What is the purpose of informed consent in a clinical trial?

• A. To maximize the dose
• B. To ensure patient is aware of risks and voluntarily agrees
• C. To speed up enrollment
• D. To release sponsor from liability

Answer: (B)

Informed consent centers on respect for patient autonomy by making sure participation in a clinical trial is based on understanding and voluntary choice. This means the person (or parent/guardian, in pediatric cases) is told what the study involves, including the procedures, potential risks and benefits, and any alternatives, so they can decide whether to participate. It also covers that participation is voluntary, with no penalty for choosing not to join or for withdrawing at any time, and that privacy and data use are explained.

For pediatric trials, a parent or guardian provides permission, and the child who can understand should give assent, recognizing the child’s developing capacity to participate in the decision.

This is not about maximizing dose, speeding enrollment, or releasing sponsors from liability. The core idea is that the participant is fully informed and freely agrees to take part.