The Inserm Ethics Review Committee, Inserm REC (CEEI-IRB)

Taking the ethical dimension into account is an integral part of the research process.

The Inserm Ethics Review Committee (CEEI-IRB) is a research ethics committee (REC) as defined by the Council of Europe. It is registered with the Office for Human Research Protections (OHRP) of the United States Department of Health, and is therefore an Institutional Review Board. The CEEI-IRB is administratively attached to Inserm’s General Management, but is independent in its organisation and decision-making.

The CEEI-IRB is a REC which essentially issues opinions on research projects which do not come under the provisions of the French Biomedical Research Act (RIPH), but which require – because funding structures require it and because international journals make it an imperative condition – an opinion from an internationally recognized research ethics committee. Set up by Inserm in the early 2000s and accredited by the OHRP, which issues the IRB number, the CEEI-IRB (IRB00003888) is an independent committee at the service of researchers. With its multidisciplinary membership, it is approved for examination of research in health and behavioural sciences.

The committee advises research teams, sometimes well in advance of their project submission if necessary, on the ethical and regulatory aspects they face in implementing their project. The interaction of project leaders with the committee enhances the ethical dimension of their project and, as a result, improves the quality of organisation and implementation of the research. To find out more : why submit a project to a REC for its opinion.

Christine Dosquet, Chair

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The CEEI-IRB in practice

The CEEI-IRB gives priority to projects submitted by Inserm and/or CNRS laboratories and researchers, but also by other major teaching and research establishments (EHESP, EHESS, INRAE, Universities, etc). Any research project involving human beings, directly or indirectly, can be submitted to the CEEI-IRB. The first stage in the committee’s examination of a project is to establish its admissibility, in particular by qualifying the research in terms of the Public Health Code (PHC).

The committee examines research projects taking place in France that do not qualify as research involving the human person (RIPH) under the CSP and therefore do not require submission to a ‘Comité de Protection de Personnes’ (CPP) under current French legislation. The research examined by the CEEI-IRB is often research in the humanities and social sciences, mainly in the field of health, and retrospective research on data and/or biobanks. When a project is submitted to the CEEI-IRB, the committee qualifies the research to ensure that it does not fall within the scope of the RIPH regime, and therefore does not have to be examined by a CPP : often faced with the perplexity of research project sponsors, and sometimes with errors in the referral of projects, the committee has drawn up a health research qualification guide for everyone’s use. The CEEI-IRB also examines projects which would qualify as RIPH but which take place outside France. It issues ethical opinions on international projects, particularly European projects, and also projects in collaboration with the USA requiring an IRB opinion. The CEEI-IRB, which meets every month, issues its opinions rapidly, taking into account the quality of the research, compliance with regulations, in particular with regard to the protection of personal data, and the ethical aspects concerning research participants, in particular the conditions under which participants are recruited and the quality of the information and consent obtained. This review often leads to recommendations for modifications or additions that ultimately improve the research and in fine result in a favourable ethical opinion.

Christine Dosquet

Updated on 25/07/2024.

How to contact the Committee ?

Contact CEEI-IRB : ceei@inserm.fr

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