The Ethics Committees

A clinical trial can only start after receibving a favourable opinion from Ethics Committee (recognized Ethics Committees) and if relevant authority (FAMHP : R&D) has not indicated any major insufficiency within the legal timeframe.

Legal texts

The European directive 2001/20 has been incorporated in national law by the law dated 7th May 2004 (French version) published in the Belgian Monitor of 18th May 2004. The new legal framework has been in force since 1st May 2004.

The law of 7 May 2004 has been modified several times (see below)

Note: the laws, royal decrees and circulars are (except for a few) not translated in English.  Therefore we refer to the links on the French and the Dutch version of the website.

Laws

Law dated 7th May 2004 (French version) related to experiments on human people. 

Modified by the following laws :

Programme law dated 27/12/04 (French version) modifying the law dated 7/05/04 (French version)

Programme law dated 27/12/05 (French version)

Health law dated 13th December 2006 (French version)

Programme law dated 13th December 2006 (French version)

Programme law dated 27th April 2007 (French version)

Law dated 24th July 2008 related to various dispositions (French version)

Law dated 19th December 2008 related to various health dispositions (French version)

Royal Decrees (laws)

Royal Decree dated 4th April 2014 (French version) determining the measures for carrying out the law dated 7th May 2004 (French version) relating to experiments on human people, regarding the ethics committe + form for the motivation of the advice (Word version) (French version)

Royal Decree dated 22th April 2007 (french version) fixing the fees to be paid in the framework of article 30, § 6 of the law dated7th May2004 (French version) relating to experiments on human people.

Royal Decree dated 30th June 2004 (French version) determining the measures for carrying out the law dated 7th May 2004 (French version) relating to the experiments on human people concerning clinical trials of medicines for human use, modified by the

Royal Decree dated 18th May 2006 (French version)

Royal Decree dated 15th July 2004 (French version) determining the fees to be paid for a request for an opinion or for authorisation to conduct a clinical trial or an experiment.

Circulars

Circular 633 (French version) + Claim statement (French version): Pending payments for ethics committees (2014).

Circular 624 (French version) + Claim statement (French version): Pending payments for ethics committees (2013).

Circular 619 (08/04/2015) (french version) : List of ethics committees having full approval according to the law dated 7th May 2004 related to experiments on human people.

Circular 618 (French version) + Claim statement (French version): Pending payments for ethics committees (2012).

Circular 613 (French version): Changes to the law of May 7, 2004 concerning experiments on human people.

Circular 609 (04/04/2014) (french version) : List of ethics committees having full approval according to the law dated 7th May 2004 related to experiments on human people.

Circular 607 (french version) : Pending payments for ethics committees (2011).

Circular 604 (French version) : Template for informed consent. English version.

Circular 597 (28/03/2013) (French version) : Pending payments for ethics committees (2010).

Circular 584 (14/02/2012) (French version) + annex : Pending payments for ethics committees (2009).

Circular 573 (French version) : Pending payments for ethics committees (2008).

Circular 566 (French version) : Pending payments for ethics committees (2007).

Circular 512 (French version) : Pending payments for ethics commissions - Indexation of the amounts for experiments - Data for the interactive website - 2007 activity reports.

Orientation documents

Eudralex Volume 10

The following information is available for the ethics committees to do their tasks as laid down in the law on the experiments:

Manual for non interventional trials: this version is available in Dutch and French

Templates for informed consent

Last updated on 29/03/2017