This new version of the template for the Informed Consent Form (ICF) for interventional clinical trials with an investigational medicinal product on adult patients was prepared by a dedicated BAREC working group consisting of representatives from some Ethics committees. During September – October 2024, feedback was requested from different stakeholders (e.g. sponsors, applicants, clinical trial centers, RUZB). Some of the stakeholder’s comments received are still under discussion at the BAREC and if necessary, changes to the templates will be implemented in future versions.
The template was approved by the College Board on 24/01/2025. As of August 1st 2025, the use of this template will be mandatory for all new initial applications for interventional clinical trials with an investigational medicinal product in adult patients.
History:
The ICF template version 1.0 was adopted by the Workgroup on Informed Consent Form on 27/06/2019. Version 1.1. contained decisions taken by the College Board and some minor adaptations and was approved by the College Board on 15/09/2023. Version 2.0 (French and English) and version 3.0 (Dutch) were approved by the College Board on 24/01/2025.
