Halloran ClinOps Brunch Series: Implications of the New Guidance on Informed Consent

Please join Halloran for a discussion on “Implications of the New Guidance on Informed Consent.” During our webinar, we will review the principles and requirements of informed consent, share common challenges and recommendations in the landscape of increasingly complex clinical studies, and unpack FDA’s final guidance on informed consent (August 2023).

We’ll discuss strategies and tactics around the sponsor’s role in the informed consent process, including:

• Implications of FDA’s final guidance on informed consent
• ICF format and delivery best practices
• Proactive considerations for patient comprehension beyond the written ICF
• Communicating new risks, benefits, or changes during an ongoing study
• Adapting consent approach to the target population, particularly vulnerable populations
• Communicating trial role and expectations with compassion and honesty

Speakers:

• Karen Travers, Associate Principal Consultant, Halloran – Moderator
• Laura Gilliam, Specialist Consultant, Halloran
• Meghan Patterson, Senior Consultant, Halloran
• Krista Tibbs, Principal Consultant, Halloran