What should be done if the participant has questions after signing the consent form?

• A. Their questions should still be addressed to ensure clarity and understanding.
• B. Questions should be ignored until the trial ends.
• C. Only the sponsor can address questions.
• D. Questions must be answered only before randomization.

Answer: (A)

The main idea here is that informed consent is an ongoing, active process, not a one-time form. If a participant has questions after signing, those questions should be answered by the investigator or other qualified study staff to ensure they truly understand what they’re agreeing to and remain willing to participate. This protects the participant’s autonomy and supports ongoing voluntary consent.

Ignoring questions, or restricting questions to before randomization, would undermine understanding and autonomy. While the sponsor may be involved in information sharing, the responsibility to address the participant’s questions rests with the research team. If new information comes up, or if the participant seeks further clarification, you may also revisit consent to reflect any changes, with appropriate documentation.