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

2. 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

3. West Midlands (South) Comprehensive Local Research Network

4. 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

5. 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

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

7. 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

11. 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

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

13. West Midlands (South) Comprehensive Local Research Network 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

14. 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

15. 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.ukcrncc.csp@nihr.ac.uk –BBC CLRN: cspbbcclrn@uhb.nhs.ukcspbbcclrn@uhb.nhs.uk –WM (N) CLRN: ns-pct.CSP-WMNCLRN@nhs.netns-pct.CSP-WMNCLRN@nhs.net –WM (S) CLRN: uhc-tr.wmsclrn@nhs.netuhc-tr.wmsclrn@nhs.net