An introduction to Research Management and Governance (RM&G) in the NHS

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1 An introduction to Research Management and Governance (RM&G) in the NHS Rachel Davis Assistant RM&G Project Manager Natassia Embury R&D Facilitator 14/04/2014 Delivering clinical research to make patients, and the NHS, better

2 Outline 1. The importance of NHS research 2. The National Institute for Health Research Clinical Research Network (NIHR CRN) landscape and what the future holds 3. Research study roles and responsibilities 4. The National Institute for Health Research Clinical Research Network (NIHR CRN) Portfolio 5. An introduction to the Integrated Research Application System (IRAS) and research study submissions 6. The Health Research Authority (HRA) - including Section An introduction to the Co-ordinated System for Gaining NHS Permission (CSP) 8. The governance review 9. Post approval 10. Useful contacts

3 1. The importance of NHS research

4 Importance Patient outcomes Wider benefits Improved treatments Front line service Strong economy Efficient services Increased skills Research is a frontline service that offers many benefits see diagram to the left There is an expectation that all Trusts in England will engage with research Research is detailed in the NHS Constitution as being a way to improve: the current and future health and care of the population. As research is so important to the development of the NHS, Research Networks exist to support and promote NHS research

5 2. The NIHR CRN landscape and what the future holds

6 Landscape The National Institute for Health Research (NIHR) Clinical Research Network, which provides more than 284m a year to support the delivery of clinical research studies in the NHS, has reconfigured and the new streamlined structure came into effect on the 1 st April 2014 Until this point, the Network has comprised 102 overlapping local networks, each supporting clinical research studies in different therapy areas or parts of the service. From April 2014, this has been rationalized into 15 local Clinical Research Networks across England, which will deliver studies across all therapy areas

7 Geography CRN: West Midlands = number 6 on the map Host: The Royal Wolverhampton NHS Trust 30 NHS Trusts 22 CCGs

8 3. Research study roles and responsibilities

9 Roles This diagram illustrates the hierarchy of a typical multi-centre study

10 Roles continued Sponsor: In relation to a clinical trial, the person/organisation who takes responsibility for the initiation, management and financing (or arranging the financing) of that trial. (As per Regulation 3.1 of SI 2004 No.1031) Chief Investigator (CI): In relation to a clinical trial conducted at a single trial site, the investigator for that site, or in relation to a clinical trial conducted at more than one trial site, the authorised health care professional, whether or not he is an investigator at any particular site, who takes primary responsibility for the conduct of the Trial. (As per Regulation 2.1 of SI 2004 No.1031) Principle Investigator (PI): In relation to a clinical trial, the authorised health professional responsible for the conduct of that trial at a trial site, and if the trial is conducted by a team of authorised health professionals at a trial site, the investigator is the leader responsible for that team. (As per Regulation 2.1 of SI 2004 No.1031)

11 4. NIHR CRN Portfolio

12 NIHR CRN Portfolio National Institute for Health Research Clinical Research Network Portfolio: High quality clinical studies that are supported by the NIHR CRN Automatically eligible (funded by NIHR, other areas of government or NIHR partners e.g. Action Medical Research, Cancer Research UK) Potentially eligible (assessed for adoption based on quality, feasibility, clear benefit to NHS, Network support required) Not eligible (e.g. funded by University or NHS Trust) Data from the Portfolio informs allocation of CRN funding Access to Research Network infrastructure e.g. nursing support, NIHR CSP

13 Portfolio Screenshot

14 5. Introduction to IRAS and research study submissions

15 IRAS Integrated Research Application System Single system for applying for permissions and approvals for health and social care research in the UK, consisting of a single dataset Before you use IRAS: 1. Set up an account 2. Use the e-learning module

16 IRAS Homepage

17 Research and Development (R&D) Form R&D Form 1 per study R&D Office Summarises the study as a whole Content determined by project filter pages Contains specific support department information Lists all sites involved in the study Part C Common pitfalls Ensure all Trusts are listed in Part C Specify in Part C whether a Trust is a site or a patient identification centre (PIC) Ensure all relevant signatures have been obtained Sponsor and CI

18 Site Specific Information (SSI) Form SSI Form 1 per site R&D Office Summarises the study on a local level Many fields pre-populated due to R&D form completion Key in determining support required from local teams / departments Common pitfalls PI vs Local Collaborator (LC) (Qu. 2) Make use of SSI Qu. 3, 8.2 and 9.2 Feasibility and recruitment target (Qu. 10) Screening notes and first approach by clinical care team (Qu. 11) Funding (Qu. 21) Signatures (Declaration by PI and LC)

19 IRAS hints and tips Project Filter Questions Completion of 11 Y/N questions customises the dataset according to the type of research project, disabling questions and sections that are not relevant Specific application form selected (REC, R&D or SSI) = the tabs and questions shown on the right hand side of the navigation page will be specific to that particular application form IRAS contains question-specific guidance, which is accessed by clicking the i buttons alongside a question Please note: Draft copies of the forms can be used to progress the governance review until a submitted and fully signed copy has been received

20 IRAS screen shot

21 Group Activity The aim of the task is to match each question to the correct IRAS form - R&D Form, SSI Form, or both forms (R&D form and SSI form) i.e. which form/s does each question appear in?

