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:
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 firstname.lastname@example.org or 410-955-7682.