Northern Ireland Hospice Research Governance

Transcription

1 Northern Ireland Hospice Research Governance Guidance Note 1 Pre-Application Guidance for Applicants How to Prepare an Application to conduct Research Studies in Northern Ireland Hospice Author: Dr. Dorry McLaughlin, Lecturer in Palliative Care/ Head of Education and Research, Northern Ireland Hospice July 2013 (Adapted from HSC Trust Research Governance Permission Note 1. Replaces Research Management System NIHCP3/2008) Date Introduced: August 2013 Date Reviewed: July

2 Table of Contents Page 1 Introduction Integrated Research Application System (IRAS) 4 2 Pre-Application Stage Setting up a Research Study... 7 Feasibility.. 7 Funding.. 7 Sponsorship. 8 Indemnity... 9 Scientific Review (Peer Review).. 10 Principal Investigator/Local Collaborator. 10 Honorary Contracts. 11 Intellectual Property Personal Public Involvement. 11 Good Clinical Practice. 12 Clinical Research Support Centre 12 Submitting the Application for R&D Permission. 12 Disputes/Resolutions.. 13 Appendices Appendix 1 Contacts for Northern Ireland Hospice. 14 Contacts for Trust Research Governance Offices 14 Appendix 2 Flowcharts Overview of permission process 15 Sponsorship and Funding 16 Ethics Approval. 17 Final Approval. 18 2

3 Appendix 3 Research Proposal Form 19 Appendix 4 Risk Assessment Form. 21 Appendix 5 Peer Review Report Form. 23 Appendix 6 Notification of a Proposed Substantial Amendment Form 25 Appendix 7 Glossary of Terms. 27 Appendix 8 Check List for Applicant. 31 The author wishes to thank Professor George Kernohan, University of Ulster/ Co-Chair NI Hospice Research Committee for peer reviewing and advising on aspects of research governance within this document. 3

4 1 Introduction 1.1 Research Governance is an administrative system to control and authorise research studies involving patients, carers, volunteers or staff working in Northern Ireland Hospice. These guidelines have been adapted for Northern Ireland Hospice from those used by the five HSC Trusts in Northern Ireland. The Northern Ireland Hospice Research Governance Committee, is co-chaired by both academic and clinical personnel, and is responsible for ensuring research governance within the organisation. Applicants wishing to conduct a multi-centre study across a number of organisations must identify a lead organisation who is willing to undertake the global (generic) governance checks on behalf of the other participating organisation. Local governance checks will be undertaken by each participating organisation. In order to identify a Lead organisation (usually a Trust), contact one of the HSC Trust Research Offices (Appendix 1). For studies being initiated and led from one of the other devolved nations co-ordinating centres (England via CSP, Scotland via NRS Permissions Co-ordinating Centre and Wales via NISCHR Permissions Co-ordinating Unit), the Western Health and Social Care Trust Research Office has agreed to act as the initial point of contact for these applications. It is important to determine whether the project that you are initiating is audit, service evaluation or a research study. Research aims to obtain new knowledge and to find out what treatments are the most effective. Audit is about quality and seeks to find out if best practice is happening. More details can be seen at the following website: All research involving patients must obtain a favourable opinion from a HPSS or NHS Research Ethics Committee. Other research studies not involving patients will still require appropriate ethical review which may involve an ethics committee at a university such as University of Ulster or Queen s University, Belfast (see appendix 2). All research applications must be submitted to Northern Ireland Hospice by using the web-based Integrated Research Application System (IRAS). IRAS 1.2 IRAS: Is a web-based system for applying for permissions and approvals for health and social care / community care research in the UK. Enables you to enter the information about your project once instead of duplicating information in separate application forms. 4

