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Fee for Industry Sponsored IRB Review

On July 1, 2009, the University of Cincinnati IRB Office will use the following fee structure for protocols that are industry sponsored with funding held external to the University of Cincinnati and submitted on or after this date.  Studies approved prior to July 1, 2009 will not be subject to the new fees for the first 2 years of the study (i.e. if/when the study goes up for the 2^nd progress report it will incur all of the relevant new fees but not prior) and the charges will only apply to industry sponsored research. 

The UC IRB Office charges fees to cover the costs associated with the IRB Board’s review and related administrative responsibilities.  Fees do not influence the decisions made by the Board. 

The following fee schedule for industry sponsored protocols is as follows: 

Initial Review of the Research Fee:*  Initial review encompasses the review of the research protocol, qualifications of the investigator, associated consent forms, protocol-related advertisements, questionnaires, screening scripts, and other submitted materials.….$2,000

Fast-track review of Initial IRB protocol submission:…..$5,000

Fast-track review requires: a) evidence from the sponsor indicating deadline/closure date for enrollment; b) evidence that approval delay would cause inability to enroll appropriate subjects for special requirement of a clinical trial; c) evidence of competitive enrollment by the sponsor.  Other requirements for fast-track review can be obtained by contacting the IRB office:  (513) 558-5259. Fast track will go before the board within 2 weeks of the office receiving and accepting  ALL of the required documents and signatures.

Continuing Review Fee: IRBs must review ongoing research at least annually and that review must be substantive and at least comparable to the initial review.  The protocol is reviewed on an annual basis, or more frequently as directed by the Board....$1,000

Changes to Research Fee:  Modifications to research such as protocol amendments, revised protocols, updates to consent forms, and new recruitment or retention materials, change of principal investigator or Co-Principal Investigator incur a Changes to Research fee.  The change in research fee applies each time Board review and preparation of regulatory documentation is required for a research site.…$250

There is no charge for administrative modifications (i.e., study personnel changes, or site additions) or submission of reportable events (i.e., unanticipated problems, adverse event/serious adverse event, protocol deviation)

*Review of an expired protocol will be reviewed as an initial protocol, these protocols can be submitted for Fast-Track review but will incur all associated fees.