Transcript Presentation about research governance

Research
Ethics-Integrity-Governance
University of Sheffield
Timeline
University Initiative:
‘02 Good Research Practice Standards
& Procedure to Investigate Potential
Research Misconduct established
‘04 Health care research governance
procedures established
The Catalyst?
Research
Councils UK
Department of
concernedHealth
with
Collect ively
governance of research conduct
‘05 Ethics Policy & Procedure for
Human Participants established
‘06 Clinical trials of investigational
medicinal products procedures
‘07 Social care research governance
Wellcome Trust
EU Legislation
Local Authorities
Research Governance
of Health Care Research
17/07/2016 © The University of Sheffield
Governance of
Health Care Research (HCR)
The term research governance is from the
Department of Health’s ‘Research Governance
Framework for Health and Social Care’ which
contains 20 Standards designed to:
Protect Human participants in research
Strengthen Scientific quality
Clarify Accountabilities & responsibilities
99% of the research affected by this is from the following
academic departments and schools:
Medicine, ScHARR, Clinical Psychology, Clinical Dentistry,
Nursing & Midwifery, Human Communication Sciences &
Information Studies
-Scientific
Review
- Costing system
- Financial probity
- Awareness
raising
- Access to &
dissemination of
research
- Appropriate
authorisation of research
- Written agreements in
place
17/07/2016 © The University of Sheffield
Summary of
the Research
Governance
Standards for
Health Care
Research
- Intellectual Property:
Identifying, owning, &
exploiting
- Ethics Review
- Informed Consent
- Data Protection
- Health &
safety
- Honorary
contracts
- Monitoring
- Adverse Events
- Preventing Fraud
& Misconduct
HCR Governance
“Nothing endures but change”
• Growing amount of regulation affecting health
care research (HCR)
• But there’s been greater consolidation &
streamlining over the years (smashing
bureaucracy) – IRAS is one example of this
• The research governance process is a linear
process with key hurdles (e.g. ethics review)
BUT some stages can take place in parallel
• It covers project’s whole life (post & pre-award)
17/07/2016 © The University of Sheffield
HCR Governance Process
Pre-award steps in the process:
1. Q. Is it a health care research (HCR) project?
2. Q. Which organisation will be the
Research Governance Sponsor?
3. Register project with the University - on URMS
(The University’s Research Management System)
4. Start filling out forms for NHS Trust registration &
for other approvals via IRAS
(Integrated Research Application System)
5. Independent scientific approval
6. Independent ethics approval
7. Governance Sponsor authorises project to start
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Step 1:
1. What is Health Care Research?
Definition:
• About protecting & promoting public health
• Undertaken in or by Dept. of Health & NHS
• Includes clinical & non-clinical research &
research by NHS staff using NHS
resources
• Includes research by universities within the
health care system that might have an
impact on the quality of those services
17/07/2016 © The University of Sheffield
Step 2:
2. Research Governance Sponsor?
This is an organisation (e.g. a university, an
NHS Trust, a pharma. company) that takes on
overall responsibility for a health care
research project from start to final, including:
i. the project initiation arrangements (scientific review, ethical
review, insurance etc.);
ii. the project’s management arrangements (maintaining a site
file, ongoing monitoring, reporting adverse events etc.);
iii. the project’s financing arrangements.
It must satisfy itself that the project meets the
Research Governance Framework’s standards &
that arrangements are established & in place for
management, monitoring, reporting & audit
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Research Governance Sponsor
(RGSponsor) is
Where
the buck
stops!
17/07/2016 © The University of Sheffield
2. How to decide which
organisation is the RGSponsor?
• Will the project involve the NHS?
• NO - then the University will be the RGSponsor
• Will the project involve a single NHS
Trust?
• YES – NHS Trust will normally be the RGSponsor
• Is the project multi-centre?
• YES - University will be the RGSponsor
(unless project is a trial of an investigational medicinal
product & involves the Sheffield Teaching Hospitals Trust)
17/07/2016 © The University of Sheffield
Step 3:
3. University Registration - URMS
For help with URMS
contact the URMS helpline
17/07/2016 © The University of Sheffield
Step 4:
4. NHS Trust Registration
• Further info:
www.shef.ac.uk/researchoffice/gov_ethics_grp/governance/rgp/rd.html
• Register for NHS Permission/R&D approval
via IRAS (IRAS stands for Integrated
Research Application System & is also the
route to apply for NHS ethics approval)
17/07/2016 © The University of Sheffield
Step 5:
5. Independent Scientific Review
Route:
• External peer review - if externally-funded
then the award letter constitutes evidence;
or
• Internal peer review (follow expectations of
project’s research governance sponsor)
- UoS-sponsored: 2 independent reviewers
(STH Trust has its own procedure)
17/07/2016 © The University of Sheffield
Step 6:
6. Independent Ethics Review for
research involving human participants
[see final set of slides for guidance]
17/07/2016 © The University of Sheffield
Step 7:
7. Sponsor Authorisation
The University as RGSponsor always
needs:
• evidence of URMS registration; and
• evidence of scientific approval; and
• evidence of ethics approval
If University is not the RGSponsor it needs:
• written confirmation of sponsorship from the
organisation that is the RGSponsor
17/07/2016 © The University of Sheffield
7. Post Award Conditions:
* Set up & maintain a Site File
* Report Adverse Events should they occur
* Provide Head of Department with standard
progress reports (after 3 months, annual, end)
* Establish arrangements to record, report &
review significant developments
(i.e. affecting participants, science,
management)
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Research Ethics
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Step 6:
6. - further information:
3 Complementary
Ethics Review Procedures
• NHS
• University (UoS)
• Alternative
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UoS Ethics Review Procedure
Remit:
Research project (investigation
(to gain knowledge & understanding)
Is led by this University
Involves human participants
Does not involve the NHS
Takes place within the UK
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NHS Procedure
Remit:
Patients & users of the NHS
(recruited due to past/present NHS treatment)
Relatives or carers of patients & users of NHS
Access to data, organs, other bodily material of
past or present NHS patients
Fetal material & IVF involving NHS patients
Recently dead in NHS premises
Use of/potential access to premises
Staff (recruited due to professional role)
17/07/2016 © The University of Sheffield
Alternative Procedure
Remit:
Research project takes place in other country
then robust procedure in country(ies) applies
(robust? – i.e. compared against University procedure)
Research project led by other organisation
then robust procedure in organisation applies
17/07/2016 © The University of Sheffield
The Big Picture …
Its about:
- protecting human participants in research
- facilitating high quality research
- clarifying accountabilities and responsibilities of
individuals & organisations involved in research
- ensuring that the public benefits from the research
- managing risks
- maintaining public confidence in research