RREC for HSE Dublin and Midlands (& HSE Centre)

Please note, the Committee no longer accepts paper submissions. All applications must be submitted through the National Electronic Research Management System (NERMS) at https://apply.nerms.ie (this link will open a new page).

On this page:

• Coverage of the RREC Dublin and Midlands (& HSE Centre)
• In-scope
• Out-of-scope
• Application procedures
• 2024/2025 meeting dates 
• Contact details for the RREC Dublin and Midlands (& HSE Centre)
• Complaints
• Committee members

Please note: Clicking on any of the links below will open a new window.

As part of the HSE Roadmap for the Reform of Health and Social Care Research Ethics Committees, the Reference Research Ethics Committee Dublin and Midlands (RREC DML Region) was appointed by the National HSE Research Governance, Management and Support Committee in 2022. It also has a remit to review research by the HSE Centre.

Coverage of the RREC Dublin and Midlands (& HSE Centre)

This RREC covers:

• HSE services and funded services (Section 38 and 39 services), which do not have access to their own REC, in the Dublin and Midlands Health Region:
  • Co. Laois
  • Co. Offaly
  • Co. Longford
  • Co. Westmeath
  • Co. Kildare
  • Dublin South City
  • Dublin South West
  • Dublin West
  • West Wicklow
• Hospitals in the geographic region which do not have a REC, namely the Midland Regional Hospitals at Tullamore and Portlaoise, and Regional Hospital Mullingar.
• HSE Centre (formerly known as HSE Corporate and National Services). HSE Centre studies must meet these criteria:

a) The research study must be under the scope of the HSE National Framework for the Governance, Management and Support for Health Research

and 

b) The study is commissioned or funded by HSE Centre

or

c) The study must be endorsed by a HSE Centre as a study required to generate evidence for the development of HSE national policies, guidelines, etc. A senior member of the HSE Centre division must be a Co-investigator in the project. A letter of endorsement from the relevant HSE Centre division head (National Director, Assistant National Director or equivalent) is required to explain how this is a priority for the HSE Centre and how the study contributes to a priority area/ policy/ guideline/ development.

Please note, for HSE Centre Studies, a completed Eligibility Checklist Form must be submitted prior to applying to the RREC to determine if the Research Project is under the Scope of the Reference Research Ethics Committee Dublin and Midlands. Email REC.B.CorporateMidlands@hse.ie to request the checklist.

In-scope

• All HSE staff (including staff in Section 38 and 39 services) who wish to carry out research which needs access to facilities, staff, patients or clients, or information pertaining to staff or patients or clients of the Dublin and Midlands Health Region, including Section 38 and 39 organisations, for the purposes of research.
• Studies by HSE Centre as detailed above.
• All students, employed by the HSE or external to the HSE, who wish to carry out research which needs access to facilities, staff, patients or clients, or information pertaining to staff or patients or clients of the Dublin and Midlands Health Region , including Section 38 and 39 services (which do not have access to their own REC), for the purposes of research.
• All investigators, external to the HSE, who wish to have access to staff, patients or clients, facilities or information pertaining to patients, clients or staff of the Dublin and Midlands Health Region, including Section 38 and 39 services which do not have access to their own REC, for the purposes of research.

Out-of-scope

• Specific activities do not require RREC review. These include:
  • Research using existing publicly available documents or data
  • Observational studies in public places that involve observing people, in which the identity of the participant remains anonymous
  • Case studies of one patient with the proviso that written informed consent has been obtained from the relevant study subject/participant
  • Quality assurance studies
  • Clinical Audits
  • Service Evaluations
• Guidance on what is research and what requires research ethics approval is available of the HSE Research and Development website.

The RREC operates under No. 314 of 2018 Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018. Some specific types of research have additional statutory regulation and are reviewed by specialised national research ethics committees (NRECs). Governance for these NRECs is provided by the National Office for Research Ethics Committee (NREC) and include;

• NREC- CT Clinical Trials for the investigation of medicinal products (S.I. No. 190/2004 - European Communities (Clinical Trials on Medicinal Products For Human Use) Regulations, 2004 and the S.I. No. 41/2022 European Union (Clinical Trials on Medicinal Products for Human Use) (National Research Ethics Committees) Regulations 2022). 
• NREC- MD Medical Devices Regulation (EU) 2017/745and In Vitro Diagnostic Medical Devices (EU) 2017/746.
• NICB REC National Irish COVID-19 Biobank

Additionally, 12 regional RECs are recognised by the Department of Health to review studies involving ionising radiation under S.I. No. 29/2023 European Union (Basic Safety Standards for Protection Against Dangers Arising From Medical Exposure To Ionising Radiation) (Amendment) Regulations 2023. A single ethics opinion is given for multi-site studies.

The RREC is not a Clinical Ethics Committee and does not deal with or give an opinion on ethics issues in clinical practice and health service provision.

The interim RREC guidance document (v1.3) is available here. This is a working draft and will continue to be updated.

The RREC operates in compliance with the Standard Code of Governance and Management Required for Reference Research Ethics Committees.

