NHS REC Applications

Transcription

1 This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document for training and reference purposes but are responsible for regularly checking the JRCO website for more recent versions NHS REC Applications SOP Reference: JRCO/SOP/003 Version Number: Final Version 6.0 Effective Date: 30/11/12 Review by: 29/11/14 Author: Becky Ward, Research Governance Manager Approved by: Gary Roper Date: 30/11/12 Version Date Reason for Change Final v July 2006 Final June 2007 Update Final June 2008 Annual Review Final February 2010 Update and Formation of Joint Research Office Final July 2011 Annual Review Final Nov 2012 Annual Review Final version /11/12 Page 1 of 17

2 Table of Contents 1. Purpose Page 3 2. Introduction 2.1 NHS REC Review 2.2 Alternatives to NHS REC review 3. Procedure 3.1 Complete the online Application Form 3.2 Complete the Applicant s Checklist 3.3 Decide Where to Apply/Book a Review Slot 3.4 Proportionate review (expedited review process for minimal risk/burden/intrusion studies) 3.5 Submission 3.6 Validation 3.7 Site Specific Information (SSI) 3.8 Review/Notification of Decision 3.9 Request for Further Written Information 3.10 After Approval Page 3 Page 3 Page 3 Page 5 Page 5 Page 6 Page 6 Page 9 Page 10 Page 10 Page 10 Page 11 Page References Page Appendix Appendix 1 Integrated Research Application System (IRAS) Content Index Integrated Dataset Page 14 Page 14 Final version /11/12 Page 2 of 17

3 1. PURPOSE This SOP details how to apply for NHS Research Ethics Committee (REC) approval for healthrelated research projects. It provides general information on the NHS REC system and outlines each step that should be completed in the application process. Please note the information within this SOP is only a summary. For more detailed guidance see the Standard Operating Procedures for RECs. SOP should also be used in conjunction with JRCO/SOP/002 Ethics Approval for Health-Related Research. The application form for UK REC review can be obtained via the Integrated Research Application System (IRAS) found at: which combines the ethics application with other regulatory forms such as MHRA applications. The IRAS application form replaces the NRES form. All UK studies must apply through this system. 2. INTRODUCTION 2.1 NHS REC Review NHS RECs will review most research conducted within the NHS. Such research could involve: Clinical Trials of Investigational Medicinal Products NHS patients/service users (including potential participants recruited by their past or present treatment and NHS patients treated under contracts with private sector institutions) Potential participants identified because of their status as relatives/carers of patients and users of the NHS Access to data (except anonymised data see alternatives to NHS REC section below), organs or other bodily material of past and present NHS patients Foetal material and IVF involving NHS patients Recently dead in NHS premises Use of/access to NHS premises or facilities Healthy volunteers, where a drug or device is being tested within the NHS A different ethics application route may be needed if your project involves gene therapy, is a Phase I CTIMP in healthy volunteers outside the NHS and/or only being conducted overseas. This is outlined further throughout this SOP and in JRCO/SOP/002 Ethics Approval for Health-Related Research. 2.2 Alternatives to NHS REC: Non-NHS resources/overseas research If your research involves: Non NHS resources Overseas research Then your project may be eligible for review by the Imperial College Research Ethics Committee (ICREC) For further information please see: or contact Christine Buicke, Research Final version /11/12 Page 3 of 17

