NIH Data Management & Sharing Plan Policy

Briefly describe the scientific data to be managed and shared:

• Summarize the types (for example, 256-channel EEG data and fMRI images) and amount (for example, from 50 research participants) of scientific data to be generated and/or used in the research. Descriptions may include the data modality (e.g., imaging, genomic, mobile, survey), level of aggregation (e.g., individual, aggregated, summarized), and/or the degree of data processing.
• Describe which scientific data from the project will be preserved and shared. NIH does not anticipate that researchers will preserve and share all scientific data generated in a study. Researchers should decide which scientific data to preserve and share based on ethical, legal, and technical factors. The plan should provide the reasoning for these decisions.

• A brief listing of the metadata, other relevant data, and any associated documentation (e.g., study protocols and data collection instruments) that will be made accessible to facilitate interpretation of the scientific data

Give plans and timelines for data preservation and access, including:

• The name of the repository(ies) where scientific data and metadata arising from the project will be archived. See Selecting a Data Repository for information on selecting an appropriate repository. 
• How the scientific data will be findable and identifiable, i.e., via a persistent unique identifier or other standard indexing tools.

• When the scientific data will be made available to other users and for how long. Identify any differences in timelines for different subsets of scientific data to be shared.

  • Note that NIH encourages scientific data to be shared as soon as possible, and no later than the time of an associated publication or end of the performance period, whichever comes first. NIH also encourages researchers to make scientific data available for as long as they anticipate it being useful for the larger research community, institutions, and/or the broader public.

Describe any applicable factors affecting subsequent access, distribution, or reuse of scientific data related to:

• Informed consent
• Privacy and confidentiality protections consistent with applicable federal, Tribal, state, and local laws, regulations, and policies
• Whether access to scientific data derived from humans will be controlled 
• Any restrictions imposed by federal, Tribal, or state laws, regulations, or policies, or existing or anticipated agreements

• Any other considerations that may limit the extent of data sharing. Any potential limitations on subsequent data use should be communicated to the individuals or entities (for example, data repository managers) that will preserve and share the scientific data. The NIH ICO will assess whether an applicant’s DMS plan appropriately considers and describes these factors. For more examples, see Frequently Asked Questions for examples of justifiable reasons for limiting sharing of data.

• What is the associated time/effort for collecting the data?
• Anticipated repository fees?
• What costs are likely to change during the course of the award?
• Archival costs? During the project period and beyond?

Reasonable, allowable costs may be included in NIH budget requests for:

• Curating data
• Developing supporting documentation
• Formatting data according to accepted community standards, or for transmission to and storage at a selected repository for long-term preservation and access
• De-identifying data
• Preparing metadata to foster discoverability, interpretation, and reuse
• Local data management considerations, such as unique and specialized information infrastructure necessary to provide local management and preservation (for example, before deposit into an established repository).
• Preserving and sharing data through established repositories, such as data deposit fees.
  • If the Data Management & Sharing (DMS) plan proposes deposition to multiple repositories, costs associated with each proposed repository may be included.

Note that all allowable costs submitted in budget requests must be incurred during the performance period, even for scientific data and metadata preserved and shared beyond the award period. 

For instance, 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 before the end of the period of performance.

Budget requests must NOT include:

• • Infrastructure costs that are included in institutional overhead (for instance, Facilities and Administrative costs) 
  • Costs associated with the routine conduct of research, including costs associated with collecting or gaining access to research data. 
  • Costs that are double charged or inconsistently charged as both direct and indirect costs 

Costs to support the activities described in the Data Management and Sharing Plan must be requested in the appropriate cost category(ies), e.g., personnel, equipment, supplies, and other expenses.

Investigators must also include a justification of the activities proposed in the DMS Plan that will incur costs. This justification must be labeled as "Data Management and Sharing Justification" within the budget justification attachment, followed by the estimated dollar amount.

The justification should include a brief summary of type and amount of scientific data to be preserved and shared, and the name of the established repository(ies) to be used. It should also indicate general cost categories (such as curating data and developing supporting documentation, local data management activities, preserving and sharing data through established repositories, etc.); each category should include an amount and a brief explanation.

The recommended length of the justification should be no more than half a page and should be included as follows:

• R&R Detailed Budget Form: Use the Budget Justification attachment
• PHS 398 Modular Budget Form: Use the Additional Narrative Justification attachment

• NIMH Data Archive (NDA)’s budgeting guide – and their NDA Data Submission Cost Estimation Tool. The tool is a spreadsheet that is NDA specific, but it has line-by-line examples of tasks, and how many PI hours and Data Manager hours would be involved at X salary to come up with a Total Cost for the project.
• "Making Research Data Publicly Accessible: Estimates of Institutional & Researcher Expenses" - a retrospective assessment of expenditures for federally funded researchers over the life cycle of selected federal awards that required compliance with DMS requirements.
• Realities of Academic Data Sharing (RADS) Initiative Public-Access Data Management and Sharing (DMS) Activities, v3 - describes what researchers and administrators at institutions that support research data sharing may need to consider when managing and sharing data to comply with funder or other data-sharing and public-access policies.

We encourage the use of the  DMPTool, a University-wide Resource for Creating Data Management Plans (DMP).The DMPTool is a free, open-source, online application that helps researchers create data management plans. It is highly recommended that Investigators utilize the DMPTool to develop and write their Data Management and Sharing Plans (DMSPs). The DMPTool provides a click-through wizard for creating a DMP that complies with funder requirements. It also has direct links to funder websites, help text for answering questions, and data management best practices resources.

• Built-in Sponsor Specific DMS plan templates (NIH, NSF)
• A click-through wizard for step-by-step plan creation
• Sample language
• Embedded guidance from the Sponsor (ie NIH), SBU, and the DMPTool
• A process for requesting feedback on your plan from SBU Offices including Research Computing, Informatics, & Innovation (RCI) & University Libraries, as well as adding your collaborators, department administrators, and others!
• A multi-format download function

SBU Libraries provide various resources and assistance with managing research data, including the following:

• Workshops covering the many steps and importance of data management
• Librarians that can review your data management and sharing plans, and provide consultations as needed (please send requests to dataservices@stonybrook.edu)

The  Research Computing, Informatics, & Innovation (RCI2) team supports the research mission of the university by meeting the computing and informatics resource needs of researchers, and enabling the proficient and appropriate use of these resources.  The (RCI2) team is pleased to offer consultation and project review services. To request consultation, email SBMIT_Research_Services@stonybrookmedicine.edu. 

• REDCap
• OnCore
• TriNetX
• Box
• Azure

Human Subject Research (IRB)

• • The Human Research Protection Program has consent templates available in the myResearch IRB library that include language related to data sharing
  • A copy of the Data Management and Sharing Plan must be submitted with your IRB application. This plan can be uploaded into the myResearch IRB electronic submission system. Once the application is submitted the IRB will look for consistency between the Data Sharing Plan and other study related documents.