A researcher plans to enroll pregnant women in a study that offers the prospect of direct benefit only to the fetus. Under Subpart B (45 CFR 46), this is permissible only if:
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A
The risk to the pregnant woman is minimal and the study is fully blinded
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B
The risk to the fetus is minimized and the fathers have provided consent
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C
The risk to the fetus is minimized and both the mother and father consent where feasible
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D
The IRB grants a waiver based on scientific necessity