1-RM testing is contraindicated for children (< 12 years) and older adults (> 60 years).Select one:TrueFalse
Question
1-RM testing is contraindicated for children (< 12 years) and older adults (> 60 years).Select one:TrueFalse
Solution 1
True
Solution 2
True
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federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). Your IRB has determined that assent of children age 8 and older is required for the study. A 10-year-old firmly declined to participate in the study described above. Which of the following procedures best describes the action to be taken by the investigator? Honor the child's decision. Seek permission from one of the child's parent instead. Request the child reconsider assenting to the study. Consent both of the child's parents instead.Question 2A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). According to 45 CFR 46, an IRB's risk assessment would likely conclude that this study involves: More than minimal risk with prospect of direct benefit to the child. More than minimal risk with no prospect of direct benefit to the child. No risk to the child and no further IRB review is required. No more than minimal risk to the child.Question 3An 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, one parent must give permission for the inclusion of the adolescent in this 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 of the child and permission of both parents are required.
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