Common Rule sIRB Mandate
The revised Common Rule went into effect on January 21 2019, except for the single IRB requirement (sIRB) which becomes effective on January 20, 2020. The single IRB requirement entails that all federally funded, nonexempt, multisite studies must use a single IRB review model. On the single IRB review model, a single IRB of record provides regulatory oversight for an entire multisite study while other engaged domestic institutions cede regulatory review to it.
NOTE: The revised Common Rule sIRB mandate is separate from the NIH single IRB policy, which went into effect in January 2018.
For more information, see the following FAQs:
Does the Common Rule sIRB mandate apply to the federally funded nonexempt multicenter studies already approved by UF IRB?
No. The U.S. Department of Health and Human Services Office of Human Research Protections (which administers the Common Rule) has issued a guidance stating that the sIRB mandate applies only to eligible studies approved on or after January 20, 2020.
How to request UF serving as a reviewing IRB?
Contact IRB at irb@ufl.edu and submit the sIRB request form. You will be contacted by the IRB to schedule a required meeting with the UF Reliance Team. The reliance meetings are held on Tuesdays from 8:30 a.m.–11 a.m. The PI and the lead coordinator must receive confirmation from UF IRB that it will serve as the sIRB for your study before you submit a sIRB application in myIRB.
Does ceding review to another IRB require local submission?
Yes. A ceded project submission is needed in myIRB in order to complete institutional local context review, which is necessary for ceding regulatory review to an external IRB.
More information about the sIRB process, including how to submit an sIRB study or how to cede review to an external IRB can be found at http://irb.ufl.edu/sirb-2.html and http://irb.ufl.edu/wp-content/uploads/Researcher-Manual_FINAL.pdf.
