Revised Common Rule

For federally funded human subjects research, multi-site/cooperative research is defined as projects that involve more than one institution.  Each institution is responsible for safeguarding the rights and welfare of human subjects at their institution.

Participation in a multi-site research study requires submission to the IRB requesting a Reliance Agreement, (also know has an IRB Authorization Agreement) and allows USC to participate as either the “Reviewing Site” meaning USC will serve as the sIRB for multiple sites, or as a “Relying Site” meaning the USC site will be a participant in a multi-site study and cede IRB review and oversight to an external IRB.

*Effective January 20, 2020 any institution located in the United States that is engaged in multi-site/cooperative research must rely upon approval by a single IRB (sIRB) for that portion of the research that is conducted in the United States.

Studies that are cooperative in nature and were approved prior to January 20, 2020 (other than NIH funded projects) are not affected by the sIRB mandate, and they will continue to be governed by the “pre-2018” humans subjects research regulations.

NIH Policy

The single IRB (sIRB) mandate is an NIH policy that requires certain types of NIH-supported studies involving multiple sites where each site will conduct the same protocol involving non-exempt human subjects research to use a single IRB to accomplish IRB review and approval for all domestic participating sites

NIH Policy on the Use of a Single IRB (sIRB)

NIH Single IRB (sIRB) Resources

NIH sIRB Policy FAQs for Extramural Community
NIH Scenarios to Illustrate the Use of Direct and Indirect Costs for (sIRB)
Fed Register Notice re: Materials To Support NIH Serving as an Institutional Review Board
NIH sIRB  Continuing Review Local Context Worksheet

SMART IRB Learning Center for Investigators and Study Teams

*Exceptions to mandated regulations: research for which any federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context, and research that is governed by state or local laws or regulations (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe.