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Erschienen in:
01.08.2013 | Editorial
Clinical research into the ICU: clouds at the horizon, once again
Erschienen in: Intensive Care Medicine | Ausgabe 8/2013
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Remember, it was back in 2001: a directive, drafted by the European Commission in Brussels, intended to give all EU Member States the same legislation for clinical trials on medicines [1]. The intent was legitimate, as the situation at that time in European countries was indeed chaotic. A working group of the ESICM published in this journal a striking picture of the diversity of the rules then governing human research [2]. An international working group, initiated by the Vienna School of Clinical Research published several articles describing the difficulties with the regulations of the directive in the practice of emergency and critical care research [3‐5]. However, the European legislators forgot to mention the case of research made in emergency situations, where the patient cannot himself consent and his/her family is not around. Such research, though so necessary, was menaced to soon become unlawful. The directive was transposed in all EU Member States before the end of 2004. The Commission turned a blind eye to countries like France that continued to authorize the waiver or deferral of consent in emergency situations. The UK adopted a similar law in 2005 [6].
Table 1
Article 32 of the proposal
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Directive 2001/20/CE
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Proposal of regulation (EU Commission, July 2012)
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Comments
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No specific provisions for emergency research.
Accordingly, waiver (or deferral) of consent is forbidden
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Article 32
“…informed consent may be obtained after the start of the clinical trial to continue the clinical trial and information on the clinical trial may be given after the start of the clinical trial provided that all of the following conditions are fulfilled:
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A great improvement from directive 2001/20; when the regulation is voted on (and included in national legislations), a clinical trial in emergency situations will be allowed to start without prior consent. Concerns include:
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(a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, it is impossible to obtain prior informed consent from the subject and it is impossible to supply prior information to the subject;
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(a) too restrictive; impossibility to consent may be caused by other conditions, for instance, sedation
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(b) no legal representative is available;
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(b) should a legal representative be put on the spot, he could be unable to grant an informed consent (due to emotional stress or because of a too short window of inclusion; example: cardiac arrest)
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(c) the subject has not previously expressed objections known to the investigator;
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(d) the research relates directly to a medical condition which causes the impossibility to obtain prior informed consent and to supply prior information;
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(d) too restrictive: impossibility to consent could be caused by another (pre-existing) medical condition, like encephalopathy)
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(e) the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject”
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(e) minimal risk research, in the context of this regulation, means research on authorized drugs only
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