IRB Fee Policy

The OHSU IRB charges fees for initial and ongoing review of non-federally supported research that receives industry funding. This includes all industry funded investigator-initiated trials (IITs), even when OHSU IRB oversight is ceded (i.e., ‘waived’) to an external IRB.

OHSU IRB – Review & Maintenance Fees
Review and maintenance fees are assessed for research studies throughout the various stages of the protocol. See the OHSU IRB Review Fees table below for details. Fees are charged after the OHSU IRB conducts the initial review/approval, even if the research does not proceed (e.g., subjects are never enrolled, the study terminates before milestones are met, expenditures exceed revenue, or a contract is never finalized). Therefore, whenever possible, studies should not be submitted for IRB review until it is certain that the research will move forward.

Central IRB – Local Compliance Review & Maintenance Fees (Waived Studies)
A local compliance review is required for waived studies by central IRB reliance agreements to ensure compliance with institutional policies, local, and state laws. This review encompasses the initial review as well as ongoing annual maintenance reviews, each incurring their own respective fee. The OHSU local compliance review fees are in addition to IRB fees that may be charged by the external IRB. See the Central IRB Review Fees table below for associated fees.

Study teams are advised to budget as early as possible for IRB fees. See the IRB fees, clinical billing, and funding section of the IRB FAQ page for further information.

If you have questions about IRB fees (including as they may apply to a specific protocol) please contact irb@ohsu.edu and your inquiry will be triaged.

Procedure

IRB fees are assessed after the IRB completes the review action, i.e., this is a fee-for-service process. The IRB typically assesses fees against the OGA sponsored account or the departmental account. For example, these fees may be applied to a departmental account alias when a study has been reviewed by the IRB but does not proceed before a contract has been finalized, or when the IRB administratively closes a study.

Invoice payment

Research departments are directly responsible for invoicing IRB fees to sponsors. Upon receipt of payment, OPAM deposits the funds received into the appropriate OGA Project and notifies the study personnel. Study personnel are responsible for monitoring whether the sponsor pays the invoice submitted to them for the IRB fee. If the sponsor does not pay in a timely fashion, the department may then wish to pursue reimbursement of the amount directly from the sponsor.

In compliance with OHSU/Central Financial Services (CFS) policy, erroneous charges must be reported to the IRB within the same fiscal year or within 90 days of posting to an account ledger.

Current and past fee schedules

OHSU IRB review Fee Billed
Initial review $3,300
Continuing review $3,100
Annual maintenance* $2,050
Modification No Charge
Administrative closure fee** $550

*Annual maintenance - If a Continuing Review is not required under federal regulations, but the study is still ongoing, the OHSU IRB has an obligation to verify compliance issues. The annual maintenance fee covers completion of this compliance review.

**Administrative closure fee - applies to all IRB protocols regardless of funding source: In the event the Principal Investigator fails to close a study after standard notifications from the OHSU Research Integrity Office, the IRB must close the study for them. Should administrative closure be necessary, the fee will be withdrawn from the Principal Investigator's departmental account.

Central IRB review Fee Billed
Compliance review/set-up fee $3,200
Continuing review N/A
Annual maintenance* $2,050
Modification No Charge
Administrative closure fee** $550

*Annual maintenance - The OHSU IRB does not complete a Continuing Review for studies under central IRB review. However, if the study is still ongoing, the OHSU IRB has an obligation to verify compliance issues. The annual maintenance fee covers completion of this compliance review.

**Administrative closure fee - applies to all IRB protocols regardless of funding source: In the event the Principal Investigator fails to close a study after standard notifications from the OHSU Research Integrity Office, the IRB must close the study for them. Should administrative closure be necessary, the fee will be withdrawn from the Principal Investigator's departmental account.

The fee schedule for your study will depend on whether the OHSU IRB reviews the study or a central IRB reviews the study as follows:

Review Category OHSU IRB Review Fee Billed Central IRB Review Fee Billed
Initial review $3,000 N/A
Compliance review/set-up fee N/A $2,900
Continuing review $2,200 N/A
Annual maintenance* $1,700 $1,700
Modification No Charge No Charge
Administrative closure fee** $550 $550

*Annual maintenance - If a Continuing Review is not required under federal regulations, but the study is still ongoing, the OHSU IRB has an obligation to verify compliance issues. The annual maintenance fee covers completion of this compliance review.

**Administrative closure fee - applies to all IRB protocols regardless of funding source: In the event the Principal Investigator fails to close a study after standard notifications from the OHSU Research Integrity Office, the IRB must close the study for them. Should administrative closure be necessary, the fee will be withdrawn from the Principal Investigator's departmental account.

Review Category Fee Billed
Initial review $2,675
Continuing review $1,320
Modification* $850
Administrative closure fee** $550

*Modification - This fee will be charged for all submissions to the IRB, with the exception of unanticipated problem reports, protocol deviation reports, responses to IRB reviews, and administrative changes initiated by the investigator. The billable modification does not necessarily amend the protocol. If you have questions regarding fees, please contact David Holmgren ( 503-346-3528 ) before submitting your modification. 

**Administrative closure fee - Applies to all IRB protocols regardless of funding source: In the event the Principal Investigator fails to close a study after standard notifications from the OHSU Research Integrity Office, the IRB must close the study for them. Should administrative closure be necessary, the fee will be withdrawn from the Principal Investigator's departmental account.

Review Category Fee Billed
Initial review $2,200
Continuing review $1,320
Modification* $825
Administrative closure fee** $550

*Modification - This fee will be charged for all submissions to the IRB, with the exception of unanticipated problem reports, protocol deviation reports, responses to IRB reviews, and administrative changes initiated by the investigator. The billable modification does not necessarily amend the protocol. If you have questions regarding fees, please contact David Holmgren ( 503-346-3528 ) before submitting your modification.

**Administrative closure fee - Applies to all IRB protocols regardless of funding source: In the event the Principal Investigator fails to close a study after standard notifications from the OHSU Research Integrity Office, the IRB must close the study for them. Should administrative closure be necessary, the fee will be withdrawn from the Principal Investigator's departmental account.