4 Governance Coordinator Tel: Studies needing R&D only approval: Following changes (Sept 2011) to the remit of RECs in the UK, the following projects need management permission from host care organisations, but are excluded from REC review: Research involving health or social care services staff, who are recruited by virtue of their professional role (no patient involvement) Studies involving retrospectively collected anonymised data Researchers undertaking the above studies should contact the R&D Trust where they wish to conduct their study. The documents that will need to be submitted for this type of project are: R&D form (in IRAS) available at If you complete the filter questions as normal and only tick NHS/HSC Research and Development offices to Q4, this will create a simplified version of the application form Protocol Participant Information Sheet Consent Form Any other supporting documents you intend to use The JRCO will then assess the study and register it on our database. Please do not start your research until you have confirmation from the JRCO that the study has been registered and are in receipt of the Trust approval letter Tissue Bank Approval: Tissue only studies: For Imperial College studies where the only research being undertaken at Imperial is tissue collection (e.g. collecting biopsies, blood only), ethics approval may be obtained from the Tissue Bank, who have been delegated authority from the REC to approve this type of project. You are advised to contact the Tissue Bank for advice (see contact details in the table in section 3.3). This type of approval can only be considered if tissue collection is the only component of the research being undertaken. If there are other research procedures involved (e.g. questionnaires, scans) then a REC review will be needed. Key characteristics of the NHS REC system are that: All applications must be made by the Chief Investigator (CI) for the study. The CI must be professionally based in the UK. For international studies: o An application must be made to an ethics committee in the UK whether or not the study has a favourable ethical opinion outside the UK, and; o If there is a coordinating investigator outside the UK, a health professional based in the UK must be nominated as CI and take responsibility for the conduct of the research in the UK. The REC must give an opinion on a project within 60 days of receiving a valid application as required in law for CTIMPs and the Research Governance Final version /11/12 Page 4 of 17

5 Framework for all other research in the NHS (unless it is a trial of a medicinal product for somatic cell therapy or the product contains a genetically modified organism, in which case the time limit is 90 days). A single ethical opinion will be given for a project, regardless of the number of sites at which it is to be conducted. A main REC will be responsible for all aspects of the ethical review. The suitability of a research site and investigator taking part in the research will be made by site specific information form (SSI) and forms part of the single ethical opinion. Each research site should have a PI responsible for the management and conduct of research at that site. Participant Identification Centres: If research participants are being identified at another organisation this organisation may be classed as a Participant Identification Centre (PIC). A PIC is an NHS Trust where participants are identified and given information on a research project but no research activity (consent, medical screening, blood tests etc.) is taking place. If research activity is to occur at an NHS Trust it must be identified as research site and complete the site specific assessment process as described in section 3.7 of this SOP. 3. PROCEDURE The procedure for applying for NHS REC approval can be divided into the following steps. More detailed information on each step is given below. 1. Complete the online Application Form 2. Complete the Applicant s Checklist 3. Decide Where to Apply/Book a Review Slot 4. Submit 5. Validation 6. Site Specific Information (SSI) 7. Review/Notification of Decision 8. Request for Further Written Information 9. After Approval 3.1 Complete the Online Application Form (the information in this SOP is based on using version 3.4 of the online form) All applications must be made using the IRAS online application form which can be accessed at you are a first time user, you will need to register for an account online, which is activated immediately. You do not have to complete the application form in one go work can be saved and reloaded for further editing. The form is designed to save you time completing it. When you fill in certain answers, information will automatically populate in other relevant places, and your answers to certain questions will deactivate or activate other sections of the form. As a result, you are never likely to complete every single page the average is around 20 pages long. Final version /11/12 Page 5 of 17

