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It is NIH policy that the results and accomplishments of the activities that it funds should be made available to the public. PD/PIs and recipient organizations are expected to make the results and accomplishments of their activities available to the research community and to the public at large. (See also Availability and Confidentiality of Information-Confidentiality of Information-Access to Research Data in Part I for policies related to providing access to certain research data at public request.) If the outcomes of the research result in inventions, the provisions of the Bayh-Dole Act of 1980, as implemented in 37 CFR 401, apply.
As long as recipients abide by the provisions of the Bayh-Dole Act, as amended by the Technology Transfer Commercialization Act of 2000 (P.L. 106-404), and 37 CFR 401, they have the right to retain title to any invention conceived or first actually reduced to practice using NIH grant funds. The principal objectives of these laws and the implementing regulation are to promote commercialization of federally funded inventions, while ensuring that inventions are used in a manner that promotes free competition and enterprise without unduly encumbering future research and discovery.
The regulation requires the recipient to use patent and licensing processes to transfer grant-supported technology to industry for development. Alternatively, unpatented research products or resources-"research tools"-may be made available through licensing to vendors or other investigators. Sharing of copyrightable outcomes of research may be in the form of journal articles or other publications.
The importance of each of these outcomes of funded research is reflected in the specific policies pertaining to rights in data, sharing of research data and unique research resources, and inventions and patents described in the following subsections.
In general, recipients own the rights in data resulting from a grant-supported project. Special terms and conditions of the award may indicate alternative rights, e.g., under a cooperative agreement or based on specific programmatic considerations as stated in the applicable RFA. Except as otherwise provided in the terms and conditions of the award, any publications, data, or other copyrightable works developed under an NIH grant may be copyrighted without NIH approval. For this purpose, "data" means recorded information, regardless of the form or media on which it may be recorded, and includes writings, films, sound recordings, pictorial reproductions, drawings, designs, or other graphic representations, procedural manuals, forms, diagrams, work flow charts, equipment descriptions, data files, data processing or computer programs (software), statistical records, and other technical research data.
Rights in data also extend to students, fellows, or trainees under awards whose primary purpose is educational, with the authors free to copyright works without NIH approval. In all cases, NIH must be given a royalty-free, nonexclusive, and irrevocable license for the Federal government to reproduce, publish, or otherwise use the material and to authorize others to do so for Federal purposes. Data developed by a consortium participant also is subject to this policy.
As a means of sharing knowledge, NIH encourages recipients to arrange for publication of NIH-supported original research in primary scientific journals. Recipients also should assert copyright in scientific and technical articles based on data produced under the grant where necessary to effect journal publication or inclusion in proceedings associated with professional activities.
Journal or other copyright practices are acceptable unless the copyright policy prevents the recipient from making copies for its own use (as provided in 45 CFR 75.322). The disposition of royalties and other income earned from a copyrighted work is addressed in Administrative Requirements-Management Systems and Procedures-Program Income.
All recipients must acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid invitations, and other documents describing projects or programs funded in whole or in part with Federal money. Each publication, press release, or other document about research supported by an NIH grant must include:
"Research reported in this [publication, release] was supported by [name of the Institute, Center, or other funding component] of the National Institutes of Health under grant number [specific NIH grant number in this format: R01GM012345]."
"The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."
If the recipient plans to issue a press release about research supported by an NIH grant, it should notify the NIH funding component in advance to allow for coordination. See http://www.nih.gov/news/media_contacts.htm for media contact information.
Publications resulting from work performed under an NIH grant-supported project must be included as part of the annual or final progress report submitted to the NIH awarding IC (see Administrative Requirements-Monitoring-Reporting-Non-Competing Continuation Progress Reports and Administrative Requirements-Closeout-Final Reports-Final Progress Report). When publications are available electronically, the url or the PMCID number must be provided. If not available electronically, one copy of the publication may be provided along with the progress report. See also NIH Public Access Policy below for additional requirements for publications resulting from NIH funded research.
The NIH Public Access Policy implements Division F, Section 217 of PL 111-8 (Omnibus Appropriations Act, 2009). The policy ensures that the public has access to the published results of NIH funded research at the NIH NLM PMC, a free digital archive of full-text biomedical and life sciences journal literature (http://www.pubmedcentral.nih.gov/). Under the policy NIH-funded investigators are required by Federal law to submit (or have submitted for them) to PMC an electronic version of the final, peer-reviewed manuscript upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The author's final peer-reviewed manuscript is defined as the final version accepted for journal publication on or after 4/7/2008, and includes all modifications from the publishing peer review process, and all graphics and supplemental material associated with the article. Institutions and investigators are responsible for ensuring that any publishing or copyright agreements concerning submitted articles reserve adequate right to fully comply with this policy. Applicants citing articles in NIH applications, proposals, and progress reports that fall under the policy, were authored or co-authored by the applicant and arose from NIH support must include the PMCID or NIHMS ID. The NIHMSID may be used to indicate compliance with the Public Access Policy in applications and progress reports for up to three months after a paper is published. After that period, a PMCID must be provided to demonstrate compliance.
