Final answer:
The assertion is false; the IRB must approve all materials, including questionnaires and screening tools, used prior to participant consent to ensure ethical treatment and proper informed consent processes.
Step-by-step explanation:
The statement that the questionnaires, pre-screening tools, and screening script of the verbal information shared with and collected from potential study subjects does NOT need to be approved by the Institutional Review Board (IRB) because the subject has not yet consented is false. The IRB is responsible for ensuring the ethical treatment of human subjects in research studies, which includes the approval of materials used during the recruitment and screening process. This is important to protect potential participants from any risks, including privacy concerns, and to make sure that they are informed about the research in a manner that is clear and respectful. Allowing participants to understand the nature and purpose of the research prior to consenting is also crucial for the integrity of the study.