Guidance and policy for members: ethical review

Governance Arrangements for Research Ethics Committees: a harmonised edition (DH, 2011)

This document is the policy of the UK Health Departments, describing what is expected from the research ethics committees that review research proposals relating to areas of the departments’ responsibility.

The full document is available for download here

 

Standard Operating Procedures for Research Ethics Committees (SOPs)

The UK health departments authorise the Research Ethics Service to establish SOPs for all RECs established in accordance with GAfREC

These SOPs also meet the obligations of the United Kingdom under Directive 2001/20/EC of the European Parliament and the Council of the European Union for the operation of ethics committees in relation to clinical trials of investigational medicinal products (CTIMPs).

 

Peer/Scientific review and the role of RECs

A framework of questions (and considerations that would arise) RECs might ask when satisfying themselves of the adequacy of peer review of applications.

 

Study Review sheet for REC Members

An assessment form [pdf, 34 KB] for use when undertaking a full ethical review. Use when reviewing the application to ensure all aspects of the ethical review are considered. It can be used when members cannot attend a meeting to guide comments to be sent to the REC Manager.

 

HARP member portal

The HARP Member Portal is now available for all members to access. This allows full applications, Proportionate Review applications and substantial amendments to be accessed electronically through the HARP Member Portal. We would like to encourage as many members as possible to use the HARP Member Portal. Using the HARP Member Portal allows you to view applications as soon as they are valid (which will often be earlier in the month than when paper copies are sent) and it allows you to download and read applications at a time which is convenient for you. Additionally, reviewing Proportionate Review applications and substantial amendments saves you from receiving large numbers of attachments to your email inbox. It also saves the NHS money and is better for the environment.

There is now a youtube video which provides a demonstration of the HARP member portal, you can provide your members with the following link – https://youtu.be/3REIfddietU

You can find the HARP member portal – user manual and the HARP member portal – Frequently Asked Questions document here.

Consistency Project

In 2016 the Research Ethics Service commenced a large programme of work to look at consistency. The programme involved various pieces of work to look at different areas of the service which are included in the Consistency Improvement Plan.

As part of the consistency programme a piece of work was undertaken to look at provisional opinions. One of the reasons for this is because the annual reports indicated significant variations between REC in terms of the percentage of provisional opinion issued and the percentage of favourable opinions with additional conditions issued. The work involved looking at a sample of provisional opinions for each REC across the UK. The Provisional Opinion Audit contains additional information about this work.

Phase 1 SSA Unit checklist

In order to assist REC members in their assessment of a non NHS facility, this checklist [pdf, 163 KB] has been provided by the European Forum on Good Clinical Practice.  It is intended as guidance only, and a negative response to any of the items should not be automatically construed as a reason to decline a proposed study.

National Research Ethics Advisors’ Panel (NREAP)

NREAP is established by the Research Ethics Service (RES) under GAfREC as a resource to the RES and the appointing authorities of RECs within that service  to help optimise research ethics review and so improve the research environment in the UK. NREAP provides advice and support to RECs and appointing authorities in exercising their responsibilities under GAfREC and SOPs.

Terms of reference, minutes of NREAP meetings, Panel members’ biographies and a library of NREAP guidance may be found here