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Insurance and Research Participant Financial Responsibility Information Sheet

IMPORTANT: This information has changed as of May 2019. You can find the up-to-date information HERE

April 2010

A Prospective Reimbursement Analysis (PRA) is required for all clinical research studies submitted after July 1, 2008 that have the potential to generate a hospital or professional fee. The PRA determines what potential charges are considered standard of care or research.  

Although this study cost information was originally included in the consent form, to streamline the consent form we created a new Insurance and Research Participant Financial Responsibility Information Sheet (Information Sheet).  Starting January 1, 2010, all new studies that required a PRA were issued an Information Sheet.  The Information Sheet contains information about participant costs that may be associated with research, and the cost section of the consent form references the Information Sheet. The Information Sheet should be signed and processed with the consent into the research chart and Epic. The Information Sheet is uploaded in the protocol workspace in eIRB under the Stamped Documents tab.

Starting April 1, 2010, studies that have a PRA and are submitting a change in research with a revised consent form will also receive an Information Sheet.  The study cost information will be removed from the consent form and should be replaced with the standard cost language in the Version 11 Informed Consent Template.

If you have questions about the new Information Sheet, please contact Karen Roz at rozka@jhmi.edu or 410-955-7682 or Victoria Hadhazy at vhadhaz1@jhmi.edu or 410-955-3008.