Implementing the Research Governance Framework Guidelines for New Researchers. Juliet MacArthur Alison Goulbourne

Transcription

1 Implementing the Research Governance Framework Guidelines for New Researchers Juliet MacArthur Alison Goulbourne March

2 Note from the authors This document is designed to provide a step by step guide to help explain how Research Governance usually works in practice. As this is a guide, it provides a hypothetical model of how to apply the Research Governance Framework (RGF) but in no way attempts to substitute local Health Board policy and procedures - it can not be specific as to how overarching principles of Research Governance are applied to particular work place settings. It is the responsibility of each researcher to find out for themselves how locally operated systems work in all areas where their research is to be conducted To collate this information we have included knowledge and expertise from key people in one Health Board to illustrate how Research Governance operates locally. These application processes and procedures may well be transferable to other NHS sites if operational systems and organisational structures reflect similar ways of working. Therefore we hope these guidelines will be particularly helpful in understanding how Research Governance applies to your own work setting, specific to your own research requirements. The main sources of information which underpin Research Governance guidelines (national and governmental information) are accessible through the Internet and listed below. We would strongly advise that they are referred to for a more detailed description of the framework and its underpinning principles. 1) The Chief Scientist Office website provides information and updates relevant to the Research Governance Framework (RGF) 2) Central Office for Research Ethics Committees New Operational Procedures for NHS REC s Guidance for applicants to Research Ethics Committees ( 3) Governance Arrangements for Research Ethics Committees (2001) GAfREC Available at ce/publicationspolicyandguidancearticle/fs/en?content_id= &chk=cncpyr 4) RD Direct - which provides a comprehensive guide to the research process. This is written from a Department of Health (England) perspective, although most of the issues are relevant to Scottish research studies ( 5) R&D Forum the network for R&D Management in health and social care, which again a Department of Health organisation ( 6) NHS Lothian University Hospitals Division, Research and Development Office. 7) Edinburgh Research and Innovation (ERI) 1

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4 Acknowledgements We would like to thank the efforts of certain individuals in helping to compile this guidance. Their expertise has enabled the evidence underpinning this guidance to be comprehensive and practical. We have made a conscientious effort to ensure that these guidelines are current, reliable and relevant to practice at the time of its most recent update (March 2007). Dr Yvonne Freer, Research and Practice Development Facilitator, Neonatology, NHS Lothian University Hospitals Division Professor Morag Gray,, Napier University Dr Colette Fulton, AHP Research Facilitator, NHS Lothian?? Rachel Smith Research and Development? 3

5 Contents Acknowledgements 2 Introduction 4 Section 1 ~ Planning or thinking into your study 5 Audit or research? 5 Reading about Research Governance 6 Finding out how Research Governance operates locally 6 Checking your study out first (scientific review) 6 Seeking out a sponsor 7 Information for students undertaking research and sponsorship 7 Section 2 ~ Obtaining management approvals 8 What is management approval? 8 Evidence of approval 8 Contractual issues 8 Section 3 ~ Obtaining a favourable ethical opinion 10 Completing your application form 10 Booking in your application form 11 Submitting your application form 11 Waiting for confirmation of a valid application 11 An overview of the ethical review process 11 for single site studies 11 for multi-site studies requiring SSA 12 Section 4 ~ Monitoring and auditing your study 12 Information specific to the monitoring of clinical trials 13 Section 5 ~ An illustrated guide to Research Governance 14 Conclusion 19 Appendix 1 Research, Audit or Service Evaluation: Guidance from COREC 20 Appendix 2 Glossary of Research Governance terms 21 Appendix 3 Background to Research Governance 25 Appendix 4 Responsibilities of the Principal Investigator 26 4

6 Introduction These guidelines have been written specifically for any health professional who is undertaking their first research study. It outlines essential elements of Research Governance (RG) as applied to studies conducted within NHS settings. Applying the RG Framework will ensure research is appropriately supported and governed through all stages of the research process - from planning through to conduct and reporting. Interpreting this guidance involves professional judgement. Using judgements effectively requires knowledge and experience in the delivery of quality research. This guidance therefore should be read in conjunction with Research Governance Framework for Health and Community Care (Scottish Executive and information available from local Research and Development Office(s) in your area of study. A comprehensive list of most UK research organisations including all NHS R&D Offices is available on the R&D Forum website ( The Chief Scientist Office website will provide regular updates of RG detail regarding standards and principles of good practice and requirements in legislation and regulation. Good governance ensures that the dignity, rights, safety and well-being of participants is upheld and that : - 1. arrangements are in place for promoting the safety and well being of everyone involved (including yourself); 2. the study is appropriately supported, managed and approved; 3. the Chief or Principal Investigator (CI, PI) can demonstrate that the study is worth doing, of high scientific quality, and represents good value for money. The booklet is divided into sections that describe essential elements of the framework. Some aspects of the process happen simultaneously. Section 1 prepares you for the nuts and bolts of securing required approvals and emphasises the importance of rigorous planning (which incorporates scientific review and securing a sponsor).. Section 2 explains what management approvals are and the role and function of the Research and Development Offices in this process. It gives some information on honorary contracts, which may be needed if you are not employed by the organisation where the data collection will take place. Section 3 describes the ethical review procedures which are essential for management to approve your study. Section 4 provides guidance on how to monitor and audit your study, once this is underway. This ensures high scientific quality underpins your investigative processes. 5

