This session will go over newly released August 2023 guidance providing insights into FDA’s regulatory expectations for informed consent procedures and roles.

The speaker will discuss the responsibilities of IRBs, clinical investigators, sponsors, and the FDA concerning informed consent. The speaker will address the Guidance’s responses to the “commonly asked questions” section whose main purpose is to clarify doubts and promote a thorough understanding of the process.

In addition, the speaker will provide tips on how to properly obtain Informed Consent so that you can be assured the participant’s decision to participate is voluntary and not coerced.

MODERATOR:

Jennifer Peterson - Director, Head of Clinical Quality - M3 Wake Research

SPEAKER:

Jamie Lucey - Sr. Director Quality and Systems - Circuit Clinical