The revised Common Rule – the primary federal regulations governing human subjects research – includes a requirement for all federally funded, multisite studies that are not exempt to use a single IRB review model. This means that those studies subject to the sIRB mandate must use a single IRB of record to provide IRB oversight for their study. NOTE: The revised Common Rule sIRB mandate is separate from the NIH single IRB policy, which went into effect in January 2018.
The revised Common Rule’s sIRB mandate is effective January 20, 2020.
Studies to which the sIRB mandate applies are:
Beginning July 1, 2019 and through the remainder of 2019, the Reliance Team (email@example.com) will begin monitoring new initial review applications in ARROW to proactively identify those which may be subject to the sIRB mandate. This outreach is being offered as a service to researchers who may not yet be aware of the sIRB mandate and its potential impact on their studies.
Using reporting from ARROW and/or the submission triage process, the Reliance Team will review federally-funded, non-exempt initial review applications to identify whether the study may fall under the sIRB mandate. This review may occur while an application is still in pre-submission or scientific review in an effort to reach out to study teams as soon as possible in the review process. The Reliance Team will also be conducting workshops and educational outreach for the remainder of 2019 to ensure the research community is aware of the sIRB mandate as well as how the Reliance Team can be of assistance.
In early 2020, a notice will be added to ARROW to alert study teams that the sIRB mandate is in effect and to consult with the Reliance Team regarding any single IRB review issues before submitting the application.
The Office of Human Research Protections (which administers the Common Rule) has indicated that sIRB mandate will apply to studies approved after January 21, 2019. While OHRP’s advice may evolve before January 2020, UW-Madison will be taking a proactive stance and work to bring affected studies into compliance with the mandate as soon as possible. This will help ensure that researchers will experience minimal disruption as the sIRB mandate comes into full effect.
If the sIRB mandate applies to your study, a single reviewing IRB will need to be identified and all sites involved in the study will need to cede IRB review that IRB. This may impact the kind of application you need to submit to a UW-Madison IRB as well as how long it may take to get IRB approval for all study sites.
The Reliance Team (firstname.lastname@example.org) is here to help researchers with any questions they may have regarding single IRB review and reliance agreements.