Application procedures

1. All applications must be submitted using the National Electronic Research Management System (NERMS) at https://apply.nerms.ie.
2. Researchers need to register in NERMS before starting their application. This includes completing the CV sections of their ‘My Profile’ and uploading their GPDR/ data protection cert (within last 24 months). Once registered on NERMS, researchers will be able to update their profile, but will not need to register again for future research projects.
3. The NERMS Privacy, Security and Retention Policy are available on the NERMS log-in page.
4. Supports for NERMS including training videos and a Research User Manual are available here.
5. Please note there is in-built guidance notes and hover text as you progress through the NERMS application.
6. Please contact the RREC for the password.
7. For other queries, please email the RREC (REC.B.CorporateMidlands@hse.ie).  
8. Please note submission deadline dates and RREC meeting dates.
9. For research being completed as part of an academic qualification, it is important that your Academic Supervisor provides guidance in preparing and reviewing the ethical application before it is submitted to the RREC.
10. More information about Data Protection in Health and Social Care Research is available from HSE Research and Development here, including access to the Health Research Data Protection Impact Assessment (HR-DPIA), the Companion Guide and the pre-DPIA screening tool (to assess whether or not a full HR-DPIA is required or not).
11. Researchers should always follow the HSE National Policy for Consent in Health and Social Care Research as it relates to their research, for more information please see the HSE Research and Development guidance here.
12. Applications will undergo a validation process which checks for completeness, accuracy, consistency and quality.
13. Applications will be returned for revisions if they do not pass the validation check. It is the responsibility of the applicant to submit the revisions on time.
14. Only validated applications will be accepted for committee review and assigned to the next available meeting. You can track your application's status in NERMS.
15. It is the responsibility of the Chief Investigator and site-level Principal Investigator(s) to ensure all documentation is completed honestly and truthfully.
16. If the RREC approves the research study the approval letter will include information indicating that the Chief Investigator, or the person they have nominated, will be required to:
    • report serious adverse reactions related to study drug/ intervention/ procedures to the RREC via NERMS.
    • submit an Annual Report an End-of-Study Report to the RREC via NERMS.  Failure to do so will result in the approval lapsing.
    • If amendments need to be made to a study previously approved by the RREC, please complete and submit an amendment request through NERMS for review by the committee.
17. The Committee considers each application in detail using a research ethics framework – see here for your information. The framework is not finite but gives an idea of what the Committee focuses on when considering an application. 
18. Applicants can expect to receive a formal decision letter within 10 working days of the RREC meeting.

2024/2025 meeting dates and closing dates for applications

Please email REC.B.CorporateMidlands@hse.ie to inform of your intention to apply to the RREC, indicating the meeting date for which you are applying. This is so that we can monitor the number of applications in case we reach our meeting limit. We will advise you if the limit has been reached.

* Applicants can expect to receive a formal decision letter within 10 working days of the RREC meeting

Contact details for RREC Dublin and Midlands (& HSE Centre)

• Jenny Lee, Manager, Department of Public Health - HSE Dublin and Midlands, HSE Area Office, Arden Road, Tullamore, Co. Offaly, R35 TY28, E-mail REC.B.CorporateMidlands@hse.ie 
• Rosie Lowndes, Administrative Support, HSE Health Library Ireland, Research and Education Centre Library, Scott Building, Midland Regional Hospital Tullamore, Co. Offaly, R35 NY51, Email REC.B.CorporateMidlands@hse.ie
• All correspondence to be directed to REC.B.CorporateMidlands@hse.ie

Complaints

• The HSE wants to provide safe and high-quality services so that patients receive the best care and treatment. Patient feedback matters as it helps to improve HSE services. The HSE wants to hear from service users about their experience of what worked, what could improve or what didn't work. There are many ways to tell the HSE about your experience as a service user. Full details are available at https://www2.hse.ie/services/hse-complaints-and-feedback/your-service-your-say.html.
• In relation to research activities specifically, complaints may be made to RREC by patients (or their family members or next of kin), research participants (or their family members or next of kin), researchers, staff of institutions, or others. The research applicant should include the RREC contact details on their participant information leaflets. All complaints will be handled promptly and sensitively by the RREC:
  • Complaints should be submitted in writing or by email to the RREC. However, if this is not possible, the RREC manager can arrange to speak to someone by phone.
  • The RREC Manager will acknowledge the complaint, and also inform HSE Research and Development, within 5 working days of its submission and outline the course of action in response to the complaint.
  • The RREC manager will keep the HSE Reference REC Support and Co-ordination Office informed of any actions and decisions made in relation to the complaint. If the HSE Reference REC Support and Co-ordination Office needs any additional information it will be supplied by the RREC
  • Should any patient, research participant, researcher, staff of institution, or others be dissatisfied with the response of this RREC to their complaint they can approach the HSE Reference REC Support and Co-ordination Office. This RREC manager will provide the necessary contact details/pathway.

Committee members

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Page last updated on 17 April 2025

Related Files

Interim RREC Guidance Midlands and Corporate (Area B)

version 1.3 updated on 02.06.2022

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Standard Application Form V5_6

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Guide for completing REC application

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RREC submission checklist v6.5

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RREC Area B review prompts

These review topics and prompts draw on the seven requirements for determining whether a research trial is ethical from “What makes clinical research ethical?”, elements of the lead reviewer form from the Health Research Authority (NHS) and checklist for ethics reviewers from the University of Sheffield. Each application received by our RREC is considered, in detail, under the requirements below. Prompts included are not intended to be an exhaustive list.

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Is a DPIA needed

questions to be asked to see if a DPIA is needed

Format:DOCX|File Size:19KB

Annual-progress-report-template

Format:PDF|File Size:276KB

RRECB-Final-Progress-Report-template

Format:PDF|File Size:140KB

Safety-reporting-template

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Request for amendment template

To use when an amendment is needed to a previously approved research application.

Format:PDF|File Size:250KB