Research Tools Policy

Explore how NIH expects funding recipients to appropriately disseminate and access research tools developed with NIH funding.

NIH Research Tools Policy

Recipients of NIH funding conducting biomedical research frequently develop unique research resources, also called research tools. NIH considers sharing research tools to be an important means for enhancing the value of NIH-sponsored research.

At the same time, NIH recognizes the rights of funding recipients and contractors to elect and retain title to subject inventions developed with federal funding, as described on NIH’s Intellectual Property Policy page.

NIH has published a set of principles and guidelines known as the NIH Research Tools Policy for funding recipients and the biomedical community. These serve as a reference for identifying an appropriate strategy for disseminating and sharing research tools. The rest of this page will explain these principles and guidelines in more detail and give suggestions on implementation.

For those working with biological materials, NIH has a policy for allowing NIH funding recipients to retain and license biological materials for which patent protection might not be pursued. To learn more, read "NIH Procedures for Handling Non-election of Title to Patentable Biological Materials".

Definition of Research Tools

NIH uses a broad definition of “research tool”. In general, NIH considers research tools to be unique research resource that encompass full range of tools that scientists use in the laboratory, including: cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as PCR), methods, laboratory equipment and machines.

To determine whether a resource is a research tool in the context of the NIH Research Tools Policy, funding recipients should consider whether:

  • The resource is primarily a tool for discovery rather than an FDA-approved product or an integral component of such a product;
  • The resource is a broad, enabling invention that will be useful to many other users, rather than a project or product-specific resource; and
  • The resource is readily useable or distributable as a tool, as opposed to an instance where private sector involvement is either a necessary means or the most expedient means for developing or distributing the resource.

Principles of Disseminating Research Tools

Access to research tools is a prerequisite for catalyzing scientific advancement. NIH urges funding recipients to develop patent, license, and material sharing strategies with this goal in mind.

Following are some principles for funding recipients to consider:

  • Ensure Academic Freedom and Publication: Institutions that receive NIH research funding have an obligation to preserve research freedom, safeguard appropriate authorship, and ensure timely disclosure of their scientists’ research findings. Recipients are expected to avoid signing agreements that unduly limit the freedom of investigators to collaborate and publish, or that automatically grant co-authorship or copyright to the provider of a material.
  • Ensure Appropriate Implementation of the Bayh-Dole Act: When research is funded by NIH, the activity is subject to various laws and regulations, including the Bayh-Dole Regulations. Generally, funding recipients are expected to maximize the use of their research findings by making them available to the research community and the public and through their timely transfer to industry for commercialization.
  • Minimize Administrative Impediments to Academic Research: Funding recipients should take every reasonable step to streamline the process of transferring their own research tools freely to other academic research institutions.
  • Ensure Dissemination of Research Resources Developed with NIH Funds: Unique research resources arising from NIH-funded research are to be made available to the research community.

Dissemination Expectations

Funding recipients are expected to ensure that unique research tools developed from NIH-funded research are available to the research community in these ways:

  • Most transfers to not-for-profit entities should be implemented under terms no more restrictive than the Uniform Biological Material Transfer Agreement.
  • Recipients are expected to use the Simple Letter Agreement of the Uniform Biological Materials Agreement, or another document with no more restrictive terms, to readily transfer unpatented tools developed with NIH funds to other recipients for use in NIH-funded projects.
  • If the materials are patented or licensed to an exclusive provider, other arrangements may be used, but commercialization option rights, royalty reach-through, or product reach-through rights back to the provider are inappropriate.
  • Similarly, when for-profit entities are seeking access to NIH-funded tools for internal use purposes, recipients should ensure that the tools are transferred with the fewest encumbrances possible.

Obligations to Other Funding Sources

Recipients of NIH funding must ensure that obligations to other sources of support or other funding of NIH-funded projects are consistent with Bayh-Dole Regulations and NIH funding requirements. Unique research resources generated under such projects are expected to be made available to the research community.

NIH provides a set of issues and points to consider in developing sponsored research agreements with commercial entities. To read more, check out "Developing Sponsored Research Agreements".

