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Research Governance: The Role of Employers and Health Care Organisations

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Title: Research Governance: The Role of Employers and Health Care Organisations


1
Research GovernanceThe Role of Employers and
Health Care Organisations
  • Prof William Rosenberg
  • Chair NHS RD Forum
  • Prof Hepatology UCL

2
OverviewWho, What, Why, How?
  • Employers and Research
  • Who is who What is what?
  • Responsibilities and why
  • Research Governance Framework
  • Medicines for Human Use (CTIMP) Regulations
  • Data Protection Act 1998
  • Human Tissue Act 2004
  • ICH-GCP
  • Making it work
  • The Good Practice Resource Pack

3
Researchers in the NHSWho is Who Courses for
horses
  • NHS Employees
  • Substantive HEI Honorary NHS contract
  • Clinical Academics
  • Clinicians contracted to provide NHS services
  • e.g. GPs.
  • Researchers with no contractual relationship with
    the NHS
  • HEI undergraduate and postgraduate students

4
Overlapping roles
Sponsor
Care Organisation
Employer
5
Who is Who?
  • Employer
  • Who issues your pay cheque?
  • Often HEI
  • Sponsor
  • Often a Care Organisation
  • Often Industry Partner
  • Sometimes HEI

6
Importance of Research for Employer
  • NHS
  • Integral to NHS mission
  • Innovative ways of preventing, diagnosing and
    treating disease
  • Provides information on the costs, effectiveness
    and broader impact of health technologies
  • Provides the evidence base for the business
  • HEI
  • Core business
  • Pressure for success

7
Research Governance FrameworkResponsibilities of
the employer
  • Promoting a quality research culture
  • Ensuring researchers understand and discharge
    their responsibilities
  • Ensuring studies are properly designed and
    submitted for independent review
  • Ensuring studies are
  • managed
  • monitored and
  • reported as agreed, according to the protocol.
  • Providing written procedures, training and
    supervision
  • Taking action if misconduct or fraud is suspected

8
Research Governance FrameworkResponsibilities of
Care Organization
  • Arranging for an appropriate person to give
    permission for research before the research
    starts
  • Ensuring conduct in line with RGF standards
  • Requiring evidence of ethical review
  • Requiring evidence a Clinical Trials
    Authorisation
  • Retaining responsibility for the care of
    participants to whom they have a duty

9
Sponsors Duties
  • Initiation, management and financing of trial
  • Quality assurance and quality control
  • Insurance and indemnity
  • Agreements
  • Regulatory authorisation
  • IRB/Ethics
  • Financial agreements
  • Selection and contracting of investigators
  • Product manufacture, supply, information
  • Compliance with GCP
  • Safety monitoring and audit

10
Principles of Responsibility Liability
  • Appropriate allocation is fundamental
  • Employer responsible for ensuring suitable
  • Training, experience and conduct
  • HEI accountable for employees
  • Actions outside care
  • Compliance with confidentiality
  • NHS
  • No over-arching responsibility
  • Communication channels described in the Good
    Practice Guide

11
Sponsor Liabilities
  • Negligent Harm
  • NHS RD permission extends indemnity to all
    agreed investigators CNST and equivalent
    schemes
  • Non-negligent Harm
  • Necessity assessed by REC
  • Not provided by Public Bodies (NHS, MRC etc)
  • Ex gratia payment possible
  • Covered by ABPI Indemnity
  • HEI may contract to provide cover

12
Oversight of Contracts
  • Share responsibility to ensure contracts are in
    place
  • Making sure all parties interests are addressed
  • Intellectual property rights
  • Control over IP
  • Royalty shares
  • Maintenance of patent claims

13
Responsibility for compliance
  • Ethics approval
  • RD approval
  • Regulatory permissions e.g. CTA
  • ICH GCP and research conduct
  • Product - manufacture, supply, information
  • Data management and confidentiality
  • Reporting of AEs
  • Annual reporting and end of study report
  • Investigators conduct and research setting

14
Monitoring and Audit
  • Extent determined by nature of study
  • Protection of subjects rights and well being
  • Trial data
  • accurate, complete and verified
  • Conduct complies with
  • GCP and regulatory requirements
  • Audit
  • Systematic and independent check on monitoring

15
Finance
  • Application of tariffs
  • Overheads
  • Full economic costs
  • Contracts
  • Profit
  • Division of profit

16
Research Integrity
  • Conflicts of interest
  • Intellectual, Mission, Loyalty
  • Financial
  • Misconduct
  • Scientific
  • Patient care
  • Fraud
  • Financial
  • Scientific
  • Publication

17
Research Passport - Context
  • Linked with Integrated Research Application
    System and other streamlining
  • Includes Pre-engagement checks
  • National guidance on issuing of honorary research
    contracts
  • Need to work across multiple NHS organisations

18
Actions
  • NHS organisations and HEIs are encouraged to
  • Accept the principles in this Good Practice Guide
  • Co-operate in its use
  • Put in place processes and policies
  • Inform researchers about local mechanisms
  • Guidance on partnership between HEI and NHS
    provided by RD Forum
  • http//www.rdforum.nhs.uk/library.htmuniversity

19
Joint Offices
When universities and health care organisations
are both involved in employing clinical academic
staff, they are expected to make joint
arrangements for appointment, supervision and
appraisal. RGF
  • Rapid and easy communication
  • Transparency
  • Familiarity with systems and processes
  • Embodiment of collaboration
  • Beware and Acknowledge
  • Conflicting objectives - IPR
  • Competing demands RAE

20
Factors Determining Success
  • Collaboration and trust
  • HEI and NHS
  • Roles agreed and documented
  • Effective communication
  • Research support and HR departments
  • Information and support
  • Provided to researchers
  • Clear policies and procedures
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