Sharing research resources, data sharing policy, sharing model organisms, genomic data sharing, GDS, genome-wide association studies (GWAS)

8.2.3 Sharing Research Resources

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.

Program staff are responsible for overseeing resource sharing policies and for assessing the appropriateness and adequacy of any proposed resource sharing plans.

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 NIH Research Tools Policy webpage explains these principles and guidelines in more detail and provides suggestions on implementation.

For recipients 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".

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 NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award., 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 NIH Research Tools Policy webpage. 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.

8.2.3.1 Operational and Security Standards for Controlled-Access Repositories

The Required Security and Operational Standards for NIH Controlled-Access Data Repositories apply to grants and cooperative agreements, for the purposes of the NIH GPS, and other funding mechanisms not covered by the NIH GPS (e.g. intramural contracts and Other Transactions), regardless of the activity code, that support NIH controlled-access data repositories and access management systems (hereafter NIH CADRs) that meet all the following criteria:

• Are supported by an NIH funding mechanism (e.g. grants and cooperative agreements);
• Provide long-term storage for, or provide access to, data for research purposes (hereafter, "data");
• Control access to data by prospective review of data access requests or partner with access systems that control access via prospective review of requests; and
• Use federal employees to conduct reviews and authorize access, or partner with access systems that use federal employees for those purposes.

NIH will determine which repositories are subject to these requirements and will maintain a public list of NIH CADRs, which can be found here. NIH will periodically update this list as needed.

Repositories and access management systems that control access to data, but do not meet the criteria of an NIH CADR as described above, will not be subject to these requirements. Repositories that only facilitate direct sharing between investigator teams, cloud workspaces that only temporarily store data, data coordinating centers, and similar activities that do not manage data sharing beyond specific programs or initiatives, will not be considered an NIH CADR.

To meet the requirements, NIH CADRs must follow the NIH Controlled-Access Data Repository Guidebook to Adhere to "Required Security and Operational Standards for NIH Controlled-Access Data Repositories" (NIH CADR Guidebook), including all relevant effective dates listed in the Guidebook.

8.2.3.2 Policy for Data Management and Sharing (DMS Policy)

The NIH Policy for Data Management and Sharing (DMS Policy) applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data. This includes research funded or conducted by extramural grants or other funding agreements regardless of NIH funding level or funding mechanism. The DMS Policy does not apply to research and other activities that do not generate scientific data, including training, infrastructure development, and non-research activities. A list of NIH activity codes subject to the DMS Policy is available on the NIH website, and the applicability of the DMS Policy will be specified in each NIH NOFO.

Applicants must submit a DMS Plan in each competitive grant application, and outline DMS costs in the appropriate cost categories in the budget (see NIH Application Guide for detailed instructions). DMS Plans should explain how scientific data generated by research projects will be managed and which of these scientific data and accompanying metadata will be shared. If DMS Plan revisions are necessary (e.g., new scientific direction, a different data repository, or a timeline revision), DMS Plans should be updated by researchers and reviewed by the NIH ICO during regular reporting intervals or sooner. DMS Plans from NIH-funded or conducted research may be made publicly available and should not include proprietary or private information. Costs associated with data management and data sharing are subject to Federal cost principles The government-wide principles, issued by OMB (or, in the case of commercial organizations, the Federal Acquisition Regulation [48 CFR 21], or, in the case of hospitals, 45 CFR 75, Appendix IX, "Principles For Determining Costs Applicable to Research and Development Under Grants and Contracts with Hospitals"), on allowability and unallowability of costs under federally sponsored agreements. See Cost Considerations-The Cost Principles for additional details. for the reimbursement of actual costs that are allowable, allocable, reasonable, and consistently treated as described in NIHGPS Section 7.2 The Cost Principles.

Under the NIH DMS Policy, NIH expects researchers will maximize the appropriate sharing of scientific data, acknowledging certain factors (i.e., legal, ethical, or technical) that may limit data sharing to some extent. Per the supplemental information "Elements of an NIH Data Management Sharing Plan," a compelling rationale for limiting scientific data sharing should be provided and will be assessed by NIH. Shared scientific data must be made accessible as soon as possible, and no later than the time of an associated publication, or the end of performance period, whichever comes first.

