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.
True
• False
Question 2
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?
The father (except if he is unable to consent because of unavailability, incompetence,
or temporary incapacity or the pregnancy resulted from rape or incest)
The mother and the father
The mother and the legally authorized representative for the fetus
The mother
Question 3
According to 1994 NIH Guidelines, which of the following is adequate justification
for exclusion of women from NIH-funded research?
There is compelling evidence that inclusion would be inappropriate with respect to
the health of the subjects,
Inclusion of women would complicate analysis of the results and increase the costs
of conducting the clinical trial,
The woman is of child-bearing potential.
