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Pregnant Women as Subjects


(a)
No pregnant woman may be involved as a subject in an activity covered by this subpart unless: (1) The purpose of the activity is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or (2) the risk to the fetus is minimal.

(b)
An activity permitted under ... this section may be conducted only if the mother and father are legally competent and have given their informed consent after having been fully informed regarding possible impact on the fetus, except that the father's informed consent need not be secured if:

(1)
The purpose of the activity is to meet the health needs of the mother;

(2)
his identity or whereabouts cannot reasonably be ascertained;

(3)
he is not reasonably available; or

(4)
the pregnancy resulted from rape. (sec. 45 CFR 46.207)


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