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?

Question

11-10-2021
Medicine

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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?

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michell96 michell96 · Answer 1 · 2021-10-14T17:59:40+02:00

Based on subpart B of the IBD guidelines the research described would be permitted.

The Institution Review Board or IBD is the entity in charge of evaluating possible research studies and determine if these are ethical.

In the case of fetuses and pregnant women, the guidelines are established in the subpart B, and the most important points include:

Research studies are ethical if the possible risks have been studied and are well known
Research studies are ethical if they provide a benefit to the fetus and/or woman
Research studies are ethical if there is no benefit either for the fetus or the woman but the risk is minimal

Based on this, the research described would be permitted because even if there is a low risk for the fetus, the study has the potential to provide benefits for both the fetus and the mother, which makes the risk to be ethical and acceptable.

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