7 Section 5 provides examples of how RG is applied in practice. These examples could reflect research similar to your own. Appendices 1-4 will further help you find your way through RG as they provide guidance on research, audit and service evaluation, a glossary of key terms, a back ground to RG and the responsibilities of the Principal Investigator. Timescales RG can be complex to instigate as it requires various organisations involved with health care research to agree areas of responsibility. Many agreements relate to individual studies, and organisations that collaborate on research work have processes in place that facilitate agreement procedures. For example, NHS organisations, Universities, primary care practices and research networks, local authorities, and the voluntary sector can work together on research and often this collaboration is not formally recognised. Obtaining agreements from all those involved in research work, through R&D Offices, local managers and clinicians, takes time. Along side which, employment contracts may need to be secured and it is essential to ensure support for your research is appropriate and clearly negotiated through adequate sponsorship of the study. It is not surprising then to realise that a well-planned study will take at least three - six months to organise, and this must be factored into your time-management. Although this may sound onerous, once completed, it will make all the difference to how smoothly the project runs, and ensures it comes in on budget and on time. Rigorous planning therefore is vital so this first section will outline essential features of RG and what needs to be considered before starting. SECTION 1: Planning or your study. Is this audit or research? Appedix 1 sets out the boundaries between audit and research as these are often blurred. Helpful information on this issue is available on the COREC website in the form of: COREC s own differentiation between research, service evaluation and audit ( This information can be found in Appendix 1. guidance from the Research and Development Forum on developing procedures within NHS organisations for appropriate authorisation and management of research and related projects ( ) If the study can be interpreted as audit, submission to a Local Research Ethics Committee (LREC) is not required, and management agreements can usually be secured locally through 6

8 clinical effectiveness structures. If you are still not sure contact your local R&D or Clinical Effectiveness Department. If the study is research then it will require ethical review and agreements which include management approvals in all areas where the research is to be conducted. Read about Research Governance Access relevant documents and papers and read these to influence your thinking about the feasibility of your study. Two essential documents Research Governance Framework for Health and Community Care (CSO) and New Operational Procedures for NHS REC s Guidance for applicants to Research Ethics Committees (COREC) can be found on respective websites. If you are not familiar with the Data Protection Act (1998) and how it relates to your own study go to the NHS Data Protection Website or the Confidentiality Website or contact the local R&D office for further information. Think about the conduct of your study and ensure that these eight enforceable principles of the Data Protection Act are reflected in the planning stages of writing your proposal. Data must be: 1. Fairly and lawfully processed 2. Processed for limited purposes and not in any manner incompatible with those purposes 3. Adequate, relevant and not excessive 4. Accurate 5. Not kept for longer than is necessary 6. Processed in line with the data subject s rights 7. Secure 8. Not transferred to countries without adequate protection There is a useful e-learning module on Data Protection issues at Finding out how Research Governance operates locally Informal discussions with your local Research and Development Office is really important. They will let you know how local systems operate and who to involve in the early stages and may even have specific guidance information they can send you.. As agreements must be obtained 7

