Introduction to Research Governance

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INTRODUCTION
TO
RESEARCH GOVERNANCE
Research Policy & Management
RACD
The plan for today
• Why Research Governance
• Research Governance Framework for
Health and Social Care
• What do you need to do to get approval
for your research
–
–
–
–
Consultation
Sponsor
NHS R&D approval
Ethics
Research Policy & Management
RACD
We’re all good people. Aren’t we?
Research Policy & Management
RACD
Research Governance Framework
for Health and Social Care
Research Policy & Management
RACD
Scope…
“All research that is concerned with the
protection and promotion of public health”
Research Policy & Management
RACD
Standards…
Health & Safety
• Adherence to regulations
• Safety of all involved is
paramount
Ethics
• Independent ethical
scrutiny
Finance
Science
• Financial Probity
• Sufficient insurance
provision
• Independent
scientific review
Quality Research
Culture
Information
• Accountability
• Openness
• Honesty
• Leadership
• Systems to protect IP
• Access to research findings
• Dissemination plan
Research Policy & Management
RACD
Roles and Responsibilities…
PI & other
Researchers
Sponsor
 Submit proposals for ethical review
 Conduct research according to agreed protocol & in accordance with
legal requirements
 Ensure participant welfare
 Record keeping
 Adverse Event reporting
 Dissemination of results
 Assure of scientific quality of proposed research
 Ensure ethics approval obtained
 Ensure arrangements in place for management & monitoring of research
Employing
Organisation
 Promote quality research culture
 Ensure researchers understand & discharge their responsibilities
 Ensure independent scientific review
 Ensure research is properly managed & monitored
Care
Organisation
 Authorises all research involving their patients, staff or facilities
 Ensure research meets standards of RGF
 Ensure ethics committee approval obtained
 Duty of Care to participants
Research Policy & Management
RACD
….summary of key implications
• Duty of Care
• Sponsor required
• Independent scientific review
• Independent ethical review
• Defined responsibilities
Research Policy & Management
RACD
The Research Governance Process
Research Idea
Consultation
Discuss Roles &
identify ‘Sponsor’
Partner Consultation
Set up TMF
Develop Protocol
Development
Develop trial docs
Secure Funding
Finalise Trial docs
Confirm Sponsor
Set up
Finalise roles and contracts
Approvals
Host
Organisation
Sponsor Approval
Ehics

Checklist
Begin
* Clinical Trial of an IMP only
Research Policy & Management
RACD
What is the ‘Sponsor’?
A company, institution or organisation
which takes responsibility for the
initiation, management and/or financing
a research project
Research Policy & Management
RACD
Applying to CU to act as ‘Sponsor’…
PI to complete and submit the following
to RACD
 SPON form
• is the registration form
•Research Governance Declaration
•To be signed by CI/PI. Confirms CI/PI is aware of
RG requirements.
 Research Protocol & Patient Info Sheet
• provides details of project for Sponsor Risk
Assessment / insurance
SPON and declaration forms can be obtained at
http://www.cardiff.ac.uk/racdv/resgov/forms/forms-procedures-sopsand-guidelines.html
Research Policy & Management
RACD
The Integrated Research Application System
(IRAS):
• single system for applying for approvals for health and
social care research in the UK
• enter information once
• Uses filters to ensure questions asked and approvals
required are appropriate to the type of study
• Retains familiar aspects of the NRES form system
ARSAC
GTAC
MHRA
Ministry of Justice
NHS / HSC R&D offices
Research Ethics Committees
Patient Information Advisory Group (PIAG)
Research Policy & Management
RACD
What forms will be generated?
• Dependant on answers to filter questions
• Self populates from full dataset
• Common forms:
–NHS REC Form
–NHS R&D Form
–NHS SSI Form
https://www.myresearchproject.org.uk/ELearning/IRAS_E_learning.htm
Research Policy & Management
RACD
I’ve completed my IRAS forms, where do I go next?
• Project has had Scientific Review
– Submission for REC and NHS R&D
approval in parallel.
• Project has not had Scientific Review
– Submission to NHS R&D first
Research Policy & Management
RACD
NHS R&D approval
Research Policy & Management
RACD
Obtain approval from the relevant host organisation…
NHS Trust R&D Office
Local Health Board
use the Integrated Research Application System (IRAS), which
is available at www.myresearchproject.org.uk
Complete R&D Form and NHS SSI From and send to each
individual Trust R&D Office
Contact individual Trust R&D Office:
http://www.rdforum.nhs.uk/links/rdlinks.htm
Research Policy & Management
RACD
Multi-Site Research
• All Wales Primary Care Research Management
& Governance Office: Streamlined NHS
Permissions Approach to Research – Cymru
(SPARC)
• NIHR Coordinated System for gaining NHS
Permission (NIHR CSP) – England only
Research Policy & Management
RACD
• Submission to R&D Office
• Review by committee (usually monthly)
• Letter of approval / amendments
• Honorary contracts / Research Passport
Research Policy & Management
RACD
NHS Research Ethics Committees
Research Policy & Management
RACD
NHS REC application
Is the research project a
clinical trial of an IMP?
No
Yes
Telephone CAS
Yes
Contact NHS REC but
may apply via CAS
Is the project taking
place in >1 domain?
No
Is the project taking
place in >1 site within
one domain?
No
Contact your Local REC
Research Policy & Management
RACD
Ethics Process…
• REC acknowledges application in 5 days
• REC has 60 days in total to make a final decision on new
application
• Investigators invited to attend meeting
• Decisions available:
– Favourable
– Provisional Favourable
– Unfavourable
Research Policy & Management
RACD
Further Information
http://www.cf.ac.uk/racdv/resgov/index.html
Chris Shaw – Research Governance Coordinator
Matthew Harris – Research Governance Officer
Nic Betty - Research Governance Admin Assistant
x79277
[email protected]
Research Policy & Management
RACD
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