Research and Ethics

Contact Names/Numbers/Email Addresses


AdministratorMs. Claire Hartin
AddressTallaght Hospital, Dublin 24
Emailclaire.hartin@amnch.ie
Telephone353 1 414 2199

Chairman – Dr. Peter Lavin, Tallaght Hospital
Vice Chairman – Dr. David Kevans, St. James’s Hospital
Alternate Vice Chairman – Dr. Anne Marie Tobin, Tallaght Hospital

Description of Department/Service

Please Note: If your research is non-clinical or an amendment, please do not wait until ethics meeting submission deadline date to send same as it may be suitable for a Chairman action

Tallaght 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 (S.I. 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 13, and approval for each site is required from the CEO/Hospital Manager.

The REC also provides ethical review for non-clinical research and this service is 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 clinical trials/amendments etc. can be found on the dohc.ie website and for a non-clinical trial on the Molecular Medicine Ireland (mmi) website, please see useful links. Forms can also be accessed here at Submissions for ethical approval forms and payment information

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 so your application may then be missed.

The fees for an application are outlined below:

SJH/AMNCH Ethical Approval Application Fees

Clinical Trial €1,000.00

Site Fee (per site) €150.00

Non-Clinical Trial €1,000.00

Substantial Amendment €200.00

Non-Substantial Amendment €64

Non-Clinical Trial/Research Amendment €64

For more information click this link 

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). Webpage is http://www.tallaghthospital.ie/About-us/Research-Ethics-Committee.html

January 18th

Submission deadline December 28th

February 15th

Submission deadline January 25th

March 15th

Submission deadline February 22nd

April 19th

Submission deadline March 29th

May 17th

Submission deadline April 26th

June 21st

Submission deadline May 24th

(4 weeks in advance of meeting in this instance)

July 19th

Submission deadline June 28th

August

No Meeting

September

Submission deadline August 23rd  

October

Submission deadline Sept 27th   

November

Submission deadline Oct 25th   

December

No meeting

Please note that submissions made after 5pm on the deadline date will not be accepted

Useful Links

http://health.gov.ie/clinical-trials-for-medicinal-products-application-forms-from-the-2007-guidance-document/

http://www.molecularmedicineireland.ie/research_ethics

https://www.hpra.ie

Submissions for Ethical Approval Forms & Payment Information

Applicant Checklist for a clinical Trial - Download

Applicant Checklist for a Non clinical Trial - Download

Fees and Payment Instruction - Download

Form 3 Site Specific Assessment (SSA) - Download

Form 6 Declaration of End of Clinical Trial - Download

Standard Application Form - Download

Research Ethics Committee

Tallaght Hospital / St. James's Hospital Joint Research Ethics Committee (REC)

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:

 
SJH/AMNCH Ethical Approval Application Fees
Clinical Trial€1000.00
Site Fee (per site)€150.00
Non-Clinical Trial€1000.00
Substantial Amendment€200.00
Non-Substantial Amendment€64
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 3 weeks prior to the meeting).

June 21st 

July 19th

September 20th

October 18th

November 15th

December

- Submission deadline May 24th

(4 weeks in advance of meeting in this instance)

- submission deadline August 23rd

- submission deadline September 27th

- submission deadline October 25th

- no meeting

The REC Secretary is Ms. Claire Hartin

Contact details:claire.hartin@amnch.ie