Research Policy & Management RACD INTRODUCTION TO RESEARCH GOVERNANCE.
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Transcript of Research Policy & Management RACD INTRODUCTION TO RESEARCH GOVERNANCE.
Research Policy & ManagementRACD
INTRODUCTIONTO
RESEARCH GOVERNANCE
Research Policy & ManagementRACD
• 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
The plan for today
Research Policy & ManagementRACD
We’re all good people. Aren’t we?
Research Policy & ManagementRACD
Research Governance Framework for Health and Social Care
Research Policy & ManagementRACD
Scope…
“All research that is concerned with the protection and promotion of public health”
Research Policy & ManagementRACD
Ethics• Independent ethical scrutiny
Science• Independent scientific review
Information• Systems to protect IP• Access to research findings• Dissemination plan
Health & Safety• Adherence to regulations• Safety of all involved is paramount
Finance• Financial Probity• Sufficient insurance provision
Standards…
Quality Research Culture• Accountability• Openness• Honesty• Leadership
Research Policy & ManagementRACD
Roles and Responsibilities…
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
Promote quality research culture Ensure researchers understand & discharge their responsibilities Ensure independent scientific review Ensure research is properly managed & monitored
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
PI & other Researchers
Sponsor
Employing Organisation
Care Organisation
Research Policy & ManagementRACD
• Duty of Care
• Sponsor required
• Independent scientific review
• Independent ethical review
• Defined responsibilities
….summary of key implications
Research Policy & ManagementRACD
Discuss Roles &identify ‘Sponsor’
Partner Consultation
Set up TMF
Secure Funding
Develop Protocol
Develop trial docs
Confirm Sponsor
EhicsHost
Organisation
Checklist
Begin
Approvals
Development
Consultation
Sponsor Approval
Set up
Research Idea
* Clinical Trial of an IMP only
The Research Governance Process
Finalise Trial docs
Finalise roles and contracts
Research Policy & ManagementRACD
What is the ‘Sponsor’?
A company, institution or organisation which takes responsibility for the
initiation, management and/or financing a research project
Research Policy & ManagementRACD
Applying to CU to act as ‘Sponsor’…
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
PI to complete and submit the following to RACD
SPON and declaration forms can be obtained at
http://www.cardiff.ac.uk/racdv/resgov/forms/forms-procedures-sops-and-guidelines.html
Research Policy & ManagementRACD
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
ARSACGTACMHRA
Ministry of Justice NHS / HSC R&D offices
Research Ethics Committees Patient Information Advisory Group (PIAG)
Research Policy & ManagementRACD
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 & ManagementRACD
• 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
I’ve completed my IRAS forms, where do I go next?
Research Policy & ManagementRACD
NHS R&D approval
Research Policy & ManagementRACD
NHS Trust R&D Office
Local Health Board
Obtain approval from the relevant host organisation…
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 & ManagementRACD
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 & ManagementRACD
• Submission to R&D Office
• Review by committee (usually monthly)
• Letter of approval / amendments
• Honorary contracts / Research Passport
Research Policy & ManagementRACD
NHS Research Ethics Committees
Research Policy & ManagementRACD
NHS REC application
Is the research project a clinical trial of an IMP?
Is the project taking place in >1 domain?
Is the project taking place in >1 site within
one domain?
Telephone CAS
Contact NHS REC but may apply via CAS
No
Contact your Local REC
No
No
Yes
Yes
Research Policy & ManagementRACD
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 & ManagementRACD
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