Complying With the HEAL Data Sharing Policy

Research teams funded by the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, must make their HEAL data Findable, Accessible, Interoperable, and Reusable (FAIR) in line with the HEAL Data Sharing Policy and the broader efforts across NIH, as outlined in the NIH Strategic Plan for Data Science

This page provides resources for researchers who are discovering best practices and compliance needs to make their data FAIR, both as they are considering applying for a HEAL grant and after a grant has been awarded.

Under the NIH HEAL Initiative Public Access and Data Sharing Policy, and the NIH Policy for Data Management and Sharing, all HEAL applicants—regardless of direct cost amounts requested for any budget or project period—are required to include a Data Management and Sharing Plan (DMSP) outlining how they will manage and share scientific data, accompanying metadata, other relevant data, and associated documentation. This guide is an applicant resource for including HEAL-compliant components in a plan. Applicants should also include details and information relevant to all other NIH policies applicable to their work (e.g., Genomic Data Sharing Policy, clinical trial dissemination requirements, and other policies).

Elements of the Public Access and Data Sharing Plan 

NIH developed overarching guidance for each element, and under each one, HEAL indicates special HEAL applicant and awardee requirements and considerations. 

Data Type 

  • Ensure your DMSP summarizes the types and estimated amounts of your anticipated scientific research data. Providing a clear description of project data types, sizes, and expected formats will help you select appropriate repositories and estimate curation-support needs. 
  • Related Tools, Software, and/or ​Code 
    • HEAL highly encourages that all protocols, software, analysis materials, and documentation necessary for study method and result empirical reproducibility be made broadly accessible and reusable within a relevant repository. 

Standards 

Access, Distribution, or Reuse Considerations  

  • To the extent possible, in alignment with human subjects data protections, HEAL awardees should integrate broad data sharing consent language pdf  735.96 KB pdf  unknown size into their informed consent forms, making as much data shareable as possible. 
  • Even when data are broadly consented and de-identified, HEAL investigators should address appropriate privacy protections in their plan and repository selections.   
  • Additional guidance on sharing data from human participants

Oversight of Data Management and Sharing  

Additional Guidance and Resources

The HEAL Data Stewardship Group (HEAL Stewards) has been funded to guide researchers with a funded HEAL award through the process of making their data FAIR. On their website, you can find a complete Checklist for HEAL-Compliant Data that deep dives into each of the items below. Completing each of these items will ensure that your work is compliant with the HEAL Data Sharing Policy and the broader efforts across NIH as outlined in the NIH Strategic Plan for Data Science. Preview the list below and contact the HEAL Stewards for help planning or implementing.

  • Award received
  • Provide Your Data Management and Sharing Plan to the HEAL Stewards
  • Register Your Study on ClinicalTrials.gov
  • Register Your Study With the HEAL Data Platform
  • Complete Your Study-Level Metadata Form
  • Select a Repository
  • Use HEAL Common Data Elements to Collect Your Data 
  • Submit Data and Metadata to a Repository
  • Report Your Research Publication

View Complete Checklist on HEALdataFAIR.org (link is external)

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About the HEAL Data Ecosystem

The HEAL Data Ecosystem aims to transform research data, findings, and publications into a virtual, annotated, searchable catalog in which datasets and findings from different studies can be analyzed, compared, and combined.

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Common Data Elements (CDEs) Program

To facilitate cross-study comparisons and improve the interpretability of findings, clinical pain research grantees collaborate and agree to use common data elements for patient-reported outcomes (PROs).

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Public Access and Data Sharing Plan

Through the NIH HEAL Initiative Public Access and Data Sharing Policy (the Policy), NIH seeks to create an infrastructure that addresses the need for researchers, clinicians, and patients to collaborate.

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