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:
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?
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.
Secretary of IDIAPJGol IEC/IRB:
Gran Via de les Corts Catalanes 591, àtic
93 482 46 04