Mushroom extract supplementation on fetal loss

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A researcher wants to examine the efficacy of mushroom extract supplementation on fetal loss, low birth weight, and severe preterm birth in healthy pregnant women. She plans to enroll women who are 12-26 weeks pregnant and randomize them to either receive the intervention or placebo until delivery. The IRB determines this intervention presents greater than minimal risk to the pregnant women subjects, and potential direct benefit to both mother and fetus. Is this research permitted under Subpart B?

Reference no: EM133795065

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