The Common Rule (45 CFR Part 46, Subpart A) protects most human subjects involved in federally-funded research. With few exceptions, research institutions subject to the Common Rule must secure informed consent from each human subject, receive approval from an Institutional Review Board (IRB), and submit assurance of compliance with the regulation in writing to the appropriate federal department or agency before research can begin. For a brief overview of the contents of the Common Rule, please read our Fast Facts below.
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