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The Health Service Executive Midland Area Research Ethics Committee was set up in 2002 to consider both hospital and community-based research in the four counties of the then Midland Health Board - Longford, Westmeath, Laois and Offaly. Unfortunately the Committee ceased taking applications in 2020 as the unprecedented workload associated with the COVID-19 pandemic meant that REC members had to prioritise health protection and service delivery.
The National Research and Development Office is working to set up new HSE Reference Research Ethics Committees.
As part of this process a new committee has been set up which incorporates the previous area covered by the Midlands REC in addition to the other areas of Regional Health Area B (see below) and Corporate Services. This committee is called The HSE Reference Research Ethics Committee (RREC) for the Midlands Area and Corporate Division (Regional Health Area B).
We are accepting applications for research ethics review. .
Initial information about the RREC is available below. Please continue to visit this page for further updates.
Coverage of the HSE RREC for the Midlands Area and Corporate Division (Regional Health Area B)
This RREC covers:
- HSE services and funded services (Section 38 and 39 services), which do not have access to their own REC, in Regional Health Area B (CHO7 and part of CHO8):
- 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 hospital ethics committee, namely (as of March 2022) Midland Regional Hospital (Mullingar, Tullamore and Portlaoise).
- HSE Corporate Services.
Research taking place in the organisations listed above, that involves the participation of health service users, their personal data and/or their biological samples, health and social care staff, or the use of HSE healthcare services, premises or infrastructure, either directly or indirectly, must be reviewed by a HSE Reference REC, with the exception of those research studies under the remit of the NRECs
- 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 HSE Midlands Area and Corporate (Regional Health Area B), including Section 38 and 39 Services, for the purposes of research.
- 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 HSE Midlands Area and Corporate (Regional Health Area B), 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 HSE Midlands Area and Corporate (Regional Health Area B), including Section 38 and 39 Services which do not have access to their own REC, for the purposes of research.
- Please note that this RREC:
- is not recognised by the Department of Health under regulation 7 of the European Communities Regulations (Clinical Trials on Medicinal Products for Human Use (S.I. 190 of 2004)). This RREC therefore does not consider clinical trials of medicinal products and devices. The National Research Ethics Committees (NRECs) are responsible for the ethical review of Clinical Trials of Investigational Medicinal Products (CTIMPs) and the clinical investigations of Medical Devices (MD) – see www.nrecoffice.ie/ for information.
- 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
- 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.
- For applications to be considered at a meeting, the submission deadline must be met to enable us to triage and prepare applications in advance of each meeting.
- Applications will be returned, without review, if they are incomplete and not accompanied by all relevant documentation upon submission. Such documentation is outlined in the checklist. It includes, among other documentation, evidence of GDPR training (in the past 24 months) for all people named in the application form; DPIA screening and, where indicated, completed DPIA signed by the DPO; participant information and consent forms. Unfortunately we will need to adhere strictly to this requirement.
- The interim RREC guidance document (v1.3) is available here. This is a working draft and will continue to be updated over the coming weeks.
- The standardised application form is available here and in-depth instructions on how to complete each question are available here.
- Each application must be accompanied by a completed checklist (each item must be ticked – yes, no or n/a as appropriate) and appropriate documentation. The checklist (version 6.3) is available here. We recommend that you familiarise yourself with the checklist so that you know what you are expected to submit with your application form and have time to compile same for submission.
- Make sure you have your DPIA screening document completed, and, if same is needed, your completed DPIA (reviewed by relevant DPO) - see below for more information. Please allow yourself sufficient time to complete the DPIA and to have it reviewed by relevant DPO prior to our submission deadlines.
- Applications and documentation should be submitted by email only to REC.B.CorporateMidlands@hse.ie by the deadline - please try to keep the attachment sizes as small as possible so that the your email is not quarantined by HSE email content filter.
- All attachments or appendices included with the application form should have a clear file name.
- Please note:
- if you need participant consent for your research project you must also submit all consent related documentation (i.e. participant information leaflet, informed consent form)
- if you are doing a research study that involves children aged under 18 years you must also submit age appropriate patient information leaflets and assent forms for each paediatric age grouping in your study
- it is the responsibility of the Principal Investigator to ensure all documentation is completed honestly and truthfully
- if the RREC approves the research study the approval letter will include information indicating that the Principal Investigator, or the person they have nominated, will be required to:
- report serious adverse reactions related to study drug/ intervention/ procedures to the RREC
- submit an annual update, end of study notification, and a final report to the RREC
- Applicants can expect to receive a formal decision letter within 10 working days of the RREC meeting.
