NREC Operations- FAQ

1. How are NRECs established?

It is the intention of the Minister for Health to appoint National Research Ethics Committees (NRECs) in the initial priority areas of clinical trials of medicinal products and clinical investigations of medical devices, in line with the imminent EU Regulations in these areas, EU CTR No. 536/2014 and EU MDR No. 207/745, respectively. A public call for Expressions of Interest for NREC membership was launched by the National Office in December 2020 to ensure the diverse membership base required to consider applications likely to be made to the NRECs, including varied expertise and experiential knowledge. Individuals with and without prior REC experience were welcome to apply. The EoI assessment process is in the advanced stages, with a view to making a selection for recommended consideration by the Minister for appointment. Recommendations are made on individuals’ merits and not necessarily in a representative capacity, mindful of the balance of expertise and perspectives required.

2. Who decides the membership of the NRECs?

The Minister for Health decides on the formal appointments to the NRECs. The National Office is managing an assessment process following a public call for Expressions of Interest for NREC membership with a view to making a selection for recommended consideration to the Minister for Health for appointment; this process is in the advanced stages. Recommendations will be 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, prospective Members may be approached to invite an Expression of Interest.

3. In what areas will future NRECs be established?

The Minister for Health will establish NRECs in select health research areas of national strategic importance. In this regard, the Head of the National Office for Research Ethics Committees will make recommendations. In the first instance, NREC remits will pertain to those areas for which Ireland has a legislative obligation, including CTIMPs and clinical investigations of medical devices. Future NRECs may be established in such areas as assisted human reproduction and genomics.

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

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

5. What is the expected turnaround time for an NREC decision?

The timelines for NREC decisions will be consistent with those required by pending EU Regulations for clinical trials (EU No 536/2014) and medical devices (EU No 2017/745). In the first instance, the National Office is planning for an NREC meeting schedule that facilitates CTIMPs to be considered twice per month and clinical investigations of medical devices to be considered monthly.

The National Office will collaborate with the HPRA in 2021 to run the CTR National Collaboration Project with select volunteer applicants to prepare for a ‘single national opinion’ by testing the processes and timelines required for the EU CTR; in this regard, the timing of an NREC decision will be coordinated with the regulatory decision of the HPRA. When the EU CTR is applicable (anticipated January 2022), the NREC-CT will work to the timelines set out in the EU CTR. From the initial launch of the NRECs in May 2021, applicants submitting to the NREC-CT may expect a decision on a valid application within 60 days.

For clinical investigations of medical devices, applicants wishing to avail of parallel regulatory & ethics review, should submit by the monthly NREC-MD cut-off date to ensure optimal review time. Applicants submitting to the NREC-MD may expect a decision on a valid application within 55 days.

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

Applicants should determine if their study meets the scope of NREC review. The scope of review of the NRECs will be determined by imminent EU Regulations in the areas of clinical trials of investigational medicinal products (EU No 536/2014) and clinical investigations of medical devices (EU No 2017/745) respectively. It is the applicant’s responsibility to determine the nature and definition of their study; however where an applicant is in any doubt as to whether their study falls under the EU CTR or EU MDR, both the HPRA and the National Office can assist.

If a study meets the definition of a CTIMP, it may be considered by the NREC-CT or a ‘recognised REC from May 2021.The majority of ‘recognised RECs’ will continue to review CTIMPs from May throughout the defined transition period until December 2021. When the NRECs are formally established, it is expected that the research community lean on the NREC system in the first instance before exploring the option of a ‘recognised REC’. The National Office team will be pleased to assist with identifying the most efficient route for ethics review, mindful of the meeting schedule and agenda of the NREC-CT.
If a study meets the definition of a medical device and its commencement date falls after 26th May 2021, it will need to be authorised under the MDR, and as such, must be considered by the NREC-MD. Applicants wishing to avail of parallel regulatory & ethics review should submit by the monthly cut-off date to ensure optimal review time.

