Implementing the New Common Rule's Single IRB (sIRB) Mandate
WHAT IS THE REVISED COMMON RULE’S SIRB MANDATE?
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.
WHEN WILL THE SIRB MANDATE GO INTO EFFECT?
The revised Common Rule’s sIRB mandate is effective January 20, 2020.
WHAT STUDIES WILL BE SUBJECT TO THE SIRB MANDATE?
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.
WHEN WILL THE IRBS BEGIN IMPLEMENTING THE SIRB MANDATE?
Beginning July 1, 2019 and through the remainder of 2019, the IRBs 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.
HOW WILL THE SIRB MANDATE BE IMPLEMENTED FOR NEW STUDIES UNTIL JANUARY 2020?
Using reporting from ARROW and/or the submission triage process, the IRBs 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.
HOW WILL THE SIRB MANDATE BE IMPLEMENTED FOR NEW STUDIES AFTER THE JANUARY 20, 2020?
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 IRB regarding any single IRB review issues before submitting the application.
HOW WILL THE SIRB MANDATE APPLY TO STUDIES ALREADY APPROVED BY THE IRB?
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.
HOW WILL STUDY TEAMS BE NOTIFIED THAT THEIR APPLICATION MAY BE SUBJECT TO THE SIRB MANDATE?
- During the remainder of 2019, the IRBs will reach out by email to those study teams whose applications for new studies may fall under the sIRB mandate.
- After January 2020, study teams will see a notice in ARROW letting them know the sIRB mandate is in effect and to contact the IRB for assistance with any sIRB questions or concerns.
IF THE SIRB MANDATE APPLIES, HOW WILL IT AFFECT MY STUDY?
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.
HOW CAN STUDY TEAMS GET MORE INFORMATION ABOUT SINGLE IRB REVIEW?
The ED/SBS IRB (firstname.lastname@example.org) is here to help researchers with any questions they may have regarding single IRB review and reliance agreements. Study teams can also review the UW-Madison Single IRB Review Matrix, which outlines options available to UW-Madison researchers for identifying an appropriate sIRB for multi-site or collaborative research projects.