title: European legislation impedes critical care research and fails to protect patients' rights.
abstract: The European Clinical Trials Directive requires an informed consent from the patient or a proxy in drug trials. Although informed consent is a valuable tool to protect patients' rights in clinical trials, this requirement largely impedes research in critical care settings, and if pursued in this context, it does not provide the patient with adequate protection. Instead of insisting on informed consent, we suggest that the focus should be shifted towards two other ethically relevant elements in human experimentation: risk assessment and selection of research subjects. When reviewing protocols in which a waiver of consent is deemed necessary, the Ethical Review Board should ensure that non-therapeutic risks are minimal, that the research is specifically designed to benefit critically ill patients, and that it cannot be conducted under circumstances where an informed consent can be obtained. If the European Directive is changed accordingly, this permits clinical trials in critical care settings, while adequate protection from risky non-therapeutic procedures is ensured and exploitation of the patient as an easily accessible research subject is prevented.
authors.affiliation: Centre of Inflammation and Metabolism, Department of Infectious Diseases, Rigshospitalet, 2100 Copenhagen Ø, Denmark. ronan@dadlnet.dk
authors.forename: Ronan M G
authors.initials: RM
authors.lastname: Berg
authors.forename: Kirsten
authors.initials: K
authors.lastname: Møller
authors.forename: Peter J Hancke
authors.initials: PJ
authors.lastname: Rossel
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D003422:Critical Care / Q000941:ethics*; D006801:Humans; D007362:Intensive Care Units / Q000941:ethics*; D018570:Risk Assessment