A Federally Funded Research Study Involving

Question:

Answer: Honor the Childs decision

Question: 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:

Answer: No more than minimal risk to the child

Question:

Answer: Assent of the child and permission of both parents are required.

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