9 from ALL organisations involved in the study, begin to make preliminary enquiries through these local R&D Offices to find out your main contacts. Remember, if you are not sure how to contact your local R& D Office you can find a comprehensive list and contact details on the R&D Forum website ( Checking the scientific merit of the study. You need to ensure your study is doable, ethical and worthwhile meaning of benefit to the public either directly or indirectly. The RGF uses the term Scientific Merit to reflect the importance of this, and states that any study which duplicates other work unnecessarily or which is not of sufficient quality to contribute something useful to existing knowledge is in itself unethical and therefore not of scientific merit. You will need to consider therefore, who has the experience to assess the scientific merit of your study in an objective way. Usually, experts in the field are approached to offer independent advice on the quality of the study. The ethics committee will want to see evidence of scientific review, as will individual R&D Offices. They will notify you if they feel that the question of scientific merit has not been adequately addressed in your application and may propose that it is submitted through its own review structures. Arrangements for scientific review are in proportion to the scope and complexity of the research and the level of risk involved to those involved. So in the case of students undertaking research to obtain academic credit, scientific merit is normally provided by the university supervisor who reviews the study as part and parcel of supervision processes. Identifying a sponsor All research with human participants, their organs, tissue or data must have an identified sponsor. This is the individual (or organisation) that takes responsibility for confirming there are proper arrangement in place to initiate, monitor, manage and finance a study. Normally, the sponsor is the organisation that takes the lead for particular aspects of the study, for example the CI s or PI s main employer or the lead organisation that provides health care (or both). Academics working outside the NHS, or students undertaking research as part of a taught research programme will be sponsored by their host university if honorary employment contracts are not required. Should this be the case, universities and NHS organisations will negotiate and share aspects of sponsorship. If you are already an NHS employee the sponsor is most likely to be the NHS organisation providing health or community care. The NHS will not take on the sponsorship of a study that involves healthy volunteers. More information about the specific responsibilities of the sponsor can be found on the CSO website ( 8

10 Whatever your research intentions, sponsorship arrangements must be clarified for you and it is imperative to obtain documentary evidence of how agreements and arrangements will work in your own specific situation. This is because sponsors need to be identified at the point of ethical application and in the case of students, ethical applications require signatures from your university supervisor(s) along with a brief summary of their CV. How to obtain documentary evidence of agreements will be supplied by your local R&D Office within the NHS or host university. When both stages of sponsorship and scientific review are complete, necessary arrangements and agreements will be in place and so all concerned can be assured that the research will be adequately governed and reflect practicalities of care delivery. 9

11 SECTION 2: Obtaining Agreements - Management approvals Management agreements include; 1. Managers and key clinicians in all areas requiring access; 2. Research and Development approval within all relevant Health Domains Health care organisations will usually agree to the conduct of the research on their premises if: A sponsor has been identified The ethical opinion is favourable The agreements for allocation of responsibilities (or indemnity and/or insurance) are acceptable The conduct of the research does not interfere with the delivery of the service What is management agreement? This operates at two levels. The first level is required for every area where the research is to occur. It means obtaining the support and permission of key clinicians and managers who will encounter the researcher on a day-to-day basis. They will need information about the potential implications for patient care and their staff. This may involve written communication and meetings with key individuals. The second level of management agreement involves formal local R&D approval. There is a national R&D form called a Site Specific Information (SSI) Form that is part of the COREC document. If your study involves more than one health domain then you will need to formally apply to the R&D Office in each domain for management approval. This is because approval by one Health Board is not transferable to all other Boards. This involves the submission of a SSI Form to each domain. If someone else is going to be involved in the actual conduct of the research in another health domain they need to be identified as a local collaborator and they will need to sign a copy of the form. A signature from managers who act on behalf of Site Management Organisation. where the study is being conducted is required. The local R&D Office will be able to advise you as to who is able to give this authorisation.. Evidence of agreements Documentary evidence relates to i) sponsorship agreements ii) favourable ethical opinion and iii) management support iv) employment contracts / permission to access clinical areas. R&D Management agreement is given when; there is an identified sponsor; there is adequate supervision of new/novice researchers, the proposal has been subjected to scientific peer review; 10

12 there is a guarantee that the care of patients (either recruited to the study or those treated alongside recruits) will not be compromised and the study therefore has management support at a clinical level a favourable ethical opinion is confirmed; the study is adequately supported financially and through existing infrastructures. Once the study has been agreed researchers will receive a letter of confirmation and a statement which outlines the responsibilities of the Chief Investigator who is this from the R&D office? Contractual issues Academic staff and other research workers who in the course of their NHS research duties, interact with individuals in a way which has a direct bearing on the quality of their care should hold an NHS honorary contract. In broad terms, honorary contracts are required if you intend to have direct contact with patients or relatives and/or their clinical records and you are not employed within the organisation where your study is to take place. This is because, if there is negligent harm during a study with NHS permission, the NHS owes a duty of care to person harmed. NHS indemnity covers NHS staff, academic staff with honorary contracts and those conducting the study. If an honorary contract is required, contact the NHS organisation as early as possible again probably through the R&D Office, although this may be done through collaborators. Although there may be local variation, the process of securing the contract may involve: o CV or standard application form two professional references one from the research supervisor and another from existing employers DISCLOSURE Scotland (criminal records check) Early application is advisable. The NHS are not able to accept Disclosure certificates from other organisations and so evidence of previous applications will not be accepted. Copies of documents (birth certificate, passport, driving licence and professional registration) need to be included. These will usually be processed by the HR Department. In some cases occupational health screening may be required. At the time of writing this document the R&D Forum has been working on clarifying the requirements for honorary research contracts and are involved in piloting a Research Passport system. The Research Passport system places the onus on the researcher to go to their employing organisation to obtain the necessary signatures and checks for example, 11

