(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.
Beaumont Hospital Local Checklist (updated 8 June 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 January 2019)
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 IndemnityLink
Radiation Declaration Form
Genomic Research with a Commercial Company Declaration Form
Invoice Details Form
Fee StructureLink
Third Parties and ContractsLink
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
Sample Size - a rough guide (Prof. R. Conroy)