Complying with the HEAL Public Access and Data Sharing Policy

Complying with the HEAL Public Access and Data Sharing Policy

Complying with the HEAL Data Sharing Policy

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 to ensure compliance with HEAL Public Access and Data Sharing Policy.

  • Select a  for long-term data storage.
  •  in the HEAL Data Platform.
  •  to the HEAL Data Platform.
  • HEAL core Common Data Elements (CDEs) are required for all clinical pain studies, involving human subjects. All other studies collecting data from human participants are encouraged to use 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”.

The HEAL Data Stewardship Group (HEAL Stewards) guides researchers with a funded HEAL award through the process of making their data HEAL-Compliant. A is available to ensure that your work is compliant with the HEAL Data Sharing Policy. The checklists include the below. Please  for help planning or implementing.

  • The Checklist for HEAL-Compliant Data include:
    • 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

Writing an Application?

Under the NIH HEAL Initiative Public Access and Data Sharing Policy, and the , 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). The DSMP outlines how the study will manage and share scientific data, accompanying metadata, other relevant data, and associated documentation.

Elements of the Public Access and Data Sharing Plan

This applicant resource is a guide 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, , and ). NIH developed , 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  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 

  • HEAL Common Data Elements (CDEs)
    • HEAL clinical pain studies, involving human subjects, are required to utilize the HEAL core CDEs. See more information on the program here.
    • Other HEAL studies, involving human subjects, are strongly encouraged to select and use CDEs, and submit CDE selections to the HEAL Data Platform. 
    • The HEAL CDE repository is available for the public for applicable elements. The repository includes both the HEAL core CDEs and domain-specific CDEs across multiple areas.
    • For questions or assistance regarding CDE selection, submission, etc. please contact the HEAL CDE team at heal_cde@hsc.utah.edu
  • Registration and metadata requirements
    • Within a year of award, HEAL awardees must complete .
    • Awardees must submit all relevant  via CEDAR within 1 year of the award issue date, completing timely updates in accordance with any study data release. Additional HEAL metadata resources:
    • Submit Variables-Level Metadata
    • Data Preservation, Access, and Associated Timelines
      • HEAL investigators must deposit their data within a . To assist, the HEAL Stewards produced a .
      • 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.

 

  • To the extent possible, in alignment with human subjects data protections, HEAL awardees should integrate  (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 .
  • 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 

 

  • Provide an oversight plan! For additional guidance, as you implement your plan, check out the .
  • 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 .

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