Tallaght University Hospital / St. James's Hospital Joint Research Ethics Committee (REC)
The Research Ethics Committee (REC) was established to provide ethical reviews for research in which patients (and sometimes healthy controls) are direct participants or which uses information derived from patients’ medical records or from biological samples.
Ethical approval is required under European Legislation (SI 190 of 2004) for clinical trials on medicinal products. These trials may be international and/or multi-site. The trial sponsor may seek approval from any REC in the country, of which there are currently 12, and approval for each site is required from the local CEO/Hospital Manager.
The REC also provides ethical review for non-clinical research and this service is generally restricted to research in Tallaght University Hospital or St. James's Hospital.
The REC does not review research proposals which do not involve patients as participants or use patient data or biological samples. Research involving, e.g. surveys of staff or process changes to improve operational efficiency are probably not our business although approval by hospital management is likely to be required. If in doubt email for clarification.
The Research Ethics Committee
The Committee comprises of expert and lay members. Expert members are doctors and other healthcare professionals, in most cases working in one of our hospitals. The Chairman is Professor Richard Deane. Membership is voluntary. Lay members must include some people who are not, and have not been, employed in the health sector. If you might be interested in being a member you are welcome to contact the administrator for further information or discussion.
The Committee and its work
The Committee meets 10 times each year, considering between eight and 10 proposals at each meeting. An expert review of each proposal is provided in advance. Discussion covers issues such as the validity and utility of the research, balance of risks and benefits and adequacy of consent processes.
Other matters concerning research ethics are dealt with between meetings by the administrator and, where required, by decision of the Chairman.
Proposals may be approved, approved subject to some clarifications or changes, deferred or not approved. Approximately 75% of all proposals are approved outright or subject to minor changes, as are almost all proposals subject to decision by the Chairman.
How to make a submission
The application document for clinical trials can be found on the dohc.ie website and below. Applications for for non-clinical trials can be found on the Molecular Medicine Ireland (mmi) website and also below. All other forms such as amendment forms, end of trial forms, patient information leaflet template, patient consent template etc. can also all be found below. To edit these forms, please click file and edit with word.
Timelines for approval
Please allow yourself a minimum of three months from first downloading an application or amendment form, to receiving a final notification (if applicable) of ethical approval. This is necessary as there may be an initial three week wait for the meeting and the committee may request amendments or a full resubmission for the next meeting. You may not make this deadline for the next meeting depending on the magnitude of changes and therefore it could be two months before your application is on the agenda again.
For non-clinical trials, we accept electronic submissions but please be prepared to submit a hard copy of the application on request.
For clinical trials, the committee require both an electronic and hard copy submission.
Applications are welcome Monday to Thursday during working hours but please take note of deadlines for specific meeting dates. Please do not submit an application or make an enquiry on Fridays as all applications made throughout the week are checked and reviewed on Fridays to the exclusion of all other work.
The fees for an application are outlined below:
|Tallaght University Hospital / St James's Hospital Ethical Approval Application Fees|
|Site Fee (per site)||€150|
|Non-Clinical Trial/Research Amendment||€64|
Please note that fees for clinical trials are non-negotiable.
When to apply
Meeting dates (submissions to be made at the latest three weeks prior to the meeting).
|April 18th (Please enquire before submission of clinical trials)||Submission Deadline is 28th March|
|May 16th||Submission Deadline is 25th April|
|June 27th||Submission Deadline is 6th June|
|July 18th||Submission Deadline is 27th June|
|August – No meeting||N/A|
|September 19th||Submission Deadline is 29th August|
|October 17th||Submission Deadline is 26th September|
|November 21st||Submission Deadline is 31st October|
|December – No meeting||N/A|
Contact details: email@example.com
Standard Application Form Non Clinical Trial 5.6
Form 1 Clinical Trial Application
Applicant Checklist for a Clinical Trial
Applicant Checklist for a Non Clinical Trial
Form 3 Site Specific Assessment Form
Form 4 Substantial Amendment
form5 Quarterly and Annual Report
Form 6 Declaration of End of Clinical Trial
Payment Information and Instructions
SJH AMNCH REC Non-Clinical Amendment Request Form
Patient Leaflet Template
Patient Consent Template