SHS procedures for IRAS authorised sponsor’s and

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IRAS Authorised Signatures. v3.3, ND 2Dec 2015
SHS procedures for IRAS authorised sponsor’s and
supervisor’s signatures for an ethics application to an NHS
Research Ethics Committee
Studies involving the recruitment of patients and/or their relatives or carers through the
NHS must be reviewed by an NHS Research Ethics Committee (NHS REC), which falls under
the remit of the Health Research Authority (HRA) 1. Studies which involve NHS staff do not
require NHS ethical approval ordinarily, but still require NHS R&D approval. The system
currently being rolled out is now known as HRA approval, a single approvals system that not
only covers ethical approval, but other regulatory approvals, including NHS R&D approval.
(Please see separate guidance: HRA Approval for SHS sponsored projects)
The system used for applications is still the Integrated Research Application System (IRAS).
Purpose of this Document
This document clarifies the authorised signatory arrangements (sponsor, and also academic
supervisor for student applications) in the School of Health Sciences, for applications for
approval submitted through IRAS and should be read by both students and staff.
The Authorisation Process
All applications to an NHS REC (and for R&D Approval only) have to be signed off
electronically via the IRAS system. Three signatures (at least) are usually required, from:
1. the applicant (The Chief Investigator)
2. the sponsor (usually a representative from City University London)2
3. the supervisor (for Master’s and PhD students)
Additionally you should name Alison Welton as the Sponsor’s contact.
You are required to name specific people in the following sections on the IRAS form:




Section A.4 - Sponsor contact: This is always Alison Welton
Section A.64-1 - Sponsor: This is the Sponsor’s representative (see below and Table 1
and Appendix 2)
Section D2 - Sponsor’s representative: same as A.64-1 above
Section D3 - Primary Supervisor (for students); these are also named in Section A.2-1
The IRAS system then sends an email to the people you name in the sections above, and
requires their authorisation of your application. Please see below for guidance on how to
manage this process.
In order to electronically sign the IRAS from, the person must be a recognised authorised
signatory within SHS (see Table 1: Details of Authorised Signatories in the School of Health
This will be subject to some change over the course of 2015/16 so and will become known as
HRA approval, see HRA website for details: http://www.hra.nhs.uk/about-the-hra/our-plansand-projects/assessment-approval/
2 City is the sponsor for almost all projects. Unless you have information to the contrary, through
a funding agreement, you can assume that City is the sponsor.
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IRAS Authorised Signatures. v3.3, ND 2Dec 2015
Sciences, below) and have registered with IRAS. No other persons are authorised to sign off
the applications. Appendix 2 has details of individual current post holders as of 1st October
2015.
Anyone submitting or authorising has to be registered with IRAS.
To register with IRAS follow this link:
https://www.myresearchproject.org.uk/Help/HelpPage.aspx .
IRAS has a user guide with information on the authorisation process (section 1.9.3),
follow this link:
https://www.myresearchproject.org.uk/Help/Contents/IRASHelp_UserManual.pdf.
Important Warning: Once authorised the application documentation cannot be altered in
any way, if you do this you will have to re-start the process, which will require new
authorisations.
Please note that in addition to the electronic authorisation process you will also be required
to submit details of provisional indemnity. You must also provide details of the insurance
cover (please see additional guidance on the School’s Research Governance webpages:
http://www.city.ac.uk/health/research/research-governance). These are obtained from
Alison Welton through submission of the Research Registration Form -EC3).
Please also note even though other individuals authorise City’s sponsorship of the project,
the sponsor’s contact for all applications is
Alison Welton
Research Governance Officer
School of Health Sciences
City University London
Northampton Square
London
EC1V 0HB
020 7040 5704
a.welton@city.ac.uk
Details of the authorisation process within SHS
Student applications: Taught postgraduate degrees
MSc, MRes and other taught masters students should get their sponsor’s authorisation from
their Dissertation Module Leader or Programme Director (in many cases this may be the
same person) and additionally their supervisor’s authorisation (checklist and electronic
authorisation of IRAS, See below). Students must allow time for the authorised sponsor’s
signatory to review the application: a minimum of one week’s notice is required and this
should be by prior arrangement with the signatory. In order to facilitate the process
students should email their Research Registration Form (EC3) and the completed Ethical
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IRAS Authorised Signatures. v3.3, ND 2Dec 2015
review form of the IRAS applications for supervisors (Appendix 1, below) to the relevant
authorised signatory in advance.
