RESEARCH AND DEVELOPMENT GAINING NHS RESEARCH PERMISSION FROM CARDIFF AND VALE UHB - GUIDANCE FOR RESEARCHERS Reference No: UHB 074 Version No: 5 Previous Trust / LHB Ref No: N/A Documents to read alongside this Guideline Research Governance Policy Classification of document: Area for Circulation: Author/Reviewee: Executive Lead: Group Consulted Via/ Committee: Approved by: Research and Development UHB Wide Research and Development Co-ordinator Medical Director Research Governance Group Research Governance Group Date of Approval: 12 July 2016 Date of Review 12 July 2019 Date Published: 9 th August 2016 Disclaimer When using this document please ensure that the version you are using is the most up to date either by checking on the UHB database for any new versions. If the review date has passed please contact the author. OUT OF DATE POLICY DOCUMENTS MUST NOT BE RELIED ON Research & Development - Gaining NHS Page 1 of 17 Reference no: UHB 074 Research Permission from Cardiff and Vale UHB Version no: UHB 4
Version Number Date of Review Approved Date Published Summary of Amendments 2 Section 7.2.1. Revision to guidance re signature requirements. Section 6.1.1. Additional information inserted regarding science review. 3 03/07/12 Section 8.0 addition of the following wording An ethical opinion must be sought for any research involving: potential research participants identified from, or because of, their past or present use of the NHS, Health and Social Care services of England, Wales, Scotland or Northern Ireland. Version 2.0 stated that An ethical opinion must be sought for any research involving services listed above. This was an error as this pertained to the GaFREC document used when writing the Guideline This is the only new change to the document. 4 23/04/13 Section 3.0: > Amended flowchart to illustrate changes described in sections 7.0, 7.1, 7.2.1. Section 6.0: > Minor updates to reflect current practice. Section 7.0: > Centre changed to NHS organisation to improve clarity. > Addition of assessment of a complete application package. This activity has always been done by the R&D office, but was not previously considered necessary for inclusion in this guidance. Following introduction of performance management of R&D permission systems by NISCHR it now needs to be included. Section 7.1: > Addition on information on the requirement for submitting IRAS checklists. This is a new requirement of the NISCHR Permissions Coordinating Process. Research & Development - Gaining NHS Page 2 of 17 Reference no: UHB 074
Section 7.2.1: > Amended to reflect changes to SSI Q23 in v3.5 of IRAS. Section 8.0: > Change of name of external organisation from National Patient Safety Agency to Health Research Authority. > Minor updates to reflect content of revised Research Governance Policy. Section 10.0: > Addition of new section to alert readers to the existence of amendment SOPs. 5 12/07/2016 09/08/2016 > Amendments throughout to reflect current terminology/organisation names (previously NISCHR PCU, now Health and Care Research Wales Permissions Service; previously global checks, now study-wide checks; previously Research and Commercial Division, now Research and Innovation Services; previously National Research Ethics Service, now Health Research Authority). >Section 4.0: inclusion of detail about devolved UK nation permission processes. >Section 5.0: addition of reference to Sponsorship Assessment Process. >Section 6.0: revised to reflect current practice. >Section 7.0: new section describing current procedure regarding preparation of R&D application and requirement for presubmission review for UHB sponsored studies. Most of the content of section 7.0 existed elsewhere, but has been moved to better reflect the current process. >Removal of requirement for completion of pharmacy form. This form is no longer used (was section 7.2.2). >Section 8.0: updated to reflect current practice. Removal of option for ink sponsor signature as per updated HRA guidelines. >Incorporation of previous section 9.0 (IRAS) into new section 7.0 preparing an R&D application. >Section 10: updated to reflect current practice. Research & Development - Gaining NHS Page 3 of 17 Reference no: UHB 074
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CONTENTS PAGE 1.0 Introduction 7 2.0 Glossary 7 3.0 Flowchart 8 4.0 Key Approvals required for NHS R&D permission 10 5.0 Sponsorship 10 6.0 Scientific review 11 6.1 Scientific review by the Cardiff and Vale Research Review Service (CaRRS) 11 6.1.1 Documents required for scientific review 11 6.1.2 How to submit documents for scientific review 12 6.1.3 7.0 Post scientific review Preparing an R&D application 12 13 8.0 Governance review 14 8.1 Submission to the Health and Care Research Wales Permissions Service 15 8.2 Cardiff and Vale UHB specific requirements 15 8.2.1 Authorisation signatures 15 8.2.2 Good Clinical Practice (GCP) training 16 9.0 Ethical opinion 16 10.0 Amendments 18 11.0 Useful contacts 19 Appendix 1 Bibliography 20 Research & Development - Gaining NHS Page 5 of 17 Reference no: UHB 074
