Research Ethics Committee

The Research Ethics Committee is a national committee that is approved to receive and approve application proposals nationally. Monthly meetings are held with the exception of August.  There is one quarter lay attendance and a quorum is required at each meeting.

Generally, the applications are approved at each meeting; if not approved the Chairman will request clarification on a particular issue.

The Research Ethics Committee (REC) of The National Maternity Hospital will consider all clinical trials and research projects which are proposed to take place in the hospital.  The  Research Ethics Committee normally will hold eleven meetings per annum. Meetings are normally held on the first Monday of the month and all submissions must be received into the secretary two weeks prior to this in order to be reviewed by the committee at this meeting.

Applications must be received by Wednesday 4th September 2019 @ 4pm. Please send 16 hard (paper) copies of your application, including Patient Information Leaflets & Consent Forms. Please refrain from using staples when submitting paperwork. All items received should be bound by paper clip only.

All applications should have a Data Protection Impact Assessment (DPIA) conducted. For more information on DPIA's please see below.

The documentation listed below on the checklist must be completed and forwarded to the Research Ethics Committee before the application can be considered. Please ensure the consent form and patient information leaflet are on separate sheets, understandable and easy to read for non-medical individuals.  It is always better for there  to be only one consent form for the study to avoid confusion.

Please note secure email addresses should only be used for studies, hotmail & gmail accounts are not acceptable.

When the study has received ethical approval from the committee it should be noted that given the potential use of hospital resources / data, permission from the appropriate departments must also be sought within the hospital e.g. Pharmacy, Laboratory, Radiology before commencement of the study.

Applications and queries for the Research Ethics Committee can be sent to:

Lee-anne Phillips,
Medical Secretary,
Research Ethics Committee,
The National Maternity Hospital,
Holles Street,
Dublin 2.
DO2 YH21

Tel: (01) 637 3588
E-mail: ethicsresearch@nmh.ie

Application Forms & Templates

Standard Application Form

Guidance Manual / Instructions for completing S.A.F

Explicit Consent Form (Template)

Patient Information Leaflet (Template)

Data Protection Impact Assessment (DPIA) Template & Information

Research Extract (part 3) from National HSE Consent Policy

Consent & Data Protection

Under the Data Protection Act (Health Research Regulations) 2018, explicit consent is required to process personal data for research purposes except if a consent declaration has been made by the Health Research Consent Declaration Committee.

  • Identifiable and pseudonymised data (e.g. linked by code) is classified as personal data by GDPR and is subject to this requirement.
  • Fully (irrevocably) anonymised data is not classified as personal data and is not subject to this requirement. However, consent is required to process personal data to make the data fully (irrevocably) anonymised and is subject to this requirement.

An explicit consent statement should:

  • specifically refer to the particular data set that is to be processed;
  • specifically refer to the precise purpose of processing (including any automated decision-making);
  • identify any risks and/or implications that might arise for the data subject as a result of the data processing;
  • provide any other relevant and specific information that might influence the decision of a data subject to give or not give their consent. 

Note to Researchers:

A consent form is not simply about a person giving you permission to involve them in your research, it is an agreement between you (the researcher ) and the research participant outlining the roles and responsibilities of each of the two parties throughout the whole of the research process.

The researcher should retain one copy of the consent form signed by both themselves and the participant. The participant should also be given a copy of the consent form as a record of what they have signed up to.

Even if a person has verbally given or signed a consent form previously, consent should still be re-established at the point of doing the intervie

Research Applications Checklist
Documents Required:

Number of Paper Copies

Required
Yes / No / N/A
Cover Letter (listing all documents for review, including Version number)                   16  

Standard Application Form RECSAF Version 5.6 Sept 2014 - revised (Aug & Oct 2018) NMH

- Refer to the guidance / Instructions for Use when completing the Application Form
                  16  
Information Leaflet(s) – use NMH template                   16  

Consent Form(s) – use NMH template

                  16  
Questionnaire / Interview Prompts                   16  
Letter to Family Doctor as per your response to Question D9                   16  
Draft Agreement / Contract (where applicable)                   16  
Draft Data Protection Impact Assessment – see template                   16