Supervisor: approval and authorisation of student IRAS applications
The application will also have to be approved by the student’s supervisor before the
authorised signatory can review the application and authorise it in IRAS. The supervisor will
need to complete the checklist- (Ethical review form of the IRAS applications for
supervisors; Appendix 1) to confirm the application has been completed to an acceptable
standard (including the protocol, methodology, PIS and consent form). If the application has
not been completed satisfactorily it should be returned to the student, by the supervisor, for
revision and re-approval. Students are required to submit the completed checklist along
with the EC3 to the relevant signatory, as detailed in the paragraph above.
The supervisor will also have to electronically authorise the IRAS form.
Please note that a supervisor who is also an STR, Research Centre Lead or other authorised
sponsor’s signatory cannot authorise a project on IRAS for which they have supervisory
responsibility. Alternative signatories are named in Table 1 below, marked as ‘exceptions’ to
normal signatory arrangements.
Student applications: Research degrees
PhD students and those studying for other research degrees should follow the guidance set
out below for staff with the following exceptions:
They should also ensure that:
 the Ethical review form of IRAS applications for supervisors (Appendix 1) has been
completed by their supervisor and forwarded with the EC3 to the authorised
sponsor’s signatory; and
 the authorised sponsor’s signatory should be the STR (Table 1 below) for the
Research Centre within which the PhD is situated.
Staff applications
Members of staff applying to NHS REC ethics approval should send their application
electronically to the Research Centre Lead (exceptionally the Associate Dean for Research or
Dean/Deputy Dean of School) with at least 1 week’s notice. (see Table 1 & Appendix 2,
below for variations). Specific arrangement will need to be made beforehand to ensure the
process runs smoothly. You will need to provide the Research Registration Form (EC3) and
prepare a verbal briefing for the authorised signatory about your project.
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IRAS Authorised Signatures. v3.3, ND 2Dec 2015
Table 1: Details of SHS Authorised Sponsor’s Signatories
IRAS application
category
MSc & MRes
Authorised Sponsor’s Signatory
Timeline for sign off
Master’s Dissertation Module Leader
You need to give the signatory 1
week’s notice that you require
their authorisation.
or
Master’s Programme Director
Exceptionally: Divisional Leads, if
the supervisor is one of the above.
You should supply them with your
Research Registration Form (EC3)
and the attached Appendix 1:
Ethical review form of IRAS
applications for supervisors.
(See Appendix 2 for Named
Individuals)
PhD
Staff
Senior Tutors for Research (STRs)
You need to give the signatory 1
week’s notice that you require
their authorisation.
(See Appendix 2 for named
individuals)
You should supply them with your
Research Registration Form (EC3)
and the attached Appendix 1:
Ethical review form of IRAS
applications for supervisors.
Exceptionally: PhD Programme
Director, Prof Christine McCourt, if
the STR is your supervisor
Book a half hour slot in Professor
McCourt’s diary at least 4 weeks
ahead of time. You should supply
her with your Research
Registration Form (EC3) and the
attached Appendix 1: Ethical
review form of IRAS applications
for supervisors.
Heads of Research Centres
You need to give the signatory 1
week’s notice that you require
their authorisation. You should
supply them with your Research
Registration Form (EC3).
(See Appendix 2, for named
individuals)
Exceptionally: Prof Francis, Associate
Dean for Research (in her absence Dr
Nick Drey, Chair SHS REC), if you are
the Head of a Research Centre
Book a half hour slot in Professor
Francis diary at least 4 weeks
ahead of time. You should supply
her with your Research
Registration Form (EC3).
Exceptionally: the Dean or Deputy
Dean.
You should make specific
arrangement with the person in
advance.
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IRAS Authorised Signatures. v3.3, ND 2Dec 2015
Appendix 1: Ethical review form of IRAS applications for supervisors
Project Title:
Supervisor:
Student:
Yes/No
Is the research proposal of good design?
Is the research design able to answer the question?
Is the conduct of the study appropriate and consistent throughout the
documentation?
Are the aims and objectives of the research clear?
Has any potential risk to the researcher been considered?
Are the recruitment arrangements appropriate?
Are the inclusion and exclusion criteria appropriate?
Has the care and protection of research participants; respect for potential
and enrolled research participants’ welfare and dignity been addressed
appropriately?
Are the participants fully informed about procedures to be used?
Are the participants fully informed about the purpose of the research?
