An updated version of our
Memorandum of Understanding with the Medicines and Healthcare products Regulatory Agency (MHRA) and other recognised ethics committees is published today.
Under the Medicines for Human Use (Clinical Trials) Regulations 2004, ethics committees and the licensing authority are required to collaborate by sharing information which is relevant to each other’s responsibilities in relation to clinical trials of investigational medicinal products.
A Memorandum of Understanding (MoU) to achieve this collaboration was first agreed between the Central Office for Research Ethics Committees (COREC, the predecessor to NRES), the
Medicines and Healthcare products Regulatory Agency (MHRA) and the
Gene Therapy Advisory Committee (GTAC) in October 2006. The MoU established a Clinical Trials Collaboration Group to oversee the arrangements. In signing the agreement, NRES acts on behalf of the United Kingdom Ethics Committee Authority (UKECA).
The MoU has improved the regulatory arrangements for medicines trials in the UK by clarifying the roles and responsibilities of each body and enabling ethics committees to raise questions and resolve concerns quickly through communication with the MHRA. The benefits include:
- Avoiding unnecessary duplication in the initial assessment of a trial, simplifying the application process for trial sponsors;
- Providing assurance to ethics committees in areas where they lack expertise;
- Enabling additional information to be brought to the attention of the MHRA where appropriate, ensuring effective regulation of trials and protection of trial subjects.
There are no changes to the underlying principles of the MoU, but it has been revised and updated by the Clinical Trials Collaboration Group to take account of:
- the establishment of AAPEC (see below);
- practical experience, including feedback from ethics committees;
- operational developments, in particular the introduction of the MHRA’s accreditation scheme for Phase 1 trial sites;
- further guidance agreed in 2008 on follow-up to reports of possible non-compliance.
The updated MoU is available
here. An updated version of the
summary of information flows between ethics committees and the MHRA under the MoU is also available as a reference for those involved and others with an interest in the oversight of clinical trials, including trial sponsors and investigators.
The
Appointing Authority for Phase 1 Ethics Committees (AAPEC) has become a party to the MoU. Ethics committees appointed by AAPEC have adopted the NRES Standard Operating Procedures and work within a common framework for ethical review of Phase 1 clinical trials.
The agreement will continue to be kept under review by the Clinical Trials Collaboration Group and updated as necessary in the light of further experience. The Chair of the recently appointed
National Research Ethics Advisors’ Panel, Professor Andrew George, has joined the Group to provide further advice on the role of ethics committees and the information and assurances they require in reviewing clinical trials.
