The Clinical Trial Regulation (CTR) came into effect in January 2022 with a transition period until January 2025. With the implementation of the CTR, the processes for submission, assessment and supervision of clinical trials throughout the EU is harmonised through the Clinical Trial Information System (CTIS). It is now the single entry point for clinical trial data in the European Union. Learn more about its functionalities and how to use it on our CTIS page.
Competent Authority
Submission Fees
No submission fees required.
Additional Information & Specifics
Ethics Committee
Submission Fees
No submission fees applicable.
Study Specific Requirements
Study participants - informed consent
No standard IC form available. However, the french national commission for research (CNRIPH) which mission is to coordinate, harmonize and evaluate the practices of national ethic committee, has published a guide for drafting the inform consent form (general outline) applicable to the studies on humain being before the entered in force of the Regulation on clinical trials on medicinal products for human use (the guide is now applicable to the others studies in France).The sponsors can always use it as a basis for drafting their IC form
Informed consent is mainly regulated in France by the CTR.
However, France has enacted some specific rules relative to the research on deceased person.
No clinical trial may be carried out on a deceased person, in a state of brain death, without his or her consent expressed during his or her lifetime or through the testimony of his or her family. However, if the deceased person is a minor, this consent must be expressed by each of the holders of parental authority. If it is not possible to consult one of the holders of parental authority, the research may be carried out provided that the other holder consents.
It is an offence in France to carry out a clinical trial or to have such a trial carried out on a person, without having obtained the free, informed and, where appropriate, written consent of the person concerned, of the legal representative or of any other person, authority or body designated to give consent to the research or to authorise it.
A clarification can also be given about the e-consent, but it is not specific to the clinical trials on medicinal products. E-consent with an electronic signature is possible in France within the compliance with the rules on the processing of personal data.(guidelines in progress in France on the more general matter of decentralized clinical trials)
We cant' say there is a specific national legal framework for the inform consent- but there are some particular rules.
Clinical trial on deceased person: L. 1121-14 of french public health code.
Legal provisions relative to the offence "conduct of a clinical trial without consent": L.1128-1 of french public health code.
French legal framework for electronic signature : 1366 and 1367 of french civil code.
Study participants - vulnerable population
The applicable rules are those set forth in the CTR (Art. 29 and Art. 32).
The rules relative to the legally designated representative of the minor or to any person or body/authority who is able to authorise the clinical trial are set forth in the french civil code (articles 372 et seq. ).
The legally designated representative of the incapacitated person is designated by the national rules according to the CTR provisions
The applicable rules in France are those set forth in the CTR (Art. 29 and Art. 31).
The rules relative to the legally representative of the incapacitated person or to any person or body/authority who is able to authorise the clinical trial are set forth in the french civil code (Articles 425 and seq)
The applicable rules in France are those set forth in the CTR (Art. 35).
The rules relative to the legally representative designated for person that cannot express his consent to pursuit his participation to the clinical trial (other than minor or incapacitated person) are set forth in the french public health code (Article L1122-1-3)
In any case, the protocol must cover the emergency situation and specify the persons who may receive the information from the investigator and give their consent if the subject cannot consent to continue the research.
As soon as its condition permits, participant must give its consent to the clinical trail.
cf above
The applicable rules are those set fort in the CTR (prerequisites of article 35 )
The applicable rules in France don't explicitly refers to the article L. 1122-1-3 of french health public code but the competent authorities applies the rules set forth in this article.
If the person is not legally protected, the persons in a position to give consent are members of the family, or the trusted support person (french concept).
In any case, the protocol must cover the emergency situation and specify the persons who may receive the information from the investigator and give their consent if the subject cannot consent to continue the research.
As soon as its condition permits, participant must give its consent to the clinical trail.
L1122-1-3 CSP
No specific provisions In France. The applicable rules are those set forth in the CTR (Article 33).
general provisions of CTR (Art. 33).
Study participants - compensation & reimbursement
A Ministerial Order of 15 February 2023 sets the maximum amount of compensation for constraints suffered that a person may receive in any one year for taking part in a clinical trial.
The order sets the total amount of compensation that a person may receive over a period of twelve consecutive months for their participation in a clinical trial at 6,000 euros.
