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Clinical Research in the NHS: Approval and Governance Requirements

Explore the essential approvals, considerations, and roles needed for successful clinical research in the NHS, including ethical approval, R&D approval, sponsorship, and regulatory requirements. Learn about the involvement of clinicians, statisticians, pathologists, and research nurses in translational research using samples and data.

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Clinical Research in the NHS: Approval and Governance Requirements

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  1. CLINICAL RESEARCH AND THE NHS

  2. CLINICAL RESEARCH AND THE NHS • Research and clinical governance • Translational research using samples and data • Qualitative research • Multidisciplinary nature of successful clinical research Considerations and regulatory approvals largely the same

  3. Who do you need on board? • Clinician/surgeon • Statistician • Pathologist • Clinical Trialist • Research Nurse

  4. What approvals are required before you start? • Ethical approval • R&D approval (NHS permission and site-specific) • Clinical trials: MHRA, GTAC • Sponsorship

  5. Ethical approval: Where do you apply? Non-NHS participants University Ethics Review Committee With or without sample collection/storage? NHS staff, premises, facilities University Ethics Review Committee NHS patients National Research Ethics Service (NRES) All types of research with or without sample collection

  6. Ethical review: What will be considered? • Identification and recruitment • Consent • Scientific validity of the study • Collection of samples; existing/prospective • Access to personal/clinical data; anonymisation • Storage and retention of personal data • Funding • Sponsorship • Incidental findings and feedback • What will happen to samples/data when study finished • Vulnerable groups

  7. R&D approval: What will be considered? • Principal Investigator • Identification and recruitment • Consent • Location • Whether procedures are additional to clinical pathway • Access to personal/clinical data; anonymisation • Storage and retention of personal data • Sponsorship • MONEY!

  8. Clinical trials • Clinical trial authorisation from the MHRA • GTAC • Good Clinical Practice • Contractual agreements • Quality Management System • Adverse event reporting

  9. Sponsor • Under the Research Governance Framework …… Requirement for all research using NHS patients, • staff and facilities • The Sponsor is legally responsible for the management of the research • Investigators appropriate • Funding • Regulatory approvals • Insurance • Current legislation e.g. Human Tissue Act, DPA

  10. Integrated Research Application Service (IRAS) Streamlining the research application process https://www.myresearchproject.org.uk/ • Ethical approval • NHS permission/R & D approval • MHRA • GTAC • NOMS, MOJ

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