Bristol REC Office Annual Report Summary April 2016 to March Regional Manager: Tom Lucas

Transcription

1 Bristol 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 Bristol 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 Tom Lucas Regional Manager Tom.lucas@nhs.net Research Ethics Service Manager (England): None Regional Manager: Tom Lucas tom.lucas@nhs.net Deputy Regional Manager: Cathy Chesham cchesham@nhs.net Deputy Regional Manager: Claudia Bywater claudia.bywater@nhs.net London Bromley REC Manager: Siobhan Bawn nrescommittee.london-bromley@nhs.net London Camberwell St Giles REC Manager: Sarah Graves nrescommittee.london-camberwellstgiles@nhs.net London Chelsea REC Manager: Sarah Graves nrescommittee.london-chelsea@nhs.net London City and East REC Manager: Rajat Khullar nrescommittee.london-cityandeast@nhs.net London Harrow REC Manager: Sadie McKeown-Keegan nrescommittee.london-harrow@nhs.net London Riverside REC Manager: Tina Cavaliere nrescommittee.london-riverside@nhs.net 1 P a g e

2 South Central Berkshire REC Manager: Sadie McKeown-Keegan South Central Berkshire B REC Manager: Lucy Roberts nrescommittee.southcentral-berkshireb@nhs.net South Central Hampshire A REC Manager: Helen Sivey nrescommittee.southcentral-hampshirea@nhs.net South Central Hampshire B REC Manager: Sarah Graves nrescommittee.southcentral-hampshireb@nhs.net South Central Oxford A REC Manager: Natasha Bridgeman nrescommittee.southcentral-oxforda@nhs.net South Central Oxford B REC Manager: Vicky Canfield-Duthie nrescommittee.southcentral-oxfordb@nhs.net South Central Oxford C REC Manager: Helen Sivey nrescommittee.southcentral-oxfordc@nhs.net South East Coast Surrey REC Manager: Rajat Khullar nrescommittee.secoast-surrey@nhs.net South West Central Bristol REC Manager: Naazneen Nathoo nrescommittee.southwest-bristol@nhs.net South West Cornwall and Plymouth REC Manager: Lucy Roberts nrescommittee.southwest-cornwall-plymouth@nhs.net South West Exeter REC Manager: Naazneen Nathoo nrescommittee.southwest-exeter@nhs.net South West Frenchay REC Manager: Natasha Bridgeman nrescommittee.southwest-frenchay@nhs.net INTRODUCTION: The Health Research Authority (HRA) is a Non Departmental Public Body, established initially as a Special Health Authority on 1 December Its purpose 2 P a g e

3 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 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 The London City Road and Hampstead REC was closed on 01/04/2017. There have been no other RECs merged, closed or moved in or from Bristol. 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. 3 P a g e

4 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 18 Committees have submitted reports for the year 1 April 2016 to 31 March 2017: London - Bromley London - Camberwell St Giles London - Chelsea London - City and East London - City Road and Hampstead London - Harrow London - Riverside Berkshire Berkshire B Hampshire A Hampshire B Oxford A Oxford B Oxford C South East Coast - Surrey South West - Central Bristol South West - Cornwall and Plymouth South West - Exeter South West - Frenchay 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. 4 P a g e

5 Recruitment of new members is by an open process and appropriate screening and interviewing takes place in line with GAfREC REC Total Number Expert Lay Resigned in period Appointed in period London Bromley lay 0 London - Camberwell St lay 1 expert 1 lay 1 expert Giles London Chelsea lay 3 expert 0 London - City and East lay 1 expert 1 lay London Harrow expert 1 lay, 2 expert London Riverside lay, 1 expert 1 expert London Surrey lay, 3 expert 4 lay, 1 expert Berkshire Berkshire lay, 1 expert 2 expert, 1 lay B lay, 2 expert 4 lay, 1 expert Hampshire A lay, 1 expert 3 lay, 2 expert Hampshire B Oxford A lay, 2 expert 3 lay, 1 expert Oxford B lay, 1 expert 2 lay, 1 expert Oxford C lay, 1 expert 3 lay, 2 expert South West - Central lay, 2 expert 1 lay Bristol South West - Cornwall lay, 2 expert 2 lay, 1 expert and Plymouth South West - Exeter lay, 2 expert 1 expert South West - Frenchay expert 2 lay Total Quorum: For meetings at which ethical review is undertaken, a quorum shall consist of seven members. Out of 170 scheduled meetings, 3 were inquorate due to less than 7 members being present. These were for the REC meetings held at Surrey on 03/05/2016, Harrow 11/10/2016 and City and East on 01/12/2016. The decisions for each were later ratified by a quorate teleconference in accordance with SOPs. 4 meetings were cancelled due to low numbers of applications. 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 per meeting. Of the 18 committees covered by this summary, 1 committee met on 11 occasions, 5 committees met on 10 occasions, 7 committees met on 9 occasions, 4 committees met on 8 occasions and 1 committee met on 7 occasions. In addition to full Committee meetings, the RECs covered in this summary held a total of 631 Sub-Committee meetings and 168 Proportionate Review Sub- Committee meetings. 5 P a g e

