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Change in JHM IRB Review Fees for Commercially-Funded Studies

MEMORANDUM

DATE:           July 2, 2018

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 for study closures and the compliance monitoring activities for select commercially-funded studies, the IRB review fees will be modified as of August 1, 2018. The changes in IRB review fees include the following:

  1. Inclusion of IRB review fees for study closures for commercially-funded studies
  2. Inclusion of fees for select studies that require monitoring by the Office of Human Subjects Research Compliance Monitoring Program.

Any new study submitted on or after August 1, 2018 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, with the changes in bold below.

Type of Review

Initial Review

Continuing Review

Changes in Research [with consent form changes]

Changes in Research [without consent form changes]

 Study Closure

Convened

$2500

$1250

$800

$700

$500

Expedited

$2000

$1000

N/A

N/A

$500

Exempt

$1000

N/A

N/A

N/A

$500

Local Context Review Fee [When Relying on an External IRB]

$1800

N/A

N/A

N/A

N/A

Monitoring Fees for Select Commercially-Funded Studies:

Investigation Type

Year 1

Years 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.