It is necessary that the following types of projects be evaluated by a Research Ethics Committee (REC):
Intervention, diagnostic, or therapeutic studies, different from routine clinical practice
Projects that require obtaining informed consent (IC) from participants
Observational projects that request or collect clinical data
Studies conducted with data from SIDIAP
In general, indexed journals request the opinion of a REC for the publication of any project (observational studies and clinical trials).
Who can submit an application to the CEIm?
Any person working in a center under the supervision of the CEIm of IDIAPJGol may submit the application (see section Centers supervised by the CEIm – list of centers).
If the person works in an ICS center, they must contact the Research Support Unit (USR) of their territory. The USR will be responsible for processing the application. You can find more information about the USRs at: https://idiapjgol.org/unitats-de-suport-territorial-usr/
In the case of SIDIAP projects, prior approval from the SIDIAP Scientific Committee is required before starting the evaluation by the CEIm. You have all the information at: https://www.sidiap.org/index.php/ca/solicituds
In the event that the study has been previously approved by another CEIm, the approval document must be attached
How to do it?
Deadline: Studies may be submitted until the 10th of the current month in order to be evaluated at the meeting held at the end of the month. The deadline closes on the 10th, and from the 11th onward, studies will be included in the following month’s meeting.
The regular meetings of the CEIm are usually held on the last Wednesday of the month.
All required documentation must be submitted according to the type of study (see the documentation section).
Language: The documentation may be submitted in Catalan, Spanish, or English. Except for the FIP-CI, which must be presented in Catalan or Spanish.
The Principal Investigator (PI) will be the point of contact with the CEIm, and is the person who will receive communications from the CEI and respond to any clarifications requested.
It is essential that before sending the documentation to the CEIm, the study’s PI is registered in the GIR management application in order to receive communications. This can be done through this link: : https://portal.idiapjgol.org:6443/gir/login/alta_externa.php
“Once the documentation has been validated, an email will be sent to notify receipt
How to present the response to the requested clarifications?
If the CEIm requests clarifications regarding the submitted documentation, the study’s PI will receive an email with the instructions.
They must submit:
An explanatory letter with the response to the requested clarifications
Modified documents with tracked changes and a new date and version (e.g., Version 2. Date 15/02/2025)
A clean version (final version)
How to submit amendments?
To submit an amendment to a project previously approved by the CEIm of IDIAP, you must send an email to cei@idiapjgol.org stating the study title, the CEIm code, and providing the following documentation:
Explanatory letter of the changes made
Modified documents with tracked changes, new date, and version. Example: Version 2. Date 15/02/2025
