Annual Report Summary for RECs in England
Agenda item:
Attachment:
HRA BOARD COVER SHEET
Date of Meeting:
29 October 2013
Title of Paper:
Annual Report Summary for RECs in England - April 2012 to
March 2013
Purpose of Paper:
To provide a management summary to the Health Research
Authority (HRA) of the annual reports in respect of the National
Research Ethics Service (NRES) Committees in England. This
summary will enable the Board to discharge its function to
monitor the performance of the RECs against the requirements
of the Department of Health Governance Arrangements for
Research Ethics Committees (GAfREC - September 2011)
Reason for Submission: For Board review and approval
Details:
Summary paper as attached. Individual REC Reports and
Summary Reports for Centre prepared for publication and
available on request.
Suitable for wider
circulation?
Yes
Recommendation /
Proposed Actions:
To Approve
To Note
Comments
Name:
Sheila Oliver
Job Title:
Head of NRES
Date:
16/09/2013
Version 1.1 2013 09 16
Yes
1
13
G
Annual Report Summary for RECs in England
April 2012 to March 2013
Purpose
To provide a management summary to the Health Research Authority (HRA) of the
annual reports in respect of the National Research Ethics Service (NRES)
Committees in England. This summary will enable the Board to discharge its
function to monitor the performance of the RECs against the requirements of the
Department of Health Governance Arrangements for Research Ethics Committees
(GAfREC - September 2011)
Background
GAfREC requires that the Appointing Authority receive and adopt the Annual Reports
for the Research Ethics Committees (RECs). The Annual Report Summaries and
this report have been structured by REC Centre, noting for each Centre the regions
in which the committees were situated at the end of the reporting period.
Copies of the REC Centre summary reports and the full annual reports are available
to the Board and will be published on the HRA website.
Introduction
Reports have been submitted for the seven REC Centres operating during the
reporting period. It should be noted that the Leeds and Cambridge REC Centres
closed on the 31 March 2013 and the committees managed from those centres were
transferred to other centres as indicated.
REC Centre
No. of RECs reporting
Current RECs
(Sept 2013)
Jarrow REC Centre
Total 7 RECs
Total 10 RECs
5 North East
1 London
1South Central
4 North East
1 London
4 Yorkshire & the
Humber
1East of England
RECs transferred
4 to Jarrow
2 to Manchester
(2 RECs merged)
Leeds REC Centre
(now closed)
Total 7 RECs
Manchester REC
Centre
Total 15 RECS
Total 15 RECs
2 London
11North West
2 West Midlands
2 London
9 North West
2 West Midlands
2Yorkshire & the
Humber
(2 RECs closed)
Nottingham REC
Centre
Total 10 RECs
Total 13 RECs
All Yorkshire & the Humber
5 East Midlands
4 West Midlands
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5 East Midlands
3 West Midlands
Regional
Manager for the
reporting period
Ann Tunley
(Linda Ellis
reporting)
Ann Tunley
Ann Tunley
Ann Tunley
(Linda Ellis
2
1 London
1 London
4 East of England
Cambridge REC
Centre
(now closed)
Total 7 RECs
RECs transferred
2 merged and
transferred to
Jarrow
4 to Nottingham
1 to London
London REC Centre
Total 14 RECs
All East of England
12 London
2 South East Coast
reporting)
Ann Tunley (April
to December)
Jonathan
Fennelly-Barnwell
(January to
March and report)
Total 12
Jonathan
10 London
Fennelly-Barnwell
1 South East Coast (Ann Tunley
1 East of England
(2 RECs moved, reporting)
1closed)
Bristol REC Centre
Total 19 RECs
Total 19 RECs
4 South West
7 South Central
8 London
4 South West
7 South Central
8 London
Jonathan
Fennelly-Barnwell
Report summaries include an update on the structural changes and reconfiguration
of RECs in each area. 79 RECs were operational during the reporting period. By the
end of the reporting period however the number of RECs operating was reduced to
69 following a planned programme of options appraisals resulting in subsequent
closures and mergers as follows:
Closures:
North East - County Durham and Tees Valley REC
North West - Cheshire REC
North West - Greater Manchester North REC
West Midlands - Staffordshire REC
South East Coast - Kent REC
London - Gene Therapy Advisory Committee
Mergers:
East of England - Welwyn REC merged with the Hertfordshire REC.
