Guest Contributor – Mark Heinemann, Principal Regulatory Specialist, Late Stage, InVentiv Health Clinical
The French Ministry of Research and Higher Education (MESR) informs in a recent update of its website (https://appliweb.dgri.education.fr/appli_web/codecoh/IdentCodec.jsp) of the modification of the declaration and authorization procedures for the preparation and / or storage of human biological samples
for research purposes.
These activities are described in Articles L. 1243-3 of the Public Health Code (CSP), preparation / storage of human biological samples for specific research needs in an organization and L. 1243-4 CSP, preparation / conservation of biological samples for purposes of transfer to other research organisations.
Required is at present a two-step process combining declaration or authorization with a consultative appreciation of an Ethics Committee.
In the context of non-interventional studies in France (Art. L. 1121-1 CSP) involving additional blood samples for research purposes, this means that parallel submissions are required to the MESR and to a French Committee for the Protection of Persons (CPP) in addition to CCTIRS approval and CNIL declaration.
The outcome of a submission to the MESR is usually not expected under three months and is completed either with a silent approval from the MESR (declaration of activities related to Articles L. 1243-3 CSP) or an authorization (for activities related to Articles L. 1243-4 CSP).
This modification comes in the context of the MESR’s announcement of the entry into force of the “Jardé” Act of 5 March 2012 on research involving human beings.
The coming into force will occur no later than 31 December 2016:
L’entrée en vigueur de la loi du 5 mars 2012 relative aux recherches impliquant la personne humaine interviendra au plus tard le 31 décembre 2016.
The law of 5 March 2012 provides new criteria for research involving human beings in view of the development of biological or medical knowledge, governed by Title II of Book I of the first part of the Code de la Santé currently relating to biomedical research (RBM). It submits to the provisions of this title Low Intervention Research and Non-Interventional Research. Thus, Low Intervention Research (still to be defined by a future bylaw) and Non-Interventional Research involving human beings will soon be submitted to the approval of an Ethics Committee (“Comité de Protection de Personnes” – CPP).
Non-interventional studies involving human beings and the activities described in Articles L. 1243-3, L.1243-4 CSP will also be subject to CPP appreciation.
Consequently, the declaration under Article L. 1243-3 CSP or the application for authorization provided for in Article L. 1243-4 of the Code will no longer be submitted to the MESR or, where applicable, to the regional health agency (ARS), where activities will be conducted as part of research involving human beings.
Unclear is, if import and export authorization (including EU countries) to be delivered by the MESR for biological samples in the context of Non-Interventional Research will still be delivered by the Ministry of Research in the future.
The instruction period for import and export authorization is 3 months. The MESR delivers a silent rejection of a dossier. No response after three months equals rejection.
In the same context it is expected that the CCTIRS (Advisory Committee for Data Processing in Health Research) will no longer be involved in the evaluation of research involving the human beings within the scope of Article L. 1121-1 CSP.
Article 54 of the Act of 6 January 1978 on Data Processing, Data Files and Individual Liberties stipulates that the French Data Protection Authority CNIL will provide a decision based on the appreciation of the Committee of protection of persons (CPP) mentioned in Article L. 1123-6 CSP.
“Indeed, Article 54 of the Act of 6 January 1978 on Data Processing, Data Files and Individual Liberties indicates that this decision will be made on the basis of approvals given by the competent committees depending on the nature of the research.”
French data protection law experts point out that the current composition of French ECs may not allow the proper implementation of these new provisions:
“Furthermore, the absence of specific skills in terms of data protection of personal data, organization and functions of the CPP may not allow implementation of the new provisions in Article 54 of the Loi Informatique et Liberté / Act on Data Processing, Data Files and Individual Liberties”.
http://www.delsolavocats.com/images/presse/EXP412_extract_Troche.pdf