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1.0 INTRODUCTION All qualitative and quantitative research involving Cardiff and Vale University Health Board (UHB) staff, patients or resources must have NHS R&D permission from the UHB before beginning. This document provides guidance to researchers, research coordinators, sponsor organisations, and R&D Office staff on the process and requirements for obtaining this permission. Permission processes are different in each UK nation. This document focuses on the process for obtaining permission for studies which are led from Wales and/or which involve Welsg NHS organisations. For guidance on obtaining NHS R&D and ethical permissions from other UK nations, please refer to guidance issued by those nations. 2.0 GLOSSARY CaRRS CTIMP GCP HRA IRAS NHS R&D REC SSI SAP - Cardiff and Vale Research Review Service - Clinical Trial of an Investigational Medicinal Product - Good Clinical Practice - Health Research Authority - Integrated Research Application Service - National Health Service - Research and Development - Research Ethics Committee - Site Specific Information - Sponsor Assessment Process 3.0 FLOWCHART The flowchart below gives a brief overview of the major elements of the process for obtaining NHS R&D permission to undertake research in Cardiff and Vale UHB. The procedure applies to all types of research, both qualitative and quantitative. Permission processes will be different depending on the location of the lead site of the research, and where it will be taking place (see section 4.0). Research & Development - Gaining NHS Page 7 of 17 Reference no: UHB 074
Obtain Sponsorship in principle Has protocol had adequate favourable independent scientific review? No Obtain science review Yes Complete IRAS forms and all supporting study documentation Is Cardiff and Vale UHB the sponsor? Yes No 1. Provide all study documentation to R&D Office for pre-submission review. 2. Make any changes requested by R&D office. 3. Action any items identified by R&D Office. 4. In IRAS, obtain sponsor s representative authorisation. 1. Telephone R&D Office to discuss study prior to submission (SSI Q23). 2. Action any items identified by R&D Office. 3. In IRAS, obtain sponsor s representative authorisation. Submit NHS R&D / REC applications Where required, submit applications for NHS Research Ethics review/ MHRA review / other regulatory approvals Submit R&D application to Health and Care Research Wales Permissions Service Permissions Service notifies R&D Offices in participating NHS organisations that governance review is to be completed Has a complete application package been submitted? Yes No Permissions Service & R&D office complete governance review Submit missing documentation to R&D Office & Permissions Service NHS R&D/REC/ other permissions issued Begin project Research & Development - Gaining NHS Page 8 of 17 Reference no: UHB 074
4.0 KEY APPROVALS REQUIRED FOR NHS R&D PERMISSION Before starting a research project involving UHB staff, patients or resources, researchers need to have four key approvals in place: Sponsorship secured Adequate scientific review Adequate governance review Favourable ethical opinion Approval processes are different in each UK nation. A shared agreement between the Devolved Administrations and the Health Research Authority (HRA) continues to ensure that existing UK compatible permissions systems support cross border research studies. The lead nation provides assurances about the governance assessment and legal compliance of a research study. Each participating nation accepts these assurances, as far as they apply, removing unnecessary duplication. For studies where the lead NHS R&D office is in England, HRA approval will be needed. HRA Approval assesses a research study s regulatory and legal compliance, including NHS REC review, where required. The Health and Care Research Wales Permissions Service holds a similar role when the lead NHS R&D office is in Wales. For studies led from Scotland, The NHS Research Scotland Permissions Coordinating Centre (NRS Permissions CC) offers a coordinated and streamlined process for obtaining Scotland-wide NHS R&D permission for multicentre clinical studies. For studies led from Northern Ireland, The NI R&D Application Gateway facilitates and supports the process of gaining Research Governance Permissions for multicentre studies involving Northern Ireland. 5.0 SPONSORSHIP Under the Research Governance Framework for Health and Social Care in Wales, 2 nd edition (2009), a sponsor organisation must be identified for all research studies. This is usually the employer of the Chief Investigator (CI), the main funder, or for projects undertaken in fulfilment of an educational qualification, the Higher Education Institution awarding the degree. The Chief Investigator (CI) or Principal Investigator (PI) should identify the sponsor organisation early in the planning process and gain agreement in principle that they will undertake this role. The sponsor is responsible for overseeing arrangements for initiation, management and resourcing of a study, for ensuring scientific and ethical review is undertaken, and for overseeing ongoing arrangements for monitoring and reporting. Researchers who require the UHB to act as sponsor for a study should discuss this when submitting an application to the R&D Office for either a) scientific review (see section 6.0) or b) pre-submission governance review (see section 8.0). Clinical Trials of an Investigational Medicinal Product (CTIMPs) requiring sponsorship by either the UHB or Cardiff University will need to be considered by the relevant Research & Development - Gaining NHS Page 9 of 17 Reference no: UHB 074