Yorkshire and the Humber - Bradford REC merged with the Leeds Central REC.
South Central - Southampton B REC merged with the Portsmouth REC
The London Bentham REC closed following failure to gain accreditation.
During the reporting period the Leeds and Cambridge REC Centres were closed and
the administration of RECs distributed across the remaining five REC Centres. The
rationale around the allocation of RECs to other centres took account of existing
staffing and management arrangements. The closures unfortunately did necessitate
the redundancy of a small number of REC staff.
Additionally during the reporting period, the administration of a number of London
RECs was moved to reduce the pressure on the centre. By the end of the reporting
period all REC Centres now manage RECs from more than one region.
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REC Membership
Each Research Ethics Committee may have up to 18 full members. As a minimum,
one third of these should be Lay members. Deputies may also be appointed.
Arrangements may be made to co-opt members from other committees, where the
meeting would otherwise be Inquorate.
The recruitment of new members is by an open process and the constitution the
committee is set by GAFREC.
A programme of options appraisals to consider the reduction in the number of RECs
prevented the timely recruitment of members to some committees. This was to
ensure that as RECs closed or merged there were sufficient places for existing
members.
Jarrow REC Centre - REC membership ranged from 11 to 15 members and the
report shows that all RECs were correctly constituted. During the reporting period
22 members resigned or completed their term of office, 12 were expert members.
71 scheduled meetings were held, all were quorate, though one additional telephone
conference meeting was held to ratify decisions made at a meeting that became
inquorate during the proceedings, 4 RECs needed to co-opt members to ensure
quoracy.
Leeds REC Centre - (Centre now closed and the administration of committees
transferred) REC membership ranged from 9 to16 (including deputies). The report for
the Bradford REC shows that the REC was not correctly constituted at the time of the
report; this was also identified during QC checks and action was taken to ensure that
meetings were quorate; recruitment of new members was not taken forward pending
an options appraisal for the reduction in the number of the RECs in the region.
During the reporting period 12 members resigned or completed their term of office, 7
were expert members. Following the merger of the Bradford and Leeds Central
RECs 11 members joined the new REC. 77 scheduled meetings were held, 3 were
cancelled because of quoracy issues, 5 RECs co-opted members to ensure quoracy.
Manchester) REC Centre - REC membership ranged from 12 to 16 members and
the reports show that all committees were correctly constituted. During the reporting
period 24 members resigned or completed their term of office, 15 were expert
members. 165 scheduled meetings were held, all were quorate, nine RECs co-opted
members to ensure quoracy or to provide specific expertise.
Nottingham REC Centre - REC membership ranged from 8 to 15 members and the
reports show that all committees were correctly constituted. During the reporting
period 18 members resigned or completed their term of office, 12 were expert
members. 108 scheduled meetings were held, all were quorate except one, a
teleconference meeting was held to complete the review of studies at this meeting In
line with SOPs. 7 RECs needed to co-opt members to ensure quoracy.
Cambridge REC Centre - (Centre now closed and the administration of committees
transferred) REC membership ranged from 11 to14 members and the reports show
that all committees were correctly constituted. During the reporting period 6 members
of the RECs not affected by merger/closure resigned or completed their term of
office; 4 were expert members. The Hertfordshire and Welwyn RECs merged
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resulting in the loss of 9 members 4 of whom were expert members.64 scheduled
meetings were held and all were quorate, four RECs needed to co-opt members to
ensure quoracy.
London REC Centre - REC membership ranged from 11 to 19 members (including
deputy members) and the reports show that all RECs were correctly constituted.
During the reporting period, 58 members resigned, completed their term of office, or
left because of REC closures, 40 were expert members. 143 scheduled meetings
were held, 2 RECs co-opted members to ensure quoracy, and 1 REC for expertise.
One meeting of the Dulwich REC became inquorate and was reconvened the next
day, ensuring studies were reviewed in compliance with SOPs.
Bristol REC Centre - REC membership ranged from 8 to19 members (including
deputies) and the report shows that all RECs were correctly constituted at the end of
the reporting period. During the reporting period 55 members resigned or completed
their term of office, 24 were expert members. 200 scheduled meeting were held, 10
RECs co-opted members to ensure quoracy. 2 inquorate meetings were held and
both were managed correctly in accordance with SOPs.
