美国与知情同意有关的一些问题

知情同意是医疗保健和医学研究的一个基本的伦理学要求。这两种情况中，当医学研究的知情同意标准比医疗保健要求更加严格时，知情同意包含了3种要素：（1）告知病人或受试者该研究的性质。包括益处，危险和其他有关内容；（2）确保病人受试者理解所提供的信息；（3）得到病人或受试者自愿的同意，没有能力参与知情同意的病人包括患痴呆和危重病等无决断 能力的病人，这些病人属弱势病人。如要获许对他们的疾病进行研究，我们必须制定保护弱势受试者有效的伦理政策，提出了关于对痴呆病人、危重病人，脑死亡病人研究的伦理学政策。

Some Issues of Informed Consent in the United States

Informed consent is a fundamental ethical requirement for both medical care and medical research.While the standards of informed consent are more strict for research than for medical care in both cases informed consent includes 3 elements:1,informing the patient/subject of the nature of the intervention,including benefits,rishs,and alternatives;2,assuring that the patient/subject understands the information provided;3,obtaining voluntary comsent from the patient/subject.Patients who are unable to participate in informed consent include patients with decisional incapacity from dementia,from critical illness and from brain death.These are vulnerable patients.If research on their disease is to be permitted,we must develop sound ethical policis that protect vulnerable subjects.This paper proposes ethical policies for research on patients with dementia,critical illness,and brain death.