13 employment, Disclosure, occupational health etc. prior to applying for an honorary research contract. The researcher can apply for a five year contract or a project limited contract and needs to present their research passport to new R&D or HR departments where they have been given approval to undertake their research. Issuing the honorary research contract should then be swift when all the correct information is present and auditable. If the researcher needs to obtain an additional honorary research contract from another trust, they only need to produce their passport and if the trust approves the research project, the letter they send to the researcher approving the project will act as the honorary research contract. For further information on this development see the R&D Forum website Is this national? 12

14 SECTION 3: Obtaining a favourable ethical opinion All research involves and element of risk to those participating in it and these risks must be in proportion to potential benefits of findings. The CSO has indicated that adherence to the RG framework should appropriately reflect students undertaking low risk research e.g. research which does not involve patients but may include NHS employees. Currently, NHS research ethics committees are not reviewing surveys or other non-research activity if they present no ethical issues for people involved. However, COREC are still to develop guidelines to help researchers and committees in deciding what is appropriate for ethical submission, so until these are published, it is prudent to submit your application irrespective of survey design. For further information on what NHS REC s are to review access section 3.1 of the Governance arrangements for NHS Research Ethics Committees (GAfREC) Applying for ethical opinion Research Ethics Committees (REC s) are independent when formulating advice on the ethics of research studies. This means that the ethical opinion is impartial neith SEHD nor NHS bodies can interfere with an NHS REC decision. Permission for research to be carried out in an organisation does not rest with RECs hence they provide opinions rather than approval. The processes of completing your ethical application takes time. Factor this into time-planning. For example: 1) completing the online application form 2) booking in of your application for submission to your local REC 3) photocopying multiple hard copies of your application form 4) compiling all supplementary documentation consent forms, information letters, data collection tools, confirmation of sponsorship arrangements, supervisor s and researcher s CV, research proposal, access letters and a statement of indemnity (see section 2, Contractual Issues). 5) waiting for confirmation of a valid application 1) Completing the application form The application form for ethical review is available on-line from the COREC website. The application form is in excess of 50 pages but as this is intelligent, so not all sections will apply. It is a good idea to print off the Question Specific Advice as some of the sections require careful scrutiny as to how to interpret ethical conduct pertinent to the design and scope of the study ( The guidance can also help ensure the application is as complete as possible. 13

15 There is an applicant s checklist on the front of the form which specifies all the additional documentation required. 2) Booking in your application for submission to your local REC The application needs to be booked in. This process triggers the allocation of an application number. The application must be with the ethics committee within 4 days of the booking which will be through either Central Allocation or your local NHS REC. Contact the Central Allocation System (CAS) if the research involves: a clinical trial of medicinal products or medical devices more than one health domain adults with incapacity. If this is the case stress to the allocation officer that the study needs to be reviewed within Scotland (it is possible for ethical applications to be distributed to committees in England or Wales, where the Adults with Incapacity Act is not in force (Scotland 2000). Contact the local NHS REC if the research involves: a multi-site study taking place in one health domain a single site study the study does not involve medicinal products or devices or adults with incapacity. 3) Submitting the form. Section A and B of the application form should be sent electronically to the relevant REC Office. Send in one paper copy of the form with all the relevant signatures in black ink. Supporting documents and the completed checklist can be submitted electronically. In the case of clinical trials - send in 6 copies of the research protocol and, if applicable, 2 copies of the Investigator Brochure. 4) Waiting for confirmation of a valid application. If booking through CAS the relevant administrator will confirm a valid application within 5 days of sending. A valid application means that the application form, and all supporting documentation is complete. All local RECs meet on a monthly basis to ensure that decisions can be made within 60 days. Confirmation that the application is valid means the 60 day clock now begins. An overview of the ethical review process 1) For single site studies 14