Attendance
To maintain competency the NRES recommends that Research Ethics Committees
should meet at least ten times per year and should aim to review between four and
six studies at main meetings. Members are required to attend two thirds of main REC
meetings or take part in Proportionate Review Sub-Committees.
Jarrow REC Centre - Of the 7 committees reporting, 1 did not meet the
requirements in terms of number of meetings held, County Durham and Tees Valley
REC met 7 times prior to closure. Generally good attendance was reported by 5
RECs. NorthTyneside 1 REC reported low attendance by 5 members, and this is
being managed through quality control.
Leeds REC Centre - (Centre now closed and the administration of committees
transferred). Of the 7 committees, 5 met the required number of times, 1 met 8 times
and 1 met 7 times because of quoracy issues leading up to the options appraisal
period (Humber Bridge and Leeds Central).Generally good attendance was reported
by the other RECs.
Manchester REC Centre - Of the 15 committees reporting 3 did not meet the
requirements in terms of the number of meetings held. Greater Manchester East met
8 times, and Greater Manchester North and Greater Manchester West 9 times this
was related to workload in the Northwest region prior to the options appraisal for the
reduction in the number of RECs, and meetings were cancelled to better manage the
workload. Generally excellent attendance was reported, 1 REC (Liverpool Central)
reported all members attended two thirds of meetings held.
Nottingham REC Centre- Of the 10 committees reporting, 1 did not meet the
requirements in terms of number of meetings held, meeting only 9 times because of
low workload and quoracy issues. Excellent attendance reported for Nottingham 1
REC with all members meeting two thirds attendance, generally good attendance
reported for 7 RECs with either 1, 2 or 3 members with slightly low attendance rates,
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other RECs reported low attendance for 4 to 6 members.
Cambridge REC Centre - (Centre now closed and the administration of committees
transferred). Of the 7 committees reporting, 5 met the required number of times. The
Welwyn and Hertfordshire RECs met 7 and 6 times respectively, the reduction in the
number of meetings held was related to the reduction in workload and the lead up to
the merger of the two RECs. Excellent attendance was reported for all RECs, with 1
REC (Cambridge Central) reporting all members attending two thirds of meetings
held, and 6 RECs reporting slightly low attendance for only 1 or 2 members.
London REC Centre(s) - Of the 14 committees reporting, three RECs did not meet
the requirements in terms of meetings held, the Kent REC because of workload and
the Bentham and GTAC RECs because they were closed during the reporting period.
Excellent attendance reported for 1 REC (Queen Square) with all members meeting
two thirds attendance requirements, generally good attendance reported for 11
RECs, showing a shortfall in attendance by 1 or 2 members. 3 RECs show low
attendance for 3 or 4 members.
Bristol REC Centre - Of the 19 committees reporting; only the Berkshire B REC
which met 8 times and the Southampton B and Bromley RECs which met 9 times did
not meet the requirements in terms of meetings held because of workload and
quoracy issues. Excellent attendance was reported by 7 RECs, having 100%
compliance with meeting attendance requirements (Berkshire, Berkshire B, Oxford A,
Oxford B, Southampton B, Exeter and City Road and Hampstead), 3 RECs reported
low attendance for only 1 member, 3 RECs reported low attendance for 2 members
and 6 reported low attendance for 3 to 5 members.
Training
Jarrow REC Centre- Reports showed that only 59 out of a total membership of 80 at
the end of the reporting period had attended training or recorded self-directed
learning. Reports for Newcastle and North Tyneside RECs 1 and 2, and Oxford C
reported the best attendance with only 1 or 2 members not attending or undertaking
training. The York REC reported only 3 members had attended training or
undertaken self-directed learning, this is being managed through quality control.
Leeds REC Centre - (Centre now closed and the administration of committees
transferred) Reports show that only 37 out of a total membership of 82 had attended
training or had completed self-directed learning. Of those 37 only 29 had met the full
training requirement. RECs with very low training attendance were Humber Bridge
and Leeds Central (now closed) with only 2 members meeting the full training
requirement and South Yorkshire with only 3 members meeting training
requirements, this is being managed through quality control.
