Clinical Trials and Human Research: Complying With New Regulatory Obligations
Requirements for Informed Consent, Disclosures, Data-Sharing and More
Recording of a 90-minute CLE webinar with Q&A
This CLE webinar will provide guidance to counsel for 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 and will outline compliance strategies to meet the new requirements.
- Recent guidance issued under the 21st Century Cures Act from NIH, FDA and other federal agencies as well as recommendations made by the U.S. Department of Health & Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) regarding the Common Rule revisions.
- Practical considerations for implementing modifications to informed consent and other changes implemented in the revised Common Rule.
The panel will review these and other key issues:
- How do the new 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 new rules?
David Peloquin, J.D.
Ropes & Gray
Mr. Peloquin works with the firm’s Corporate Department, primarily on healthcare matters, and particularly in the... | Read More
Mr. Peloquin works with the firm’s Corporate Department, primarily on healthcare matters, and particularly in the area of clinical research and health data privacy. Prior to attending law school, he worked as a project manager for a leading supplier of electronic medical records. Mr. Peloquin is a frequent author and lecturer on clinical research/human subject protection issues, among others.Close
Leslie A. Thornton, Ph.D., J.D.
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.Close