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.
With some adjustments they can be used for clinical studies on Medical devices as well.
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)