Manchester REC Centre - Reports showed that 131 out of a total membership of
195 at the end of the reporting period had attended training. 8 out of 15 RECs show
excellent compliance with training requirements with either all (Greater Manchester
Central, East and South) members, or all but 1 or 2 members attending training.
Shortfalls in training were noted for the London Fulham REC, the North West Preston
REC and the West Midlands Black Country REC, this is being managed through
quality control.
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Nottingham REC Centre - Reports showed that 95 out of a total membership of 134
at the end of the reporting period had completed some form of training or recorded
self-directed learning. Of those 95, 84 had met the full training requirement. The
Derby, Edgbaston and South Birmingham reports show all members attended
training or undertaken self-directed learning. The West London & GTAC REC
reported only 4 members had undertaken training, this is being managed through
quality control.
Cambridge REC Centre - (Centre now closed and the administration of committees
transferred). Reports show that 59 out of a total membership of 87 had attended
training or recorded self-directed learning. One REC (Cambridge Central) shows
training completed by all members, 4 RECs show minor shortfalls in training with one
to four members not attending training, the Welwyn and Hertfordshire RECs recorded
poor attendance, with only 2 and 3 members respectively attending training,
shortfalls are being managed through quality control.
London REC Centre - Reports show that only 87 out of a membership of 200 have
attended training or recorded self-directed learning. Of those 87, 83 had met the full
training requirement. Reports showing RECs with particularly poor compliance with
training requirements were Brent, Bentham, Chelsea, Dulwich, GTAC, Hampstead,
London Bridge, Surrey Borders, Westminster and Kent. London Central. Queen
Square, and Stanmore RECs show attendance at training for all but 1 or 2 members,
shortfalls are being managed through quality control.
Bristol REC Centre - Reports show that 185 out of a total membership of 244 at the
end of the reporting period had attended training or had completed self-directed
learning. Five RECs reported 100% of members attended training or completed selfdirected learning, a further two RECs reported all but one member meeting training
requirements. Six RECs reported 50% or less members meeting training
requirements (Southampton A, Southampton B, Frenchay, Camberwell St Giles,
South East and Surrey), and this is being managed through quality control.
Summary of activity
Key
FOSC
FOAC
UFO
PO
PR
Favourable Opinion with Standard Conditions
Favourable Opinion with Additional Conditions
Unfavourable Opinion
Provisional Opinion
Proportionate Review
The opinion rates reflect an average for each REC Centre. There is significant
variation in opinion rates between RECs with some having 0% in some opinion
categories. The annual report summaries are discussed at National Research Ethics
Advisor (NREAP) Chairs' meetings. Additionally, where there are significant outliers,
discussions with individual RECs have been undertaken.
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Jarrow REC Centre
No.
%
%
of
FOSC FOAC
RECs
7
4.8% 21.0
%
UFO
%
PO
7.2% 66.7%
Invalid
Total PR
Apps
0
334
113
Leeds REC Centre (Centre now closed and the administration of committees
transferred)
No.
%
%
%
%
Invalid Total PR
of
FOSC FOAC UFO PO
Apps
RECs
7
5.0% 18.2% 5.3% 75.0% 0
340
66
Manchester REC Centre
No.
%
%
%
of
FOSC FOAC UFO
RECs
15
8.0% 21%
5.9%
%
PO
Invalid Total
Apps
64.7% 0
672
PR
235
Nottingham REC Centre
No.
%
%
%
%
Invalid Total PR
of
FOSC FOAC UFO PO
Apps
RECs
10
4.2% 23.9% 7.0% 64.5% 0
528
193
Cambridge) REC Centre (Centre now closed and the administration of committees
transferred)
No.
%
%
%
%
Invalid Total PR
of
FOSC FOAC UFO PO
Apps
RECs
7
2.0% 11.5% 5.7% 80.8% 0
297
59
London REC Centre
No.
%
%
%
%
Invalid Total PR
of
FOSC FOAC UFO PO
Apps
RECs
14
7.4%
19.7% 7.0% 65.3% 0
702
65
Bristol REC Centre
No.
%
%
%
of
FOSC FOAC UFO
RECs
19
6.0%
17.6% 5.7%
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%
PO
Invalid Total
Apps
70.2% 1
985
PR
254
8
Timescales for Research Ethics Committee Decisions
The United Kingdom Clinical Trials Regulations and NRES Standard Operating
Procedures require that decisions are made within the following timelines (working
days).
