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Applying to a Research Ethics Committee

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Why do we need Research Ethics Committees (RECs)? (cont.) RECs review ... Committee for ethical review ... MS Blank Presentation Applying to a ... – PowerPoint PPT presentation

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Title: 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 RD 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/Publicationsandstatisti
    cs/Publications/PublicationsPolicyAndGuidance/DH_4
    005727
  • Standard Operational Procedures (SOPs)
  • http//www.nres.npsa.nhs.uk/news-and-publica
    tions/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 RD
  • Check with a REC
  • or
  • e-mail queries_at_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 RD 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-appli
    cation-form/guidance-on-the-form

17
How to develop your project
  • Seek advice from RD 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
  • - Sponsors Representative (usually RD
    Manager)
  • Checklist
  • CVs for Chief Investigator and Educational
    Supervisor
  • Dates and version numbers

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

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 RECs
    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_at_nationalres.org.uk
  • Help with the application form ithelpdesk_at_Infoneti
    ca.co.uk 0207 099 2015
  • Sefton Research Ethics Committee office
  • Sue Culshaw sue.culshaw_at_liverpoolpct.nhs.uk
    0151 330 2052
  • Kayleigh Roberts kayleigh.roberts_at_liverpoolpct.nhs
    .uk 0151 330 2051
  • (to book in an application for review)

32
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) info_at_mha.gsi.gov.uk

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
  • http//www.mhra.gov.uk/home/idcplg?IdcServiceSS_G
    ET_PAGEnodeId91 Guidance Note 8 What is a
    medicinal product
  • http//www.nres.npsa.nhs.uk/docs/guidance/NRES_lea
    flet_Defining_Research.pdf
  • http//www.ukcrc-rgadvice.org/aboutus/Pages/defaul
    t.aspx
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