You are here

Common Rule

  • The "Common Rule" is the popular term for the Federal (U.S.) Policy for the Protection of Human Subjects, 45 CFR part 46, which outlines the criteria and mechanisms for IRB review of human subjects research.

    • Decision Trees: Exempt Human Subjects Research Decision trees displaying the criteria and potential review paths, including system generated determination,  for exempt categories 1 - 4, 7 & 8 under the 2018 Common Rule. 
    • IRB-HSBS: Key Changes to the Common Rule IRB-HSBS general session presentation (updated 10/12/2017) explaining key changes in the 2018 Common Rule (Regulations for the Protection of Human Subjects ~ 45 CFR 46)
    • IRBMED: Changes to the Common Rule Link to IRBMED's Seminar Series webpage containing two presentations explaining the changes to the 2018 Common Rule.  The presentations differ in content based on information known as of the presentation date.
    • Tip Sheet: Exemption #1 Provides the full definition and explanation of exemption category #1 (educational exemption) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
    • Tip Sheet: Exemption #2 Provides the full definition and explanation of exemption category #2 (surveys, interviews, educational tests, and observations of public behavior exemption) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
    • Tip Sheet: Exemption #3 Provides the full definition and explanation of exemption category #3 (benign behavioral intervention) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.