SSStudyParticipantsInformedConsent object
Yes
For the purpose of simplification, harmonization and better information to the patient, Belgian ECs developed 4 different validated templates for informed consent (see Circular n° 604)
1. A basic model for interventional clinical trials on adults capable of autonomy,
2. A specific introduction for the inclusion of a participant with consent of a legal representative,
3. A specific introduction for the inclusion of a participant in an emergency situation,
4. A basic model for non-interventional studies on adults.
All four templates can be downloaded at the FAMHP website under section: Human medicines > Research & Development > Ethic Committee >Templates for informed consent.
The templates for informed consent have been published in August 2013, they will be re-evaluated after an evaluation period in the presence of all Ethics Committees with a complete recognition.
Yes
Participants must give their free and informed consent before the commencement of a trial (according to the provisions specified in Chapter III Art 6 of Law 7 May 2004)