What do I need to know?
- Applies to all NIH researchers generating scientific data.
- Institutes, Centers, and Offices (ICOs) may have additional guidance or policies.
- Investigators must: submit a DMS plan, submit a DMS plan budget; comply with the approved DMS plan.
- Plans must detail how scientific data will be managed and shared.
- Data must be shared at the time of publication or end of performance period, whichever comes first.
- NIH encourages investigators to use established repositories for data sharing.
- Plans are reviewed for acceptability by NIH staff and they may request modifications prior to funding; peer reviewers may consider budget items.
- Investigators will update on their DMS plan during regular reporting. Changes to the approved DMS plan may be made by “submit[ting] a timely formal prior approval request to the funding NIH Institute, Center, or Office (ICO)”.
- “Applications subject to NIH’s Genomic Data Sharing (GDS) Policy should also address GDS-specific considerations within the elements of a DMS Plan (see NOT-OD-22-189).”
One of the required elements of a DMS plan is Oversight of Data Management and Sharing (element six). This element requires that investigators describe how compliance with the DMS Plan will be monitored and managed, the frequency of oversight, and by whom (e.g., title, roles). This element refers to oversight by the funded institution, rather than by NIH. The DMS Policy does not create any expectations about who will be responsible for Plan oversight at the institution.
The following is draft language that investigators may use to satisfy this element of their DMP:
Monitoring of and compliance with this Data Management and Sharing Plan will be the responsibility of the project’s Principal Investigator. The plan will be implemented and managed by professional staff working under the direction of the PI.
The PI of the proposal will make the plan available to all personnel involved in the project. The PI will be responsible for ensuring faithful adherence to the DMS Plan and revising the plan annually, as the research project evolves.
HRPP Quality and Compliance Analysts from the UW Office of Research Compliance Post-Approval Monitoring Program conduct grant/protocol congruence reviews on a selection of grants awarded by the NIH. Going forward, this review will verify that the DMS plan is consistent with the IRB approved protocol and consent documents. Aside from this, investigators are responsible for ensuring that the data that is actually shared with the NIH is consistent with their approved plan.