5 Uses filters to ensure the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required. Helps you meet regulatory and governance requirements. 1.3 IRAS captures the information needed for the relevant approvals from the following review bodies: Administration of Radioactive Substances Advisory Committee (ARSAC) Gene Therapy Advisory Committee (GTAC) Medicines and Healthcare products Regulatory Agency (MHRA) Ministry of Justice NHS / HSC Research and Development offices NRES / NHS / HSC Research Ethics Committees 1.4 IRAS is just one element of a broader effort to reduce bureaucracy for researchers. IRAS can be accessed at: and an account should be created by following the instructions on the website. It is recommended that new researchers should undertake the e-learning IRAS training programme available on under Quick Links section. By doing so, this should familiarise applicants with the software and enable efficient navigation through the system. 1.5 It is hoped by adopting a streamlined approach to research governance that it will encourage researchers and enhance the attractiveness of Northern Ireland as a site for large scale research projects (commercial and non-commercial). Furthermore, by forging links with the other research governance permission initiatives led in England, Scotland and Wales, the aim is to streamline the processes for cross border studies in an attempt to attract UK-wide studies opening in a more timely and efficient manner. 1.6 To carry out research within Northern Ireland Hospice Research Governance Permission is required before a study can commence. Research Governance Permission is required if your research involves: 5

6 Patients/clients (tissue, organs, data) Staff or volunteers Resources (consumables, equipment) Premises (facilities) 1.7 The Research Governance system is designed to: (a) provide a streamlined and consistent approach for obtaining Research Governance Permission for studies and (b) protect all those involved in research (participants, researchers, care organisation and employing organisation) by ensuring that all regulatory and governance approvals are in place and are adhered to. Occasionally under strictly controlled conditions, the Hospice may use patient information for research. Any information will generally be anonymised, so that patients are not identified. However if patients are to be identified or personally involved in the research study consent will be obtained. 6

7 2 Pre-Application Stage Firstly it is important to clearly establish that you are actually conducting research within Northern Ireland Hospice, rather than service evaluation/service development or clinical audit. (See or The following areas have been identified for the applicant to consider, prior, to submitting an IRAS application to Northern Ireland Hospice for research governance permission. Setting up a Research Study 2.1 When setting up a research study it is important to make contact with the Northern Ireland Hospice in the early stages of the study development. Key areas of feasibility, funding, sponsorship, scientific review, indemnity, identification of local Principal Investigator/Local Collaborator, and requirement for honorary contracts, must be secured, prior to submitting IRAS applications for Northern Ireland Hospice Research Governance Permission. This will ensure that relevant governance issues can be identified early in the process, avoiding delays in the later stages. For non-northern Ireland Hospice staff, it is advisable that researchers involving Universities should similarly make early contact with the Education and Research Department, for advice. Projects should be initiated and prepared in draft through the Integrated Research Application System. Draft applications can be transferred to members of the research team for review and, where applicable, to the Northern Ireland Hospice and relevant HSC Trust Research Office to review in terms of application for sponsorship and funding only. Feasibility 2.2 The feasibility of all studies should be considered as part of the development of the study protocol, with particular reference to the patient/client population to be sampled and available resources. If the study requires input from support departments of HSC Trusts, e.g. Pharmacy, Laboratory, Medicine, Radiology/ Radiation Protection, contact must be made with the Heads of those Services/Departments to discuss feasibility and costs at an early stage. Details of contacts for support departments is available from HSC Trust Research Offices. Funding 2.3 For externally sponsored and funded studies, applicants can proceed directly to IRAS submission, and should make immediate contact with Northern Ireland Hospice. 7

