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For your protection, the National Research Act requires government oversight of clinical trials. Food and Drug Administration regulations require scientific review, approval by a review board (IRB), and your signature on a consent form prior to participating in any trial. Your oncologist is responsible for reviewing and explaining the entire informed consent form which describes the study design, potential risks and benefits, and study procedures. Remember: Participation in a trial is voluntary. You can choose not to participate or may withdraw from a study at any time. Your oncologist may also determine that it is in your best interest to withdraw from the study.