Staak M
MMW Munch Med Wochenschr. 1979 Apr 13;121(15):513-6.
Human experiment and therapeutic trials are regulated by the drug law and the jurisdiction of the supreme court. The qualification of the trial leader and the personification of his responsibility with reference to indication, performance and evaluation of the trial are just as much criteria of his obligations as the protection--derived from medical ethical motives--of the patient or subject. It would certainly be welcomed if the legal regulations affecting the testing of drugs could simply be transferred to clinical research in humans and dispense with the all too closely meshed regimentation.
人体实验和治疗试验受药品法以及最高法院的管辖权约束。试验负责人的资质以及其在试验的适应症、实施和评估方面责任的具体化,与出于医学伦理动机对患者或受试者的保护一样,都是其义务的标准。如果影响药物测试的法律法规能够简单地适用于人体临床研究,并且无需过于繁琐的严格规定,那肯定是值得欢迎的。