8 2.4 Applicants should provide written evidence of funding arrangements for the research study. If funding has not yet been secured before submission for research governance approval, the funding body may require changes to the research study, which could result in the need to submit substantial amendments (appendix 5) or even withdraw and re-submit the application. 2.5 Northern Ireland Hospice research governance permission for the conduct of research requires assurance that the study is properly funded with sufficient personnel, financial and material resources to ensure responsible conduct of the study until completion. This shall include an assessment on research, treatment and service support costs as well as impact upon the provision of care and services by Northern Ireland Hospice. All financial aspects of projects may need to be reviewed by Northern Ireland Hospice Finance staff before final research governance permission can be granted. It is extremely important that all financial implications to the organisation are carefully considered at the outset of a project. 2.6 Researchers are reminded that research that requires access to the resources, patients, staff and/or premises of Northern Ireland Hospice will, in many cases, have cost implications for the organisation concerned. 2.7 Researchers are requested to ensure that ALL grant applications in support of research studies involving Northern Ireland Hospice take account of these costs and include sufficient funds to cover them. Sponsorship 2.8 It is a requirement for all research to have a sponsor. The main role(s) of the sponsor are to assure the scientific quality of the research and that arrangements are in place for the management and monitoring of the project. 2.9 The sponsor takes responsibility for the initiation, management, indemnity and, where necessary, financing (or arranging the financing of that research study). This involves ensuring the design of the study meets the required standards and that arrangements are in place to ensure appropriate conduct and reporting Prior to requesting any study approvals through IRAS (REC, R&D, MHRA etc) sponsorship arrangements must be in place. Where an external sponsor cannot be 8

9 secured for a project, application may be made to a HSC Trust Research Office or university to sponsor/co-sponsor your project. If the HSC Trust is sponsoring your project it will ensure that it is of an appropriate scientific quality. If the study has been, or will be reviewed for scientific quality by an external funder it may not need further review. If the study will not be reviewed by an external funder, the HSC Trust Research Office may facilitate the peer review of the project The Northern Ireland Hospice must verify that the sponsorship/co-sponsorship arrangements are appropriate for a study whether the study will be sponsored/cosponsored by the HSC Trust or a university. Once the sponsor is agreed, it is a formal requirement to have the sponsor either: Sign / electronically authorize the Declaration by the sponsor's representative part of the IRAS application; or Enclose a letter confirming their agreement to the Declaration by the sponsor s representative part of the IRAS application When making a sponsorship/co-sponsorship application to the HSC Trust Research Office/University the following should be submitted: Draft IRAS NHS R&D Form and IRAS SSI Form 1 Research Protocol (version control and date) External Referees or other scientific critique report (if available) or Funding Confirmation letter from a recognised funder completing peer review Peer review nominations (if external scientific critique not available) 2.13 The university/ Trust Research Office will review your project, complete a peer review if required, assess the appropriate sponsorship/co-sponsorship arrangements, initiate sponsorship/co-sponsorship agreements and negotiate contracts. Indemnity 2.14 Before a research project starts it is imperative that agreements are in place clarifying the legal responsibility for death or injury to a patient or volunteer as a result of their participation in the research study. It is the responsibility of the chief 1 At this stage, the IRAS form does not need to be fully completed but should contain as much information as available at the time of sponsor request. 9

10 investigator to ensure that the Hospice is informed of any planned research and indemnity arrangements are in place prior to commencement of the study In circumstances where a Pharmaceutical Company are involved and are supplying indemnity cover for the research project, documentary evidence of this must be submitted to Northern Ireland Hospice prior to commencement of the study. In circumstances where indemnity is not available from an external source then the study and all relevant documentation must be presented to the Northern Ireland Hospice Senior Management Team who will consult with Northern Ireland Hospice Insurers to determine if the project is indemnified. If the project is not indemnified an estimate for this process will be sought from the insurers. Please note that Northern Ireland Hospice may not always be in a position to meet insurance costs Scientific Review (Peer Review) 2.16 When making an application, the organisation expects to receive a research study protocol that has already obtained a favourable scientific review (also known as peer review or scientific critique). For studies conducted by University staff and students, these will normally already have been subject to peer review. The sponsor of the research is responsible for the scrutiny of the hypothesis, design, methodology and analysis of a proposed research study. This review should be carried out by independent experts. Arrangements for peer review should be commensurate with the scale of the research and the potential risks or burdens involved for participants. A risk assessment should be carried out for each research project associated with Northern Ireland Hospice (appendix 3). Principal Investigator/Local Collaborator 2.17 Where a Chief Investigator is not based in Northern Ireland Hospice, a Principal Investigator/Local Collaborator must be identified for Northern Ireland Hospice dependent on the contribution/collaboration required. If you are unable to identify a suitable Principal Investigator/Local Collaborator within Northern Ireland Hospice, contact the Education and Research Department who will be able to assist in identifying a suitable member of staff to fulfill such a role and to be a point of contact until the study is completed. 10

