Frequently asked questions
1. When should I submit my application to NREC COVID-19?
The NREC COVID-19 meets every Wednesday afternoon as needed to consider valid applications for ethical approval of COVID-19-related health research. An application can be submitted anytime but no later than the preceding Wednesday midday for consideration at the following week’s committee meeting. This is to allow the necessary time for a comprehensive validation check of received applications and ensure a coordinated process with the other bodies involved in the regulation of health research including the Health Products Regulatory Authority (HPRA) and the Health Research Consent Declaration Committee (HRCDC), where applicable.
2. Is my application in scope for consideration by the NREC COVID-19?
The National Research Ethics Committee for COVID-19-related health research (NREC COVID-19) is being established to accelerate the initiation and delivery of COVID-19 research. The NREC COVID-19 will review COVID-19-related studies that fall under the definition of health research as set out in the Health Research Regulations 2018. 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.
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 research ethics committee (REC) (or in the absence of an obvious local REC), they feel review by the NREC COVID-19 would best support expedited review.
Depending on volume of applications received, the Chair of NREC COVID-19 in consultation with the Head of the Office for National Research Ethics Committees (NRECs) may necessarily need to prioritise applications for review in any given period to manage workflow and to seek to optimise review of the most time-critical research studies at that time. Applicants will be kept informed by the Office for NRECs of validation and review dates for their applications.
3. How long will it take to receive a decision from NREC COVID-19?
Applicants to the NREC COVID-19 can enable expedited review of their applications by submitting complete and accurate documentation, including confirmation of funding or conditional offer, and by promptly responding to queries as they arise. If a study meets the criteria for review and a complete application is submitted, an applicant will be informed that the application was validated and may receive a decision within 7 days of confirmation of a valid application. Depending on volume of applications received, the Chair of NREC COVID-19 in consultation with the Head of the Office for NRECs may necessarily need to prioritise applications for review in any given period to manage workflow and to seek to optimise review of the most time-critical research studies at that time. Applicants will be kept informed by the Office for NRECs of validation and review dates for their applications.
4. My study includes a Clinical Trial of an Investigational Medicinal Product – should I contact the HPRA also?
Yes. 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 (firstname.lastname@example.org or email@example.com) for assessment in line with existing requirements. The HPRA and NREC COVID-19 will work in close coordination to facilitate expedited timelines for decisions.
5. My study requires a consent declaration in addition to ethics approval - should I submit an application separately to the Health Research Consent Declaration Committee (HRCDC)?
No, this is not necessary as one of the advantages of submitting your application to the NREC COVID-19 is that coordination with all other appropriate bodies is already purposefully built into the process. The application form for NREC COVID-19 ethics approval also incorporates the specific questions seeking the necessary information for those studies seeking a consent declaration from the HRCDC. In line with a streamlined process, the Office for NRECs with liaise closely with the HRCDC Secretariat to coordinate concurrent reviews for ethics and consent declaration purposes. The HRCDC Secretariat will contact applicants directly should queries arise with the application for a consent declaration. Applicants can expect decisions from both the NREC COVID-19 and HRCDC within the same expedited timeframe. Application forms should be submitted to firstname.lastname@example.org. Specific queries about HRCDC requirements should be directed to email@example.com
6. I haven’t secured funding for my study yet – in the meantime, should I submit an application for ethical review by NREC COVID-19?
With the objective of maximising efficiencies and to direct committee 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 (or conditionally) secured, and which represent the “final” protocol after peer review comments and revisions have been taken into account. Funding confirmation will form part of the validation step. However, applicants should start completing the NREC COVID-19 application form in anticipation of their funding outcome to minimise delays in initiating their research study. Once an application is validated, an applicant can expect to receive a decision within 7 days.
7. I haven’t secured funding for my study yet– should I submit an application for ethical approval to my local research ethics committee (REC)?
The temporary dedicated NREC-COVID-19 was established by the Minister for Health with the key objective of supporting researchers to avail of a robust ethical review in an expedited timeframe. It also builds coordination with the HPRA and HRCDC into the process. Similar expedited and coordinated processes have been put in place internationally in line with the WHO R&D Roadmap for Pandemics. Therefore, applicants are strongly encouraged to avail of this dedicated mechanism to advance their COVID-19 projects in an expedited manner as many of the studies are time-critical.
