Airedale NHS Foundation Trust Research Management Approval Submission Pack CONTENT Page Number Introduction 2 Research Governance Framework 3 Step-By-Step guide 4 Process flowchart 7 R&D Department contact details 8 APPENDIX I Submission checklist 9 APPENDIX II Peer review guidelines 11 Peer review form 12 Peer review response form 13 APPENDIX III Sponsorship 14 APPENDIX IV Research Passport Scheme 16 Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 1 of 15
INTRODUCTION Research and Development Department The aim of the Research and Development Department (R&D) is to help build research capacity within Airedale NHS Foundation Trust and to develop partnerships between the Trust, academic institutions and our partners in the local health community. The Department assists and helps to ensure that all research associated with the Trust, including clinical trials, is of high quality, ethically sound and of benefit to patient care, treatment and rehabilitation. The Department aims to encourage all clinical professionals to adopt an evidence-based approach to clinical practice. Airedale NHS Foundation Trust has enthusiastically adopted this approach, which is led by the Research and Innovation Strategy Group (RISG), where we discuss and evaluate ongoing/proposed research. The aim of this pack is to provide researchers with guidance on conducting good research in a proper manner whilst adhering to guidelines and policies set forth by the Department of Health (DH) and other organisations. N.B. During 2015 the process of obtaining NHS permission to do research is changing and will gradually be devolved to the Health Research Authority (HRA). This application pack will be updated throughout 2015 as changes occur. Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 2 of 15
RESEARCH GOVERNANCE FRAMEWORK FOR HEALTH AND SOCIAL CARE The Department of Health s Research Governance Framework for Health and Social Care (2 nd Edition) published in 2005 gives guidance on good practice in the collaboration between researchers, health and social care teams and their employers and funders. This framework includes guidance relating to the Medicines for Human Use (Clinical Trials) Regulations 2004, the Human Tissue Act 2004 and the Mental Capacity Act 2005. Clinical research is part of core NHS business and is essential to creating an evidencebased decision making culture. According to the NHS Constitution 2013 and the Health and Social Care Act 2012 the NHS in England has a statutory responsibility to promote clinical research. Research governance concerns all those who: participate in research host research in their organisation fund research proposals or infrastructure manage research undertake research The purpose of this document is to provide guidance on: the standards required for high quality research at Airedale; how to apply for permission to carry out research at Airedale; the processes and procedures followed to ensure that research meets the high standards required; how research will be assessed and monitored. This is in order to improve the quality of research and safeguard the public by: enhancing ethical and scientific quality; promoting good practice; reducing adverse incidents and ensuring lessons are learned; preventing poor performance and misconduct. The Research Governance Framework for Health and Social Care document can be found at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/139565/dh _4122427.pdf. Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 3 of 15
SUBMISSION PROCESS FOR RESEARCH MANAGEMENT APPROVAL AT AIREDALE NHS FOUNDATION TRUST STEP-BY-STEP GUIDE Before a research study begins, the research team MUST obtain both Research and Development (R&D) approval and written ethics committee approval. Approval is required for research that involves patients, patient data, human organs/tissue, NHS staff or NHS facilities. STEP 1 ASCERTAIN WHETHER YOUR PROPOSED PROJECT FALLS UNDER THE REMIT OF RESEARCH Research can be defined as the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods. Research Governance Framework for Health and Social Care, second edition, 2005 Research generates evidence to refute, support or develop a hypothesis. Research aims to find out what happens if we add or change (manipulate) clinical or service practice in some way, or aims to find out in a systematic way the views/ opinions/ experiences/ understandings of stakeholders. It may also require only observation, without any intervention, and may be prospective or retrospective. It may be qualitative or quantitative (or both) in approach. The results of research or the theories derived from the research should be generalisable or transferable beyond the population upon which the research was based. If you are unsure whether your study is defined as research, further information is available in the leaflet Defining Research, or contact the research office (details at the end of this document). Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 4 of 15
