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