Implications of FDA’s Final Guidance on Informed Consent
Are you sponsoring a clinical trial and wondering how to develop an Informed Consent Form (ICF) that best facilitates the informed consent process? If you are, you’re not alone. If you aren’t, you should be. 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).
The Halloran Team discusses strategies and tactics around the sponsor’s role in the new guidance on informed consent 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
Watch as our team unlocks the challenges and opportunities for sponsors to support sites in optimizing the consent process from a clinical, quality, and technology perspective. Walk away with actionable steps to improve the clarity, simplicity, and transparency of informed consent forms to improve participant experience and understanding.
Karen Travers, Principal Consultant, Halloran
Krista Tibbs, Principal Consultant, Halloran
Laura Gilliam, Specialist Consultant, Halloran
Meghan Patterson, Senior Consultant, Halloran
YouTube Link here!