NIH encourages funding recipients to share the guidelines on this page with potential co-sponsors. Any agreements covering projects in which NIH funds will be used along with other funds are expected to contain language to address the issue of dissemination of unique research resources. Below are four examples of acceptable language:

  1. “The project covered by this agreement is supported with funding from the National Institutes of Health. Provider agrees that upon publication, unpatented unique research resources arising out of this project may be freely distributed.”
  2. “In the event an invention is primarily useful as a research tool, any option granted shall either be limited to a non-exclusive license or the terms of any resulting exclusive license shall include provisions that ensure that the research tool will be available to the academic research community on reasonable terms.”
  3. “Provider agrees that Recipient shall have the right to make any materials and inventions developed by Recipient in the course of the collaboration (including materials and inventions developed jointly with Provider, but not including any Provider materials (or parts thereof) or Provider sole inventions available to other scientists at not-for-profit organizations for use in research, subject to Provider’s independent intellectual property rights.)”
  4. “Subject to Recipient’s obligations to the U.S. government, including 37 CFR Part 401, the NIH Grants Policy Statement, and the NIH Guidelines for Obtaining and Disseminating Biomedical Research Resources, Recipient grants to Sponsor the following rights:” ***

Limiting Exclusive Licenses to Appropriate Field of Use

The use of exclusive licenses for research tools (in instances where no further research and development is needed to realize the invention’s usefulness as a tool) should generally be avoided except in cases where the licensee undertakes to make the research tool widely available to researchers through unrestricted sale, or the licensor retains rights to make the research tool widely available.

When an exclusive license is necessary to promote investment in commercial applications of a subject invention that is also a research tool, the recipient should ordinarily limit the exclusive license to the commercial field of use retaining rights regarding use and distribution as a research tool. Examples of possible language include:

  1. “‘Research License’ means a nontransferable, nonexclusive license to make and to use the Licensed Products or Licensed Processes as defined by the Licensed Patent Rights for purposes of research and not for purposes of commercial manufacture, distribution, or provision of services, or in lieu of purchase, or for developing a directly related secondary product that can be sold. Licensor reserves the right to grant such nonexclusive Research Licenses directly or to require Licenses on reasonable terms. The purpose of this Research License is to encourage basic research, whether conducted at an academic or corporate facility. In order to safeguard the Licensed Patent Rights, however, Licensor shall consult with Licensee before granting to commercial entities a Research License or providing to them research samples of the materials.”
  2. “Licensor reserves the right to provide the Biological Materials and to grant licenses under Patent Rights to not-for-profit and governmental institutions for their internal research and scholarly use.”
  3. “Notwithstanding anything to the contrary in this agreement, Licensor shall retain a paid-up, nonexclusive, irrevocable license to practice, and to sublicense other not-for-profit research organizations to practice, the Patent Rights for internal research use.”
  4. “The grant of rights provided herein is subject to the rights of the United States government pursuant to the Bayh-Dole Act and is limited by the right of the Licensor to use Patent Rights for its own research and educational purposes and to freely distribute Materials to not-for-profit entities for internal research purposes.”
  5. “Licensor reserves the right to supply any or all of the Biological materials to academic research scientists, subject to limitation of use by such scientists for research purposes and restriction from further distribution.”
  6. “Licensor reserves the right to practice under the Patent Rights and to use and distribute to third parties the Tangible Property for Licensor’s own internal research purposes.”

Prompt Publication Expectation

NIH expects agreements for acquiring materials for use in NIH-funded research to address the timely dissemination of research results. When entering into agreements, funding recipients should not agree to significant publication delays, any interference with the full disclosure of research findings, or any undue influence on the objective reporting of research results. A publication delay of 30–60 days to allow for patent filing or review for confidential proprietary information is generally viewed as reasonable.

Consistent Obligations to Share Materials

Funding recipients are expected to avoid signing agreements to acquire research tools that are likely to restrict their ability to promote broad dissemination of additional tools that may arise from the research. This might occur when an agreement gives a provider an exclusive license option to any new intellectual property arising out of the project. For example, a new transgenic mouse developed during the project could fall under this license option and become unavailable to third party scientists as a result. The following are four examples of possible language to include in material transfer agreements, sponsored research agreements, and other agreements that either acquire materials from or co-mingle funds with nongovernment sources:

  1. “The project covered by this agreement is supported with funding from the National Institutes of Health. Provider agrees that after publication, unpatented unique research resources arising out of this project may be freely distributed.”
  2. “In the event an invention is primarily useful as a research tool, any option granted shall either be limited to a non-exclusive license or the terms of any resulting exclusive license shall include provisions which insure that the research tool will be available to the academic research community on reasonable terms.”
  3. “Provider agrees that Recipient shall have the right to make any materials and inventions developed by Recipient in the course of the collaboration (including materials and inventions developed jointly with Provider, but not including any Provider materials (or parts thereof)) or Provider sole inventions available to other scientists at not-for-profit organizations for use in research, subject to Provider’s independent intellectual property rights.”
  4. “Subject to Recipient’s obligations to the U.S. government, including 37 CFR Part 401, the NIH Grants Policy Statement, and the NIH Guidelines for Obtaining and Disseminating Biomedical Research Resources, Recipient grants to Sponsor the following rights:” ***

Grantbacks

Agreements to acquire materials from for-profit entities for use in NIH-funded research may provide a “grant back” of non-exclusive, royalty-free rights to the provider to use improvements and new uses of the material.

