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:__________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

Answer 1

Answer: Option(B) is correct option

Explanation:

Under 45 CFR 46, IRB reviews and assess human research study conducted specially on children, pregnant women , fetuses etc to provide additional protection wile research and study.  

According to the question ,IRB risk assessment will deduce research study as no more than slight risk to children because children are of 8-12 years old and no harsh or unsafe method and illegal mode is used except for void sample collection.Thus, minimum risk is present in this research study.

Other options are incorrect because IRB risk assessment will not conclude study as more than minimum risk with view of direct child benefit,more than minimum risk without outlook of child benefit and IRB review is not required.Thus, the correct option is option(b).