[药物试验中的法律责任]
[Legal liability in drug trials].
作者信息
Frölich J C
机构信息
Institut für Klinische Pharmakologie, Medizinische Hochschule Hannover.
出版信息
Z Arztl Fortbild (Jena). 1995 Nov;89(6):641-6.
PMID:8588438
Abstract
Studies on humans are carried out in all nations with scientific trials. These studies are concerned with all kinds of goals, i.e. pharmacological treatment procedures. This necessitates clinical and pharmaceutical testing on healthy volunteers or patients. Lawyers watch over the activities of the clinical drug testing. The participation on human tests requires voluntariness and information. The documentation of the voluntariness and the information about goals, methods, and risks are very important.
摘要
所有国家都通过科学试验对人类进行研究。这些研究涉及各种目标，即药物治疗程序。这就需要对健康志愿者或患者进行临床和药物测试。律师监督临床药物测试活动。参与人体测试需要自愿性和知情权。记录自愿性以及有关目标、方法和风险的信息非常重要。
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