6 The application form is structured as in the table below. question topic see Appendix 1. For a breakdown of each Part Project Filter A B Details Asks a limited number of key questions about the nature of your research. An application form specific to your project will be created from the answers you give. You need to select your answers carefully. Asks for generic information relevant to all research proposals. Certain questions will be deactivated depending on your answers to the project filter. Is divided into several discrete sections, which refer to particular specialist topics. These appear (or disappear) in response to your answers to the project filter. C Asks for a list of sites that the study will be conducted at. We have put together some Top Tips for making valid NHS REC applications, explaining how to avoid some of the more common errors in applying, see applications. More detailed information about using the form is available through the help pages on the IRAS form website Complete the Applicant s Checklist You must also complete the Applicant s Checklist with your IRAS ethics application to ensure that all of the paperwork required to support your application is sent to the REC. You can complete the checklist in hard copy or online through the IRAS form system. A different version of the checklist must be completed depending on the type of research; there is one for CTIMPs and another for any other research in the NHS. The online system automatically generates the relevant checklist depending on your answers to the project filter. You must ensure you have the appropriate copies of any supporting documentation, as outlined in the Applicant s Checklist. 3.3 Decide Where to Apply/Book an Agenda Slot When you finish your application, you need to decide where to apply and book an agenda slot at the next meeting of an appropriate REC. Bookings should either be made direct with a local REC in the NHS domain in which the research is to be conducted via the Central Allocation System (CAS) or via the London Local Allocation System (LLAS) depending on the nature of your project, as in the table below. A domain is the area covered by a NHS Strategic Health Authority. The relevant domain for Imperial College Academic Health Science Centre (AHSC) associated NHS Trusts is North West London and incorporates the following RECs: London - Chelsea Final version /11/12 Page 6 of 17

7 London Fulham London West London London Riverside London - Brent London - Central Contact details for above RECs can be found at Type of Project Student Research - non-ctimp NHS REC Booking Route Book with any REC or via the Local Allocation System (LAS) in the Strategic Health Authority For London Local Allocation System : Tel (9.30 a.m. to 4.30 p.m. weekdays) southenglandlas@nhs.net CTIMP Apply via Central Allocation System (CAS) (to a Type 3 REC) Tel: (9.30 a.m. to 4 p.m. weekdays). CAS@nhs.net Phase 1 CTIMPS in Healthy Volunteers ONLY Directly to an NHS REC or Independent Ethics Committee with Type 1 recognition. CAS can identify the first available agenda slot for NHS RECs in UK CAS Tel: (9.30 a.m. to 4 p.m. weekdays). CAS@nhs.net Recommend booking via CAS but can be booked through LLAS Medical Device LLAS Tel: (9.30 a.m. to 4.30 p.m. weekdays) CAS Tel: (9.30 a.m. to 4 p.m. weekdays). CAS@nhs.net Audit or Service Evaluation Check with Joint Research that this is not considered research. If it is not research, no ethical review required. Involves adults lacking capacity to consent - research falling under the Mental Capacity Act or Adults with Incapacity (Scotland) Act Apply via CAS (to a flagged REC) Tel: (9.30 a.m. to 4 p.m. weekdays). CAS@nhs.net Final version /11/12 Page 7 of 17

8 Any project which involves prisoners Apply via CAS (to a flagged REC) Tel: (9.30 a.m. to 4 p.m. weekdays). CAS@nhs.net Book via the Gene Therapy Advisory Committee (GTAC) Tel: Gene Therapy or Stem Cell Clinical Trials In addition to GTAC approval, any gene therapy study taking place at Imperial College Healthcare NHS Trust should also go through the ICHT Joint Clinical Research Safety Committee (JCRSC) Contact: Sharon Wood, Director of Safety Services, USC Ltd, Tel: Sharon.wood@imperial.nhs.uk ) Recommend booking via CAS but can be booked through LLAS Establishing a Research Tissue Bank LLAS Tel: : (9.30 a.m. to 4.30 p.m. weekdays) CAS Tel: (9.30 a.m. to 4 p.m. weekdays). CAS@northwest.nhs.uk Recommend booking via CAS but can be booked through LLAS Establishing a Research Database LLAS Tel: (9.30 a.m. to 4.30 p.m. weekdays) CAS Tel: (9.30 a.m. to 4 p.m. weekdays). CAS@nhs.net Research funded by US Department of Health and Human Sciences Apply via CAS (to a flagged REC) Tel: (9.30 a.m. to 4 p.m. weekdays). CAS@nhs.net Final version /11/12 Page 8 of 17

