August 4, 2020

University of Maryland Baltimore Research Community,

As you are aware, the University of Maryland Baltimore Institutional Review  Board (UMB IRB) has charged fees for several years for initial and continuing review of industry sponsored protocols in which funding is greater than >$10,000. These fees help to offset personnel costs in the Human Research Protections Office. Those fees were last adjusted in 2014. Since then, the federal regulations governing human subjects research have been revised, requiring more effort for both review of protocols undergoing local IRB review and for those requesting reliance on external IRBs.

After solicitation of feedback from UMB stakeholders and a review of fee structures from similar academic institutions, the decision has made to go to a flat-fee structure in order to both simplify the billing processes and decrease administrative burden.

Effective October 1, 2020 the charge to industry sponsors will be as follows:

• For contracts <$10,000,or studies that are investigator -initiated, there will continue to be no associated IRB fees.
• For contracts $10,000 or greater, with a term of contract less than two years, a flat fee of $4000.00 will be charged.
• For contracts $10,000 or greater, with a term of contract more than two years, a flat fee of $7000.00 will be charged.

This change in fee structure is to defray the costs of both:

• UMB IRB review of protocols, amendments, advertisements, reportable new information, revised consent documents and post-approval monitoring.
• Human research protections review of applications requesting to rely on an external IRB, including execution of reliance agreements, local context review and post-approval monitoring.

Julie Doherty DM, MSN, CIP

Director, Human Research Protections Program

University of Maryland, Baltimore