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Codex of clinical research
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45 CFR 46

From Codex of clinical research

The U.S. Department of Health and Human Services (HHS) regulations for the protection of human subjects in research at 45CFR 46 include five subparts:

  • subpart A, also known as the Common Rule, provides a robust set of protections for research subjects
  • subparts B, C, and D provide additional protections for certain populations in research
  • subpart E provides requirements for IRB registration [1].

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