sIRB Fees

Definitions

NIH/Federally funded sIRB study:

A multisite research protocol involving an investigational or FDA approved product and where there is NIH or other federal agency reimbursement to the institution. This does include studies funded by academic medical centers.

Commercial/Industry sponsored sIRB study:

A multisite research protocol involving an investigational or FDA approved product and where there is a commercial/industry sponsor supplying either fixed or per-subject reimbursement to the institution. This does not include studies funded by academic medical centers.

Charge for IRB review

NIH/Federally Funded

• No fees assessed for primary IRB review activities
  • Examples of primary activities include:
    • Initial protocol review
    • Overall protocol modifications
    • Annual continuing review

Commercially/Industry Sponsored

Participating Site (pSite) Review

Participating site review fees apply to all multisite studies with UNMC as the sIRB, regardless of funding type. During the sIRB request consultation, a cost estimate is provided that is calculated based on the anticipated study duration (in years), the number of study sites (excluding the local site), and estimated number of pSite review activities. Actual fees will be assessed from the lead site per pSite per review activity on a rolling basis according to the following schedule:

Please complete the following information:

Responsible Finance Person:

Department:

Identification of Commercial Sponsor:

Method of payment:

Departmental WBS or Cost Center to be billed.

A waiver of the IRB review fee is requested. Provide justification in the text box.