11 Honorary Contracts 2.18 For research involving non Northern Ireland Hospice staff wishing to have access to patients/clients, staff, premises, it is a requirement that an honorary contract application/letter of access be completed (along with any necessary pre-employment requirements for e.g. occupational health clearance, Access NI). Further details of honorary contract applications can be obtained from Northern Ireland Hospice as local requirements may differ. It is advisable to make early application for honorary research contracts, as these involve other support departments e.g. Human Resources and Occupational Health Departments. It is hoped that a HSC Research Passport or Regional HR process will be introduced to avoid the need for duplication of checks and issuing of honorary contracts. It is envisaged that in many instances a letter of access may suffice, rather than an honorary contract. This work is in progress and being led by the R&D Managers in association with other stakeholders, to reach a resolution to streamlined honorary research contracts. Intellectual Property 2.19 Encouraging and exploiting innovation is one of the strategic priorities for the HSC R&D Strategy Research for Health & Wellbeing The importance of identifying, managing and exploiting innovation is also stressed in the Research Governance Framework for Health and Social Care Accordingly all HSC bodies must identify, manage and exploit Intellectual Property Rights (IPR), arising from HSC research. This requirement is reinforced in the Controls Assurance Standard for Research Governance. Criterion 13 of this standard, requires Trusts/organisations to supply evidence verifying that they have satisfactorily complied with these requirements. The HSC R&D Division of the Public Health Agency established HSC Innovations, as a regional service for the support and management of innovation and IP within the HSC. HSC Innovations has the necessary professional resources and funding to offer this essential support service to HSC Bodies and Northern Ireland Hospice, and all HSC Trusts have signed a Memorandum of Understanding to this effect with HSC Innovations. Further advice on IP for HSC R&D can be obtained via the HSC Trust Research Offices. Personal and Public Involvement (PPI) 2.20 Organisations have a statutory duty to involve users and the public in the commissioning, planning and delivery of all Health and Social Care services. This process 11

12 is known as PPI. Integrating PPI into the research process ensures that researchers prioritise topics that are important for service users, and formulate questions, processes and outcomes that are patient and public centric rather than solely researcher led. Engaging with PPI representatives as partners rather than research subjects has been shown to produce a range of benefits and impacts. It brings about benefits to researchers, PPI representatives themselves and to the wider community. In relation to engaging PPI representatives within specific research projects, it is recommended where no PPI contact is available to the researcher, to make contact with the Education and Research Department who may be able to assist in identifying suitable contacts. Good Clinical Practice (GCP) Training 2.21 Anyone wishing to participate in clinical trials involving Health and Social Care must have completed GCP training and provide Northern Ireland Hospice with certified evidence. GCP training must be updated every 3 years, and is provided by the HSC Trusts on a regular basis. Clinical Research Support Centre (CRSC) 2.22 The aim of the CRSC is to promote and support high quality research and development covering the spectrum of Health and Social Care activity from clinical practice to health and social services provision. The CRSC team can offer support at various stages of a research project from, planning a study, conducting a study and developing research skills. Other such services include Data Management services, clinical research monitors and training workshops. For further guidance, contact the Trust Research Offices. Submitting the Application for R&D Governance Permission 2.23 Once all of the stages of pre-application are complete, the application may be formally submitted to the Education and Research Department where it will be forwarded to the appropriate Directors for initial approval. The application will then be reviewed by the Northern Ireland Hospice Research Governance Committee and applicants seeking to do research studies involving Northern Ireland Hospice patients, carers, staff or volunteers will be asked to attend one of the committee meetings to discuss the study. See Appendix 2 of this document for an overview of the research permission process and for details of application for a single site study or a multi-centre study. Annual Reports and End of Study Reports should be submitted to the Northern Ireland Hospice Research Governance 12