22 Comfort Break

23 6. HRA

24 The purpose of the HRA The Health Research Authority website: The Health Research Authority (HRA) safeguards the rights, safety, dignity and wellbeing of people participating in research in the NHS They review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical The HRA are entirely independent of research sponsors and investigators. This enables them to put participants at the centre of their research Section 251 was established to enable the common law duty of confidentiality to be overridden to enable disclosure of confidential patient information for medical purposes, where it was not possible to use anonymoised information and where seeking consent was not practicable HRA approval (also known as REC approval) is required for all NHS research unless it involves NHS staff ONLY: please see Governance Arrangement for Research Ethics Committees (GAfREC) for more details

25 REC Process 1. Prepare the Research Ethics Form (REC Form) in IRAS and all other study documentation (version control is key!) 2. Book an appointment via the central allocation system ( ). This appointment will be made with an appropriate REC Committee 3. Input REC details in the REC Form (question 3) and submit in IRAS 4. Submit REC form and documents to the REC directly within four days of booking appointment 5. If the application is valid, you will be invited to attend a REC meeting 6. It is advised that the CI or another appropriate member of the central research team attend the meeting if possible 7. A REC decision (favourable, conditional, provisional, or unfavourable) will be made within 10 working days of the meeting Please see the REC application process document included in your pack

26 REC Decisions Favourable opinion with standard conditions Favourable opinion with standard and additional conditions Provisional opinion with request for further information, clarification or revision Provisional opinion pending consultation with a referee Unfavourable No opinion refer to full meeting for further review of significant ethical issues

27 Key Documents and Tips The REC will expect to see your REC Form, in addition to all documents outlined in the IRAS checklist e.g. patient information sheet, consent form, patient invitation letter, proof of insurance etc For guidance on how to create a PIS and consent form, please visit the NRES website where a guidance document for researchers is available: Before any documents can be used for the study they will need to be granted with REC Approval. If during the study amendments are required the REC approval will be needed for the document for it to be included in the approval for the study

28 Approval process how REC fits in Researcher Submits Complete Document Set The REC Team work to a 60 day clock Research Ethics Committee RM&G Team The RM&G Team work to a 30 day clock Ethics Favourable Opinion Trust NHS Permission Research Indemnified: Project Can Begin As an R&D office we advise you submit your application to the REC at the same time you submit to us to allow NHS permission to be granted as soon as it possibly can

29 7. CSP system

30 Co-ordinated System for gaining NHS Permission (CSP) A centralised system through which applications for NHS permission from NIHR CRN portfolio studies can be received All CRNs have access to CSP It s a coordinated approach for the R&D approval of a study because: A Lead CRN conducts a study-wide review, shared with all other sites All documentation is automatically shared via the Document Repository A Lead CRN can track approval status at all the sites and can assist with governance queries

31 CSP Screenshot - Task View

32 CSP Task View Task View Informs the CRN that they have received: 1. An R&D Form for a new study that they are Lead CRN for; the CI is based in that CRNs region 2. An R&D Form for a new study where one of the Trusts within the CRNs patch is participating; the Trust has been listed in Part C 3. An SSI Form has been received for one of the CRNs member NHS Trusts; this will need to be validated and the governance review needs to begin 4. An amendment has been received (either to review as Lead CRN, or to review simply as a participating site) All of these Tasks are triggered through submissions in IRAS the Researcher submits a form, and the CRN receives a Task

33 CSP- Document View Document View All documentation uploaded to either: 1. The R&D Form IRAS checklist when submitting the R&D Form or 2. The SSI Form IRAS checklist when submitting the SSI Form will appear in the Document Repository automatically As the study progresses, any documentation sent to the Lead CRN will be manually uploaded by them into the Document Repository. Amendments submitted via IRAS will also appear in the Document Repository

34 8. Governance review

35 Types of R&D Review Study-wide review Local review Industry/ Commercial review

36 Industry Research Sponsored by pharmaceutical, medical device or biotechnology company Core CRN business priority High Level Objective: Increase amount of commercial research delivered in the region Source of income more details on the NIHR Industry costing template Facilitates access to leading edge treatments and technologies For general enquiries please

37 Coordinated Network Support National scheme aimed at supporting the delivery of multi-centre studies Aimed at easing the challenges of multi-centre set up through streamlining the applications process and avoiding duplication of effort: o o o o o Costing a study e.g. advising on potential nurse support Distribution of study documents to participating research sites Advising participating research sites of any problematic aspects Key point of contact for the central study team Advising on and managing study amendments

38 Study-wide Valid Submission Study-wide submission by the CI Signed NHS R&D Form and documents detailed in the checklist REC favourable opinion letter and all relevant correspondence Medicines and Healthcare Products Regulatory Agency (MHRA) clinical trial authorisation (for clinical trials involving an investigational medicinal product (CTIMP); MHRA notice of no objection letter (medical device studies only) Protocol / proposal Study contract (where required) Confirmation of insurance/indemnity, if non-nhs sponsored Letter from funder confirming funding (if applicable) Any material participants will see PIS, consent form, questionnaires

