To: / BSO Board
From: / Dircector of Customer Care and Performance
Subject: / Executive Summary for the Office of Research Ethics Committees (HSC RECs) for 2013/14
Status: / For Noting
Date of Meeting: / 28 August 2014

There is a duty under the principle of research ethics transparency to publish the annual reports of the Health and Social Care Research Ethics Committees (HSC RECs) and to sharethese with the Committees’ Appointing Authority, the BSO, before publishing on the ORECNI section of the BSO website.

During the financial year 2013-14, the three longstanding committees (HSC RECs 1, 2 and 3which were formed originally in February 2004) functioned until 14th February 2014. On 15th February 2014, these committees were merged and two new committees were formed called HSC REC A and B. Therefore this Executive Summary summarises the workload and achievements of HSC REC 1, 2 and 3 from 1st April 2014 to 14th February 2014 and the activities of the new committees HSC RECs A and B from 15th February to 31st March 2014.

This financial year, the committees at the ORECNI underwent reconfiguration ( 3 committees were merged into 2) and the ORECNI service also celebrated its 10 year anniversary, and that of its HSC RECs. The Chairing teams of HSC RECs 1, 2 and 3 stepped down and new chairing teams of the reconfigured RECs, HSC REC A and B were welcomed.

As Head of the ORECNI I wish to formally note appreciation to the committee members who have provided a voluntary service to protect the rights, dignity and safety of research participants within the HSC and wider NHS.

Since inception 10 years ago, the ORECNI has via its HSC RECs, provided ethical review to 1804 new research studies, and 1055 amendments to studies. These have come from a wide range of research in the field of Health and Social Care including drug studies, medical devices, research involving children, persons with mental incapacity and prisoners. Additionally, the studies have included approval of research tissue banks and databases.

The service reconfiguration has been necessary as a result of a UK wide service improvement to review of studies which are risk-assessed as having no material ethical issues, and therefore are not reviewed by a formal meeting of the full REC. Such studies are now being reviewed by a rolling rota of 3 members from a pool of the memberships of HSC REC A and B; a system known as Proportionate Ethical Review. All studies with material ethical issues continue to be reviewed by the standing full HSC RECs A and B.

I request the BSO in its capacity as Appointing Authority to note that there are new Chairing teams, for HSC REC A (Chair Dr Catherine Hack (Lecturer in Bioinformatics, University of Ulster), Vice Chair Dr Alastair Walker (Former Head of Educational services CCEA, Education Consultant) and Alternate Vice Chair Mrs Celia Diver-Hall (Oncology Research Manager, Western HSC Trust)) and for HSC REC B ( Chair, Professor Patrick Murphy (Social and Economic Policy Advisor), Vice Chair, Dr Anne Moorhead (Lecturer in Health & Interpersonal Communication, University of Ulster) and Alternate Vice Chair Ms Sue Trouton (Maternity Peripatetic Assessor, Southern HSC Trust)).

I wish to acknowledge the voluntary contribution of all those long serving members who had come to the end of their terms of office, during this financial year, and who are listed in the HSC REC annual reports. I would also like to thank, in particular, the former Chairs of HSC REC 1, 2 and 3 (Mr Mark Nelson, Dr Ronald Atkinson and Dr Hilary Russell) for their exceptional leadership to HSC RECs 1, 2 and 3.

I also wish to thankand recognise the staff at the ORECNI for their professionalism and forbearance in a time of substantive change (Ms Janet Daley, Mrs Katrina Greer (Ms Jane Keenan who is providing cover for Mrs Greer), Ms Kathryn Taylor and Mrs Christine Fawcett). The professionalism of the staff at the ORECNI is always highly commended in our annual BSO customer survey.

During this financial year, a total of 173 new research ethics applications were considered (30% of these were new studies reviewed by proportionate review work stream). Also a total of 105 amendments to studies which have been previously approved by the committees were reviewed. The committees also continue to review studies from other parts of the UK, particularly first time in man tested drug studies known as Phase 1 Clinical Trials of Investigational Medicinal Products (CTIMPs).

The committees have met all legal timelines. For example, the legal timeline for ethical review is 60 calendar days. For new studies reviewed by full REC (which have material ethical issues) 60% of studies have been reviewed in less than or equal to 40 calendar days. For new studies with no material ethical issues, 100% of all studies have been reviewed within 14 days. We continue to strive to provide an efficient and professional service to research ethics applicants whilstmaking every effort to maintain the quality and rigour of ethical review.

Of the 3 types of ethical decisions made favourable, provisional and unfavourable, a summary is provided in the table below.

Decision Type (%) / HSC REC 1 / HSC REC 2 / HSC REC 3 / Average
Favourable / 9.5 / 19 / 17.2 / 15.2
Unfavourable / 9.5 / 22.5 / 3.5 / 11.8
Provisional / 81 / 58 / 79 / 72.7
Other / 0 / 0.5 / 0.3 / 0.3

I have not reported on the ethical decision types of the new committees HSC RECs A and B, as they only met for the last 6 weeks of this financial year. Also where provisional decisions are made 95% ultimately revert to favourable once the applicant had made the necessary changes asked by committee in the provisional opinion decision letter, so in effect 88% of studies ultimately receive a favourable ethical opinion.

At the start of the financial year the workload to the full RECs was highlighted as ‘amber’ on the balanced scorecard for BSO’s Key performance Indicator for the ORECNI, I am pleased to say that with the service reconfiguration completed in February 2014 and realignment of workstreams within the service, we have noted a rebalance and increase in the workload activity. The balanced scored card at the end of the financial year was’ green’.