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Single IRB Review for Multi-Site Research

The ¹ú²ú¶ÌÊÓƵ (USF) Institutional Review Board (IRB) is ready to serve as an sIRB for federally-funded human subjects research. The ¹ú²ú¶ÌÊÓƵIRB will charge for sIRB services and will provide you with a quote that must be included in your budget proposal. The IRB charges a flat rate based on a number of study factors, so you know exactly what the cost of sIRB review services will be for the life of the project. sIRB fees are not subject to the University’s indirect cost rate and must be budgeted as a direct cost.

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Request a Budget Quote

Submit a request for a budget quote (email). In your request, make sure to include the project title, funding agency, funding period, a copy of the draft proposal and the names of the other sites along with their PIs. The ¹ú²ú¶ÌÊÓƵIRB will respond in 2 business days or less.

NOTE: A quote does not represent a payment statement. Separate statements will be sent in order to receive payment at specified time points.

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When do the sIRB fees apply?

sIRB fees will be charged for all federally-funded studies for which the lead PI works for USF. The ¹ú²ú¶ÌÊÓƵsite will not be charged for IRB review as this cost is included in the university’s indirect cost rate.

How does the ¹ú²ú¶ÌÊÓƵIRB calculate sIRB fees?

The ¹ú²ú¶ÌÊÓƵ sIRB fee for each study is calculated based on the following factors:

Number of years the study will be open. The longer a study is open, the more sIRB review effort is needed. This results in a higher fee for service.

Number of participating research sites that need sIRB review. The more sites involved, the more sIRB review effort is needed. This results in a higher fee for service.

Level of risk of the protocol. Greater than minimal risk protocols require more sIRB review effort. These studies generally have longer consent documents, and more study procedures.  This contributes to the increase in sIRB review effort and higher fee for service.

The ¹ú²ú¶ÌÊÓƵIRB does not charge an itemized, per-submission fee based on the number of documents a study uses, the number of amendments submitted, or the number of continuing reviews. We charge a flat rate each year based on whether your study is interventional or non-interventional and the median amount of sIRB effort needed for such a study. If you use more than the median amount of effort, we will not charge you more. Additionally, we review all reportable problems and events free of charge.

What does the sIRB review fee cover?

Reliance Consultation & Confirmation Services

• Reliance agreement negotiation with each site
• Communication and coordination with the Human Research Programs (HRPs) at each site
• Reliance documentation procurement

 Initial Site Review

• Site-specific protocol and supporting documents review
• Site-specific informed consent review (unlimited number of documents)
• Recruitment material review (unlimited number of documents)
• Site-specific community and institutional considerations

 Ongoing sIRB Review

• Amendment reviews (unlimited number of amendments)
• Continuing/annual reviews
• Reportable problem and event reviews
• Regulatory auditing/monitoring for certain participating sites (see additional information below)

What is NOT covered by the sIRB review fee?

Regulatory Auditing/Monitoring – Travel Costs

The ¹ú²ú¶ÌÊÓƵQA/QI program provides comprehensive regulatory audit/monitoring services for sites that are not AAHRPP accredited or do not have a local auditing program. If the ¹ú²ú¶ÌÊÓƵQA/QI team must travel to a site to conduct auditing or monitoring, the ¹ú²ú¶ÌÊÓƵPrincipal Investigator (lead PI) is responsible for covering the costs of travel.

How is the sIRB fee billed?

The ¹ú²ú¶ÌÊÓƵIRB will send payment requests to the ¹ú²ú¶ÌÊÓƵlead PI’s department. sIRB fees for all participating sites will be paid from the lead PI’s budget. Individual payment requests will not be sent to each participating site PI.

The initial payment will be requested within 30 days after approval of the first participating site. After a study is approved, an annual fee will be assessed for the lifetime of the study to cover services provided in the previous year.