1. What types of research do NRECs review?

NRECs 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 and hospitals. The scope of review of the NRECs is determined by EU Regulations in the areas of Clinical Trials of Investigational Medicinal Products (CTIMP) (EU No. 536/2014), Clinical Investigations of Medical Devices (EU No. 2017/745), and 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, where an applicant is in any doubt as to whether their study falls under the EU Clinical Trials Regulation, EU Medical Devices Regulation or 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), from May 2021, applicants can submit an application for ethics review to the NREC-CT.

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 are NRECs established?

The Minister for Health appoints members to National Research Ethics Committees (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 wlecomed.  The NRECs for Clinical Trials (NREC-CT) and Medical Devices (NREC-MD) were formally appointed in May 2021.

4. Who decides the membership of the NRECs?

The Minister for Health makes formal appointments to the NRECs. The National Office 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’ merits 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 best practice. Where in the view of the National Office there is likely to be a particular gap in expertise or representation, we may approach prospective Members to invite an Expression of Interest.

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 ethics standards. The mixed-model system will be supported by parallel reforms in research governance led by the Research & Development Team at the HSE.

6. What about studies involving ionising radiation?

Studies involving ionising radiation are reviewed by RECs 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 is committed to transparency. We make the minutes of NREC meetings and details of decisions taken 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 review.

9. Could you clarify what happens with non-trial clinical multicentre studies – local RECs or NREC?

Multi-centre studies that do not fall under the EU Regulations, and therefore 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 multisite clinical studies in the future.

10. What is the REC pathway for external organisations such as charities, 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 in clinical trials of investigational medicinal products, clinical investigation of medical devices and performance studies of in vitro diagnostic medical devices. 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/.

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, a 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 required as part of the submission process?

No. The NRECs do not require a DPIA as part of the assessment. The National Office has developed a template 'Statement of Compliance' that is requireed when submitting applications for ethics assessment. For all submisssion requirements, please visist the 'Apply' section of our website. 

Please review the National Office guidance on data protection requirements for the NREC ethics assessment process: Guidance on the submission of a ‘Statement of Compliance’ for data protection compliance. 

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 for studies that fall under the Clinical Indemnity Scheme (CIS), and NREC approval is recognised for insurance purposes under the Clinical Indemnity Scheme (CIS). It is the responsibility of the applicant to notify the State Claims Agency of their study. This is an important requirement of research governance and for good research practice.

14. Are there fees associated with NREC reviews?

Yes, applicants must pay the relevant fee in advance of submission to the National Office for Research Ethics Committees.

For NREC-CT, in the first instance, the fees for ethics review are aligned with those currently in place for the local REC system. It is anticipated that in January 2022 a new fee structure will be required for the NREC-CT with application of the EU Clinical Trials Regulation (CTR). These fees will be determined in consultation with the relevant Government departments including the Department of Health and Department of Business, Enterprise & Innovation. Fees due under the EU CTR will represent a combined fee for both NREC and HPRA approval.

For NREC-MD, the fees in relation to the MDR applications are set by Statutory Instrument 671/2023, which gives national effect to the EU Medical Devices Regulation (MDR).  The same fees apply for the performance studies of in vitro diagnostic medical devices applications. You can find out more about our fees here.

15. What if an ongoing study originally approved by a local REC requires a substantial amendment?

The responsibility for review of substantial amendments to ongoing studies, previously approved by local RECs (including ‘recognised RECs’), which now fall within the remit of the NREC-CT or NREC-MD, lies with the respective NREC. In this case, the applicant will be requested to provide all original documentation that supported the original local REC approval, to the National Office. The National Office and the local REC may share information in relation to the study in question to support informed ethics review and oversight of the study. Such amended studies will report to the NREC thereafter including annual, final, and safety reporting.

For NREC-CT, the transition to the NREC system is triggered by a substantial amendment. Once a study transitions to the NREC system through the submission of a substantial amendment, the National Office will take on the role of monitoring and reporting for that study.

For NREC-MD, the transition of all ongoing clinical investigations of medical devices to the NREC system is triggered by submission of a substantial amendment, or notification of non-substantial amendment, safety report, device deficiency report or annual report.

16. What documents are required for submission of a Substantial Modification?

Submission of a Substantial Modification should be accompanied by the NREC Substantial Modification form, any relevant documentation as designated by the form, and evidence of fee payment.

In the case of studies previously approved by local RECs, historical documents from the study should also be submitted within one month of submission of the Substantial Modification. This documentation should include the original REC submission, cover letters and approval letters for any substantial amendments, and the most recent version of the documents.

17. What role will the NRECs take on in relation to safety reporting?

As of the 1st of July 2024, the NREC-MD no longer requires the submission of Annual Progress Reports or Safety Reports for clinical investigations and performance studies. Applicants should ensure that all relevant regulatory reporting requirements to the Health Products Regulatory Authority (HPRA) have been met.

In line with the Clinical Trials Directive, applicants must notify the relevant NREC about urgent safety measures, suspected serious unexpected adverse reactions, and submit applicable annual safety reports for notification, related to studies approved by the NREC.

For clinical trials of investigational medicinal products ongoing prior to May 2021, the safety reporting relationship is established to the NREC-CT from the time it considers a substantial amendment. All correspondence around safety reporting should include the assigned NREC code (21-NREC-CT-xxx) to ensure orderly tracking of clinical trials. Safety reports for studies that have not yet transitioned should continue to report to the local RECs.

All safety reports will be acknowledged in writing (i.e., via an email response) by the National Office. The National Office is not in a position to return a signed copy of the Safety Cover Form. The National Office does not accept password protected safety notifications and will not issue acknowledgement of receipt in instances where encrypted or password protected documents have been sent.

The process for the assessment of safety reporting has changed under the EU CTR and all safety notifications will be submitted through the CTIS and/or EudraVigilance platform. Please review the following document for further information - https://www.nrecoffice.ie/wp-content/uploads/Appendix-1-NREC-CT-Operational-Framework-CTR-DRAFT-V1.0.pdf

Assessment of safety reports and notifications will be undertaken by the HPRA.

18. What about annual reporting for ongoing studies previously approved by a local REC?

As of the 1st of July 2024, the NREC-MD no longer requires the submission of Annual Progress Reports or Safety Reports for clinical investigations and performance studies. Applicants should ensure that all relevant regulatory reporting requirements to the Health Products Regulatory Authority (HPRA) have been met.

For clinical trials that have not yet transitioned to the NREC system, they should continue to report to the local REC where they received their initial ethics approval.

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

The National Office seeks to work in partnership with research institutions and local RECs and is pleased to answer any queries on the NREC process including sharing summary information on applications receiving approval. Queries should be directed to nationaloffice@nrec.ie.