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Revised Prospective Reimbursement Analysis Process

December 18, 2009

Dear Colleagues:

As you know, the Prospective Reimbursement Analysis (PRA) process began in 2008. All clinical research studies submitted after July 1, 2008 that have the potential to generate a hospital or professional fee have been reviewed by Clinical Research Support Services (CRSS) and investigators, and the IRBs were notified when a PRA was required. The PRA determines what potential charges are considered standard of care or research. Cost information from the PRA has been included in the study consent forms and, unfortunately, the result was the creation of a consent form that was even longer than desired.

To streamline the consent form and present cost information in a more meaningful manner, we have decided to remove the cost information from the consent form and present it in a separate document, the Insurance and Research Participant Financial Responsibility Information Sheet. The new Information Sheet will contain information about participant costs that may be associated with research, and the Cost section of the consent form will reference the Information Sheet. The participant should be given a copy of the Information Sheet but does not have to sign it. CRSS will upload the Information Sheet in eIRB under the Stamped Documents tab, where other approved documents such as consent forms, recruitment materials, PRA and insurance clearance forms are located. All studies submitted to the JHM IRB after Jan. 1, 2010 that require a PRA will use the Information Sheet. For studies that already include PRA cost information within the consent form, no changes are required; however, if you want to use the Information Sheet you may submit a Change in Research to request an Information Sheet and a revised consent form.

In addition, Clinical Research Support Services and the IRB have implemented a revised process for PRA communication. Notification will be sent via eIRB regarding status and approvals of the PRA. The message will read:

“The Prospective Reimbursement Analysis (PRA) has been completed for the above-referenced eIRB application and is ready for your review. Use the link above to access the application. Click on the Review PRA activity on the left side of the application workspace to access the PRA document and complete your review.”

Thank you for your continued support and cooperation as we strive to improve our administrative clinical research processes. If you have questions about the new Information Sheet, please contact Karen Roz at rozka@jhmi.edu or 410-955-7682.

Sincerely,

Daniel E. Ford
Vice Dean for Clinical Investigation