IRAS Ref:
Enter IRAS Ref No
Page 1 of 11
UK Study-Wide Governance Report
The following Governance Report is intended to aid the streamlined and consistent
governance review of research study applications for NHS R&D Permission1 within
the UK.
The study-wide (global) governance review of a research study application is generic
to the study and is undertaken once through a UK permissions coordinating function
on behalf of all organisations being asked to host the research study. It is the
intention of this Governance Report to assemble the evidence to aid the host NHS
organisation in making their decision whether to grant NHS R&D Permission or not.
Although the study-wide (global) governance review is conducted through a UK
permissions coordinating function on behalf of the host organisations, as legal entity
it still remains the host NHS organisation’s decision to grant NHS R&D Permission or
not.
Described in the following pages of this report are the details of:



the governance criteria considered as per the UK Study-Wide Governance
Criteria for R&D Review;
the authorisations and approvals; and
the associated documents
of the research study.
1
In the UK, NHS R&D Permission is granted by the NHS Trusts of England, the Health and Social
Care Trusts of Northern Ireland, the Health Boards of Scotland, and the Health Boards and NHS
Trusts of Wales.
Version 1 August 2014
IRAS Ref:
Enter IRAS Ref No
Page 2 of 11
Study details:
The study-wide (global) governance review has been completed for the research
study below:
IRAS Reference:
Study Title:
Study Type:
Chief Investigator:
Sponsor:
Funder:
Lead NHS R&D office
location:
Lead Nation:
Review completed by:
Correspondence email
address:
Date:
REC reference (if available):
UKCRN Portfolio study (if
applicable):
Version 1 August 2014
Enter the complete IRAS Ref No from the NHS R&D
Form used to complete the governance review. The
study governance review should be completed using
the NHS R&D Form authorised/ signed by both the
Chief Investigator and Sponsor.
Enter the short title of the study from the NHS R&D
Form project filter.
Enter the study category selected in Qu.2 of the
NHS R&D Form project filter.
Enter the Chief Investigator name.
Enter the Sponsor organisation name from Qu. A64
of the NHS R&D Form.
Enter the Funding organisation name from Qu. A65
of the NHS R&D Form.
Enter the location of the Lead NHS R&D office from
Qu. 3a of the NHS R&D Form. The location of the
Lead NHS R&D office determines which UK nation’s
permission coordinating function is responsible for
undertaking the study-wide (global) governance
review.
Enter the lead nation responsible for completing the
study-wide (global) governance review.
Enter the details of the organisation completing the
study-wide (global) governance review for the
permission coordinating function. NB: In some UK
nations a lead organisation is nominated to carry out
the review for the permissions coordinating function.
Enter the correspondence email address of the
organisation completing the study-wide (global)
governance review for the permission coordinating
function.
Enter the date the governance report is completed.
If known enter the REC Ref No for the research
study. If unknown enter “Unknown”.
If known, enter if the research study is a UKCRN
Portfolio study (i.e. “Yes” or “No”). If unknown enter
“Unknown”.
IRAS Ref:
Enter IRAS Ref No
Page 3 of 11
List of reviewed documents
Please find below a list of documents reviewed during the study-wide governance
review.
Document
Enter the document type as it
appears on the NHS/HSC
R&D submission checklist
Subtitle
Enter any document sub-title,
or additional information that
aids document identification
Version
Enter the document
version and/ or
date
NB: Only list those current documents used to complete the study-wide (global)
governance review upon receipt of all regulatory and ethical authorisations/
approvals, as applicable.
Version 1 August 2014
IRAS Ref:
Enter IRAS Ref No
Page 4 of 11
Governance review
Please find below the governance criteria considered during the review of this
research study and the comments associated with these criteria.
1
Application Package
Enter2
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the study-wide (global) governance criteria under
review, for example where issues have been identified during the completion of the
review these should be identified together any actions undertaken to resolve the
identified issues.
1.1 IRAS project filter completed
correctly
Outcome:
If the outcome of the review is positive then minimal text is required about the
evidence to support this.
2
Risk to participants
Enter2
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the study-wide (global) governance criteria under
review, for example where issues have been identified during the completion of the
2.1 Participant information/ consent
documents and consent process
2
Outcome:
For the review outcome of the criteria enter one of the following three options:
 ‘Completed – Proceed’: This term should be used when the study-wide
(global) governance reviewer is content that the check has been completed
satisfactorily and there are no further issues to be resolved.
 ‘Completed – Advisory’: This term is used when the study-wide (global)
governance reviewer is content that the check have been completed
satisfactorily but there is information that they wish to highlight to a hosting
NHS organisation for consideration in reaching their decision to grant
permission. For example:
o A model agreement is to be used in the study but the template received
as part of the review has been heavily modified.
o There is potentially an excessive requirement for NHS resources.
o There are national differences that will need to be considered as a
result of differences in national law.
 ‘Not applicable’: This term is used to indicate the check is not relevant to the
research study being reviewed.
Version 1 August 2014
IRAS Ref:
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Page 5 of 11
review these should be identified together any actions undertaken to resolve the
identified issues.
If the outcome of the review is positive then minimal text is required about the
evidence to support this.
3
Risk to study
Enter2
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the study-wide (global) governance criteria under
review, for example where issues have been identified during the completion of the
review these should be identified together any actions undertaken to resolve the
identified issues.
3.1 Protocol assessment
Outcome:
If the outcome of the review is positive then minimal text is required about the
evidence to support this.
4
Risk to organisation
Enter2
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the study-wide (global) governance criteria under
review, for example where issues have been identified during the completion of the
review these should be identified together any actions undertaken to resolve the
identified issues.