The NREC COVID-19 will necessarily restrict its review to applications with funding already (or conditionally) secured, and which represent the “final” protocol after peer review comments and revisions have been taken into account in order to maximise efficiencies and to direct committee work towards areas of most urgent need in any given week. Applicants can, however, start completing the NREC COVID-19 application form in anticipation of their funding outcome to minimise delays in initiating their research study. Once an application is validated, an applicant can expect to receive a decision within 7 days.
If you have already submitted your application to a local REC, you are not obliged to withdraw it. This is down to the discretion of the applicant and the local REC in question. The answer is likely to differ on a case by case basis depending on when the local REC can review your proposal and/or whether you need a HRCDC or HPRA review. You may choose to let it proceed with the local REC if it can accommodate an expedited review or you may decide to send to the NREC-COVID-19 to ensure an expedited review and co-ordination with other bodies. The important thing is that you don’t send it to both.
8. My study has existing ethical approval but requires ethical approval of an amendment that is COVID-19-related – should I submit to NREC COVID-19?
Yes. NREC COVID-19 will and can review amendments to studies with existing ethical approval given the study meets the definition of health research as set out in the Health Research Regulations 2018, is COVID-19 related, and would benefit from expedited review.
9. I have already submitted an application for a COVID-19-related project to my local REC and I have already received approval. Do I need to re-submit this to the NREC-COVID-19?
No, if you have received prior approval form the necessary bodies (REC, HPRA or HRCDC) for a COVID-19 study then you do not need re-submission or re-review.
10. I have submitted an application for ethical approval to my local REC but I do not have a decision yet – should I withdraw it and send it to the NREC-COVID-19?
This is down to the discretion of the applicant and the local REC in question. The answer is likely to differ on a case by case basis depending on when the local REC can review your proposal and/or whether you need a HRCDC or HPRA review. You may choose to let it proceed with the local REC if it can accommodate an expedited review or you may decide to send to the NREC-COVID-19 to ensure an expedited review and co-ordination with other bodies. The important thing is that you don’t send it to both.
11. My COVID-19-related study is an Irish multisite study - will one application to NREC COVID-19 suffice?
Yes. The NREC COVID-19 is a committee with a national mandate and as such can return a ‘single national opinion’ on the ethics of COVID-19-related health research . It is expected that decisions arising from the NREC COVID-19 are respected country-wide. This is one of the advantages of the process for health research studies spanning multiple sites. This means that the information required for the committee to make a decision on a multisite study can be provided in one application, submitted by a lead applicant / Principal Investigator from one of the sites. The application form requests confirmation of authorisation from each site to conduct the study, which applicants should complete carefully.
12. How will I be informed of the outcome of my application?
Decision letters from the NREC COVID-19 will be issued to applicants by email from the Office for NRECs as soon as possible after the committee meeting. Detailed minutes of the committee’s discussion and decisions arising will be made publicly available online.
13. My study comes under the Clinical Indemnity Scheme. Do I still need to provide evidence of insurance?
If your study or members of your research team are covered by the Clinical Indemnity Scheme, you do not need to provide evidence of insurance. However, the Principal Investigator will be required to notify the State Claims Agency of the study.
The information you should provide to the State Claims Agency is:
- Title of study
- Brief description of study
- Name of lead institution and Principal Investigator
- If the study is multisite, name of additional sites and research team members at those sites
- If the study involves a Sponsor, detail of additional insurance cover from the Sponsor
- Confirmation of ethics approval from the NREC COVID19
Once your study has been approved by the NREC COVID-19, this information should be sent to Aon Insurance who will process the information on behalf of the State Claims Agency – firstname.lastname@example.org .
14. Should I inform my local REC and host research body of the NREC COVID-19 decision on my research study?
Yes, in line with good research practice and research governance, applicants should notify their local REC and Research Office or equivalent body in their organisation of decisions from the NREC COVID-19. As a component of the application process for the NREC COVID-19, applicants are requested to confirm that the necessary local approvals are in place to conduct the research at the sites proposed. The NREC COVID-19 seeks to work in partnership with local RECs and research performing organisations; consistent with its commitment to transparency, the National Office on behalf of the NREC COVID-19 will share summary information on applications receiving approval, including contact details of named investigators.