Overview of School of Medicine Research Ethics Committee Review Process

Level 2 School of Medicine Research Ethics Application for Review

The School of Medicine Research Ethics Committee reviews applications from staff and students from the School of Medicine TCD. These applications must match the Level 2 Research Ethics checklist as set out here:.  All applicants must register their application using their TCD email address and supply their TCD Staff Number on the Application Form.

If your study does not meet the Level 2 Research Ethics checklist criteria, you must apply to the relevant Research Ethics Committee listed below;

• Level 3 Research Ethics Applications for Review
  All research ethics applications matching the Level 3 criteria must be submitted to the Faculty Research Ethics Committee. 
• Animal Research Ethics Applications                                                                                                                    All research ethics applications involving animals must be approved by the TCD Animal Research Ethics Committee.
• Hospital Research Ethics Applications                                                                                                                  Any patient related research being undertaken on the St James/ Tallaght hospital site which requires ethical approval requires a submission to be made via Joint Research Ethics Committee (JREC): Claire.Hartin@tuh.ie 

Should you be unsure of whether your application meets the criteria for the School of Medicine Level 2 Committee review please send an email to somrec@tcd.ie providing a short description of the research you wish to undertake, and advice will be provided.

Once an ethics application has been approved by SOMREC, the researcher(s) is responsible for ensuring that the study is conducted in adherence to the protocols outlined in their ethics application. 

Amendment requests to approved studies may be considered where the amendment request constitutes a minor change to the original application that does not materially change the previously approved study. Examples of the type of change that may be submitted as an amendment request include: 

• Extension to the end date of the study where there is no change to methods of the approved study (no change to the study methods, recruitment, or data collection). 
• Extension of recruitment to the study (for example accessing a wider sample/participants) with no change to the study methods or data collection. 
• Inclusion of an additional member of the research team
• Addition of a new data collection site
• Limited changes to the protocol that will not have a major impact on the content of the participant information leaflet, DPIA etc.

Small changes to the wording of an interview schedule, for example, do not require that an amendment be submitted, unless the content explored is substantially different.

Any alterations to an approved study that involve a change in study methods (for example introducing a new methodology such as the inclusion of a qualitative component, recruitment of a new sample/participants where the study methods are also changing), need to be submitted as a new and separate REC application and will be queued for full review by the committee at the next available meeting. 

To submit an amendment click on ‘New Ethics Application’, verify the checklist and select ‘Amendment’ from the ‘Application Type’ drop down list. A yellow pop up will appear summarising what constitutes an amendment.

Another pop-up will also appear giving you a list of your existing applications. Choose the one you wish to amend, then make sure to put this in as the project title so that both the amendment project title and the existing application share the same name. The fields in the amendment will automatically populate from the original application and will be badged ‘amendment’ to signify this. Make the changes to the relevant sections. Please then complete this form and upload it as an attachment to your amendment. You can then resubmit the application.

Some specific item attachments (named person, site, method) may need to be re-uploaded prior to submission.

Submit to REAMS

For all queries related to your application to the School of Medicine Research Ethics Committee, please email SOMREC@tcd.ie