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.
- 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.
- HEAL pain core CDEs, supplemental CDEs
- New HEAL clinical pain studies are required to submit their case-report forms/questionnaires to the HEAL Clinical Data Elements (CDE) Program. The program creates CDE files containing standardized variable names, responses, coding, and other information. HEAL Initiative clinical studies using copyrighted questionnaires must obtain use licenses, and share them with the HEAL CDE team and program officer prior to using copyrighted material or collecting data.
- Registration and metadata requirements
- Within a year of award, HEAL awardees must complete Study Registration within the HEAL Platform.
- Awardees must submit all relevant HEAL Study-Level Metadata via CEDAR within 1 year of the award issue date, completing timely updates in accordance with any study data release. Additional HEAL metadata resources:
- Tools and Resources for Creating Machine-Readable Variable-Level Metadata (forthcoming)
- Platform Submission Documentation and Portal (forthcoming)
- Data Preservation, Access, and Associated Timelines
- HEAL investigators must deposit their data within a HEAL Data Ecosystem-Compliant Repository. To assist, the HEAL Stewards produced a Repository Selection Guide.
- Shared scientific data should be made accessible as soon as possible, and no later than the time of an associated publication, or the end of performance/award/support period, whichever comes first.
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
Provide an oversight plan! For additional guidance, as you implement your plan, check out the Step-by-Step Guide to HEAL-Compliant Data.
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.
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).
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.