13 Committee using the relevant forms available from the Office for Research Ethics Committees Northern Ireland (ORECNI). Disputes/Resolutions 2.24 Any concerns or dissatisfaction with the Northern Ireland Hospice Research Governance Permission process must be addressed, in the first instance, to the Head of Education and Research. If a satisfactory outcome is not reached, then the relevant Chair of the Northern Ireland Hospice Research Governance Committee may be approached to resolve any outstanding issues. Any remaining issues can be addressed through the Director of Medical and Care Services, the Director of Nursing and Patient Care Services or the Director of Children s and Young People s Services, as appropriate. HSC Research Office Contact Details 2.25 Contact details for Northern Ireland Hospice and, where appropriate, each HSC Trust Research Offices can be found at Appendix 1 13

14 APPENDIX 1 Education and Research Department, Northern Ireland Hospice, Jennymount Business Park, North Derby Street, Belfast. BT15 3HN Research & Development Office Belfast Health & Social Care Trust Room 2010, 2 nd Floor King Edward Building Royal Hospitals Site Grosvenor Road Belfast, BT12 6BA Tel: Alison.Murphy@belfasttrust.hscni.net Research & Development Office Southern Health and Social Care Trust Ramone Building Craigavon Area Hospital 68 Lurgan Road, Portadown BT63 5QQ Tel: Irene.Knox@southerntrust.hscni.net Research & Development Office South Eastern Health and Social Care Trust Room 19, Home 3 Ulster Hospital Dundonald Belfast BT16 1RH Tel: Paul.Carlin@setrust.hscni.net Research & Development Office Northern Health & Social Care Trust Bush House Antrim Area Hospital Antrim BT41 2QB Tel: / Margaret.Smyth@northerntrust.hscni.net Research & Development office Western Health & Social Care Trust Clinical Translational Research & Innovation Centre (C-TRIC) 14

15 Altnagelvin Area Hospital Glenshane Road Londonderry, BT47 6SB Tel:

16 APPENDIX 2 Flowchart of the Northern Ireland Hospice permission process overview INITIAL APPROVAL Submit IRAS Form/Research Proposal (6 page)/risk Assessment and Peer Review Report to Director of Medicine and Care Services / Director of Nursing and Patient Care Services or Director of Children s and Young People s Services for approval via the Education and Research Department PROTOCOL APPROVAL Northern Ireland Hospice Research Governance Committee SPONSORSHIP AND FUNDING Is a sponsor secured? Is funding agreed? Is indemnity agreed ETHICS APPROVAL Office of Research Ethics Committee (ORECNI) or/and University of Ulster/QUB Ethics Committee FINAL APPROVAL Chair of Northern Ireland Hospice Research Group Are ethics approval, sponsorship & funding secured? Are all honorary contracts in place? Has indemnity been confirmed? RESEARCH Follow agreed protocol. Manage, monitor and report. Forward annual research reports Forward end of study report CLOSURE Disseminate findings. Manage intellectual property rights. Formally close the project. Ensure Northern Ireland Hospice research database is completed 16

17 Appendix 2.1 Sponsorship and Funding Detailed Approved Protocol Compiled on IRAS (Research Proposal) Submit to Funder(s) Is Funder also Sponsor? YES NO Internally driven peer review If favourable review Submit for registration or approval, if necessary. 17

18 APPENDIX 2.2 Ethics Approval Approved Protocol (Research Proposal) Complete IRAS REC Application and Submit REC Approval NO YES Appeal YES Proceed to Final Approval Annual Reports and End of Study Report to ORECNI Revise IRAS REC Application and Submit YES NO ENDS 18

