Research Ethics Committee

Research Ethics Committee

The Research Ethics Committee (REC) of The National Maternity Hospital is a National Committee that is approved to receive and approve application proposals nationally. The REC will consider research projects which are proposed to take place in the hospital.

Monthly meetings are held with the exception of August.  There is one quarter lay attendance and a quorum is required at each meeting. All submissions must be received into the Secretary two weeks prior to this in order to be reviewed by the committee at this meeting.

Generally, the applications are approved at each meeting; if not approved the Chairman will request clarification on a particular issue. Please note secure email addresses should only be used for studies, hotmail & gmail accounts are not acceptable

Important Information – The Research Ethics Committee never access patient information / records.  Therefore, this should not be information that you include on the Patient Information Leaflet. 

Applications for the March 2024 meeting must be received by Thursday 7th March 2024 @ 4pm. Please send EIGHT paper copies of ALL your documentation e.g. Standard Application Form, Patient Information Leaflets, Consent Forms to the Secretary at the address below.  We will also need an electronic copy of these documents sent to ethicsresearch@nmh.ie

All applications must have a Data Protection Impact Assessment (DPIA) conducted, see the form below.

The documentation listed below on the checklist must be completed and forwarded to the Secretary before the application can be considered. Please ensure the consent form is reviewed  & amended accordingly as not all paragraphs or sentences in this sample will apply to your particular study. The consent form and patient information leaflet should be 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.

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 Medical Records Dept
The National Maternity Hospital,
Holles Street,
Dublin 2.
DO2 YH21


Tel: (01) 637 3542
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) Form

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)              6  

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
              6  
Information Leaflet(s) – use NMH template                 6  

Consent Form(s) – use NMH template

                6  
Questionnaire / Interview Prompts                 6  
Letter to Family Doctor as per your response to Question D9                 6  
Draft Agreement / Contract (where applicable)                 6  
Draft Data Protection Impact Assessment – see template                 6