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  • Title: FDA seeks tighter controls over research with human subjects.
    Author: Hershey N, Miller RD.
    Journal: Hosp Med Staff; 1978 Dec; 7(12):1-7. PubMed ID: 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.
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