§ Dr. StarkeyTo ask the Secretary of State for Health what assessment he has made of the compatibility of the operations of multi-centre Research Ethics Committees with the EU Clinical Trials Directive. [84347]
§ Ms JowellThe European Union Clinical Trials Directive is still under negotiation and the text may change. It is therefore not possible to reach a final view of its compatibility with the operations of Research Ethics Committees in the United Kingdom.
§ Dr. StarkeyTo ask the Secretary of State for Health what was the average time taken for ethics committee approval of research and clinical trial proposals in(a) the year before and (b) the period since the introduction of multi-centre research ethics committees. [84345]
§ Ms JowellThe time taken for ethics approval of research and clinical trials is not data which was systematically collected before the introduction of multi-centre research ethics committees. An evaluation of the first full year of operation of multi-centre research ethics committees is currently being analysed and will be available later this year.
§ Dr. StarkeyTo ask the Secretary of State for Health what review the Government have undertaken of the operation of local and multi-centre research ethics committees since their introduction; and what proposals he has to amend their method of operation. [84346]
§ Ms JowellMulti-Centre Research Ethics were introduced in 1997. Based on evolving experience with the operation of Multi-Centre Research Ethics Committees, and the relationship between their work and that of Local Research Ethics Committees, the Department of Health is currently conducting a review of policy and practice with the intention of issuing revised guidance later this year.