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Eurecnet - National Information: Belgium

National Information: Belgium (Last update: January 2023)

Short description of RECs system:

The Belgian Ethics Committee’s (ECs) mission is to contribute to the protection of general welfare, safety, dignity, rights and privacy of patients/healthy volunteers (subjects) participating in clinical investigations. In accordance with the Belgian Law of 22 August 2002 on Patient’s Rights and the Belgian Law of 30 July 2018 on Data Privacy.

The Belgian ECs assess, among other points, the scientific and ethical justification of the proposed studies, the scientific scope (i.e. design, statistics, numbers) and completeness of the protocol, the competence of the investigators, the safety of the participants, the completeness of the information provided to the participants, the voluntary nature of the participation (See Belgian Law of 7 May 2004 and Belgian Law of 7 May 2017).

In its mission, the Belgian ECs respect international guidelines on human research as described in the latest version of the Declaration of Helsinki, the World Health Organisation (WHO) guidelines for ECs and the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines. It works in accordance with the relevant laws and requirements of the Belgian and European administrations.
It also takes into account the guidelines of the Belgian Advisory Committee on Bioethics and the National Council of the Order of Physicians.

Specific for the CTR/MDR/IVDR, a CT-College has been created that makes the link between the FAMHP (Belgian Federal Agency for Medicines and Health Products) and the ECs

In Belgium, The ECs have joined together to create the BAREC (Belgian Association of Research Ethics Committees): https://barec.be/. It is a common association established since June 2016. Its main objectives are to stimulate debate on relevant topics and mutual exchange of knowledge and expertise between ECs, to formulate advices and harmonise the work of the ECs, to represent the Belgian ECs, giving them a voice in various debates and platforms.”

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