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.

HEAL-specific Requirements

These HEAL-specific requirements should be integrated into data management and sharing plans developed for HEAL applications, and implemented during data generation for HEAL-funded projects.

Select a HEAL compliant repository for long-term data storage.
Register your HEAL study in the HEAL Data Platform.
Submit metadata to the HEAL Data Platform.
Pain clinical studies must use HEAL core Common Data Elements (CDEs). All studies collecting data from human participants should prioritize using HEAL-specified CDEs if possible.
To the extent possible, HEAL awardees should use broad consent language.

Program officers evaluating HEAL DMSPs should ensure these components are included. Specific requirements under each element are integrated in the details below. Implementation details are included under “Preview the Checklist for HEAL-compliant data”.

Writing An Application?

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).

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.
Genomic data have special Data Management and Sharing Plan requirements for both non-human and human genomic data. These requirements are detailed in Section IV of the NIH Genomic Data Sharing Policy

Standards

HEAL 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.
- All HEAL studies collecting data from human participants and planning to use CDEs are strongly encouraged to search for applicable CDEs within the HEAL database, and use questionnaires from this database if possible. HEAL CDEs can be accessed in the HEAL CDE repository (core set) and contacting [email protected] (supplemental set).
- Studies using CDEs, regardless of whether they are part of the HEAL repository, will be required to report which questionnaires are being used.
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) 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.
Genomics data have special consent and controlled access requirements. For more information, please refer to sections 4.C.3 and 4.C.4 of the NIH Genomic Data Sharing Policy

Provide an oversight plan! For additional guidance, as you implement your plan, check out the Step-by-Step Guide to HEAL-Compliant Data.
Institutional certification should be provided prior to award, consistent with the genomic data sharing plan submitted with the request for funding. For more details about institutional certification, please refer to section 4.C.5 of the NIH Genomic Data Sharing Policy.

Additional Guidance and Resources

Already Funded?

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
Ensure HEAL-supported Manuscripts are Immediately Publicly Open and Accessible
Report Your Research Publication

View Complete Checklist on HEALdataFAIR.org

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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.

View the webpage

Common Data Elements (CDEs) Repository

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).

Access the CDEs Repository

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.