Who must sign and date the written informed consent prior to participation?

• A. The signer must be the subject.
• B. The subject or the subject's legally acceptable representative, and the person who conducted the consent discussion, must sign and date.
• C. The sponsor must sign.
• D. The IRB must sign.

Answer: (C)

Understanding informed consent requires documenting the participant’s voluntary agreement to participate. The written consent form must be signed and dated by the person who participates (the subject) or their legally acceptable representative, and by the person who conducted the consent discussion (usually the investigator or designated staff) to confirm they provided the study information and answered questions. If a legally authorized representative signs on behalf of someone unable to consent, they must also sign and date. The sponsor does not sign the participant’s consent form; the sponsor’s role is oversight and funding, not signing each consent document. The IRB reviews and approves the consent form, but does not sign the participant’s consent as part of the enrollment process.