Introduction

• The aim of the new system of MRECs and LRECs is to facilitate good quality research in the UK, particularly multi-centre research applications.
• The new system is here to stay (fully operational from l.10.97).
• The system is designed to work in accordance with the International Committee on Harmonisation Good Clinical Practice (ICH GCP) Guidelines, but this does cause some difficulties of interpretation.
• Applications for research, planned to start after lst October 1997 and involving more than 5 UK LRECs, must first be submitted to an MREC.
• The principal investigator of any multi-centre study is responsible for ensuring the MREC application is made.
• The MREC response will be fed back to the principal investigator who is then responsible for ensuring that it accompanies each individual LREC application.
• MRECs and LRECs have different areas of responsibility. The role of the MREC is to ensure a protocol is scientifically valid and ethical. The LREC comments on the suitability of the individual researcher and other local issues (ie is the patient population already ‘over-researched?)
• There is no hierarchy - LRECs do not ‘belong’ to their regional MREC.

Multi-centre Research Ethics Committees (MRECs)

• MRECs now in place and operational are located as follows (l in Scotland, 1 in Wales, 8 in England and none in N. Ireland).
• Although there are 10 MRECs, they should be regarded as one national committee. The regional division is for practical purposes: there is an internal system for channelling applications from one busy MREC to another which is less busy.
• A national operating framework exists for all MRECs. This will encompass common paperwork, including application forms, now available on the Internet (http://dspace.dial.pipex.com/mrec), and including also details of membership of the MRECs and deadlines for submission to each of the Committees.
• How to apply to an MREC? Read the guidance notes carefully; answer all the questions; provide all the supporting material requested; if in doubt, contact the MREC Administrator for advice. How will the application be considered? The MREC Chairman and Statistician, as a minimum, will receive all papers. Other members will receive the application forms.
• Possible outcomes are as follows:
  • Approved
  • Rejected - often because science is too poor to prove the required results.
  • Deferred - substantial amendments and resubmission to MREC required and/or scientific peer review required
  • Approved subject to amendment - minor amendments required which can be dealt with by Chairman’s action.
• Follow up action by the MREC - A questionnaire will be sent to the principal investigator one year after approval. If no response is received, it is possible that ethics approval may be withdrawn.

MRECS - Common Causes of problems:

• There have inevitably been some initial teething problems, which are being ironed out.
• The excessive workload of some MRECs was not anticipated, but steps have been taken to spread the workload.
• Excessively technical terminology; insufficient statistical data provided; inadequate patient information sheet.
• Delays in response from researchers to comments from MRECs.
• Excessive and unhelpful ‘badgering’ of MREC Administrators!

Local Research Ethics Committees (LRECs)

• Responsible for advising the NHS body under the auspices of which the research is intended to take place. But it is possible for an LREC to give approval for a research application, and for the NHS Trust to subsequently refuse to support it.
• LREC concerned with advising that research may go ahead in their geographical area, and advising on local issues, such as suitability of local investigator.
• Once MREC approval has been obtained, the LRECs in every locality concerned, will have the opportunity to accept or reject the proposal for local reasons . They cannot change a protocol, once it has been approved by an MREC.
• LRECs continue to have a key role in reviewing proposals for non-multi-centre research.
• Frequency of LREC meetings may vary from one geographical area to another.

LRECS - Common Causes of problems:

• LREC application form submitted at the same time as the MREC application.
• Insufficient local details.
• No details by local researcher of current/previous research.

N.B. Retrospective MREC approval for multi-centre UK studies, opened pre October 1997, is required only if a new UK centre is subsequently added. There is a possibility that MREC approval may not be given. This should be fed back to other centres already participating.

See also: MREC Web Site

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