Data Management and Sharing

Hackensack Meridian Health delegates stewardship of research data to the Principal Investigator. It is the responsibility of the PI to ensure data is appropriately managed and shared as appropriate by the professional standards, funder requirements, and/or federal regulations. Below are resources and tools to ensure best practices and compliance with data management and sharing requirements.

Sharing Data Requirements, Considerations, and Resources

Whether you are required to share your data or you choose to disseminate your data below are resources to help you identify appropriate repository and the relevant public access mandates. Fill out this form and a member of research compliance staff will help you navigate this process.

• NIH Data Management and Sharing {hyperlink to content on slide 9}
• Repository Finder

• Additional disclosure language within informed consent
• Assurances to protect PHI/PII, including review and approval by DTS

If you are required or planning to make data resulting from a clinical trial available on clinicaltrials.gov, please contact elli.gournapaleoudis@hmhn.org.

Leadership and Training Resources

• Making the Right Moves (HHMI)
• Health Tips for Research Groups (Nature)
• Why Some Professors Welcome New Lab Members with Clear Expectations - In Writing

Hackensack Meridian Health Data Management Resources

• Hackensack Meridian Health Data Management Plan Guidance
• Hackensack Meridian Health Data management webinar slides

Data Management Plan Writing Tools

• DMP Tool
• Data Management Budgeting
• Allowable Costs for Data Management and Sharing (NIH)

Data Management for Clinical Research and ClinicalTrials.gov compliance

• Data Management for Clinical Research on Coursera (Vanderbilt)
• CT.gov Data Element Definitions

2023 Data Sharing Policy NOT-OD-21-013

• Applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data.
  1. These include: research projects, some career development awards (Ks), small business, and research centers
  2. It does not include: training (Ts), fellowships (Fs), construction (C06), conference grants (R13), resource (Gs), research-related infrastructure programs (e.g. S06)
• Effective for applications submitted on/after January 25, 2023
• DMS Plan is part of Award Terms and Conditions
• NIH encourages scientific data to be shared as soon as possible, and no later than the time of an associated publication or end of the performance period, whichever comes first.
• Applications submitted on or after October 1, 2003, but before January 25, 2023 will continue to follow the 2003 Data Sharing Policy NOT-OD-03-032

Scientific Data is defined as data 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 includes any data needed to validate and replicate research findings.
• Scientific data does 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.

Hackensack Meridian Health Resources

Hackensack Meridian Health Webinar on NIH DMS
Sample Plans and Templates

NIH Resources

Slides from NIH DMS 2-part Webinar
NIH DMS Website
Allowable Costs for Data Management and Sharing (NIH)