(Clinical Trials of Medicinal Products /
Clinical Investigations of Medical Devices requiring HPRA authorisation)

taking place in Beaumont Hospital only
Please confirm with HPRA if you are uncertain if your study is a clinical trial of a medicine or a clinical investigation of a medical device requiring HPRA authorisation.

Since the 26th May 2021, only the national research ethics committee for medical devices can give an opinion in relation to a clinical investigation of a medical device, or a post-marketing follow up investigation of a medical device which involves invasive or burdensome procedures.

Medical Devices include standalone software including 'apps' and medical device accessories - if your study involves a medical device and the aim is to investigate or evaluate the device itself, as opposed to use the device as part of the study - to collect data etc. - please always obtain the advice of the HPRA - It is particularly important to obtain the advice of the HPRA if any medical device is being used without a CE mark, or outside the terms of its CE mark.

This committee does not accept clinical investigations of medical devices or post marketing investigations of medical devices for review.
Beaumont Hospital Local Checklist (updated 13 September 2021)
The checklist outlines this committee's requirements, the documents for submission, and the method of submission
Beaumont Hospital Local Signatory Page (updated January 2019)
The signatory page contains declarations to be signed by Investigators and Academic Supervisors
Research Ethics Committee Standard Application Form (RECSAF) 5.6 (adapted version, copyright Beaumont Hospital)(last updated 8 June 2021)
Substantial Change to Application Form, 8.6.21
Only forms downloaded from this website will be accepted for review.
Always refer to the accompanying Instructions, the Health Research Regulations, and the HSE Consent Policy when completing the application form on this site
Guidance Manual / Instructions 5.6 (adapted 31 August 2018, copyright RCSI & Beaumont Hospital)
Frequently Made Mistakes (updated September 2021)
Sample Answers J1 and J2 - Beaumont only
Template Data Protection Impact Assessment (Beaumont)Link
Template Information Leaflets and Consent Forms (Beaumont)Link
Standard Form of Indemnity, 18.8.21Link
Radiation Declaration Form
Genomic Research with a Commercial Company Declaration Form
Invoice Details Form
Fee StructureLink
Third Parties and ContractsLink
Step by Step Guides for ResearchersLink
Health Research Regulations 2018Link to HRB Website
Health Research Consent Declaration CommitteeLink to CDC Website
Health Research Regulations, Capacity and the HRCDCLink
HSE National Consent Policy (2019)(Please note any references to Data Protection in his document pre-date GDPR 25th May 2018, and the Health Research Regulations 8th August 2018, and hence are no longer accurate.)Link to HSE Website
European Commission Ethics and Data Protection (November 2018)Link to EC website
Recurring Review Themes
The RCSI Sample Size Handbook - a rough guide (May 2021 version) Prof. R. Conroy