NIH

All sites participating in multi-site studies funded by NIH must use a single IRB to review these studies. The NIH single IRB policy became effective in January 2018. This policy applies to the domestic (not international) sites where each site will conduct the same protocol involving non-exempt human research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training or fellowship awards.

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Common Rule

The revised Common Rule – the primary federal regulations governing human subjects research – now requires that federally funded, multisite studies that are not exempt use a single IRB review model. Studies to which the sIRB mandate applies are:

• Not exempt
• Federally funded
• Multisite, defined as sites engaged in non-exempt human subjects research within the United States; and
• Not otherwise legally prohibited from using a single IRB.