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从临床医生角度看临床试验中的法律责任

[Legal liability in clinical trials from the viewpoint of the clinician].

作者信息

Luft F C

机构信息

Franz-Volhard-Klinik, Klinikum Berlin-Buch.

出版信息

Z Arztl Fortbild (Jena). 1995 Nov;89(6):646-8; discussion 649-52.

PMID:8588439
Abstract

After a long-term work in the U.S., the liability for clinical trials is explained. The researching physician carries the responsibility for new drugs. He has to apply for the license for the study by the appropriate authority and he carries the responsibility for the consent of the volunteers which have to be informed before the trial. The studies initiated by the pharmaceutical companies relieve the researching physician from some of the responsibilities. They exert a strong control during the drug tests. The researching physician has the responsibility as a "scholarly mediator". The ethic commission inspects all stages of the study.

摘要

在美国长期工作之后,对临床试验的责任进行了解释。研究医生对新药负有责任。他必须向相关当局申请研究许可,并且对志愿者的同意负责,志愿者必须在试验前被告知相关情况。制药公司发起的研究使研究医生免除了一些责任。他们在药物测试期间进行严格控制。研究医生作为“学术调解人”负有责任。伦理委员会会检查研究的各个阶段。

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