News Category: Regulatory news
The HPRA, in conjunction with the Department of Health, the National Office for Research Ethics Committees and the Health Research Declaration Committee (HRCDC), have agreed an expedited review process for human health research related to COVID-19 (SARS-CoV-2, coronavirus).
A key development is the establishment of a dedicated COVID-19 national research ethics committee (NREC-COV19) by the Minister for Health. In the interests of time and resource efficiency, applications for ethical review of all human health research studies related to COVID-19 should be submitted to the NREC-COV19.
Applications for clinical trials of human medicines, or clinical investigations of medical devices, will be given a priority and expedited review by the HPRA. The NREC-COV19 will review applications concurrently with regulatory review processes and will endeavour to facilitate an expedited ethical review.
Applications for clinical trials or clinical investigations should be marked ‘COVID-19’, and this should be included in the research title.
Applications can be sent in parallel to HPRA and the COV19-REC to obtain an expedited national decision. Please copy the HPRA clinical trials (email@example.com) or medical devices (firstname.lastname@example.org) mailbox when making an application.
Please also contact us as early as possible in advance of the submission, to ensure that we can prioritise the application.
Clinical trials should be submitted through the usual CESP route, and copied to email@example.com.
For further information, see the HPRA Guide to Clinical Trial Applications or contact firstname.lastname@example.org.
Information on clinical investigations of medical devices is available here.
For further information on the HPRA response to COVID-19, see our dedicated webpage.
All applications for ethical review should be submitted to email@example.com. This will be the central contact point for both the NREC-COV19 and HRCDC.