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Activities Directed toward Fetuses In Utero as Subjects

No fetus in utero may be involved as a subject in any activity covered by this subpart unless: (1) The purpose of the activity is to meet the health needs of the particular fetus 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 imposed by the research is minimal and the purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other means.

An activity permitted under paragraph (a) of this section may be conducted only if the mother and father are legally competent and have given their informed consent, except that the father's consent need not be secured if:

His identity or whereabouts cannot reasonably be ascertained,

he is not reasonably available, or

the pregnancy resulted from rape. (sec. 45 CFR 46.208)

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