Research Ethics Committees (RECs) are a fundamental part of the process of the governance of health research. The role of RECs is to protect the safety, welfare, and rights of participants in health research.
RECs are responsible for ensuring research adheres to high quality ethical standards. They provide an independent assessment of all ethical considerations of a research study before it can commence. They are also responsible for ongoing oversight of research studies when amendments or changes to the original protocol or other relevant study documentation are required, or when safety issues arise.
The HSE research ethics committee landscape is in the process of being reformed in order to establish a cohesive and sustainable approach to research ethics review.
You may also find it helpful to refer to our Frequently Asked Questions page
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Projects that require approval by a HSE/Hospital Research Ethics Committee
A project requires approval by a HSE/Hospital Research Ethics Committee when the following applies:
- It is research which involves HSE health service users, their personal data and/or their biological samples, health or social care staff, HSE healthcare services, premises or infrastructure.
- It is a research project.
- It is not a regulated clinical trial or investigation with medical devices. These types of projects require approval by the National Office for Research Ethics Committees (NREC).
Note that if you are a student or a member of staff of an academic organisation your project may also require academic REC approval.
Under NO circumstances should a research study requiring HSE/Hospital REC or National Research Ethics Committee approval go ahead without it.
Finding the correct REC for a research project
Clinical Trials for Investigational Medicinal Products (CT-IMPs) and Clinical Investigations with Medical Devices hosted by HSE or HSE funded services need to be approved by the National Office for Research Ethics Committee (NREC). The NREC can provide single approval even if the study involves multiple sites.
All other studies need to be approved by the HSE/Hospital REC that is responsible for the site hosting the research, as follows:
- Studies hosted by community based healthcare services
- Studies hosted by hospital based healthcare services
- Studies hosted by Corporate Divisions and National Services
- Studies hosted by General Practitioners (GP)
At present studies involving multiple healthcare sites require multiple REC approvals with the exception of Clinical Trials for Investigational Medicinal Products (CT-IMPs) and Clinical Investigations with Medical Devices. HSE R&D is leading a program of reform to address this problem with a view to enable single REC approval by 2023.
What documentation is required for REC submission?
REC submissions include a completed REC application form and other additional documentation.
Most HSE/Hospital RECS use the REC Standard Application form, but you should check the relevant REC website or administrator before applying.
In addition to the REC Standard Application form , other documentation you will need to submit depends on the type of study and you can download a check list to help you plan your submission.
It may include:
- Proof of Insurance
- Study Protocol
- Summary CV for Principal Investigator (two pages only)
- Material that will be shared with the prospective participant
- Research Participant Information Leaflet
- Research Participant Consent Form
- Research Participant Assent Form
- Letter of Invitation for participant
- Cover letter on headed paper
- Case Report Form
- If the study involves a questionnaire:
- Validated Questionnaire
- Non-validated Questionnaire
- Interview schedule
- Any other written materials provided to the participant e.g. participant diary
- Copies of recruitment material for research participants, e.g. posters, newspaper adverts, website where appropriate, a printed script for video or audio recordings
- Risk Scoring tool
Download Checklist for HSE Reference Research Ethics Committees (Word / 108KB)
Resources and support for applicants
- Information on Consent: Patient Consent for research
- Research ethics application: A guide for the novice researcher
Resources and support for HSE/Hospital Research Ethics Committees
Resources and support for the HSE and Hospital Research Ethics Committees is available via the HSE National REC Support and Coordination Office.
Roadmap for the Reform of the health service RECs system
The HSE is in the process of reforming the health RECs system. The reform will result in the establishment of six regional RECs aligned to the Sláintecare regional health areas. These RECs are called HSE Reference RECs and they will follow a Standard Code of Governance and Management, report to the National HSE Committee for the Governance, Management and Support of Research and are supported by the National REC Support and Coordination Office.
What is the difference between the various RECs?
There are several types of research ethics committees within the public health service:
- Hospital RECs: They review applications for research only involving the hospital site.
- Regional HSE RECs: They provide a service to several healthcare services (community and hospital based) within a regional area.
- The National Office for Research Ethics Committees (NREC) is a statutory REC under the auspices of the Department of Health, responsible for providing a single REC opinion for regulated clinical trials and investigations of medical devices.
- The ICPG REC review research applications from General Practitioners nationwide.
- Academic RECs are responsible for REC approval of research projects taking place for an academic qualification or by an academic member of staff undertaking the project under the auspices of the university. Academic REC approval is part of the third level education approval processes and at the moment is required in addition to HSE/Hospital REC approval for relevant projects.
The roadmap for the reform of the HSE REC system envisages the establishment of processes to enable a single REC approval for projects involving multiple sites. Until the roadmap is implemented, (non-regulated) studies involving multiple sites still require multiple REC approvals.
Are you interested in becoming a member of a HSE Reference REC?
If you are interested in becoming a member of a HSE Reference REC , find out more about what it involves, what is in it for you and how to express an interest.