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)
Standard Operational Procedures (SOPs)

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’
Check with R&D
Check with a REC or

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
Access the standard application form
Refer to the question-specific guidance

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 and original signatures from:
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
One copy only - except protocol 6 copies IB 3 copies.
The form must be signed and submitted electronically and on paper.

23. Essential documents (cont)
Protocol (project proposal)
Accompanying documents e.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
One copy only - except protocol 6 copies IB 3 copies.
The form must be signed and submitted electronically and on paper.

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
Help with the application form
Sefton Research Ethics Committee office:
Sue Culshaw
Kayleigh Roberts
(to book in an application for review)

32. Useful Contacts (cont)
Central Allocation System
(for specialist areas e.g. clinical trials of investigational medicinal products, research on prisoners)
Human Tissue Act
Medical Research Council
Medicines and Healthcare Products Regulatory Agency (MHRA)

33. Any questions?

34. Glossary 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

35. Useful web sites
– Guidance Note 8: What is a medicinal product