Clinical Trials and Human Research: Complying With Regulatory Obligations; Privacy Considerations

This CLE course will guide counsel on navigating regulatory changes for clinical trials and human subjects research. The panel will also address the impact that increasing privacy regulation may have on the collection and sharing of research data. The panel will examine the practical impact that this evolving regulatory landscape will have on those sponsoring, conducting, or otherwise involved with clinical trials, as well as outline compliance strategies to meet the new requirements.

In the past few years, the federal government 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 the updated guidance on informed consent for clinical investigations, the final rule providing an exception to obtaining informed consent for minimal risk investigations, and the new final rule on laboratory developed tests, reverting to the text of the regulation as it existed prior to the effective date of the May 2024 final rule.

Further, data privacy laws, including enhanced enforcement of the Health Breach Notification Rule and Section 5 of the Federal Trade Commission (FTC) Act by the FTC, the EU's General Data Protection Regulation, China's Personal Information Protection Law, 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. These laws can present difficulties, particularly where obligations may vary across jurisdictions.

Attorneys advising organizations sponsoring, conducting, or involved with clinical trials and human subjects research should understand the scope, complexity, and implications of such legal developments to ensure their clients are in compliance.

Listen as our authoritative panel examines these changes, providing guidance on these requirements and offering best practices for meeting evolving standards.