Is informed consent a one-time event?

Is informed consent a one-time event?

• A. Yes
• B. No
• C. It depends on the study
• D. Only for low-risk studies

Answer: (B)

Informed consent is an ongoing process, not a one-time event. The initial discussion and signature before joining a study establish a voluntary agreement, but the participant’s understanding and willingness must be maintained throughout the trial. As new information becomes available or as the study procedures change, investigators are obliged to share those updates and, when appropriate, obtain re-consent. This ensures that the participant continues to agree to the risks, burdens, and data use under the current conditions. The right to withdraw at any time remains intact, reinforcing that consent is dynamic and centered on ongoing autonomy.

Informed consent is an ongoing process, not a one-time event. The initial discussion and signature before joining a study establish a voluntary agreement, but the participant’s understanding and willingness must be maintained throughout the trial. As new information becomes available or as the study procedures change, investigators are obliged to share those updates and, when appropriate, obtain re-consent. This ensures that the participant continues to agree to the risks, burdens, and data use under the current conditions. The right to withdraw at any time remains intact, reinforcing that consent is dynamic and centered on ongoing autonomy.