Revised Common Rule

[Transition | Resources]

University of Kentucky Office of Research Integrity (ORI)
Revised Common Rule Transition [PDF]

The Federal Policy for the Protection of Human Subjects (commonly referred to as “the Common Rule”), provides ethically based regulations for the review and conduct of human research studies. The Department of Health and Human Services (HHS) Office for Human Research protections (OHRP) issued changes to modernize, strengthen, and streamline the rule in January 2017. However, the rule was amended to delay the effective and compliance dates.  Most changes went into effect on January 21, 2019.

The following outlines the University’s plan for transitioning to the revised rule.  See also ORI's Transition to the Revised Common Rule handout. [PDF]

Pre 2019 versus Revised Common Rule
Existing Protocols
New Protocols
FDA Protocols


[Transition | Resources]

Resources

  • Federal Policy for the Protection of Human Subjects [HTML]
  • University of Kentucky (UK) Office of Research Integrity (ORI) Revised Common Rule Overview [PDF]
  • University of Kentucky (UK) Office of Research Integrity (ORI) Informed Consent Resources [HTML]
  • University of Kentucky (UK) Office of Research Integrity (ORI) Exemption Categories Tool [PDF]
  • Collaborative Institutional Training Initiative (CITI) Revised Common Rule Course UK ORI FAQs [HTML]
  • Collaborative Institutional Training Initiative (CITI) Final Rule Resources [HTML]
  • Office for Human Research Protections (OHRP) Videos & Resources [HTML]
  • Office for Human Research Protections (OHRP) Revised Common Rule FAQs [HTML]
  • Office for Human Research Protections (OHRP)  Companion Q & As About the Revised Common Rule [PDF]
  • Public Responsibility in Medicine and Research (PRIM&R) Common Rule Resources [HTML]