Manchester REC Office Annual Report Summary April 2016 to March 2017

Manchester REC Office Annual Report Summary April 2016 to March 2017 Purpose Recommendations Presenter Contact RECs To present a summary of the annual reports from Research Ethics Committees (RECs) managed from the Manchester REC Office. The reports cover the activity between April 2016 and March 2017 and copies of the full reports are available on the HRA website. That the annual reports be received and noted Noel Graham Regional Manager noelgraham@nhs.net Regional Manager: Noel Graham, noelgraham@nhs.net London Bloomsbury, REC Manager Matt Rogerson, nrescommittee.london-bloomsbury@nhs.net London Central, REC Manager Elaine Hutchings nrescommittee.london-central@nhs.net London Fulham, REC Manager Anna Bannister, nrescommittee.london-fulham@nhs.net London Hampstead, REC Manager Matt Rogerson, nrescommittee.london-hampstead@nhs.net London Queen Square, REC Manager Katherine Ashley nrescommittee.london-queensquare@nhs.net London South East, REC Manager Margaret Hutchinson, nrescommittee.london-southeast@nhs.net London Westminster, REC Manager Rachel Katzenellenbogen, nrescommittee.northwest-haydock@nhs.net North West GM Central, REC Manager Katherine Ashely nrescommittee.northwest-gmcentral@nhs.net North West GM East, REC Manager Rinat Jibli, nrescommittee.northwest-gmeast@nhs.net North West GM South, REC Manager Gemma Warren, nrescommittee.northwest-gmsouth@nhs.net 1 P a g e

North West GM West, REC Manager Anna Bannister, nrescommittee.northwest-gmwest@nhs.net North West Haydock, REC Manager Rachel Katzenellenbogen, nrescommittee.northwest-haydock@nhs.net North West Lancaster, REC Manager Carol Ebenezer, nrescommittee.northwest-lancaster@nhs.net North West Liverpool Central, REC Manager - Carol Ebenezer, nrescommittee.northwest-liverpoolcentral@nhs.net North West Liverpool East, REC Manager Gemma Warren, nrescommittee.northwest-liverpooleast@nhs.net North West Preston, REC Manager - Carol Ebenezer, nrescommittee.northwest-preston@nhs.net INTRODUCTION: The Health Research Authority (HRA) is a Non Departmental Public Body, established initially as a Special Health Authority on 1 December 2011. Its purpose is to protect and promote the interests of patients and the public in health research. The HRA does this by supporting and promoting a robust and efficient regulatory and governance framework in the UK and providing the Research Ethics Service in England (RES). The Research Ethics Service in England is part of the Operations and Approval Directorate within the HRA and has a dual mission. to protect the rights, safety, dignity and well-being of research participants; and to facilitate and promote ethical research that is of potential benefit to participants, science and society. We do this by: providing robust and responsive ethical review of research by Research Ethics Committees (RECs); providing ethical guidance and management support to RECs; delivering a quality assurance framework for the research ethics service; delivering a training programme; working with colleagues across the UK to maintain a UK-wide framework for ethical review; working with colleagues in the wider regulatory environment to streamline the processes for approving research; and working with colleagues to promote transparency in research 2 P a g e

The HRA is the Appointing Authority for RECs in England and is required by the Governance Arrangements for RECs (GAfREC) to receive and adopt the REC Annual Reports. Update on changes since 2015/2016 Summary of Annual Reports: A pilot project on the review of applications by the proportionate review service (PRS), including an extended review timeline from 14 to 21 days, was undertaken during 2016 and a number of RECs across the UK took part in this project. The timeline for PR review was formally extended to 21 days for all UK RECs in December 2016. North West Lancaster REC was closed in January 2017 following an options appraisal. Annual Reports: As the Appointing Authority, the HRA is responsible for the establishment, appointment, support and training of Research Ethics Committees. The HRA also takes full legal liability for the actions of those members in the course and performance of their duties subject to compliance with terms and conditions of service. Research Ethics Committees are required to submit Annual Reports to the Appointing Authority no later than 30 September. Copies of the full reports are available upon request. The Governance Arrangements for Research Committees (GAfREC, harmonised edition DH 2011) requires annual reports to include the following minimum information. The REC s name, address and other contact details The type of REC, including details of any recognition by UKECA and/or designation by the Research Ethics Service for review of certain types of research proposal Details of the officers and staff of the REC Details of the membership of the REC, including for each member and deputy member their occupation, expert/lay status, initial date of appointment, and where applicable the date on which the term of membership expired or the member resigned The current register of members interests The attendance record of each member and deputy member during the year A list of full meetings held during the year and the number of members attending The training record of each member and deputy member A list of the applications reviewed during the year, including the final decision reached on each application and the time taken to complete the review (or the current status of the review) A report by the Chair on the REC s work during the year 3 P a g e

