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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

  • 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.

  • In relation to the processing of personal data, a document outlining your handling of such procedures must be filed with the DPO.

  • The application must be submitted and signed by a holder of a Unit belonging to the University

  • 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

 Les dossiers doivent être reçus deux semaines avant les réunions. N'oubliez pas de joindre les questionnaires associés à votre étude.

Files must be received two weeks before meetings. Do not forget to attach any questionnaires linked to your study.

Date of the meeting

Deadline for submission of application

January 20, 2022

January 6, 2022

February 17, 2022

February 3, 2022

March 17, 2022

March 3, 2022

April 14, 2022

March 31, 2022

May 12, 2022

April 28, 2022

June 9, 2022

May 25, 2022

July 7,  2022

June 23, 2022

September 8, 2022

August 25, 2022

October 6, 2022

September 22, 2022

November 17, 2022

November 3, 2022

December 15, 2022

December 1, 2022

Please note: the session of July 7, 2022 is full. The new protocols will be examined at the meeting of September 8, 2022.

Applying for an ethics review of a research protocol

The procedure for submitting a protocol to the CER is as follows:

  1. Download the blank submission form below (please see ‘useful documents’ below)
  2. 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.
  3. Submit your file here

  4. 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).

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.

Research Ethics Committee (CER) - List of members 2022