organisation(s). For UHB CTIMPs the decision to sponsor is managed through the Sponsorship Assessment Process (SAP). Researchers must contact the UHB R&D Office or Cardiff University Research and Innovation Services (RIS), as appropriate, to discuss individual requirements. If a project is sponsored by a commercial company, the researcher should contact the Commercial Trials Administrator for advice before proceeding. Telephone 029 2074 5339 or email CAV_commercial.trials@wales.nhs.uk. 6.0 SCIENTIFIC REVIEW All research protocols must undergo an adequate independent scientific review before an R&D application for governance review can be submitted. Scientific review should be provided either by: a funding organisation named on the Health and Care Research Wales Clinical Research Portfolio eligible funders list ; the commercial organisation acting as sponsor; a NHS R&D scientific review Panel; a scientific review process recognised as adequate by the NHS organisation hosting the study. For studies sponsored by the UHB, or Cardiff University, if no adequate independent scientific review has already taken place, this review can be undertaken by the Cardiff and Vale Research Review Service (CaRRS). Researchers who are unsure as to whether their protocol has had adequate scientific review should approach the organisation sponsoring their study for further advice. 6.1 Scientific review by the Cardiff and Vale Research Review Service (CaRRS) CaRRS is a joint UHB and Cardiff University research review Panel consisting of expert reviewers who assess research proposals to ensure they are of sound scientific or methodological quality and value. 6.1.1 Documents required for scientific review For studies requiring scientific review by CaRRS, a study protocol must be submitted to the R&D Office together with any other available relevant documentation e.g. questionnaires, interview schedules, participant information sheets, consent forms or agreements. Protocols for Clinical Trials of Investigational Medicinal Products (CTIMPs) should follow the International Conference on Harmonisation: Harmonised Tripartite Guideline for Good Clinical Practice E6 (CPMP/ICH/135/95), European Commission (2002) (ICH-GCP). Protocols for non-ctimps should follow the format described in the R&D Office Information Sheet, Protocol Content (ISR-RP-004). Please contact the R&D Office for an up-to-date version. Research & Development - Gaining NHS Page 10 of 17 Reference no: UHB 074
6.1.2 How to submit documents for scientific review All documents should be emailed to CAV_research.development@wales.nhs.uk. The following additional information should be included in the covering email: Name, contact details and employer of Principal Investigator Details of academic qualification being undertaken, where appropriate Details of academic institution supervising the study, where appropriate Details of proposed funding arrangements Details of proposed sponsor organisation Where the above is not provided by the investigator, the R&D Office will contact the PI to obtain the information before the protocol is submitted to CaRRS for review. 6.1.3 Post scientific review Following CaRRS review, the researcher will be notified by email of the review outcome. Where the Panel requests clarifications / revisions to the protocol, the researcher will be asked to provide a response to the queries. Occasionally, the Chair of CaRRS may request to meet with the researcher to discuss the proposal in more detail. Once the Panel is satisfied with the scientific and methodological quality of the study, the researcher will be notified by letter and advised on the next steps in preparing an R&D application. The procedure will differ depending on the study sponsor (see section 7.0). 7.0 PREPARING AN R&D APPLICATION The R&D application consists of completed, relevant forms from the online Integrated Research Application System (IRAS) together with supporting study documentation i.e. protocol, participant information sheets, consent forms, questionnaires etc. Guidance on content of participant information sheets and consent forms can be found on the HRA website. IRAS can be accessed on-line at www.myresearchproject.org.uk and is used to apply for NHS governance review, NHS ethics review, and to a number of additional bodies which may be relevant for some types of project (e.g. the Medicines and Healthcare products Regulatory Agency (MHRA) for CTIMPs). For NHS governance review in Wales, the researcher must complete the following: NHS R&D form this provides an overview of the study (save in pdf and xml formats) Site Specific Information (SSI) form this provides information on local involvement. A separate SSI form must be completed for each participating NHS organisation in Wales (save in pdf and xml formats) Research & Development - Gaining NHS Page 11 of 17 Reference no: UHB 074
