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


Conducted on Thursday, January 18, 2018

Recorded event now available

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Program Materials

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.

Description

In the past few years, Congress and federal departments and agencies have issued several statutory and regulatory changes that affect the conduct of human subjects research. Developments include the passage of the 21st Century Cures Act, the various guidance documents that have been issued in response to statutory revisions made by the 21st Century Cures Act (e.g., the FDA’s July 2017 guidance on waivers of informed consent and the NIH’s September 2017 policy on certificates of confidentiality) and the final rule revising the Common Rule.

Attorneys advising organizations sponsoring, conducting or involved with clinical trials and human research must fully understand the scope and complexity of legal developments 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 new 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 requirements.

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Outline

  1. 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.
  2. Practical considerations for implementing modifications to informed consent and other changes implemented in the revised Common Rule.

Benefits

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?

Faculty

Peloquin, David
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

Thornton, Leslie
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

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