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2021 Fee Change Announcement

MEMORANDUM

DATE: June 1, 2021

TO: JHU SOM Department Directors, Administrators & Principal Investigators

FROM: Daniel Ford, M.D., M.P.H., Vice Dean for Clinical Investigation

SUBJECT: Change in JHM IRB Review Fees for Commercially-Funded Studies

The JHM IRB bills for review of commercially-funded studies with financial support in excess of $10,000. The fees collected from reviewing commercially-funded studies help fund services provided by the IRB.

To help cover the costs of IRB review the IRB review fees will be modified as of July 1, 2021.

Any new study submitted on or after July 1, 2021 will be subject to the new fee schedule. After reviewing fee structures at similar institutions conducting human subjects research, we have determined the new fees to be in line or below the national average. The new fee schedule is as follows:

Type of ReviewInitial ReviewContinuing ReviewChanges in Research [with consent form changes]Changes in Research [without consent form changes]Study Closure
Convened$3000$1750$1200$1000$750
Expedited$2500$1500$500N/A$750
Exempt$1500N/AN/AN/A$750
Local Context Review Fee [When Relying on an External IRB]$2500N/AN/AN/AN/A

No changes to Monitoring Fees:

Monitoring FeesYear 1Years 2 and Beyond
Commercially funded studies where the JH PI holds the IND/IDE$375$675/yr
Commercially funded studies that require HRRC review$375$675/yr
Commercially funded studies where JH relies on an external IRB$225$375/yr
Commercially funded studies that qualify as expedited but involve drugs/devices$225$375/yr

To ensure each department is treated fairly and to increase overall efficiency, we continue to require each department to specify a non-sponsored account for billing IRB review fees. All IRB review fees for principal investigators in that department will be billed against that account until it is determined that a study specific Internal Order number has been assigned to the reviewed study.

Additionally, to help investigators seeking single IRB (sIRB) review services from the JHM IRB in planning their budgets, we have posted a fee schedule for sIRB review.

This fee schedule reflects the JHM IRB fee rate for sIRB review that will be applied to all new requests for sIRB services approved on or after 7/1/2021. Each request for sIRB services must be submitted to the JHM IRB via a reliance request. A study specific budget will be prepared for each reliance request that is approved.

sIRB FeesFee per Site
Initial Participating Site Onboarding Fee$1500/site
Continuing Review$1000/site
Study-wide Amendment$500/site
Participating Site Modification$250/site
Compliance Monitoring Fee$250/site
Site Termination$250/site

Sincerely,

Daniel E. Ford, M.D., M.P.H.
Vice Dean for Clinical Investigation