Which statement best reflects the basis of informed consent?

• A. It allows coercion if compensation is offered.
• B. It requires that consent be freely given and based on adequate information.
• C. It is optional for low-risk studies.
• D. It is sufficient to sign after a brief pause.

Answer: (B)

Consent rests on a person's voluntary decision to participate, made after understanding what the study involves. This means information must be given in a way the person can understand and must cover the purpose, procedures, potential risks and benefits, alternatives, and the right to withdraw without penalty. The participant should have time to consider the information, ask questions, and discuss with others if they wish. Consent is not merely signing a form; it is an ongoing process, and any new information can require re-consent. Coercion or undue influence undermines validity, and simply signing after a brief pause does not establish that the decision was informed or voluntary. Therefore, the basis of informed consent is that it is freely given and based on adequate information.