Consistent with 2 CFR 200.403 and the NIHGPS Section 7.4, budget requests must not include infrastructure costs that are included in institutional overhead (e.g., indirect costs Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived.) or costs associated with the routine conduct of research. Costs associated with collecting or otherwise gaining access to research data (e.g., data access fees) are considered costs of doing research and should not be included in scientific data management and sharing budgets. Costs may not be double charged or inconsistently charged as both direct and indirect costs Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived..

Applicants may request data management and sharing costs that are allowable and reasonable when associated with (1) Curating data and developing supporting documentation, including formatting data according to accepted community standards; de-identifying data; preparing metadata to foster discoverability, interpretation, and reuse; and formatting data for transmission to and storage at a selected repository for long-term preservation and access. (2) Local data management considerations, such as unique and specialized information infrastructure necessary to provide local management and preservation (e.g., before deposit into an established repository). (3) Preserving and sharing data through established repositories, such as data deposit fees necessary for making data available and accessible. For example, if a DMS Plan proposes preserving and sharing scientific data for 10 years in an established repository with a deposition fee, the cost for the entire 10-year period must be paid prior to the end of the period of performance. If the DMS Plan proposes deposition to multiple repositories, costs associated with each proposed repository may be included.

Generally, DMS Plans are not considered during peer review, unless the NOFO identifies data sharing as integral to the project. DMS Plans will undergo programmatic assessment by NIH staff following peer review. ICs may request additional information at Just-in-Time NIH policy allows the submission of certain elements of a competing application to be deferred until later in the application process, after review when the application is under consideration for funding. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. in order to meet expectations for data management and data sharing in support of programmatic priorities or to expand the utility of the scientific data generated from the research.

Once approved, the DMS Plan will become a Term and Condition of the NOA, and failure to comply may result in an enforcement action, including additional special terms and conditions or termination of the award, and may affect future funding decisions. In accordance with NIHGPS Section 8.1.1 NIH Standard Terms of Award, recipients must obtain prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). to make changes to the previously approved DMS Plan (e.g. change in scientific direction, change in repository, or change in the timeline). All prior approval Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). requests must be submitted in the eRA Prior Approval Module (see NIH Application Guide).

All allowable Data Management and Sharing costs in budget requests must be incurred (e.g., curation fees, data repository fees) during the performance period, even for scientific data and metadata preserved and shared beyond the award period.

Recipients are required to provide updates on the activities described in the DMS plan as part of the annual RPPR, and the IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. will use this information to assess compliance with the previously approved DMS Plan.

For additional information and resources, see the grants policy website on the Data Management and Sharing Policy.

8.2.3.3 Genomic Data Sharing (GDS) Policy

The NIH Genomic Data Sharing (GDS) 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 the GDS Policy, the genome is the entire set of genetic instructions found in a cell and large-scale genomic data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data. The grants policy website on Genomic Data Sharing Policy Overview provides examples of genomic research projects that are subject to the Policy and the timeline for submission and sharing of data from such projects.

All applications, regardless of the amount requested, proposing research that will generate large-scale genomic data, are expected to describe plans for sharing genomic data in the Data Management and Sharing (DMS) Plan submitted with the application as described in 8.2.3.2 Policy for Data Management and Sharing. For guidance on developing a DMS plan that meets the requirements of the DMS and GDS policies, refer to the grants policy website on Writing a Data Management & Sharing Plan. Once approved, the DMS Plan will become a Term and Condition of the NOA and compliance and enforcement will be handled as described in 8.2.3.2 Policy for Data Management and Sharing.

