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 known as 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. USC IRB will act as the single IRB (sIRB) for full board multi-site studies of no more than 5 participating sites (including USC) due to limited resources.
*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.
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 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.