Research Ethics Committees (Hansard, 31 March 2004)

§ Lord Clement-Jones
asked Her Majesty's Government:
How many National Health Service Research Ethics Committees there are; and how many members there are on each committee; and [HL2095]
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What assessment was made of the training needs of Research Ethics Committees' members before a training strategy was finalised; and [HL2099]
Why the Association of Research Ethics Committees was not consulted on—
(a) the training strategy for Research Ethics Committees (REC) members and administrators;

(b) the accreditation system for RECs;

(c) the standard operating procedures for RECs; and

(d) the draft regulations to implement the European Union clinical trials directive; and [HL2100]
What are the service standards for the Central Office for Research Ethics Committees in answering correspondence. [HL2136]

§ The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)
There are 180 National Health Service Research Ethics Committees (RECs) in England, including 10 multi-centre RECs. The numbers of members on each REC have not been recorded centrally. The maximum membership is 18, and committees should have enough members always to meet the quorum of seven.
A training strategy for REC members has yet to be finalised, although training has continued to be made available, through an identified training budget. Discussions and meetings were held with key stakeholders including leading members of the Association of Research Ethics Committees (AREC) and potential training providers. An initial discussion meeting was held in October 2002, to which delegates were invited from RECs in the United Kingdom. A follow-up meeting was held in 2003.
The AREC does not include all ethics committees. Through the Central Office for Research Ethics Committees (COREC), the department seeks to inform and consult all committees when necessary. The main current Department of Health guidance is Governance Arrangements for NHS Research Ethics Committees. The then chair of AREC was closely involved in drafting it. AREC will be consulted when this guidance is revised.
All RECs have been given the opportunity to comment on developments in training at the national and regional level. They were sent information about the proposed scheme for quality assurance and many REC members have volunteered to be assessors. The chair of the Accreditation Working Group is the vice-chair of AREC. A representative working group of REC administrators devised the standard operating procedures with COREC. Comments have been requested. The then Medicines Control Agency consulted on the draft regulations electronically as well as by paper copy. Every REC was consulted, and responses included one from AREC.
The standards of COREC include that correspondence is logged on receipt and distributed to the most appropriate individual for reply, if one is required. If an early reply is not anticipated, then a holding 171WA acknowledgement is arranged. Communication also takes place by telephone, electronic mail and at meetings.

§ Lord Clement-Jones
asked Her Majesty's Government:
How the Central Office for Research Ethics Committees justified the 50-fold increase in manpower for the oversight of Research Ethics Committees since 1996, when the number of such committees has dropped; and [HL2098]
How many people work for the Central Office for Research Ethics Committees, centrally and in the regions; and [HL2096]
When the first regional managers of the Central Office for Research Ethics Committees were appointed; how many are now in post; and how many such appointments there have been in total; and [HL2097]
Whether they have set any limit on the number of staff employed by the Central Office for Research Ethics Committees. [HL2137]

§ Lord Warner
The Central Office for Research Ethics Committees (COREC) provides management, budget and support services for the ethical review system. It was created in 2000 to help National Health Service Research Ethics Committees (RECs) operate consistently within a framework of governance; and to prepare them for operational changes required by Directive 2001/20/EC. It is misleading to compare this with the situation in 1996, when health authorities had responsibility for supporting RECs and funded this work; and an official in the Department of Health maintained information on them for policy purposes.
In COREC there are 13 full-time posts and four part-time posts based centrally, and 11 full-time posts and four part-time posts based regionally. The first of the COREC regional managers was appointed in the autumn of 2002. Nine are in post at present, and one takes up post on 1 April 2004. A total of 13 regional managers have been appointed.
The department decides the annual budget for COREC following discussion with St George's Hospital NHS Trust, which provides COREC under contract. The level of staffing is based on the activities the department requires COREC to carry out during the year in question.

§ Lord Clement-Jones
asked Her Majesty's Government:
What assessment they have made of the proportion of Research Ethics Committee members likely to resign at or soon after 1 May 2004 because:
(a) the indemnity arrangements for their Research Ethics Committee work are inadequate;

(b) their Research Ethics Committee will be barred by the Central Office for Research Ethics Committees from reviewing clinical trials; and

(c) their Research Ethics Committee will no longer be allowed to review research on which any of their members is a named researcher; and [HL2138]
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Why only a minority of Research Ethics Committees will be recognised by the Central Office for Research Ethics Committees to review clinical trials; and [HL2139]
Other than administrative convenience, Research Ethics Committees that serve Phase 1 trial units outside the National Health Service will come within the National Health Service system; and [HL2140]
What assessment they have made of the likely effect on independent phase 1 trial units, and on the number of trials which the Government will be offered by the pharmaceutical industry. if their Research Ethics Committees are required to become part of the National Health Service and work to different timescales. [HL2141]

§ Lord Warner
There is no reason to believe that the indemnity arrangements for National Health Service Research Ethics Committees (RECs) are inadequate. There is no indication of any significant number of resignations for this reason. The Government are not aware of any formal resignations because of the possibility that a committee may not be recognised for clinical trials under the proposed Medicines for Human Use (Clinical Trials) Regulations. Since 2001, it has been Department of Health guidance that it is unacceptable for RECs to review research protocols on which any of their members is a named researcher. Very few members are known to have resigned or not extended their membership because of this potential conflict of interest. Precise numbers are not available.
The Central Office for Research Ethics Committees would not be responsible for recognising ethics committees to review clinical trials under the regulations. This would be the responsibility of the proposed United Kingdom Ethics Committee Authority (UKECA). The number of ethics committees recognised for this purpose will depend on the number, type and location of clinical trials. RECs review many proposals for studies that are not clinical trials under the proposed regulations.
The regulations would require that ethics committees must be recognised by the UKECA before they may review clinical trials under the regulations. Research ethics committees outside the National Health Service will not be required to come within the NHS system if they have an acceptable appointing authority.
The timescales in the proposed regulations will reflect those in Directive 2001/20/EC, which apply to any ethical review of clinical trials under that directive.