The NREC COVID-19 has come to the end of its tenure and will not be reviewing any further new applications. A standing sub-committee of the NREC COVID-19 is now in place, on approval from the Department of Health, to review applications for amendments to studies receiving ethics approval from the NREC COVID-19.
Amendment submission deadlines
|23 Sept 2020|
|28 Oct 2020|
|2 Dec 2020|
|13 Jan 2021|
Amendment forms can be found here - https://www.hrb.ie/covid-19-ethical-review/apply/
As part of Ireland’s response to the COVID-19 pandemic, and in accordance with a recommendation in the WHO Roadmap for R&D, the Minister for Health is establishing a temporary National Research Ethics Committee (NREC) for COVID-19 to deliver an expedited process for review for all COVID-19-related research studies.
This response by the Department is an important measure to accelerate urgent studies clearly positioned to provide significant evidence for national and global efforts to deal with the virus outbreak. The Minister acknowledges the need for expedited and coordinated decisions for those seeking to get COVID-19 research studies off the ground in Ireland in the days and weeks ahead, and this need will be even more pressing as investigators secure additional funding for COVID-19 studies through rapid response funding calls. This dedicated NREC is being established to accelerate the initiation and delivery of COVID-19 research while maintaining international best practice and standards. Staff in the newly established Office for National Research Ethics Committees (housed in the Health Research Board) will provide support for the new NREC and will be the point of contact for the research community.
The NREC COVID-19 will review all COVID-19-related studies that fall under the definition of health research as set out in the Health Research Regulations 2018 – which means that it will consider across the full spectrum of human health research including basic research, translational research, clinical research, diagnostics and treatment, population health research, social research, health services research and applied health policy research. The Chair of NREC COVID-19, in close collaboration with the Office for NRECs, is cognisant of the need to review and refine the process to best meet the evolving needs of the research community, research-performing organisations, research funders and the broader strategic national research agenda; consequently, the NREC COVID-19 will prioritise review of the following study types:
- All COVID-19 clinical trials, including Clinical Trials of Investigational Medicinal Products (CTIMPs) and trials of medical devices, observational trials and all COVID-19 intervention studies;
- Cross-institutional COVID-19 studies;
- COVID-19 studies carried out at national level, for example in multiple settings including but not limited to large cohort studies;
- International COVID-19 studies, including CTIMPs and registries, in which Ireland is a participant;
- COVID-19 studies involving linkage of datasets;
- COVID-19 studies that will, directly or indirectly, result in the establishment of, or expansion of, a biobank;
- Other COVID-19-related health research where, following consideration between the applicant and their local REC (or in the absence of an obvious local REC), they feel review by the NREC COVID-19 would best support expedited review.
The opinion of the Chair of the Committee will be sought where there is any doubt that an application meets the criterion of COVID-19-related research and warrants expedited review on the grounds of public health.
The temporary NREC COVID-19 is designed to include structured and coordinated interaction with other bodies involved in regulation of health research including the Health Products Regulatory Authority (HPRA) and the Health Research Consent Declaration Committee (HRCDC). In this way, researchers and sponsors can expect to receive all the necessary decisions from appropriate parties within the same expedited timelines. The ambition of the NREC COVID-19 is to relay decisions back to researchers within 7 days of confirmation of a validated application.
Should a study include a clinical trial of an investigational medicinal product (CTIMP), or a clinical investigation of a medical device, an application should also be submitted to the HPRA (email@example.com or firstname.lastname@example.org) for assessment in line with existing requirements. The HPRA and NREC COVID-19 will work in close coordination to facilitate expedited and common timelines for decisions.
Prior to submitting an application to the NREC COVID-19, applicants should consider whether their study requires a consent declaration from the HRCDC for data processing for health research, where it is not feasible to obtain explicit consent and the research represents a substantial public interest. To facilitate a streamlined submission and review process, and avoid duplication, the NREC COVID-19 form includes additional sections specifically required when seeking a consent declaration from the HRCDC. The NREC Office will provide the application to the HRCDC Secretariat for HRCDC concurrent consideration. The HRCDC decision will be made on the basis of the case made by the applicant.
Queries directly related to the consent declaration process should be directed to the HRCDC Secretariat. The HRCDC Secretariat will directly liaise with the applicant to communicate i) if there are further queries as they relate to a consent declaration request, and ii) the HRCDC decision.
In the interests of time and resource efficiency, it is expected that ethical review of all human health research studies related to COVID-19 be directed to this temporary NREC in line with this streamlined process. Additionally, to maximise efficiencies and to direct work towards areas of most urgent need in any given week, the NREC COVID-19 will necessarily restrict its review to applications with funding already secured and this will form part of the validation step. This is particularly important for studies that are not commercially sponsored and require significant financial support from other bodies. Funding bodies, in considering funding requests, may require changes to the protocol and it may be necessary to make substantial amendments or to even withdraw or re-submit the application.
It is the intention that responsibility for REC review would transition back to the existing distributed REC committee system once the peak volume of applications has been processed and projects are underway. The Minister will initiate a review in 3 months from establishment of the NREC COVID-19 and decisions on next steps will be communicated fully to all research stakeholders in a timely manner.
Applicants to the NREC COVID-19 should enable expedited review of their applications by ensuring that they submit complete and accurate documentation, including confirmation of funding or conditional offer, and by promptly responding to queries should they arise.
All applications should be submitted to email@example.com
All queries relating to the NREC COVID-19 application process and ethical review should be directed to firstname.lastname@example.org
All queries relating to the HRCDC consent declaration process should be directed to the HRCDC Secretariat at email@example.com
Please visit 'Apply' to download the new single application for ethical review for all COVID-19-related health research.
The application is also inclusive of an expedited review for those seeking a Consent Declaration from the Health Research Consent Declaration Committee (HRCDC), if required.
Applications need to be submitted with a completed documentation checklist and the corresponding documents. Only applications that have secured funding, or conditional funding, should be submitted.