Legal Perspective on Informed Consent Forms and Patient Information Sheets: Do They Really Have to Be So Long?

Have you ever wondered why Informed Consent Forms (ICFs) and patient information sheets in clinical trials are so lengthy? Is this level of detail truly necessary? What legal requirements must be included, and could these be simplified without losing essential information?

This presentation aims to answer these questions by examining the legal landscape surrounding ICFs. It explores how these documents protect patient rights and ensure ethical conduct in clinical research. Additionally, it discusses the potential risks for patients, physicians, and sponsors if ICFs do not meet legal requirements or if these requirements are not clearly understood by patients.

Whether you find legal topics intriguing or typically avoid them, this session promises to provide valuable insights and practical knowledge that will enhance your understanding of the legal requirements for ICFs in the European Union and help you engage more effectively with legal advisers on this topic.

Franka Felsner, Boehringer Ingelheim Middle East & Africa GmbH

Biography

As a lawyer with extensive experience in the pharmaceutical industry, Franka Felsner is dedicated to helping her clients confidently and effectively navigate an ever-evolving regulatory landscape around the world. As Senior Legal Counsel at Boehringer Ingelheim, she provides expert legal support for all aspects of clinical development, with a particular focus on Informed Consent Forms in the European Union and beyond. Before joining Boehringer Ingelheim, Franka worked for an international law firm in London, Brussels, and Frankfurt, and holds a law degree from the University of Oxford.