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National Information: United Kingdom

Short description of the UK REC system

The UK has a hybrid system of RECs. Some are institution-based. Others are location or region-based; some are centralised, covering the whole country. Several different types of RECs exist. They can be split into two main categories of non-NHS RECs (e.g. institution-based higher education RECs) and NHS RECs.

Formally existing since 1991, National Health Service (NHS) RECs consist of between seven and 15 individuals (one-third of whom must be ‘lay’) who are independent of research sponsors, funders, and investigators, and serve to opine on the ethical acceptability of research involving NHS staff, or patients and/or their tissue and data, among other kinds of health-related research. Currently, there are over 150 staff members (e.g. REC Managers/Co-ordinators, HRA Regional Managers, etc.) and over 1000 volunteer members of NHS RECs across the UK. RECs review around 6,000 research applications across the UK. On average, they given an ethics opinion in less than 40 days.

The United Kingdom has 85 NHS Research Ethics Committees (as of April 2019): 65 in England, 11 in Scotland, 7 in Wales and 2 RECs in Northern Ireland. NHS RECs, also known more formally as ‘RECs within the UK Health Departments’ Research Ethics Service’, are region-based ethics committees. Officially overseeing a local health area within the NHS system, in practice they operate within a centrally administered system that enables them to review research applications and provide an ethics opinion on health research involving humans in the NHS taking place anywhere in the UK. In addition to research involving participants identified from, or because of, their past or present use of the NHS, common categories of NHS REC review include: clinical Trial of an Investigational Medicinal Product (CTIMP), including NHS Phase 1 CTIMPs in healthy volunteers; research involving medical devices; social care research); biomedical research involving children; biomedical research involving prisoners; research involving adults lacking capacity; the establishment of research tissue banks/biobanks; and the establishment of research databases.

NHS RECs are overseen by central regulators, including the United Kingdom Ethics Committee Authority (UKECA) for those RECs ‘recognised’ to give an ethics opinion on a CTIMP. In England, RECs are overseen by the Research Ethics Service (RES), an office under the auspices of the Health Research Authority (HRA), which itself is an arm’s-length body situated in England’s Department of Health. The HRA’s RES operates five offices across England (London, Bristol, Nottingham, Manchester, and Jarrow), which in turn manage NHS RECs more or less within their region. Each office is led by a RES Regional Manager, though a Managers may be responsible for managing more than one office. There are equivalent Research Ethics Services in each of the devolved nations. In Scotland, the Health Boards function as the HRA equivalent, while four Scientific Officers and a Chief Scientist Office (CSO) ethics ‘point person’ function as the equivalent for the RES for RECs within NHS Scotland. There are equivalent bodies in Northern Ireland (ORECNI) and Wales (Division for Social Care and Health Research), but in practice, the HRA through its RES has taken a leading (and coordinating) role for managing RECs throughout the UK.

While NHS RECs handle a range of health research studies, there are in fact two broad categories of committees. First, some of these RECs are ‘recognised’ (i.e. legally recognised by UKECA) to give an ethical opinion on a CTIMP to be undertaken anywhere in the UK. These UKECA-recognised RECs may review CTIMPs of either ‘Type 1’ (healthy volunteers anywhere in the UK) or ‘Type 3’ (patients anywhere in the UK), or both. The second category of RECs are ‘authorised’, which means that they are established under the GAfREC (Governance Arrangements for Research Ethics Committees, which is a guidance document), but are not recognised by UKECA, and therefore cannot review applications relating to a CTIMP. Since 2007, all NHS RECs are subject to an accreditation scheme now managed by the HRA (under its RES). Some RECs also have specialist expertise (known as ‘committee flags’) in areas such as research involving children, research involving prisoners, the establishment of research tissue banks, qualitative research, or research involving adults lacking mental capacity. Proposed research falling within these areas is steered towards RECs that are ‘flagged’ to review such research.

History of and networking between UK RECs

There has been a substantial development in the organisation and networking of RECs over the past few decades to achieve greater consistency and standardisation across the UK.

In 1991, RECs were first formally founded in the NHS, when the Department of Health issued Health Service Guideline (91)5: ‘Local Research Ethics Committees’. This Guideline replaced HSC(IS)153 from 1975 and formally introduced local RECs (LRECs) in England (Scotland and Wales shortly followed suit). This was followed by the establishment of multi-centre RECs (MRECs) in 1997. HSG(97)23 required research studies conducted in the UK that involved four or more LREC geographic localities (i.e. four or more health authority boundaries) to have approval from both a single ‘MREC’ in the country (out of 13 that eventually existed), and the LREC for each participating site.

A Central Office for Research Ethics Committees (COREC) in the whole UK was founded shortly after that (in 2000); COREC’s mission was to improve the system of operation of RECs and to advise the Department of Health on necessary policy requirements concerning their operation.

In March 2001, the Department of Health published the first edition of the Research Governance Framework for Health and Social Care (RGF), which set forth a quality and accountability framework within which research was to be undertaken in the NHS. In June 2001, the Department of Health released its Governance Arrangements for NHS Research Ethics Committees (GAfREC) as guidance to provide a standards framework for the process of review of the ethics of all proposals for research in the NHS. In 2004, version 1.0 of the UK-wide Standard Operating Procedures for Research Ethics Committees (REC SOPs) was produced to meet the obligations of the EU Clinical Trials Directive for the operation of ethics committees in relation to CTIMPs. The RGF, GAfREC and REC SOPs have been revised over the years since their first release.

In April 2007, the National Research Ethics Service (NRES) was established, incorporating both COREC and NHS RECs in England as a means of maintaining a UK-wide regulatory framework for ethical review of research within the NHS.

In 2010, the Proportionate Review Service was introduced across the UK. This ‘PR’ service, as it is called, allows researchers whose studies present ‘no material ethical issues’, as determined by RES staff and REC members via a Proportionate Review sub-committee rather than at a full meeting of a REC, to not have to wait as long for a REC opinion as researchers with more ‘ethically complex’ studies. Indeed, the aim of PR is to deliver the final ethics opinion letter to the applicant within 21 calendar days of receipt of a valid application.

In December 2011, the HRA was created by the UK Government as an interim Special Health Authority. Since transformed into a statutory Non Departmental Public Body, the HRA’s mission is to promote and protect the interests of patients, streamline regulation, and promote transparency in health and social care research. The Care Act 2014 authorises the HRA to recognise, establish, and abolish RECs in England and to ‘ensure’ that these RECs ‘provide an efficient and effective means of assessing the ethics of health and social care research’.

In October 2017, the HRA released a new UK Policy Framework for Health and Social Care Research (‘Policy Framework’). This Policy Framework was published in accordance with the Care Act 2014, which requires the HRA to ‘publish guidance’ on ‘principles of good practice in the management and conduct of health and social care research.’ Symbolising the efforts of the HRA to harmonise the health research regulatory environment across the UK, the Policy Framework replaces separate Research Governance Frameworks that were previously published in each of the four nations. Indeed, as an exercise in joint policy-making and public engagement, the Policy Framework was developed by the HRA and the Health Departments in Northern Ireland, Scotland and Wales, following public consultation.

As regards networking between RECs, the HRA regularly holds training events for REC members. There are also regional REC Chair meetings held twice a year (across regions in England), with invitations extended to RECs in the Devolved Administrations. The UK previously had an independent Association of Research Ethics Committees (AREC), which then became the Association for Research Ethics (AfRE). Self-governed by REC members, it has since been disbanded. No equivalent organisation now exists in the UK.

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