How should questions about the trial be handled during the informed consent process?

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Ensuring understanding and voluntary participation is the heart of informed consent. During the consent process, questions from the participant or their legally authorized representative should be answered in a way that satisfies their understanding, using clear, plain language and giving them time to consider the information. The investigator bears the responsibility for this exchange; the sponsor does not decide what is explained. Answering questions just to avoid delays or ignoring questions after the form is signed would undermine the participant’s autonomy and the ongoing nature of consent. If the participant cannot fully understand, involvement of a legally authorized representative is appropriate, and all questions should still be addressed to their satisfaction. Remember, consent is an ongoing process, and questions can arise at any time and must be answered appropriately.