Clinical Trials and Human Research: Complying With Regulatory Obligations; Privacy Considerations
Requirements for Informed Consent, Disclosures, Data-Sharing, and More
Recording of a 90-minute CLE video webinar with Q&A
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.
Outline
- Regulatory landscape for clinical trials and human research
- Privacy and data collection/sharing considerations
- The practical impact on organizations sponsoring, conducting, or involved in clinical trials or human research
- What providers and counsel need to do to ensure compliance
- Informed consent
- Disclosures
- Data sharing
- Secondary research
- 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?
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... | Read More
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... | Read More
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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