Morgans Amee
Department of Community Based Emergency Health and Paramedic Practice, Monash University.
Monash Bioeth Rev. 2010 Mar;29(1):07.1-16. doi: 10.1007/BF03351323.
Informed consent is a vital part of ethical research. In emergency health care research environments such as ambulance services and emergency departments, it is sometimes necessary to conduct trial interventions or observations without patient consent. At times where treatment is time critical, it may be impossible or inappropriate to seek consent from next of kin. Emergency medicine is one of the few areas where the process of informed consent can be waived to allow research to proceed without patient consent. This article will explore the ethics of informed consent in the prehospital emergency research context. This will include an overview of current Australian guidelines for ethical research, and recent changes in law internationally which have affected the conduct of international emergency health research. An overview of the ethical reasoning behind the waiver of informed consent in emergency research is presented, also addressing issues relating to emergency health research such as proxy consent, unconscious patients, and patient decision making capacity. The unusual circumstances encountered in the prehospital ambulance environment will also be discussed, including the dependent and coercive relationship between patients and ambulance professionals, and a lack of alternatives for care and transport for patients who refuse consent. The conflict arising from differences in medical culture and values between patients and health care professionals will also briefly be discussed. It will be argued that, while emergency care research should not require informed consent due to the restrictions of time and dependent nature of the relationship between patient and health professional, emergency health researchers still have a responsibility to consider the patients' perspective when considering the ethical issues of an emergency research project, particularly in the prehospital environment.
知情同意是伦理研究的重要组成部分。在诸如救护车服务和急诊科等紧急医疗研究环境中,有时有必要在未经患者同意的情况下进行试验干预或观察。在治疗时间紧迫的情况下,可能无法或不适宜寻求近亲的同意。急诊医学是少数几个可以免除知情同意程序以允许在未经患者同意的情况下进行研究的领域之一。本文将探讨院前急诊研究背景下知情同意的伦理问题。这将包括对澳大利亚当前伦理研究指南的概述,以及国际上影响国际紧急卫生研究开展的法律近期变化。介绍了急诊研究中免除知情同意背后的伦理推理,还讨论了与紧急卫生研究相关的问题,如代理同意、无意识患者以及患者的决策能力。还将讨论院前救护车环境中遇到的特殊情况,包括患者与救护车专业人员之间的依赖和强制关系,以及拒绝同意的患者缺乏护理和运输替代方案的情况。还将简要讨论患者与医疗保健专业人员之间医疗文化和价值观差异所产生的冲突。有人认为,虽然由于时间限制以及患者与医疗专业人员关系的依赖性质,急诊护理研究不应要求知情同意,但急诊卫生研究人员在考虑急诊研究项目的伦理问题时,尤其是在院前环境中,仍有责任考虑患者的观点。