德国与美国关于临床试验的法律比较。

Pediatr Pharmacol (New York). 1983;3(3-4):353-9.

In German and American law, clinical trials require a positive benefit-risk evaluation, free and informed consent, medical and scientific qualification of the doctor, and a written research protocol. American law requires a written consent, which is free of undue influence, the subject being instructed that he is free to withdraw from the trial. In German law, an orally given consent is sufficient for therapeutic trials. With minor or incompetent research subjects, informed consent to therapeutic clinical experimentation has to be given by their parents or guardians, the permissibility of which, in other trials, is controversial. In non-therapeutic trials, blind studies, double-bind studies, and trials involving placebos, special attention has to be paid to the risk-benefit analysis and to informed consent, which in these cases, even in Germany, must be written. The most outstanding feature of American law of clinical trial is that the experimentation is subject to previous control and approval by institutional review boards. The most interesting difference in German law is the investigator's duty to effect an insurance against the risks of the research subject's death or invalidity.

在德国和美国法律中，临床试验需要进行积极的效益风险评估、获得自由且知情的同意、医生具备医学和科学资质以及有书面研究方案。美国法律要求有书面同意书，该同意书不受不当影响，且需告知受试者其可自由退出试验。在德国法律中，对于治疗性试验，口头同意就足够了。对于未成年或无行为能力的研究受试者，其父母或监护人必须给予对治疗性临床试验的知情同意，而在其他试验中，这一点的可允许性存在争议。在非治疗性试验、盲法研究、双盲研究以及涉及安慰剂的试验中，必须特别关注风险效益分析和知情同意，在这些情况下，即使在德国，也必须是书面的。美国临床试验法律最突出的特点是试验需事先得到机构审查委员会的控制和批准。德国法律最有意思的不同之处在于研究者有责任为研究受试者的死亡或残疾风险购买保险。