Human Subjects Research Continuing Legal Education

Clinical Trials and Human Research: Complying With Regulatory Obligations

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

Recording of a 90-minute CLE video webinar with Q&A

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Conducted on Tuesday, August 30, 2022

Recorded event now available

• Presentation

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This CLE course will guide counsel on navigating regulatory changes for clinical trials and human subjects research. The panel will examine the practical impact for 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, Congress and federal departments and agencies have issued several statutory and regulatory changes that impact the conduct of human subjects research. Developments include the passage of the 21st Century Cures Act and the implications for researchers of the information blocking rule promulgated thereunder, increased enforcement of transparency obligations related to ClinicalTrials.gov, and the issuance of FDA guidance on the final rule revising the Common Rule (i) diversity in clinical trials, and (ii) use of real-world evidence in regulatory decision-making.

Further, privacy laws, including the EU's General Data Protection Regulation (GDPR), China's Personal Information Protection Law (PIPL), and various U.S. state laws have heightened requirements related to collecting and sharing personal data, which can encompass personal data collected in the context of a clinical trial or other research studies. These laws can present difficulties, particularly where the obligations may vary across jurisdictions. Attorneys advising organizations sponsoring, conducting, or involved with clinical trials and human research must fully understand the scope and complexity of legal developments and the implications of new developments under GDPR and other privacy laws to ensure clients are in full compliance.

Listen as our authoritative panel examines the changes in the regulatory environment for clinical trials and human research. The panel will provide guidance on the requirements and discuss the impact on organizations sponsoring or conducting clinical trials and human research. The panel will offer best practices for meeting the changing standards.

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Outline

1. Regulatory landscape for clinical trials and human research
2. GDPR compliance
3. The practical impact of 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 change the requirements for clinical trials or other human subjects research?
• What will the practical impact 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?

Faculty

Michael DiMaio
Attorney
Ropes & Gray

Mr. DiMaio advises healthcare providers, pharmaceutical and medical device manufacturers, and other healthcare...  |  Read More

David Peloquin, J.D.
Partner
Ropes & Gray

Mr. Peloquin works with the firm's Corporate Department, primarily on healthcare matters, and particularly in the...  |  Read More

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CLE On-Demand Video

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Download

Downloads include the entire presentation including Q&A. Presentation materials can be viewed on your screen. PDFs of the presentations are also available on each program's web page.

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Source: https://www.straffordpub.com/products/clinical-trials-and-human-research-complying-with-regulatory-obligations-2022-08-30

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