Responsible Unit: OSA | Executive Lead: Provost
Created: 1/6/2023 | Reviewed/Revised: N/A | Effective: 2/14/2023
Compliance: Final NIH Policy for Data Management and Sharing, NOT-OD-21-013 (effective January 25, 2023; Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing NOT-OD-21-015
Approving Body: PAC | Classification: Institution-wide
Policy:
Federal Agencies, including the National Institutes of Health (NIH) have had a longstanding commitment to making the results and outputs of NIH-funded research available to the public through effective and efficient data management and data sharing practices. Data sharing enables researchers to rigorously test the validity of research findings, strengthen analyses through combined datasets, reuse hard-to-generate data, and explore new frontiers of discovery. In addition, NIH emphasizes the importance of good data management practices, which provide the foundation for effective data sharing and improve the reproducibility and reliability of research findings.
Under the NIH Data Management and Sharing Policy (DMS), effective J, NIH requires researchers to prospectively plan for how scientific data will be preserved and shared through submission of a Data Management and Sharing Plan (Plan). Upon NIH approval of a Plan, NIH expects researchers and institutions to implement data management and sharing practices as described. NIH recognizes that making data accessible and reusable for other researchers may incur costs. For that reason, investigators may request funds from the NIH toward data management and sharing in the budget and budget justification sections of their applications.
This PNWU Sponsored Programs Data Management and Sharing Policy is designed to ensure PNWU’s compliance with NIH DMS Policy and other applicable federal data sharing requirements. This policy applies to NIH grant and cooperative agreement applications submitted on or after January 25, 2023 (see NOT-OD-21-013).
Definitions:
N/A
Procedures:
PROCEDURES FOR IMPLEMENTATION
a. General Guidelines and Definitions
1. Definitions:
Scientific Data: The recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Scientific data do not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens.
Data Management: The process of validating, organizing, protecting, maintaining, and processing scientific data to ensure the accessibility, reliability, and quality of the scientific data for its users.
Data Sharing: The act of making scientific data available for use by others (e.g., the larger research community, institutions, the broader public), for example, via an established repository.
Metadata: Data that provide additional information intended to make scientific data interpretable and reusable (e.g., date, independent sample and variable construction and description, methodology, data provenance, data transformations, any intermediate or descriptive observational variables).
Data Management and Sharing Plan (Plan): A plan describing the data management, preservation, and sharing of scientific data and accompanying metadata.
2. Scope
This 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, contracts, Intramural Research Projects, or other funding agreements regardless of NIH funding level or funding mechanism. This Policy does not apply to research and other activities that do not generate scientific data, including training, infrastructure development, and non-research activities.
3. Requirements
All applications for NIH research funding must include the submission of a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations. Compliance with the awardee’s plan as approved by the NIH will be required.
Costs associated with data management and data sharing may be requested from the NIH as part of the project budget. See Section 6 below regarding Budgeting and Allowable Costs for Data Management and Sharing.
4. Data Management and Sharing Plans
Researchers planning to generate scientific data are required to submit a Plan to the NIH as part of the Budget Justification section of the application for extramural awards, as part of the technical evaluation for contracts, as determined by the Intramural Research Program for Intramural Research Projects consistent with the objectives of this Policy, or prior to release of funds for other funding agreements. 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 Plan revisions are necessary (e.g., new scientific direction, a different data repository, or a timeline revision), Plans should be updated by researchers and reviewed by the NIH during regular reporting intervals or sooner. Plans from NIH-funded or conducted research may be made publicly available and should not include proprietary or private information.
5. Managing and Sharing Scientific Data
In drafting Plans, researchers should 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. Any potential limitations on subsequent data use should be communicated to individuals or entities (e.g., data repository managers) that will preserve and share the scientific data.
- Considerations for Scientific Data Derived from Human Participants: NIH prioritizes the responsible management and sharing of scientific data derived from human participants. Applicable federal, Tribal, state, and local laws, regulations, statutes, guidance, and institutional policies govern research involving human participants and the sharing and use of scientific data derived from human participants. NIH also respects Tribal sovereignty in the absence of written Tribal laws or polices. This DMS Policy is consistent with federal regulations for the protection of human research participants and other NIH expectations for the use and sharing of scientific data derived from human participants, including the NIH’s 2014 Genomic Data Sharing (GDS) Policy, 2015 Intramural Research Program Human Data Sharing Policy, and 45 CFR 46. Researchers proposing to generate scientific data derived from human participants should outline in their Plans how privacy, rights, and confidentiality of human research participants will be protected (i.e., through de-identification, Certificates of Confidentiality, and other protective measures).
NIH strongly encourages researchers to plan for how data management and sharing will be addressed in the informed consent process, including communicating with prospective participants how their scientific data are expected to be used and shared. Researchers should consider whether access to scientific data derived from humans, even if de-identified and lacking explicit limitations on subsequent use, should be controlled.
- Data Repository Selection: NIH strongly encourages the use of established repositories to the extent possible for preserving and sharing scientific data.
- Data Preservation and Sharing Timelines: Shared scientific data should 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. Researchers are encouraged to consider relevant requirements and expectations (e.g., data repository policies, award record retention requirements, journal policies) as guidance for the minimum time frame that scientific data should be made available, which researchers may extend.
6. Budgeting and Allowable Costs for Data Management and Sharing
NIH recognizes that making data accessible and reusable for other researchers may incur costs. For that reason, investigators may request funds from the NIH as part of their project budget toward data management and sharing in the budget and budget justification sections of their applications.
All allowable costs submitted 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. Consistent with 45 CFR 75.403 and the NIH Grants Policy Statement 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.
Reasonable, allowable costs may be included in NIH budget requests when associated with:
- 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.
- 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).
- Preserving and sharing data through established repositories, such as data deposit fees necessary for making data available and accessible. For example, if a Data Management and Sharing 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 Plan proposes deposition to multiple repositories, costs associated with each proposed repository may be included.
Related Documents:
N/A