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. 1 1 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 2 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. 3 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. 4 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 5 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 6 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 7 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 8