Opinion request for a new study / an amendment

Opinion request procedure for a new study / an amendment

Please consult the submission procedure on the Ministry of Health website.

For studies with medical devices, see also the dedicated page on the Ministry of Health website.

Note: if a dossier should be submitted to the CNER but does not require ministerial authorisation, the synthetic sheet (form) must be filled in and attached to the opinion request dossier.

Recommendations for the content of the participant information sheet and informed consent form

See downloadable templates on the "Publications" page.

Basic content of a research protocol

Here is a list of the elements that normally appear as basic information in a study protocol.

Oral presentation of a new study to the CNER

After the dossiers have been sent to the CNER secretariat in due form, the principal investigator is invited to present the study at the next CNER meeting. If the study is a medical study, it is imperative that one of the responsible physicians be present.

Please note that the oral presentation should be short (not exceeding 10 minutes), made without a PowerPoint support, and it should address the main points relevant to the CNER*. 

*i.e. it should include: a summary description of the project and its aims, recruitment procedures, risks and benefits for participants, information and informed consent procedures, protection of personal data, insurance covering the risk of participants and investigators, remuneration of participants and investigators if applicable.

Deadline for the response

The Ethics Committee delivers its opinions within 10 working days from the date of the meeting at which the project was evaluated. For amendments, the deadline is 35 days from the date of receipt of the dossier.

Resubmission in case of a negative opinion

Negative opinions issued by the CNER are detailed. It is possible to submit a reworked project in view of the comments made by the CNER. The submitted dossier must be complete and will then be treated under the normal procedure as a new study.