PD / PIs should register all studies with human genomic data that fall within the scope of the GDS Policy in the NIH database of Genotypes and Phenotypes (dbGaP) by the time that data cleaning and quality control measures begin. After registration in dbGaP, PD / PIs, through the recipient institution, should submit large-scale human genomic data as well as relevant associated data (e.g., phenotype and exposure data) to an NIH-designated data repository in a timely manner, consistent with their NIH-approved DMS Plan. PD / PIs should also submit any information necessary to interpret the submitted genomic data, such as study protocols, data instruments, and survey tools.

For research that falls within the scope of the GDS Policy, institutions submitting data, through their Institutional Review Boards (IRBs), privacy boards, or equivalent bodies, are to review the informed consent materials to determine whether it is appropriate for data to be shared for secondary research use. For studies proposing to use genomic data from cell lines or clinical specimens that were created or collected after the effective date of the GDS Policy, NIH expects that informed consent for future research use and sharing will have been obtained even if the cell lines or clinical specimens are de-identified. The responsible Institutional Signing Official of the submitting institution must provide an Institutional Certification to the funding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. prior to award. For guidance on completing an Institutional Certification under the GDS Policy, see the NIH Scientific Data Sharing website and section 2.3.7.10.

If there are compelling scientific reasons that necessitate the use of genomic data from cell lines or clinical specimens that were created or collected after the effective date of this Policy and that lack consent for research use and data sharing, investigators should provide a justification in the funding request for their use. The funding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. will review the justification and decide whether to make an exception to the consent expectation. In some instances, the funding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. may need to determine whether to grant an exception to the data submission expectation under the GDS Policy. Studies provided exceptions to data submission under the GDS Policy will still be expected to be registered in the NIH Database of Genotypes and Phenotypes (dbGaP) for transparency.

Investigators approved to access data and their institution are responsible for maintaining the confidentiality, integrity, and security of data accessed from a NIH-designated repository in accordance with the NIH Security Best Practices for Users of Controlled-Access Data included in Data Use Certifications (DUCs), or similar data use agreements, stipulating terms of access and the requirements of the Genomic Data User Code of Conduct. Violating these terms and requirements is considered a data management incident.

If an investigator plans to use a Cloud Service Provider (CSP) and/or a third-party IT system to store and analyze controlled-access data, NIH expects the CSP and/or third party IT system to meet the same standards as outlined in the NIH Security Best Practices for Users of Controlled-Access Data.

The institution, not the CSP and/or third-party IT system, will be held responsible for any failure in the oversight of controlled-access data.

NIH requires Lead Developers, and those they directly supervise, who seek access to controlled-access human genomic data under the GDS Policy for developer work (e.g., testing platforms, pipelines, analysis tools, and user interfaces that store, manage, and interact with human genomic data; providing infrastructure development and repository maintenance), to submit a request containing a Developer Use Statement (DUS) to the NIH Developer Data Access Committee ([email protected]) no later than at Just-in-Time NIH policy allows the submission of certain elements of a competing application to be deferred until later in the application process, after review when the application is under consideration for funding. Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. Through this module, institutions can electronically submit the information that is requested after the review, but before award. See Completing the Pre-Award Process-Just-In-Time Procedures for additional information. (JIT) for grants and cooperative agreements. If a project has multiple Lead Developers, (e.g., for multicomponent awards), each Lead Developer must submit a DUS. All Lead Developers must be associated with an institution that is receiving or applying for NIH or other federal support for the developer work with a funding mechanism that has incorporated the developer terms of access. Once established, Lead Developers must follow the Developer Terms of Access.

Additional information about the GDS Policy can be found on NIH's "Genomic Data Sharing Policy" webpage.

8.2.3.4 Sharing Model Organisms

All applications, regardless of amount requested, 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, Arabidopsis, fruit fly, zebrafish, and frog. Research resources to be shared include, but are not limited to, genetically modified organisms, mutant organisms, sperm, embryos, vectors, non-human embryonic stem cells, established cell lines, protocols for genetic and phenotypic screens, mutagenesis protocols, genetic and phenotypic data for all mutant strains.

For additional information on this policy, see the NIH Scientific Data Sharing Model Organism Sharing Policy website.