STEP 2 IRAS (INTEGRATED RESEARCH APPLICATION SYSTEM) The standard application for Ethics and Research Management approval is a single, Integrated Research Application System (IRAS). IRAS can be found at the following web page: www.myresearchproject.org.uk. Please refer to Appendix I for the checklist of supporting documentation to be sent alongside the application to the Research Office. Contact the Research Office for further advice on submitting your research proposal. Contact details: Mechele Couch-Upite Research Support and Governance Manager C/O Research Office Ward 12 Airedale General Hospital Skipton Road Keighley, BD20 6TD Tel: 01535 294655 Direct email: Mechele.Couch-Upite@anhst.nhs.uk Alternative email: research.development@anhst.nhs.uk For information on the Ethics process, please refer to the Health Research Authority (HRA) website: http://www.hra.nhs.uk/research-community/applying-forapprovals/research-ethics-committee/. There is a central telephone number for booking an ethics committee approval for your study. This process can be concurrent with your application for NHS approval. Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 5 of 15
STEP 3 PEER REVIEW Ensure your project (proposal/protocol) has been peer reviewed. Please refer to accompanying peer review guidelines. Appendix II. If you are a student, a letter or email from your University supervisor may be sufficient. STEP 4 RESEARCH PASSPORTS, HONORARY CONTRACTS AND LETTERS OF ACCESS If you are not NHS staff or do not hold an honorary contract with the NHS you will be required to apply for an Honorary Contract (HC) or Letter of Access (LOA). For guidance please refer to the guidance notes in Appendix IV. Alternatively contact the Research Office for advice or follow this link for additional information: http://www.nihr.ac.uk/policy-and-standards/research-passports.htm. STEP 5 SUBMISSION FOR APPROVAL Submit your application to the Research Office for Research Management approval. We require: 1 signed electronic or hardcopy of the SSI (Site-Specific Information) form (If this is a multi-site study) 1 signed electronic or hardcopy of the R&D form (IRAS Parts A-D) Letter from Sponsor* Supporting documentation** Please send all documentation to Mechele Couch-Upite, Research Support and Governance Manager (address above). *Please refer to the Sponsorship section (Appendix III). **Please refer to Submission Checklist (Appendix I). Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 6 of 15
RESEARCH MANAGEMENT APPROVAL PROCESS Research Applicant Contacts Research Office REC Approval Required R&D approval required No Approval Required Researcher submits IRAS Application and applies for ethics and R&D approval File in Research Office REC Review for Ethical Approval Review for Science and Funding Issues N Return queries to researcher or inform researcher that project cannot commence Y Study receives R&D approval N Return queries to researcher or inform researcher that project cannot commence Re-submission Research Office to notify researcher they can commence project subject to regular reports and audit Re-submission where applicable Final study report to be sent to the Research Office Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 7 of 15
Please feel free to contact any member of the Research Team for further assistance or advice. Carole Paley Head of Research & Innovation 01535 292278 Carole.Paley@anhst.nhs.uk Mechele Couch-Upite Research Support & Governance Manager 01535 294655 Mechele.Couch-Upite@anhst.nhs.uk Lucy Sootheran Research Support and Governance Officer 01535 294655 Lucy.sootheran@anhst.nhs.uk Airedale NHS Foundation Trust Research Support & Governance Office C/O Research Office Ward 12 Airedale General Hospital Skipton Road Keighley, BD20 6TD Research.development@anhst.nhs.uk Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 8 of 15
APPENDIX I SUBMISSION CHECKLIST FOR R&D APPROVAL PLEASE ENSURE THAT YOU: Use the checklist available on IRAS to ensure that the correct documentation is submitted. The R&D Management Approval process will not commence until a complete and valid application is received. When collating please do NOT staple documents as they will need to be photocopied. The following documents may be required, depending on the type of study you are proposing. Covering Letter National NHS R&D application Form (IRAS Parts A-D) National NHS R&D SSI Form (only for multi-site studies) Main ethics approval letter Letter from sponsor (or email if University sponsored) Letter from funder Research Protocol Clinical Trials Agreement Form of Indemnity (for pharmaceutical/ industry-sponsored studies) MHRA Authorisation (for clinical trials involving medicinal products or medical devices) Evidence of peer review (if required by R&D office) Questionnaires (if applicable) Letters of invitation to research participants (if applicable) Participant information sheets Participant consent form Data collection sheets/case report forms Summary CV for site Principal Investigator Honorary Contract/Letter of Access (if required) Other relevant information Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 9 of 15
