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Policies and Regulations

2018 Revised Common Rule

The 2018 Revised Common Rule went into effect on January 21, 2019. Since that date, all new research that is subject to HHS oversight is reviewed under the 2018 SOPs listed below unless the research is FDA-regulated. The Revised Common Rule Overview and Guidance provides details about the regulatory changes.

Standard Operating Procedures (SOPs) for the 2018 Revised Common Rule

Standard Operating Procedures (SOPs) for studies approved under pre-2018 Common Rule

The four SOPs listed below apply to any FDA regulated studies and to any study approved by the IRB prior to January 2019 when the new common rule came into effect. Any "2018 requirement" SOPs not listed below apply to all studies approved by the IRB.

KUMC Policies Related to Research

Links to Federal Policies and Regulations

Last modified: Jan 07, 2021