Research Involving Pregnant Women, Fetuses, and Neonates (ID 10) Question and answers already passed A research project is designed to evaluate a new experimental type of fetal surgery to correct diaphragmatic hernia in the fetus (a potentially life- threatening condition for the baby) prior to delivery. This research is directed toward the fetus as subject to meet the health needs of the fetus. The pregnant woman is otherwise healthy. The investigator must obtain consent from whom? - correct answer ✔The pregnant woman and the father of the fetus.According to current NIH Guidelines, which of the following is adequate justification for exclusion of women from NIH-funded research? - correct answer ✔There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects.Investigators wish to evaluate a new treatment for eclampsia (a life- threatening condition in pregnant women) in women 30 - 50 years of age. The research is intended to directly benefit the pregnant woman who is otherwise healthy and competent. The investigator must obtain consent from whom? - correct answer ✔The pregnant woman only.A researcher wants to collect data about fetuses that were exposed to high levels of lead during their mother's pregnancy. The researcher plans to review the medical records for a control group (not known to be exposed to high levels of lead) and an experimental group (exposed to high levels of lead) of fetuses from 12 weeks of gestation through delivery. Is this research permitted under Subpart B? - correct answer ✔Yes - research with neonates of uncertain viability may be involved because there is no additional risk
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