Research Governance Framework

1
Research Governance Framework

• RD Implementation

2
Changing environment
9 Regional Offices NHS Executive
1998
Decreasing Support
4 Directorates of Health and Social Care
2001
1 central DH Office for NHS Support, Richmond
House
2004
3
Study implications, independent review types

• peer-review
• ethics committee
• Trust not ethics
• Trust

• Scientific
• Ethical
• Legal
• Technical/ feasibility

4
Legal

• IRMER
• Human Tissue
• Drug dispensing
• Special studies gene therapy, fetal research,
  xenotransplantation
• Data protection
• COREC make clear that ethics committees are not
  responsible for ensuring legality of research
  studies

5
Feasibility

• MRI, CT, PET scanning costs scheduling
• Drug dispensing clear procedures where deviate
  from standard protocols
• Laboratory
• Inpatient/outpatient/theatre scheduling

6
Monitoring Compliance with RGF

• Board/Chief Executive internal audits
• Strategic Health Authorities (except Foundation
  Trusts)
• Medicines and Healthcare Products Agency (CTIMPs
  only, compliance with EU Directive rather than
  RGF)
• Healthcare Commission (all healthcare providers)
• Department of Health Self reporting compliance
  in Annual Reports

7
Evolving (?) Standards
RGF Implementation Plans
Controls Assurance
Healthcare Commission
8
Controls Assurance RG Criteria

• 17 Standards, Trusts now have to be able to
  demonstrate compliance with all of them
• Criterion 3
• The organisation ensures financial probity in all
  matters concerning research governance
• Criterion 4
• The organisation has a written agreement with
  research partners documenting the allocation of
  research responsibilities
• Criterion 5
• The organisation has arrangements in place to
  issue NHS honorary contracts to non-NHS
  researchers
• Criterion 6
• All research undertaken by the organisation
  complies with statutory legislation and guidance
• Criterion 7
• There is a system in place to record all adverse
  events arising from any research undertaken by
  the organisation and staff are made aware of and,
  where necessary, trained in adverse incident
  reporting requirements
• Criterion 8
• All research undertaken by the organisation has a
  nominated sponsor

9
Controls Assurance (2)

• Criterion 9
• The organisation has a system in place to detect
  and deal with research misconduct and fraud
• Criterion 10
• The organisation has systems in place to identify
  the involvement of consumers in research and to
  ensure that consumers are involved in the
  development and execution of research projects
• Criterion 11
• There are systems in place to inform service
  users and members of the public about research
  undertaken within the organisation
• Criterion 12
• All research is appropriately disseminated
• Criterion 13
• The organisation has systems in place for the
  appropriate management of intellectual property
• Criterion 14
• The organisation ensures that all relevant staff
  are aware of their roles and responsibilities
  with regard to the research governance framework

10
RD Approval Issues

• Signatures
• Sponsorship
• Clarification with ethics
• Legal issues IRMER, data protection
• Honorary contracts
• Peer-review (either evidence of adequate review,
  or local undertaking in theory, ethics
  pre-requisite, but in practice)
• Lack of PI involvement

11
Approvalssince Jan 1st 2004

• 50 fully approved (i.e. ethics approved before
  RD requirements met)
• 50 provisionally approved (i.e. RD requirements
  met before ethics approved)
• Of which 30 had provisional approval withdrawn
• Of which 56 eventually got full approval (so far)

12
Improvements

• Standard RD Form
• Honorary contract passport
• Standard agreements?
• NHS RD champions?

13
DH RD Annual Reports

• Research programmes
• Partnerships - agreements
• Budget allocations, PNF/SfS split
• Output and Impacts of research
• Publications
• Income
• Later patient numbers collected through NRR
  returns

14
What can you do to help?

• Communicate with NHS RD offices at the earliest
  opportunity (not just as about to apply for SSA)
• Ensure that local PI fully understands study and
  has discussed implications with pharmacy,
  imaging, labs etc.
• Make information about the study easily
  accessible e.g. website (protocol, Patient
  information sheet, approvals, sponsorship details
  etc.)