UK - RECs and Medical Research

History

RECs in the UK were first established in the UK National Health Service (NHS) in the mid-1960's. At this time the system was purely voluntary. Now, there are two kinds of RECs: Local Research Ethics Committees (LRECs) and Multi-centre Research Ethics Committees (MRECs). The LREC system was organised initially by Department of Health Guidance in 1991 in England and Wales and in 1992 in Scotland. The MREC system was created in 1997. LRECs are responsible for reviewing protocols conducted in their own area and MRECs are responsible of reviewing protocols held in more than four locations.

There were further regulations (see below) issued in 2002 that were the first to give explicit statutory duties to RECs. The ethical review system of clinical trials was further regulated in 2004 by the Medicines for Human Use (Clinical Trials) Regulations 2004 which implemented Directive 2001/20. This created the United Kingdom Ethics Committee Authority (UKECA) to authorise and oversee RECs. In practice, this function is carried out by the Central Office for Research Ethics Committees (COREC) in England and by the relevant Ministers in Scotland, Wales & Northern Ireland. COREC issued new Standard Operating Procedures for RECs in 2004. For clinical trials permission is also required from the Medicines and Healthcare Products Regulatory Agency (MHRA).

-Standard Operating Procedures for RECs, COREC, 2004
-Governance Arrangements for NHS Research Ethics Committees (GAFREC), 2001
-Research Governance Framework for Health and Social Care (RGF), Department of Health, 2001.
-Health Service Regulations 2002
-Adults with Incapacity Regulations 2002 (Scotland).

Other RECs can be found in particular agencies, such as the Medical Research Council, UK Universities and the pharmaceutical industry. These organisations created their own REC in order to review their own research protocols.

Summary of UK RECs

Type of REC	LRECs	MRECs	RECs of particular Organisations
Where situated?	NHS	NHS	Medical Research Council UK Universities Pharmaceutical industry
Who applies to them?	Researchers	Researchers	Researchers from the institute where the committee is situated
Formal/Informal	Formal	Formal	Informal
National/Regional	Local	Regional	Local
Laws Involved (see below)	Health Service Regulations 2002 Adults with Incapacity Regulations 2002 (Scotland) Medicines for Human Use (Clinicla Trials) Regulations 2004	Health Service Regulations 2002 Adults with Incapacity Regulations 2002 (Scotland) Medicines for Human Use (Clinical Trials) Regulations 2004	-
Guidance Involved	Governance Arrangements for NHS Research Ethics Committees Research Governance Framework for Health and Social Care Standing Operating Procedures for Research Ethics Committees	Governance Arrangements for NHS Research Ethics Committees Research Governance Framework for Health and Social Care Standing Operating Procedures for Research Ethics Committees	-
Membership requirements	Except in Scotland: <18 Members of which one third must be lay members with the remainder being expert members. In Scotland: <18 Members including doctors, a nurse, a pharmacist, a clinical pharmacologist, a person with experience in the treatment of adults with incapacity & 3 lay members.	Except in Scotland: <18 Members of which one third must be lay members with the remainder being expert members. In Scotland: <18 Members including doctors, a nurse, a pharmacist, a clinical pharmacologist, a person with experience in the treatment of adults with incapacity & 3 lay members.	-
Responsible/accountable to whom?	To the UKECA or the body they have nominated e.g. COREC in England	To the UKECA or the body they have nominated e.g. COREC in England	-
Approval or Advisory powers	Approval	Approval

Not submitting research or failing to follow review

Under the2004 regulations, penalties are provided: fine or imprisonment.

Which body, if not the REC itself takes this action, and how do they proceed?

Penalties will be enforced through the UKECA, not the REC.

Impact of Directive 2001/20 EC

The UK has implemented Directive 2001/20/EC through the Medicines for Human Use (Clinical Trials) Regulations 2004. These were passed by the UK Parliament on 1 April 2004 and entered into force on 1 May 2004. They include several sections concerning REC practice.

This law will only cover trials involving medicinal products for human use. It will not not cover trials using medicinal devices or non-interventional trials. The Department of Health, however, has said that they will regard these regulations as covering all REC review.

Legal action that can be taken against RECs

RECs could be subject to actions in public law, EC law and under the Human Rights Act but for the time being, there is no UK case in either public or private law where an REC has been brought to Court because of a decision it has made. From the Department of Health's perspective, RECs are not liable for their decisions and are not provided with legal assistance in making their decisions.
UKECA will not be responsible for the RECs decisions because it will not have day-to-day responsibilities for REC activities.
The responsibility of RECs also seems difficult to find under common law.

Links section

Laws & Regulations

Institutions

Department of Health Guidelines

Standing Operating Procedures for Research Ethics Committees in the UK, 2004
Governance Arrangements for NHS Research Ethics Committees (GAFREC) (England), 2001
Governance Arrangments for NHS Research Ethics Committees in Scotland (GAFREC Scotland), 2001
Research Governance Framework for Health and Social Care (RGF) (England), 2001
Research Governance Framework for Health and Social Care (Scotland), 2001
Research Governance Framework for Health and Social Care (Wales), 2001
Northern Ireland Framework (currently under consultation)
Local Research Ethics Committees 1991