Proposed revisions to the EU clinical trials directive--comments from the European Resuscitation Council.

An editorial written by Fritz Stertz et al. in 2002 and pubished in this journal was one of the first to highlight concerns bout the introduction of a new European Union (EU) clinical trils directive (Clinical Trials Directive 2001/20/EC) particularly for esearch in emergency settings.1 The directive sought “to simplify nd harmonize the administrative provisions governing clinical rials in the European Community, by establishing a clear, transarent procedure for conducting studies involving investigational edicinal products”. It is widely acknowledged that the Directive rought inunnecessary administrative and regulatoryburdens. The nflexibility of the Directive led to individual countries creating ocal legislation in an attempt to facilitate emergency research, hich increasedvariationbetweencountries, andaddeddelays and ncreased costs for researchers.2 A group of clinicians, ethicists and awyers (the ‘Vienna Initiative to save European Research’ (VISEAR) nvestigators) produced a consensus document to promote a unied approach to local legislation,3 although the recommendations ere never fully implemented. The EU announced its intent to revise the Clinical Trials Direcive 2001/20/EC in July 2012.4 The consultation paper draws pecific attention to research in patients without capacity statng: “Regarding clinical trials in emergency situations, Directive 001/20/EC does so far not address the specific situation where, ecause of the urgency of the situation, it is impossible to obtain ree and informed consent from the subject or the legal repreentative (‘clinical trials in emergency situations’). To address this, pecific provisions on clinical trials in emergency situations have een added in linewith existing international guidance documents n this issue.”