NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This project, N01-OD-4-2139, Task Order No. 80, received support from the evaluation set-aside Section 513, Public Health Service Act. The U.S. Department of Health and Human Services provided this support, with additional support provided by the Greenwall Foundation. The views presented in this report are those of the Institute of Medicine Committee on Assessing the System for Protecting Human Research Subjects and are not necessarily those of the funding agencies.

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