What is the Data Management and Sharing Policy?

Sharing research data supports the mission of the National Institutes of Health (NIH). It is essential to facilitate the translation of research results into knowledge, products, and procedures that improve human health. To set forth expectations that ensure the broad and responsible management and sharing of research data, NIH issued the Data Management and Sharing (DMS) Policy, which took effect on January 25, 2023. Sharing scientific data accelerates biomedical research discovery, in part by enabling validation of research results, providing accessibility to high-value datasets, and promoting data reuse for future research studies.

The Office of Intramural Research has specified that DMSP applies to research associated with a:

• ZIA (human and non-human research)

• A clinical protocol that will undergo IC Initial Scientific Review

• Genomic Data Sharing (GDS) project

The DMS Policy requires sharing scientific data, defined as data of sufficient quality to validate and replicate the research findings¹. For additional information on the DMS Policy, please refer to the Center for Cancer Research (CCR) DMS Policy Home Page. To help you determine which Data Sharing Policies apply to your research, the NIH Office of Science Policy has created an online tool, What Policies Apply to My Research. This approach involves answering a few questions about your research, which you submit to obtain information about which policy or policies apply to your research.

The DMS Policy has been harmonized with the Genomic Data Sharing (GDS) Policy (see Figure below²); the single DMS Plan incorporates the requirements of both the DMS and GDS policies.   

Research outside the Scope of the DMS Policy:

Examples of NIH-funded research or research-related activities that are outside the Policy’s scope include, but are not limited to, projects that do not meet the criteria in the above examples and involve:

• Instrument calibration exercises.

• Statistical or technical methods development.

Genomic Data Sharing details can be found on this page — Genomic Data Sharing 

Note: If you are requesting for a DMSP waiver, you do not need to submit a DMSP on the portal.

Resources 

Websites

• NIH Data Management and Sharing Policy Website
• CCR Protocol Data Management and Sharing submission portal
• CCR Data Management and Sharing Plans website
• NCI Office of Data Sharing website
• NIH Office of Science Policy Scientific Data Sharing website
• NIH Office of Intramural Research 2023 NIH Data Management and Sharing Policy website
• Data Repositories and Trusted Partners for genomic data

dbGAP Study Registration

•  dbGaP: Complete a Study Registration

Data Submission

• Genomic_Data_Sharing_and_dbGaP_submissions_slides.pptx

• dbGaP_Submissions_QA

• dbGaP Study Submission Guide 

Data Access

• dbGaP: Apply for Controlled Access Data

• Assign Downloaders for dbGaP Data

• dbGaP: Renew Authorized Access

• dbGaP: Close Out a Controlled Access Project

References:

1. 2023 Data Management and Sharing Policy: Policy Scope https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm?anchor=56772, accessed 6/23/2023.
2. NCI Office of Data Sharing Tactic meeting presentation held on May 2023. Author: Emily Boja.