Sheffield Health and Social Research Consortium

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Sheffield Health and Social Research Consortium

• Research Governance
• and the Consortium

Dr Jonathan Boote, Research Manager (Governance)
A multi-agency consortium of NHS Trusts,
Universities and Social Services In Sheffield
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Plan of presentation

• What is Research Governance?
• The Consortium and Research Governance
• Scientific review
• Research Governance approval
• Project monitoring
• Project audits

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NHS Research Governance
What is Research Governance? Research Governance
is aimed at continuous improvement and the
reduction of unacceptable variations in research
practice across health and social care (DoH,
2001)

• Why has Research Governance come about?
• Unacceptable NHS research scandals (e.g. Alder
  Hey, Bristol, Addenbrookes)
• DoH identified the need to define good research
  practice in the NHS, and to define the roles and
  responsibilities of key players in the research
  process

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NHS Research Governance

• Is for all those who
• participate in NHS research (e.g. patients,
  users, carers,
• NHS employees)
• host NHS research in their organisation
• fund NHS research proposals
• manage and monitor NHS research
• undertake NHS research

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NHS Research Governance Framework for Health and
Social Care

• sets standards on
• ETHICS
• SCIENTIFIC INTEGRITY
• INFORMATION
• FINANCE
• QUALITY RESEARCH CULTURE
• defines mechanisms to deliver the above
  standards
• describes monitoring and assessment arrangements

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NHS Research Governance Framework for Health and
Social Care

• The Framework lays down responsibilities to key
  players in the research process
• Chief Investigator
• Employer of chief investigator (including
  universities)
• Ethics committee
• Funder
• Care organisation (and responsible Care
  professional)
• Sponsor

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The Consortium and Research Governance

• The Consortium handles applications for Research
  Governance on behalf of its NHS, University and
  Social Services partners
• North Sheffield PCT
• South East Sheffield PCT
• Sheffield South West PCT
• Sheffield West PCT
• Sheffield Care Trust
• Sheffield Social Services
• Sheffield Childrens Hospital (for
  community-based studies)
• University of Sheffield
• Sheffield Hallam University

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Obtaining Research Governance Approval from the
Consortium

• First stage is to ensure that the studys
  scientific quality has been reviewed
  independently
• This has to be done before applying for Research
  Governance approval and a favourable ethical
  opinion from a REC
• Independent scientific review can be done
  through the Consortiums Scientific Review Panel
  which meets fortnightly
• Send the following documents to begin the peer
  review process
• - Protocol
• - Summary CVs of all local research team
  members
• - All data collection instruments (where
  relevant and already developed)
• - Information sheets and consent forms (where
  relevant and already
• developed)

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Obtaining Research Governance Approval from the
Consortium

• The Consortium screens all proposals sent for
  peer review, to check
• that an independent review has not already been
  carried out to the satisfaction of the Consortium
• that the research takes place on our patch
• which programme area the project comes under
• if the study is being undertaken for an
  educational qualification and if the supervisor
  has agreed for the project to go for independent
  review

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Obtaining Research Governance Approval from the
Consortium

• Submitting a valid Research Governance
  Application
• Declaration from an identified sponsor
• Evidence of independent scientific review
• Copy of the full COREC application pack as sent
  to the REC
• The Standard NHS Research Development
  Application Form
• Summary CVs of all the research team
• When appropriate, a completed Consortium NHS
  Honorary Contract or Letter of Authority
  Application Form
• Applicant's Checklist
• Cheque for 500 (for clinical trials sponsored by
  companies)

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The NHS RD Application Form

• Developed by the NHS RD Forum
• Standard form for applying for RD approval
• Form is not mandatory BUT
• All NHS RD departments strongly recommended to
  use it
• Online form can be accessed at rdform.org.uk
• Guidance on completing the form available from
  the website

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Obtaining Research Governance Approval from the
Consortium

• What does the Consortium do with a valid
  application for Research Governance approval?
• a screen will be sent out to those whose
  authorisations are required for the research to
  take place e.g. indemnity advisers, research
  leads, financial advisers, Caldicott
  Guardians/data protection officers, pharmacy
  advisers
• authorisations are chased and obtained
• Honorary Contracts for non-NHS researchers are
  obtained
• Research Governance approval is issued once a
  favourable ethical opinion is given and all
  authorisations have been obtained
• RG approval is issued with guidance on how to
  maintain a site file

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Project Monitoring

• Research Governance approval issued on the
  understanding that monitoring reports will be
  sent to the Consortium by each PI
• PIs should send copies of all monitoring reports
  submitted to the REC, which include
• Annual progress reports
• Declaration of end of study
• All substantive protocol amendments to which the
  REC is notified should be copied to the
  Consortium (assuming Consortium did not review
  scientific quality)
• If the Consortium approved the scientific
  quality, then we should be notified of
  substantial protocol amendments before the REC,
  to deliberate on any impact on scientific quality
• Consortium should receive notification of all
  adverse events

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Project Audits

• Consortium is required to audit 10 of projects
  per financial year
• Audits are carried out to ensure that
• The rights and wellbeing of research participants
  are protected
• The conduct of the research is compliant with the
  approved protocol and all relevant regulatory
  requirements
• PIs are required to complete a self-completion
  audit form prior to the day of the audit
• The audit team audits the content of the site
  file, compares findings to the PIs
  self-completion form, and inspects all consent
  forms
• A report is produced of the audit, with any
  recommendations to improve the site file
• Routine audits that reveal issues of concern will
  be followed up
• Researchers with doubts about the conduct of a
  study may approach the Consortium in confidence
  and ask for a for cause audit to be carried
  out.

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Sheffield Health and Social Research Consortium
Further reading Department of Health (2001),
Research governance framework for health and
social care. London Department of Health.
Further information on the Consortiums RG
process visit Consortium web-site
www.shsrc.nhs.uk
For advice, contact the Consortiums Research
Support Team on 0114 271 8804
Dr Jonathan Boote, Research Manager (Governance),
Sheffield Health and Social Research Consortium,
jonathan.boote_at_sct.nhs.uk
A multi-agency consortium of NHS Trusts,
Universities and Social Services In Sheffield