16 It is standard practice to be invited to attend the REC meeting or, if this is not possible, be available by phone. This being the case, it is advisable to attend if at all possible as points of clarification there and then will speed up decision making processes. The outcome of the opinion will be: Favourable Favourable with ammendments Unfavourable In the case of the latter two outcomes, the 60-day clock stops and starts again when the committee receives an amended application. Amendments must be made in full for the clock to restart. Once this has occurred, the committee will review the submission but only on the amendments made. RECS can not raise any new issues at this juncture. The application will then be re-reviewed within 14 days and a response issued within 35 days. 2) For Multi-site studies requiring an site specific assessment (SSA) Exactly the same procedures apply for multi-site studies with the SSI form being required for each local REC as well as R&D Office. Approval for each site can only be granted by the Main REC. However, ethical approval is dependent on SSA s issuing a notification of no objection to the Main REC. Each time a new site is approved by the SSA s, the Main REC re-issues the approval letter with the additional site. New sites may be added at any stage by the same process. NHS RECs require researchers working in their organisations to keep them informed of the progress of the study. Any changes to the design of the research or composition of the research team, the committees are responsible for reviewing their advice on the ethical acceptability of a study in the light of such information. SECTION 4: Monitoring and auditing your study Rigorous research requires monitoring. The Chief Investigator, their employer, the sponsor and the care organisation are responsible for ensureing a study follows agreed practices and protocols. They are also responsible for monitoring, auditing and reporting on progress. Methods of monitoring and quality assurance will be evidenced in the information submitted to the ethics committee and the R&D Office. As the study progresses, aspects of the research may change in light of the challenges of conducting research in the real world! Don t panic this is normal! However, the ethics committee and the R&D Office to have formally agree changes, 15

17 and if data collection is protracted, which effects contractual obligations the employing authority and the sponsor need to be notified in order to extend tenures of employment. The requirements for clinical trials stipulate that a Study Site File must be maintained 1 includes evidence of Ethics opinions Local NHS Management approval Patient Information Sheets Patient Consent Sheets CVs of all study team Indemnity cover Financial information Financial disclosure forms Correspondence with ethics Correspondence with local NHS Correspondence with the Sponsor company Correspondence with the DISCLOSURE (if applicable) Protocols Amendments signed and dated List of signatures of all study personnel and Although there are no specific regulations for studies outside the EU Clinical Trials Directive, the need for monitoring or audit of the study once in progress should be viewed as good practice. Most R&D Offices will have arrangements for monitoring studies and you may be contacted to participate in such a review. Information specific to the monitoring of clinical trials Monitoring of research studies is now a requirement for all studies that fall under the regulations of the EU Clinical Trials Directive. This will be the responsibility of the sponsor, and for studies involving medicines for human use, it may also be carried out by the Medicines for Healthcare products Regulatory Agency (MHRA). 1 This information on the contents of a Study Site File has been developed from Morris S (2004) Auditing and Monitoring through the eyes of a Research Nurse, R&D Matters Newsletter of the R&D Office, NHS Lothian - University Hospitals Division, Edinburgh. Issue 11 September 2004 p4-5 16

18 DISSEMINATION OF FINDINGS Health research is conducted to benefit service users, care professionals and the public generally. There should be free and open access to information both on the research being conducted, and on the findings of the research be it positive or negative. It is imperative therefore that findings are disseminated in the public domain. The process for dissemination should be negotiated with managers, funders and sponsors at the outset. The research is not finished until this stage has been completed. SECTION 5: An illustrated guide to Research Governance The following five case studies illustrate how research governance may be applied. Each case is different in terms of context, researcher expertise, methodology and pragmatic considerations. The purpose in presenting these separate cases is to demonstrate the principles of RG procedures which should be fairly standard, despite the variety and scope of the research. An overview of each case will present the differences between context, expertise, methods used and pragmatic issues pertinent to each study. The flow diagrams in the cases will indicate processes applied. Case study one Context Researcher experience Methodology Pragmatic issues Case study two Context Researcher experience Methodology Pragmatic issues Case study three Context Researcher experience Methodology Pragmatic issues Case study four Context Researcher experience 1 health domain, 1 site within a community setting An experienced qualified nurse who is undertaking her MSc. by dissertation Focus groups to collate the views of a variety of health professionals The research will be carried out within her work setting and participants are colleagues 1 health domain, 2 sites 1 primary care, 1 acute care Academic researcher undertaking PhD Non-participant observation of NHS staff, interviews Requires access to clinical area and contact is direct. Participants are deemed incapable under the Adults with Incapacity Act (Scotland 2000). 2 health domains and a variety of sites in primary and acute care. Experienced physiotherapist and a student undertaking M.Sc. by dissertation Survey - questionnaires and focus groups Multi-site study but does not require local investigators. One site is her work setting. She is required to submit further information to the ethics committee 1 health domain, 2 sites in primary care settings NHS and private sector. Experienced nurse working in the private sector and a student undertaking M.Sc. by dissertation 17

