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Common Rule (45 Cfr 46)

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The Common Rule, also known as 45 CFR 46, is a set of regulations that govern research involving human subjects conducted or supported by the U.S. Department of Health and Human Services.

Key Features

  • Protection of human subjects
  • Informed consent
  • IRB (Institutional Review Board) oversight
  • Risk assessment and minimization

Pros

  • Ensures the protection of human subjects in research
  • Requires informed consent from participants
  • Sets standards for ethical research conduct

Cons

  • Can be burdensome for researchers to navigate and comply with all requirements
  • Some critics argue that the regulations can be overly restrictive and hinder certain types of research

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Last updated: Wed, Apr 1, 2026, 09:03:25 AM UTC