19 APPENDIX 2.3 Final Approval All Relevant Documentation Ends NO Northern Ireland Hospice. Research Group Approval YES All Contracts in Place YES Indemnity Confirmed 1. If indemnity from an external source submit evidence Ulster University/Northern Ireland Hospice Research Group. 2. If source of indemnity is N.I.H. obtain documentary evidence. Research Commences Annual Report and End of Study Report to NI Hospice and ORECNI 19

20 APPENDIX 3 Research Proposal Form Part 1- Preliminary Approval Short Project Title Date submitted Submitted by Having reviewed the Project Outline presented, we can confirm that the proposed project: 1. Aligns with our research strategy, 2. Has included all the major resource components, and 3. It appears feasible for the research to be conducted in this organisation. On that basis, we grant preliminary approval for the project. Signed by Date of signing Director of Nursing & Patient Services Director of Medical and Care Services Director, Children s & Young People s Services Name Please print clearly Director of Nursing & Patient Services Director of Medical and Care Services 1 Director of Children s & Young People s Services Part 2 Protocol Approval Date submitted Submitted by Having reviewed the Protocol presented, we confirm that: 1. All sections are completed, the level of detail is appropriate and it contains nothing extraneous that should be removed. 2. In the following table, all Departments impacted by the project have been identified correctly and their agreement to provide the requested resource/service has been sought and received. Please complete both rows and all columns with yes or no, as appropriate. Department Medical Nursing Social Work Physiotherapy Occupational Therapy Chaplaincy Human Resources Administration Impacted? 20

21 Agreed? 3. There is evidence that any legal and/or ethical requirements have been taken into consideration, and 4. The presentation is of a high standard. 5. External peer review is required YES/NO On that basis, we grant approval for the Protocol. Signed by Date of signing Name Please print clearly On behalf of the 1 Northern Ireland Hospice Research Group Part 3 - Financial Approval Having reviewed the costings section of the Protocol presented, I confirm that: 1. All reasonably foreseeable resources required and other costs have been identified and included, 2. Correct values have been applied for all standardised costs, and 3. Non standard costs have been correctly quantified. On that basis, I agree with the financial costing for the project Signed by Date of signing Name Please print clearly Administrative Director/ Finance Manager 1 Department Part 4 - Final Approval Date submitted Submitted by Having reviewed the following documentation: 1. Finalised working Protocol, 2. Funding confirmation, 3. Sponsorship agreement, 4. Favourable Ethics Committee opinion, And, if applicable: 5. Statutory approval, 6. Commercial contract(s). We grant approval for the project to start, subject only to receipt of a copy of the Certificate of Indemnity Signed by Date of signing Name Please print clearly On behalf of the 1 Northern Ireland Hospice Research Group 21

22 APPENDIX 4 Name of Chief Investigator Risk Assessment Form Organisation Project Title Hazard(s) Please identify and describe Who is exposed to the hazard? (e.g. Research subjects/ participants/ staff/students/) Inherent Risk (i.e. the risk present before any precautions are put in place) Please refer to the table overleaf to assess the risk and then record it below None Low Medium High Very High Controlling the Inherent Risk For inherent risk in the medium to very high range, please describe the precautions to be put in place: Will these precautions eliminate, significantly reduce or otherwise reduce the inherent risk? Please comment: Residual Risk- (eg: remaining risk once precautions are put in place) Please refer to the table overleaf to assess the remaining risk and then record it below None Low Medium High Very High Please note that if the residual risk is not in the none/low range, you might need to take further steps to address the risk or consider redesigning your research proposal I confirm that an appropriate risk assessment has been conducted Signature (Chief Investigator) Date 22

