What is the role of the investigator or delegated staff in the informed consent process?

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The main idea is that the investigator or their delegate must ensure that informed consent comes from providing accurate information and confirming that the participant’s agreement to join the study is voluntary. Informed consent is a process, not a one-time signature. The investigator explains the study’s purpose, procedures, risks, benefits, and alternatives in clear language, checks the participant’s understanding, answers questions, and respects the person’s right to decline or withdraw at any time without penalty. Only after the participant (or a legally authorized representative, when applicable) freely agrees should any study procedures occur, and this consent must be documented before enrollment or data collection begins. The other options would either bypass voluntary decision-making, occur after procedures have started, or rely on a family member’s consent alone, which does not align with proper consent practices.