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.
- 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
- 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
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.
- 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
- 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