What must be obtained from every subject prior to clinical trial participation?

• A. Informed consent should be freely given.
• B. Consent forms are only needed after the trial ends.
• C. Consent from a family member suffices.
• D. Consent is not required if the subject understands risks.

Answer: (A)

Informed consent must be obtained before any study-related procedures are performed on a subject. This ensures the person’s autonomy is respected and that participation is voluntary and based on adequate information about the study’s purpose, procedures, risks, benefits, alternatives, confidentiality, and rights. The consent is documented with a signed form, and it defines that the subject can withdraw at any time without penalty.

Consent after the trial ends is not acceptable, and a family member’s consent cannot substitute for the subject’s own consent. Even if someone understands the risks, formal informed consent is still required because participation is a voluntary decision based on full, comprehensible information.