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Clark Crawford: Ethics and Governance - The Life Cycle of a Clinical Project.
- 1. Ethics and Governance Or The Life Cycle of a Clinical Project Clark Crawford
- 2. Clarifications Funds Grant Funded Project Clinical Study Activity that delivers Grant Funded Grant Funded Grant Funded Project Grant Funded Project Project Project Many to one One to many Many Clinical Study Clinical Study Clinical Study Clinical Study Clinical Study Clinical Study
- 3. Clinical Trial vs. Clinical Study • Trial: – – – – Surgery Investigatory Drugs Radiotherapy Investigatory Medical Devices – MHRA Inspect-able studies – “High Risk” • Study: – Tissue/biological sample/data collection – Questionnaires – Qualitative – Physiological measurements – Medium-Low risk? – Consider: • Pregnant Women • < 5 Years of Age
- 4. Actual Difference • In legislation only? • Additional bureaucracy? • All should be conducted to high standard. – Safeguard the science, patients and data. – Institutional/Personal Reputation. – Best practice: Good Clinical Practice (GCP). • Requirement of Funding Bodies.
- 5. • Pre-award • • Discussions NHS R&D(s) ? IRAS forms + Associated documents Sponsor Letter Insurance Documents NHS Ethics •REC Form • ? NHS NHS R&D NHS •SSI R&D R&D(s) Form •R&D •SSI Sponsorship •Pink form Insurance •Insurance Questionnaire •SSI(s) •R&D Form •One R&D Form Initiation – After all Local NHS R&D management approvals – Notification of amendments – Yearly report • ? Clinical Trial Unit IRAS System Post Award (3 Months) – – – – Sponsor + Insurance NHS Ethics NHS R&D(s) Sponsor NHS Ethics NHS R&D(s) Sponsor Close – Close of study report
- 6. • Pre-award • • Discussions NHS R&D(s) ? IRAS forms + Associated documents Sponsor Letter Insurance Documents NHS Ethics •REC Form • ? NHS NHS R&D NHS •SSI R&D R&D(s) Form •R&D •SSI Sponsorship •Pink form Insurance •Insurance Questionnaire •SSI(s) •R&D Form •One R&D Form Initiation – After all Local NHS R&D management approvals – Notification of amendments – Yearly report • ? Clinical Trial Unit IRAS System Post Award (3 Months) – – – – Sponsor + Insurance NHS Ethics NHS R&D(s) Sponsor NHS Ethics NHS R&D(s) Sponsor Close – Close of study report
- 8. Exceptions Research Tissue Bank Sponsor Laboratory study only involving samples from an NHS REC approved Tissue Bank Research Database Sponsor Study only involving Data from an NHS REC approved Data Bank University REC (UREC) Sponsor NHS R&D(s) UREC Sponsor Study involving healthy participants without storing tissue for research Study involving NHS Staff without storing tissue for research
- 9. • Pre-award • • Discussions NHS R&D(s) ? IRAS forms + Associated documents Sponsor Letter Insurance Documents NHS Ethics •REC Form • ? NHS NHS R&D NHS •SSI R&D R&D(s) Form •R&D •SSI Sponsorship •Pink form Insurance •Insurance Questionnaire •SSI(s) •R&D Form •One R&D Form Initiation – After all Local NHS R&D management approvals – Notification of amendments – Yearly report • Clinical Trial Unit IRAS System Post Award (3 Months) – – – – Sponsor + Insurance NHS Ethics NHS R&D(s) Sponsor NHS Ethics NHS R&D(s) Sponsor Close – Close of study report
- 10. Favourable Ethical Opinion • NHS Ethics Committee – IRAS NHS REC form NHS Ethics •REC Form • National Guidance: – http://www.nres.npsa.nhs.uk/ • University Ethics Committee – http://www.rcs.bham.ac.uk/ethics/index.shtml • For studies involving: Healthy volunteers, relatives of patients only. • Not suitable for participants involved by virtue of their disease
- 11. R&D Management Approval • Applications to each relevant NHS organisation. • Submit: NHS R&D(s) •SSI(s) •One R&D Form – the study-wide R&D form generated from the integrated dataset in IRAS; – the Site-Specific Information (SSI) Form providing specific information about the conduct of the research at the research site; – supporting documentation as specified in the R&D submission checklist in IRAS.
- 12. Multicentre studies • Projects involving more than one NHS Trust • NHS R&D management approval co-ordinated by Coordinated System for gaining NHS Permission (NIHR CSP). • Generic review approval – Conducted on behalf of all Trusts • Local review approval – Can the local health trust host the study? • Submit all documents to CSP NHS NHS R&D(s) NHS R&D(s) •SSI(s) R&D(s) •SSI(s) •One R&D Form •SSI(s) •One R&D Form •One R&D Form – CSP distributes to relevant NHS Health Trusts • For more information. – http://www.crncc.nihr.ac.uk/about_us/processes/csp
- 13. Free to start study? • Final document to allow study start: – Local NHS Management Approval Letter – “Green Light Approval”
- 14. • Pre-award • • Discussions NHS R&D(s) Sponsor + Insurance •Costs (if necessary) IRAS System Post Award (3 Months) – – – – IRAS forms + Associated documents Sponsor Letter Insurance Documents NHS Ethics •REC Form • NHS NHS R&D NHS •SSI R&D R&D(s) Form •R&D •SSI Sponsorship •Pink form Insurance •Insurance Questionnaire •SSI(s) •R&D Form •One R&D Form Initiation – After all Local NHS R&D management approvals – Notification of amendments – Yearly report • Clinical Trial Unit NHS Ethics NHS R&D(s) Sponsor NHS Ethics NHS R&D(s) Sponsor Close – Close of study report
- 15. NHS Ethics / University Ethics Study Amendments • Substantial Amendments – Changes that will affect: • The safety of the subjects of the trial • The scientific value of the trial • The conduct or design of the trial • Minor Amendments • Examples of substantial and non-substantial amendments can be found on NRES website. • Forms are part of IRAS • Amendments must be notified to – The Sponsor for approval in principle – The REC – The NHS R&D providing NHS R&D Management Approval
- 16. Study Reporting • Annual Study reports to be sent to: – The Sponsor – The REC – NHS R&D providing NHS R&D Management Approval • And final report at the end of your study. • Same document to all – NRES website for form • http://www.nres.npsa.nhs.uk/
- 17. GCP training • Key members of the research team have GCP training. • Mandatory for Trials • Strongly advised for Studies – 1 day – Updates required every 2 years. • www.crncc.nihr.ac.uk/training – Taster course – 9th of March
- 18. Study Clinics • Worried about the complex bureaucracy? • Need some guidance? • Want a “health check” for your ongoing studies? • One on one clinics lead by Research Governance Officer + Research Facilitator • Friendly and supportive! • Accelerate start-up