2 CRN - Setting up research in the NHS: practical and ethical considerations

2 CRN - Setting up research in the NHS: practical and ethical considerations

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  Setting up Researchin the NHS - NIHR Clinical Research Network (CRN) Perspective Dr Mobeena Naz 25/02/16
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  Infrastructure
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  Idea stage -New to Research… where do I begin • The first is a way of deciding whether or not your project is categorised as research rather than audit or service evaluation, and the second is for deciding whether or not NRES ethics approval is required. The links to the toolkits are below: –http://www.hra-decisiontools.org.uk/research/index.html –http://www.hra-decisiontools.org.uk/ethics/ • If you think your project is research, then you should register on IRAS, the Integrated Research Application System (IRAS) which is a ‘one-stop shop’ for applying to multiple agencies such as the REC, R&D, MHRA etc. If your research involves NHS patients, staff and/or facilities, your research cannot proceed without formal approval from the R&D Office(s) at each of the NHS Trusts in which your research is to take place. • IRAS link https://www.myresearchproject.org.uk/help/hlpupdates.aspx
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  IRAS - theplatform for all research
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  What is onoffer by the Clinical Research Network? Training – GCP – Intro to Valid Consent – Informed Consent in Peads – Adverse Events and Safety Reporting – Writing SOPs – Site File Management and Delegation of Duties – Introduction to Clinical Research – Intro to IRAS and Research Management in the NHS – IRAS and Amendments – Cost Attribution – Commercial Trials Workshop – Cancer Researchers Introductory Course – PI Masterclass – For more information please see https://learn.nihr.ac.uk/course/index.php?categoryid=24 9
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  What is onoffer by the Clinical Research Network? – Support with identifying new sites for your studies – Support finding potentially suitable studies for you to join – Performance management for Lead and Participating sites – Facilitate sharing good practice and help overcoming barriers – Access to Local Clinical Expertise (Clinical Research Leads) – Access to local non clinical expertise (Research Delivery Managers, Industry Managers, Portfolio Managers, Lead Nurses, Study Support Services) – Support from lead Nurses with access to generic nursing team 10
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  Early Contact andEngagement with Researchers (ECER) In summary; –Part of the CRN Study Support Service (CSSS) –Starts at the Research Idea stage of the Research Delivery Pathway –Ends once NHS Permission/ HRA Ready to Recruit has been obtained at the majority of sites (although the Research Delivery Manager continues support) –Supports both commercial and non-commercial studies –Ensures tailored support is provided to the researcher –Provides a single point of contact for the research team –Addresses potential issues at an early stage in the Research Delivery Pathway before they become a concern 11
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  Early Contact andEngagement with Researchers (ECER) • Early Contact and Engagement with Researchers (ECER) –Identifying the specific support required across the Research Delivery Pathway –Advising on the approvals process e.g. HRA –Providing cost attribution advice (AcORD) –Identifying the service support infrastructure required and confirming this with the other CRNs/ Trusts involved –Identifying NIHR training requirements e.g. GCP, IRAS/ CSP, cost attribution –Linking in with the appropriate Research Delivery Manager, Clinical Support Services, and local/ national Specialty Leads –Signposting to Research Design Service (RDS) for protocol development –Keeping the CI and their research team informed of progress and helping to resolve any problems 12
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  Key Messages…. • Pleaseencourage researchers to contact their R&D departments and the Study Support Service Team as early as possible. (Multi-centre CLAHRC studies may require Clinical Research Network support if study activity (e.g. recruitment) is occurring in sites external to the NHS Trust/s in receipt of the CLAHRC award. Applications for these studies to be considered for CRN support should be made via IRAS (select Yes to Question 5b “Do you wish to make an application for the study to be considered for NIHR Clinical Research Network (CRN) Portfolio?”). If deemed eligible for CRN support these studies will be added to the Portfolio Database) Key Contacts • R&D Contact: Jo McCormack (Lead Nurse – Research) [email protected] • Study Support Services team: [email protected] • Primary Care Teams sit within the Network and provide assurance for Primary Care Studies on behalf of GP Practices and validation of Research Passports for non NHS employed staff working on NHS Premises: [email protected] 13