Objectives of the presentation
An overview of:
• NHS National Research Ethics Service
• How to apply to a Research Ethics Committee for ethical review
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)
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
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.
Why do we need Research Ethics Committees (RECs)? (cont.)
RECs review research proposals in order to:
1. Protect research participants
2. Facilitate and promote good quality research
3. Protect researchers
4. Enable researchers to obtain funding
5. Enable research to be published
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
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.
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
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
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
Legislative and guidance frameworks for NHS RECs (cont)
• Human Tissue Act 2004
• Mental Capacity Act 2005
• EU Clinical Trials Directive (2001/20/EC)
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 [email protected]
Which research requires NHS ethical review?
The most common types are those involving:
• patients and users of the NHS b. relatives or carers of patients and users of the NHSc. data or bodily material of NHS patientsd. fetal material and IVF involving NHS patientse. NHS staff recruited as research participants by
virtue of their professional rolef. the use of NHS premises or facilities
Research review in UK
• NHS RECs
• University RECs
• Research Governance R&D approval is required for all research in the NHS
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 guidancehttp://www.nres.npsa.nhs.uk/applicants/nres-application-form/guidance-on-the-form
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
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
Aspects requiring care (cont)
• Confidentiality • Anonymity• Suitability of researcher and facilities• Data analysis• Security of data• Risks to researcher
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
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
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
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
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
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
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
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)
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.
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.
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
Useful Contacts
Main website www.nres.npsa.nhs.uk
Queries [email protected]
Help with the application form [email protected] 0207 099 2015
Sefton Research Ethics Committee office:
Sue Culshaw [email protected] 0151 330 2052
Kayleigh Roberts [email protected] 0151 330 2051(to book in an application for review)
Useful Contacts (cont)
Central Allocation System 0845 270 4400
(for specialist areas e.g. clinical trials of investigational medicinal products, research on prisoners)
Human Tissue Act www.hta.gov.uk
Medical Research Council www.mrc.ac.uk
Medicines and Healthcare Products Regulatory Agency (MHRA) [email protected]
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
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