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/
A single application form should be submitted for ethical review of health research studiess considered to be COVID-19-related.
The application form is also inclusive of an expedited review for those seeking a Consent Declaration from the Health Research Consent Declaration Committee (HRCDC), if required.
To support the expedited review process, applications should only be submitted if funding, or conditional funding, has been secured.
Completed application forms must be submitted to firstname.lastname@example.org with the relevant documentation.
- Review the checklist to ensure all relevant documentation are included with the application.
- Checklist must be submitted alongside application and relevant documentation.
- Failure to submit the correct documents or submitting incomplete applications forms may delay the review process.
- All applications should be signed (digital signature accepted) and dated by the Principal Investigator.
- Funding or conditional funding should be secured before any application is submitted.
- HRCDC Guidance notes
- Guidance Manual for the ethical review of health related research studies which are not clinical trials of medicinal products for human use
The Office for National Research Ethics Committees will undertake a validation check of each application to ensure the NREC COVID-19 receives a complete application.
Only valid and complete applications that have secured funding, or conditional funding, are forwarded to the NREC COVID-19 in advance of a weekly meeting. 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.
If a consent declaration is also being sought, the Office for NRECs will liaise with the Secretariat of the HRCDC to forward applications to the HRCDC for consideration, where the review process will be carried out concurrently with that of the NREC COVID-19.
Need help? Get in touch
Please contact the Office for National Research Ethics Committees if you have any questions or queries about the process – email@example.com
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 review.
Should your study require a consent declaration, please get in contact with the Secretariat of the Health Research Consent Declaration Committee secretariat at firstname.lastname@example.org, and/or visit www.hrcdc.ie ,for pre-submission advice.