Mastering the ICF and Assent Best Practises

Effective communication with children and parents involved in clinical trials is crucial for fostering trust and ensuring informed participation. Ensuring that children and their parents fully understand the information provided during clinical trial participation is both a legal and ethical imperative.

However, the complexity and length of informed consent forms (ICFs) often pose significant challenges. This presentation will explore the key issues surrounding the design and delivery of trial information to families, including language accessibility, readability, and the emotional and cognitive needs of children and their guardians. It will also highlight common barriers in ICFs, such as medical jargon, lack of age-appropriate content, and insufficient emphasis on participants’ rights and potential risks. By examining best practices and innovative approaches to simplify and personalise trial information, this session aims to improve understanding, empower decision-making, and enhance the overall experience for families in clinical trials.

Bojana Mirosavljevic, ZIVOT (LIFE) Patient Organisation, Serbia & Balkan Region

Bojana Mirosavljevic is the Director of Patient Advocacy Strategy at ICON, and has 15+ years of Rare Disease Patient Advocacy Strategy experience focused on the clinical development process. Bojana has extensive experience in creating and implementing Patient Advocacy strategies for rare diseases in pharma and contract research organisations (CROs). Bojana is a chemist and embryologist specialised in pre-implantation genetic testing (PGT).

Bojana is the Founder and President of ZIVOT (LIFE), a Patient Organisation operating in Serbia and the Balkan region. She successfully lobbied for Zoya’s law, which increased access to early diagnostic and newborn screening in Serbia. She is a certified EUPATI Patient Expert for Rare Diseases and was a recipient of the prestigious EURORDIS Black Pearl Award.