APPENDIX II PEER REVIEW GUIDELINES In order to ensure your project complies with all components of the Research Governance framework for health and social care, the project must undergo a process of peer review prior to submission for ethical and research management approval. Peer review intends to assess research in terms of scientific quality, strategic relevance and value for money and according to the Research Governance Framework (2005) should be independent, expert and recorded. Independent reviewer has no involvement in any part of the project whatsoever and has no conflicts of interest. Expert reviewer has the appropriate qualifications and expertise to comment on the rationale, scientific quality, methods and outcome measures. Recorded a clear written or typed comprehensive review of the project. Externally Funded If your project has been or is being reviewed by a funding body (e.g. MRC, Cancer Research Campaign etc.) then details should be given on the ethics application form. No further peer review of these projects is required. Student Projects One peer review is required and should be provided by your supervisor. Other Projects For projects not falling into the above groups Two peer reviews are required prior to submission. It is the researchers responsibility to provide an independent, expert, recorded peer review. Once you have identified a reviewer, they must be supplied with sufficient information to perform an appropriate critique of the proposed project. The attached peer review form and response form may be used, if you wish, as evidence that you have addressed the peer reviewer s comments or justified not doing so. Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 10 of 15
R&D PROJECTS PEER REVIEW Chief Investigator Ethics Reference Number Full Title of Proposed Project Thank you for your help in refereeing this project. Please could you give your views on the overall quality and relevance of this project, dividing comments into major and minor concerns? Points for consideration: is there a hypothesis/or clear study objective, does the background section require any more work, are the methods clear and appropriate for the question posed, does the clinical/biological significance require further explanation, are study numbers justified, is further statistical analysis required? Major Comments Minor Comments In your opinion does the investigator have the experience to perform the study? YES/NO I declare that I have not been involved in the design of this study and that I have no conflicts of interest in acting as a referee. Signature Printed Name Date Position Please return this document to the researcher. Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 11 of 15
R&D PROJECTS PEER REVIEW RESPONSE FORM Chief Investigator Ethics Reference Number Full Title of Proposed Project Reviewer Please address each of the peer reviewers comments in turn. Provide justification if a comment has not been acted upon. Major Comments 1. 2. 3. 4. Minor Comments 1. 2. 3. 4. 5. 6. Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 12 of 15
APPENDIX III SPONSORSHIP Does your research study have a Sponsor as defined in the Research Governance Framework for Health & Social Care? The sponsor is responsible for ensuring that specific duties are performed, properly distributed, allocated and accepted by investigators and their employing institutions and care organisations, and for the governance of the research study from conception to final completion, including design, management, and finance. The sponsor satisfies itself that appropriate checks have been undertaken to ensure that the study meets the relevant standards, and makes sure arrangements are put and kept in place for authorisation, management, monitoring and reporting. Full details are contained in the Research Governance Framework (DH 2005) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031), which should be consulted for further information. Basic Principles 1. The sponsor is the individual or institution that takes responsibility for the initiation, management and financing (or arranging the financing) of the study. In the case of academic research the University acts as sponsor. The sponsor satisfies itself that the study meets the relevant standards and ensures that arrangements are put and kept in place for management, monitoring and reporting. 2. Sponsors can formally delegate one or more of the elements of sponsorship, e.g. to the Chief Investigator, but the sponsor remains accountable for all aspects of sponsorship, whether delegated or not. 3. The factors which determine sponsorship are the nature of the funding body, the employer of the chief investigator and the duty of care to patients as outlined below. a) Where a commercial organisation (company) funds a study for which it retains ownership of the intellectual property rights, the company invariably acts as the sponsor. b) Where a study is funded by a research council, medical charity or other non-commercial body, the funder may be willing to act as the sponsor, particularly where it also employs members of the research team or retains an interest in any intellectual property that is generated. Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 14 of 15
