Applying to a Research Ethics Committee

1. Applying to a Research Ethics Committee Sue Culshaw Sefton Research Ethics Co-ordinator

2. Objectives of the presentation An overview of: NHS National Research Ethics Service How to apply to a Research Ethics Committee for ethical review

3. National Research Ethics Service (NRES) • The National Research Ethics Service (NRES) was launched on 1 April 2007 • It comprises the former Central Office for Research Ethics Committees (COREC) and Research Ethics Committees (RECs)

4. NRES - Mission The National Research Ethics Service maintains a UK-wide system of ethical review to: • protect the safety, dignity and well being of research participants • facilitate and promote ethical research in the NHS

5. Why do we need Research Ethics Committees (RECs)? The Department of Health requires that research is reviewed independently to ensure it meets the required ethical standards.

6. Why do we need Research Ethics Committees (RECs)? (cont.) RECs review research proposals in order to: • Protect research participants • Facilitate and promote good quality research • Protect researchers • Enable researchers to obtain funding • Enable research to be published

7. Constitution of RECs • RECs are sub-committees of Strategic Health Authorities • RECs are: - not accountable to NHS Trusts - separate from R&D Departments • RECs are made up of expert and lay members with a maximum of 18 members

8. Constitution of RECs (cont.) • Lay members must make up a minimum of one-third of the Committee • Half of the lay members must never have been a health or social care professional nor been involved in carrying out research.

9. An example of the composition of a REC • Hospital Consultants • General Practitioner • Nurse/Midwife • Clinical Psychologist • Pharmacist • Public Health Physician • Social Scientist • Statistician • Lay members

10. REC meetings For a meeting to be quorate, 7 REC members must be in attendance including the Chair or Vice Chair, 1 expert member and 1 lay member

11. Legislative and guidance frameworks for NHS RECs Governance Arrangements for Research Ethics Committees (GAfREC) http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4005727 Standard Operational Procedures (SOPs) http://www.nres.npsa.nhs.uk/news-and-publications/publications/standard-operating-procedures

12. Legislative and guidance frameworks for NHS RECs (cont) Human Tissue Act 2004 Mental Capacity Act 2005 EU Clinical Trials Directive (2001/20/EC)

13. When is ethical review required? What is the project - research, audit or service evaluation? Only research requires ethical review. If unsure: • See the NRES leaflet ‘Defining Research’ http://www.nres.npsa.nhs.uk/applicants/guidance/ • Check with R&D • Check with a REC or • e-mail queries@nationalres.org.uk

14. Which research requires NHS ethical review? The most common types are those involving: • patients and users of the NHS • relatives or carers of patients and users of the NHS • data or bodily material of NHS patients • fetal material and IVF involving NHS patients • NHS staff recruited as research participants by virtue of their professional role f. the use of NHS premises or facilities

15. Research review in UK • NHS RECs • University RECs • Research Governance R&D approval is required for all research in the NHS

16. How to apply to an ethics committee The application must be made by the Chief Investigator • Refer to the Guidance for Applicants http://www.nres.npsa.nhs.uk/applicants/guidance/ • Access the standard application form http://www.nres.npsa.nhs.uk/applicants/my-online-applications • Refer to the question-specific guidance http://www.nres.npsa.nhs.uk/applicants/nres-application-form/guidance-on-the-form

17. How to develop your project • Seek advice from R&D at an early stage • Look at your project as if you were a research participant

18. Aspects requiring care • Justification of the research • Explaining the project in lay-friendly language • Risks v benefits • Recruitment of participants • Informed consent • Insurance/indemnity arrangements

19. Aspects requiring care (cont) • Confidentiality • Anonymity • Suitability of researcher and facilities • Data analysis • Security of data • Risks to researcher

20. Booking a “slot” with a REC The applicant should contact the REC office to: • Seek advice on correct allocation • Book an agenda slot for review of the project • Obtain a REC reference number (e.g. 08/H1009/1) • Check when the closing date is for receipt of the paper application