6 Summary of activity for all RECs administered from the Bristol 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 Bromley London - Camberwell St Giles London Chelsea London - City and East London Harrow London Riverside London Surrey Berkshire Berkshire B Hampshire A Hampshire B Oxford A Oxford B Oxford C South West - Central Bristol South West - Cornwall and Plymouth South West - Exeter South West - Frenchay Total 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 Bromley London - Camberwell St Giles London Chelsea London - City and East London Harrow London Riverside London Surrey Berkshire Berkshire B Hampshire A Hampshire B Oxford A P a g e

7 Oxford B Oxford C South West - Central Bristol South West - Cornwall and Plymouth South West - Exeter South West - Frenchay Total 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 Bromley London Camberwell St Giles London Chelsea London - City and East London Harrow London Riverside London Surrey Berkshire Berkshire B Hampshire A Hampshire B Oxford A Oxford B Oxford C South West Central Bristol South West Cornwall and Plymouth South West Exeter South West - Frenchay Total Key NOSA Notice of Substantial Amendment 7 P a g e

8 MOD INFO PI NON SR SAE APR FR SSA 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 REC 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 and 95% of amendments to receive a decision within 28 calendar days. Performance 884 studies were reviewed by full Committee of which 99.55% were given an opinion within the 60 day timeline, and 85.97% within the 40 day timeline. 381 studies were reviewed by Proportionate Review Sub-Committees of which 90.55% were given an opinion within the 21 day timeline. Of the 1980 Substantial Amendments reviewed, 96.41% were given a final opinion within the 35 day timeline and 83.73% within the 28 day timeline. There were 5 Section 30 applications reviewed during the reporting period. % 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 Bromley London - Camberwell St Giles London Chelsea London - City & East London Harrow London Riverside London Surrey Berkshire Berkshire B Hampshire A Hampshire B Oxford A P a g e

9 Oxford B Oxford C South West - Central Bristol South West - Cornwall and Plymouth South West - Exeter South West Frenchay Average for Centre 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. 10 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. RECs Achieving Full Accreditation at first review REC London Harrow Berkshire Berkshire B Oxford B London - Camberwell St Giles London Riverside London Surrey South West - Frenchay RECs who have received full accreditation having completed an action plan REC Oxford A London - City and East Appeals received between April 2016 and March 2017 There was 1 appeal against a decision given as part of a full review by a REC managed from the Bristol Centre; this did not proceed. 9 P a g e

10 There were 3 appeals related to substantial amendments; none of these progressed, 3 modified amendments were submitted to the RECs for review and all were given a favourable opinion. Complaints received between April 2016 and March 2017 There was 1 complaint in relation to a REC managed from the Bristol Centre; this was partly upheld. Conclusion and Acknowledgements The Research Ethics Committees managed from the Bristol 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. Tom Lucas Regional Manager for Bristol 14/08/17 10 P a g e

11 Appendix A % Opinion rates for each REC Applications reviewed at Full Committee meetings REC FOSC FOAC UFO PO POPC Total SSB London Bromley London - Camberwell St Giles London Chelsea London - City and East London Harrow London Riverside London Surrey Berkshire Berkshire B Hampshire A Hampshire B Oxford A Oxford B Oxford C South West - Central Bristol South West - Cornwall & Plymouth South West - Exeter South West - Frenchay Average for Centre 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 Bromley London - Camberwell St Giles London Chelsea London - City and East London Harrow London Riverside London Surrey Berkshire Berkshire B Hampshire A Hampshire B Oxford A Oxford B Oxford C South West - Central Bristol South West - Cornwall and Plymouth South West - Exeter South West - Frenchay Average for Centre P a g e

12 h 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 12 P a g e