This monthly feature presents questions from clinical trial professionals with answers from WCG’s expert staff. This issue features insights from WCG IRB Medical Chair Andrea Itskovich.

Question: What information needs to be included in the cost section of an informed consent form?

Answer: FDA regulations require disclosure of any additional costs to the subject that may result from participation in the research.

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 to sources of 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 help the prospective participant understand 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.

Question: What are some examples of cost language to include in the informed consent form?

Answer: The following are some examples to consider:

• 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 copayments 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 nonstudy procedures and/or nonstudy medications 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.