Regulatory Issues in Electronic Health Records for Adolescent HIV Research: Strategies and Lessons Learned

Area of Science:

• Clinical Trials
• Health Informatics
• Public Health Research

Background:

• Electronic Health Records (EHRs) offer a cost-effective foundation for clinical trial research.
• Utilizing EHRs in real-world settings enables pragmatic intervention studies for emerging adult HIV populations.
• Regulatory complexities in multisite EHR trials can cause delays and noncompliance.

Purpose of the Study:

• To highlight the regulatory process and challenges in implementing a multisite pragmatic trial using EHRs.
• To assist future researchers in navigating regulatory hurdles for similar studies.
• To ensure compliance with study timelines and institutional guidelines.

Main Methods:

• Engaged eight sites, with four for intervention/data extraction and four for data management/analysis.
• Established regulatory infrastructure for EHR data collection on retention and viral suppression.
• Developed institutional reliance and data use agreements, alongside site-specific training.

Main Results:

• A phased approach (data extraction then intervention sites) addressed unique regulatory needs.
• Regulatory onboarding took 6 months for data extraction/intervention sites.
• Regulatory onboarding extended up to 10 months for data management/analysis sites.

Conclusions:

• Multisite EHR trials necessitate advanced planning from the proposal stage.
• Key considerations include training, data use agreements, reliance agreements, and IRB review.
• Thorough planning ensures successful implementation and adherence to pragmatic trial timelines.