What expenses information must be included in the consent?

• A. The anticipated expenses, if any, to the subject for participating in the trial.
• B. The subject will have no expenses.
• C. All expenses are covered by the sponsor.
• D. Travel expenses only.

Answer: (A)

Disclosing anticipated expenses the subject may incur by participating in the trial is required. The consent form should spell out any costs the participant would bear, or explicitly state that there are no expenses. This helps the participant make an informed decision and avoids unexpected financial burden. Saying that there are no expenses or that all costs are covered, or that only travel costs exist, would be incorrect unless those statements truly reflect the trial’s plans; the form must accurately reflect what is or isn’t covered and what the participant might personally pay.