France - RECs and Medical Research

History

In France the protection of the person in case of Medical Research is provided by the Huriet-Sérusclat Law of the 20th December 1988 which has most recently been amended in 2004 (Law of the 9th August 2004). The purpose of this recent review was to implement Directive 2001/20/EC.

The authorities for the legal protection of the persons participating to a research and of his/her personal data have to be distinguished from the Ethics Committees who are only concerned with Ethical issues related to research. In France different authorities have different roles for protecting the person and his/her personal data in case of medical research:

The Committees for the Protection of Persons (CPPs): the committee issues an opinion to the investigator of the biomedical research for the protection of the person and for any subsequent amendments to the research protocol.
The National Consultative Committee for the processing of Information in the health sector gives an opinion on the processing of personal data in the health sector.
The CNIL (Data Protection Supervisory Authority) supervises any use of personal data, especially in case of biomedical research and gives its authorisation for the processing of health personal data
The National Consultative Ethics Committee has a general reflection on ethical issues but do not review research protocol.
Local and institutional Ethics Committees issue specific and general decisions on ethical issues and rarely review research protocols.

In order for biomedical research to be given approval, a legal procedure has to be followed by the sponsor. If the research involves the processing of personal data, then approval of the research protocol be followed, in parallel, with a separate legal procedure for data processing in order to be lawful. While the research protocol is considered by a CPP and then referred for approval to either the Ministry of Health or the Agency for the Sanitary Security of Health Products, data protection issues are considered separately by the National Consultative Committee on the processing of Information in the Health Sector and then referred for approval to the Data Protection Supervisory Authority.

Summary of French Research Committees

Type of REC	Committees for the Protection of Persons (CPPs)	National Consultative Committee on the processing of Information in the Health Sector	CNIL-Data Protection Supervisory Authority
Where situated?	48 CPPs in the French regions		Paris
Who applies to them?	The sponsor	The Controller	The Controller
Formal/Informal	Formal	Formal	Formal
National/Regional	Regional	National	National
Laws Involved	Law Hurriet-Serusclat of 20th December 1988, amended by the Law of 9th August 2004	Law of the 1st July 1994 modifying the 1978 Act: Official Journal 2nd July 1994 Decree No. 95-682 of the 9th May 1995 for the application of Chapter V of the 1978 Act	Law of the 6th January 1978 on data protection. Law of 1st July 1994 modifying the 1978 act.
Guidance Involved			Recommendation of the 4th February 1997 of the CNIL on the processing of health personal data
Membership requirements	12 members per CPP: General practitioners Specialist doctors Pharmacists Nurses Psychologists An ethicist A sociologist a lawyer Representatives of patients' associations	14 members and 1 president nominated for 3 years. All members are scientists.	17 members nominated for 5 years: 2 Deputies 2 Senators 2 Members of the Economics and Social Committee 2 Members or Former Members of the Cour de Cassation, of the States Council and of the Cour des Comptes 2 Qualified persons in Computer Science 3 Persons Designated by the Council of Ministers 1 President elected by the CNIL's Members
Responsible/accountable to whom?	Totally independent	Subordinate to the Ministry of Health	Independent Administrative Authority. Its decision can be appealed to the Administrative judge
Mission	Remit includes any trials or experimentation on humans for the purpose of developing biological and medical knowledge, either for a therapuetic or non-therapeutic purpose. Providing an opinion on whether the rules on the protection of the person involved in the research have been respected or not in each submitted research protocol. Consent is especially considered. Do not provide ethical opinions. Do not have a legal role in relation to the protection of personal data but in practice can be consulted on this topic	Competent only for the processing of personal data in health matters. Give an opinion on the methods of the research in relation to the data protection law.	Supervision, information and advice in relation to the data protection law.
Approval or advisory powers	Advisory powers. It is however compulsory to receive their opinion in order to obtain authorisation from the French Agency for the Sanitary Security of Health Products or from the Minister for Health.	Approval powers	Approval powers: The CNIL gives its authorisation.