19 Methodology Pragmatic issues Case study five Context Researcher experience Methodology Pragmatic issues Interviewing relatives of people with Alzheimer She requires management approval to access variety of sites within NHS and private sector. 4 health domains and a variety of sites in primary and acute care. Experienced nurse, academic and researcher. Clinical trail on the effectiveness of a treatment intervention Multi-site study requiring local investigators and so an SSA. Participants are deemed incapable under the Adults with Incapacity Act (Scotland 2000). Ethical opinion was unfavourable. 18

20 CASE STUDY 1 You are a qualified nurse working full time in the community. You are completing your Masters level course with a dissertation by research. You sponsor will be the university, and as such your proposal has been approved and you have been allocated a supervisor who will oversee the quality and conduct of your research. You are the PI. The dissertation you have proposed identifies your work colleagues as your intended sample group. The qualitative approaches you have chosen to use will include five focus groups and 8 individual interviews with your work colleagues from various health care centres throughout your Health Board region. You are now in a position to apply for managerial approval and an ethical opinion. MANAGEMENT AGREEMENTS ETHICAL REVIEW ROLE OF SPONSOR Notify R&D Office with outline of proposal. Discuss your research ideas with the relevant clinical managers to obtain their approval and support in principle Submit SSI Form and all related documentation (including ethics notification of approval and application from) to R&D office. Optional - Notify Director of Nursing with brief outline and seeking permission to proceed Management approval letter indicating responsibilities of PI Complete COREC application form You will need to apply to an authorised REC Once the application is complete, book in to obtain REC Reference Number Submit your application within 4 days of booking Receive letter of confirmation that application is valid (within 5 days). 60 day clock starts ticking! Favourable Ethical opinion received Complete relevant documentation for parent HEI that formally notifies your intention to research. Ensure supervisor is in receipt of documentation that confirms required agreements are in place to support and resource your research Ensure sponsor and supervisor sign COREC form Supervisor informed of ethical decision 14

21 CASE STUDY 2 You are a qualified nurse working as a lecturer in a university outside Lothian. You are undertaking your PhD and are ready to commence the data collection. You sponsor will be the university that employs you and your proposal has been approved. You have two academic supervisors who will oversee the quality and conduct of your research. You are the PI. Your research involves a single domain but two different clinical areas within the local teaching hospital. Your study subjects are registered nurses and you want to recruit 15 to take part in semi-structured interviews. Your research theme relates to the care of patients who may be defined as incapable under the terms of the Adults with Incapacity Act (2000). You also wish to undertake a period of participant observation within the two clinical areas where you will recruit your subjects in order to explore the context of care. You anticipate spending up to 4 weeks within each clinical area. You are now in a position to seek ethical opinion and to apply for managerial approval. MANAGEMENT AGREEMENTS HONORARY CONTRACT/ ETHICAL REVIEW ROLE OF SPONSOR LETTER OF CLINICAL ACCESS Optional - Notify Director of Complete COREC application form Internal processes relating to Nursing with brief outline and supervision and ethical seeking permission to proceed You will need to apply to a Recognised scrutiny REC as your study will involve adults with incapacity Identify relevant clinicians and managers to contact for approval. Discuss research governance issues Complete SSI Form and secure appropriate signatures Submit copy of ethics documentation (notification of approval and application from) to R&D office. Management approval letter Study involves direct patient contact Honorary Contract CV 2 Professional References DISCLOSURE Occupational Health CPR/Fire/Infection Control Training Manual Handling Training Favourable ethical opinion received Once the application is complete, phone Central Allocations System to book in your application and obtain REC reference number Submit your application with all supporting documents. To be received within 4 days of booking and receive confirmation that application is valid. Clock starts ticking Request for further information. Clock stops while waiting response Sponsor signs COREC form and confirms indemnity arrangements Referral of ethical decision to external body. Internal process for supervision and study monitoring. Supervisor informed of ethical decision Address outstanding issues. Consider feasibility of study within time scale 15

22 CASE STUDY 3 You are a qualified nurse undertaking a part-time MSc at a your local University. You are employed by the NHS. Your sponsor will be the university, and as such your proposal has been approved and you have been allocated a supervisor who will oversee the quality and conduct of your research. You are the PI, your host university is acting as your sponsor. Your research involves two Health Domains. Your study subjects are multidisciplinary teams working in stroke services. You want to recruit 50 staff to complete a structured questionnaire and from this, sample a further 10 subjects to participate in a focus group. You are now in a position to seek ethical opinion and to apply for managerial agreement. MANAGEMENT AGREEMENT HONORARY CONTRACT/ ETHICAL REVIEW ROLE OF SPONSOR LETTER OF CLINICAL ACCESS Optional - Notify Director of Nursing in each domain with brief outline and seeking permission to proceed Identify relevant clinicians and managers to contact for approval. Discuss research governance issues Complete SSI Forms and secure appropriate signatures Submit copy of ethics documentation (notification of favourable opinion and application from) to R&D office. Study does not involves direct patient contact Letter of Clinical Access will be required Management approval letter Complete COREC application form You will need to apply to a Recognised REC as your study involves more than one domain. Once the application is complete, phone Central Allocations to book in application and obtain REC Reference Number Submit your application with all supporting documents to be received within 4 days of booking Receive letter of confirmation that application is valid (within 5 days). 60day clock starts ticking! Favourable ethical opinion received Internal processes relating to supervision and ethical scrutiny Sponsor signs COREC form and confirms indemnity arrangements Referral of ethical decision to external body. Internal process for supervision and study monitoring. Supervisor / student informed of response 16

