Applying for REC Approval in the Republic of Ireland

1. Applying for REC Approval in the Republic of Ireland Gillian Vale, Administrator, Ethics (Medical Research) Committee Beaumont Hospital

2. Content Current Legislative Landscape – Medicines Current Landscape – Devices Committees: Application Forms, Checklists & Timelines [Contracts at Sites] Committee Comments – Beaumont Hospital Applicant Feedback – Beaumont Hospital Future Landscape

3. Current Legislative Landscape (Medicines) • S.I. 190/2004 • Clinical trials of medicinal products • 13 RECS = 1 opinion • DOHC application form • DOHC site specific assessment form • DOHC guidelines for RECS • Irish Medicines Board = 1 authorisation

4. Outside of S.I. 190 / 2004 • Devices / Non-interventional trials of medicinal products / Cosmetics / Foodstuffs / Radiation therapy trials / Surgical Trials / Translational studies / Biobanks / Registries etc.

5. Current Landscape (Devices) • Where are they? Hospitals + Universities +++ • How many? 32 • Remit? Local

6. Committees & Application Forms 32 listed on: molecularmedicineireland.ie/research_ethics 29 / 32 -accepting applications on the ‘Research Ethics Committee Standard Application Form’ -each has a Local Checklist / Signatory Page – outlining their local requirements

7. Applying to Beaumont Hospital Contact committee administrator Book an agenda slot at next available committee meeting Refer to website: beaumontethics.ie - for this committee’s local checklist & signatory page. Begin to complete / compile docs on the checklist

8. Committees and Checklists Application Form Protocol / Clinical Investigational Plan Information Leaflet (s) / Consent Form(s) Recruitment Material / Questionnaire / Interview Prompts Letter to Family Doctor CV of Principal Investigator

9. Committee Checklist Continued Proof of Insurance for each investigator / site not covered by CIS Standard HSE Form of Indemnity (for Beaumont Hospital)(for RCSI) Draft Agreement / Contract with Site Cert of Insurance for Sponsor Company Fee Other e.g. Device Manual / Proof of CE Mark

10. Committees & Timelines Prepare Submission for Ethics Committee All enclosures, copies, signatures Submit Review takes place Receive committee comments Respond to committee comments Receive committee final decision

11. Contracts at Site Remember to link in with the site: - • To negotiate payments to hospital; • To address insurance issues; • To arrange sign off on contracts

12. Committee Comments 40% of this committee’s comments relate to patient documentation Section D – Research Procedures (13%) Section B – Design / Methodology (12%) Section E – Data Protection (9%) Section C – Consent / Recruitment (8%) Section A – General Study Details (7%)

13. Applicant Feedback 85% of respondents in a 2012 service evaluation survey found the committee comments fair / helpful / and proportionate to the level of risk the study posed. “Any sponsor using the committee has spoken highly of the service provided, the excellent website and that the study appears to be well reviewed”

14. Applicant Feedback “Professional, efficient process and service.” “I found whole process to be very user friendly, with info available online etc.”

15. Future Landscape – Preparation The Health Information & Quality Authority have Appointed a Research Ethics Committee Manager (July 2011) Set up a Research Ethics Committee Advisory Group (Sept 2011) Published an International Review of Research Ethics Committee Structures (April 2012)

16. Future Landscape Planning HIQA plan to: develop standards for the operation of RECS in Ireland monitor compliance with those standards on an ongoing basis Recognise /approve RECS which meet the criteria