French Public Health Code
In forceResearch organised and carried out on human beings with a view to developing biological or medical knowledge is authorised under the conditions set out in this Book and is hereinafter referred to as "research involving the human person".
There are three categories of research involving the human person:
1° Interventional research involving an intervention on a person that is not justified by the person's usual care;
2° Interventional research involving only minimal risks and constraints, the list of which is set by order of the Minister for Health, after consultation with the Director General of the National Agency for the Safety of Medicines and Health Products;
3° Non-interventional research involving no risks or constraints in which all procedures are carried out and products are used on a routine basis.
The natural person or legal entity who is responsible for research involving the human person, ensures that it is managed and verifies that it is financed is known as the sponsor. The sponsor or its legal representative must be established in the European Union. When several persons take the initiative for the same research involving the human person, they designate a natural or legal person who will have the status of sponsor and will assume the corresponding obligations in application of this book.
The natural person or persons who direct and supervise the performance of the research on a site are called investigators.
Where the sponsor of research involving the human person entrusts its performance to several investigators at several sites in France, the sponsor shall appoint a coordinator from among the investigators.
If, at one site, the research is carried out by a team, the investigator is the head of the team and is referred to as the principal investigator.
The provisions of this Title, with the exception of those mentioned in Chapters IV, V and VI, shall not apply to:
a) Clinical trials of medicinal products governed by the provisions of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014;
(b) Clinical investigations of devices referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 governed by the provisions of that Regulation.
c) Performance studies of in vitro diagnostic medical devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 governed by the provisions of that Regulation.
By way of derogation from the previous paragraph, Chapters I to IIIa, with the exception of the provisions of Article L. 1123-10, and Chapter VIII of this Title cover research involving the human person relating to devices mentioned in Article 1 of the aforementioned Regulation (EU), which are not governed by this Regulation and meet at least one of the following conditions:
-study conducted on a device bearing the CE mark, whether or not used for its intended purpose, or not bearing the CE mark, the results of which cannot influence decisions relating to the care of the participant or are not used to guide care, and involving neither invasive surgical removal carried out solely for the purposes of the study, nor any additional invasive procedure or other risks for the participant in the study ;
-a study conducted on a device bearing the CE mark and used for its intended purpose, the results of which may influence decisions relating to the participant's care or be used to guide care, and which does not involve any additional invasive or cumbersome procedure;
-a study evaluating devices referred to in paragraph 5 of Article 5 of the aforementioned Regulation (EU) which are manufactured and used exclusively in healthcare establishments, within the meaning of the same Regulation, and which meet all the conditions referred to in points a to i of this paragraph 5.
Within the framework of this research, the notification of serious adverse events and device defects referred to in Article 1 of the aforementioned Regulation (EU) shall be carried out in accordance with Article 76 of the same Regulation.
