NIH Data Management and Sharing
Beginning on January 25, 2023, all NIH researchers will be required to include a data management and sharing (DMS) plan in all funding applications. To provide guidance to the university community, the NIH has launched a Scientific Data Sharing Website addressing its new data sharing requirements.
Background
Since 2003, NIH has required data management and sharing plans for awards in excess of $500,000 in direct costs in any single year of the project period. However, the new Final NIH Policy for Data Management and Sharing applies to all NIH grants applied for after January 25, 2023, and imposes new expectations on what must be included in a DMS Plan.
Key Points
- ➤ DMS plan elements include:
- Data type to be managed, preserved, and shared
- Tools, software and/or code required to access or manipulate shared scientific data
- Standards that will be applied to the scientific data and associated metadata
- Timelines for data preservation and access
- Access, distribution, or reuse considerations
- Description of how compliance with the Plan will be monitored and managed
➤ DMS plans should be no longer than two pages.
➤ The costs associated with satisfying data sharing obligations may be charged to the NIH but must be included in the budget, even for scientific data and metadata preserved and shared beyond the award period.
➤ Researchers are expected to call out any ethical, legal, or technical considerations that might limit the nature and extent of data sharing, particularly for research involving human subjects.
➤ NIH Institutes, Centers, and Offices (ICO’s) may add additional data sharing requirements in connection with specific solicitations.
➤ Solicitations may specify NIH-supported repositories into which data must be placed or allow researchers to select repositories external to NIH.
➤ Data should be made available as soon as possible and no later than the time of an associated publication. Data must also be released in a timely way even if no publications arise from the research.
DMS Resources for USC Researchers and Administrators
USC has developed a suite of resources to support the research community in understanding and adhering to the new NIH DMS requirements.
For a more detailed overview of NIH’s Data Sharing initiative, please review the NIH Data Sharing presentation prepared by the Office of Culture, Ethics, and Compliance (OCEC).
In addition, OCEC has developed a series of one-page guidance sheets addressing key points of the new DMS requirement. Please click on any of the links below for topic-specific guidance:
- Required Elements of a Data Sharing Plan
- Data Sharing Plans (Additional Considerations for Human Subjects Data)
- Allowable Costs for Data Management and Sharing
- Selection of a Data Repository
- Selection of a Data Repository (Additional Considerations for Human Subjects Data)
- Method of Submission of Data Sharing Plans
- Benchmarking of Available Third-Party Repositories
Throughout the Fall of 2022, USC offered live training sessions to researchers and research administrators designed to familiarize the research community with the new NIH DMS requirements. To review a video recording of one of the sessions, please visit NIH Data Management and Sharing Requirements. Should you have interest, OCEC and OOR are also happy to schedule additional live training sessions for your department, unit, or school.
Below are examples of DMS Plans that follow the required structure of the NIH Rule and discuss some key points for consideration as you develop a plan that is appropriate for your research project. The first link explains various criteria to consider for each plan element. The remaining links are examples of DMS Plans to use as reference.
- DMS Plan Guidance by Required Plan Element
- Sample DMS Plan: Biomedical Research (Human Subjects)
- Sample DMS Plan: Social/Behavioral Research (Human Subjects)
- Sample DMS Plan: Basic Science
For general guidance on key points to consider when developing a DMS Plan, please review this checklist.
The USC Libraries offers the USC Digital Repository as a service to our NIH researchers who are looking for a repository solution that meets NIH’s expectations. The Libraries will supply text and a quote for costs to be added into grant applications. To learn more about the repository services offered by the Libraries, please visit NIH Data Management and Sharing Repository Services to learn more about services and pricing.
➤ DMP Tool
DMP Tool is a free, open-source, online application that helps researchers create data management plans (DMP’s). Please visit https://dmptool.org/ to create a free account and obtain access to the tool. Because DMP Tool assists in the creation of DMP’s for multiple sponsors, be sure to select NIH as the sponsor when creating your plan.
➤ FAQ’s
Please visit the NIH’s Scientific Data Sharing Website to review a series of frequently asked questions addressing topics like the scope of the policy, effective practices to manage and share data, and considerations for scientific data derived from human participants, among other topics.
➤ “FAIR” Principles
A guiding principle of the NIH Strategic Plan for Data Science is that all biomedical research data should adhere to FAIR principles. This means data should be Findable, Accessible, Interoperable, and Reusable. To learn more, visit the GO FAIR Initiative or read The NIH Strategic Plan for Data Science.
➤ NIH Guide Notices: Data Management and Sharing
- NOT-OD-21-013 (Final NIH Policy for Data Management and Sharing)
- NOT-OD-21-014 (Supplemental Information: Elements of an NIH Data Management and Sharing Plan)
- NOT-OD-21-015 (Supplemental Information: Allowable Costs for Data Management and Sharing)
- NOT-OD-21-016 (Supplemental Information: Selecting a Data Repository)
- NOT-OD-22-213 (Supplemental Information: Protecting Privacy When Sharing Human Subjects Data)
- NOT-OD-22-214 (Supplemental Information: Responsible Management and Sharing of American Indian/Alaskan Native Participant Data)
Office of Culture, Ethics, and Compliance: Daniel Shapiro, AVP for Research Compliance (Daniel.shapiro@usc.edu)
Office of Research: Kristen Grace, Research Integrity Officer (gracekri@usc.edu)