About the Course
Introduction
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.
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, 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.
Presented By
Mr. Peloquin advises clients on a wide range of legal and regulatory issues in the area of clinical research and related activities. He counsels academic medical centers, life sciences companies, information technology companies and other clients that sponsor, support and conduct research. With a broad client base and knowledge of a range of laws and regulations, from the Common Rule and FDA regulations to HIPAA and GDPR, to state and federal fraud and abuse laws Mr. Peloquin offers clients clear, practical advice on how the complex legal landscape intersects with an array of research activities. In addition to his advisory work, Mr. Peloquin collaborates with the private equity group to conduct regulatory diligence of clinical research investments and works with the firm’s litigation practice on government and civil investigations involving clinical research. He speaks and writes frequently on issues in healthcare law and data privacy.
Ms. Thornton advises academic medical centers, technology and biotechnology companies, universities, hospitals, pharmaceutical and medical device manufacturers, and other health- and research-focused organizations on a broad range of compliance, regulatory, and transactional issues. Before rejoining the health care group, she was senior health privacy counsel at a publicly traded, global consumer technology company. In that role, Ms. Thornton supported the company’s health research initiatives, working directly with business and engineering teams to design privacy solutions for related products and services.
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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Date + Time
- event
Tuesday, August 18, 2026
- schedule
1:00 PM ET/10:00 AM PT
I. Regulatory landscape for clinical trials and human research
II. Privacy and data collection/sharing considerations
III. The practical impact on organizations sponsoring, conducting, or involved in clinical trials or human research
IV. What providers and counsel need to do to ensure compliance
A. Informed consent
B. Disclosures
C. Data sharing
D. Secondary research
E. Others
The panel will review these and other key issues:
- How do recent regulations and guidance change the requirements for clinical trials or other human subjects research?
- How will privacy regulations impact the collecting and sharing of personal data in research studies?
- What will the practical effect be on organizations involved in clinical trials or other human subjects research?
- What must organizations sponsoring or conducting clinical research do now to ensure compliance with the rules?
Related Courses
Clinical Trials and Human Research: Complying With Regulatory Obligations; Privacy Considerations
Tuesday, August 18, 2026
1:00 PM ET/10:00 AM PT