Data protection and research
For information about data protection and research, please visit https://hseresearch.ie/data-protection-and-research/ and see https://www.nrecoffice.ie/wp-content/uploads/NREC-Guidance-on-data-protection-and-data-sharing-Final.pdf
The Health Research Data Protection Network have published their Practical guide on data protection for health researchers and it is available on their website - www.ncto.ie
HSE Research and Development hosted a webinar, Beginners guide to completing a DPIA, which you may find useful. The slides are available to download from on www.hseresearch.ie
We ask for proof of GDPR training - it would be anticipated that this training should have taken place within the last 24 months. If training predates that, we would suggest that it should be taken again and current certificate(s) submitted with application. HSE staff can access GDPR training on HSELaND.
Data Protection Impact Assessment (DPIA)
For information about Data Protection Impact Assessments (DPIA), please see https://www.dataprotection.ie/en/organisations/know-your-obligations/data-protection-impact-assessments
In the absence of a site specific DPIA, the HSE's standard Privacy Impact Assessment form is available at https://healthservice.hse.ie/filelibrary/staff/privacy-impact-assessment-form.pdf :
Activities not requiring RREC review
Specific activities do not require RREC review. These include:
- Research using existing publicly available documents or data
- Observational studies in public places in which the identity of the participant remains anonymous
- Case study 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
It can be difficult to differentiate research, audit and evaluation. The HSE National Review of Clinical Audit (see page 41) distinguishes between clinical audit, service evaluation and research and indicates when research ethics committee review is required. The Standard Code of Governance and Management Required for HSE Reference Research Ethics Committees (see pages 26-28) outlines additional activities that generally do not require ethical approval.
The NHS's Health Research Authority, in conjunction with the UK's Medical Research Council, has developed a useful decision making tool to help you decide if your activity is a research project, clinical audit, evaluation study or usual practice. It is available at http://www.hra-decisiontools.org.uk/research/index.html (please note that this a UK tool and therefore refers to UK structures, however, it remains a useful tool to determine if your activity is research).
For further information please see HSE’s Research & Development page “What is Research” at https://hseresearch.ie/.
If this RREC is consulted about whether or not RREC review is required because of uncertainty as to whether the work is research, audit or service evaluation, you will be asked to consult the guidance above. If, having considered the guidance above, you are still in doubt about the need for a RREC review, you will likely be advised to submit a full RREC application as this is the only way that the RREC will have all relevant information to hand in order to make a decision. This is because a review of a study by the Chair and/or the Vice-Chair to decide whether it should go to the RREC for ethics review is quite an involved process, particularly if additional information is required. Requests like these are often made before the project is fully worked up. These sort of requests often become more delayed than straightforward submission and review. If you ask this RREC whether review is required and the information is unclear or there is great uncertainty, you will most likely be advised to submit the project for full ethics review. Ultimately, it is the decision for the principal investigator to decide whether to submit a project for ethics review.
For staff wishing to publish the results of an activity that is not research and does not require RREC review, this RREC does not provide a letter stating that review or approval is not needed. We would suggest that you link in, as appropriate, with your Quality and Patient Safety lead or your clinical audit department for guidance. For further information about the National Centre for Clinical Audit, please visit www.hse.ie/eng/about/who/nqpsd/ncca/
2022 meeting dates and closing dates for applications
|Submission Date - no later than 5p.m. on
||RREC meeting on*:
* Applicants can expect to receive a formal decision letter within 10 working days of the RREC meeting.
- Laura Smith, Manager – Reference Research Ethics Committee Midlands Area and Corporate (Regional Health Area B)
- Karen Guilfoyle, Administrator - Reference Research Ethics Committee Midlands Area and Corporate (Regional Health Area B)
C/o Department of Public Health - Public Health Area B | HSE Area Office | Arden Road | Tullamore | Co. Offaly | R35 TY28 | E-mail: REC.B.CorporateMidlands@hse.ie
- 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 (clicking this link will open the your service your say webpage in a new window)
- 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 the HSE Reference REC Support and Co-ordination Office, 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.
Click on + to see a bio for each member
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