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.
Final results of MRC CRASH, A randomised placebo controlled trial of intravenous corticosteroids in adults with head injury-outcomes at 6 months. Crash Trial Collaborators. Lancet2005; 365: 1957–1959.
BeyleveldDPattinsonS. Medical research into emergency treatment: regulatory tensions in England and Wales. Web Journal of Current Legal Issues2006 at http://webjcli.ncl.ac.uk/2006/contents5.html.
10.
Additional protocol to the Convention on Human Rights and Biomedicine, concerning biomedical research 2005 conventions. Available at coe.int/treaty/en/treaties/html/195.htm.
