1. R&D – a perspective Dr Nana Theodorou Research Coordinator Sheffield Clinical Research Office

2.  Research Governance Framework  R&D: role and support 2

3. Outlines principles of good governance that apply to all research in health and social care organisations, to ensure that all research is conducted to high scientific & ethical standards https://www.gov.uk/government/publications/rese arch-governance-framework-for-health-and-social- care-second-edition https://www.gov.uk/government/publications/rese arch-governance-framework-for-health-and-social- care-second-edition. 3

4. 4 Issued in 2001 Implemented 2003 Revised edition published in 2005 to include the EU Directive on Clinical Trials guidance Currently under review

5.  Safeguard participants in research  Protect researchers/investigators (by providing a clear framework to work within)  Enhance ethical and scientific quality  Minimise risk  Monitor practice and performance  Promote good practice and ensure lessons are learned 5

6. 6 Research Governance Framework comprises:  Human Tissue Act (HTA)  National Research Ethics Service (NRES)  Mental Capacity Act (MCA)  Data Protection Act  Medicines for Human Use Regulations (MHRA)  The Ionising Radiations Regulations

7. 7  Study registration  At Grant stage  Pre-Authorisation  Post-Authorisation  Education and training 7

8. 8  Type of study  Student/staff  Lead/participating site  Clinical trial (drug/medical device)  Data only/Tissue bank  Chief/Principal Investigators  Sponsor  Commercial  Academic/NHS 8

9. 9  Identify suitable funding streams  Prepare and submit funding proposals  PPI  Provide costs for external bids 9

10. 10  Study set up and authorisation  Study documentation and scientific review  Regulatory and local approvals  Indemnity/insurance  Finance  R&D Approval  Guidance  RGF  Legislation  Agreements and Contracts 10

11.  Essential  Protocol  Additional  Participant information sheet  Consent form  Participant Invitation letter  Leaflets/posters  GP letter  Patient card/diary  Questionnaires

12. Ethics University/NHS REC/None MHRA Drug/device Confidentiality Advisory Group (CAG) Gene Therapy Advisory Committee (GTAC) Human Fertilisation and Embryology Authority

13.  New edition of GAfREC came into effect September 2011.  Previously all clinical research involving the NHS was automatically reviewed by REC. http://www.dh.gov.uk/en/Publicationsandstatistics/Public ations/PublicationsPolicyAndGuidance/DH_126474

14. Research involving previously collected, non- identifiable information  Staff studies  Clinical databases  Extraction of information from notes by clinical care team with removal of identifiers prior to analysis Check with sponsor whether University ethics is required.

15. 15  Social or scientific value  Recruitment arrangements  Favourable risk benefit ratio  Care and protection of research participants  Informed consent process and participant information  Suitability of the applicant and supporting staff  Independent review

16. The IRAS is a single online system for applying for permissions and approvals for health and social care/community research in the UK. It streamlines the process for seeking relevant approvals, as researchers no longer need to enter the details for a single project in separate application forms. IRAS can be accessed at www.myresearchproject.org.uk www.myresearchproject.org.uk

17. 17 Research has to have a confirmed sponsor, appropriate approvals & written permission from the care organisation before it commences

18. 18  Amendments  Finance and contract variations  Performance management  Accrual  RTT  Monitoring and audit  Pharmacovigilance  Study close out  Archiving 18

19. The NHS REC letter lists all approved study documents with version and date for each. Any changes to the approved documents need to be submitted as an Amendment (substantial or non-substantial) and approved by the original REC.

20. Huge variation in study documents and approval letters. Only receive the Ethics letter and not the ethics form. Favourable opinion v approval

27. http://www.sheffieldclinicalresearch.org Nana.Theodorou@sth.nhs.uk 27