Medical insurance is a complicated thing. The decision to participate in a research study can also be a complicated thing. For many biomedical research studies, insurance coverage and research participation intersect.
This intersection stems from many research studies involving study-specific medical procedures, in addition to the participants’ standard care. Consent form language routinely describes who will pay for what. Most often, study sponsors cover the cost of study-specific care, with routine care being billed to the participants’ insurance companies. These consent forms also add a disclaimer about “your insurance company may not agree that these procedures are routine care and decline to pay for them.” They then go on to indicate potential subjects can contact their insurance companies for more information to see what will be covered.
Talking to an insurance company can be an intimidating in the best of circumstances. When you’re considering research participation and have to ask about coverage for procedures you haven’t had yet (and may not even know what all of them are), the prospect of cold-calling one’s insurance company is downright daunting. This complexity is why the UAMS IRB routinely requires potential subjects to be told that study or billing staff can help them contact their insurance company for more information about what it will cover.
So, in the part of the consent form that addresses who will pay for what, please include language specifically indicating that someone from the study team or billing staff is available to help get more information from an insurance company.