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NIHR Governance Systems

NIHR Governance Systems. Regimantas Pestininkas Deputy Research Governance Manager 1 July 2010. Government’s Ambition. Making the NHS a world-class environment for research

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NIHR Governance Systems

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  1. NIHR Governance Systems Regimantas Pestininkas Deputy Research Governance Manager 1 July 2010

  2. Government’s Ambition • Making the NHS a world-class environment for research • Mission: “to create a health research system in which the NHS supports outstanding individuals, working in world-class facilities, conducting leading-edge research, focused on the needs of patients and the public” • Developed with input from government departments, industry, universities and NHS organisations

  3. Research Governance • A broad range of regulations, principles and standards of good practice that exist to achieve and continuously improve research quality across all aspects of healthcare in the UK and worldwide • Managing risks & ensuring public confidence • Often viewed as bureaucratic

  4. Research Governance Initiatives • Improve the quality, speed and coordination of clinical research by removing the barriers to research in the NHS. Strengthen and streamline systems for research management and governance • Integrated Research Application System • NIHR CSP • Research Passports

  5. Regulatory Approvals: Overview Research in the NHS NHS Permission Ethics Other regulatory bodies Create Forms on IRAS All research All research Non-Portfolio Portfolio Apply via Individual Trusts Apply via CSP Apply to REC Apply to relevant regulatory body

  6. Integrated Research Application System (IRAS) • https://www.myresearchproject.org.uk • IRAS is a dataset, not a form • Once dataset is created, multiple forms can be populated very easily (REC, R&D, MHRA, NIGB, GTAC, etc) • Data is only entered once! • Ethics and R&D are related, but independent processes; however, they both start through IRAS

  7. Coordinated System for gaining NHS Permission (CSP) • A consistent, standardised process for gaining NHS permission • A system run through CSP Unit and CLRNs to ensure a coordinated approach with local input • A single point to which researchers need to apply to gain NHS permission • Distinction between global and local checks – removing duplication

  8. Researcherapplies for NHS Permission and other regulatory approvals via IRAS NIHR CSPGovernance Review & QA checks undertaken by NIHR CC &CLRNs Governance Report Issued NHS Organisation receives the Governance Report and issues NHS Permission Researcher receives the permission letter; research can now begin at that site

  9. Research Passport Scheme • Allows sharing of pre-engagement information about a researcher with relevant NHS organisations via a Research Passport • Only ONE set of checks are performed on a researcher • Clarifies NHS contractual arrangements for researchers • IMPORTANT: The Research Passport does not remove the need for honorary contracts; it allows them to be issued quicker

  10. Future Developments • R&D Management Information System (RDMIS) • For information input, retrieval and dissemination • Sharing of information between partners • Easy-to-follow guidance on permissions & conducting research • Progress monitoring (recruitment & permissions) • Research Support Services • National framework for research support services • Proportionate risk-based interpretation of policies and rules • Primary focus – facilitating NIHR research, Secondary – facilitating other health research in the NHS

  11. Further Information • www.nihr.ac.uk • www.myresearchproject.org.uk • www.ukcrn.org.uk • CSP: • National: crncc.csp@nihr.ac.uk • BBC CLRN: cspbbcclrn@uhb.nhs.uk • WM (N) CLRN: ns-pct.CSP-WMNCLRN@nhs.net • WM (S) CLRN: uhc-tr.wmsclrn@nhs.net

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