LEGISLATION FOR RESEARCH IN HUMANS

The decree n° 2016-1537 of 16 November 2016 in application to the law n° 2012-300 of 6 March 2012 concerning Research in Human Subjects (otherwise known as the Law Jardé), modified by Government order n° 2016-800 of 16 June 2016) was published on 17 November 2016 in the ‘Journal Official’. It came into force on 18 November 2016.

INTERVENTIONAL/NONINTERVENTIONAL CT

The scope of the provisions of law n° 2004-806 of 9 August 2004 covering biomedical research is limited to Research in Human Subjects designated as “interventional”

DEFINITIONS

Interventional Clinical Studies (CS) include:

ž   CS concerning drugs

ž   CS concerning cosmetic products

ž   CS concerning medical devices

ž   CS except health products

ž   CS concerning tissues and/or organs

ž   CS concerning labile blood products

 

Non-interventional CS are those in which all acts are performed and all products are used in a habitual manner, without recourse to any supplementary or unusual diagnostic or monitoring procedure. 

 

INTERVENTIONAL CT

In order to begin, an interventional clinical study must have obtained

  • ž  a favourable advice from the Institutional Review Board / Independent Ethics Committee
  • an authorisation from the National Agency for the Safety of Medicines and Health Products (Agence National de Sécurité du Médicament et des produits de santé - ANSM)

INDEPENDENT ETHICS COMMITTEE (IEC)

The law provides that the competent IRB/IEC for examining a research project, prior to being implemented, is designated randomly (article L.1123-6 of the Public Health Code). The random designation of the IRB/IEC applies to all dossiers falling within the scope of competence of an IRB/IEC.

French Drug Safety Agency (ANSM)

The ANSM adjudicates with regard to the safety of people participating in research, taking into consideration mainly

  • ž  the safety and quality of the products used in the research conforming, where applicable, to current standards and conditions of use.
  • ž  the safety of people with regard to the acts performed and the methods used as well as the arrangements proposed for follow-up of those people.

 

Instruction deadline: a maximum of 60 days starting from the reception date of the complete dossier. The absence of a written reply from the ANSM after 60 days equates to authorization of the clinical study.