Research Ethics Committee
About
The Research Ethics Committee (REC) at The National Maternity Hospital is formally approved to review and authorise research proposals nationally. If you are planning a study within the hospital, the REC is here to ensure your work meets the highest ethical and data‑protection standards while supporting you through the application process.
The Committee meets monthly (except August). To have your study reviewed, your full application must reach the administrator, via the REC email, at least two weeks before the meeting date. Each meeting requires a quorum and includes one‑quarter lay representation to ensure a balanced, patient‑centred perspective.
Most applications are approved at the meeting they are presented. If clarification is needed, the Chair will contact you via the REC email. Please note that secure email addresses must be used for all research correspondence; personal accounts such as Hotmail or Gmail cannot be accepted.
The REC never accesses patient records or identifiable clinical information, so these must not appear in your Patient Information Leaflet.
Applications: Please submit ALL your documentation electronically e.g. Standard Application Form, Patient Information Leaflets, Consent Forms; to the Administrator, via the REC email address: ethicsresearch@nmh.ie
All applications must have a Data Protection Impact Assessment (DPIA) conducted, see the form below.
The documentation listed below must be completed and forwarded to the Secretary before the application can be considered. Please ensure the consent form is reviewed and 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.
If 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 the Research Ethics Committee:
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:
Cover Letter (listing all documents for review, including Version number)
Number of Paper Copies Required- 8
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
Number of Paper Copies Required- 8
Information Leaflet(s) – use NMH template
Number of Paper Copies Required- 8
Consent Form(s) – use NMH template
Number of Paper Copies Required- 8
Questionnaire / Interview Prompts
Number of Paper Copies Required- 8
Draft Agreement / Contract (where applicable)
Number of Paper Copies Required- 8
Draft Data Protection Impact Assessment – see template
Number of Paper Copies Required- 8
Contact
Research Ethics Committee
The National Maternity Hospital
Holles Street, Dublin 2, DO2 YH21