What is the appropriate handling of questions during the consent process?

• A. They should be addressed by the investigator during the consent process to the participant's satisfaction.
• B. They should be addressed only by the sponsor.
• C. They should be addressed after the trial begins.
• D. They should be ignored if there are many questions.

Answer: (A)

During the consent process, the core obligation is to ensure the participant truly understands what participation involves. The investigator should actively engage with the person, answer all questions, and confirm that the participant is satisfied with the clarity and sufficiency of the information before consent is given. This protects the participant’s autonomy and satisfies the requirement for truly informed consent. The sponsor is not the appropriate party to handle the participant’s questions in place of the investigator, and questions should not be deferred until after the trial starts or ignored altogether. If needed, use appropriate language support and comprehension checks, since obtaining consent is an ongoing, patient-centered process that may need revisiting if new information arises.