Title: Research Governance: The Role of Employers and Health Care Organisations
1Research GovernanceThe Role of Employers and
Health Care Organisations
- Prof William Rosenberg
- Chair NHS RD Forum
- Prof Hepatology UCL
2OverviewWho, 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
3Researchers 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
4Overlapping roles
Sponsor
Care Organisation
Employer
5Who is Who?
- Employer
- Who issues your pay cheque?
- Often HEI
- Sponsor
- Often a Care Organisation
- Often Industry Partner
- Sometimes HEI
6Importance 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
7Research 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
8Research 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
9Sponsors 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
10Principles 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
11Sponsor 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
12Oversight 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
13Responsibility 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
14Monitoring 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
15Finance
- Application of tariffs
- Overheads
- Full economic costs
- Contracts
- Profit
- Division of profit
16Research Integrity
- Conflicts of interest
- Intellectual, Mission, Loyalty
- Financial
- Misconduct
- Scientific
- Patient care
- Fraud
- Financial
- Scientific
- Publication
17Research 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
18Actions
- 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
19Joint 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
20Factors 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