Full Applications
Proportionate Review Applications
Substantial Amendments
Site Specific Assessments
- 60 days (GTAC - 90 days)
- 14 days
- 35 days
- 25 days,
The NRES is also working towards achieving the following KPIs (Key Performance
Indicators), 95% of applications to full committee to receive a final decision within 40
calendar days, 95% of amendments to receive a decision within 28 calendar days.
Jarrow REC Centre
No. of RECs
No. of
applications
over 60 days
No. of SSAs
over 25 days
7
0
1(0.2%)
No. of
substantial
amendments
over 35 days
6 (1.0%)
No. PRS
applications
over 14 days
3 (2.7%)
334 studies were reviewed by full Committee of which 99.7% were given an opinion
within the appropriate timescale. 113 studies were reviewed by Proportionate Review
Sub-Committees of which 97.3% were given an opinion within the appropriate
timescale. 9 SSAs reviewed, 100% were given a final opinion within the appropriate
timescale. Of the 531 Substantial Amendments reviewed, 99% were given a final
opinion within the appropriate timescale.
Leeds REC Centre (Centre now closed and the administration of committees
transferred)
No. of RECs
No. of
No. of SSAs
No. of
No. PRS
applications
over 25 days
substantial
applications
over 60 days
amendments
over 14 days
over 35 days
7
3 (0.9%)
1 (5.6%)
11 (2.3%)
7 (10.6%)
340 studies were reviewed by full Committee of which 99.1% were given an opinion
within the appropriate timescale. 66 studies were reviewed by Proportionate Review
Sub-Committees of which 89.4% were given an opinion within the appropriate
timescale. 18 SSAs were reviewed, 94.4% were given a final opinion within the
appropriate timescale. Of the 473 Substantial Amendments reviewed, 97.7% were
given a final opinion within the appropriate timescale
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Manchester REC Centre
No. of RECs
No. of
applications
over 60 days
No. of SSAs
over 25 days
15
0
2 (0.3%)
No. of
substantial
amendments
over 35 days
31 (2.4%)
No. PRS
applications
over 14 days
7 (2.9%)
672 studies were reviewed by full Committee of which 99.7% were given an opinion
within the appropriate timescale. 235 studies were reviewed by Proportionate Review
Sub-Committees of which 97.9% were given an opinion within the appropriate
timescale. 131 SSAs reviewed, 100% were given a final opinion within the
appropriate timescale. Of the 1172 Substantial Amendments reviewed, 97.6% were
given a final opinion within the appropriate timescale. It should be noted that the
transfer mid-year of two RECs previously managed from the London REC Centre,
the Fulham and Bloomsbury RECs has had a negative effect on the performance
figures with 29 of the substantial amendments over 35 days emanating from those
RECs.
Nottingham REC Centre
No. of RECs
No. of
applications
over 60/90
days
10
19 (3.5%)
No. of SSAs
over 25 days
2 (1.9%)
No. of
substantial
amendments
over 35 days
42 (3.7%)
No. PRS
applications
over 14 days
8 (4.1%)
528 studies were reviewed by full Committee of which 96.5% were given an opinion
within the appropriate timescale. 193 studies were reviewed by Proportionate Review
Sub-Committees of which 95.9% were given an opinion within the appropriate
timescale. 104 SSAs reviewed, 98.1% were given a final opinion within the
appropriate timescale. Of the 1112 Substantial Amendments reviewed, 96.3% were
given a final opinion within the appropriate timescale. It should be noted that the
London West and GTAC REC which was transferred from the London REC Centre
mid-year has negatively affected the performance figures for the centre accounting
for 14 of the 19 applications over timelines and 38 of the 42 substantial amendments
over timelines.
Cambridge REC Centre (Centre now closed and the administration of committees
transferred)
No. of RECs
No. of
No. of SSAs
No. of
No. PRS
applications
over 25 days
substantial
applications
over 60 days
amendments
over 14 days
over 35 days
7
8 (2.7%)
6 (12.5%)
19 (3.3%)
15 (25.4%)
297 studies were reviewed by full Committee of which 97.3 % were given an opinion
within the appropriate timescale. 59 studies were reviewed by Proportionate Review
Sub-Committees of which 74.6% were given an opinion within the appropriate
timescale. 48 SSAs reviewed, 87.5% were given a final opinion within the appropriate
timescale. Of the 578 Substantial Amendments reviewed, 96.7 % were given a final
opinion within the appropriate timescale.