For instance, if a for-profit entity agrees to provide a proprietary compound for use in an NIH-funded project, the agreement could include a nonexclusive grantback so that the entity would not be blocked from using new uses or improvements of that compound discovered during the NIH-funded project.

Agreements may also provide an option for an exclusive or non-exclusive commercialization license to new inventions arising directly from use of the material. These should be limited to circumstances where the material sought to be acquired is unique.

If such agreements are made, funding recipients must ensure that licenses granted to providers under such options are consistent with the Bayh-Dole Regulations. 

In determining the scope of license or option rights that are granted in advance to a provider of materials, the funding recipient should balance the relative value of the provider’s contributions against the value of the rights granted, cost of the research, and importance of the research results. The rights granted to providers should be limited to inventions that have been made directly through the use of the materials provided. Funding recipients should reserve the right to negotiate license terms that will ensure: (1) continuing availability to the research community if the new invention is a unique research resource; (2) that the provider has the technical and financial capability and commitment to bring all potential applications to the marketplace in a timely manner; and (3) that if an exclusive license is granted, the provider will provide a commercial development plan and agree to benchmarks and milestones for any fields of use granted.

However, NIH expects that agreements to acquire NIH-funded materials from not-for-profit entities for use in NIH-funded research will not include commercialization option rights, royalty reach-through, or product reach-through rights back to the provider. In those cases, funding recipients should use the Simple Letter Agreement or Uniform Biological Material Transfer Agreement. For patented materials, the agreement should be a simple license agreement that does not request reach-through to either future products or royalties. If the providing not-for-profit organization is constrained in sharing the material due to a preexisting sponsored research agreement or license, NIH expects that not-for-profit provider to negotiate a suitable resolution with the private research sponsor or licensee. The co-mingling of NIH and sponsored research funds is allowed, however, the funding recipient is responsible for ensuring that conditions on the use of the sponsored funds do not interfere with the open dissemination of research tools.

Definitions of Materials in Agreements

It is important for providers of materials to be aware that an NIH recipient of materials does not gain any ownership or interest in a provider’s material by virtue of the recipient of NIH funding using the material in an NIH-funded activity. 

Examples of acceptable definitions for ‘‘materials’’ when used in the context of an agreement are:

  1. “‘Materials’ means the materials provided as specified in this document.”
  2. “‘Materials’ means the materials provided as specified in this document. Materials may also include Unmodified Derivatives of the materials provided, defined as substances created by the Recipient which constitute an unmodified functional subunit or product expressed by the original material, such as subclones of unmodified cell lines, purified or fractionated subsets of the original materials, proteins expressed by DNA/RNA supplied by the Provider, or monoclonal antibodies secreted by a hybridoma cell line.”
  3. “‘Materials’ means the materials provided as specified in this document. Materials may also include Progeny and Unmodified Derivatives of the materials provided. Progeny is an unmodified descendant from the original material, such as virus from virus, cell from cell, or organism from organism. Unmodified Derivatives are substances created by the Recipient which constitute an unmodified functional subunit or product expressed by the original material, such as subclones of unmodified cell lines, purified or fractionated subsets of the original material, proteins expressed by DNA/RNA supplied by the Provider, or monoclonal antibodies secreted by a hybridoma cell line.”
  4. “‘Materials’ means the materials being transferred as specified in this document. Materials shall not include: (a) Modifications, or (b) other substances created by the recipient through the use of the Material which are not Modifications, Progeny, or Unmodified Derivatives. Progeny is an unmodified descendant from the Material, such as virus from virus, cell from cell, or organism from organism. Unmodified Derivatives are substances created by the Recipient which constitute an unmodified functional subunit or product expressed by the original Material, such as subclones of unmodified cell lines, purified or fractionated subsets of the original Material, proteins expressed by DNA/RNA supplied by the Provider, or monoclonal antibodies secreted by a hybridoma cell line.”

Note that under the Bayh-Dole Regulations, agreements to acquire materials for use in NIH-funded projects cannot require that title to resulting inventions be assigned to the provider of the materials. For this reason, definitions of “materials” that include all derivatives or modifications are unacceptable. Definitions of “materials” that include any improvements, or any other materials that could not have been made without the provided material, are also unacceptable. 

Examples of acceptable agreements include:

  • No formal agreement
  • A cover letter
  • The Simple Letter Agreement of the Uniform Biological Material Transfer Agreement
  • The Uniform Biological Material Transfer Agreement itself.