IRAS & SHS REC Authorised Signatures. V5 30.01.17

School of Health Science procedures for authorising research ethics applications

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 ethical approval submitted to the NHS, through IRAS.

It also clarifies the authorisation process for internal (City, University of London) research ethics applications, including: Senate Research Ethics Committee (SREC), School of Health Sciences Research Ethics Committee (SHS REC) and proportionate review (PR) within SHS. It should be read by both students and staff.

Contents:

  • Part 1: SHS procedures for IRAS authorised sponsor’s and supervisor’s signatures for an ethics application to an NHS Research Ethics Committee.
  • Part 2: SHS procedures for authorisation of a research ethics application to a City, University of London REC, including: Senate REC, SHS REC and proportionate review within SHS.
  • Appendix 1: Ethical review form of IRAS applications for supervisors
  • Appendix 2: Current Post Holders

Part 1: SHS procedures for IRAS authorised sponsor’s and supervisor’ssignatures 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). Studies which involve NHS staff do not require NHS ethical approval ordinarily, but still require NHS R&D approval and may require HRA assessment. 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).

The Authorisation Process

All applications to an NHS REC (and for NHS 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)[1]
  3. the supervisor(for Master’s and PhDstudents)

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 sections 1-3 below,Table 1 and Appendix2)
  • Section D2 - Sponsor’s representative: this is the same person asfor section A.64-1 covered in the preceding bullet point
  • Section D3 - Primary Supervisor(for students);the supervisor should also be 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 form as Sponsor’s representative, the person must be a recognised authorised signatory within SHS (see Table 1: Details of Authorised Signatories in the School of Health 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 1stFebruary2017.

Anyone submitting or authorising has to be registered with IRAS.

To register with IRAS follow this link: .

IRAS has a user guide with information on the authorisation process (section 1.9.3), follow this link:

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: 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

Details of the authorisation process within SHS

1Student applications: Taught postgraduate degrees

MSc, MRes and other taught masters students should get their sponsor’s authorisation from their Supervisor’s Research Centre Leadand additionallytheir supervisor’s authorisation (checklist and electronic authorisation of IRAS, See below). Students must allow time for theauthorised sponsor’s signatory to review the application: a minimum of two weeks’ 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 completedEthical review form of the IRAS applications for supervisors (Appendix 1, below) to the relevantauthorised 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 a 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.

2Student applications: Research degrees

PhD students and those studying for other research degrees should follow the guidance set out below for staff with the following exception: they should ensure thatthe 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.

3Staff 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 2 weeks’ notice (see Table 1 & Appendix 2, below for variations). Applicants are responsible for making a specific arrangement with the authorised signatory 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.

Table 1: Details of SHS Authorised Sponsor’s Signatories for IRAS applications

IRAS application category / Authorised Sponsor’s Signatory / Timeline for sign off
Master’s degrees / Supervisor’s Research Centre Lead
Exceptionally: Prof Chris Hull, Associate Dean for Research, if the Research Centre Lead is also the Supervisor (Deputy Dean or Dean in his absence)
(See Appendix 2 for Named Individuals) / You need to give the signatory 2weeks’ notice that you require their authorisation.
You should supply them with your Research Registration Form (EC3) and the Ethical Review Form of IRAS Applications for Supervisors (Appendix 1).
If necessary, you should make a specific arrangement with the Dean or Deputy Dean or Associate Dean for Research in advance.
PhD / Supervisor’s Research Centre Lead
Exceptionally: Prof Chris Hull, Associate Dean for Research, if the Research Centre Lead is also the Supervisor (Deputy Dean or Dean in his absence)
(See Appendix 2 for Named Individuals) / You need to give the signatory 2weeks’ notice that you require their authorisation.
You should supply them with your Research Registration Form (EC3) and the attached Appendix 1: Ethical review form of IRAS applications for supervisors.
If necessary, you should make a specific arrangement with the Dean or Deputy Dean or Associate Dean for Research in advance.
Staff / Research Centre Lead
Exceptionally: Prof Chris Hull, Associate Dean for Research, if the Research Centre Lead is also the Supervisor (Deputy Dean or Dean in his absence)
(See Appendix 2 for Named Individuals) / You need to give the signatory 2weeks’ notice that you require their authorisation.
You should supply them with your Research Registration Form (EC3).
If necessary, you should make a specific arrangement with the Dean or Deputy Dean or Associate Dean for Researchin advance.

Part 2: SHS procedures for authorisation of a research ethics application to a City, University of London REC, including: Senate REC, SHS REC and proportionate review within SHS.

In order to decide which research ethics committee should approve internal ethics applications (Senate REC, SHS Rec of SHS Proportionate Review), please see additional guidance on the SHS Research Governance Website.For research that does not require HRA approval you should apply initially to the SHS REC or SHS Proportionate Review, as appropriate, at City, University of London. Exceptionally projects that are considered high risk will be seen by Senate Research Ethics Committee but you should approach the chair of the SHS REC in the first instance.

All applications should be signed off by the applicant, student and supervisor, if appropriate. Additionally research ethics applications will have to be approved by the appropriate research centre lead, (See Table 2 below for details of signatories).

Table 2: Details of Authorisation for Internal Ethics Applications

City, University of London RECs / Authorised Signatory / Timeline for sign off
Senate REC / Associate Dean for Research
(Exceptionally Deputy Dean or Dean in his absence)
(See Appendix 2 for Named Individuals) / You need to give the signatory 2 weeks’ notice that you require their authorisation.
You should supply them with your full ethics application & Research Registration Form (EC3) and, for students, the Ethical Review Form of IRAS Applications for Supervisors (Appendix 1).
If necessary, you should make a specific arrangement with the Dean or Deputy Dean in advance.
SHS REC / For students: your supervisor’s Research Centre Lead
For staff: your Research Centre Lead
Exceptionally: Prof Chris Hull, Associate Dean for Research, if the Research Centre Lead is also the Supervisor
(See Appendix 2 for Named Individuals) / You should give the signatory 2 weeks’ notice that you require their authorisation.
You should supply them with your full ethics application & Research Registration Form (EC3) and, for students, the Ethical Review Form of IRAS Applications for Supervisors (Appendix 1).
SHS PR / For students: your supervisor’s Research Centre Lead
For staff: your Research Centre Lead / You should give the signatory 2 weeks’ notice that you require their authorisation.
You should supply them with your Research Registration Form (EC3) and, for students, the Ethical Review Form of IRAS Applications for Supervisors (Appendix 1).

Appendix 1: Ethical review form of IRAS applications for supervisors (also to be used for internal applications- part of EC3)

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

Appendix 2: Current Post Holders

Post/Role / Name
Deanery
Associate Dean for Research
Dean
Deputy Dean / Prof Chris Hull
Prof Stan Newman
Prof Debra Salmon
Heads of Research Centres
Applied Vision Research
Health Services Research
Language and Communication Science Research
Maternal and Child Health Research
Mental Health Research / Prof David Crabb
Prof Jill Francis (ProfLeanne Atkinsduring Prof Francis’ sabbatical until July ‘17)
Prof Nicola Botting
Prof Susan Ayers (Prof Christine McCourt during Prof Ayers’ sabbatical until June ‘17)
Prof Alan Simpson

1

[1]City is the sponsor for almost all projects. Unless you have information to the contrary, through a funding agreement, or an agreement of an NHS Trust, you can assume that City is the sponsor.