§ Baroness Greengrossasked Her Majesty's Government:
How long it takes on average for the multi-centre research ethics committee to consider cases submitted to it from the date when they are submitted until a decision is made; and whether they have any plans to reduce this timescale; and [HL245]
Whether the multi-centre research ethics committee meets in public; and [HL246]
Why the multi-centre research ethics committee does not take evidence from the applicant in person; and [HL247]
How the multi-centre research ethics committee is regulated; and to whom it is accountable; and [HL248]
Who are the members of the multi-centre research ethics committee; how are they appointed; and for how long they serve; and [HL249]
What is the remit and role of the multi-centre research ethics committee. [HL250]
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)The information requested was not collected centrally prior to the introduction in March 2004 of a new operating system at the Central Office of Research Ethics Committees.
62WAThe average time taken by multi-centre research ethics committees (MREC) to deal with applications submitted in May 2004 was 50 days. Preliminary data for subsequent months show an improvement in this aspect of MREC performance.
Research ethics committees (RECs) meet in private. They need to be able to discuss freely the proposals that come before them which are confidential and frequently contain material which is commercially sensitive, or involves unpublished intellectual property. However, the outcome of the Committee's discussion is in the public domain. Applicants may be invited to attend MREC meetings.
For the purpose of review of clinical trials of medicinal products, the MRECs are recognised by the United Kingdom Ethics Committee Authority, which has approved their standard operating procedures. For other research, the English MRECs operate under the policy published as governance arrangements for NHS research ethics committees (GAfREC) on the Department of Health's website (www.dh.gov.uk). The Central Office of Research Ethics Committees provides operational oversight and management support on behalf of the department. MRECs are independent with regard to their opinion on the ethical standards of the applications they review.
MRECs have a maximum of 18 members, of whom at least one-third must be lay members. The remainder are health professionals (drawn from a variety of disciplines) and other experts. Appointments are made by an open process, compatible with the Nolan standards, as required by department policy laid down in the GAfREC. This includes public advertisement or advertisement through professional networks, as appropriate. Membership of each committee is listed in each MREC's annual report, and applicants are provided with a list of those present at the meeting at which their application was considered.
There are 13 MRECs, of which 11 are in England, two in Scotland and one in Wales. The opinion of any one MREC covers the whole of the United Kingdom.
The remit and role of RECs (including MRECs) is published in full in the GAfREC. In brief, their role is to provide independent advice to participants, researchers, funders, sponsors, employers, care organisations and professionals on the extent to which proposals for research studies comply with recognised ethical standards.
The work of all RECs is currently under review. The review group, chaired by Mr Michael O'Higgin, has been asked to recommend steps to improve the efficient operation of the REC system. building on changes already under way.