21. Validation of applications • Read your application form prior to submission to ensure it is complete/valid • The REC Co-ordinator will review the application for completeness/validity on receipt • The 60 day time limit for the REC to give its final decision starts when a valid application is received by the REC office

22. Essential documents • Application form – completed paper copy with lock code in the bottom right hand corner of each page (e.g. AB/111111/1) and original signatures from: - Chief Investigator - Educational Supervisor - Sponsor’s Representative (usually R&D Manager) • Checklist • CVs for Chief Investigator and Educational Supervisor • Dates and version numbers

23. Essential documents (cont) • Protocol (project proposal) • Accompanying documentse.g. Participant Information Sheet, Consent Form, questionnaires, letters to GPs with version numbers and dates • Non NHS sponsors – evidence of indemnity or insurance for the project

24. Before the meeting • The application is received by the REC office and checked for validity • A letter is sent to the applicant. This letter: - acknowledges receipt of the application - advises whether or not it is valid - invites the applicant to attend the REC meeting when the application is reviewed. • A member of the REC is appointed as lead speaker for the application • Committee members review all applications prior to the meeting

25. Before the meeting (cont) • The application is copied to all REC members • A lead reviewer is appointed for the application • All Committee members read all the applications

26. At the meeting • The lead reviewer makes comments on the application and additional input is given by other members • The applicant may attend the meeting (usually for about ten minutes) to answer queries • Discussion takes place • Consensus is reached on the decision

27. Decisions available to a REC • Final opinion: either favourable (the project may begin immediately) unfavourable (the project must not be undertaken) • Provisional opinion i.e. the REC is content with the project subject to the receipt of further information/clarification/amendment. • No opinion – specialist referee being sought (included in 60 day timeline)

28. Unfavourable opinion • Appeal - a second review of the same application may be obtained from another REC by giving notice of appeal to NRES or • Re-submission- a new application can be submitted, provided it addresses the REC’s concerns. This is treated as a new application.

29. How to get the best result • Make use of NRES guidance and REC Co-ordinators • Make sure you have selected the correct study type on the filter page of the application form • Obtain a scientific/statistical critique of your project where appropriate.

30. How to get the best result (cont) • Answer all the questions on the application form • Use the model Information Sheet and Consent Form • Show you have thought about the ethical problems with your study

31. Useful Contacts Main website www.nres.npsa.nhs.uk Queries queries@nationalres.org.uk Help with the application form ithelpdesk@Infonetica.co.uk 0207 099 2015 Sefton Research Ethics Committee office: Sue Culshaw sue.culshaw@liverpoolpct.nhs.uk 0151 330 2052 Kayleigh Roberts kayleigh.roberts@liverpoolpct.nhs.uk 0151 330 2051 (to book in an application for review)

32. Useful Contacts (cont) Central Allocation System0845 270 4400 (for specialist areas e.g. clinical trials of investigational medicinal products, research on prisoners) Human Tissue Actwww.hta.gov.uk Medical Research Council www.mrc.ac.uk Medicines and Healthcare Products Regulatory Agency (MHRA) info@mha.gsi.gov.uk

33. Any questions?

34. ALC – Adults Lacking Capacity AWI – Adults with Incapacity CAS – Central Allocation System CTIMP – Clinical Trial of an Investigational Medicinal Product Domain – A SHA area GAfREC – Governance Arrangements for RECs IB – Investigator Brochure IRAS – Integrated Research Application System MCA – Mental Capacity Act MHRA – Medicines and Health-care Regulatory Agency NRES – National Research Ethics Service SSA – Site specific assessment SSIF – Site Specific Information Form SOPs – Standard Operating Procedures UKCRN – UK Clinical Research Network Glossary

35. Useful web sites • http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=91 – Guidance Note 8: What is a medicinal product • http://www.nres.npsa.nhs.uk/docs/guidance/NRES_leaflet_Defining_Research.pdf • http://www.ukcrc-rgadvice.org/aboutus/Pages/default.aspx