Will the consent of participants be obtained?
Is it clear to the participants that they may withdraw at any time?
Where participants are vulnerable because of their social, psychological or
medical circumstances, has this been taken into account in obtaining
consent?
Are the supporting information (e.g. GP letter, interview schedules,
questionnaires, PIS, consent form etc.) suitable?
Have arrangements been made to ensure that material obtained from or
about a participant remains confidential?
Does the student have the appropriate skills and ability to carry out the
research?
Has the documentation been proof-read?
I confirm that the above checks have taken place on the attached documentation and that
I am satisfied with the suitability of the study.
Signed (supervisor)
Date
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IRAS Authorised Signatures. v3.3, ND 2Dec 2015
Appendix 2: Current Post Holders
Post/Role
Name
Dean
Prof Stanton Newman
Deputy Dean
Prof Debra Salmon
Associate Dean for Research
Prof Jill Francis
Chair of SHS Research Ethics Committee
Dr Nick Drey
Heads of Research Centres
Applied Vision Research
Prof David Crabb
Health Services Research
Prof Jill Francis
Language and Communication Science
Research
Prof Nicola Botting
Maternal and Child Health Research
Prof Susan Ayers
Mental Health Research
Prof Alan Simpson
Public Health Research
Prof Amanda Burls
Senior Tutors for Research
Applied Vision Research
Dr Simon Grant
Prof Chris Hull
Health Services Research
Dr Shashi Hirani
Dr Mark Haddad
Language and Communication Science
Research
Dr Katerina Hilari
Dr Lucy Dipper
Maternal and Child Health Research
Dr Gill Craig
Mental Health Research
Dr Julia Jones
Public Health Research
Dr Gill Craig
Divisional Leads
Division of Health Services Research and
Management
Dr Eamonn McKeown
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IRAS Authorised Signatures. v3.3, ND 2Dec 2015
Division of Language and Communication
Sciences
Dr Paul Turner
Division of Optometry and Visual Sciences
Prof Chris Hull
Conjoint Division of Radiography and
Midwifery
Dave Flinton
Division of Nursing
Dr Lisa Reynolds
Taught Masters Programmes
MRes Dissertation Module CRM002
Dr Eamonn McKeown
Clinical Optometry Dissertation module
Prof Ron Douglas
MSc Advanced Practice Health and Social
Care (APHSC)
Alison Coutts
MSC APHSC (Nursing)
Alison Coutts
MSc APHSC (Advanced Nurse Practitioner)
Daniel Apau
MSc APHSC (Advanced Nurse Practitioner)
Neonatal
Rosemary Lanlehin
MSc APHSC (Ophthalmic Nursing)
Alison Coutts
MSc APHSC (Long Term Conditions and Long
Term Care)
Prof Julienne Meyer
MSc APHSC (Child & Adolescent Mental
Health)
Sarah Campbell
MSc APHSC Adult Mental Health
Dr Louise Phillips / Sarah Campbell
MSc APHSC (Midwifery)
Dr Mandie Scamell
MSc APHSC (Radiotherapy)
Ricardo Khine
MSc / PG Dip / PG Cert Radiography
(Radiotherapy)
Ricardo Khine
MSc APHSC (Speech, Language &
Communication )
Prof Jane Marshall
MSc APHSC (Ophthalmic Nurse Practitioner)
Michelle L Hennelly
MSC APHSC (Clinical Optometry)
Michelle L Hennelly
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IRAS Authorised Signatures. v3.3, ND 2Dec 2015
MSc Clinical Optometry
Michelle L Hennelly
MSc Radiography (Medical Magnetic
Resonance)
Paul Bland
MSc Radiography (Computed Tomography)
Paul Bland
MSc/Diploma/Certificate Medical Ultrasound Gill Harrison
MSc Nursing Conversion
Alison Coutts
MSc Speech and Language Therapy
Conversion
Prof Jane Marshall
MSc Midwifery Conversion
Dr Mandie Scamell
SCPHN (HV, SN and DN) Conversion
Val Thurtle
Master of Public Health
Dr Divya Parmar
MSc Health Management
Greg Layther
MSc Health Policy
Dr Justin Needle
MRes Clinical Research
Dr Madeline Cruice
MSc/MRes Health Services Research
Dr Martin Cartwright
MSc Speech, Language and Communication
Needs (SLCN) in Schools: Advanced Practice
Prof Shula Chiat
MSc Speech and Language Therapy
Bernard Camilleri
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