Clinical Research Billing Unit
The Clinical Research Billing Unit (CRBU) was created to ensure items/services that research teams intend to bill to Medicare and other third party payers are consistent with federal and institutional policies related to research billing. The IRBMED protects the rights and welfare of research subjects and ensures research studies are compliant with federal human subjects regulations.
The missions of the IRBMED and the CRBU intersect in the review of an informed consent document (ICD) for a research study. The IRBMED must make sure the ICD conveys what financial burdens subjects might take on from participation in research and that the ICD does not contain any exculpatory language. The CRBU must ascertain that the billing calendar, the clinical trial agreement (if applicable), the internal and sponsor budgets (if applicable) and the ICD are in agreement with regard to which charges will be made to the research account and which will be made to a third party payer (including Medicare) or the subject, if uninsured.
All research studies that involve billable items and services (initiated after November 1, 2006) are required to create a billing calendar and submit it to the CRBU along with the study documents. See the CRBU Web site for contact information, more information about which studies require CRBU review, training, how to create a billing calendar and more. Although the CRBU is proactively contacting research teams who have submitted information on eResearch, all research teams are encouraged to contact the CRBU directly when new clinical research is being initiated.
Sections 4 and 8 of the IRBMED standard informed consent document template are the specific sections that must match the billing calendar. All of the items/services on the billing calendar, and listed in the study protocol, should be described in consent section 4.1 whether or not they are considered the actual investigational item(s). It should be clear in the consent which items are considered routine care and which are study-specific. The items and services do not need to be repeated in Section 8.1, but it should be made clear in this section that the study-specific or research-related items are being covered by research funds. Section 8.1 should also outline whether or not research funds are paying for adverse events and/or subject related injury per the clinical trial agreement (if applicable). If the subject is going to be responsible for paying for any items/services, this should also be included in Section 8.1.
The template instructions (PDF) for sections 4 and 8 direct researchers to distinguish between research procedures and those that are investigational/research-only. These instructions and those found at the CRBU Web site should be reviewed prior to writing these sections of the ICD.Original 8/22/08
