Office of Clinical Research
NIH Data Management & Sharing Plan Requirements
NIH Data Management & Sharing Policy (2023)
This page is intended to inform the Penn community about the new National Institutes of Health (NIH) policy.
The current NIH policy on sharing research data expires January 25, 2023.
More Information on how Penn is preparing and providing resource: https://guides.library.upenn.edu/NIH
What is new about the 2023 NIH Data Management and Sharing Policy?
Beginning on January 25, 2023, ALL grant applications or renewals that generate Scientific Data must include a detailed plan for managing and sharing data through the entire funded period with plans for data dissemination. You must provide this information in a Data Management and Sharing Plan (DMSP). In addition, once the award is made and plan approved, compliance with the DMSP will be a determining condition of the work, meaning it can impact future funding decisions.
Why is the NIH making these changes?
The NIH is emphasizing good data stewardship with the goals of advancing rigorous and reproducible research and promoting public trust in scientific endeavors.
How does the NIH define scientific data?
Scientific Data are "the recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Scientific data do not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens."
Am I required to share my data?
The policy encourages efforts to maximize appropriate sharing, but recognizes exceptions (i.e., legal, ethical, or technical reasons). These reasons must be communicated in the NIH DMSP. In addition, sharing plans must be communicated in informed consent documents. In the end, ALL data must be managed, even if not all data can be shared.
Permissions & Guidance:
- IRB Regarding Approvals
- Clinical Trials.gov
- Privacy Policies and Guidance
- Penn Clinical and Biospecimen Data Sharing
- Federal and State-Specific Laws - HIPAA Waiver Form
(Search HIPAA on left hand side menu, and click update)
- DART website regarding secure storage and computing options
- Penn Research Analytic Storefront regarding where to find clinical data for research
- Data Analytics Center (DAC) for submitting data request
- ORS regarding research inventory system for submitting DUA, MTA, BAA, etc.
- DMP Tool
- Scholarly Commons
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