This new template for the Informed Consent Form (ICF) for clinical investigations for adult patients involving a medical device was prepared by a 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 become mandatory for all new initial applications for clinical investigations with an investigational medical device in adult patients and that are assessed by an independent Belgian Ethics Committee recognized under the Belgian legislation of 7 May 2017. In other words, this ICF template is intended for clinical investigations who are being evaluated following one of the following regulatory pathways:
- A clinical investigation with a CE-marked medical device used within the area of intended use, in the context of a Post-Market-Clinical-Follow-up, involving burdensome or invasive procedures.
- A clinical investigation with a CE-marked medical device used outside the area of intended use.
- A clinical investigation with a medical device for which CE marking has yet to be obtained.
- A clinical investigation with a medical device where CE marking is not provided, and the data is used for a conformity procedure.
