sIRB & Multi-site Research

Regulations/Policies about Single IRB (sIRB)

As part of the revised Common Rule and the NIH single IRB mandate, all domestic, federally funded, multi-site research studies are required to use a single IRB.

NIH Policy, effective date January 25, 2018

  • This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research.
  • It does not apply to career development, research training or fellowship awards, foreign sites, VA sites, sites involving tribal nations and noncompeting continuation awards.

Additional Resources for NIH Policy:

Revised Common Rule Regulations, effective date January 20, 2020

  • This policy applies to all domestic sites participating in a federally funded multi-site study following the Common Rule requirements
  • This policy does not apply to:
    • research for which any Federal department or agency supporting or conducting the research determines and documents that the use of the single IRB is not appropriate
    • cooperative research for which more than single IRB review is required by law

Additional Resources for revised Common Rule in relation to sIRB:

 

 

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