STUDIES OTHER THAN CTIMPS and IMDS
(Clinical Trials of Medicinal Products /
Clinical Investigations of Medical Devices /
Post-Marketing Follow Up Studies of Medical Devices
taking place in Beaumont Hospital only |
- Please confirm with the Health Products Regulatory Authority (HPRA) if you are uncertain if your study is a clinical trial of a medicine.
- Please confirm with the National Research Ethics Committee for Medical Devices (NREC-MD) if you are uncertain if your study is a clinical investigation of a medical device, or a post-marketing follow up study of a medical device.
- Clinical Trials of Medicines cannot be accepted for review.
- Studies which fall under the remit of the NREC-MD cannot be accepted for review.
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Beaumont Hospital Local Checklist (updated 2 Feb 2024)
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| The checklist outlines this committee's requirements, the documents for submission, and the method of submission |
| Beaumont Hospital Local Signatory Page (updated December 2022) | |
| 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 26 June 2023)
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Substantial Change to Application Form, 26.6.23
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| 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) | 
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Frequently Made Mistakes (updated June 2023)
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Sample Answers J1 and J2 - Beaumont only
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| Template Data Protection Impact Assessment (Beaumont) | Link |
| Template Information Leaflets and Consent Forms (Beaumont) | Link |
| Clinical Trial Indemnity Form, 18.8.21 | Link |
| Radiation Declaration Form | |
| SUPPLEMENTARY Questions when applying for a single national opinion for a study which involves exposure to medical ionising radiation (2 Feb 2024) | |
| Genomic Research with a Commercial Company Declaration Form | |
| Invoice Details Form | |
| Fee Structure | Link |
| Third Parties and Contracts | Link |
| How to submit to Beaumont Ethics | Link |
| Health Research Regulations 2018 | Link to HRB Website |
| Health Research Consent Declaration Committee | Link to CDC Website |
| Health Research Regulations, Capacity and the HRCDC | Link |
| HSE Consent Policy for Research (2023) | Link to HSE Website |
| European Commission Ethics and Data Protection (November 2018) | Link to EC website |
Recurring Review Themes
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The RCSI Sample Size Handbook - a rough guide (May 2021 version) Prof. R. Conroy
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