In 1985, all aspects of the performance of the Clinical Center were investigated by a distinguished team of nongovernment scientists and administrators. The committee urged that all protocols take full advantage of the special resources available at the NIH, avoiding studies that could be done as well or better elsewhere. The review group recommended applying four criteria to all protocols:
These criteria have merit, and the PI should strive to make the protocol plan consistent with them. The ultimate goal, however, is conducting high-quality, ethical, human-subjects research – a tightly designed protocol that accrues the correct number of patients (no more and no less) to answer a scientifically important question.
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