Effective Janaury 25, 2023
NIH has issued a new policy to promote the management and sharing of scientific data generated from NIH-funded or conducted research. The policy establishes the requirement for submission of a data management and sharing plan (DMS plan) with the funding application for research that results in the generation of scientific data. The DMS policy applies to all funding mechanisms submitted on or after the effective date. The new policy does not introduce new requirements for the protection of human research participants but does have implications for privacy protections and informed consent.
NIH program staff determine if the DMS plan is acceptable. The plan must address the 6 key elements described below. For research that is subject to both the DMS Policy and the NIH Genomic Data Sharing (GDS) Policy, a single plan that addresses both policies is required at the time of application. See Writing a Data Management and Sharing Plan for more information about NIH expectations.
- Data Type: scientific data to be managed and shared
- Related Tools, Software, and/or Code: any tools needed to access or manipulate shared data
- Standards: any standards that will be applied to the scientific data
- Data Preservation, Access and Associated Timelines: repository to be used, persistent unique identifier, and when/how long data will be available. NIH requires data to be shared no later than the time of publication or end of the award, whichever comes first.
- Access, Distribution or Reuse Considerations: description of factors affecting subsequent access, distribution, or re-use of data.
- Oversight of data management and sharing: how compliance with DMS plan will be monitored and managed. Noncompliance with the NIH approved DMS plan may result in an enforcement action.
Considerations for sharing human subjects data
- Communicate plans for future sharing and use of scientific data in consent forms.
- Assess the privacy and confidentiality protections needed for sharing data from research participants. Unless a participant consents to sharing identifiable data, it should generally be shared only in a de-identified format.
- Consider justifiable limitations to sharing data. These include (but are not limited to) uses of the data as described in the consent form and when sharing would compromise subject privacy or safety.
For more information, see NIH’s supplement to the DMS policy Protecting Privacy When Sharing Human Research Participant Data and the webpage Sharing Data from Human Participants.
NIH recognizes that making data accessible and reusable may incur costs. Researchers may request funds toward data management and sharing as explained in Budgeting for Data Management and Sharing.
- NIH Scientific Data Sharing Website
- Data Management & Sharing Policy Overview
- 2023 Data Management & Sharing FAQs
- Selecting a Data Repository