NIHR Governance Systems

West Midlands (South) Comprehensive Local Research Network

NIHR Governance SystemsNIHR Governance Systems

Regimantas PestininkasRegimantas PestininkasDeputy Research Governance ManagerDeputy Research Governance Manager

1 July 20101 July 2010

West Midlands (South) Comprehensive Local Research Network

Government’s AmbitionGovernment’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 GovernanceResearch 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 InitiativesResearch 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: OverviewRegulatory Approvals: Overview

Research in the NHS

NHS Permission Ethics Other regulatory bodies

Non-Portfolio Portfolio

Apply via Individual

Trusts

Apply via CSP

Create Forms on IRAS

All research

Apply to REC

All research

Apply to relevant regulatory body

West Midlands (South) Comprehensive Local Research Network

Integrated Research Application System (IRAS)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)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

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

West Midlands (South) Comprehensive Local Research Network

Research Passport SchemeResearch 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 DevelopmentsFuture 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 InformationFurther Information• www.nihr.ac.uk• www.myresearchproject.org.uk• www.ukcrn.org.uk• CSP:

– National: [email protected] – BBC CLRN: [email protected] – WM (N) CLRN: [email protected] – WM (S) CLRN: [email protected]