FDA seeks tighter controls over research with human subjects.
作者信息
Hershey N, Miller R D
出版信息
Hosp Med Staff. 1978 Dec;7(12):1-7.
PMID:10239337
Abstract
The Food and Drug Administration and other federal agencies have proposed or adopted regulations for institutions involved in research with human subjects. As a consequence, institutional review boards (IRBs) are becoming a necessity in many hospitals that did not previously need them. Unfortunately, the various requirements, especially those proposed by the FDA, imposed upon IRBs often make compliance for hospitals a complex undertaking.
摘要
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