What Information Must Be Included in the Cost Section of an Informed Consent Form?

Question

What information must be included in the cost section of an informed consent form?

Response

When a person considers enrolling in a clinical trial, the individual may assume that all expenses will be covered by the trial and not even consider that some costs might be billed to them or to their insurance company.

U.S. Food and Drug Administration’s (FDA) regulations require disclosure of any additional costs to the subject that may result from participation in the research [21 CFR 50.25(b)(3)].

The FDA recommends that any additional cost that may be charged to the subject, the subject’s insurance, or similar reimbursement process be explained during the informed consent process as is noted in the FDA guidance document on informed consent.

Participants need to be made aware of the possibility that their insurance might not fund all or part of the medical care they receive while participating in a clinical research trial. This is true even when the care they will receive in the trial is considered standard care that their insurance might otherwise have reimbursed if they were not participating in the research.

Participants also need to be informed if they might be responsible for deductibles or copayments, if insurance is charged for any medical costs related to the research.

If the sponsor or study site plans to cover all costs or those not covered by insurance, how these funds will be made available to subjects needs to be clearly explained in the consent form, or the consent form needs to direct subjects where to obtain further information.

Consider adding language that would refer people to a knowledgeable financial specialist to explain the costs that might be incurred, insurance coverage, and reimbursement issues before deciding to sign the consent form.

Other indirect costs that might result from participation in a clinical trial also need to be considered such as time off work, child or elder care, or transportation costs. To assist the prospective participant in understanding these additional costs, the consent process should describe the protocol requirements in sufficient detail (e.g., number and duration of study site visits and procedures) to help people appreciate how much time they may need to take away from work, childcare, or elder care.

Cost Language Examples:

• There is no cost to you for participation in this study.
• Study drug will be provided by the sponsor free of charge. Any visits, procedures, or tests that are required only for the study protocol and would not be performed if you did not participate in the study, will be paid for by sponsor. The costs for routine care (tests and procedures that are required by the study protocol, but your study or regular physician would perform even if you were not taking part in this study) will be billed in the usual way. This means you and/or your insurance will be responsible for payment of the costs of routine care. You will be responsible for any deductibles or co-payments required by your insurance company.
• You (and/or your insurance company) will not be expected to pay for any tests or procedures that are done solely for the purposes of this study. You (and/or your insurance company) will not be expected to pay for study treatments. You will still need to pay for your usual medical care. You (and/or your insurance company) will be responsible for costs of care that are associated with your usual care, which includes some tests and procedures that are done while you are in this study. This could include any non-study procedures and/or non-study medication that are needed while you are in this study. You should contact your medical insurance company to find out if they will pay for routine medical care while you are in this study.
• You will not need to pay for study treatment and study visits or any medical tests specifically needed for this study (these are tests you would not receive as the usual care for your disease). You may want to talk to your study team about the difference between medical tests for your usual care and medical tests specifically needed for this study, as well as any other questions you may have about costs.
• You may be responsible for other costs which may include travel expenses, medical tests that you would receive as the usual care for your disease which may be covered by your insurance, and any lost income for study participants and their caregivers (such as taking time off work to attend appointments).
• In some cases, insurance does not pay for services ordinarily covered because these services were performed in a research study. You should check with your insurance to see what services will be covered by your insurance and what you will be responsible for paying.