This policy applies to all peer-reviewed articles resulting from research supported in whole or in part with direct costs from NIH, including research grant and career development awards, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, SBIR/STTR awards, and NIH intramural research studies.
Additional information can be found at: http://publicaccess.nih.gov/.
Investigators conducting biomedical research frequently develop unique research resources. NIH considers the sharing of such unique research resources (also called research tools) an important means to enhance the value of NIH-sponsored research. Restricting the availability of unique resources can impede the advancement of further research. Therefore, when these resources are developed with NIH funds and the associated research findings have been accepted for publication, or after they have been provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. At the same time NIH recognizes the rights of recipients and contractors to elect and retain title to subject inventions developed with federal funding pursuant to the Bayh-Dole Act. See the Office of Extramural Research, Division of Extramural Inventions & Technology Resources (DEITR), Intellectual Property Policy page: http://grants.nih.gov/grants/intell-property.htm.
Program staff are responsible for overseeing resource sharing policies and for assessing the appropriateness and adequacy of any proposed resource sharing plans.
To provide further clarification of the NIH policy on disseminating unique research resources, NIH published Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (64 FR 72090, December 23, 1999; http://grants.nih.gov/grants/intell-property_64FR72090.pdf). This document will assist recipients in determining reasonable terms and conditions for disseminating and acquiring research tools.
The terms of those agreements also must reflect the objectives of the Bayh-Dole Act and the Technology Transfer Commercialization Act of 2000 to ensure that inventions made are used in a manner to promote free competition and enterprise without unduly encumbering future research and discovery.
In addition to sharing research resources with the research community, upon request of the NIH awarding IC, the recipient also must provide a copy of documents or a sample of any material developed under an NIH grant award. The recipient may charge a nominal fee to cover shipping costs for providing this material. Income earned from these charges must be treated as program income (see Administrative Requirements-Management Systems and Procedures-Program Income).
To facilitate the availability of unique or novel materials and resources developed with NIH funds, investigators may distribute the materials through their own laboratory or organization or submit them, if appropriate, to entities such as the American Type Culture Collection or other repositories and should ensure that those entities distribute them in a way that is consistent with the above referenced Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources. Investigators are expected to submit unique biological information, such as DNA sequences or crystallographic coordinates, to the appropriate data banks so that they can be made available to the broad scientific community. When distributing unique resources, investigators are to include pertinent information on the nature, quality, or characterization of the materials.
NIH believes that data sharing is essential for expedited translation of research results into knowledge, products, and procedures to improve human health. NIH endorses the sharing of final research data to serve these and other important scientific goals and expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers. "Timely release and sharing" is defined as no later than the acceptance for publication of the main findings from the final data set. All investigator-initiated applications with direct costs of $500,000 or more (excluding consortium F&A costs) in any single year are expected to address data-sharing in their application. In some cases, FOAs may request data-sharing plans for applications that are less than $500,000 (excluding consortium F&A costs) in any single year.
NIH recognizes that data sharing may be complicated or limited, in some cases, by organizational policies, local IRB rules, and local, State and Federal laws and regulations, including the HIPAA Privacy Rule (see Public Policy Requirements and Objectives-Confidentiality of Patient Records: Health Insurance Portability and Accountability). The rights and privacy of individuals who participate in NIH-sponsored research must be protected at all times. Thus, data intended for broader use should be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects. When data-sharing is limited, applicants should explain such limitations in their data-sharing plans.
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.
Organizations that believe they will be unable to meet these expectations should promptly contact the GMO to discuss the circumstances, obtain information that might enable them to share data, and reach an understanding in advance of an award.
All applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding so that other researchers can benefit from these resources, or state appropriate reasons why such sharing is restricted or not possible. Model organisms include but are not restricted to mammalian models, such as the mouse and rat; and non-mammalian models, such as budding yeast, social amoebae, round worm, fruit fly, zebra fish, and frog. Research resources to be shared include genetically modified or mutant organisms, sperm, embryos, protocols for genetic and phenotypic screens, mutagenesis protocols, and genetic and phenotypic data for all mutant strains.
This expectation is for all applications where the development of model organisms is anticipated, regardless of funding amount.
For additional information on this policy, see the NIH Model Organism for Biomedical Web site.
The National Institutes of Health (NIH) Genomic Data Sharing (GDS) Policy sets forth expectations that ensure the broad and responsible sharing of genomic research data. Sharing research data supports the NIH mission and facilitates the translation of research results into knowledge, products, and procedures that improve human health.
