IRB Fee Policy

The OHSU IRB charges an IRB use fee for review of industry-sponsored and industry-funded clinical trials. The fees are for real expenses incurred and paid by the IRB in the process of reviewing protocols. IRB fees should be included in the study budget. IRB fees are charged to all studies with industry sponsorship, therefore investigators should budget IRB fees even for investigator-initiated trials.

Please note that IRB fees are charged even if subjects are never enrolled, the study terminates before milestones are met, expenditures exceed revenue, or a contract is never finalized. If there is uncertainty as to whether or not the contract will be finalized or the trial will actually go forward, sponsors may wish to delay incurring the charge for IRB review until all plans are final.

See the IRB fees, clinical billing and funding section of the IRB FAQs page for further information. If you have questions or comments about IRB fees, how they are charged, or wish to discuss these fees as they relate to a specific protocol, please contact David Holmgren ( 503-346-3528 ).

Procedure

IRB fees are assessed at the time the IRB completes the action, i.e., this is a fee-for-service system. The IRB assesses the fee against the OGA sponsored account. In the event that a sponsored account is not established within 90 days of the billable service, the fee will be assessed to an unrestricted departmental account or PDA. 

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 or not 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. If the sponsor has been unresponsive to efforts to contact them, the department can contact OPAM for assistance in contacting 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 $3,000
Continuing review $2,200
Annual maintenance* $1,700
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 $2,900
Continuing review N/A
Annual maintenance* $1,700
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.

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.