Frequently Asked Questions

1. Can recognised local RECs continue to review Clinical Trials of Investigational Medicinal Products (CTIMPs) in addition to the NREC-CT?

Yes; to enable a smooth transition, the majority of ‘recognised RECs’ have agreed to continue to provide research ethics review for CTIMPs during a defined period. Accordingly, both the NREC-CT and ‘recognised RECs’ will have authority to review CTIMPs, and therefore will collectively support this important research area, from May to 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’ for the duration of the transition.

The concurrent operation of NREC-CT and ‘recognised RECs’ over the transition period will maintain momentum in clinical trial research while maximising opportunity for preparedness at a national level for the EU Clinical Trials Regulation (CTR) (EU No 536/2014). In line with the anticipated application of the EU CTR in January 2022, it is essential that Ireland has a fully operational national system for CTIMP regulation and review, including returning nationally applicable ethics opinions, following processes in line with international best practice. Importantly, the NREC review process will run in coordination where necessary with the HPRA to ensure Ireland meets its Member State obligations to return a ‘single national opinion’ in relation to the EU CTR, in addition to the EU Medical Device Regulation (EU No 2017/745). This will be best achieved by a cohesive system of independent NRECs supported operationally by the National Office; correspondingly, existing ‘recognised RECs’ will not have authority to review CTIMPs after the transition period. This will not affect the local REC jurisdiction in relation to health research that falls beyond the scope of the defined remit of the NRECs.

We recognise that this transition represents a major change to the research environment and our goal is to make it as seamless as possible; this will require coordination, communication and a degree of patience from the parties involved, in particular the National Office, local RECs and the research community.

2. 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 REC’), 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.

The transition to the NREC system triggered by a substantial amendment will begin in May once the NRECs are fully established. 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 more information on substantial amendments please visit our Guide for substantial amendments.

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

In the spirit of pragmatism, CTIMP studies previously approved by local RECs (including those ‘recognised’) and ongoing in May 2021, should continue to report operationally (e.g. annual reporting, safety reporting) to the approving REC. The requirement for a substantial amendment to an ongoing study that now falls within the remit of the NREC-CT will be the trigger for review by the NREC. Such amended studies will report to the NREC thereafter including annual and safety reporting (see Q7).

4. Can applications be made to local RECs for clinical investigations of medical devices in addition to the NREC-MD?

No; a pivotal component of the NREC system will be the return of a single nationally applicable ethics opinion following robust processes in line with international best practice. There is no mechanism currently for a multisite medical device study (‘clinical investigation’) to secure ethics approval that is nationally applicable. Importantly, the NREC review process will run in coordination where necessary with the HPRA to ensure Ireland meets its Member State obligations to return a ‘single national opinion’ in relation to pending EU Regulations, including for CTIMPs (EU No 536/2014) and clinical investigations of medical devices (EU No 2017/745). This will be best achieved by a cohesive system of independent NRECs supported operationally by the National Office.
The NREC-MD will be established in May 2021 and will provide ethics review for clinical investigations of medical devices in line with the MDR. This will not affect the local REC jurisdiction in relation to health research that falls beyond the scope of the defined remit of the NREC-MD. To minimise disruption to the research community, local RECs will continue to facilitate ethics review for as long as practically possible up to the transition.
The MDR will be applicable in Ireland from 26th May 2021. Clinical investigations that are due to be commenced after the 26th May 2021 will need to be authorised under the MDR, and therefore will need to be issued with a single nationally applicable ethics opinion. Any application ‘in hand’ by local RECs for which the date of commencement of the clinical investigation is indicated after 26th May 2021 should be forwarded to the National Office (copying the applicant) for NREC-MD review.
We recognise that this transition represents a major change to the research environment and our goal is to make it as seamless as possible; this will require coordination, communication and a degree of patience from the parties involved, in particular the National Office, local RECs and the research community.

5. 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.

6. Do researchers need to seek approval from their local REC in addition to the NREC?

No; NRECs will be legislatively mandated to return decisions that are applicable nationally, and as such, the research community including local RECs, will be 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, researchers 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.

7. What if a research institution or local REC has a query on an 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

8. What’s the mixed-model REC system?

Health research infrastructure will be strengthened in Ireland by a mixed-model system of research ethics review as provided for by the NREC Bill. 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 R&D Team at the HSE.

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

Non-trial clinical multicentre studies do not come under the imminent EU Regulations, 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 about external organisations such as charities, services that do not come under HSE or Hospital RECs - where do they go the get ethical review?

Both the NREC-CT and NREC-MD will have defined health research remits in line with the respective relevant EU Regulations in clinical trials and 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.

11. Will the currently used local forms be used for NREC review?

For practicality and to assist with a seamless transition of ethics review, in the immediate term the National Office will accept applications for NREC-CT review on application documentation currently used in the local REC system. The NREC-CT will also require a Data Protection Impact Assessment (DPIA) or statement why this is not required, and site-specific assessment form(s). Additional supporting information or documentation may be requested of applicants to inform the NREC review process. The format for application documentation will likely be revised in in January 2022 to meet EU CTR requirements; the research community will be informed of this in a timely manner.
The National Office will initially accept applications for NREC-MD review on the Standard Application Form for Non-clinical Trials, currently used for medical device studies in the local REC system. A DPIA, or statement why a DPIA is not required, and a site-specific assessment form (or site suitability form) will also be required.

 

If you have any other questions about the application process, don’t hesitate to contact us at nationaloffice@nrec.ie.

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