Initiative-Specific Policies

NIH HEAL Initiative® requires that funded research follows specific policies to ensure studies are transparent, of high quality, and broadly useful. These policies are designed to maximize the long-term value of HEAL-supported research and accelerate progress against the opioid crisis.

Clinical Trial Enrollment and Reporting

Transparency in clinical research protects participants, builds public trust, and strengthens scientific integrity. Registering and reporting trials ensures the public and healthcare providers know which studies are underway, makes all results accessible regardless of outcome, prevents duplication of effort, and demonstrates compliance with federal law and NIH policy.

HEAL-funded clinical trials expecting to enroll more than 75 participants, or those needing enhanced oversight, must report enrollment at least twice a year and stay on track with recruitment milestones.

Carefully review the full HEAL Clinical Trials Policy.

Public Access and Data Sharing

Research teams must make their HEAL data Findable, Accessible, Interoperable, and Reusable (FAIR), in line with the broader efforts across NIH, as outlined in the NIH Strategic Plan for Data Science. 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. 

Carefully review the full HEAL Public Access and Data Sharing Policy, as well as guidance for complying with HEAL Public Access and Data Sharing Policy. The HEAL Data Ecosystem and HEAL Common Data Elements (CDEs) program assist investigators in meeting HEAL data requirements.

HEAL Data Ecosystem

The HEAL Data Ecosystem brings together tools, repositories, and expert teams to help investigators meet HEAL data requirements and maximize the impact of their research. Ecosystem teams provide hands-on support with:

• Data management and sharing
• Applying data standards
• Performing data analysis
• Selecting appropriate repositories
• Registering studies and submitting metadata to the HEAL Data Platform
• Accessing and working in a secure, cloud-based workspace

Read more about the HEAL Data Ecosystem

HEAL Common Data Elements

Common Data Elements (CDEs) provide a standardized framework that makes data easier to share, compare, and analyze across studies. By using CDEs, researchers improve the quality and interpretability of their findings, enable large-scale pooled analyses, and ensure consistent collection of patient-reported outcomes.

NIH HEAL Initiative® awardees, studying pain, involving human subjects are required to collect the HEAL core set of CDEs. Other studies involving human subjects are encouraged to use CDEs, when possible.

The HEAL CDE Repository is available for all researchers to search for validated questionnaires and corresponding CDEs.

Read more about the HEAL Common Data Elements (CDE) Program