Ethics Submissions

Chairperson: Prof. Patrick Dillon,

Consultant Anaesthetist,

University Hospital Limerick, Dooradoyle, Limerick.

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We are moving to an online submission process for Ethics Committee Submissions from September 2024 in an effort to streamline processing and get committee decisions and other approval decisions back to you as soon as possible so that you can get on with your research. It is essential however that the submission is complete to avoid backwards and forwards communication which inevitably will slow dow approval so make sure you get the submission right first time!

Committee remit

Reviews applications to conduct research in:

• University Hospital Limerick
• University Maternity Hospital Limerick
• St. John’s Hospital
• Croom Hospital
• Ennis Hospital
• Nenagh Hospital
• CHO3 

Committee contact details

• Name of Committee: Research Ethics Committee, UL Hospitals Group, Mid-West Region
• Contact Person: Ms. Nicola Moloney
• Research Ethics Committee Manager
• Address:  Research Directorate (Mid West), St Camillus Site, Shelbourne Road, Limerick
• Phone: 061 482817
• Email:  ULHGResearchEthicsandClinicalTrials@hse.ie

Local requirements

A submission should include Information Leaflets, Consent Forms, Questionnaires, and Study Protocol, Principal Investigator Curriculum Vitae, Evidence of GDPR Training, etc. (if applicable). Please take care when completing your submission as incomplete submission will not be accepted. This will only delay the REC approval process for your research.

The DPIA Screening Tool should be completed and if indicated from the DPIA Screening Tool, a Privacy Impact Assessment Form should be completed. You should also submit the completed and reviewed PIA as part of your submission to the REC if required.

Please note only a limited number of applications can be reviewed each month. These will be reviewed on a first come, first served basis for all full and completed applications. Applications not reviewed within a given month will be added to a waitlist for the following month.

Making your submission on-line

From September 2024 onward, all scientific ethics submissions will be made online. The submission process is comprehensive, covering all necessary governance steps to fully appraise the submission. You can complete the process incrementally and revisit your submission at any time until you press the submit button. Once submitted, the application is no longer accessible and is effectively finalized. It cannot be modified thereafter.

What happens next?

Your application is received by the Research Directorate and is scheduled for the next scientific ethics committee meeting (the submission must be made at least 14 working days prior to the meeting). Simultaneously, the application undergoes Data Protection appraisal, details of which can be found here. Any study involving a third-party contract is automatically assessed by our external Legal adviser. Other studies requiring legal appraisal may also be submitted. Details of this process can be found here. Most studies undergo assessment for insurance risk.

Any study financially supported by a third party, such as a pharmaceutical or device company, or funding agency such as the HRB or Welcome Trust must also be assessed by our Finance Department.

All these governance elements must be appraised and signed off before the principal investigator receives the outcome of the appraisal process which will be one of the following:

1. Approved
2. Approved Provisional (requires a Supplementary Approval Form {SAF}).
3. Rejected

In general, we aim to provide a decision within six weeks of the study being presented to the scientific ethics committee. However, additional details may be required before approval, which can occur at any governance stage by returning a completed SAF to nicola.moloney@hse.ie.

The governance appraisal process is not iterative and documentation cannot be sent back and forth. If significant difficulties arise during the governance appraisal, the application may be rejected entirely, or a request for a de novo application may be made.