By Sara Gonzales, MS, MLIS, Data Librarian and Pamela Shaw, MSLIS, MS, Biosciences & Bioinformatics Librarian 

Throughout 2022 the National Institutes of Health (NIH), publishers, and institutional stakeholders across the US have been working to inform researchers of the NIH’s Final policy for Data Management and Sharing, which goes into effect January 25, 2023. In an effort to support reproducibility of research, the NIH has instituted this policy, which builds on a foundation of NIH data sharing policies, to encourage replication of studies and sharing of biomedical research data to the greatest extent possible.

The policy requires submission of a data management and sharing plan (DMSP) that outlines how data and metadata will be shared. The plan is to be submitted in the Budget Justification for extramural awards or in the technical evaluation (performed by NIH-ICO staff) for contracts. Data management and sharing plans, not meant to exceed two pages, should describe the types of data to be collected, preserved, and shared. These plans must note the software used to produce or collect the data, the types of data and metadata standards that will be used in the project, and a data submission timeline in addition to a listing of the repository that will be used for data sharing. Data management and sharing plans must also detail how sharing, access, and re-use are affected by any privacy concerns or other restrictions, and how data management and sharing will be overseen in the project. 

Plan compliance will be measured by data being shared in the manner described in the DMSP by the time of an associated publication, or the end of the grant’s performance period, whichever comes first. Compliance will be monitored by NIH program staff and non-compliance can impact future funding decisions.

The NIH has publicized a wide variety of online resources to familiarize researchers with the upcoming policy requirements and how to remain compliant. The NIH Scientific Data Sharing Website is a one-stop clearinghouse of information on the policy, including supplemental draft guidance documents, information on how to access NIH-supported data, and other sharing policies based on specific data types. Of key interest are the Data Management and Sharing Policy’s supplemental documents, which outline:

• Section-by-section guidance for writing a DMSP Elements of an NIH Data Management and Sharing Plan 
• A cost-defining supplement, outlining the data management and sharing costs that can be written into grants: Allowable Costs for Data Management and Sharing 
• A repository selection supplement, for selecting where to share data: Selecting a Repository for Data Resulting from NIH-Supported Research 

The Galter DataLab is Feinberg’s resource for information and assistance related to the NIH Final Policy for Data Management and Sharing. We have developed specialized support around the upcoming policy change, including:

• A new Galter class, “Getting to know the NIH Data Management and Sharing Policy" 
• A GalterGuide, Creating an NIH Data Management and Sharing Plan 

For questions and consultation support on creating a data management and sharing plan, contact the Galter DataLab or Data Librarian Sara Gonzales.

For additional information on the NIH’s Final Policy for Data Management and Sharing, see:

• Two upcoming presentations in the NIH Data Management and Sharing Policy Webinar Series 
• Introduction to the NIH Data Management and Sharing Plan by Lisa Federer / Network of the National Library of Medicine  
• NIH Data Management and Sharing Session 5. Policy Recap and Q&A /Network of the National Library of Medicine