16 Committees have submitted reports for the year 1 April 2016 to 31 March 2017: London Bloomsbury London Central London Fulham London Hampstead London Queen Square London South East London Westminster North West GM Central North West GM East North West GM South North West GM West North West Haydock North West Lancaster North West Liverpool Central North West Liverpool East North West Preston Membership as at 31 March 2017: Each Research Ethics Committee may have up to 15 full members. As a minimum, one third of these should be Lay members. Deputies may also be appointed. A maximum of two members may be co-opted per meeting, from other Research Ethics Committees, where the meeting would otherwise be inquorate. Recruitment of new members is by an open process and appropriate screening and interviewing takes place in line with GAfREC 4.2.5 REC Total Number Expert Lay Resigned in period Appointed in period London - Bloomsbury 14 7 7 5 expert 5 expert London Central 14 8 6-1 lay, 1 expert London Fulham 12 4 8 2 lay 1 lay London Hampstead 16+1 10+1 6 2 expert 2 lay deputy deputy London Queen Square 12 8 4 3 lay, 4 expert 1 lay, 2 expert London South East 15 8 7 - - London - Westminster 11 5 6 3 expert 1 expert North West GM Central 11 5 6 6 expert 1 expert North West GM East 12 4 8 3 expert - North West GM South 11 8 3 2 lay, 3 expert 1 lay, 3 expert North West GM West 13 8 5 0 1 lay, 2 expert North West Haydock 13 9 4 1 lay 1 lay, 1 expert North West Lancaster 13 7 6 1 lay - North West Liverpool 13 8 5 1 expert 3 expert Central North West Liverpool East 11 5 6 1 lay, 4 expert 2 lay, 1 expert North West Preston 14 10 4 2 lay 2 expert TOTAL 205 +1 deputy 114 +1 deputy 91 31 expert, 12 lay 23 expert, 10 lay 4 P a g e

Quorum: For meetings at which ethical review is undertaken, a quorum shall consist of seven members. Out of 161 scheduled meetings, 4 were cancelled due to low workload. 1 meeting was held as a business meeting only and 2 meetings were cancelled due to the closure of a REC. Research Ethics Committees meetings To maintain competency the RES recommends that Research Ethics Committees should meet at least ten times per year and should aim to review six studies at main per meeting. Of the 16 committees covered by this summary, 10 RECs held 10 meetings, 1 REC held 11 meetings and 4 RECs held 9 meetings and 1 REC held 5 meetings before closure. In addition to full Committee meetings, the RECs covered in this summary held a total of 421 Sub-Committee meetings and 141 Proportionate Review Sub- Committee meetings Summary of activity for all RECs administered from the Manchester Office operating during 2016/17 Numerical information for REC workload and outcomes contained in the individual annual reports has been summarised below. Applications for review at full Committee meetings REC FOSC FOAC UFO PO POPC Total SSB London - Bloomsbury 7 9 1 21 1 39 0 London Central 1 12 2 40 0 55 1 London Fulham 2 19 1 30 1 53 0 London Hampstead 9 10 2 33 0 54 0 London Queen Square 3 11 2 38 0 54 0 London - South East 10 11 5 22 4 52 0 London - Westminster 5 5 0 33 1 44 0 North West GM Central 3 7 1 36 0 47 0 North West GM East 5 12 1 25 0 43 0 North West GM South 2 8 0 41 0 51 0 North West GM West 3 24 4 19 0 50 0 North West - Haydock 6 19 3 19 2 49 0 North West - Lancaster 1 8 1 9 0 19 0 North West Liverpool Central 2 7 0 42 0 51 0 North West Liverpool East 2 9 4 29 0 44 1 North West - Preston 2 14 3 27 0 46 0 TOTAL 63 185 30 464 9 751 2 Key FOSC FOAC UFO PO POPC SSB Favourable Opinion with Standard Conditions Favourable Opinion with Additional Conditions Unfavourable opinion Provisional opinion Provisional Opinion Pending Consultation with Referee Number of studies sent back to full committee meeting for final opinion 5 P a g e