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London REC Centre
No. of RECs
No. of
applications
over 60 days
No. of SSAs
over 25 days
14
10 (10.4%)
124 (17.7%)
No. of
substantial
amendments
over 35 days
279 (25.6%)
No. PRS
applications
over 14 days
34 (52.3%)
702 studies were reviewed by full Committee of which 82.3% were given an opinion
within the appropriate timescale. 65 studies were reviewed by Proportionate Review
Sub-Committees of which 47.7% were given an opinion within the appropriate
timescale. 96 SSAs reviewed, 72.9% were given a final opinion within the appropriate
timescale. Of the 1087 Substantial Amendments reviewed, 73.8% were given a final
opinion within the appropriate timescale.
The performance of the London REC Centre is a cause for concern. The Board have
been appraised of the performance of the London REC Centre during the reporting
period and arrangement to improve the performance going forward.
Bristol REC Centre
No. of RECs
No. of
applications
over 60 days
No. of SSAs
over 25 days
19
62 (6.3.%)
16 (11.6%)
No. of
substantial
amendments
over 35 days
122 (6.5%)
No. PRS
applications
over 14 days
35 (13.7%)
985 studies were reviewed by full Committee of which 93.7% were given an opinion
within the appropriate timescale. 254 studies were reviewed by Proportionate Review
Sub-Committees of which 86.3% were given an opinion within the appropriate
timescale. Of 137 SSAs reviewed, 88.4% were given a final opinion within the
appropriate timescale. Of the 1857 Substantial Amendments reviewed, 93.5% were
given a final opinion within the appropriate timescale. It should be noted that the
mid/end year transfer of one London and one South East Coast REC had a negative
effect on the performance figures, with 52 of the substantial amendments over 35
days emanating from those RECs.
Appeals and Complaints
Area
Jarrow REC Centre
Leeds REC Centre (now closed)
Manchester REC Centre
Nottingham REC Centre
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Appeals
1 for full application
1 for an amendment
(both allowed)
1 for full application
1 for an amendment
(both allowed)
2 for full applications
(both allowed)
4 for amendments (1
progressed, 3 not
progressed)
2 for full application
Complaints
0
2 (both upheld)
3 (2 upheld, 1
partially upheld
5 (4 upheld)
11
Cambridge REC Centre (now
closed)
London REC Centre
Bristol REC Centre
1 for a PR application
(allowed)
1 for an amendment
(withdrawn by the
researcher)
3 (all were allowed, all
upheld)
5 (all were allowed and
upheld)
1(third party
complaint)
17 (14 upheld, 1
partially upheld, 2
not upheld)
7 (3 upheld, 3
partially upheld, 1
not upheld)
Accreditation of Research Ethics Committees
The HRA Quality Assurance Department audits RECs on a three year rolling
programme. REC Centres are also audited, currently only the London REC Centre
has not been audited and therefore is not yet accredited. A decision has been made
to postpone further REC Centre Accreditation audits and incorporate as part of the
ISO 9001 internal audit programme.
Information related to the Accreditation status of RECs was included in Annual
Report Summaries. Reports showed the number of RECs audited during the
reporting period, together with accreditation status.
REC Centre
RECs achieving
accreditation at first review
Jarrow REC Centre
(no audits completed during the
reporting period)
Leeds REC Centre
Manchester REC Centre
Leeds Central
Greater
Preston
Solihull REC
Nottingham REC Centre
Cambridge REC Centre
(now closed)
Cambridge East
London REC Centre
Brighton & Sussex
Bristol REC Centre
Bristol Central
Number of RECs
achieving accreditation
having completed an
action plan
Camden & Islington
South Yorkshire
0
Edgbaston
West London & GTAC
Cambridge South
Essex
Norfolk
London Surrey Borders
Westminster
Frenchay
Harrow
One London REC (Bentham) failed to attain accredited status and was subsequently
closed.
All other RECs hold accredited status and will be re-audited as scheduled.
