Vanderbilt's cost flow template abets studies

Process for selecting cost template language

The human research protection program at Vanderbilt University of Nashville, TN, has created a flow chart that assists investigators with making decisions about how to insert cost language in study informed consent forms.

Investigators are encouraged to ask themselves, "What cost language will be most informative to the research participant?"

Here are some sample items from the flow chart:

  • Does the protocol/consent form include intervention/procedures potentially affecting the health outcome of the participant? If no, then does the billing plan have any procedures billed to the participant or insurance? If no, then is this for a healthy volunteer? If yes, then use this language: "There is no cost to you for taking part in this study."
  • If the study is not for healthy volunteers, then use this language: "There is no cost to you for taking part in this study. However, you are still responsible for paying for the usual care you would normally receive for the treatment of your illness. This includes treatment and tests you would need even if you were not in this study. These costs will be billed to you and/or your insurance."
  • Has item 2 in the consent form clearly itemized routine care versus research? If yes, then use this language: "If you agree to take part in this research study, you and/or your insurance will not have to pay for the tests and treatments that are being done only for research."
  • Does the protocol describe any usual or routine care that will occur regardless of the study? If yes, then use this language: "However, you are still responsible for paying for the usual care you would normally receive for the treatment of your illness. This includes treatments and tests you would need even if you were not in this study. These costs will be billed to your and/or your insurance."
  • Does the protocol describe delivery of any usual or routine care or research because of the study protocol? If yes, then use this language: "You have the right to ask what it may cost you to take part in this study. If you would like assistance, financial counseling is available through the Vanderbilt Financial Assistance Program. The study staff can help you contact this program. You have the right to contact your insurance company to discuss the costs of your routine care (non-research) further before choosing to be in the study. You may choose not to be in this study if your insurance does not pay for your routine care (non-research) costs and your doctor will discuss other treatment plans with you."
  • Is this a device study? If yes, and there is additional pertinent cost information for the participant, add that information under the header: "Additional cost information" (i.e., specific information from the Medicare Letter or warranty information).