This Overview summarizes key Common Rule updates pertinent for human subject research investigators and staff. 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. Most changes went into effect on January 21, 2019.
Revised Common Rule
University of Kentucky Office of Research Integrity (ORI) Revised Common Rule Overview
Resources
Federal Policy for the Protection of Human Subjects
University of Kentucky (UK) Office of Research Integrity (ORI) Revised Common Rule Overview
University of Kentucky (UK) Office of Research Integrity (ORI) Informed Consent Resources
University of Kentucky (UK) Office of Research Integrity (ORI) Exemption Categories Tool
Collaborative Institutional Training Initiative (CITI) Final Rule Resources
Office for Human Research Protections (OHRP) Videos & Resources
Office for Human Research Protections (OHRP) Revised Common Rule FAQs
Office for Human Research Protections (OHRP) Companion Q & As About the Revised Common Rule
Public Responsibility in Medicine and Research (PRIM&R) Common Rule Resources