Sheffield Health and Social Research Consortium

1. Sheffield Health and Social Research Consortium The Consortium’s Systems for Research Governance Dr Jonathan Boote – Research Manager (Governance) The Realities of User and Carer Involvement in Research, Leamington Spa, 26th January 2006 A multi-agency consortium of NHS Trusts, Universities and Social Services In Sheffield

2. Plan of Presentation • Brief introduction to Research Governance • Background to the Consortium • Scientific Review • Obtaining Research Governance approval • - COREC Form • - NHS R&D Application Form • - Consortium Honorary Contract Request Form • Project monitoring • Project audits SHSRC

3. Background to 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) • Improves research quality and safeguards the public by: • Enhancing ethical and scientific quality • Promoting good practice • Reducing adverse incidents and ensuring lessons are learned - Preventing poor performance and misconduct SHSRC

4. Research Governance Framework for Health and Social Care • sets standards on: • ETHICS • SCIENTIFIC INTEGRITY • INFORMATION • FINANCE • HEALTH AND SAFETY • QUALITY RESEARCH CULTURE • defines mechanisms to deliver the above standards • describes monitoring and assessment arrangements SHSRC

5. Background to the Consortium A Consortium of primary/community care organisations, universities and a support agency comprising • North Sheffield PCT • South East Sheffield PCT • Sheffield South West PCT • Sheffield West PCT • Sheffield Care Trust • Sheffield Social Services • Sheffield Children’s Hospital (for community-based studies) • University of Sheffield • Sheffield Hallam University • Trent Research and Development Support Unit SHSRC

6. Background to the Consortium Programme areas: • Family health & community health, well-being and pathways • Evaluating new mental health services • Psychological therapies in health service settings • Socially excluded groups, health inequalities, service users and carers • Complex and refractory mental health problems  • Ageing and the health of older people • Health and social care of children in the community All programmes lead by an academic and/or clinician to oversee the strategic direction of each programme SHSRC

7. Background to the Consortium Outline Structure • Consortium Board and Chair • setting strategic objectives, monitoring research governance and receiving financial reports. • Management Group • the day-to-day management of the work plan of the Consortium and for research governance. • Academic Advisory Group • Ensures good partnership arrangements between the Universities and the NHS/Social Services, and acts to promote high academic standards. • Director and Research Support Team • Responsible for overseeing policies and procedures elating to Research Governance and Research Development SHSRC

8. Background to the Consortium Research Support Team • Director: Dr Adrian Carr • Manager: Dr Robert Dixon • Research Manager (Governance): Dr Jonathan Boote; • Research Manager (Development): Dr Sam Taylor • Consortium Administrator team: Lynne Shaw • Projects Administrator Rebecca Hampsey • Assistant Projects Administrator Dylan Knight SHSRC

9. Obtaining Research Governance Approval from the Consortium First stage is to ensure that the study’s 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 Consortium’s 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) SHSRC

10. 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 SHSRC

11. 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) SHSRC

12. The COREC Form • Compulsory form for all research projects involving data collected from NHS staff or patients • Form can be filled in and sent to COREC online (www.corec.org.uk) • Each submission is given as unique identifier number • Detailed guidance provided on the web on each question • Form is in 3 parts: • Part A: background to the research – title, investigators, rationale, methods, potential risks, recruitment, consent, indemnity, dissemination, sponsorship and funder details, data analysis • Part B: technical information sought on use of medicinal products, use of medical devices, radiation, use of existing stored samples • Part C: site-specific assessment – details of PI, local arrangements, SHSRC

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

14. The Consortium’s Honorary Contract Request Form • This will need to be filled in by all non-NHS members of the research team who require access to patients during the research • Letters of authority may be obtained if researchers already have honorary contracts from elsewhere • CRB checks may be necessary • We ask researchers to meet the cost of this • Honorary contracts issued to the research team with the RG approval letter SHSRC

15. 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 to the PI once a favourable ethical opinion is given and all authorisations have been obtained SHSRC

16. The RG Approval letter This is issued to the PI with the following provisos and advice: • The PI alerts the Consortium of project start and end dates • All project monitoring forms that are sent to the REC are to be copied to the Consortium • The Consortium should be alerted of all substantial amendments to protocol • A site file be prepared and maintained using the Consortium’s site file guidance • The PI finds out how to report any research-related adverse events to the host organisation • The PI should be familiar with the Consortium’s policy on Intellectual Property • The research should be disseminated appropriately to academics as well as research participants and those organisations representing their interests SHSRC

17. 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 SHSRC

18. 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 PI’s 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. SHSRC

19. Sheffield Health and Social Research Consortium For further information please… Visit the Consortium website: www.shsrc.org.uk Contact me for Research Governance advice: Dr Jonathan Boote 0114 271 8804 Contact Dr Sam Taylor for Research Development advice: 0114 271 8804 A multi-agency consortium of NHS Trusts, Universities and Social Services In Sheffield