Informed consent and the investigational use of medical devices: a comparison of common law duties with those imposed on researchers under Section 520(g) of the Medical Device Amendments of 1976.
作者信息
Field Thomas G, Piacenza Dominic S
出版信息
Food Drug Cosmet Law J. 1977 Dec;32(12):585-95.
PMID:11664943
Abstract
摘要
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Informed consent and the investigational use of medical devices: a comparison of common law duties with those imposed on researchers under Section 520(g) of the Medical Device Amendments of 1976.知情同意与医疗器械的研究性使用：普通法义务与1976年《医疗器械修正案》第520(g)条对研究人员规定的义务之比较。
Food Drug Cosmet Law J. 1977 Dec;32(12):585-95.
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Informed consent process and document is criticized in court.知情同意程序和文件在法庭上受到批评。
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The burgeoning law of medical experimentation involving human subjects.涉及人类受试者的医学实验的新兴法律。
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The FDA's final regulations: IRBs and medical devices.美国食品药品监督管理局的最终规定：机构审查委员会与医疗器械
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Drug trials in children: ethical, legal, and practical issues.儿童药物试验：伦理、法律及实际问题
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Research subject loses case against physician, IRB, and hospital.研究对象在针对医生、机构审查委员会和医院的诉讼中败诉。
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Informed consent process is deemed "legally and ethically invalid" by witness.知情同意过程被证人视为“在法律和伦理上无效”。
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8
Considering experimentation and elusive truth: informed consent made difficult.考虑到实验与难以捉摸的真相：知情同意变得困难。
Issues (St Louis Mo). 1992 Mar-Apr;7(2):1-8.
9
Proposal on waiver of informed consent poses major issues for research ethics.关于放弃知情同意的提议给研究伦理带来了重大问题。
Hum Res Rep. 1997 Sep;12(9):1-3.
10
The Senate's definition of voluntary and informed consent: another view.参议院对自愿和知情同意的定义：另一种观点。
IRB. 1980 Jun-Jul;2(6):5-7.
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