PIRC and Clinical Research qualification

PIRC and clinical research qualification

Each research category has its own complex ethical and regulatory framework involving a wide range of authorities and public bodies. In France, these include:

  • the National Agency for the Safety of Pharmaceuticals and Health Products or ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé),
  • the French Ethics Research Committees or CPPs (Comité de Protection des Personnes),
  • the National Data Protection Authority or CNIL (Commission Nationale de l'Informatique et des Libertés),
  • and the Advisory Committee for Data Processing in Health Research or CCTIRS (Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé),
whose roles and responsibilities differ depending on the research category – they may be required to give clearance or merely act in an advisory capacity.

International research projects also have to take into consideration the national requirements in force in each of the countries concerned.

It is all the more important for scientists to understand these administrative procedures to be planned ahead in order  to identify and avoid any obstacles that might hinder their research projects. This requires dedicated structures and staff, such as the Institut Pasteur Clinical Research Department (PIRC). The PIRC’s expertise is increasingly important given the growing complexity of research in a context of constant innovation.

For each research project carried out at the Institut Pasteur, the research is firstly classified by the PIRC according to the categories shown in the grid below. This makes it easier to identify the ethical and regulatory procedures that need to be followed and to obtain the clearance required in good time.

Act No. 2012-300 of March 5, 2012 (the Jardé Law) on research involving human subjects has amended the terminology and classification of research on humans. This Act will come into force once the implementing decrees are published in the French Official Journal. The information on this page will be updated when this happens.

Click on the image to open in a new tab (in French until the release of an English version of the grid updated following the Jardé Law)