Multi-Site Study sIRB Review3
Description | Protocol Review Fees4 | Relying Site Fees5,6 |
---|
Initial Review | $2,500 | $1,200 to $3,000 |
Per Year Fees (includes annual update and 2 amendments) | $2,500 | $1,200 to $3,000 |
Additional Fees for multiple site-level amendments | | $500 |
3MU IRB will only serve as the IRB of record for studies where the University is engaged in the research. MU IRB will not serve as the IRB of record for international sites.
4For federally-funded studies, Protocol Review Fees are waived since MU will be a participating site and these fees are covered as part of the indirect costs associated with Facilities and Administration (F&A) rate.
5Consultation required with MU IRB prior to any external sites being added to a new or existing study. Not all sites will meet the criteria necessary to participate and the number of sites allowed will be determined based upon study specific criteria. Fees charged for relying sites include secondary activities which may include negotiating reliance agreements, communicating with the sites about IRB oversight, reviewing site and investigator qualifications, collecting site-specific information, revising and issuing site-specific consent forms, evaluating adverse events and other site-specific updates, and reviewing site-specific information at the time of continuing review. These fees will be dependent upon the study design and site specifics and should be included by the lead site (MU) in the grant budget as direct costs.
6Relying site must have Federalwide Assurance (FWA). MOU required if relying site does not have an IRB.