To ensure a patient participant’s insurance is not billed for research related services, as well as to make sure all applicable billing compliance rules are followed, OCRICC expects that research teams follow the instructions provided within the Froedtert Health OCRICC Administrative Approval Letter.

We also have several guidance documents that provide additional assistance related to the process.

The Principal Investigator is ultimately responsible for the conduct of their research.

Consent Conversation

It is the research team’s responsibility to have a thorough verbal informed consent discussion that includes a detailed discussion about out-of-pocket costs to the participant. In order to make sure that participants understand their out-of-pocket expenses and what may or may not be covered by their insurance, research teams should encourage patients to check with their insurer for details. Uninsured participants should be informed that they are responsible for all costs not provided free by the study.

Providing a Copy of Signed Consent to Froedtert Health OCRICC

Electronic (PDF) versions of the signed research informed consent form must be sent to OCRICC within 24 hours of enrollment. This will trigger OCRICC staff to associate that patient with that particular research project in EPIC. This is the process used by Froedtert Health to prevent claims from being billed incorrectly. More information can be found in our Informed Consent Guidance document.

Documenting Activities and Services in EPIC

Any activities/services that are considered care and treatment as part of the research project, and/or anything that impacts the care and treatment of the patient participant, or is important for the patient participant’s provider to know, should be documented in the legal health record. Any questions should be directed to the assigned OCRICC Consultant on your project.

Notifying OCRICC of Services Performed

Notification to OCRICC is required as outlined in the projects Froedtert Health Administrative Approval. Typically, for services being carried out per the agreed upon MCA/Billing plan, no separate notification is required unless otherwise instructed in the project-specific Administrative Approval. E-mail notification to the is always required when services are either not performed according to the agreed upon plan or repeated/performed for a particular subject solely for research purposes. Notification must be sent to OCRICC within 24 hours.

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