Evaluation Requeriments for Research Projects:

 

Which projects should be sent to the IEC/IRB/?

An evaluation by IEC/IRB is necessary in the following types of projects:

• Intervention, diagnostic or therapeutic studies, different from the usual clinical practice
• Projects that requiere the request for informed consent (CI) to the participants
• Observacionals projects that request or collect clustered data
• Studies carried out with SIDIAP database

In general, indexed magazinesrequest an assessment of a CEIC for the IEC/IRB for the publication of any project (observational and clinical trials).

 

Who can send a request to the CEI?

The request can be sent by anyone working at a Primary Care Centre under the tutelage of IDIAPJGol (see list of centres).

The Principal Investigator (PI) will be the interlocutor with the CEI and will answer to the clarifications requested.

 

What documentation should be sent to the IEC/IRB?

Application for the evaluation of the research study:

Validation application filled out by the corresponding Research Support Unit (USR) or the Central Research Unit. This request must be completed by any research project.

 

Study protocol (with version and date): any protocol format can be presented, providad that it contains the sections described in the model that we propose below:

 

Information sheet for the participant and informed consent (with version and date), if applicable:

Consentiment informat mostres biològiques (model 06) 

Consentiment informat cessió imatges (model 07) 

  

In the event that it has been aproved previously by another IEC/IRB, you shoud attach a document of approval of the same (IRC/IRB assessment).

 

In case of SIDIAP projects, prior approval of the SIDIAP Scientific Committee must be approved.

 

How to do it?

The application must be sent to the e-mail address:  This email address is being protected from spambots. You need JavaScript enabled to view it.

Once the application has been received, the secretary of the CIS will review the proposal and inform the research team via email of the correct reception of the research team and whether it is accepted or if more information is needed.

 

How to Submit Responses to Requested Clarifications

If the Ethics Committee (CEIm) requests clarifications to the submitted documentation, the Principal Investigator (PI) of the study will receive an email with the instructions.
Modified documents must be submitted with track changes. For each response to the clarifications submitted, the version and date of the modified documents should be changed, e.g. Version 2. Date 15/02/2023.

 

How to Submit Amendments

To submit an amendment to a project previously approved by the CEIm of IDIAP, you should send an email to This email address is being protected from spambots. You need JavaScript enabled to view it., including the study title, CEIm code, and the following documentation:
• A letter explaining the changes made.
• Modified documents with the new version number and date, with track changes and the final version. For example: Version 2. Date 15/02/2023.
The CEIm secretariat will ensure that it is included in the relevant meeting.

 

 

 

 

Contact:

Secretary of IDIAPJGol IEC/IRB:

Gran Via de les Corts Catalanes 591, àtic

93 482 46 04

 This email address is being protected from spambots. You need JavaScript enabled to view it.