Clinical research into the ICU: clouds at the horizon, once again

Abstract

Remember, it was back in 2001: a directive, drafted bythe European Commission in Brussels, intended to giveall EU Member States the same legislation for clinicaltrials on medicines [1]. The intent was legitimate, as thesituation at that time in European countries was indeedchaotic. A working group of the ESICM published in thisjournal a striking picture of the diversity of the rules thengoverning human research [2]. An international workinggroup, initiated by the Vienna School of ClinicalResearch published several articles describing the diffi-culties with the regulations of the directive in the practiceof emergency and critical care research [3–5]. However,the European legislators forgot to mention the case ofresearch made in emergency situations, where the patientcannot himself consent and his/her family is not around.Such research, though so necessary, was menaced to soonbecome unlawful. The directive was transposed in all EUMember States before the end of 2004. The Commissionturned a blind eye to countries like France that continuedto authorize the waiver or deferral of consent in emer-gency situations. The UK adopted a similar law in 2005[6].In July 2012, the EU Commission [7] proposed aregulation which would replace the directive 2001/20.The alleged rationale for revising directive 2001/20 is thatthe implementation of the European legislation hasresulted in useless bureaucracy and finally, in harm toclinical research, which many investigators and sponsorshave denounced. The legal form of a regulation has to beimplemented directly in all national laws with no adap-tation, as opposed to a directive. Regulation has beenchosen by the Commission in order to ensure that therewill be consistency in application across the EU. Themain objective of the proposed regulation is to simplifyand speed up the process of authorization and conductionof clinical trials on medicines. To achieve that, sponsorswill submit their research projects via a European portal,one unique reporting Member State will evaluate thedossier, and a single piece of advice (authorization orrejection) will be issued, no matter the number of ‘‘con-cerned’’ Member States. Approval times will be reduced(?). Ethical review of projects will remain in the MemberStates’ domain and competence. All these provisionssound reasonable.Deferred consent in emergency situations is possible inthe new proposal, as it states that ‘due to the urgency ofthe situation, caused by a sudden life-threatening or othersudden serious medical condition, it is impossible toobtain prior informed consent from the subject and it isimpossible to supply prior information to the subject’.However, there is also a major threat to research con-ducted in emergency situations. While authorizing thestart of such research without initial consent, article 32 ofthe proposal limits the scope of this provision to situationswhere ‘‘the clinical trial poses a minimal risk to, andimposes a minimal burden on, the subject’’ (Table 1). Inthe context of the proposed regulation, it means thatdeferred consent will be accepted only when research willapply to authorized drugs. In other words, emergencyresearch on new and innovative drugs will no longer bepossible, which will constitute a major step backward forthose countries that can today carry out such research.The proposal for a clinical trials regulation is nowunder examination by the European Parliament. The