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Clinical Trial Events
SOCRA 18th Annual Device Research & Regulatory Conference

Talk

Regulatory and Compliance Considerations for Human Subjects Research: Recent Developments Affecting Informed Consent, Data Privacy, and Consumer Protection, including as Related to Digital Health Technologies Used in Research

Fri, Apr 25, 2025 · 8:00–9:00 AM PDT Hyatt Regency Newport Beach

About this session

The federal government recently has enacted numerous statutory and regulatory changes that impact the conduct of human subjects research, including ever-evolving FDA guidance on topics affecting clinical research such as updated guidance on informed consent for clinical investigations and draft guidance on diversity action plans, as well as the NIH’s recommendations for informed consent for research using digital health technologies. Further, data privacy laws, including enhanced enforcement of the Health Breach Notification Rule and Section 5 of the Federal Trade Commission (FTC) Act and an increasing number of U.S. state laws have imposed heightened requirements for the collection and sharing of personal data, which can encompass personal data collected in clinical trials or other research, including via online tracking technologies. These laws can present difficulties, particularly where obligations may vary across jurisdictions. This talk will examine these developments and offer best practices for their implementation within an ever-evolving legal landscape.

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