39 Study-wide review Target: 30 calendar days CSP Facilitator R&D Facilitator RM&G Manager RM&G Manager Clock starts Allocate studywide Governance Reviewers & QCs Perform study wide governance Perform study wide QC Clock stops If passed QC press Submit No longer any tasks in Task View

40 Local Valid Submission Local submission by the PI / Research Nurse Signed NHS SSI form and documents detailed in the checklist Localised participation documentation (PIS, consent form, invitation letter, GP letter, and any other document the participant will see) Summary CV for members of the research team (preferably signed and dated)

41 Local review Target: 30 calendar days CSP Facilitator R&D Facilitator CSP Facilitator CSP Facilitator R&D Facilitator RM&G Manager R&D Facilitator Clock starts Validate SSI Submission Assess SSI submission Validate SSI Submission Allocate local Governance Reviewers and QCs Perform local governance Perform local QC Clock stops Grant NHS Permission Invalidating the SSI Form returns the Date SSI Submission Received to 0 days.

42 The Review Departmental support / authorisation Costs Contracts Guidance and legislation Research passports

43 Departmental support / authorisation

44 Departmental Support Radiology capacity, Clinical Radiation Expert (CRE), Medical Physics Expert (MPE), The Administration of Radioactive Substances Advisory Committee (ARSAC) licence Pathology capacity, costs, material transfer agreement (MTA) required? Pharmacy capacity, excess treatment costs? General all interventions

45 Group Activity Interventions Standard care Above standard care Blood taken for safety monitoring 5 2 Urine collection Which department/s does the R&D Department need to approach in order to obtain support for the governance review? 2. What other information does the R&D Department require in order to obtain support from this department i.e. what information is missing?

46 Costs

47 Cost Breakdown Research costs: These are the costs of the research itself. They end when the research ends. These are activities being undertaken to answer the research question. Service support costs: Additional patient care costs associated with the research which end once the research activity in question ends e.g. obtaining informed consent. Treatment costs: Patient care costs that would continue to be incurred if the patient care in question continued to be provided after the research ends. Excess treatment costs: Difference between the cost of standard care and the cost of the treatment provided for the research. Please refer to the Attributing the costs of health and social care Research and Development (AcoRD) document for more information

48 Contracts

49 Contracts Model Agreements for studies are between the Sponsor and Site They list the responsibilities of each party along with financial information All contacts need to be reviewed and signed. Three copies are usually required for the review Addendums to the contract will need to be reviewed and signed also It is important to check whether a study requires a contract or one is available

50 Guidance and legislation

51 Research Governance Framework Guidance that: Ensures high quality research high scientific, ethical and financial standards Safeguards participants in research Protects researchers/investigators Minimises risk Monitors practice and performance Promotes good practice

52 Legislation things to consider + UK Clinical Trials Regulations + Human Tissue CTIMP? + Children + Radioactive Materials + Gene Therapy Regulated procedure? Overarching laws e.g. DPA Local policies and SOPs Vulnerable participants? + Adults lacking capacity + Prisoners + Others Research Governance Framework + Others Research in NHS

53 Research passports

54 Research Passport Scheme NHS staff who wish to work in an NHS Trust they are not employed by: NHS staff will be issued with a Letter of Access; never an Honorary Research Contract This Letter will be issued on the basis of a signed and dated CV, and a completed Confirmation of Pre-Engagement Checks document NHS staff do not require a Research Passport The CRN will advise upon the requirements once they have received an SSI form

55 Research Passport Scheme Non-NHS university staff who wish to enter an NHS Trust Non-NHS university staff will be asked to complete a Research Passport The Research Passport is a single form completed by the researcher, line manager, human resources department and NHS Trust The purpose of this form is to demonstrate that all the necessary preengagement checks have been carried out on the researcher A Letter of Access or Honorary Research Contract will then be issued as appropriate The CRN will advise upon the requirements once they have received an SSI form

56 Granting NHS Permission All checks complete Sent to Signatory for review Complete approval Approval letter issued permission granted

57 9. Post approval

58 Recruitment to Time and Target Assessing studies on how many participants they recruit, compared to their stated targets Reasons for this measurement: If a study recruits fewer than its target, it could be seen as less clinically effective/relevant If a study takes too long, it reduces the speed at which patients can benefit from that research and may actually be overtaken by other research, making that study irrelevant If the UK does not act competitively, research will be taken else where in the world

59 Amendments CSP Amendments The Lead CRN will class the amendments into the following categories Substantial, notifiable Substantial, non-notifiable Non-substantial, notifiable Non-substantial, non-notifiable These amendments are processed through the CSP system Non CSP amendments These are approved and acknowledged by the CRN. The impact of amendment will be reviewed and an approval acknowledgment will be made. For all research Amendment queries

60 Summary 1. What is NHS research 2. Research study roles and responsibilities 3. The tools used to obtain NHS Permission 4. The importance of a valid submission 5. The governance review 6. Post approval activities Any Questions?

61 10. Useful contacts

62 Contacts Research Governance Advice: CSP Advice: Academy: Industry: Research Amendments:

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