Cost of Single IRB Review

Two costs to consider

IRB Review Fees

The costs for IRB review of research conducted at a single institution by that institution’s IRB have typically been considered an indirect cost covered under an institution’s Facilities and Administration (F&A) rate (except for industry-initiated-and-sponsored studies). However, many institutions who will serve as single IRBs (sIRBs) will charge fees to review other sites. Additionally, fees charged by independent IRBs, such as WCG IRB or Advarra, will not be paid for by the institution. The fees are the responsibility of the lead site and should be included in the grant budget as direct costs. This is a new responsibility.

Additional Study Personnel

The lead site will have additional responsibilities for coordinating sIRB review and requirements throughout the life of the study which may require additional staffing resources.

Which IRBs charge fees for serving as a single IRB?

Each IRB determines whether or not it will charge study-specific fees. In general:

• An IRB operated by a federal agency will not charge fees
• An “independent” IRB (e.g., WCG IRB, Advarra) will charge fees
• An IRB affiliated with a university, academic medical center or research institute may or may not charge fees.

Read the list of options for single IRB review for UW PIs for more information about which specific IRBs charge fees.

Obtaining fee information for sIRB review

There is no nationwide standard or federal mandate for how IRB fees are assessed or how much they are. Some IRBs charge for each review action they complete (e.g. initial approval, modifications, continuing review) for each site. Some IRBs charge annual fees for the study based on the number of sites. For others, the fees vary based on institutional or organizational affiliations.

You should obtain fee information from the IRB that is specific to the study you are proposing. This may require asking the IRB office for a study-specific fee estimate. Consult the list of options for single IRB review for UW PIs for how to contact IRBs to obtain information about fees.

Grant budget guidance

NIH-funded Research

NIH is expecting that funding proposals may include fees for sIRB review as direct costs and has provided detailed information at the sIRB FAQ and a specific costs guidance document, including topics such as:

• Which budget category on the SF424 (R&R) form should be used
• Which costs should be charged as direct vs. indirect costs under different IRB review scenarios
• The relationship with the $500,000 cap on direct costs
• Where to put the sIRB cost information on the budget forms

If you have questions, contact:

• The NIH financial officer identified in your FOA or RFP and/or
• Your department’s contact person at the UW Office of Sponsored Programs (OSP)

Research Funded by Other Agencies

Other federal funding agencies have not issued guidance on budgeting for IRB fees or additional personnel to support sIRB review.