Fetuses Ex Utero, including Nonviable Fetuses

(a)

Until it has been ascertained whether or not a fetus ex utero is viable, a fetus ex utero may not be involved as a subject in an activity covered by this subpart unless:

(1)

There will be no added risk to the fetus resulting from the activity, and the purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other means, or

(2)

The purpose of the activity is to enhance the possibility of survival of the particular fetus to the point of viability.

(b)

No nonviable fetus may be involved as a subject in an activity covered by this subpart unless:

(1)

Vital functions of the fetus will not be artificially maintained,

(2)

Experimental activities which of themselves would terminate the heartbeat or respiration of the fetus will not be employed, and

(3)

The purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other means.

(c)

In the event the fetus ex utero is found to be viable, it may be included as a subject in the activity only to the extent permitted by and in accordance with the requirements of other subparts of this part.

(d)

An activity permitted under ... 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 informed consent need not be secured if:

(1)

his identity or whereabouts cannot reasonably be ascertained,

(2)

he is not reasonably available, or

(3)

the pregnancy resulted from rape. (sec. 45 CFR 46.209)

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