Ethical Approval for Research in the HSE & its funded organisations

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 and that appropriate informed and explicit consent for health and social care research is obtained, recorded and retained. 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 research project requires approval by a HSE/Hospital Research Ethics Committee when the following applies:

  1. It is a health research project.
  2. It is under the scope of the HSE National Framework for the Governance, Management and Support of Health Research [Download PDF]. This includes health research projects
    • which recruit participants via the HSE health service users, and/or their personal data and/or their biological samples
    • which involve the participation of health or social care staff or require HSE healthcare services, premises, or infrastructure.
  3. It is research outside the scope of the National Office for Research Ethics Committees (NREC). This includes non-regulated clinical trials etc.

Note that if you are carrying out research as part of an academic qualification or are an academic member of staff, 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.

Other activities, such as clinical audits, standard service evaluations and quality improvement projects, statutory public health work or advanced health analytics routinely carried out by the HSE for the planning and delivery of health and social health care services, are outside the scope of the research framework and do not require research ethical approval. However, in certain instances, ethical oversight outside the remit of the REC maybe required for such activities and this can be provided by a variety of mechanisms in accordance with the local governance requirement of each service.

When ethical oversight is deemed necessary but no other arrangement for ethical governance exist at local level, the relevant REC may agree to review the activity. In these cases it is recommended that the REC membership includes members with expertise in such types of activities. A checklist [Download Word] can be used to determine whether ethical oversight is required.

Further useful information is available in the Guide to managing ethical issues in quality improvement or clinical audit projects published by the Healthcare Quality Improvement Partnership in the UK.

Finding the correct REC for a research project

Health and social care research in Ireland is overseen by various different types of RECs each with specific areas of focus and jurisdiction (some of which may overlap). Only some RECs, for certain types of research, can provide single ethical approval even for multisite studies, e.g., Clinical Trials for Investigational Medicinal Products (CTIMPs) and Clinical Investigations of Medical Devices and Performance Studies of In Vitro Diagnostic Medical Devices hosted by HSE or HSE-funded services need to be approved by the National Office for Research Ethics Committee (NREC). Under S.I. No. 29/2023, there are 12 RECs recognised by the Department of Health to review studies involving ionising radiation (the 12 RECs are listed below). Only for studies involving ionising radiation can these 12 RECs provide a single ethical opinion even for multisite studies. 

Section 38 RECs are voluntary hospital RECs (these are funded under Section 38 of the Health Act, 2004). Section 39 RECs are a variety of different community, voluntary and not-for-profit organisations (funded under Section 39 of the Health Act, 2004)

All other studies need to be approved by the HSE/Hospital REC that is responsible for the site hosting the research, as follows:

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
  • Data Protection Impact Assessment (DPIA) scoring tool (XLSX / 263 KB)

Download Checklist for HSE Reference Research Ethics Committees (Word / 108KB)

Research Ethics Review Pathways

A key objective of the REC Reform Roadmap is to develop best practice guidelines to risk assess studies and create a standardised approach to full and proportionate research ethics review pathways. This is underpinned by the principle that HSE RECs conduct reviews in a manner that is proportionate to the level of ethical risk represented by each individual study. These pathways will be rolled out with the establishment of Reference RECs in the HSE. All research ethics applications to HSE RECs are subject to a full research ethics committee review process until these best practice guidelines are developed.

Resources and support for applicants

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.

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updated 06/06/24