23 CASE STUDY 4 You are a qualified nurse working in the private sector. You are undertaking an MSc at a local University and are ready to commence the data collection. Your sponsor will be the university. You are the PI. Your research involves a single domain and also nursing homes in the private sector. Your study subjects are families of patients suffering from Alzheimer and you want to investigate their experience of the transition of care between the NHS and private sector when a patient requires acute secondary healthcare. You would like to recruit subjects and interview them while their relative is receiving NHS care and follow them up post discharge to the nursing home. Interviews will take place in a location that is suitable for the research subjects. You are now in a position to seek ethical opinion and to apply for managerial approval. The following outline relates to approval within the NHS domain. MANAGEMENT AGREEMENTS HONORARY CONTRACT/ ETHICAL REVIEW ROLE OF SPONSOR LETTER OF CLINICAL ACCESS Optional Notify Director of Nursing with brief outline and seeking permission to proceed Identify relevant clinicians and managers to contact for approval. Discuss research governance issues Complete SSI Form and secure appropriate signatures Submit copy ethics documentation (notification of approval and application from) to R&D office. Management approval letter Study does not involve direct patient contact but does involve direct carer contact while the patient is within the NHS Honorary Contract CV 2 Professional References DISCLOSURE Honorary Contract awarded Favourable ethical opinion received Complete COREC application form You will need to apply to an authorised REC Once the application is complete, phone local ethics committee to book in application and obtain REC Reference Number Submit your application with all supporting documents to be received within 4 days of booking Receive letter of confirmation that application is valid (within 5 days). 60day clock starts ticking! Request for further information. Clock stops while waiting response Internal processes relating to supervision and ethical scrutiny Sponsor signs COREC form and confirms indemnity arrangements Referral of ethical decision to external body Internal process for supervision and study monitoring. Supervisor informed of ethical decision Address outstanding issues. Consider feasibility of study within time scale 17

24 CASE STUDY 5 This is a multi-centred intervention study. You are a qualified nurse working as a lecturer in Aberdeen. You are undertaking a PhD that compares two different interventions for the management of incontinence in stroke patients. The study will involve the NHS in Aberdeen, Tayside, Lothian and the Western Isles and you have identified Continence Specialists in each study site to act as local PI s. Your sponsor will be Robert Gordon University. You are the CI. Your study subjects are patients admitted to a dedicated stroke service (acute and rehabilitation) and they will be allocated to one of two treatments bladder scanning and intermittent catheterisation from the time of admission, or indwelling catheterisation until assessed to be ready for trial without catheter. You need to train nurses in the participating centres and the Continence Specialists will be responsible for recruiting and consenting patients for participation in the study. Your research may relate to the care of patients who may be defined as incapable under the terms of the Adults with Incapacity Act (2000). You are now in a position to apply for ethical review managerial approval. MANAGEMENT AGREEMENTS HONORARY CONTRACT/ ETHICAL REVIEW ROLE OF SPONSOR LETTER OF CLINICAL ACCESS Download and complete COREC Optional Notify Directors of Nursing application form Internal processes in each study site with brief outline relating to supervision and seeking permission to proceed You will need to apply to a Recognised and ethical scrutiny REC as your study may involve adults with incapacity Identify relevant clinicians and managers to contact for approval. Discuss research governance issues Phone Central Allocations to book in your application and get REC Reference Number Referral for ethical decision to external body. This study could not proceed on ethical grounds. You cannot recruit subjects who are unable to consent to participation if there are others who also fulfil your selection criteria and are able to give valid consent. Submit your application with all supporting documents to be received within 4 days of booking Receive letter of confirmation that application is valid (within 5 days). 60day clock starts ticking! Unfavourable ethical opinion received Internal process for supervision and study monitoring. Meet with supervisor to address issues 18

