What should be disclosed about anticipated expenses related to trial participation?

• A. Any anticipated expenses related to trial participation
• B. Only travel expenses
• C. No expenses are disclosed
• D. Expenses are billed to the participant's insurer

Answer: (A)

When obtaining consent, you must disclose all reasonably foreseeable costs that could be incurred by participating in the trial. This means providing a clear statement of anticipated expenses, such as travel, accommodations, tests or procedures not covered by the sponsor, and any other out-of-pocket costs, along with information about who will pay or reimburse them (for example, what the insurer might cover and what the sponsor will or will not reimburse). This full disclosure helps the participant make an informed decision without unexpected financial burdens.

Limiting disclosure to travel misses other potential costs; saying no expenses will be disclosed would deprive the participant of essential information; and stating that expenses are billed to the insurer alone does not convey the need to inform about all anticipated costs and who bears them.