Objective: To analyse how patients in the acute phase of a myocardial infarct experience the informed consent procedure of a clinical trial. Design: A questio nnaire based follow up survey including patients who gave ...Objective: To analyse how patients in the acute phase of a myocardial infarct experience the informed consent procedure of a clinical trial. Design: A questio nnaire based follow up survey including patients who gave informed consent as we ll as patients who did not consent to the trial. Patients: 103 patients who gave informed consent and 78 who did not consent to the second Danish acute myocardi al infarction trial(DANAMI 2). Results: 76%of the trial participants and 63%o f the nonparticipants agreed or mostly agreed that they felt able to make a deci sion about whether or not to participate in the trial; 50%of the trial particip ants and 34%of the non participants found it acceptable that patients in their situation have to make such a decision. Only 28%of the trial participants and 7%of the non participants read the information sheet before they made the deci sion. Conclusions: Informed consent should be sought in acute myocardial infarct ion trials despite the emergency situation and the medical condition of the pati ents. Patientsself assessed ability to make a decision should be explicitly ad dressed during the informed consent process and patients should not be pressuris ed into decision making. Physicians and research ethics committees should focus specifically on improving the oral information.展开更多
文摘Objective: To analyse how patients in the acute phase of a myocardial infarct experience the informed consent procedure of a clinical trial. Design: A questio nnaire based follow up survey including patients who gave informed consent as we ll as patients who did not consent to the trial. Patients: 103 patients who gave informed consent and 78 who did not consent to the second Danish acute myocardi al infarction trial(DANAMI 2). Results: 76%of the trial participants and 63%o f the nonparticipants agreed or mostly agreed that they felt able to make a deci sion about whether or not to participate in the trial; 50%of the trial particip ants and 34%of the non participants found it acceptable that patients in their situation have to make such a decision. Only 28%of the trial participants and 7%of the non participants read the information sheet before they made the deci sion. Conclusions: Informed consent should be sought in acute myocardial infarct ion trials despite the emergency situation and the medical condition of the pati ents. Patientsself assessed ability to make a decision should be explicitly ad dressed during the informed consent process and patients should not be pressuris ed into decision making. Physicians and research ethics committees should focus specifically on improving the oral information.