NHS R&D and SSI form checklists these are used to confirm that all documents pertaining to the application have been provided Guidance on creating xml / pdf files and IRAS checklists is available from the IRAS website or the Permissions Service. The IRAS form includes a number of declarations which must be completed as electronic authorisations within IRAS. Please note that if any subsequent alterations are made, electronic authorisations will be invalidated by the IRAS system. Further guidance on using IRAS for an R&D application is available from the R&D Office. A national helpline is available during office hours to provide technical support for IRAS users (see IRAS website for phone and email contact details). The SSI form states that the local research team are responsible for contacting the local NHS R&D office about the research project. Failure to engage with the local NHS R&D offices may lead to unnecessary delays in the process of NHS research permissions. The researcher must complete a declaration in Q23 of the SSI form to confirm that the R&D office has been contacted to discuss the needs of the project. Discussion with the R&D Office differs depending on the study sponsor: For studies sponsored by the UHB: The researcher must provide the R&D Office with the full R&D application package. These will be used to undertake a presubmission review in which the R&D Office will assess the application to identify points which need to be amended, or where additional action is required. The aim is to ensure the application meets the requirements to satisfy the governance review. Once the pre-submission review has been satisfied, the researcher will be advised to request a Sponsor s Representative authorisation via IRAS. For studies sponsored by other organisations: The researcher should telephone the R&D Office to complete a short, pre-submission questionnaire. This is used to identify any areas which will need to be addressed as part of the governance review. The researcher should undertake any actions identified during the telephone conversation in order to minimise delays in the governance review process. 8.0 GOVERNANCE REVIEW The R&D application is used to undertake a NHS Governance review. This review is required for any prospective or retrospective research involving Cardiff and Vale UHB including research involving: Staff as researchers Staff as participants UHB patients or access to their data or samples Relatives and carers of UHB patients UHB resources Research & Development - Gaining NHS Page 12 of 17 Reference no: UHB 074
The process of obtaining governance review is different depending on which UK nation is leading the research. For studies led from England, HRA review will be needed (see HRA website for details). For studies led from Scotland or Northern Ireland, please contact local R&D Offices for guidance. Where the research study is led from Wales and/or the research involves Welsh NHS organisations, the governance review process is coordinated in Wales by the Health and Care Research Wales Permissions Service (Permissions Service). This service oversees the assessment of a complete application package and completion of a series of study-wide and local governance checks to ensure that any risks involved with a study have been satisfactorily addressed. Where an incomplete application package is received, the researcher will be notified by email of what is required to complete the application package. For multi-nhs organisation studies, study-wide checks will be completed by the Permissions Service, whilst local checks will be completed by each participating NHS organisation. For single-nhs organisation studies, both study-wide and local governance checks will be completed by the NHS site hosting the study. The R&D office will liaise with the researcher and/or sponsor as necessary to satisfy the governance review. Once a completed application package has been received and all governance checks have been satisfied, NHS R&D permission will be issued. 8.1 Submission to the Health and Care Research Wales Permissions Service Once a study has had favourable, independent scientific review and once the presubmission review/discussion has been completed (see section 7.2.1), the R&D application may be submitted by email to the Health and Care Research Wales Permissions Service. Researchers should consult Health and Care Research Wales guidance: Gaining NHS research permission in Wales a guide for researchers for further details. 8.2 UHB specific requirements 8.2.1 Authorisations required prior to R&D approval Cardiff and Vale UHB specific authorisation requirements are as follows: Directorate R&D Lead - required for all projects Authorised support service signatory needed for projects using support departments for tests/services, for example, blood tests carried out by biochemistry, x-rays in radiology. The researcher must obtain email authorisations from the designated signatories before submitting an R&D application. Failure to do so may delay the time to NHS R&D permission. Details on appropriate signatories will be provided by the R&D Office as part of the pre-submission review/discussions. Authorisations may be included with the R&D application submission to the Permissions Service or emailed directly to the R&D Office. All authorisations should include the study Research & Development - Gaining NHS Page 13 of 17 Reference no: UHB 074
