European legislation impedes critical care research and fails to protect patients rights.docVIP

Berg et al. Critical Care 2011,15:148 /content/15/2/148 COMMENTARY European legislation impedes critical care research and fails to protect patients’ rights Ronan MG Berg* , Kirsten M?ller and Peter J Hancke Rossel 1 1,2 3 stressful situation, absence of duress cannot be pre- Abstract supposed, either with regard to a patient’s or a relative’s (proxy) consent. In contrast to the most recent revision of the Declaration of Helsinki [2], the European Directive o? ers no means of exemption from this requirement [1]. us, while the requirement of informed consent hampers clinical trials on potentially life-saving drugs in critical care settings [3], it does not protect the patient’s rights in this context. 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 speci?cally designed to bene?t 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 re