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

Description

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topics affecting clinical research such as the updated guidance on informed consent for clinical investigations and the draft guidance on diversity action plans, the final rule providing an exception to obtaining informed consent for minimal risk investigations, and the final rule on laboratory developed tests (LDTs), 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 by the FTC, the EU's General Data Protection Regulation (GDPR), China's Personal Information Protection Law (PIPL), 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.