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 Version 1.2 2013 09 16 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. Version 1.2 2013 09 16 3 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 Version 1.2 2013 09 16 4 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, Version 1.2 2013 09 16 5 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. Version 1.2 2013 09 16 6 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. Version 1.2 2013 09 16 7 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% Version 1.2 2013 09 16 % 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 Version 1.2 2013 09 16 9 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. Version 1.2 2013 09 16 10 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 Version 1.2 2013 09 16 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 Version 1.2 2013 09 16 12 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. Version 1.2 2013 09 16 13 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
© Copyright 2024