Applications reviewed at Proportionate Review Sub-Committee meetings REC FOSC FOAC NOT PO UFO Total London - Bloomsbury 0 0 0 0 0 0 London Central 5 8 4 12 1 30 London Fulham 9 7 0 5 1 22 London Hampstead 8 8 2 5 0 23 London Queen Square 2 2 3 12 0 19 London South East 15 0 0 6 0 21 London - Westminster 5 14 8 6 0 33 North West GM Central* 0 0 0 0 0 0 North West GM East 4 0 3 7 0 14 North West GM South 12 4 0 13 0 29 North West GM West 6 7 6 3 0 22 North West - Haydock 9 8 3 3 0 23 North West - Lancaster 4 7 0 11 0 22 North West Liverpool Central 8 10 1 8 0 27 North West Liverpool East 6 1 2 14 0 23 North West - Preston 14 4 2 6 0 26 TOTAL 107 80 34 111 2 334 Key FOSC FOAC NOT PO UFO Favourable Opinion with Standard Conditions Favourable Opinion with Additional Conditions No Opinion, transfer to Full Committee for review Provisional Opinion Unfavourable Opinion Summary of workload after REC favourable opinion REC NOSA MOD INFO PI NON SR SAE APR FR SSA London - 123 3 2 29 112 54 4 81 30 38 Bloomsbury London 173 9 1 47 138 67 0 91 6 8 Central London 115 0 1 23 67 46 1 92 67 7 Fulham London 163 1 0 44 175 28 0 98 17 11 Hampstead London 83 3 0 0 102 0 4 29 3 6 Queen Sq. London 92 2 1 27 86 36 0 112 41 2 South East London - 123 9 1 24 106 37 0 99 22 3 Westminster North West 152 10 0 36 123 43 2 78 32 38 GM Central North West 52 1 0 0 51 0 0 84 43 1 GM East North West GM South 105 2 4 18 84 39 20 89 40 10 6 P a g e

North West 58 1 0 0 107 0 0 39 38 0 GM West North West 165 1 1 65 115 31 0 114 29 29 - Haydock North West 59 2 0 0 39 0 0 53 37 1 - Lancaster North West 152 5 2 54 85 53 0 160 39 18 Liverpool Central North West 103 4 3 32 100 45 3 56 19 1 Liverpool East North West - Preston 51 0 0 0 51 0 0 37 15 2 TOTAL 1769 53 16 399 1541 479 34 1312 478 175 Key NOSA MOD INFO PI NON SR SAE APR FR SSA Notice of Substantial Amendment Modified Amendment Substantial Amendment received for information only Substantial Amendment received for new sites/pis Non-substantial amendment Safety Report Serious Adverse Event Annual Progress Report Final Study Report Site Specific Assessment Timescales for Research Ethics Committee Decisions All new studies presented to the committees should be given an opinion within 60 calendar days, Substantial Amendments within 35 calendar days, and Proportionate Review Applications should be reviewed within 21 calendar days. Site Specific Assessments (SSAs) are now being carried out by the main REC. During the reporting period the RES was 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 proportionate review applications to receive a final decision in 21 days and 95% of amendments to receive a decision within 28 calendar days. Performance 751 studies were reviewed by full Committee of which 99.46 % were given an opinion within the 60 day timeline, and 85.23% within the 40 day timeline. 334 studies were reviewed by Proportionate Review Sub-Committees of which 97.32% were given an opinion within the 21 day timeline. Of the 1769 Substantial Amendments reviewed, 98.6% were given a final opinion within the 35 day timeline and 86.01% within the 28 day timeline. There were no Section 30 applications reviewed during the reporting period. 7 P a g e

REC % of full applications reviewed within 60 days % reviewed meeting the 40 day KPI % of Substantial amendments reviewed within 35 days % reviewed meeting the 28 day KPI % of PR applications reviewed within 21 days London - 100.00 76.92 98.37 79.67 n/a Bloomsbury London Central 100.00 98.18 100.00 97.11 100.00 London Fulham 100.00 94.34 100.00 79.13 95.45 London 100.00 98.15 98.77 88.96 95.24 Hampstead London Queen 100.00 90.74 96.39 74.70 100.00 Square London South 100.00 69.23 97.83 79.35 100.00 East London - 97.73 63.64 98.37 73.17 96.00 Westminster North West GM 100.00 76.60 96.71 78.29 n/a Central North West GM 100.00 72.09 100.00 80.77 100.00 East North West GM 100.00 82.35 99.05 92.38 96.55 South North West GM 100.00 96.00 100.00 93.10 93.75 West North West - 97.96 89.80 99.39 89.09 95.00 Haydock North West - 100.00 100.00 100.00 98.31 100.00 Lancaster North West 98.04 88.24 98.68 97.37 100.00 Liverpool Central North West 97.73 70.45 94.17 74.76 95.00 Liverpool East North West - 100.00 97.83 100.00 100.00 95.83 Preston Average for Centre 99.46 85.28 98.60 86.01 97.32 Accreditation of Research Ethics Committees The HRA accreditation scheme aims to ensure that RECs are operating according to guidance set down by the Department of Health. The Quality Assurance Department audit RECs every 3 years to check that they are interpreting procedures and standards correctly in order to maintain a consistent ethical review process across the UK. 4 RECs in the Centre were audited during the reporting period. To supplement the audit process RES Operations undertakes quality control checks of each committee every six months. 8 P a g e

