Human Research Protection Office (HRPO)

Investigators wishing to engage students on Hennepin Healthcare research involving human subjects must follow HHS requirements: HHRI Research Trainees with HHS – Key Components and Processes

Effectively immediately, send all paper-based materials as electronic documents to: tschmidt@hhrinstitute.org or chanson@hhrinstitute.org

Approval letters and other communications from the IRB will be returned via email.

Revised Common Rule Single IRB Mandate Now in Effect

Effective January 20, 2020, the revised Common Rule requires that research involving human subjects that is conducted by more than one U.S. institution must use a single IRB (sIRB) unless the research meets exemption criteria.  

What does this mean?

Federally-funded research involving more than one U.S.-based institution engaged in non-exempt human research will require the use of a single IRB unless the research meets exception criteria described in §46.114(b)(2). 

What are the exceptions to the Common Rule “cooperative research” provision?

The following research is not subject to this provision:

• Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or
• 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
• Cooperative research conducted or supported by DHHS agencies other than NIH, if an IRB approved the research before January 20, 2020
• Cooperative research conducted or supported by NIH if either:
  • The NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or
  • NIH excepted the research from its single IRB policy before January 20, 2020

What are my options for obtaining sIRB review?

sIRB review may be conducted by a participating site when their IRB agrees to serve as the IRB of record or an independent IRB. The institution submitting the grant application or the federal awarding agency is responsible for selecting an sIRB.

Hennepin Health Research Institute (HHRI) IRB is not currently agreeing to serve as the sIRB for cooperative research. Efforts are currently underway to evaluate and prepare for the HHRI IRB to serve in this capacity; more information will be provided as this process evolves.