A 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:

no more than minimal risk to the child

Explanation:

45 CFR Part 46 focuses on the protection of human subjects, as they pertain to demonstration projects, making sure that they are safe. IRB's risk assessment would likely conclude that this study involves no more than minimal risk to the child due to the test only requiring samples that the subjects provide naturally on a daily basis and involves no invasive procedures or drastic changes in the subject's life.

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