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Correspondence
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Volume 346:2093-2095 June 27, 2002 Number 26
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Protecting Research Subjects

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 by Steinbrook, R.
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To the Editor: The Health Policy Report by Steinbrook on the crisis at Johns Hopkins (Feb. 28 issue)1 skirts the key issues. There were 2600 protocols that required re-review as part of the corrective plan, as indicated in the article, but there is no indication of the total number of studies that were stopped when the Food and Drug Administration (FDA) intervened. Clearly, more research was affected. It was noted that the institutional review board (IRB) was criticized because it had to consider 800 new protocols — presumably its workload for a year — in addition to its annual reviews. . . . [Full Text of this Article]




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