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
植入前遗传学诊断(Preimplantation Genetic D iagnosis PGD)是辅助生育技术与分子生物学技术相结合而发展的孕前遗传学诊断技术,在植入子宫前淘汰了遗传异常的胚胎,是产前诊断技术的重大进展。但是,由于技术本身存在着一定局限性和不...植入前遗传学诊断(Preimplantation Genetic D iagnosis PGD)是辅助生育技术与分子生物学技术相结合而发展的孕前遗传学诊断技术,在植入子宫前淘汰了遗传异常的胚胎,是产前诊断技术的重大进展。但是,由于技术本身存在着一定局限性和不确定性,同时,受到病人认知能力等因素的影响,由此引发了系列伦理学争议。在进行PGD前,一个明了、详尽的患者知情同意过程是必须的。包括通俗全面告知PGD有关信息、手术和检测的局限性和可能结果;充分告知通过PGD所获得的利益和风险。在此基础上针对不同的遗传病检测签署详细的书面知情同意书。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.
文摘植入前遗传学诊断(Preimplantation Genetic D iagnosis PGD)是辅助生育技术与分子生物学技术相结合而发展的孕前遗传学诊断技术,在植入子宫前淘汰了遗传异常的胚胎,是产前诊断技术的重大进展。但是,由于技术本身存在着一定局限性和不确定性,同时,受到病人认知能力等因素的影响,由此引发了系列伦理学争议。在进行PGD前,一个明了、详尽的患者知情同意过程是必须的。包括通俗全面告知PGD有关信息、手术和检测的局限性和可能结果;充分告知通过PGD所获得的利益和风险。在此基础上针对不同的遗传病检测签署详细的书面知情同意书。
