European legislation impedes critical care research and fails to protect patients' rights
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European legislation impedes critical care research and fails to protect patients' rights. / Berg, Ronan M G; Møller, Kirsten; Rossel, Peter J Hancke.
I: Critical Care, Bind 15, Nr. 2, 2011, s. 148.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - European legislation impedes critical care research and fails to protect patients' rights
AU - Berg, Ronan M G
AU - Møller, Kirsten
AU - Rossel, Peter J Hancke
PY - 2011
Y1 - 2011
N2 - 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.
AB - 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.
KW - Biomedical Research/ethics
KW - Critical Care/ethics
KW - Humans
KW - Intensive Care Units/ethics
KW - Risk Assessment
U2 - 10.1186/cc10113
DO - 10.1186/cc10113
M3 - Journal article
C2 - 21542880
VL - 15
SP - 148
JO - Critical Care
JF - Critical Care
SN - 1364-8535
IS - 2
ER -
ID: 236993795