Implications Of FDA's Final Guidance On Informed Consent

Are you overseeing a clinical trial and seeking guidance on developing an Informed Consent Form (ICF) that enhances the informed consent process? Watch this presentation webinar where industry experts from Halloran Consulting delve into the principles and requirements of informed consent, address challenges and recommendations in the evolving landscape of complex clinical studies, and unpack the FDA's final guidance on informed consent issued in August 2023.

The Halloran Team, including Karen Travers, Principal Consultant; Krista Tibbs, Principal Consultant; Laura Gilliam, Specialist Consultant; and Meghan Patterson, Senior Consultant explore strategies and tactics related to the sponsor's role under the new guidance, covering:

• Implications of the FDA's final guidance on informed consent
• Best practices for ICF format and delivery
• Proactive considerations for ensuring patient comprehension beyond the written ICF
• Communication strategies for introducing new risks, benefits, or changes during an ongoing study
• Tailoring the consent approach for specific populations, especially vulnerable groups
• Compassionate and honest communication of trial roles and expectations

Unravel the challenges and opportunities for sponsors in optimizing the consent process, considering clinical, quality, and technological perspectives. Gain actionable insights to enhance the clarity, simplicity, and transparency of informed consent forms, ultimately improving participant experience and understanding.