Legal and ethical framework for research

Whenever research involves human beings, it falls under the scope of the Jardé Law, whether it concerns clinical research or research in the humanities and social sciences.

Types of research

Research involving human participants is defined under Article R.1121-1 of the French Public Health Code as research organised and conducted on healthy or sick volunteers, with the aim of advancing biological or medical knowledge and assessing:

the functioning of the human body, whether normal or pathological
the efficacy and safety of procedures, or the use or administration of products for diagnostic, therapeutic or preventive purposes in pathological conditions

Such research is regulated under the Jardé Law.

Research involving human participants (RIPH) is divided into three categories: interventional research, interventional research with minimal risks and constraints, and non-interventional research.

When research does not involve human participants (for example, studies based on existing data), it is considered to fall outside the Jardé Law.

Interventional research

This involves interventions on individuals that are not without risk and/or involve significant constraints. It may include clinical trials of medicines or other health products outside routine care.

Interventional research with minimal risks and constraints.

The list of such studies is defined by ministerial decree. They may involve the use of health products within their usual conditions of use, or minimally invasive procedures (blood sampling, imaging, etc.).

Non-interventional (observational) research

These studies involve no risk or constraint for participants. All procedures and products used are part of routine care, with no additional or unusual diagnostic, treatment, or monitoring procedures.

Regulatory procedures

Depending on the situation, the regulatory steps to be taken differ. These steps can take time, sometimes several months, in the development of a research project.

It is up to the promoter of the research to carry out these steps. (The promoter is the individual, company or institution that is responsible for and manages the research).

Participant consent

Research under the Jardé Law requires a favourable opinion from a Research Ethics Committee for the Protection of Persons (CPP). These committees issue a prior opinion on the ethical validity of research involving human participants.

To obtain CPP approval, participants must be provided with detailed information about the study and must give either written, free and informed consent (for interventional studies) or non-opposition (for non-interventional studies).

For research outside the Jardé Law, the Ethics and Scientific Committee for Research, Studies and Evaluations in Health (CEREES) is consulted.

Authorizations

The French National Agency for Medicines and Health Products Safety (ANSM) must be consulted for any research falling under the Jardé Law.

Interventional studies require ANSM authorisation
The other two categories require only notification, including submission of the study summary and CPP opinion

For research outside the Jardé Law, ANSM involvement is not required. However, it is possible and recommended to inform a research ethics committee to ensure there are no objections.

Data protection and privacy

Compliance with the French Data Protection Authority (CNIL) is mandatory. This can be achieved in different ways through reference methodologies.

For interventional research, compliance with Reference Methodology 001 (MR001) must be ensured, or a CNIL authorisation or declaration must be obtained.

For non-interventional research, as well as research outside the Jardé Law, compliance with Reference Methodology 003 (MR003), or a CNIL authorisation or declaration, is required.

Insurance

Interventional research requires insurance coverage, unlike non-interventional research and studies outside the Jardé Law.

Clinical trials registration

Finally, all research falling under the Jardé Law must be registered on the Clinical Trials registry before the first participant is enrolled.

Jardé Law			Outside Jardé Law
Interventional research		Non-interventional research	Pre-existing data, human and social science studies, satisfaction surveys, care practices.
Research on drugs and other health products	Research with minimal risks and constraints	Observational research
Requires a favorable opinion from the Comité de Protection des Personnes (CPP)			Ethics committee opinion recommended
Authorization from ANSM required	ANSM authorization not required, information sufficient	ANSM authorization not required	INDS filing for CEREES opinion
Information and written consent of participants required		Information and non-opposition of participants mandatory	Information and non-opposition of participants recommended
CNIL declaration, CNIL authorization or MR001 compliance commitment		CNIL declaration, CNIL authorization or MR003 compliance undertaking
Insurance essential		Insurance not required
Clinical Trials registration required			Clinical Trials registration not required

Summary table of steps to be taken

pictogramme représentant un document officiel et un tampon

_{Pictorial credit: Freepik}

Acronyms and definitions

ANSM = Agence nationale de sécurité du médicament et des produits de santé. French National Agency for Medicines and Health Products Safety Public agency responsible for evaluating health risks of medicines and health products. (See the ANSM website)

CPP = Comité de protection des personnes. Research Ethics Committee for the Protection of Persons
Appointed by Regional Health Agencies (ARS), these committees assess participant protection, recruitment procedures, clarity of information, consent processes, scientific relevance, and ethical compliance. (See the website of the Conférence nationale des comités de protection des personnes)

CEREES = Comité éthique et scientifiques pour les recherches, les études et les évaluations dans le domaine de la santé. Ethics and Scientific Committee for Research, Studies and Evaluations in Health Provides opinions on studies involving health data, focusing on purpose, methodology, ethical relevance, and scientific quality.

Research ethics committees. These are consultative bodies set up at university or teaching hospital level, whose aim is to help researchers consider the ethical dimension of their work, to guarantee the ethics of their protocols.

CNIL = Commission nationale de l'informatique et des libertés. French Data Protection Authority Independent authority responsible for protecting personal data and privacy.(See CNIL website)

MR001 = Reference methodology for health-related research involving the collection of consent. CNIL reference methodologies defining compliance frameworks for health research with or without informed consent. (See details of MR001)

MR003= Reference methodology for healthcare research without consent. (See details of MR003)

Clinical Trials = Database of clinical trials conducted worldwide. (See Clinical trials)

Useful links

Dedicated clinical research section on the Horizon Europe European research and innovation program website.
Download the Qualification guide for INSERM health research
Find general information on clinical research on the Inserm website or on the Our clinical research website.
The Groupements interrégionaux de recherche clinique (GIRCI) regularly offer formations, notably on the following topics:
- Regulatory news in clinical research (Loi Jardé, CNIL, SNDS, RGPD)
- Designing a research protocol
- From idea to completion of a clinical research study
- Writing the patient information document and consent form in a research protocol.
Report New approaches in clinical trials: Identification and analysis of cases in evaluations by regulatory bodies (FDA, EMA, HAS)
SmartREg tool from GIRGI île de France: What approach for my clinical research?
Multidisciplinary university network for primary care research in territories: MUST can provide support at all stages of the research project.