9 Research Not listed Above Proportionate Review If your research presents minimal risk, burden or intrusion for the participants, it may be eligible for proportionate review (see 3.4) Apply via LLAS Tel: (9.30 a.m. to 4.30 p.m. weekdays) To submit through the London Local Allocation Service Tel: Research involving tissue only collected at Imperial Research which involves: Healthy volunteers (except tissue and drug trials) Non-NHS Resources Overseas Research Staff only studies or research that involves retrospective data collection of anonymised data Contact Joint Research or Tissue Bank Manager. Tissue Bank Manager contact details: Sarah Chilcott-Burns Tissue Bank Manager Department of Surgery & Cancer Faculty of Medicine Imperial College London Hammersmith Hospital campus Rm G02, Ground floor G Block Du Cane Road London W12 0HS tel: s.chilcott-burns@imperial.ac.uk Apply through Imperial College Research Ethics Committee (ICREC) For further information contact: Christine Buicke (Joint Research Coordinator): c.buicke@imperial.ac.uk Contact Joint Research for R&D management permission: Becky Ward becky.ward@imperial.ac.uk for Hammersmith Hospital, Charing Cross Hospital projects ( ) Lucy Parker lucy.parker@imperial.ac.uk for St Mary s Hospital projects ( ) For further information on what constitutes an NHS domain or research site, please refer to paragraphs and of NRES s Standard Operating Procedures for Research Ethics Committees Proportionate Review The aim with the system of proportionate review is for a project to be reviewed, and a decision letter issued, within 14 working days of receipt of a valid application. However, the project may be referred on to a full committee if necessary (which will extend the timescale to the usual 60 days). For your application to be considered for proportionate review, it should fit one of the following categories: Research using data or tissue that is anonymous to the researcher Final version /11/12 Page 9 of 17

10 Research using existing tissue samples already taken with consent for research Research using extra tissue (e.g. further blood taken at time of routine sampling or tissue taken at clinically directed operation) Questionnaire research or research interview/focus group that does not include highly sensitive areas or where accidental disclosure would not have serious consequences Research surveying the safety or efficacy of established non-drug treatments, involving limited intervention and no change to the patients treatment Research involving children may be considered for proportionate review where it meets the above criteria. For further information, please refer to: Submission Once you have booked an agenda slot with the CAS or a local REC, you should be sent confirmation of your booking by , together with a unique REC reference number and the closing date for your application. You must make sure you add the REC reference number to your online application form at this point; it should be inserted in the header section of Page 1 (along with the name of the NHS REC and the submission date). After this information has been added, you will then need to seek the authorisations for your application (you can request electronic signatures) and proceed to submission. For bookings through the CAS, you will need to submit the application electronically to the REC that you have been allocated within 4 working days of your booking. For local applications, you may be required to submit within 4 working days of your booking or at another specified time before the meeting. For projects booked in for proportionate review, you have 2 days to submit your documents. You also need to send the REC office the following in paper copy by the closing date: Application form, with signatures in ink (or electronic signature) Applicant s Check List All relevant supporting documents, as indicated on the Checklist 3.6 Validation If your application is correct and you have submitted it with all the relevant documents by the closing date, you will be issued a validation letter within 5 working days, acknowledging your submission and confirming it is valid. The letter will also provide details (time and venue) of the REC meeting and invite you to attend. It is recommended that you attend the meeting, in order to answer any questions that the REC may wish to address. If Imperial College AHSC is named as sponsor for your research, the Joint Research (JRCO) will also receive a copy of this letter. 3.7 Site Specific Information (SSI) If your research is multi-site, once you have received the validation letter, you can instruct the PIs at each site to apply for SSI and Research and Development (R&D) approval. Final version /11/12 Page 10 of 17

