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 in 2010 a new Insurance and Research Participant Financial Responsibility Information Sheet (Information Sheet) was created. 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 is uploaded in the protocol workspace in eIRB under the Stamped Documents tab. The Information Sheet should be discussed with research participants as part of the consent process. Receipt of the form is documented by research participants via signature on the informed consent form. Note, the requirement to also sign the information sheet has been eliminated.
A copy of both the signed research consent form and information sheet must be provided to participants and stored in the research chart. The study team should upload a copy of the consent form in the medical record.
If you have questions about the Information Sheet, please contact Karen Roz at firstname.lastname@example.org or 410-955-7682 or the Office of Human Subjects Research at email@example.com or 410-955-3008.