The GDS Policy, an extension of the 2008 NIH Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (the NIH GWAS Policy), applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. For the purposes of this Policy, the genome is the entire set of genetic instructions found in a cell and large-scale genomic data include GWAS, single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data. Supplemental Information to the GDS Policy provides examples of genomic research projects that are subject to the Policy and the timeline for submission and sharing of data from such projects.
The GDS Policy became effective on January 25, 2015 for grant applications with due dates on or after that date. Research that was initiated prior to the effective date of the GDS Policy will continue to operate under the terms of the policies that were in effect when the research began, such as the NIH GWAS Policy, however, NIH strongly encourages investigators to comply with the expectations outlined in the GDS Policy. All applications, regardless of the amount requested, proposing research that will generate large-scale genomic data, are expected to include a genomic data sharing plan (see Developing GDS Plans for guidance on developing a genomic data sharing plan).
Effective March 27, 2015, investigators who wish to use cloud computing for storage and analysis will need to indicate in their Data Access Request (DAR) that they are requesting permission to use cloud computing and identify the cloud service provider or providers that will be employed. They also will need to describe how the cloud computing service will be used to carry out their proposed research.
As with data stored in institutional systems, the institution's signing official, Program Director/Principal Investigator, IT Director, and any other personnel approved by NIH to access the data are responsible for ensuring the protection of the data. The institution, not the cloud service provider, assumes responsibility for any failure in the oversight of using cloud computing services for controlled-access data.
The NIH Security Best Practices for Controlled Access Data Subject to the NIH Genomic Data Sharing (GDS) Policy, which have been updated to include best practices for cloud computing, are available at http://www.ncbi.nlm.nih.gov/projects/gap/pdf/dbgap_2b_security_procedures.pdf. The Model Data Use Certification has also been updated and is available at http://gds.nih.gov/pdf/Model_DUC.pdf.
The Bayh-Dole Act of 1980 (Public Law 96-517; 35 U.S.C. 200-212) and the related EO 12591 (April 10, 1987) provide incentives for the practical application of research supported through Federal funding agreements. To be able to retain rights and title to inventions made with Federal funds, so-called "subject" inventions, the recipient must comply with a series of regulations that ensure the timely transfer of the technology to the private sector, while protecting limited rights of the Federal government.
The regulations apply to any subject invention-defined as any invention either conceived or first actually reduced to practice in the performance of work under the Federal award-and to all types of recipients of Federal funding. This includes non-profit entities and small businesses or large businesses receiving funding through grants, cooperative agreements, or contracts as direct recipients of funds, or as consortium participants or subcontractors under those awards.
Some of the steps required by the regulation to retain intellectual property rights to subject inventions include:
Exhibit 8 summarizes recipient responsibilities for invention reporting as specified in the regulations in 37 CFR 401. Recipients should refer to 37 CFR 401 (available on the Interagency Edison) for a complete discussion of the regulations.
Exhibit 8. Extramural Invention Reporting Compliance Responsibilities
|Invention Reporting Requirement||Action Required||When Action Must Be Taken||Discussion||37 CFR 401 Reference|
|Employee Agreement to Disclose All Inventions||Recipient employees working under the funding award (e.g., PD/PI) must sign an agreement to abide by the terms of the Bayh-Dole Act and the NIHGPS as they relate to intellectual property rights.||At time of employment-term of employment.||Recipient organizations and consortium participants must have policies in place regarding ownership of intellectual property, including conflict of interest issues.||401.14(a)(f)(2)|
|Invention Report and "Disclosure"||The recipient organization must submit to NIH a report of any subject invention. This includes a written description (the so-called "invention disclosure") of the invention that is complete in technical detail to convey a clear understanding to the extent known at the time of the disclosure, of the nature, purpose, operation, and the physical, chemical, biological or electrical characteristics of the invention||Within 2 months of the inventor's initial report of the invention to the recipient organization.||There is no single format for disclosing the invention to the Federal government. The report must identify inventor(s), NIH grant number(s), and date of any public disclosure including any publication, sale or public use of the invention and whether a manuscript describing the invention has been submitted for publication and, if so, whether it has been accepted for publication at the time of disclosure.||401.14(a)(a)(2) 401.14(a)(c)(1)|
|Rights to Consortium Participant Inventions||Consortium participants under NIH grants retain rights to any subject inventions they make.||Within 2 months of the inventor's initial report of the invention to the consortium participant. (The consortium participant has the same invention reporting obligations as the recipient.)||The recipient cannot require ownership of a consortium participant's subject inventions as a term of the consortium agreement.||
|Election of Title to Invention||The recipient must notify NIH of its decision to retain or waive title to invention and patent rights.||Within 2 years of the initial reporting of the invention to NIH.||
