REQUEST FOR OPINION FOR A NEW STUDY / AMENDMENT Minimize

 

  • Opinion request procedure for a new study or amendment

--> Follow the application procedure as outlined on the Health ministry's website  

 

  • Guidance regarding elements to include in the participant information sheet and informed consent form :

Participant information sheet and informed consent form - recommendations (in French, English, and German) - DOWNLOAD  

 

  • Information regarding the oral presentation of your study to the CNER

After the requested documents have been received at the CNER secretariat, the principal investigator is invited to orally present his study to the CNER at its next meeting. If the study is a medical study, it is imperative that one of the responsible physicians be present. Please note that the presentation should be short (not exceeding 5 minutes), that it should address the main aspects relevant to the CNER's review* and be done without powerpoint support.

* i.e. it should include the following : description of the project, its aims and scope, recruitment procedure, intervention(s), risks and potential benefits to the participants, insurance, possible investigator / participant remuneration details, data protection. 

 

  • Deadline for reply:

The National Research Ethics Committee replies to requests within a period of 60 days following the receipt date of the request in due form.

 

  • 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 dossier submitted must be complete and will then be treated in accordance with the normal procedure as a new study.

 

 

  
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