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  1. Clinical Trials and Human Subject Protection

HSP/BIMO Initiative

Reports accessible from this site provide updates on the Human Subject Protection (HSP)/Bioresearch Monitoring (BIMO) Initiative.  Launched in 2006 as a part of the Critical Path Initiative, the HSP/BIMO Initiative is aimed at modernizing and strengthening the agency's oversight and protection of subjects in clinical trials and the integrity of resulting data. The HSP/BIMO Initiative encompasses all FDA-regulated clinical trials, that is, those related to human drugs and biological drug products, devices, foods, and veterinary medicine. The overarching goals of the agency's BIMO program are to protect the rights, safety, and welfare of subjects involved in FDA-regulated clinical trials; to determine the accuracy and reliability of clinical trial data submitted to FDA in support of research or marketing applications; and to assess compliance with FDA's regulations governing the conduct of clinical trials, including those for informed consent and ethical review.

HSP/BIMO Initiative Accomplishments

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