Clinical Research Compliance: Multi-Agency Considerations

This CLE presentation examines the evolving regulatory landscape of clinical research compliance, emphasizing how multiple federal and state agencies—beyond the FDA—are shaping enforcement priorities in the clinical trial space. The session outlines the distinct roles of the DOJ, OIG, ORI, and state regulatory bodies, and provides a comprehensive overview of civil, criminal, contractual, and administrative liability risks for research sponsors, clinical investigators, and research institutions. Attendees are introduced to current enforcement trends including grant fraud, billing misrepresentations, data integrity concerns, inadequate informed consent, and unlawful remuneration under the Anti-Kickback Statute and Stark Law. Special focus is given to the compliance risks that arise during mergers and acquisitions, the corporate practice of medicine, and telemedicine-related state law conflicts in decentralized trials. The course also reviews expectations for effective compliance programs, recent DOJ guidance on voluntary self-disclosure, and emerging considerations under privacy laws including HIPAA, GDPR, CCPA, and state-specific mandates.