A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to asses

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A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to asses

s 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:__________A. No risk to the child and no further IRB review is requiredB. No more than minimal risk to the childC. More than minimal risk with prospect of direct benefit to the childD. More than minimal risk with no prospect of direct benefit to the child

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1 answer:

Elza [1.5K] · Answer 1 · 2026-02-20T13:58:19+03:00

Answer: Option (B) is the correct choice

Explanation:

Under 45 CFR 46, the IRB evaluates and reviews human research studies, especially those involving children, pregnant women, and fetuses, to ensure additional protections during research.

In this scenario, the IRB's risk assessment will categorize the research as presenting no more than minimal risk to children since the participants are aged 8-12 years and no harsh or unsafe methods are used other than the collection of void sample. Therefore, minimal risk exists concerning this research study.

Other options are invalid because the IRB risk assessment wouldn't classify the study as more than minimal risk considering direct child benefits, categorizing it as more than minimal risk without the prospect of direct benefit, or stating that IRB review is unnecessary. Thus, the correct response is option (B).