HRA AND DEVOLVED ADMINISTRATIONS
ACCREDITATION SCHEME REPORT
FOR PERIOD OCTOBER 2016 TO MARCH 2017
Introduction
This report includes data relating to REC audits conducted and action plans completed
under the 2016 scheme.
The report is reviewed by the UK wide Operational team in order to review trends and to
take forward any actions in order to improve the service provided by the Research Ethics
Service (RES).
1. REC audits and accreditation status awarded
Name of REC
Audit period
London – West London & GTAC
London - Hampstead
South Central – Oxford A
Wales REC 4 (re-audit)
South Central - Oxford B
East Midlands – Nottingham 1
Scotland A
East Midlands - Nottingham 2
London – City & East
North West – Liverpool Central
North West – Haydock
London - Fulham
London - Bloomsbury
South Central - Berkshire
North East - York
Yorkshire & The Humber - Leeds West
London - Brent
London – London Bridge
North East - Newcastle & North
Tyneside 1
Yorkshire & The Humber - Sheffield
East of Scotland REC 2
London - South East
East of England - Cambridge East (Reaudit)
Jul 2015 -Jun 2016
Jul 2015 -Jun 2016
Jul 2015 – Jun 2016
Mar 2016 - Aug 2016
Aug 2015 – Jul 2016
May 2015 – Apr 2016
Aug 2015 – Jul 2016
Aug 2015 – Jul 2016
Sep 2015 – Aug 2016
Sep 2015 – Aug 2016
Sep 2015 – Aug 2016
Sep 2015 – Aug 2016
Oct 2015 – Sep 2016
Oct 2015 – Sep 2016
Oct 2015 – Sep 2016
Nov 2015 – Oct 2016
Nov 2015 – Oct 2016
Dec 2015 – Nov 2016
Dec 2015 – Nov 2016
Accreditation status
awarded
Full accreditation
Full accreditation
Accreditation with conditions
Provisional Opinion
Full accreditation
Full accreditation
Provisional Opinion
Provisional Opinion
Provisional Opinion
Full accreditation
Provisional Opinion
Accreditation with conditions
Provisional Opinion
Full accreditation
Provisional Opinion
Full accreditation
Full accreditation
Full accreditation
Provisional Opinion
Jan 2016 – Dec 2016
Jan 2016 – Dec 2016
Jan 2016 – Dec 2016
Sep 2016 - Feb 2017
Full accreditation
Full accreditation
Full accreditation
Accreditation with conditions
HRA and Devolved Administrations Accreditation Report October 2016 to March 2017
2. RECs Achieving Full Accreditation after completion of an action plan
Name of REC
South Central –
Berkshire B
South East Scotland
1
East of England Cambridge Central
South Central –
Oxford A
Latest date which
action plan should
be completed
(including
extensions)
11-Nov-16
Date completed
action plan
received from REC
Date full
accreditation
received
09-Nov-16
14-Nov-16
06-Jan-17
30-Sep-16
10-Oct-16
27-Jan-17
27-Jan-17
06-Feb-17
13-Jan-17
13-Jan-17
01-Feb-17
3. Numbers of issues in relation to number of RECs audited identifed through the
reporting period
Graph showing the number of RECs granted provisional
accreditation/accreditation with conditions and the
number of unmet standards between October 2016 and
March 2017
8
7
Number of RECs
6
5
4
3
2
1
0
1-3
4-6
Number of unmet standards
2
7+
HRA and Devolved Administrations Accreditation Report October 2016 to March 2017
Standards not met
Graphs 8a and 8b show the trends in unmet standards (that are detailed in action plans) for
RECs audited during the past three reporting periods, and are illustrated using 2 key areas;
membership and administration.
% of issues raised within the 6 month
reporting period
Accreditation Trends Relating to Membership
25
20
Indemnity
15
Attendance
10
Constitution
5
Training
0
Recruitment
Oct 15 - Mar 16
Apr 16 - Sep 16
Oct 16 - Mar 17
accreditation reporting periods
Graph 8a
% of issues raised within the 6 month
reporting period
Accreditation Trends Relating to Administration
35
30
25
20
15
10
5
0
Compliance with
SOPs/Processes
HARP
Minutes/Letters
Timelines
Oct 15 - Mar 16
Apr 16 - Sep 16
Oct 16 - Mar 17
accreditation reporting periods
Graph 8b
3
Other
HRA and Devolved Administrations Accreditation Report October 2016 to March 2017
4.
Analysis of recommendations detailed in audit reports
Recommendations are issues which are deemed to be low enough risk not to warrant an
action plan requiring review and sign off by the HRA QA department. Compliance against
recommendations is checked through Quality Control (QC) checks.
The recommendations made in relation to the 23 audits conducted during the reporting
period, have been collated and analysed to provide broad trends on the two key areas –
membership and administration.
Membership
The majority of recommendations (61) were made in relation to the recording of member
details and associated documents on HARP – issues included incorrectly detailing start and
end dates, training information and declarations of interest not being recorded correctly.
There were 34 recommendations made relating to meeting the membership training
requirement and 8 relating to the need to monitor and manage the requirement for members
to attend 2/3rds of REC meetings.