11 Each PI should complete a SSI and R&D form and submit it to the relevant Research and Development (R&D) department, along with a signed and dated copy of his/her CV. If the research is single-site, then the CI should complete an SSI and R&D form and submit to the local R&D office with a signed and dated copy of his/her CV for review. Following a favourable ethical opinion, the PI should send the R&D office a copy of the REC letter and all supporting documents approved by the REC. Each R&D department will notify the PI whether or not there is any objection to the research on site-specific grounds. If there are no objections, the Trust will issue the PI with a R&D approval letter. Please note that any studies taking place on Imperial College Healthcare NHS Trust (ICHT) premises or recruiting ICHT Trust patients or staff must go through the ICHT Trust R&D process and obtain Trust R&D approval, in addition to ethical approval, before they start. Please see JRCO/SOP/031 Trust approval. If studies are taking place at other sites, permission must be obtained from the R&D department at each site, before any research commences there. 3.8 Ethical Review/Notification of Decision At the REC meeting, the Committee will review the ethics of your research in a completely independent way, free from bias or any conflicts of interest. They will consider such things as: Arrangements for the recruitment of subjects How informed consent will be obtained, including the adequacy of written information for participants Provision for compensation in the event of injury attributable to the research Any insurance or indemnity to cover the liability of an investigator or sponsor The Committee must notify you of their decision within 60 days of receiving your valid application. If you find this has not happened, you can complain to the Centre Manager in the first instance (details can be found on: You can also contact:. Complaints Manager Health Research Authority Skipton House 80 London Road London, SE1 6LH Tel: The REC can reach one of five decisions about your application: Final decision which could be favourable, favourable with conditions or unfavourable Provisional decision with a request for further written information No opinion a referee needs to be consulted Final version /11/12 Page 11 of 17

12 You should receive notification of the decision within 10 working days of the review meeting. If Imperial College AHSC is named as Sponsor for your research, the JRCO will also be notified of the ethical decision. 3.9 Request for Further Written Information The REC may make a provisional decision about your research and ask for further information about specific aspects of the project. Such a request can only be made once and the 60 day clock stops whilst the REC awaits your response. If Imperial College AHSC is sponsor of your study, you should send a copy of your response to the request for information and any supporting documents to the JRCO. If your response is not deemed satisfactory, the committee may ask you to respond again to the same questions (no new issues can be raised) or reject your application. The clock only starts again when a complete response is received. A final decision should then be issued After Approval Once you have received NHS REC approval, you still must not start your research until you have all the relevant regulatory approvals e.g. MHRA, NIGB, internal College approval and R&D approval from the relevant NHS Trust(s). Your research must start within 12 months of the date on which a favourable opinion was given. A study is generally considered to have commenced when the first subject gives written informed consent to participate or, where this does not apply, when any procedures in the protocol are initiated. If your research does not commence within 12 months, a substantial amendment will have to be submitted to the REC (and if it does not start within 24 months, you will have to re-apply). After approval, you will also need to: Apply to the main REC for approval of any substantial amendments to the protocol. For any Imperial AHSC sponsored study, you will need permission from the Joint Research before submitting any amendment. You must also apply to each Trust for R&D approval of any amendment before it is implemented at that site (please see JRCO/SOP/006 Amendments to Healthcare Research and JRCO/SOP/032 Trust Amendments ) Submit safety reports when appropriate (please see JRCO/SOP/001) Apply to the relevant R&D department for SSI of any subsequently enrolled research site Provide an annual progress report to the main REC each year of the project s duration Inform the main REC when the project finishes using the end of study declaration form Please note that if Imperial is sponsoring your study then you must also copy safety reports, annual progress reports and end of study reports to the JRCO. Final version /11/12 Page 12 of 17

13 4. REFERENCES Standard Operating Procedures for Research Ethics Committees (version 5.1), March Medicines for Human Use (Clinical Trials) Regulations 2004 NRES website IRAS form website NHS Health Research Authority website - Final version /11/12 Page 13 of 17

