Research Involving Pregnant Women, Neonates, and Fetuses

Definitions

Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.

Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other means.

Fetus means the product of conception from implantation until delivery.

Neonate means a newborn.

Nonviable neonate means a neonate after delivery that, although living, is not viable.

Pregnancy encompasses the period of time from implantation until delivery. A woman will be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.

Viable, as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist in determining whether a neonate is viable for purposes of this subpart. If a neonate is viable then it may be included in research only to the extent permitted and in accordance with the requirements of subparts A and D of this part.

Regulatory Requirements

For research involving pregnant women, fetuses, or neonates the IRB will approve the conduct of the research only if it finds that the research meets the regulatory criteria for approval addressed under the federal regulations at 45 CFR 46 Subpart B (45 CFR 46.204, "Research involving pregnant women or fetuses prior to delivery"; 45 CFR 46.205, "Research involving neonates"; 45 CFR 46.206, "Research involving, after delivery, the placenta, the dead fetus, or fetal material").

For research that does not meet the criteria for approval addressed under 45 CFR 46.204, "Research involving pregnant women or fetuses prior to delivery"; 45 CFR 46.205, "Research involving fetuses after delivery"; or 45 CFR 46.206, "Research involving, after delivery, the placenta, the dead fetus, or fetal material," the IRB must find that:

  • the research presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women or fetuses; and
  • the research, if federally supported, will be submitted for review and approval by the Secretary, DHHS, in accordance with the provisions of 45 CFR 46.207, “Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women or fetuses”. If the research study is not federally-supported, the IRB will use a review by a panel of obstetrician/ gynecology experts (2 members with expertise in the area who are not currently IRB members) and an ethicist to recommend whether to approve the study as research that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women or fetuses.

Consent

Pregnant Women/Fetus Prior to Delivery

For research involving pregnant women or the fetus prior to delivery, the documented, written informed consent of the pregnant women or her authorized representative will be obtained in accordance with the provisions of 45 CFR 46.204; unless the IRB grants either a waiver of informed consent in accordance with 45 CFR 46.116(d) or a waiver of the requirement to document informed consent in accordance with 45 CFR 46.117(c).

Neonates of Uncertain Viability

For research involving neonates of uncertain viability, the documented, written informed consent of either parent or the authorized representative of either parent will be obtained in accordance with the provisions of 45 CFR 46.205; unless the IRB grants either a waiver of informed consent in accordance with 45 CFR 46.116(d) or a waiver of the requirement to document informed consent in accordance with 45 CFR 46.117(c).

Nonviable Neonates

For research involving nonviable neonates (i.e., neonates determined to be unable, after delivery, to survive to the point of independently maintaining heartbeat and respiration), the documented, written informed consent of both parents will be obtained in accordance with the provisions of 45 CFR 46.205.

  • If either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the IRB may approve the research based on the consent of one parent. (Note: the consent of the father need not be obtained if the pregnancy resulted from rape or incest.)
  • Note: the IRB may not grant approval for authorized representative (i.e., proxy) consent or a waiver of the requirement to obtain consent (i.e., 45 CFR 46.116 (c) or 45 CFR 46.116 (d)) for research involving nonviable neonates.

Fetal Material Derived from Abortion

For research involving the dead fetus or fetal material derived from an induced abortion, the documented written informed consent of the mother must be obtained in accordance with the Pennsylvania Abortion Control Act.

  • The research protocol must specify that informed consent for use of the fetal tissue for research will be obtained separately from, and after, the consent is obtained for the abortion.
  • No remuneration, compensation or other consideration of any kind may be offered to a woman to consent to the use of fetal tissues for research.
  • The donor may not designate the recipient of fetal tissue.

All persons who participate in the procurement, use or transplantation of fetal tissue must be informed as to the source of the tissue (e.g., abortion, miscarriage, still birth, ectopic pregnancy). Any protocol that involves an intervention derived from fetal tissue must include the information as part of the informed consent document and/or process.

Under Pennsylvania law, any nontherapeutic medical procedure performed upon a fetus may be considered to be a third degree felony. 18 Pa.Con.Stat Section 3216(a).

If researchers are obtaining fetal tissues or organs from sources outside of the University of Pittsburgh, confirmation must be provided from the outside source that the material was collected with appropriately obtained consent under applicable laws.

Fetal research funded by the DOD must comply with the US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g.