25 were raised regarding indemnity and terms and conditions – these ranged from incorrect
appointment dates being detailed on letters, delays in issuing reappointment letters and
terms and conditions and the need to reissue appointment letters to cover officers
appointments over 10 years.
There were 5 recommendations relating to the management of member’s break in service
and the subsequent uploading of letters and emails.
Administration
145 recommendations related to the use of HARP and recording and uploading of
information in accordance to the HARP dataset. One of the reoccurring issues related to the
mis-recording of version numbers on HARP and not having a clear audit trail of approved
documents.
There were 109 recommendations made in relation to the quality of the minutes; these
ranged from the need to proof read minutes prior to release in order to correct spelling and
typographical errors to suggestions around grouping of issues in order to aid the applicants
understanding of the issues that needed to be addressed.
Recommendations relating to the management of the HARP clock were detailed in 11 audit
reports and compliance with SOP timelines.
5. Report Turnaround Times
All the HRA QA procedure timelines were met during the reporting period.
6. Feedback from REC Managers of audited RECs
Feedback is sought from REC Managers of RECs undergoing audit seeking their views on
the accreditation procedure. REC Managers are sent a copy of the feedback form along
with their final decision letter. Eight REC Managers provided feedback from the twenty three
RECs audited. A report detailing feedback can be found in Appendix 1.
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HRA and Devolved Administrations Accreditation Report October 2016 to March 2017
7. Conclusion
During the reporting period 23 audits were completed with 65% of RECs being issued with
either full accreditation or accreditation with conditions; 35% of RECs received a provisional
opinion status with an action plan to complete. It is noted that the number of provisional
opinions have increased from the last reporting period (18% for April – September 2016).
Two of the audits completed were re-audits at the request of RES Management.
There were decreases in action plan issues being raised in respect of REC members
indemnity, training and the constitution with only a slight increase in issues being raised in
relation to poor meeting attendance by members. Of the issues raised three related to the
consitution of RECs; lack of lay+ members and the absence of a Vice Chair for a prolonged
period. Non-completion of the training and attendance requirement was detailed in five of
the action plans and issues relating to the lack of appropriate appointment, reaapointment
and signed terms and conditions featured in six of the action plans issued during the
reporting period.
In relation to administrative compliance there were increases in issues being raised in
relation to minutes and letters, compliance with SOPs/processes, timelines and HARP.
Non-compliance in relation to the use of specialist advice was detailed in five of the action
plans and non-compliance with the HARP dataset was issued for four of the action plans
(issues related to mis-management of the clock, not using HARP generated documents, and
unclear audit trails of review). Of the issues raised in relation to the minute taking and letter
writing, five related to inconsistency between minutes and the recording of issues for the
applicant to address (as part of the decision) and three action plan issues related to minutes
not being ratified and uploaded to HARP in a timely manner. Only one issue was raised in
relation to non-compliance with SOP timelines.
The feedback from REC Managers on the accreditation process has been positive and
shared with operational colleagues where appropriate.
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HRA and Devolved Administrations Accreditation Report October 2016 to March 2017
Appendix 1
Feedback received from audits completed between October 2016 and March
2017
Views of REC Managers on the audit procedure
Percentage per score
Rating guideline 1=poor, 5=excellent
Activity
1
4
5
The checklist made clear the standards
to be met in the audit.
25%
75%
Completing the checklist helped to
prepare for the audit
14%
86%
37%
63%
37%
63%
HRA QA staff were approachable, fair
and methodical
25%
75%
The issues raised in the audit report and
action plan were a fair reflection of the
situation.
37%
63%
The interpretation of standards during
the audit was a fair reflection of
GAfREC, SOPs and other NRES
guidance.
The audit was fair and reasonable with
the opportunity to discuss and clarify
issues during the process
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2
3
HRA and Devolved Administrations Accreditation Report October 2016 to March 2017
Comments received from REC Managers through the feedback form
REC 1
I have not answered the second question as I did not complete the checklist.
I was nervous about the audit but I had a very pleasant experience with the audit team. I
found the team to be fair and understanding; allowing time for points to be explained and
they took this into consideration without ever being dismissive.
REC 2
Thanks to Jane for her guidance throughout the audit process and thanks to the Centre staff
for their support.
REC 3
When issues have been found in minutes or letters it would be helpful to detail fully where
the issues are and which parts of the minutes or letter needs looking at rather than just
naming the study. I am finding it hard to find the issues in the minutes which were
referenced. It would be also helpful in the audit interview that these were gone through in
detail so they could be discussed further.
REC 4
Jane Martin conducted the audit interview in such a way as to make me feel comfortable
throughout. I feel I got a lot out of the audit, not just in terms of accreditation for the REC but
in terms of valuable experience to put towards my own professional development.
I understood the importance of the audit, why it was taking place and what was expected of
me.
Nicki Watts was very helpful throughout preparation for the audit, and I had a great deal of
support from my management who were all incredibly supportive throughout. My Chair
provided a great deal of support, encouragement and help both for myself, and for members
of the REC to ensure they were compliant with everything expected of them – as she always
does.
Overall I am very happy with the audit experience, and feel proud to be a part of the REC, of
the Manchester office, and of the RES and HRA.
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