[Answer] A research study is designed to assess the rate of lung maturation of preterm infants with Down syndrome by measuring the Lecithin to Sphingomyelin ratio (L/S ratio) in amniotic fluid as a surrogate of adequate surfactant production. Weekly amniocentesis are performed during the last trimester of pregnancy. The rate of miscarriage due to amniocentesis is estimated at one in 200 procedures. The IRB determines that this procedure carries a greater than minimal risk to the fetus and that there is no direct benefit to the mother or to the fetus. Which of the following is true?

Answer: As described the research is not approvable under subpart B. - Research that is not intended to meet the health needs of the mother or the fetus is only approvable under subpart B if the risk to the fetus is minimal. Consent of one or both of the parents in this case is irrelevant. For greater than minimal risk research under subpart B benefit to society does not outweigh risk to the fetus.

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A research study is designed to assess the rate of lung maturation of preterm infants with Down syndrome by measuring the Lecithin to Sphingomyelin ratio (L/S ratio) in amniotic fluid as a surrogate of adequate surfactant production. Weekly amniocentesis are performed during the last trimes...

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