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Ethical Approval for Research in the HSE & its funded organisations

Research Ethics Committees (RECs) in the health service 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.

HSE and Hospital RECs are responsible for ensuring research proposals adhere to high ethical standards and that obtaining informed and explicit consent for health and social care research is in line with the HSE National Policy for Consent in Health and Social Care. 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.

However, the REC does not oversee research integrity, data accuracy or the policing of research publications.

The HSE research ethics committee landscape is being reformed 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, under the scope of the HSE National Framework for the Governance, Management and Support of Health Research [Download PDF]. This includes health research projects where any of the following apply:
    1. requires recruitment of participants via the publicly funded health and social care service 
    2. requires the processing of personal data from service users’ healthcare records for research purposes 
    3. requires the use of biological samples from service users for research purposes 
    4. involves health and social care staff in the publicly funded health and social care service; 
      • as participants
      • as researchers, when that research falls within the RGMS Scope.
    5. Is hosted within the publicly funded health and social care service and/or makes use of health and social care services infrastructure or requires support by healthcare services staff.
  2. 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.

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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).

Single national REC approval for Research under the Scope of the RGMS Framework

Certain RECs can provide a single national ethical approval for studies involving multiple sites including: 

Local REC approval for Research under the Scope of the HSE RGMS Framework

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

Additional REC approvals that maybe required

Depending on the nature of the study, additional review by other RECs such as university RECs, the TUSLA REC, ICPG REC, etc. may also be required. If review by additional RECs is required, details such as study title, name of Principal Investigator, protocol/ study plan etc. should be identical across all the applications.

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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)

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Research Ethics Review Pathways

The HSE is improving how Research Ethics Committees (RECs) review health and social care research. We now have one standard way to check the ethical risk of each study. This means studies should receive a review that is proportionate to its ethical risk.

Studies of higher ethical risk (for example, it could affect people’s health, privacy or dignity in a big way) receive more detailed considerations. While lower ethical risk studies receive reviews that are proportionate to the risk but still safeguards participants.

This risk check helps keep research safe for both participants and researchers. To make sure this is done fairly and in the same way for everyone, we worked with RECs and other experts to create:

When new Reference Research Ethics Committees are set-up, they will develop Standard Operating Procedures to fully describe their research ethical review pathways.

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Training and Support

Whether you’re applying for research ethics approval, supporting a Research Ethics Committee (REC), or looking to deepen your understanding of research ethics, the following resources are available:

Research Ethics Course

We partnered with the Irish Platform for Patient Organisations, Science and Industry (IPPOSI), the National Office for Research Ethics Committees, patient partners, and other key stakeholders to co-develop a course in research ethics. The course is designed to equip the public, patients, researchers and staff with the knowledge and skills to contribute meaningfully to ethical review processes, such as participating in Research Ethics Committees or supporting the ethical design of research studies.

This self-paced, 5-hour course provides a foundational introduction to research ethics. The course includes four core modules and a fifth optional module featuring video lessons and interactive knowledge checks:

  • Module 1: Introduction to Research Ethics: Explores the history and core principles of research ethics, and what makes health and social care research ethical.
  • Module 2: Research Ethics in Ireland: Introduces the structure and function of RECs in Ireland, explains how ethics reviews are carried out, and outlines the role of PPI in the process.
  • Module 3: Putting Principles into Practice: Examines key topics such as informed consent, data protection, and inclusive and respectful research practices.
  • Module 4: Ethical Concerns for Different Research Populations: Discusses additional ethical considerations when involving children, vulnerable populations, and the general public in research, particularly in population health studies.
  • Module 5: Specialised Topics: Covers advanced topics including biobanking, artificial intelligence in research, and ethical issues in social care and social science research.

Upon completion of the four core modules, learners receive a certificate of completion. We recommend revisiting the course every three years to keep knowledge up to date.

How to Access the Course

This course is open to all. To access it, simply register as a Volunteer on HSeLanD. For step-by-step instructions on how to locate the course once registered, please click here to access our “How to Access” Graphic.

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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.

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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.

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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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Home » Ethical Approval for Research in the HSE & its funded organisations

updated 10/10/25