materials. These plans will undergo review by program staff and the national advisory council prior to award. Return to Top 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 labor, 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, 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 require specific contract instructions. Existing contracts may require an amendment and specific approval of the Contracting Officer to render them allowable. Return to Top C. 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 to not 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 for commercial purposes with appropriate restrictions and licensing terms as they and their institution deem necessary. Institutions are reminded that some of these products may be inventions subject to the various laws and regulations applicable to patents and must be reported to the Extramural Inventions Reports Office of the NIH. 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 37 CFR 401 and NIH Guide for Grants and Contracts, Vol. 19, No. 6, February 9, 1990.)

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