7. What about studies involving ionising radiation?

Studies involving ionising radiation represent a regulated remit for health research and as such, will be encompassed in the national system of research ethics review. The National Office is working with the Department of Health and local REC stakeholders to find an appropriate mechanism for review of studies involving ionising radiation, recognising the niche expertise required. It is expected that a national route for ethics review of studies involving ionising radiation for medical purposes will be developed by Q4 2021. In the meantime, such applications should continue to be directed to existing ‘recognised RECs’ under this remit.

8. When will the EU Clinical Trial Regulation be applicable in Ireland?

The EU Clinical Trial Regulation (EU CTR) No 536/2014 was adopted and entered into force in 2014. The timing of its application depends on confirmation of the full functionality of the Clinical Trial Information System (CTIS), the centralised EU portal and database for clinical trials. The EU CTR becomes applicable six months after the European Commission publishes notice of this confirmation. The European Medicines Agency (EMA) and Member State representatives are developing a ‘go-live’ plan for the CTIS with a working assumption of a ‘go-live’ date of January 2022. The National Office and HPRA are represented on a number of the Member State working groups and are committed to staying abreast of developments with the EU CTR and CTIS.

9. Will there be fees associated with NREC reviews?

Yes; applications for NREC review should be submitted to the National Office accompanied by a prescribed fee. In the first instance from the time of NREC launch, the fees for ethics review will align with those currently in place for the local REC system.

It is anticipated that a new fee structure will be required for the NREC-CT with application of the EU CTR, anticipated in January 2022. 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 ethics and regulatory approval.

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

The National Office is committed to transparency and will make publicly available on our website the minutes of NREC meetings and details of decisions taken.

11. Will NREC review pre-clinical studies or pilot studies for medical devices?

The NREC-MD will review clinical investigations of medical devices as defined in the Medical Devices Regulation (MDR; EU No 2017/745). Pre-clinical studies do not come under the MDR and therefore should be reviewed by the relevant local RECs. Early-stage clinical investigations can be regulated studies per the MDR so they may fall within the NREC-MD remit. Applicants should discuss the appropriate route for ethics review of their study with the National Office in advance.

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

In line with current practice, from the time of NREC launch, applicants must notify the NREC-CT about urgent safety measures, suspected serious unexpected adverse reactions, and submit annual safety reports for notification, related to studies approved by the NREC-CT. For studies ongoing prior to May 2021, the safety reporting relationship is established to the NREC-CT from the time it considers a substantial amendment (see Q7). Assessment of safety reports and notifications will be undertaken by the HPRA.
The process for the assessment of safety reporting will necessarily change under the EU CTR. In this regard, the specific role of the NREC-CT in safety reports will be further be clarified.

13. Why is a DPIA required as part of the submission process?

Under the Health Research Regulations 2018, a data protection impact assessment (DPIA) is required when the assessment of the data protection implications of the health research indicates high risk to the rights and freedoms of individuals.
The NRECs will need to be assured that any research study is undertaken in accordance with national and European data protection legislation. For this reason, a DPIA will be required as part of an NREC application submission where relevant to the study. If a DPIA is not required for a study, a statement outlining why this is the case will be submitted as part of the application.
For the purposes of NREC review, the DPIA will need to be completed by the Data Controller of the research study and reviewed by the Data Protection Officer (DPO).
Where the Data Controller is based in a non-EU country with an adequacy decision from the European Commission, the National Office will accept DPIAs reviewed by a person with the equivalent role and responsibilities as a DPO.
Where the Data Controller is situated outside of Ireland, the National Office strongly advises that the DPO of the lead Irish-based institution should be given the opportunity to review and provide comment on the DPIA. All DPIAs should be accompanied by evidence of DPO input.
The National Office will not be issuing an NREC-specific DPIA template. Instead we will accept submissions using institutional DPIA templates.

14. What documents are required for submission of a Substantial Amendment?

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

In the case of previously approved trials by local RECs, historical documents from the trial should also be submitted within one month of submission of the Substantial Amendment. 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.

Further details on Substantial Amendments can be found here:

https://www.nrecoffice.ie/substantial-amendments/

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