25 Conclusion It is imperative for the safety of all those concerned that the principles underpinning all aspects of Research Governance are understood and applied in full. These guidelines have been designed to facilitate the experience of implementing the Research Governance framework as it addresses processes and procedures for gaining ethical opinion and management agreement at various levels. A comprehensive understanding of these principles will ensure the first experience of conducting research is a positive learning experience. Application of these guidelines it is hoped, with enhance the experience of undertaking research in the messy and chaotic world of practice. Once familiar with its stages, the process becomes easier for all those other studies still to come. And to that end, we would like to wish you every success! 19

26 APPENDIX 1: AUDIT, RESEARCH OR SERVICE EVALUATION The following is guidance from COREC and appears on the first page of the online application form so you can only usually access it once you have commenced the process of completing your online application. AUDIT OR SERVICE EVALUATION? Audit or service evaluation projects do not require formal NHS REC ethical review. There is no need to complete the application form. If the project raises significant ethical issues on which you would value REC advice, please write to the Chair of a Local or Multi-Centre Research Ethics Committee with a summary of the proposal. DIFFERENCES BETWEEN RESEARCH, AUDIT AND SERVICE EVALUATION RESEARCH CLINICAL AUDIT SERVICE EVALUATION The attempt to derive generalisable new knowledge including studies that aim to generate hypotheses as well as studies that aim to test them. Quantitative research designed to test a hypothesis. Qualitative research identifies/explores themes following established methodology. Addresses clearly defined questions, aims and objectives. Quantitative research -may involve evaluating or comparing interventions, particularly new ones. Qualitative research usually involves studying how interventions and relationships are experienced. Usually involves collecting data that are additional to those for routine care but may include data collected routinely. May involve treatments, samples or Designed and conducted to produce information to inform delivery of best care. Designed to answer the question: Does this service reach a predetermined standard? Designed and conducted solely to define or judge current care. Designed to answer the question: What standard does this service achieve? Measures against a standard. Measures current service without reference to a standard. Involves an intervention in use ONLY. (The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference.) Usually involves analysis of existing data but may include administration of simple interview or questionnaire. Involves an intervention in use ONLY. (The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference.) Usually involves analysis of existing data but may include administration of simple interview or questionnaire. 20

27 investigations additional to routine care. Quantitative research - study design may involve allocating patients to intervention groups. Qualitative research uses a clearly defined sampling framework underpinned by conceptual or theoretical justifications. No allocation to intervention groups: the health care professional and patient have chosen intervention before clinical audit. No allocation to intervention groups: the health care professional and patient have chosen intervention before service evaluation. May involve randomisation No randomisation No randomisation ALTHOUGH ANY OF THESE THREE MAY RAISE ETHICAL ISSUES, UNDER CURRENT GUIDANCE:- RESEARCH REQUIRES R.E.C. REVIEW AUDIT DOES NOT REQUIRE R.E.C. REVIEW SERVICE EVALUATION DOES NOT REQUIRE R.E.C. REVIEW If in doubt you may ask the COREC queries line. queries@corec.org.uk.. You may however ask for an REC to comment on such a project. NHS R&D approval is generally not required for such projects. For further guidance consult your R&D office. 21

28 APPENDIX 2: GLOSSARY OF RESEARCH GOVERNANCE TERMS The RGF and other governance arrangements have introduced a number of new terms that you need to be familiar with: Adults with Incapacity Act Part 5 of the Adults with Incapacity Act (Scotland) 2000 covers medical treatment and research and came into force on July 1st The Act prohibits the involvement of adults with incapacity in research (in Scotland), unless the following conditions can be shown to be met: The research question(s) could not be addressed by involving adults who can consent. It is not sufficient to say that there are no capable volunteers for the study. (This condition is paramount). The research is of direct benefit to the adult involved. A possible exception is when the research is likely to improve the scientific understanding of the adult's condition, and as such is likely to produce a real and direct benefit to persons suffering from the same incapacity. Ethical opinion on the study must be obtained from the Recognised REC for Scotland. The research involves no or only minimal risk to the adult and imposes no or only minimal discomfort (these conditions should be seen in context of the adult's standard treatment). Before research involving the adult is undertaken, consent must be obtained from a guardian or welfare attorney who has powers to consent in relation to the adult's participation in research. If none has been appointed, the consent of the adult's nearest relative is required. Central Allocation System (CAS) The CAS is a booking system for EU Recognised Research Ethics Committees (REC s). All EU Directive Work (clinical trials of medicinal products and devices) and multi-site studies in more than one Health Board (domain) must be made via the CAS. The telephone number for the CAS can be found on the COREC website ( Multi-site studies within one domain may go via the CAS. Chief Investigator (CI) The CI is the authorised health care professional who takes primary responsibility for the conduct of the study, irrespective of whether or not they are the investigator at any particular 22