Research Involving Pregnant Women, Human Fetuses and Neonates
18.3.1 Definitions
Dead fetus - a fetus that exhibits no heartbeat, spontaneous respiratory
activity, spontaneous movement of voluntary muscles, or 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 means a newborn. A newborn is considered a neonate up to 30 days of
age. A newborn, 31 days old will be considered a child for research purposes.
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.
Stillborn death or stillbirth means death prior to the complete expulsion or extraction
from its mother of a product of human conception, occurring after the twentieth week
of pregnancy and does not include “induced termination of pregnancy. Colorado
Revised Statutes, §25-2-102(4.5).
Induced termination of pregnancy means the purposeful interruption of a
pregnancy with the intention other than producing a live-born infant or removing a
dead fetus that does not result in a live birth. Colorado revised statutes, §25-2102(2.7).
18.3.2 Research Involving Pregnant Women or Fetuses
Research that involves pregnant women and fetuses can only occur if all of the
following conditions are met (45 CFR 46.204):
When appropriate, preclinical studies including studies on pregnant animals and
clinical studies, including studies on non-pregnant women, have been conducted and
provide data for assessing the potential risks to pregnant women and fetuses;
 The risk to the fetus is caused solely by interventions or procedures that hold
out the potential of direct benefit for the woman or the fetus,
or
 If there is no potential of benefit, the risk to the fetus must be minimal, and
the purpose of the research is the development of important biomedical
knowledge which cannot be obtained by any other means.
Any risk is the least possible for achieving the objectives of the research. No
inducements, monetary or otherwise, may be offered to terminate a pregnancy.
Researchers may not take part in decisions as to the timing, method, or procedures
used to terminate a pregnancy.
Members of the research team may not determine the viability of a neonate.
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18.3.2.1 Who Can Consent
The mother may consent for the study if:
The research holds out the potential of direct benefit to the pregnant woman, or both
the pregnant woman and fetus, or;
If there is no benefit for the woman or fetus and the risk to the fetus is minimal,
and; The purpose of the research is the development of important biomedical
knowledge that cannot be obtained by any other means.
The mother and father must consent for the study if:
The research holds out the potential of direct benefit solely to the fetus,
The father’s consent need not be obtained if he is unable to consent because of
unavailability, incompetence or temporary incapacity or the pregnancy resulted
from rape or incest.
COMIRB requests that you document the reasons for not obtaining the father’s
consent in your study records.
Each individual providing consent must be fully informed regarding the reasonably
foreseeable risks of the research on the fetus or neonate.
Any minor parent can give permission for their child to participate in research but the
parent/guardian of the minor parent must give permission for the minor parent to
participate in the research. Parental permission is not required if the minor parent
is emancipated as defined by Colorado State Law.
18.3.2.2 VA Regulations
 Research in which the subject is a fetus, in-utero or ex-utero (including human
fetal tissue) must not be conducted by VA investigators while on official duty, or at
VA facilities, or at approved off-site facilities.
 Research related to in vitro fertilization must not be conducted by VA
investigators while on official duty, or at VA facilities, or at approved off-site
facilities.
18.3.3 Research Involving Neonates
Neonatal research is dependent on the viability status of the neonate (45 CFR 46.205). A
neonate that is viable may participate in research only to the extent outlined by 45 CFR
46 subparts A and D.
Neonates whose viability is not certain may participate in research if COMIRB
determines that the research:
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Holds out the prospect of enhancing the survival of the neonate to the
point of viability and the risk is minimized for achieving that goal,
or
The development of important biomedical knowledge which cannot be obtained
by other means, and there can be no added risk to the neonate from the
research.
In addition:
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The appropriate preclinical and clinical studies have been carried out that allow
for adequate risk assessment.
A neonatologist or pediatrician not associated with the research determines the
viability of the neonate.
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Informed consent of either parent of the neonate is obtained
If neither parent is able to consent because of unavailability, incompetence, or
temporary incapacity, the legally authorized representative [LAR] of either parent
may provide informed consent. COMIRB requests that you document the reasons
for why you obtained the legally authorized representative’s consent.
The consent of the father is not needed if the pregnancy resulted from rape or
incest.
After delivery, nonviable neonates may be involved in research only if the following
conditions are met:
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The vital functions of the neonate are not artificially maintained
The research will not terminate the heartbeat or respiration of the neonate
There are no additional research risks to the neonate
The purpose of the research is the development of important biomedical
knowledge that cannot be obtained by other means
Informed consent of either parent of the neonate is obtained
If neither parent is able to consent because of unavailability, incompetence, or
temporary incapacity, the legally authorized representative of either parent may
provide informed consent. COMIRB requests that you document the reasons
why you obtained the legally authorized representative’s consent. The consent of
the father is not needed if the pregnancy resulted from rape or incest
18.3.4 Research Involving After Delivery: The Placenta, Dead Fetus or Fetal Material
Research involving the placenta following delivery; the dead fetus, macerated fetal
material; or cells, tissue, or organs removed from the dead fetus shall follow the
appropriate federal, state or local laws and regulations (45 CFR 46.206).
If the above tissue’s information is recorded so that living individuals can be identified,
then the living individuals are considered research subjects. Informed consent must be
obtained from the living individuals.
No physician or institution that performs procedures for the induced termination of
pregnancy shall transfer such tissue for valuable consideration to any organization or
person that conducts research using fetal tissue or that transplants fetal tissue for therapeutic
purposes. (Colorado revised statutes, §25-2-111.5). [Valuable consideration means simply
any profit or gain.]
For additional information about research using fetal or embryonic tissues, please see
section 26.8.
18.3.5 Neonatal Research not Otherwise Approvable
For research not funded by DHHS, if the COMIRB finds that the research presents a
reasonable opportunity to further the understanding, prevention, or alleviation of a
serious problem affecting the health or welfare of pregnant women, fetuses or
neonates; and the research is not approvable under the above provisions, then the
COMIRB will consult with a panel of experts in pertinent disciplines (for example:
science, medicine, ethics, law). Based on the recommendation of the panel, the
COMIRB may approve the research based on either:
a. That the research in fact satisfies the conditions above, as applicable;
or b. The following:
o The research presents a reasonable opportunity to further the
understanding, prevention, or alleviation of a serious problem affecting
the health or welfare of pregnant women, fetuses or neonates;
o The research will be conducted in accord with sound ethical principles;
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and
o Informed consent will be obtained in accord with the provisions
for informed consent and other applicable sections of this
manual.
DHHS-funded research that falls in this category must be approved by the Secretary of
Health and Human Services. If the COMIRB finds that the research presents a
reasonable opportunity to further the understanding, prevention, or alleviation of a
serious problem affecting the health or welfare of pregnant women, fetuses or
neonates; and the research is not approvable under the above provisions, then the
research will be sent to OHRP for DHHS review.
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