Research Ethics Committee (CER)
The Paris-Saclay CER does not comment on compliance with protection measures against Covid-19. Research managers must comply with the measures recommended by the supervisory authorities hosting the research units concerned in order to protect participants and those involved in on-site and off-site research.
However, if you have documents about health procedures which have been put in place for COVID 19 (e.g. a handout for participants, questionnaires), you can attach them to the file. We will only review ethical aspects.
The CER can only assess 8 files per session. As a result, some files may be placed on a waiting list.
PLEASE NOTE: Any request for assessment, or any amendment or response to the CER must be carried out using the submission of files platform (please see Submission procedure, point 3) and not by email.
Submissions of files
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In the case of umbrella protocols (i.e. the grouping together of a series of similar experiments), the form submitted to the CER must contain sufficient information on all the experiments to be carried out so that the assessors have a precise picture of each of the tasks/tests to be given to the participants and the conditions under which these are to be done. Rather than submitting an umbrella protocol, it is also possible to submit amendments to outline new additions to experiments on a previous protocol. These can then be quickly reviewed.
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In relation to the processing of personal data, a document outlining your handling of such procedures must be filed with the DPO.
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The application must be submitted and signed by a holder of a Unit belonging to the University
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Check the dates of the study carefully
How to become part of the CER- Paris-Saclay (CER-PS)?
It is important that members of the CER-PS come from a range of scientific disciplines. If you would like to become a part of the CER-PS, send an email with a CV attached to the CER Office at the following address cer.polethis@universite-paris-saclay.fr
How the CER-PS functions
The research ethics committee (CER) at Université Paris-Saclay operates under the guidance of POLETHIS. Its role is to offer an advisory ethical opinion on research protocols involving human subjects carried out by the University's researchers if these protocols do not aim to advance biological or biomedical knowledge. Its consultation is not automatic or compulsory.
The opinions of the CER-PS are delivered following expert assessment of the research protocol in terms of an ethical analysis of the objectives, the method and, more specifically, the procedures for inclusion, information, consent, data collection and storage, respect for confidentiality, support and respect for the dignity, integrity and rights of the people involved during the research.
The CER-PS also aims to encourage and promote good practice in non-interventional or observational research within Université Paris-Saclay. Its goal is to inform and advise researchers at Université Paris-Saclay in the development of their protocols and, if necessary, to guide them in their dealings with an Institutional Review Board (IRB - Comité de Protection des Personnes (CPP)).
If you have any questions about the research ethics committee, please write to cer.polethis@universite-paris-saclay.fr.
Since December 2018, the CER Association has brought together the various institutional research ethics committees (CER) in the region.
Schedule
Files must be received two weeks before meetings. Do not forget to attach any questionnaires linked to your study.
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Date of the meeting |
Deadline for submission of application |
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January 19, 2023 |
January 05, 2023 |
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February 16, 2023 |
February 02, 2023 |
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March 16, 2023 |
March 02, 2023 |
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April 20, 2023 |
April 06, 2023 |
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May 25, 2023 |
May 11, 2023 |
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June 22, 2023 |
June 08, 2023 |
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July 13, 2023 |
June 29, 2023 |
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September 21, 2023 |
September 07, 2023 |
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October 19, 2023 |
October 05, 2023 |
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November 16, 2023 |
November 02, 2023 |
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December 14, 2023 |
November 30, 2023 |
Please note: Due to a technical problem related to the submission, we cannot receive the submission protocols for the moment. We will come back to you as soon as it recovers.
The number of files for the sessions of the first half of 2023 has been closed. The next file submissions will be examined from September 2023.
When the CER resumes, it may exceptionally agree to evaluate protocols for experiments
that started between October 2022 and the resumption of the CER to give an opinion a posteriori.
These files will not be given priority. As no modification can be requested by the REB, this opinion will be either favorable from the outset, or unfavourable.
We therefore advise project leaders to be particularly attentive to the drafting of documents and to have them proofread
by people outside the project. In addition, if your project is likely to fall within the framework of the Jardé law, your responsibility is engaged and you must contact a CPP.
Applying for an ethics review of a research protocol
The procedure for submitting a protocol to the CER is as follows:
- Download the blank submission form below (please see ‘useful documents’ below)
- Fill it in and save it as a pdf file. Your file must contain the submission form as a minimum requirement. It can be supplemented with attachments such as an information sheet, the consent or non-objection form, the document for contacting volunteers and the questionnaires used, etc.
- Following a response from the CER and if you need to make changes to your file, you must go through the online submission platform again (link in point 3) (your file number appears in the notification which was sent to you) and submit the documents with the modified elements highlighted in colour. If necessary, you can also write a letter in reply to the CER.
The file will be dealt with during a standard CER meeting (please see the meeting dates below) bearing in mind that the evaluation process requires applications to be received two full weeks before the date of the meeting at which they are to be considered. The start date of the protocol must be compatible with the assessment date of the file. The result of the assessment is returned within a fortnight and may either validate the protocol as it stands, or request minor revisions, or request major revisions, or for it to be further considered by an IRB. The full procedure is laid out in the CER’s methods of operation (please see below).
Useful documents:
Compulsory document to submit a file: submission form to Paris-Saclay
Optional: Disclosure and informed consent form
Terms of operation
Which research protocols are concerned?
The CER has a very wide field of expertise. This is reflected in the diversity of its members. It can appraise any research involving human subjects, provided it is established that the research does not fall within the remit of the IRBs to which all studies aimed at advancing knowledge in the biomedical field must be referred in particular. The CER is particularly competent in the examination of studies in the areas of Human Physiology, Human-Machine Interaction, Virtual and Augmented Reality, Sport Science and Movement, Robotics, Education Sciences, Cognitive Science, Behavioural Economics, Sociology of Use, etc.