-CITE-

    45 CFR Sec. 46.209

-EXPCITE-

    Title 45
    SUBTITLE A
    PART 46
    Subpart B

-HEAD-

    Sec. 46.209 Activities directed toward fetuses ex utero, including
        nonviable fetuses, as subjects.

-TEXT-

      (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 paragraph (a) or (b) 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 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.
    (40 FR 33528, Aug. 8, 1975, as amended at 43 FR 1759, Jan. 11,
    1978)