NIHR Governance Systems Regimantas Pestininkas Deputy Research Governance

NIHR Governance Systems Regimantas Pestininkas Deputy Research Governance Manager 1 July 2010 West Midlands (South) Comprehensive Local Research Network

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 West Midlands (South) Comprehensive Local Research Network

West Midlands (South) Comprehensive Local Research Network

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 West Midlands (South) Comprehensive Local Research Network

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 West Midlands (South) Comprehensive Local Research Network

Regulatory Approvals: Overview Research in the NHS Permission Ethics Other regulatory bodies Create Forms on IRAS Non-Portfolio All research Apply via Individual Trusts Apply via CSP Apply to REC Apply to relevant regulatory body West Midlands (South) Comprehensive Local Research Network

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 West Midlands (South) Comprehensive Local Research Network

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 West Midlands (South) Comprehensive Local Research Network

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

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 West Midlands (South) Comprehensive Local Research Network

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 West Midlands (South) Comprehensive Local Research Network

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 West Midlands (South) Comprehensive Local Research Network