4.1 Allocation of responsibilities and
rights are agreed and documented
Outcome:
If the outcome of the review is positive then minimal text is required about the
evidence to support this.
Enter2
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the study-wide (global) governance criteria under
review, for example where issues have been identified during the completion of the
review these should be identified together any actions undertaken to resolve the
identified issues.
4.2 Insurance/ indemnity arrangements
assessed
Version 1 August 2014
Outcome:
IRAS Ref:
Enter IRAS Ref No
Page 6 of 11
If the outcome of the review is positive then minimal text is required about the
evidence to support this.
Enter2
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the study-wide (global) governance criteria under
review, for example where issues have been identified during the completion of the
review these should be identified together any actions undertaken to resolve the
identified issues.
4.3 Financial arrangements assessed
Outcome:
If the outcome of the review is positive then minimal text is required about the
evidence to support this.
5
Legal compliance
Enter2
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the study-wide (global) governance criteria under
review, for example where issues have been identified during the completion of the
review these should be identified together any actions undertaken to resolve the
identified issues.
5.1 Compliance with the Data Protection
Act and data security issues
assessed
Outcome:
If the outcome of the review is positive then minimal text is required about the
evidence to support this.
5.2 CTIMPs – Arrangements for
compliance with the Clinical Trial
Regulations assessed
Enter2
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the study-wide (global) governance criteria under
review, for example where issues have been identified during the completion of the
review these should be identified together any actions undertaken to resolve the
identified issues.
Outcome:
If the outcome of the review is positive then minimal text is required about the
evidence to support this.
5.3 Compliance with any applicable laws
or regulations
Version 1 August 2014
Outcome:
Enter2
‘Completed – Proceed’
IRAS Ref:
Enter IRAS Ref No
Page 7 of 11
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the study-wide (global) governance criteria under
review, for example where issues have been identified during the completion of the
review these should be identified together any actions undertaken to resolve the
identified issues.
If the outcome of the review is positive then minimal text is required about the
evidence to support this.
6
Approvals and authorisations
Enter2
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the study-wide (global) governance criteria under
review, for example where issues have been identified during the completion of the
review these should be identified together any actions undertaken to resolve the
identified issues.
6.1 NHS Research Ethics Committee
favourable opinion received for
applicable studies
Outcome:
If the outcome of the review is positive then minimal text is required about the
evidence to support this.
6.2 CTIMPs – Clinical Trials
Authorisation (CTA) letter received
Enter2
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the study-wide (global) governance criteria under
review, for example where issues have been identified during the completion of the
review these should be identified together any actions undertaken to resolve the
identified issues.
Outcome:
If the outcome of the review is positive then minimal text is required about the
evidence to support this.
6.3 Devices – MHRA Notices of no
objection received
Enter2
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the study-wide (global) governance criteria under
review, for example where issues have been identified during the completion of the
review these should be identified together any actions undertaken to resolve the
identified issues.
Version 1 August 2014
Outcome:
IRAS Ref:
Enter IRAS Ref No
Page 8 of 11
If the outcome of the review is positive then minimal text is required about the
evidence to support this.
Enter2
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the study-wide (global) governance criteria under
review, for example where issues have been identified during the completion of the
review these should be identified together any actions undertaken to resolve the
identified issues.
6.4 Other regulatory approvals and
authorisations received
Outcome:
If the outcome of the review is positive then minimal text is required about the
evidence to support this.
Version 1 August 2014
IRAS Ref:
Enter IRAS Ref No
Page 9 of 11
Additional information
Please find below additional information relating to this research study that has not
been covered within the governance review of this research study.
Additional information
Enter any additional information/ comments relating to the research study that should
be highlighted to the hosting NHS organisation that have not been covered within the
study-wide (global) governance review of the research study.
Version 1 August 2014
IRAS Ref:
Enter IRAS Ref No
Page 10 of 11
National differences
This section of the Governance Report is to be used by the permissions coordinating
functions of the participating nations to address any national differences applicable
to the governance review of the research study
NB: In some UK nations a lead organisation is nominated to carry out the review for
the permissions coordinating function. In this section the nominated lead
organisation is reviewing the research study for the national differences applicable to
their nation only.
2
Risk to participants
Enter
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the following aspects of the study-wide (global)
governance criteria under review that affect your nation.
 ‘Consent of young people and children (non-CTIMP)’
2.1 Participant information/ consent
documents and consent process
4
Outcome:
Risk to organisation
Enter
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the following aspects of the study-wide (global)
governance criteria under review that affect your nation.
 ‘Model agreements’
4.1 Allocation of responsibilities and
rights are agreed and documented
Outcome:
Enter
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the following aspects of the study-wide (global)
governance criteria under review that affect your nation.
 ‘Single costing – Scotland’
4.3 Financial arrangements assessed
5
Outcome:
Legal compliance
5.1 Compliance with the Data Protection
Act and data security issues
Version 1 August 2014
Outcome:
Enter
‘Completed – Proceed’
IRAS Ref:
Enter IRAS Ref No
Page 11 of 11
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the following aspects of the study-wide (global)
governance criteria under review that affect your nation.
 ‘Data without consent’
assessed
Enter
‘Completed – Proceed’
‘Completed – Advisory’
‘Not applicable’
Enter any comments relating to the following aspects of the study-wide (global)
governance criteria under review that affect your nation.
 ‘Adults unable to consent for themselves (non-CTIMP)’
 ‘Human Tissue’
 ‘Language’
5.3 Compliance with any applicable laws
or regulations
Version 1 August 2014
Outcome: