Pregnant Women, Fetuses & Neonates
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Pregnant Women, Fetuses & Neonates
Research Involving Pregnant Women, Human Fetuses and Neonates
The following applies to all research regardless of funding source. Since, according to the University of Illinois FWA, Subpart B of 45 CFR 46 applies only to DHHS-funded research, the funding source specific requirements are noted in the appropriate sections.
Dead fetus - a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.
Delivery - complete separation of the fetus from the woman by expulsion or extraction or any other means.
Fetus - the product of conception from implantation until delivery.
Neonate - a newborn.
Nonviable neonate - a neonate after delivery that, although living, is not viable.
Pregnancy encompasses the period of time from implantation until delivery. A woman is 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.
Research Involving Neonates
The following policies and procedures apply to all research involving neonates, regardless of funding source. Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following conditions are met:
- Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to neonates.
- Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the neonate.
- Individuals engaged in the research will have no part in determining the viability of a neonate.
- The requirements of Neonates of Uncertain Viability or Nonviable Neonates (see below in this section) have been met as applicable.
Neonates of Uncertain Viability
Until it has been ascertained whether or not a neonate is viable, a neonate may not be involved in research covered by this subpart unless the following additional conditions have been met:
- The research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective, or
- The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research; and
- The legally effective informed consent of either parent of the neonate or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent's legally authorized representative is obtained in accord with the provisions of permission and assent, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.
After delivery, nonviable neonates may not be involved in research covered by this subpart unless all of the following additional conditions are met:
- Vital functions of the neonate will not be artificially maintained;
- The research will not terminate the heartbeat or respiration of the neonate;
- There will be no added risk to the neonate resulting from the research;
- The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and
- The legally effective informed consent of both parents of the neonate is obtained in accord with the provisions of permission and assent, except that the waiver and alteration of the provisions of permission and assent do not apply.
- However, if either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent of a nonviable neonate will suffice to meet the requirements of this paragraph, except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest. The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will not suffice to meet the requirements of this paragraph.
A neonate, after delivery, that has been determined to be viable may be included in research only to the extent permitted by and in accord with the requirements of IRB Review Process and Research Involving Children.
Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs excised from a dead fetus, must be conducted only in accord with any applicable federal, state, or local laws and regulations regarding such activities.
If information associated with material described above in this section is recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals, those individuals are research subjects and all pertinent sections of this manual are applicable.