The payment of compensation to healthy participant may be made by means of benefits in kind, when the following two conditions are met:
the sponsor has carried out a financial evaluation of these benefits in kind and checked that the amount of €6,000 is not exceeded;
the sponsor has justified the use of these benefits in terms of the specific nature of the research or the target population.
The national ethical committee must accept it.
https://www.legifrance.gouv.fr/eli/arrete/2023/2/15/SPRP2305216A/jo/texte
Data protection
Commission Nationale de l'Informatique et des Libertés - CNIL / National Committee for Data Protection
In accordance to articles 66 and 73 of the french data protection law, Where the processing complies with a reference methodology, in this case MR-001, it may be implemented without authorisation from the CNIL. The data controller must first submit a declaration of compliance to the CNIL. It is a fast track and simplified process because the declaration is made on line on the CNIL website.
If the data processing cannot comply with MR-001, the data controller must submit an application for to obtain the authorisation to implement the data processing. The application is the application is examined by a committee the CEREES assessing the scientific and ethical aspect and after by the CNIL;
Insurance
The insurance contracts referred to in article R. 1121-4 of french public health code may not provide cover for less than :
1° 1,000,000 euros per victim ;
2° 6,000,000 euros per protocol;
3° 10,000,000 euros for all claims made during one insurance year in respect of several research protocols.
a specific legal framework applies in France set forth in the french public health code
Article R1121-4 and seq
Certain clauses excluding insurance cover are prohibited.
Contracts may provide for an excess per victim.
National legislations
General Information
LEGIFRANCE: https://www.legifrance.gouv.fr/
Legal and regulatory framework for research involving human beings
LOI n° 2012-300 du 5 mars 2012 relative aux recherches impliquant la personne humaine (JO n°0056 du 6 mars 2012) ( Commonly called the "Jardé law")
Ordonnance n° 2016-800 du 16 juin 2016 relative aux recherches impliquant la personne humaine (JO du 8 décembre 2017).
Décret n° 2017-884 du 9 mai 2017 modifiant certaines dispositions réglementaires relatives aux recherches impliquant la personne humaine (JO n°0109 du 10 mai 2017)
Décret n° 2016-1537 du 16 novembre 2016 relatif aux recherches impliquant la personne humaine ( JO n°0267 du 17 novembre 2016)
Data protection legislation
Loi n° 78-17 du 6 janvier 1978 relative à l'informatique, aux fichiers et aux libertés. in its latest amended version
*** BACKGROUND
Since the entered in force of the Clinical Trial Regulation (536/2014), the jardé law no longer applies in principle to clinical drug trials (principle of direct effect of european regulations). However, of all of the law doesn't apply to clinical trials of medicinal products, some articles remain applicable, those are specified in article L. 1124-1 of french public health code.
Clinical trials on IMPs in Humans
Radiation & Radiotherapy
Chapter 3 (section 5, Article R1333-56) CSP: specific requirements apply in case that study participants are exposed to ionizing radiation or radioactive substances in the clinical trial.
Further information can be found on the website of IRSN (Institute de Radioprotection et de sûreté nucléaire)
Biobanking
There is a specific framework in France for storing and using biological samples obtained either as part of clinical research or as part of healthcare (secondary ude of the humain biological sample).
The subject must be informed of the secondary use and do not oppose to it (.Article L1211-2- and other ethical principles L. 1211-3 and seq of french health public code)
Some regulatory procedures with the ministry of research are required in order to use the human biological samples for internal research purposes or to sell, import or export them.
Definitions
Observational study
(Article L. 1121-1, 3° of the Public Health Code) Non-interventional research involving no risk or constraint, in which all procedures are carried out and products are used in the usual way.
these studies are called "non-interventional studies" - this is a French particularity because they are considered to be carried out on human beings with interventions considered to be without risks and without constraints. The list of procedures is set by a ministerial decree of April 12, 2018 https://www.legifrance.gouv.fr/loda/id/JORFTEXT000036805820
Jardé law provisions apply to these studies.
Academic sponsors
No definition. However, jardé law defines the "Non-commercial research" as esearch whose results are not exploited for profit, which pursues a public health objective and whose promoter or investigator(s) are independent of the companies which manufacture or which market the products that are the subject of the research.
Article L1121-16-1 of french public health code