title and the IRAS project number (from the project navigation and my projects pages of the IRAS form). If a project is sponsored by a commercial company, the researcher should contact the Commercial Trials Administrator for advice before proceeding to obtain authorisations. Telephone 029 2074 5339 or email CAV_commercial.trials@wales.nhs.uk. 8.2.2 Good Clinical Practice (GCP) training The UHB Research Training Requirements Including GCP procedure (SR-RG-016 / UHB 317) requires that all Principal Investigators undertake approved Good Clinical Practice training every two years. Other research team members may require GCP training, depending on the nature of the study and their specific delegated responsibilities. GCP training should be considered best practice for all staff undertaking research activities. Evidence of GCP training should be submitted for all relevant research staff in accordance with the requirements of this procedure. A copy of the guideline is available via the Cardiff and Vale UHB intranet; from the Cardiff and Vale UHB R&D Office 9.0 ETHICAL OPINION NHS Research Ethics Committees (RECs) are not connected to Universities, NHS R&D Offices, sponsors or funders. They offer an independent opinion about whether the proposed participant involvement in a study is ethical. Where it is required, written evidence of a favourable opinion from an appropriate REC must be obtained prior to commencing research. Researchers should consult the NHS Health Research Authority website and contact their sponsor if further advice is required. Before submitting an application to a REC it must be authorised by a designated signatory on behalf of the sponsor organisation. For studies sponsored by Cardiff and Vale UHB this authorisation is requested from the R&D Office via the Integrated Research Application System (IRAS). The authorisation confirms to the REC that the project has been satisfactorily scientifically reviewed. For studies sponsored by other institutions, refer to their local procedures for obtaining a sponsor s representative signature. Detailed information on applying for an ethics opinion can be obtained on-line from the NHS Health Research Authority website.. 10.0 AMENDMENTS Research & Development - Gaining NHS Page 14 of 17 Reference no: UHB 074
Amendments are changes to research after approval has been given. Amendments may arise from changes made to a protocol, other study documentation or other aspects of arrangements for managing and conducting a research study. For information on classification of amendments and the procedures to be followed when a study amendment is required, please refer to the HRA website and the following R&D documents: UHB302: Managing amendments for UHB sponsored research ISR-RP-015: Amendments to research studies which are being hosted by Cardiff and Vale UHB information on submission and review Research & Development - Gaining NHS Page 15 of 17 Reference no: UHB 074
11.0 USEFUL CONTACTS Cardiff and Vale UHB R&D Office 2 nd Floor TB2, University Hospital of Wales Heath Park Cardiff, CF14 4XW 029 2074 6986 CAV_research.development@wales.nhs.uk Wales REC 1 Health and Care Research Wales Support Centre Castlebridge 4 15-19 Cowbridge Road East Cardiff CF11 9AB 02920 230457 (see http://www.healthandcareresearch.gov.wales/gaining-ethical-approval/ for details of Wales RECs 1 7) Carl.Phillips@wales.nhs.uk (for ethics queries) Health and Care Research Wales Permissions Service Health and Care Research Wales Support Centre Castlebridge 4 15-19 Cowbridge Road East Cardiff CF11 9AB 029 2023 0457 Research-permissions@wales.nhs.uk Cardiff University Research and Innovation Services 7th Floor, 30-36 Newport Road Cardiff, CF24 0DE 029 2087 5834 Falconerhe@cardiff.ac.uk Research & Development - Gaining NHS Page 16 of 17 Reference no: UHB 074
Appendix 1 Bibliography Research Governance Framework for Health and Social Care in Wales. Second edition (2009). Welsh Assembly Government [on-line]. Available from: http://wales.gov.uk/docs/dhss/publications/governance/090929researchen.pdf [Accessed: 24 May 2016] EMeA European Medicines Agency (2002) ICH Topic E6 (R2) Guideline for Good Clinical Practice [on-line]. 23 July 2015 Available from: http://www.ema.europa.eu/docs/en_gb/document_library/scientific_guideline/2015/08/wc 500191488.pdf [Accessed: 24 May 2016] IRAS Integrated Research Application System (2011) IRAS Integrated Research Application System [on-line]. Available from: https://www.myresearchproject.org.uk/ [Accessed: 24 May 2016] Health and Care Research Wales [online]. Clinical Research Wales eligibility. Available from: http://www.healthandcareresearch.gov.wales/eligibility/ [Accessed 24 May 2016] Health Research Authority [online]: www.hra.nhs.uk [Accessed 24 May 2016] Health and Care Research Wales. Gaining NHS research permission [online]. Available from http://www.healthandcareresearch.gov.wales/gaining-nhs-research-permission/ [Accessed 24 May 2016] NHS Research Scotland [online]: http://www.nhsresearchscotland.org.uk/services/permissions-co-ordinating-centre [Accessed 14 June 2016] Research and Development in Northern Ireland [online]: http://www.research.hscni.net/nird-application-gateway [Accessed 14 June 2016] Research & Development - Gaining NHS Page 17 of 17 Reference no: UHB 074