The NHS Research Ethics Service in Scotland How to get a Favourable Opinion

1. The NHS Research Ethics Service in ScotlandHow to get a Favourable Opinion 10th Feb 2010 Judith Godden Manager/ Scientific Officer West of Scotland Research Ethics Service

2. NRES National Research Ethics Service • Protecting the rights, safety, dignity and well-being of research participants • Facilitating ethical research which is of potential benefit to participants, science and society

3. NHS REC Structure in Scotland 4 Regions WoSRES NoSRES Lothian Tayside 5 2 4 3 REC Governance NRES Health Board UKECA CSO CTIMPs NHS REC

4. WoSRESBenefits of a Regionalised Service Standard procedures across four Scottish regions The West of Scotland regional service covers the requirements of five health boards and draws committee members and expertise from across the five health boards.

5. West of Scotland Research Ethics Service WoSRES Regional research ethics service Ayrshire & Arran HB Dumfries & Galloway HB Greater Glasgow & Clyde HB Lanarkshire HB Special HB (Golden Jubilee) Others

6. WoSRES WoS 1 Recognised Type III WoS 2 Authorised WoS 3 Authorised WoS 4 Authorised Tissue Bank WoS 5 Authorised CTIMPS Multicentre Dental Paediatrics General Dental Paediatrics General Biorepositories Neonatal General Paediatrics Primary Care Mental Health General

7. Research ethics enquiries Research Ethics Co-ordinators Committee Chairs Scientific Advisor Local Health Board R&D Departments Local Data Protection Caldicott Guardian, Clinical Audit/Clinical Governance Departments

8. Why is there an ethics service? Nuremberg Code, WMA Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects, European Union Directive 2001/20/EC Run by the National Research Ethics Service (NRES). A single ethical opinion given by a Research Ethics Committee (REC) To protect the rights, safety, dignity and well-being of (potential) participants To provide independent, competent and timely review of the ethics of proposed studies

9. NHS Research Ethics Committee Comprises of volunteer expert and lay members (one third of members lay) Chaired by an expert or lay member REC run by coordinator Committee can run with 7-18 members In Scotland overseen by Scientific Officers

10. When is NHS Research Ethics approval required? • Is it research? • NRES guidance ‘Defining Research’

11. Research • The primary aim of research is to derive generalizable new knowledge, whereas the aim of audit and service evaluation projects is to measure standards of care. • Neither audit or service evaluation uses an intervention without a firm basis of support in the clinical or health community. • Neither audit or service evaluation allocate treatment or service by protocol. It is a joint decision by the clinician and patient. • If it involves randomisation it is nearly always research.

12. When is NHS Research ethics required? • Is it research? Yes • Is the research within the remit of an NHS REC?

13. What is the Remit of an NHS REC?GAFRECGovernance arrangements for NHS Research Ethics Committees in Scotland July 2001 (to be replaced shortly) Patients or users of the NHS Relatives or carers of NHS patients/users Access to the personal data or bodily material of NHS patients Foetal material and IVF involving NHS patients The recently dead in NHS premises The use of, or potential access to, NHS premises/facilities NHS staff recruited as research participants by virtue of their professional role

14. When is NHS Research Ethics approval required? • Is it research? Yes • Is the research within the remit of an NHS REC? Yes

15. Scientific peer review Are you collecting tissue? Study numbers (power calculation) Recruitment Who? How? How long to consider? • PIS • Questionaires • Adverts • Consent form • Payments involved? Are you collecting data? ISD CHI number Sponsor Indemnity • Children • Adults with incapacity • Other special groups eg prisoners etc

16. IRAS • Integrated Research Application System https://www.myresearchproject.org.uk/ • Enables you to enter information about your intended research project in one place.- generating a number of research applications. • Operates via filters/sieves to generate the forms your project requires

17. NHS REC Form NHS R&D Form Project Data Form Filter SSI MHRA Form ARSAC Form

18. IRAS forms • REC • ethics application form • R&D • outlines the proposed research project • SSI • Site Specific Information • outlines the research team activities and individual responsibilities at the site

19. Integrated Research Application System (IRAS) IRAS captures the information required to complete multiple application forms simultaneously www.myresearchproject.org.uk

20. IRAS training module www.myresearchproject.org.uk

21. How to apply to a REC Fill out an application using IRAS Submit a paper copy of the ethics application form and all supporting documentation to the WoSRES office If valid you will receive an acknowledgement and a time/date for the meeting. If not valid, the application will be withdrawn You cannot submit any more information

22. Which REC do I send the application to? Dates for meetings are on the NRES website Non-CTIMP, non-AWI studies. Single-site or multi-site research to any WoS REC. CTIMP, Adults with Incapacity, (other flags). Approach via Central Application System: 0845 270 4400 Cross-border AWI studies are the only studies requiring more than one ethical review

23. What is a valid Application? Use the checklist Signatures: Chief Investigator, Educational Supervisor, Sponsor (letter or signature). Can use electronic signatures Include questionnaires, adverts, GP letters, PIS & consent Date and version control everything

24. What happens at the meeting? The committee will discuss the application Invite the investigator in and the Chair will lead a discussion and then ask you to leave The REC will make a decision: Final Favourable opinion Provisional opinion Unfavourable opinion Refer to specialist referee

25. What happens after the meeting? Coordinator will take notes and send a letter within 10 days detailing the decision including any changes that need to be made Send further information to the coordinator Receive ethical approval Decision within 60 days You can appeal

26. Post approval Amendments: any changes to the protocol, PIS, CF, any change to the risk/benefit ratio. You will get a decision within 35 days For CTIMPs the Sponsor decides what is substantial For non-CTIMPs the REC decides A new protocol requires a new application Progress reports: once a year Final reports: within a year

27. What is R&D approval? • Legal requirement • ensures protection for patients and staff • Condition of • ethics approval • grant bodies • publication • Indemnity • no R&D approval = no insurance All research conducted within the NHS must have R&D Management Approval

28. Enquiry to WoSRES Office Enquiry to R&D Office Letter issued detailing the decision and recommending local governance arrangements for study Is this research ? NO Does it involve NHS patients or staff? Ethics Favourable opinion Ask investigator to complete IRAS form and submit to R&D & ethics ensuring all sponsor requirements are in place Management Approval R&D MHRA (CTIMPs only) CTA

29. Useful websites IRAS https://www.myresearchproject.org.uk National Research Ethics Service (NRES)http://www.nres.npsa.nhs.uk/ Data & Tissues Tool Kit http://www.dt-toolkit.ac.uk/home Clinical Trials Tool Kit http://www.ct-toolkit.ac.uk/ Stem Cell Tool Kit http://www.sc-toolkit.ac.uk/ WoSRES judith.godden@ggc.scot.nhs.uk