Intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock: Design and rationale of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial.
“Because most of the patients will not be able to provide full informed consent before randomization, an individualized informed consent process covering 4 different scenarios has been validated and approved by the central ethical committee at the University of Leipzig, Germany, and also all local ethical committees. If the patient is not able to provide informed consent, 2 independent physicians assess the assumed patient's will (if possible by additional contact of relatives). In patients with limited ability to provide consent, a short version, and in patients with full capacity to consent, a long version of the informed consent will be used. If an initially impaired patient recovers, it is required to obtain the long version of informed consent retrospectively.”