Belgium - RECs and Medical Research

History

Ethics committees first appeared in Belgium at the end of the 1970's and the first ethics commission was created in 1979 by the Foundation for Scientific and Medical Research (FRSM). The National Council of the Order of Doctors defined ethics regulations in 1984. In 1991 they further clarified the function & role of RECs.

The Royal Decree of 27 September,1994 made RECs compulsory for every hospital or group of hospitals. This law also defined the RECs aims, composition & function, closely following the code of deontology of the Order of Doctors.

Currently there are 200 RECs of which 20 are non-hospital based. There is a central Consultative Committee for Bioethics, officially installed in 1996, which formulates opinion & informs the public, acting only in a consultative way.

On 7 May 2004 the Law relating to Experimentation on Humans came into force, which for the first time endows RECs with a legal status. It covers all types of medical experimentation, not just clinical trials.

Summary of Belgian RECs

Type of REC	Consultative Committee for Bioethics	Hospital	Outside hospital
Where situated?	Centrally	Hospital	e.g. faculty of Medicine, pharmaceutical firms, professional associations
Who applies to them?	On own initiative Government Scientific research body Healthcare provider Local REC	researchers	researchers
Formal/Informal	Formal	Formal	Formal
National/Regional	National	Local	Local
Laws Involved (see below)	Royal Decree of 27 September 1994 Royal Decree of 22 September 1992	Royal Decree of 27 September 1994 Royal Decree of 22 September 1992	Royal Decree of 27 September 1994 Royal Decree of 22 September 1992
Guidance Involved	Declaration of Helsinki EC-GCP Guidelines ICH-GCP Guidelines Code of Deontology of the National council of the Order of Doctors	Declaration of Helsinki EC-GCP Guidelines ICH-GCP Guidelines Code of Deontology of the National council of the Order of Doctors Consultative Committee on bioethics	Declaration of Helsinki EC-GCP Guidelines ICH-GCP Guidelines Code of Deontology of the National council of the Order of Doctors Consultative Committee on bioethics
Membership requirements	35 actual members & the same number of substitutes: balance between Christians/Non-Christians, French & Dutch speakers, those with a scientific background & those with a background in philosophy, law & social sciences, and also between male & female.	8-15, of both sexes: A majority of doctors connected to the hospital At least 1 GP not connected to the hospital At least 1 nurse connected to the hospital A lawyer Other interested persons, who cannot be: Director of the hospital Head doctor President of the Medical Council Head of Nursing	8-15, of both sexes
Responsible/accountable to whom?	To government	To the medical faculty	To the body responsible for the institute
Approval or Advisory powers	Advisory	Approval	Approval

Not submitting research or failing to follow review

There is no legal provision for sanction against anyone not fulfilling their obligation to have REC approval, although this is being looked into currently and may change. The opinion of an REC is a legal obligation for new experimental research of drugs for human use.

Which body, if not the REC itself takes this action, and how do they proceed?

Any disciplinary action would be taken by the Order of Doctors, although there is no provision in law for sanction against anyone who did not fulfil their obligation to obtain REC approval for a clinical trial. Again this may change under current review of the law.

Impact of Directive 2001/20 EC

European Directive 2001/20/EC was implemented in Belgium by The Law relating to Experimentation on Humans which came into force on 7 May 2004. This law concerns not only the clinical trials of drugs, but also medical experimentation in general. The implementation of this new law has made the following changes:

It is now compulsory to receive a favourable opinion from an REC before the start of any clinical trial
There must be a single opinion for multi-centre trials
There is a time limit of 60 days for an REC to give an opinion.
Only a single request for information from the study sponsor will be allowed.
RECs are endowed with a legal status.
RECs must now evaluate protocols according to criteria defined by law.

Legal action that can be taken against RECs

No legal action can be taken, as they do not have legal status, but as before this may change.

Links section

Consultative Committee for Bioethics in Belgium (in French & Dutch)

The Law relating to Experimentation on Humans ‘Loi relative aux Expérimentations sur la Personne Humaine’ Moniteur Belge, 18 May 2004 -in French and Dutch
Belgian State Legislation- Belgisch Staatsblad (in Dutch, French & German)
Belgian Laws (in Dutch, French & German)

Register of ethics committees (in Dutch & French)
Directorate-General for Medicinal Products
Links to Belgian legal websites
Belgian Order of Doctors (in Dutch & French)

Papers:

Delfosse, M-L and Lebeer, G
L'éthique clinique à l'hôpital: quelques questions
in "Ethica Clinica", 1999, pp. 24-29.

Lebeer, G (ed.)
Ethical Function in Hospital Ethics Committees,
Amsterdam/Berlin/Oxford, IOS Press, 2002.

Lebeer, G.
Clinical Ethics Committees in Europe: assistance in medical decisions, fora for democratic debates, or bodies to monitor basic rights?,
http://www.ccels.cardiff.ac.uk/, 2003.

*See the REC bibliography section for more links and papers, and the Data Protection Page*