history of human subjects protections; the laws, processes, and groups that regulate human research; critiques of the current system for protecting human research subjects; sample accreditation programs; and ethical issues surrounding human research.


Due to the fast-track nature of this study, the Institute of Medicine sought to assist the committee in completing its task in a timely manner. For this reason, the IOM funded the completion of a two-year effort by PRIM&R to establish accreditation standards. The resulting standards were intended to assist the committee in its deliberations about accreditation strategies and their strengths and weaknesses.

In addition, in the course of the committee's analysis, the draft standards developed by NCQA under contract with the Department of Veterans Affairs were provided to the committee for inclusion in their assessment of accreditation standards.

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