23 Please use the table below to assess the inherent risk and then the residual risk. For example, where the potential harm is assessed to be minor (e.g. slight physical discomfort or pain, temporary emotional upset or similar) and the probability is assessed to be likely, then the risk is deemed to be in the medium range. It is expected that research being conducted within the organisation will fall within the None to Low range of risk. Studies that are likely to fall within the High to Very High range of risk are unlikely to be permitted to proceed. POTENTIAL HARM PROBABILITY NONE INSIGNIFICANT MINOR MODERATE MAJOR UNLIKELY None Low Low Medium High POSSIBLE None Low Medium High Very High LIKELY None Low Medium High Very High ALMOST CERTAIN None Low High Very High Very High POTENTIAL HARM INSIGNIFICANT reflective of trivial, routine or commonplace day-to-day levels of harm MINOR unexpected event requiring minor remedial action e.g. first aid attention sufficient to treat minor injury, interview suspended due to temporary upset of participant MODERATE e.g. results in time of work, broken bones, hospitalization, reversible disablement, serious emotional upset or psychological reaction, threat of violence to researcher, potential legal challenge to the researcher or the University MAJOR e.g. loss of limb, loss of sight in one or more eyes, permanent disablement, death, irreversible psychological harm, violence against researcher PROBABILITY UNLIKELY probably will never happen POSSIBLE might happen but would be an unusual occurrence LIKELY expected to happen sometimes ALMOST CERTAIN expected to happen frequently 23

24 NI Hospice Research Governance Permission Guidance Note 1: Pre-Application Guidance Appendix 5 Peer Review Report Form Project Title Chief Investigator On the basis of the assessment below, this application: should proceed to the Office for Research Ethics Committees N. Ireland (ORECNI) should be amended by the applicant as indicated in the comments and then proceed to the Office for Research Ethics Committees N. Ireland (ORECNI) requires substantial changes and should be revised and returned for further review is not viable in its current form and should be withdrawn by the applicant Peer Review conducted by 1. Date 2. The application and both pages of this form should now be returned to the Chief Investigator If the answer to any of the following questions is No, please use the box to add comments where appropriate Yes No 1. Does the proposed research make a contribution to the knowledge base or is it otherwise justified for educational or training purposes? 24

25 NI Hospice Research Governance Permission Guidance Note 1: Pre-Application Guidance 2. Does the application demonstrate appropriate understanding of the background and key issues on the part of the applicant(s)? Yes No 3. Does the applicant have a record of research in the area or is the study otherwise justified as a research/scientific training exercise? 4. Are the aims and objectives/research questions clearly stated? 5. Is the methodology adequate and appropriate? 6. Is the project planning adequate? 7. Is the envisaged outcome likely to be achieved? 8. Have the likely risks and ethical issues been identified and addressed? 25

26 NI Hospice Research Governance Permission Guidance Note 1: Pre-Application Guidance Appendix 6 Notification of a Proposed Substantial Amendment Form Chief Investigator: Approved Study Title: New/Amended Title (if appropriate): Type of Amendment (please indicate any that apply): Amendment to application form [ ] Amendment to description/protocol [ ] Amendment to the information sheet/consent or other [ ] supporting information Please submit the appropriate amended documentation in each case, ensuring that new text is highlighted to enable comparison with the previous version to be made. Summary of Changes: 26

27 NI Hospice Research Governance Permission Guidance Note 1: Pre-Application Guidance Summary of Changes (continued): Additional ethical considerations: List of enclosed documents: Declaration: I confirm that the information in this form is accurate and that implementation of the proposed amendment will benefit the study appropriately. Signed Date (Chief Investigator).. Northern Ireland Hospice/Ulster University Research Group Decision This amendment: is appropriate to the needs of the study, and should be implemented [ ] is appropriate to the needs of the study, and should be submitted to OREC [ ] is NOT appropriate and should be reconsidered or withdrawn [ ] Signed (Chair of Northern Ireland Hospice/ Ulster University Research Group) Date.. 27

