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Breadcrumb

  1. HHS
  2. OHRP
  3. Regulations, Policy & Guidance
  4. Regulations
  5. Revision of the Common Rule
  • Belmont Report
  • Regulations
    • 45 CFR 46
      • 2018 Requirements (2018 Common Rule)
      • Exemptions (2018 Requirements)
      • Subpart B
      • Subpart C
      • Subpart D
      • Subpart E
      • List of Expedited Categories (1998)
      • Annotated version of 2018 Requirements
      • Pre-2018 Common Rule
      • Exemptions (Pre-2018 Requirements)
    • Revision of the Common Rule
      • Preamble to the Revised Common Rule (2018 Requirements)
      • Path to Revising the Common Rule (2011–2018)
      • Explanation of Terminology
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    • Pre-2018 Requirements Decision Charts
    • 2018 Requirements Decision Charts
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    • OHRP Guidance on COVID-19
    • OHRP Guidance on Elimination of IRB Review of Research Applications and Proposals
    • OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements
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  • Regulations & Policy Archived Materials

Revision of the Common Rule

The Common Rule was revised and revisions were published in January 2017. The updated provisions, called the 2018 Common Rule or 2018 Revisions, became effective in January 2019. OHRP provides here information on the process of revising the Common Rule, the text of the preamble to the revised Rule, and a detailed explanation of the relevant terminology.

Preamble to the Revised Common Rule (2018 Requirements)

Path to Revising the Common Rule (2011-2018)

Explanation of Terminology

Content created by Office for Human Research Protections (OHRP)
Content last reviewed March 8, 2021
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