SOM NIH Data Management and Sharing Policy: Multisite Studies

Element 1: Data Type

For studies with a large number of different types of data, consider including a table to organize your DMSP. For each data type, a table can include the data type name, data format, data standards used, and destination repository.

An example data type table:

Element 4: Data Preservation, Access, and Associated Timelines

Outline how data will be shared, stored and preserved across different sites.

• How will data be transmitted from subsites to the main site?
• Which site(s) will prepare and upload the final dataset(s) to repositories?
• Which site(s) will be responsible for preserving data that is not shared?

Element 5: Access, Distribution, or Reuse Considerations

Make sure to discuss with your collaborators any limitations on data sharing, particularly data that is being collected at subsite. Limitations on data sharing/reuse may vary by institution. If you are reusing an existing dataset for your grant, make sure to find out any limitation on reuse before writing your DMSP. Include these limitations in Section 5.

Element 6: Oversight

The PI is usually the one ultimately in charge of overseeing data management and sharing. However, consider whether you need to name stewards at each site.

Budget

For multi-site research, consider if sub-recipients will perform DMS activities (curating data, de-identification, formatting data according to community standards, transmission to and/or storage at the selected repository, developing supporting documentation, etc.).  If so, make sure data management costs accrued by all sites are included in the budget. Refer to NIH for more information on DMS Costs.

From the NIH Sharing FAQ:

A2. How does the DMS Policy interact with the data sharing expectations of other research partners (e.g., other funding agencies, collaborators)?

Award recipients are responsible for ensuring that any research partnerships allow for compliance with the DMS Policy. Data sharing expectations should be established prior to the initiation of a partnership, whenever feasible, and any limitations to sharing should be described in Plans. Researchers and award recipients are advised to consult with the funding NIH ICO on how to comply with all applicable data sharing policies potentially affecting their NIH-supported research project.

B10. Should multiple DMS Plans be submitted with each application for funding, including large, multicomponent awards?

No. The DMS Policy expects only one DMS Plan to be submitted with each application and does not expect separate Plans to be developed for individual projects under that application. In multicomponent applications, the DMS Plan must be in included in the Overall component. Applicants are encouraged to determine whether and how to coordinate responsibilities with respect to Plans with all Program Directors/Principal Investigators and all Key Personnel on the same application.

F3. How do I include data management and sharing (DMS) costs incurred by subawards within my application?

DMS costs for each subaward must be listed as a single line item on the R&R Budget for the subaward (F. Other Direct Costs, 8-17 Other). If no DMS costs are anticipated on the subaward, the line item is not required. A DMS costs line item must still be listed on the project/parent R&R Budget Form for the parent DMS costs, including $0 if no costs are anticipated for the parent.

For complex grant applications that involve an overall budget and multiple project/core budgets, DMS costs must be included within the applicable component(s), as outlined in the application instructions.

For grant applications submitting a modular budget, include all DMS costs request information in the Additional Narrative Justification attachment on the PHS 398 Modular Budget Form, as outlined in the application instructions.

In addition to the requirements of the DMS policy, an NIH-funded study being conducted at more than one U.S. site involving non-exempt human subjects research may be subject to the NIH Single IRB policy and/or the revised Common Rule (rCR) cooperative research provision ( §46.114).