The revised Clinical Trials Directive - A threat to emergency care research in Europe?

摘要

The European Parliament is currently debating a revision to the Clinical Trials Directive (2001/20/EC) and Articles 30 and 32 are very relevant for emergency care research {http:llec.mropa.mlhealthlhuman-uselclintcal-trialsltndexjn.htm). It is encouraging to see that emergency care is included in the revision, as there was no provision for emergency research in the previous Directive, leaving individual member states to apply their own variable rules. However as emergency care research is now encompassed within the legislation, it is vital that these Articles are clearly written in a way that enables and facilitates high quality ethical research in emergency care.