28 NI Hospice Research Governance Permission Guidance Note 1: Pre-Application Guidance Appendix 7 Glossary Amendment A change made to the terms of an application for NHS permission, the protocol or any other supporting documentation after the study has started. A study is normally considered to start with the commencement of any protocol procedures. ARSAC Administration of Radioactive Substances Advisory Committee. Chief Investigator (CI) The investigator with overall responsibility for the research. In a multi-site study, the CI has coordinating responsibility for research at all sites. Global governance checks The checks generic to the study. They are undertaken once on be half of all NHS organizations/care organisations taking part in the study. Governance checks A number of checks which aim to provide assurances that a study complies with applicable regulatory and statutory requirements. GTAC Gene Therapy Advisory Committee. GTAC has UK-wide responsibility for the ethical oversight of proposals to conduct clinical trials involving gene or stem cell therapies. The Committee also advises Ministers on the development and use of gene and stem cell therapies and works with other Government agencies with an interest in this area, such as the Medicines and Healthcare products Regulatory Agency (MHRA), the Health and Safety Executive (HSE) and the Human Tissue Authority HSC Health and Social Care IRAS Integrated Research Application System. Local Collaborator Studies that do not require a local principal investigator at each site, but require someone that is willing to act as the Northern Ireland Hospice contact for the coordination and facilitation of the research. Local governance checks The checks required to be undertaken by an individual organisation in respect of the study. They must be conducted by Northern Ireland Hospice. MHRA Medicines and Healthcare products Regulatory Agency. NHS National Health Service. NHS organisation All organisations within the National Health Service who provide health or social care (i.e. NHS Trust). NHS permission The permission from the NHS organisation providing care to 28

29 NI Hospice Research Governance Permission Guidance Note 1: Pre-Application Guidance conduct the research at a NHS site before any research procedures are commenced at a particular site, i.e. permission from the Local Health Boards. Also known as R&D approval or Research Governance Approval. NHS REC Form The application form which collects the study data required by a Research Ethics Committee to review a study. The online form is a smart form designed to save time when completing it. As certain questions are answered, information will auto populate in other relevant places and the answers to certain questions will deactivate or activate other sections of the form. NHS/HSC R&D Form The NHS/HSC R&D form is split into NHS/HSC R&D form (project information) and NHS/HSC R&D form (SSI). Applications for NHS permission require both forms, the NHS/HSC R&D form (project information) which contains the project-wide information and the relevant NHS/HSC R&D form (SSI) with local information. These forms are used by the R&D or Research Governance offices to review a study. The project-wide information allows the study to be assessed and the SSI local information allows an assessment of the suitability of the local investigator, site and facilities. NRES National Research Ethics Service. Primary care The provision of services by GPs and primary care teams in health centres and surgeries; and the services provided by independent contractor professions like opticians, dentists and pharmacists. Principal Investigator (PI) Where the research takes place in more then one site, this is the individual who is responsible for the research at a particular site; there will be one PI per site. R&D Research and Development. REC Research Ethics Committee. Research The attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods. Scientific review The scrutiny of the hypothesis, design, methodology and statistics of a proposed research study. The Research Governance Framework for Health and Social Care 2006 states that the review should be by experts in the relevant fields able to offer independent advice on the quality of the research study. Arrangements for review should be commensurate with the scale of research. Sponsor The person who takes responsibility for initiation, management and financing (or arranging finance) for that trial/study. SSI Site Specific Information. Supporting documentation All documents associated with the main application for obtaining NHS permission. 29

30 NI Hospice Research Governance Permission Guidance Note 1: Pre-Application Guidance Validation A check carried out by the RMG office to verify that an application is complete and may be accepted for review. 30

31 NI Hospice Research Governance Permission Guidance Note 1: Pre-Application Guidance Appendix 8 Check List for Applicant Northern Ireland Hospice Research Governance Submit to the Education and Research Department for initial organisational approval: Completed IRAS Form (including details of sponsor, indemnity and any funding) Completed 6 page Research Protocol (Research Proposal) Completed Risk Assessment Completed Peer Review Report Following ethical review (by ORECNI or University REC) submit evidence of this process and the outcome: Research Ethics Review Report Submit during the research process: An annual report An end of study report (Forms to complete these reports are available from ORECNI) Initial approval forms and annual/end of study reports should be forward to Tracey McTernaghan who can be contacted at: tracey.mcternaghan@nihospice.org : 31