医疗技术人体试验中受试者的知情同意权

Human subjects’informed consent in medical technology research involving human subjects

自纽伦堡大审判以来,医疗技术人体试验中取得受试者的知情同意已经成为人体试验的首要原则。受试者知情同意权包括知情权和同意权。对缺陷告知而实质上影响到受试者的选择权或未经受试者同意实施的试验行为,不管在人体试验中试验者是否尽到注意义务,由此试验行为造成的损害均由试验者承担。

Since the Nuremberg trials,protection of the informed consent of human subject in medical technology research has become the primary clinical trial principles.The right includes the right to know and the right to consent. Researcher is responsible for the damage caused by the research if defect informing has essentially influenced the subject’s right to choose or the research is taken without consent,regardless of whether the researcher has fulfilled the obligation of care.