RECs Achieving Full Accreditation at first review REC London - Fulham London - Hampstead London - South East North West - Liverpool Central RECs who have received full accreditation having completed an action plan REC None Appeals received between April 2016 and March 2017 There was 1 appeal for a full application given as part of a full review by RECs from the Manchester Centre; this was not progressed, a new application was submitted resulting in a favourable opinion after further information. There were 4 appeals related to substantial amendments; all were not progressed, 3 modified amendments were submitted to the RECs and given a favourable opinion and 1 submitted a new application. Complaints received between April 2015 and March 2016 No complaints were received in relation to RECs managed from the Manchester Centre. Conclusion and Acknowledgements The Research Ethics Committees managed from the Manchester REC Office continued to provide valuable independent advice to researchers, sponsors and employers whilst protecting the dignity, rights, safety and wellbeing of actual and potential participants. The Centre achieved a high level of performance and the work of the local management and staff is acknowledged. The Research Ethics Service continues to look at how best to support the Research Ethics Committees across the country and to ensure that each is able to maintain its expertise. The REC members contribution to the performance of the RECs in the Centre is acknowledged and the services of our volunteer members are greatly appreciated. Noel Graham Regional Manager 16 August 2017 9 P a g e

Appendix A - % Opinion rates for each REC Applications reviewed at Full Committee meetings REC FOSC FOAC UFO PO POPC Total London - Bloomsbury 17.95 23.08 2.56 53.85 2.56 100 London Central 1.82 21.82 3.64 72.73 0.00 100 London Fulham 3.77 35.85 1.89 56.60 1.89 100 London Hampstead 16.67 18.52 3.70 61.11 0.00 100 London Queen Square 5.56 20.37 3.70 70.37 0.00 100 London South East 19.93 21.15 9.62 42.31 7.69 100 London - Westminster 11.36 11.36 0.00 75.00 2.27 100 North West GM Central 6.38 14.89 2.13 76.60 0.00 100 North West GM East 11.63 27.91 2.33 58.14 0.00 100 North West GM South 3.92 15.69 0.00 80.39 0.00 100 North West GM West 6.00 48.00 8.00 38.00 0.00 100 North West - Haydock 12.24 38.78 6.12 38.78 4.08 100 North West - Lancaster 5.26 42.11 5.26 47.37 0.00 100 North West Liverpool Central 3.92 13.73 0.00 82.35 0.00 100 North West Liverpool East 4.55 20.45 9.09 65.91 0.00 100 North West - Preston 4.35 30.43 6.52 58.70 0.00 100 Average for Centre 8.45 25.25 4.03 61.13 1.15 100 Key FOSC FOAC UFO PO POPC SSB Favourable Opinion with Standard Conditions Favourable Opinion with Additional Conditions Unfavourable opinion Provisional opinion Provisional Opinion Pending Consultation with Referee Number of studies sent back to full committee meeting for final opinion Applications reviewed at Proportionate Review Sub-Committee meetings REC FOSC FOAC NOT PO UFO Total London Bloomsbury* 0.00 0.00 0.00 0.00 0.00 0 London Central 16.67 26.67 13.33 40.00 3.33 100 London Fulham 40.91 31.82 0.00 22.73 4.55 100 London Hampstead 34.78 34.78 8.70 21.74 0.00 100 London Queen Square 10.53 10.53 15.79 63.16 0.00 100 London South East 71.43 0.00 0.00 28.57 0.00 100 London - Westminster 15.15 42.42 24.24 18.18 0.00 100 North West GM Central* 0.00 0.00 0.00 0.00 0.00 0 North West GM East 28.57 0.00 21.43 50.00 0.00 100 North West GM South 41.38 13.79 0.00 44.83 0.00 100 North West GM West 27.27 31.82 27.27 13.64 0.00 100 North West - Haydock 39.13 34.78 13.04 13.04 0.00 100 North West - Lancaster 18.18 31.82 0.00 50.00 0.00 100 North West Liverpool Central 29.63 37.04 3.70 29.63 0.00 100 North West Liverpool East 26.09 4.35 8.70 60.87 0.00 100 North West - Preston 53.85 15.38 7.69 23.08 0.00 100 Average for Centre 32.40 22.52 10.28 34.24 0.56 100 * These RECs did not take part in PR during the reporting period 10 P a g e

Key FOSC FOAC NOT PO UFO Favourable Opinion with Standard Conditions Favourable Opinion with Additional Conditions No Opinion, transfer to Full Committee for review Provisional Opinion Unfavourable Opinion 11 P a g e