1. Research Policy & Management RACD INTRODUCTION TO RESEARCH GOVERNANCE

2. Research Policy & Management RACD 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 The plan for today

3. Research Policy & Management RACD Were all good people. Arent we?

4. Research Policy & Management RACD Research Governance Framework for Health and Social Care

5. Research Policy & Management RACD Scope… All research that is concerned with the protection and promotion of public health

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

7. Research Policy & Management RACD 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 Assure of scientific quality of proposed research Ensure ethics approval obtained Ensure arrangements in place for management & monitoring of research Promote quality research culture Ensure researchers understand & discharge their responsibilities Ensure independent scientific review Ensure research is properly managed & monitored 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 PI & other Researchers Sponsor Employing Organisation Care Organisation

8. Research Policy & Management RACD Duty of Care Sponsor required Independent scientific review Independent ethical review Defined responsibilities ….summary of key implications

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

10. Research Policy & Management RACD What is the Sponsor? A company, institution or organisation which takes responsibility for the initiation, management and/or financing a research project

11. Research Policy & Management RACD Applying to CU to act as Sponsor… 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 PI to complete and submit the following to RACD SPON and declaration forms can be obtained at http://www.cardiff.ac.uk/racdv/resgov/forms/forms-procedures-sops- and-guidelines.html

12. Research Policy & Management RACD 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. Research Policy & Management RACD 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. Research Policy & Management RACD 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 Ive completed my IRAS forms, where do I go next?

15. Research Policy & Management RACD NHS R&D approval

16. Research Policy & Management RACD NHS Trust R&D Office Local Health Board Obtain approval from the relevant host organisation… use the Integrated Research Application System (IRAS), which is available at www.myresearchproject.org.ukwww.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. Research Policy & Management RACD 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. Research Policy & Management RACD Submission to R&D Office Review by committee (usually monthly) Letter of approval / amendments Honorary contracts / Research Passport

19. Research Policy & Management RACD NHS Research Ethics Committees

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

21. Research Policy & Management RACD 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. Research Policy & Management RACD 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