Another threat to research in the United Kingdom

摘要

Medical research in the United Kingdom is under a substantial and immediate threat that was mentioned neither in the editorial on the European Union clinical trials directive nor in Moulton's letter in the same issue. Many research ethics committees may be unable to function fully after 1 May 2004 and may not comply with international regulations. This will be the result both of regulations drafted by the Medicines and Healthcare products Regulatory Agency and of arbitrary decisions taken by the Central Office for Research Ethics Committees. Research ethics committees are not in general worried about the requirements of the European Union directive itself. However, the regulations to implement the directive in the United Kingdom, recently laid before parliament, include several elements of great concern to research ethics committees. Although these concerns were drawn to the attention of the Medicines and Healthcare products Regulatory Agency last year, only one has been dealt with. Originally the regulations were written so as to disbar large categories of people from membership of research ethics committees; the version now before parliament is more sensible.