INTRODUCTION TO RESEARCH GOVERNANCE

1. INTRODUCTIONTO RESEARCH GOVERNANCE

2. The plan for today • Why Research Governance • Research Governance Framework for Health and Social Care • What do you need to do to get approval for your research • Consultation • Sponsor • NHS R&D approval • Ethics

3. We’re all good people. Aren’t we?

4. Research Governance Framework for Health and Social Care

5. Scope… “All research that is concerned with the protection and promotion of public health”

6. Standards… • Health & Safety • Adherence to regulations • Safety of all involved is paramount • Ethics • Independent ethical scrutiny • Finance • Financial Probity • Sufficient insurance provision • Science • Independent scientific review • Quality Research Culture • Accountability • Openness • Honesty • Leadership • Information • Systems to protect IP • Access to research findings • Dissemination plan

7. Roles and Responsibilities… • Submit proposals for ethical review • Conduct research according to agreed protocol & in accordance with legal requirements • Ensure participant welfare • Record keeping • Adverse Event reporting • Dissemination of results PI & other Researchers • Assure of scientific quality of proposed research • Ensure ethics approval obtained • Ensure arrangements in place for management & monitoring of research Sponsor • Promote quality research culture • Ensure researchers understand & discharge their responsibilities • Ensure independent scientific review • Ensure research is properly managed & monitored Employing Organisation • Authorises all research involving their patients, staff or facilities • Ensure research meets standards of RGF • Ensure ethics committee approval obtained • Duty of Care to participants Care Organisation

8. ….summary of key implications • Duty of Care • Sponsor required • Independent scientific review • Independent ethical review • Defined responsibilities

9. The Research Governance Process Research Idea Consultation Discuss Roles & identify ‘Sponsor’ Partner Consultation Set up TMF Development Develop Protocol Develop trial docs Secure Funding Finalise Trial docs Set up Confirm Sponsor Finalise roles and contracts Approvals Host Organisation Ehics Sponsor Approval  Checklist Begin * Clinical Trial of an IMP only

10. What is the ‘Sponsor’? A company, institution or organisation which takes responsibility for the initiation, management and/or financing a research project

11. Applying to CU to act as ‘Sponsor’… PI to complete and submit the following to RACD • SPON form • is the registration form • Research Governance Declaration • To be signed by CI/PI. Confirms CI/PI is aware of RG requirements. • Research Protocol & Patient Info Sheet • provides details of project for Sponsor Risk Assessment / insurance SPON and declaration forms can be obtained at http://www.cardiff.ac.uk/racdv/resgov/forms/forms-procedures-sops-and-guidelines.html

12. The Integrated Research Application System (IRAS): • single system for applying for approvals for health and social care research in the UK • enter information once • Uses filters to ensure questions asked and approvals required are appropriate to the type of study • Retains familiar aspects of the NRES form system ARSAC GTAC MHRA Ministry of Justice NHS / HSC R&D offices Research Ethics Committees Patient Information Advisory Group (PIAG)

13. What forms will be generated? • Dependant on answers to filter questions • Self populates from full dataset • Common forms: • NHS REC Form • NHS R&D Form • NHS SSI Form https://www.myresearchproject.org.uk/ELearning/IRAS_E_learning.htm

14. I’ve completed my IRAS forms, where do I go next? • Project has had Scientific Review • Submission for REC and NHS R&D approval in parallel. • Project has not had Scientific Review • Submission to NHS R&D first

15. NHS R&D approval

16. Obtain approval from the relevant host organisation… NHS Trust R&D Office Local Health Board use the Integrated Research Application System (IRAS), which is available at www.myresearchproject.org.uk Complete R&D Form and NHS SSI From and send to each individual Trust R&D Office Contact individual Trust R&D Office: http://www.rdforum.nhs.uk/links/rdlinks.htm

17. Multi-Site Research • All Wales Primary Care Research Management & Governance Office: Streamlined NHS Permissions Approach to Research – Cymru (SPARC) • NIHR Coordinated System for gaining NHS Permission (NIHR CSP)– England only

18. Submission to R&D Office • Review by committee (usually monthly) • Letter of approval / amendments • Honorary contracts / Research Passport

19. NHS Research Ethics Committees

20. Yes Yes No NHS REC application Is the research project a clinical trial of an IMP? Telephone CAS No Is the project taking place in >1 domain? No Contact NHS REC but may apply via CAS Is the project taking place in >1 site within one domain? Contact your Local REC

21. Ethics Process… • REC acknowledges application in 5 days • REC has 60 days in total to make a final decision on new application • Investigators invited to attend meeting • Decisions available: • Favourable • Provisional Favourable • Unfavourable

22. Further Information http://www.cf.ac.uk/racdv/resgov/index.html Chris Shaw – Research Governance Coordinator Matthew Harris – Research Governance Officer Nic Betty - Research Governance Admin Assistant x79277 resgov@cardiff.ac.uk