4.2 - Pregnancy

Pregnancy encompasses the period of time from the confirmation of implantation until the expulsion or extraction of the fetus. A fetus is the product of conception from the time of conception until a determination is made, following expulsion or extraction, that it is viable. Viable as it pertains to the fetus means being able, after either spontaneous or induced delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heart beat and respiration. Nonviable refers to a fetus ex utero which is living but not viable. Dead fetusmeans a fetus ex utero that exhibits neither heart beat, spontaneous respiration, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord. In vitro fertilization means any fertilization of the human ova that occurs outside the body of a human female. Special DHHS regulations applying to pregnant women and fetuses may be found in 45 CFR 46, Subpart B. No research may be conducted with pregnant women or fetuses unless the following conditions have been met:

  • appropriate studies on animals and non-pregnant individuals have been conducted;
  • the risk to the fetus is minimal, except where the activity is to meet the health needs of the mother or particular fetus, and the activity involves the least possible risk;
  • individuals engaged in research will have no part in (a) decisions as to the timing, method, and procedures used to terminate the pregnancy, and (b) determining the viability of the fetus at the termination of the pregnancy;
  • when the pregnancy is terminated, no changes in standard procedure will be introduced for the purpose of research if the changes cause greater than minimal risk to the mother or the fetus;
  • no monetary or other inducements may be offered to terminate a pregnancy for the purpose of research.