|Confirmatory License||For each invention, the recipient must provide a user license to NIH for each invention.||When the initial non-provisional patent application is filed.||401.14(a)(f)(1)|
|Government Support Clause||The recipient must include, within the specification of any United States patent applications and any patent issuing thereon covering a subject invention, the following statement, "This invention was made with government support under (identify the contract) awarded by (identify the Federal agency). The government has certain rights in the invention."||When the initial non-provisional patent application or Patent Cooperation Treaty (PCT) application is filed.||401.14(a)(f)(4)|
|Patent Application||The recipient must inform NIH of the filing of any non-provisional patent application. The patent application must include a Federal government support clause.||Within 1 year after election of title, unless there is an extension.||Initial patent application is defined as a non-provisional U.S. application. The patent application number and filing date must be provided. The following language is to be used on patent application: "This invention was made with government support under (identify the funding award) awarded by (identify the IC and Federal Agency). The government has certain rights in the invention." All communications for such requests must be sent to OER.||401.14(a)(c)(3) 401.2(n) 401.14(a)(f)(4)|
|Assignment of Rights to Third Party||If the recipient is a non-profit organization, it must ask NIH approval to assign invention or U.S. patent rights to any third party, including the inventor(s).||As needed. All communication for such requests must be sent to OER. The NIH Office of Technology Transfer serves in an advisory capacity to OER for the processing of such assignment requests.||Recipients that are for-profit entities (including small businesses) do not need to ask approval, but ongoing reporting remains a requirement for each invention.||401.14(a)(k)|
|Issued Patent||The recipient must notify NIH that a patent has been issued.||When the patent is issued.||The patent issue date, number, and evidence of Federal government support clause must be provided.||401.5(f)(2)|
|Extension of Time to Elect Title or File Patent||The recipient may request an extension of up to 2 years for election of title, or an extension of up to 1 year for filing a patent application.||As needed.||Request for extension of time must be made. Such requests are preapproved.||401.14(a)(c)(4)|
|Change in Patent Application Status||The recipient must notify NIH of changes in patent status.||At least 30 days before any pending patent office deadline.||This notification allows NIH to consider continuing the patent action.||401.14(a)(f)(3)|
|Invention Utilization Report||The recipient must submit information about the status of commercialization of any invention for which title has been elected.||Annually.||This report gives an indication of whether the objectives of the law are being met. Specific reporting requirements can be found in iEdison (http://iEdison.gov).||401.14(a)(h)|
|Annual Invention Statement||The recipient must indicate any inventions made during the previous budget period on all grant awards.||Part of all competing applications and non-competing continuation progress reports.||The information is requested as a checklist item on the PHS 398 application and on the non-competing continuation progress report.||PHS 398 and PHS 2590|
|Final Invention Statement and Certification||The recipient must submit to the NIH awarding IC GMO a summary of all inventions made during the entire term of each grant award.||Within 120 days after the project period (competitive segment) ends.||Required information is specified on the HHS 568 form. If no inventions occurred during the project period, a negative report must be submitted.||401.14(a)(f)(5)|
Failure of the recipient to comply with any of these or other regulations cited in 37 CFR 401 may result in the loss of patent rights or a withholding of additional grant funds.
The Bayh-Dole Act includes provisions for the recipient to assign invention rights to third parties. Recipients that are non-profit organizations must request NIH approval for the assignment. If the assignment is approved and the rights are assigned to a third party, invention and patent reporting requirements apply to the third party. The recipient should review existing agreements with third parties and revise them, as appropriate, to ensure they are consistent with the terms and conditions of their NIH grant awards and that the objectives of the Bayh-Dole Act are adequately represented in the assignment.
Any invention made using funds awarded for educational purposes, e.g. fellowships, training grants or certain types of career development awards, is not considered a subject invention and therefore is not subject to invention reporting requirements (as provided in 45 CFR 75 and 37 CFR 401.1(b)). The recipient should seek the advice of NIH to verify whether any invention made under a career development award should be considered a subject invention.
Bayh-Dole regulations permit funding recipients to report inventions electronically (37 CFR 401.16). To meet the grants management streamlining objectives of the Federal Financial Assistance Management Improvement Act of 1999 (P.L. 106-107), NIH requires electronic reporting through an internet-based system, iEdison (http://iEdison.gov). iEdison supports confidential transmission of required information and provides a utility for generating reports and reminders of pending reporting deadlines. All required iEdison submissions that are submitted via fax, mail, drop offs, etc. will not be accepted and will be returned to the submitter. Details regarding invention reporting and iEdison are discussed under Administrative Requirements-Monitoring-Reporting-Invention Reporting.
All issues or questions regarding extramural technology transfer policy and reporting of inventions and their utilization should be referred to the Division of Extramural Inventions and Technology Resources Branch, OPERA, OER. See Part III for contact information.