Date post: | 14-Jun-2015 |
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Health & Medicine |
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What are Global Governance Checks? The NISCHR Permissions Co-ordinating Process
(PCP)
Matthew Harris, NISCHR PCU Officer
NISCHR PCP
• Permissions Co-ordinating Process (PCP) – launched 4th July 2011
• Co-ordinates the process of gaining research permission from NHS Organisations– Co-ordinated Nationally by NISCHR PCU– Delivered locally by NHS R&D Offices
• NHS responsible for Granting NHS research permission
A single point of access
Clear channels of
communication
Reduces duplication
Provides consistency
and standardisation Reduces
the time
Facilitates the process of
gaining NHS research
permission
What’s the point of PCP?
Multi site Research Studies
Single site Research Studies
Primary Care
Secondary Care
Participant Identification
Centres (PICs)
Shares information with
other UK Nations
NISCHR PCP
Only facilitates the process of gaining NHS
research permission!
Exercise 1
• What makes a complete NHS R&D Application submission?
– Spend 5/10 mins discussing what you feel is a complete NHS R&D application submission.
Documents Yes No
NHS R&D Form Checklist
All documents listed on the NHS R&D form Checklist, e.g. Study protocol, PIS & ICF
NHS R&D form PDF File
NHS R&D form XML file
NHS REC form Checklist & all study documents
NHS REC form PDF & XML File
Exercise 1: Complete NHS R&D Application
Documents Yes No Further information
NHS R&D Form Checklist
Generated via IRAS
All documents listed on the NHS R&D form Checklist, e.g. Study protocol, PIS & ICF
Documents required prior to final NHS Permission may be submitted after the
initial application, e.g. NHS REC Favourable opinion/ MHRA Authorisation
NHS R&D form PDF File Must be final version with authorised signatures, e.g. Chief Investigator &
Sponsor Representative
NHS R&D form XML file XML file generated via IRAS
NHS REC form PDF & XML File
If a study pre dates 2008 - NHS REC form is required
NHS REC form Checklist & all study
documents
Exercise 1:Complete NHS R&D Application
Global Checks!
Global Checks
• Global Checks – checks generic to the study; undertaken once on behalf of all NHS organisations participating in the study
Local Checks!
Local Checks
• Local Checks – checks required to be undertaken by an individual NHS organisation in respect of the study. They must be conducted by each NHS organisation participating in the study
Exercise 2
• Research Governance checks – Global or Local?
– Spend 5/10 mins discussing whether a Research Governance check is Global or Local
Exercise 2
Governance Review Checks Global Local
IRAS project filter completed correctly
Implications for internal departments assessed
Protocol assessment
Scientific quality of research has been assessed
Principal Investigator (PI) / research team suitability assessed
Allocation of responsibilities and rights is agreed and documented (e.g. site agreements)
Insurance / indemnity arrangements assessed
Compliance with Welsh Language Act assessed
Exercise 2
Governance Review Checks Global Local
IRAS project filter completed correctly G
Implications for internal departments assessed L
Protocol assessment G
Scientific quality of research has been assessed G
Principal Investigator (PI) / research team suitability assessed
L
Allocation of responsibilities and rights is agreed and documented (e.g. site agreements)
G L
Insurance / indemnity arrangements assessed G
Compliance with Welsh Language Act assessed G
Global ChecksGovernance Review Checks Global
IRAS project filter completed correctly G
Protocol assessment G
Scientific quality of research has been assessed G
Arrangements for disseminating findings G
Insurance / indemnity arrangements assessed G
Compliance with Welsh Language Act assessed G
Research Ethics Committee favourable opinion received G
CTIMPs - Clinical Trials Authorisation (CTA) letter received G
Devices - MHRA Notice of no objection received G
Other regulatory approvals and authorisations received G
Combined Checks
Governance Review Checks Combined Global and Local Checks
Participant information & consent documents and process G&L
Risks to NHS organisation assessed G&L
Financial management arrangements assessed G&L
Allocation of responsibilities and rights is agreed and documented G&L
Compliance with Data Protection Act and data security issues assessed
G&L
CTIMPs - Arrangements for compliance with the Clinical Trials Regulations assessed
G&L
Compliance with any other applicable laws or regulations G&L
Local ChecksGovernance Review Checks Local
ChecksEmergency / Backup / Support arrangements assessed L
Principal Investigator (PI) / research team suitability assessed L
Implications for internal departments assessed L
Adequacy of facilities assessed L
Risks to researcher assessed L
Arrangements for compliance with the Mental Capacity Act assessed L
Principal Investigator (PI) / research team Human Resources arrangements in place
L
Radiation - Arrangements for compliance with IRMER assessed L
Radiation - ARSAC approval received L
• Amendments...............–Submitted to NISCHR PCU–Assigned to NHS Organisations–NHS Organisation will notify the CI/ PI
whether they are happy to approval the amendment (Letter of No objection)
Q&A