IRELAND

Research Ethics Committees

Legislation

Clinical investigations on medical devices

Performance studies on in vitro diagnostic medical devices

Clinical trials on medicinal products for human use

Health Research Regulations

Ionising Radiation Regulations

Overview of the Irish mixed-model REC system

Health and social care research in Ireland, is assessed though mixed-model ethics review system that involves a variety of research ethics committees (RECs).

These RECs deliver ethics opinions that are recognised either locally and nationally, across regional health areas and within regulated and unregulated areas of health and social care.

The follow sets out a general summary of the mixed-model ethics review system in Ireland:

• National Research Ethics Committees (NRECs), are mandated under legislation, or by ministerial instruction, to deliver a ‘single national ethics opinion’ for regulated research, that is respected nationally,
• Health Services Executive (HSE) RECs and its funded Section 38 and Section 39 organisation RECs, deliver ethics opinions for unregulated research health research,
• Private Hospital RECs, that that ethically assess unregulated research health carried out within the respective private hospitals,
• Local or institutional RECs, that ethically assess unregulated research health carried out within its own institution,
• ‘Recognised’ RECs, mandated under legislation to ethically assess studies involving ionising radiation.

The National Office for Research Ethics Committees

The National Office for Research Ethics Committees, a EUREC member, was established in early 2020 as a key component of the reform of the research ethics committee framework in Ireland, led by the Department of Health. It is an independent unit within the Health Research Board and has a statutory function that serves to support NRECs to drive best ethical practices in conducting primarily regulated health research in Ireland, as follows:

• Clinical investigations of medical devices
• Performance studies of in vitro diagnostic medical devices
• Clinical trials on medicinal products for human use
• The National Irish COVID-19 Biobank (NICB)

We work closely with the national competent authority, the Health Products Regulatory Authority (HPRA), to ensure that all national ethics opinions delivered for regulated research areas is achieved in a parallel and coordinated manner, in accordance with national and EU legislation.

The NRECs operate within a national legislative framework, where statutory instruments for Clinical investigations of medical devices, Performance studies of in vitro diagnostic medical devices  and Clinical trials on medicinal products for human use,  transposes the EU Regulations (MDR, IVDR, CTR) into Irish law.

The Health Service Executive & its funded organisations

The HSE research ethics committee landscape is currently under reform, to establish a cohesive and sustainable approach to research ethics review for unregulated research. It aims to introduce RECs for each Health Region in Ireland.  These committees will co-exist and work in a coordinated fashion with the existing RECs in voluntary hospitals.

Private Hospital RECs

There are approximately 25 private hospitals that may operate RECs for the purpose of ensuring ethical oversight for the research (non-regulated) carried out within its organisations; Beacon Hospital, County Dublin, Blackrock Clinic, County Dublin, Mater Private Hospital Dublin

Local, institutional RECs

There are a number of RECs are operating outside of the National Research Ethics Committees and HSE RECs, for example:

• The ICPG REC review research studies from General Practitioners nationwide.
• The RCPI REC review research studies performed under the governance of the College, predominantly educational studies, and studies carried out by RCPI Trainees, large national public health studies to which a member or fellow of the college is a co-investigator, such as those involving the Department of Health, or other governmental organisations.
• Third-level 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 institutional. For example, the ~ 8 research active universities have institutional RECs that provide ethical oversight health research.

RECs for studies involving ionising radiation

Under S.I. No. 29/2023, there are 12 RECs recognised by the Department of Health to review studies involving ionising radiation. Only for studies involving ionising radiation can these 12 RECs provide a single ethics opinion even for multisite studies.