1. What types of research do NRECs review?

The National Research Ethics Committees (NRECs) in the Republic of Ireland currently review three types of research: clinical trials on investigational medicinal products, clinical investigations of medical devices, and performance studies of in vitro diagnostic medical devices.

Other forms of research are reviewed by local research ethics committees based at research institutions including universities and hospitals. The scope of review of the NRECs is determined by EU regulations in the following areas:

• Clinical Trials of Investigational Medicinal Products (CTIMP) (EU No. 536/2014)
• Clinical Investigations of Medical Devices (EU No. 2017/745)
• Performance Studies of In Vitro Diagnostic Medical Devices (EU No. 2017/746)

Applicants should determine if their study meets the scope of NREC review; however, when an applicant is in any doubt as to whether their study falls under the EU Medical Devices Regulation or the EU In Vitro Diagnostic Medical Devices Regulation, both the HPRA and the National Office for Research Ethics Committees can assist.

2. What if an applicant is unsure of the route to take for ethics approval of their study?

If a study meets the definition of a clinical trial of investigational medicinal products (CTIMP) as per the EU Clinical Trials Regulation (EU No. 536/2014), as of May 2021, applicants must submit an application for ethics review to the NREC-CT via the EU portal, the Clinical Trials Information System (CTIS).

If a study meets the definition of a clinical investigation of a medical device under the EU Medical Devices Regulation, as of 26 May 2021 applicants must submit it for review by the NREC-MD.

If a study meets the definition of a performance study of an in vitro diagnostic medical device under the EU In Vitro Diagnostic Medical Devices Regulation, as of 26 May 2022, applicants must submit it for review by the NREC-MD.

3. How were the NRECs established?

The National Research Ethics Committees for Clinical Trials (NREC-CT) and Medical Devices (NREC-MD) were formally appointed in May 2021. The Minister for Health appoints members to NRECs in select areas of health research;  for clinical trials of investigational medicinal products NREC-CT), clinical investigations of medical devices, and performance studies of in vitro diagnostic medical devices (NREC-MD). 

The National Office has a rolling Expressions of Interest call for NREC membership  which can be viewed here 'become a member'. Expressions of Interest from individuals with varied expertise, experiential knowledge, and with and without prior REC experience are welcomed.  

4. How are members of the NRECs selected? 

The Minister for Health makes formal appointments to the NRECs. The National Office for Research Ethics Committees manages the the Expressions of Interest application process for NREC membership and forwards a recommendation for the NREC(s) for consideration by the Minister for Health for appointment. Recommendations are made on individuals’ range of experience and skills and not necessarily in a representative capacity, mindful of the balance of expertise and perspectives required. Member recommendations are also informed by appropriate representation of both ‘expert’ and ‘lay’ members in line with legislative requirements and best practice. The National Office may approach prospective members to invite an Expression of Interest when, in the view of the National Office, there is likely to be a particular gap in expertise or representation.

5. What is the mixed-model REC system?

The mixed-model system of research ethics review is provided for by the NREC Bill, which will strengthen the health research infrastructure in Ireland. This means that NRECs will work alongside local RECs, each with clearly defined remits, to ensure that Irish health research is underpinned by the highest ethical standards. The mixed-model system will be supported by parallel reforms in research governance led by the Research & Development Team at the HSE.

6. Who reviews studies involving ionising radiation?

Studies which utilise ionising radiation and which are conducted under the EU Regulations (below) are reviewed by the National Research Ethics Committees (NRECs).

• Clinical Trials of Investigational Medicinal Products (CTIMP) (EU No. 536/2014)
• Clinical Investigations of Medical Devices (EU No. 2017/745)
• ­Performance Studies of In Vitro Diagnostic Medical Devices (EU No. 2017/746)

Studies which utilise ionising radiation but which are not conducted under the EU Regulations (above) are reviewed by the research ethics committees (RECs) which are listed in S.I. 29/2023 European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) (Amendment) Regulations 2023.

7. Will decisions taken by the NRECs be made public?

The National Office for Research Ethics Committees is committed to transparency. The National Office make the minutes of the NREC meetings and decision details publicly available on our website.

8. Should single-site studies be directed to NRECs for ethics review?

Yes; if the study falls within the remits of health research defined for the NRECs, it should be submitted to the National Office for Research Ethics Committees for review. The scope of review of the NRECs is determined by EU Regulations in the following areas:

• Clinical Trials of Investigational Medicinal Products (CTIMP) (EU No. 536/2014)
• Clinical Investigations of Medical Devices (EU No. 2017/745)
• Performance Studies of In Vitro Diagnostic Medical Devices (EU No. 2017/746)

9. Who reviews studies which take place at non-trial clinical multi-centre studies – local RECs or NREC?

Multi-centre studies that do not fall under the EU Regulations remain within the remit of the local RECs. Parallel reforms in research governance and the local REC system led by the R&D Team at the HSE will assist in streamlining REC approvals for multi-site clinical studies in the future.

10. What is the REC pathway for external organisations such as charities and services that do not have access to institutional RECs?

Both the NREC-CT and NREC-MD have defined health research remits in line with the respective relevant EU Regulations, as follows below. Any research study that falls within the remits of the NREC-MD or NREC-CT must be reviewed through the NREC system. The NRECs will not review studies that do not come under these Regulations. For more information on research ethics committees in other areas of research, please consult https://hseresearch.ie/research-ethics/. ­

• Clinical Trials of Investigational Medicinal Products (CTIMP) (EU No. 536/2014)
• ­Clinical Investigations of Medical Devices (EU No. 2017/745)
• ­Performance Studies of In Vitro Diagnostic Medical Devices (EU No. 2017/746)
  

11. As an applicant, do I need to seek approval from my local REC in addition to the NREC?

No; NRECs are legislatively mandated to return decisions that are applicable nationally and, as such, the research community including local RECs, are expected to respect the outcomes from the NREC process. Conversely, an NREC will not revisit a decision made by a local REC within its local remit. In line with good research practice and research governance, applicants should secure the necessary local approvals required to conduct the research at each site and notify their local REC and Research Office or equivalent body in their institution of NREC decisions.

12. Is a Data Protection Impact Assessment (DPIA) required as part of the submission process?

No. The NRECs do not require a DPIA as part of the assessment. The National Office for Research Ethics Committees has developed a template 'Statement of Compliance' that is required when submitting applications for ethics assessment. 

Please review the National Office guidance on data protection requirements for the NREC ethics assessment process.

For general information regarding data protection legislation requirements in Ireland please the website of the Data protection Commission.

13. Are NREC-approved studies recognised for insurance purposes under the Clinical Indemnity Scheme (CIS)?

The State Claims Agency has confirmed that studies that fall under the Clinical Indemnity Scheme (CIS) and have NREC approval are recognised for insurance purposes under the Clinical Indemnity Scheme (CIS). It is the responsibility of the applicant to notify the State Claims Agency with regard to their study. 

14. What if a research institution or local REC has a query on an NREC-approved study?

The National Office for Research Ethics Committees seeks to work in partnership with research institutions and local research ethics committees (RECs) and is pleased to answer any queries on the NREC-MD/NREC-CT review process. Queries should be directed to nationaloffice@nrec.ie.