14 5. APPENDIX Appendix 1 IRAS Content Index - Integrated Dataset Part A A1 Title of research A2-1 Student project details A2-2 CI for student project A3 Chief Investigator details A4 Central study co-ordinator details A5-1 Research reference numbers A5-2 Other linked studies or applications A6-1 Lay summary A6-2 Overview of study purpose and design A7 Methodology description A8 Type of CTIMP A9 Phase of CTIMP A10 Principal research question/ objective A11 Secondary research question/objective A12 Scientific justification A13 Summary of design and methodology A14-1 Patient/public involvement A14-2 Consulting patients/public on use of data without consent A15 Sample group or cohort A16 First time in humans? A17 Inclusion/ exclusion criteria A18 Details of non-clinical interventions or procedures A19 Details of clinical interventions or procedures A20 Withholding of clinical interventions or procedures A22 Potential risks and burdens A23 Potential for distress in interviews, questionnaires, or group discussions A24 Potential benefits A25 Arrangements for continued provision of intervention after research finished A26 Potential risks for researchers A27-1 Identification of potential participants Final version /11/12 Page 14 of 17

15 A27-2 Screening personal data A27-3 Methods/resources A27-4 Access to personal data outside the care team A27-5 Consent to access identifiable data A28 A29 Details of recruitment through posters or adverts How and by whom potential participants will be approached A30-1 Informed consent A30-2 Recording consent A30-3 Use of data without consent A31 A32 A33-1 Time to decide on participation Participants involvement in other research Participants with inadequate English language skills or special communication needs A33-2 Welsh language A34 A35 A36 A37 A38 A39 A40 A41 A42 A43 A44 A45 A46 A47 A48 Providing information to participants during the research Loss of capacity to consent during the study Checklist of data processing activities Physical security of data storage Confidentiality of data Separation/encryption of identifiers Access to identifiable data during the study Analysis of data and location Data custodian Retention of identifiable data at end of study Period of data storage Long term arrangements for data storage Financial payments/incentives (participants) Financial payments/incentives (researchers) Conflicts of interest A49-1 Notifying GP or health professional A49-2 Permission to notify A50 A51 A52 A53 A54 Trial registration Dissemination of study results Ensuring the anonymity of published data Informing participants of the study results Scientific critique Final version /11/12 Page 15 of 17

16 A55 Assessment by Expert Advisory Group and Commission on Human Medicine A56 Statistical critique A57 Primary outcome measure A58 Secondary outcome measures A59 Sample size A60 Sample size determination A61 Randomisation A62 Methods of analysis A63 Key collaborators A64-1 Lead sponsor A64-2 Sponsor's contact point A64-4 Legal representative in EEA A65 External funding A66 Subcontractors A67 Previous rejection by a REC A68 Lead R&D contact A69 Duration of study A70 Definition of the end of the study A72 Overview of host organisations A73-1 Identification of participants by other organisations A73-2 NHS participant identification centres (PICs) A73-3 Resources for PICs A74 Monitoring and auditing the conduct of the research A75 DMC and stopping rules A76-1 Insurance/indemnity - management of study A76-2 Insurance/indemnity - design of study A76-3 Insurance/indemnity - conduct of study A77 No fault compensation A78 Intellectual property A79 Level of commercial participation Final version /11/12 Page 16 of 17

17 Part B - Additional information for specific applications B1 B2 B3 B4 B5 B6 B7 B8 B9 B10 Investigational medicinal products Medical devices (populates MHRA Devices forms) Exposure to ionising radiation (populates ARSAC forms) Use of existing human tissue samples Use of new human tissue samples Adults unable to consent for themselves Children Additional information for NIGB (populates NIGB form) Information security measures (populates NIGB form) Additional information for Ministry of Justice (populates MoJ form) Part C List of Research Sites C1 List of research sites NHS participant identification centres Part D - Declarations D1 D2 D3 D4 Chief Investigator Sponsor's representative Academic supervisor Information Guardian (NIGB only) Final version /11/12 Page 17 of 17