Question:

Answer: The pregnant woman and the father of the fetus.

Question:

Answer:

Question: According to current NIH Guidelines, which of the following is adequate justification for exclusion of women from NIH-funded research?

Answer: There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects.

Question: According to the 1994, NIH Guidelines, the only justification for exclusion of non-pregnant women of childbearing potential was compelling evidence that inclusion would be inappropriate with respect to the health of the subjects, or to the purpose of the research.

Answer:

Question: 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?

Answer: The pregnant woman only.

Question: According to 46.204(d), if the purpose of the activity is to meet the health needs of the mother, then the consent of the father is NOT required.

Answer:

Question:

Answer: Yes - research with neonates of uncertain viability may be involved because there is no additional risk

Question: The research study is no greater than minimal risk for the pregnant woman and the fetus, and holds the prospect of direct benefit to both the pregnant woman and the fetus. Who needs to provide consent under Subpart B?

Answer: The mother

Question: Pregnant women, fetuses, and neonates are often considered vulnerable categories of subjects. Additional protections are provided through regulation, however, the protections are meant to be inclusive and not exclusive of pregnant women in research.

Answer: True

Question:

Answer: Yes - this research is permitted.