A revised version of the NRES Standard Operating Procedures (SOPs) for Research Ethics Committees in the UK is published today.
With the exceptions mentioned below, the SOPs come into effect on
1 September 2011 alongside implementation of the harmonised UK-wide edition of the
Governance Arrangements for Research Ethics Committees (GAfREC).
This version follows a comprehensive revision of the SOPs in consultation with REC offices and operational managers across the UK and with external stakeholders. Plans for the revision were originally announced in August 2010.
To access and download version 5.0 of the SOPs, please go to our
SOPs page. You can also see a version of the SOPs showing all tracked changes from version 4.1, and a
full list of changes. Key changes are highlighted below.
The NRES SOPs are kept under continuous review in the light of feedback and suggestions from stakeholders. Any feedback or queries about the revised SOPs may be sent to
nres.queries@nhs.net.
Changes to the remit of RECs
The harmonised UK-wide edition of GAfREC includes revised requirements for ethical review of research by RECs. To check whether this affects the need to apply for ethical review for your research under either legislation or the policy of the UK Health Departments, please see the following:
Researchers are advised to refer to this guidance in the first instance. Further advice may be sought from R&D offices, REC Chairs or the NRES Queries Line.
Proportionate review
Following evaluation of a successful pilot scheme which began in September 2009, NRES has introduced procedures for proportionate review into the SOPs. The timing of implementation will depend on operational considerations at each REC centre.
The Proportionate Review Service (PRS) provides for expedited, proportionate review of research studies raising no significant ethical issues, including projects involving straightforward issues which can be identified and managed routinely in accordance with standard research practice and existing guidelines. Criteria for PRS are developed with advice from the
National Research Ethics Advisers’ Panel.
Under PRS, new applications are reviewed by a sub-committee rather than at a full meeting of a REC, with the aim of notifying the final decision to the applicant within 14 calendar days of receipt of a valid application.
Proportionate review is being phased in across all REC centres in England, and implementation is also under consideration by Research Ethics Service managers in Scotland, Wales and Northern Ireland. For further guidance on the current criteria, which REC centres currently offer PRS and how to book applications, please refer to our
proportionate review page.
Electronic submission of applications from IRAS
Functionality is gradually being phased in to support the electronic submission of application forms and supporting documentation from the
Integrated Research Application System (IRAS) to the systems of reviewing bodies. The functionality will become available for all types of submission to RECs, including new applications, substantial amendments and Site-Specific Assessments for non-NHS sites (where required).
The SOPs include revised procedures to anticipate the introduction of e-submission once the functionality has been fully tested. Following implementation, no paper copies of any application documentation will be required.
Further announcements will be made in due course, and the submission guidance within IRAS will be updated. In the meantime, existing procedures continue to apply as described under the
Submission tab for the REC application form in IRAS.
Safety reporting in CTIMPs
A revised version of the
European Commission guidance on adverse reaction reporting was issued in June 2011. Section 9 of the SOPs has been updated in line with this guidance.
From 1 September 2011, all annual safety reports on clinical trials of investigational medicinal products (CTIMPs) should be presented in the form of a
Development Safety Update Report (DSUR), in line with the Commission guidance. DSURs should comply with the
ICH E2F standard. A full copy of the DSUR should be provided to the REC.
Under the previous version of the SOPs, 6 monthly safety reports and line listings were provided by commercial sponsors conducting international trials. There was also a requirement to provide a final safety report with the end of trial declaration for a first-in-human Phase 1 trial.
Such reports are no longer required under the revised guidance from the European Commission and reference to them has been omitted from the revised SOPs. From 1 September 2011, these reports should not be sent to RECs.
Guidance on our
safety reporting page has been updated in line with these changes.
We have also updated the
safety reporting form for CTIMPs used as a cover sheet when sending expedited SUSAR reports, DSURs and other safety reports to RECs. Please note this form and all enclosures should be sent to the REC office by email or other electronic means. A signature is no longer required on the cover sheet.
Substantial amendments - appeals
Procedures have been introduced to allow applicants to appeal against an unfavourable opinion on a substantial amendment (or modified amendment). Refer to paragraphs 5.54-5.59 of the SOPs for further details.
Gene Therapy Advisory Committee
The Gene Therapy Advisory Committee (GTAC) is now part of the NRES and has adopted the revised SOPs.
As well as its statutory responsibility for reviewing gene therapy clinical trials, GTAC is the national flagged REC for other types of trial, including all advanced therapy medicinal products. For further details of the remit of GTAC, refer to paragraph 1.19 and Annex J of the SOPs. For advice on whether a particular study is suitable for review by GTAC, please
contact the GTAC Secretariat.
Parallel review of applications with the NIGB and ARSAC
Section 13 of the SOPs sets out the NRES policy and procedures for collaborating with regulatory bodies where dual review by a REC and another regulator is required. The aim is to streamline the approvals process, minimise duplication and provide consistent, harmonised guidance to researchers and sponsors.
As well as existing arrangements between NRES and the MHRA (both for CTIMPs and clinical investigations of medical devices), the SOPs include new procedures for collaboration with:
The new procedures will come into effect as soon as agreements between NRES and these bodies have been finalised and, in the case of ARSAC, new functionality is ready within IRAS. Further announcements will be made shortly.
