An investigator proposes a study to determine the clinical relevance of a new assay technique to measure minimal residual disease (MRD) in adolescent (age 14-16) cancer patients undergoing chemotherapy. The study requires that two additional bone marrow aspirates be performed during the course of chemotherapy. The subject's chemotherapy will not be altered based on the results of the assay technique measures. However, future patients with cancer would benefit from improved interventions based on study findings. The IRB determined that the activity was a minor increase over minimal risk. Which of the following statements best describes the IRB approval requirements for involving adolescent cancer patients in the research study? Assent is not required, however, both parents must give permission for the inclusion of the adolescent child.
Assent of the child only is required.
Assent is not required, however, one parent must give permission for the inclusion of the adolescent in this study.
Assent of the child and permission of both parents are required.