January 2010

Prospective Reimbursement Analysis

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.

In order 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 Insurance and Research Participant Financial Responsibility Information Sheet. This 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 January 1, 2010 that require a PRA will use this new 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."

Your continued support and cooperation are appreciated 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.

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January 2010 articles:
Prospective Reimbursement Analysis
Seminar Series
Damon Runyon Clinical Investigator Award for 2010
Lasker Foundation Medical Research Awards
Global Probiotics Council - Young Investigator Grant for Probiotics Research (YIGPRO)
2010 Senior Scholar Awards in Aging
Major Changes for NIH Grant Applications with Due Dates on or after 1/25/10

This Month's Departmental Listings

Upcoming Deadlines for January, February and March



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