Abstract

In December 2006 there was an amendment to the Medicines for Human Use (Clinical Trials) Regulations 2004, the statutory instrument that translated the European directive into UK law. I will demonstrate how the European directive stifled much needed clinical research in urgent critical states whilst there is an international consensus that research in these situations be allowed. The amendments to the UK Medicines for Human Use (Clinical Trials) Regulations 2004 in allowing such exception have failed to preserve the high degree of respect and protection of the participants' interest as reflected in the spirit of the numerous guidelines, conventions and laws appertaining to the ethics of research in clinical emergencies.