制药行业的伦理审查。
Ethical review in the pharmaceutical industry.
作者信息
Ramsay L E, Tidd M J, Butler J K, Venning G R
出版信息
Br J Clin Pharmacol. 1977 Feb;4(1):73-6. doi: 10.1111/j.1365-2125.1977.tb00670.x.
Abstract
- There seems no reason why clinical pharmacology studies conducted within the pharmaceutical industry should be exempt from the requirement of ethical review, and independent review in this situation reduces the vulnerability of the company and its employees, in addition to serving its primary function of protecting the volunteer subjects. 2. Experience within one company has shown that independent ethical review need not seriously influence the pace of research. 3. It is important that such committees should be seen to be independent and competent.
摘要
- 制药行业内开展的临床药理学研究似乎没有理由免于伦理审查要求，在这种情况下进行独立审查，除了能发挥保护志愿者受试者的主要作用外，还能降低公司及其员工面临的风险。2. 一家公司的经验表明，独立伦理审查不一定会严重影响研究进度。3. 重要的是，此类委员会应被视为独立且有能力的。
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