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 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 affect the extent to which scientific data are preserved and shared. 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., Facilities and Administrative costs) 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 NIH Scientific Data Sharing website.

8.2.3.2 Genomic Data Sharing (GDS) Policy

The NIH Genomic Data Sharing (GDS) Policy sets forth expectations that ensure the broad and responsible sharing of genomic research data. Sharing research data supports NIH's mission and facilitates the translation of research results into knowledge, products, and procedures that improve human health.

The 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 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.

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 DMS Plan submitted with the application, and not in a separate GDS Plan or 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., consistent with the changes described in 8.2.3.1 Policy for Data Management and Sharing. For guidance on development a DMS plan that meets the requirements of the DMS plan that meets the requirements of the GDS policy, see the NIH Scientific Data Sharing website.

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 The individual(s) designated by the applicant organization/recipient to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as program directors/principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the official(s) at the applicant organization/recipient, or as appropriate, to a collaborating organization for the proper conduct of the project, program, or activity including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI., 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 has been updated to include best practices for cloud computing. The Model Data Use Certification has also been updated and is available at http://gds.nih.gov/pdf/Model_DUC.pdf.

8.2.3.3 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.