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Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

    Intermediate

  • work Practice Area

    Health

Date & Time
  • event Date

    Thursday, August 29, 2024

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

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

$297.00
CLE
ALL

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.

Faculty

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.

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Leslie A. Thornton
Counsel
Ropes & Gray

Ms. Thornton practices in the firm’s corporate department with an emphasis on healthcare. She advises academic medical centers, universities, research institutes, hospitals, pharmaceutical and medical device manufacturers, managed care plans, health-focused startups, long-term care providers and other healthcare organizations regarding a broad range of compliance, regulatory and transactional issues.

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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.

Outline

  1. Regulatory landscape for clinical trials and human research
  2. Privacy and data collection/sharing considerations
  3. The practical impact on organizations sponsoring, conducting, or involved in clinical trials or human research
  4. What providers and counsel need to do to ensure compliance
    1. Informed consent
    2. Disclosures
    3. Data sharing
    4. Secondary research
    5. Others

Benefits

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?