Until it has been ascertained whether or not a fetus ex utero is viable, a fetus ex utero may not be involved as a research subject in an activity unless:
- There will be no added risk to the fetus resulting from the research, and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means.
- The purpose of the research is to enhance the possibility of survival of the particular fetus to the point of viability.
No viable fetus may be involved as a subject in an activity unless:
- Vital functions of the fetus will not be artificially maintained.
- Experimental activities which of themselves would terminate the heartbeat or respiration of the fetus will not be employed.
- The purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other means.
Research permitted with fetuses ex utero as subjects 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:
- His identity or whereabouts cannot reasonably be ascertained.
- He is not reasonably available.
- The pregnancy resulted from rape.
Activities involving the dead fetus, macerated fetal material, or cells, tissue, or organs excised from a dead fetus must be conducted only in accordance with any applicable state or local laws regarding such activities and federal policy on fetal tissue research.