A new NIH Data Management & Sharing Policy will go into effect January 25, 2023. While the focus is on the new responsibilities of researchers, the policy will have an impact on NIH Chief Information Officers (CIOs). Here is what CIOs need to know.
First, the policy applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data.”1
Investigators and institutions are required to:
- Plan and budget for managing and sharing scientific data generated by NIH funded research.
- Prepare and submit a Data Management and Sharing (DMS) Plan during the funding application process.
- Comply with the approved DMS Plan.
For CIOs, the policy triggers new procedures and oversight on an Institute or Center (IC) basis for both extramural and intramural research. CIOs should expect new queries from researchers about available repositories for data sharing. In addition, proactive communication about access and security considerations will prevent future challenges.
Data Management and Sharing Plans
Each NIH Intramural Research Program (IRP) determines the procedures for submitting and managing DMS Plans. CIOs should engage with the appropriate IRP offices to advise and assist.
CIOs supporting extramural research grant application and funding systems will need to add associated features and functionality to capture and store DMS Plans.
Supplemental policy guidance provides details about expected contents for DMS Plans and recommends a length of two pages or less.2 Exhibit 1 summarizes the DMS Plan content expectations.
Exhibit 1. Summary of Data Management and Sharing Plan Content Elements
|Data Type||Summarize data types and amount, may describe data modality, level of aggregation, degree of data processing |
Describe scientific data planned for preservation and sharing with reasoning behind ethical, legal, and technical factor decisions
Brief list of metadata, other relevant data, and associated documentations planned for facilitating scientific data interpretation
|Related Tools, Software and/or Code||Identify any specialized tools needed to access or manipulate the shared scientific data for replication or reuse|
|Standards||Describe planned standards for application to scientific data and metadata, for example, data formats, data dictionaries, data identifiers, definitions, unique identifiers, and other data documentation|
|Data Preservation, Access, and Associated Timelines||Describe plan and timeline for: |
Name of repository identified for scientific data and metadata archivalHow the scientific data will be findable and identifiableWhen, and for how long, the scientific data will be available
|Access, Distribution, or Reuse Considerations||Identify applicable considerations for subsequent access, distribution, or reuse related to informed consent, privacy and confidentiality protections, control of data derived from humans, regulatory or policy restrictions, other potential limitations|
|Oversight of Data Management and Sharing||Identify institutional oversight roles and responsibilities for monitoring and managing compliance with the documented plan|
1. Research Covered Under the Data Management & Sharing Policy | Data Sharing. Accessed October 18, 2022. https://sharing.nih.gov/data-management-and-sharing-policy/about-data-management-and-sharing-policy/research-covered-under-the-data-management-sharing-policy
2. Writing a Data Management & Sharing Plan | Data Sharing. Accessed December 14, 2022. https://sharing.nih.gov/data-management-and-sharing-policy/planning-and-budgeting-for-data-management-and-sharing/writing-a-data-management-and-sharing-plan#elements-to-include-in-a-data-management-and-sharing-plan