The Research Ethics Committee (REC) is 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 (S.I. 190 of 2004) for clinical trials (trials of medicinal products). These trials are sometimes international and/or multi-site. The trial sponsor may seek approval from any REC in the country (there are currently 13)and local CEO/Hospital Manager will need to give approval for each site.

The REC also provides ethical review for non-clinical research and this service is generally restricted to research in Tallaght 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 usually a senior Consultant, currently Dr. Peter Lavin of Tallaght Hospital. 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 Secretary for further information or discussion.

The Committee and its work.

The Committee meets 11 times each year, considering about 12 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 for a clinical trial can be found on the dohc.ie website and for a non-clinical trial on the Molecular Medicine Ireland (mmi) website. Forms and amendment forms can also be obtained from the Secretary, please apply by email clarifying if clinical or non-clinical trial.

Please allow yourself a minimum of 3 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 a Friday as all applications made throughout the week are checked and reviewed on a Friday to the exclusion of all other work.

The fees for an application are outlined below:

Please note that fees for clinical trials are non-negotiable.

When to apply.

Meeting dates (submissions to be made at the latest 3 weeks prior to the meeting).

The REC Secretary is Ms. Claire Hartin

Contact details:claire.hartin@amnch.ie