Manchester -South
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Conclusions and Actions
General
Where issues were noted during the review of the annual reports and the production
of summary reports they were brought to the attention of NRES and Regional
Managers for action.
To supplement the Accreditation Audits, Regional Managers undertake Quality
Control checks twice yearly on each REC. Identified issues are subject to action
plans.
Membership
All RECs were correctly constituted except one, and this was as a result of a delay in
recruiting pending plans for expected closures and mergers as a result of options
appraisals. Care had been taken to ensure that REC meetings were quorate.
Reports show that a total of 180 members resigned, completed their term of office, or
left because of REC closures and mergers; this is a slight decrease in loss of
members from the previous year. The number of expert members leaving was 103,
compared to 118 in the previous year. We were fortunate to retain a number of
members during REC closures and mergers.
During the reporting period April 2012 to March 2013, 30 new members were
recruited and appointed of which 20 are Expert Members. Additionally, from April
2013 to September 2013 a further 42 new members have been appointed of which
22 are Expert Members.
Attendance
Attendance at meetings is generally good across most RECs; however where there
are shortfalls NRES and Regional Managers to ensure this is followed up and
addressed through QC checks and action plans.
Training
Attendance at training and recording of self-directed learning has declined
considerably since the previous year and is a problem across all centres. Reasons
given are difficulty in obtaining time off from clinical roles to attend, however there is
the ability for all members to undertake learning in their own time.
Figures show that that only 64% of members met training requirements this year
compared to 88% in the previous year. The range of compliance across the centres
ranged from 75% in the Bristol Centre to 43% in the London Centre.
NRES and Regional Managers have been asked to ensure that shortfalls in training
and recording of that training are addressed where necessary, and also that care is
taken to ensure that members full training requirements are met
REC activity
Opinion rates have been further scrutinised and are being presented and discussed
at NREAP hosted Chair's network meetings. Additonally, where there are significant
outliers, discussions with individual RECs will be undertaken.
Timelines for Research Ethics Committee Decisions (see appendix A)
Timelines for REC review of new applications and substantial amendments is
excellent in 6 out of the 7 Centres reporting, timelines for London have not improved.
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The move of some London RECs to other centres mid-year (Nottingham, Manchester
and Bristol) has had a negative effect on timelines for those centres, though figures
since the end of the reporting period show that this has improved. Timelines for
London have been seen to have improved since the end of the reporting period.
Chairs overview
There were a number of suggestions made by Chairs in the reports which should be
considered:
Better recognition of the contribution of REC members
Concerns about lack of/delay in recruitment
Involving researchers more in the delivery of training
Recommendation
In accordance with GAfREC the Board of the Health Research Authority is required
to receive and adopt the Annual Reports for the RECs in England and to publish
them on its website.
Acknowledgements
The Health Research Authority acknowledges the contribution made by its
volunteer members and staff in providing an effective and robust ethical review
service and expresses its appreciation for their commitment to providing high
quality ethical review.
In particular this year the Board would wish to further acknowledge the
professionalism of staff and members of closing Centres for their continued
dedication to the service up to 31 March 2013.
Version 1.2 2013 09 16
14
Appendix A
Applications reviewed within 60 day timeline
2012/13
2011/12
2010/11
Jarrow
99.7%
100%
99.3%
Leeds
99.1%
99%
94.5%
Manchester
99.7%
100%
100%
Nottingham
96.5%
99.4%
98.6%
Cambs
97.3%
94.5%
97.5%
London
82.3%
89.1%
90%
Bristol
93.7%
96.5%
93.5%
London
73.8%
82.6%
85%
Bristol
93.5%
92.7%
88%
Substantial amendments reviewed within 35 day timeline
2012/13
2011/12
2010/11
Jarrow
99%
97.5%
99.5%
Leeds
97.7%
96.2%
87.9%
Manchester
97.6%
99.7%
98.9%
Nottingham
96.3%
99.3%
98.5%
Cambs
96.7%
97.3%
95.2%
Proportionate review applications reviewed within 14 day timeline
2012/13
Jarrow
94.7%
Leeds
89.4%
Version 1.2 2013 09 16
Manchester
97.9%
Nottingham
95.9%
Cambs
74.6%
London
47.7%
Bristol
86.3%
15