Summary of French RECs - table 2

Type of REC	National Consultative Ethics Committee	Ethics Committees linked to research organisations	Local Ethics Committees
Where situated?	Paris	Scientific organisations eg: INSERM and CNRS	hospitals
Who applies to them?	Presidents of Parliamentary Assembly, Members of the Government, Foundation of Public Usefulness, Public Organisation of Research.	CNRS: Administrative Council of the CNRS, or the Scientific Council of the CNRS or the General Director of the CNRS or the Ethics Committee itself
Formal/Informal	Formal	CNRS: Formal	Informal
National/Regional	National	In research organisations	Local
Laws Involved (see below)	Decree No. 83-42 of 23rd February 1983 Amendments to the Law Hurriet-Serusclat of 20th December 1988 by the Law of 9th August 2004	CNRS: Decree no. 2000-1059 of 25 October 2000, Article 21-2
Guidance Involved		CNRS Charter
Membership requirements	39 members and 1 president: 5 persons belonging to the 'main philosophical and spiritual family' chosen by the President of the Republic. 19 persons chosen for 'their competency and interest in ethical issues' 15 persons belonging to the research sector	CNRS: 1 President chosen for 4 years by the General Director of the CNRS on the proposition of the Administrative Council. 12 members, scientists or persons coming from the civil society.
Responsible/accountable to whom?	Independent	CNRS: Independent ethics committee near the Administrative Council of the CNRS.
Mission	Reflection on ethical and social issues in biological, medical and health sector. Give general opinion on general cases- never on individual cases. Do not review research protocols.	General mission to consider ethical issues Maintain dialogue between the biomedical research community and society. Do not review research protocol.	Give opinions especially on clinical ethics issues met in practice.
Approval or Advisory powers	Advisory powers. No legal effects.	Advisory	Advisory powers. No legal value.

Not submitting research or failing to follow review

It is an obligation to ask a CPP for its opinion on a research Protocol. Sanction: 1 year imprisonment and 15,000 Euros fine (Article L. 1126-5 of the Code of Public Health).
It is an obligation to appeal to the National Consultative Committee for the processing of Information in the health sector and to the CNIL in case of processing personal data. Sanction: 5 years imprisonment and 300,000 Euros fine (Article 226-16 of the Penal Code).
It is not compulsory to appeal to an Ethics Committee. However in the CNRS, the absence of appeal to the COPE could lead the CNRS not to renew the Research Unit.

Legal action that can be taken against RECs

None. Only the decision taken by the CNIL can be appealed to the Administrative Judge.

Links section

Laws

Law no. 2004-801 of 6 August 2004 modifying the law Huriet-Sérusclat (in French).
Decision for the creation of the Ethics Committee of the CNRS: Decision of the 20th August 2002 (in French).
Code of the Public Health (in French)
Ethics Committee of the CNRS: Decree n°2000-1059 of 25 October 2000.
Law No 94-548 of the 1st July 1994 on the processing of personal data for purpose of research in the health sector (in French).
Law Huriet-Sérusclat No 88-1138 of the 20th December 1988 on the protection of persons participating in Biomedical Research (in French.)
Law No 78-17 of the 6th January 1978 on Informatics and Freedoms (in French).
Legifrance - contains French legislation, codes and laws in preparation

Organisations and Ethics Committees

National Consultative Ethics Committee
List of the CCPPRBs -former CPP system before 2004 Law
CNIL
CNRS - COPE
INSERM (in French & English)

Articles

B. Le Mintier, Rapport sur " Les comités régionaux d'éthique en France : Réalités et perspectives ", Ministère de la justice, Ministère du travail et des affaires sociales, octobre 1998.
Rapport sur " De l'éthique au droit en passant par la régulation professionnelle " sous la direction de B. Feuillet-Le Mintier, pour le Ministère du Travail et des affaires sociales et le Ministère de la justice, octobre 1999.
Cordier, A. ‘Ethique et Professions de santé’, a report delivered to the Minister of Health, May 2003.
Rapport sur " L'application des lois bioéthiques du 29 juillet 1994", sous la direction de B. Feuillet-Le Mintier, Mission de Recherche Droit et Justice, Ministère de la justice, octobre 1999.

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