• videocam Live Webinar with Live Q&A
  • calendar_month August 18, 2026 @ 1:00 PM ET/10:00 AM PT
  • signal_cellular_alt Intermediate
  • card_travel Health
  • schedule 90 minutes

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

Requirements for Informed Consent, Disclosures, Data-Sharing, and More

About the Course

Introduction

This CLE webinar 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 year, the federal and state governments have enacted several statutory, regulatory and policy changes that have had a major impact on the conduct of clinical trials and other research involving human subjects. Topics that will be addressed during this webinar include the following:

  • The U.S. Department of Health and Human Services announcement of “Operation Trialblazer”
  • Major shifts in U.S. federal research funding, including the Office of Management and Budget’s Proposed Rule to overhaul the Uniform Guidance governing federal grants and cooperative agreements  
  • Passage of the BIOSECURE Act and related national security developments
  • Implementation of the U.S. Department of Justice Data Security Program/Bulk Data Rule, related National Institutes of Health policies, and similar state law restrictions

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

Presented By

David Peloquin
Partner
Ropes & Gray

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.

Leslie A. Thornton
Counsel
Ropes & Gray

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.

Credit Information
  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.


  • Live Online


    On Demand

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?