c) Where an investigator undertakes a study on behalf of his/her employing institution and the funding body is unwilling to act as the sponsor, the employing institution may act as a sponsor. d) Where an investigator undertakes a study in which the participants are owed a duty of care by the host rather than the investigator s employing institution, the host institution may act as a sponsor. However, the duty of care remains the responsibility of the host institution, irrespective of whether they are a sponsor. e) Under the Clinical Trials Regulations, it is possible for an individual investigator to take on the role of sponsor. However, many institutions prohibit their employees from doing so, in view of the potential risks this might involve. f) Where no other sponsor can be found to take on the role, the NHS care organisation concerned may act as the sponsor. If no one is willing to take on the sponsor role, the study may not proceed. 4. Where two or more organisations share a significant interest in a study, e.g. one as employer of the Chief Investigator and another as the principal host institution, they may elect to act as co-sponsors and divide the responsibilities of sponsorship between them. The allocation of the responsibilities of sponsorship will be determined by the expertise and capacity of the individual or institution to discharge them in relation to the risk posed by the study. 5. For clinical trials of medicines, the UK Clinical Trials Regulations require insurance or indemnity for liabilities of the sponsor and of the investigator to be specified. The Regulations also require the sponsor to ensure that the trial conforms to GCP as set out in Schedule 1 of the Statutory Instrument. The Regulations do not change existing liabilities. 1 1 Responsibilities, liabilities and risk management in clinical trials of medicines. Universities UK & DH joint statement, May 2004. Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 15 of 15
APPENDIX IV HONORARY CONTRACTS Do all members of the research team have substantive or honorary contracts of employment with Airedale NHS Trust? The Department of Health Research Governance Framework makes explicit requirements with regard to honorary contracts. It states that researchers who do not have a paid contract with a NHS body but whose research involves NHS staff or patients, their organs, tissue or data must have an honorary contract with an NHS body. There is mutual advantage in this arrangement. The NHS body accepts that researchers with honorary contracts (and thus University and other non-nhs employees) are covered, like NHS staff, by NHS indemnity. The NHS organisation must discharge its 'duty of care', for which the Chief Executive is personally accountable. By issuing University and other non-nhs staff with honorary contracts, Airedale ensures that all researchers working on its premises or otherwise with its staff, patients, their organs, tissue or data are contractually bound to take proper account of the NHS duty of care. Thus, these arrangements afford protection to both parties. If you work for an NHS organisation other than Airedale NHS Trust, you will require a letter of access from the Trust giving you permission to attend the Trust s premises for the required purposes. For more information and how to apply for an honorary contract/ letter of access, please contact Mechele Couch-Upite at the address provided, giving details of the research activity that you wish to carry out. In order to apply for an honorary contract you will be required to provide the following: Most recent Curriculum Vitae (CV) with contact details and date of birth. 2 completed written references (statements or references from the referee must be provided - not just contact details). If professionally registered, as required in current job and to fulfil your role under the honorary contact, please provide details of your registration. The dates as to when research work will commence and cease. Details of study title. REC number (if applicable). Name, address and contact number of current substantive employer/ place of study. We also accept Research Passports. Airedale NHS Foundation Trust R&D Study Submission Pack V 5.0 Page 16 of 15