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Pregnant Women, Human Fetuses, and Neonates
Introduction:
The IRB recognizes the additional protections required under Federal law for pregnant
women, human fetuses and neonates who participate in research (45 CFR 46, Subpart B).
Definitions:
Pregnancy encompasses the period of time from implantation until delivery. A woman
shall 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 (45 CFR 46.202, Subpart B).
Fetus means the product of conception from implantation until delivery. (45 CFR 46.202,
Subpart B).
Neonate means a newborn. (45 CFR 46.202, Subpart B).
Policy:
A research protocol is considered to include pregnant women, human fetuses, and/or
neonates when:
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any of the above are the target population that will be recruited; or
pregnancy occurs during the course of a research study and information about the
pregnancy, fetus and/or neonate will be obtained as part of the research study.
A) Pregnant women and fetuses
In order to approve the inclusion of pregnant women in a research protocol, the following
conditions listed in 45 CFR 46.204, Subpart B must be met:
 Where scientifically appropriate, preclinical studies, including studies on pregnant
animals and clinical studies on non-pregnant women, have been conducted and
provide data for assessing potential risks to pregnant women and fetuses.
 The risk to the fetus:
o is caused solely by interventions or procedures that hold out the prospect
of direct benefit for the woman or the fetus; or,
o if there is no prospect of benefit, the risk to the fetus is not greater than
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.
 The research must either:
o holds out the prospect of direct benefit to the pregnant woman, the
prospect of direct benefit for the woman or the fetus; or
o no prospect of benefit for the woman nor fetus when risk to the fetus is
not greater than minimal and the purpose of the research is the
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development of important biomedical knowledge that cannot be obtained
by any other means
And her consent is obtained in accord with the informed consent provisions of 45
CFR 46 Subpart A.
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If the research holds out the prospect of direct benefit solely to the fetus, then the
consent of the pregnant woman and the father must be obtained in accord with the
informed provisions of 45 CFR 46 Subpart A, except that 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 in rape or incest.
Each individual providing consent is fully informed regarding the reasonably
foreseeable impact of the research on the fetus or neonate.
For children who are pregnant, assent must be obtained from the pregnant child and
consent from her parent or legal guardian.
No inducement, monetary or otherwise will be offered to terminate a pregnancy.
Individuals engaged in the research will have no part in determining the viability of a
neonate.
The research protocol must address how these conditions are met and provide sufficient
justification for inclusion of pregnant women.
If a research protocol proposes to collect information from the pregnant partner of a
research subject, the pregnant partner becomes a “research subject” and the provisions
under OHRP and FDA regulations, including 45 CFR 46 Subpart B, are applicable. This
includes obtaining informed consent from the pregnant partner for participation.
B) Neonates
The IRB may approve research that involves the following categories of neonates:
neonates of uncertain viability, non-viable neonates, viable neonates if all of the
following are met (45 CFR 46.205, Subpart B), as well as additional criteria listed for
each special population below:
 Where scientifically appropriate, preclinical and clinical studies have been conducted
and provide data for assessing potential risk 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.
1) Neonates of uncertain viability
A neonate whose viability has not yet been ascertained may only be involved in research
if all of the following additional conditions are 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
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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 the unavailability, incompetence, or temporary
incapacity, the legally effective informed consent of either parent’s legally authorized
representative is obtained, except that the consent of the father or his legally
authorized representative need not be obtained if the pregnancy resulted from rape or
incest.
2) Nonviable neonate
After delivery, a neonate that is living but is not considered viable may be involved in
research if 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.
 The legally effective informed consent of both parents of the neonate must be
obtained. 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 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.
3) Viable neonates
A neonate determined to be able to survive to the point of independently maintaining
heartbeat and respiration (“viable”) upon delivery may be included in research to the
extent permitted by and in accordance with OHRP (including Subpart D) and FDA
requirements
C) Additional considerations when the pregnant subject is a
minor
In addition to the regulations under 45 CFR 46 Subpart B, if the pregnant subject is also a
minor, there are additional considerations that must be accounted for under 45 CFR 46
Subpart D, Additional Protections for Children Involved as Research Subjects. Please see
IRB policy “Protocol Submission Requirements” and “Assent from Children in Research
Studies” for more information.
Prior to inclusion of pregnant minors in research, parental permission must be obtained or
the IRB must approve a waiver of the requirement for parental permission in accordance
with 45 CFR 46.116 or 45 CFR 46.117.
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In research protocols that involve pregnancy testing of subjects who are minors, the
following is required:
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If the female age 13 years or younger, positive results of the pregnancy test must
be shared with both the child and the parent or legal guardian. In addition, the
pregnancy must be reported to the local public children’s service agency (PCSA)
per UHCMC reporting requirements (see UHCMC Clinical Policy 1.2 “Child
Abuse and Neglect”. This must be documented in the research record.
If the female is age 14 years or older, the results of the pregnancy test must be
shared with the minor. The results do not automatically have to be shared with
the parent or legal guardian unless the parent or legal guardian asks for the results.
This must be documented in the research record.
If the research study is a clinical trial and wishes to obtain information and/or
enroll the minor pregnant partner of a currently enrolled male research subject,
the following additional protections are required:
o If there is no known risk to the pregnancy as a result the male partner’s
participation in the research study, the study staff may ask the male
partner to talk to the minor female partner to see if she wishes to
participate in the research study with her parents consent. If the female
pregnant partner wishes to participate, she and her parent or legal guardian
can contact the study staff to discuss participation in more detail.
o If there is a known or theoretical risk to the pregnancy as a result of the
male partner’s participation in the research study, the male subject should
instruct his pregnant partner to contact study staff. The study staff should
disclose relevant information about the study, including possible risks to
pregnancy and potential follow-up. The pregnant partner should discuss
this with her parent or legal guardian, who should then contact the study
staff for follow-up.
References and/or Regulatory Citations:
45 CFR 46, Subpart B
45 CFR 46.204
45 CFR 46.205
Related Policies:
IRB Policy, Assent from Children for Research Studies
IRB Policy, Protocol Submission Requirements
IRB Policy, Department Review of Protocols
IRB Policy, Additional Required Reviews
UHCMC Clinical Policies, Administrative Policy and Procedure Manual II, “1.2: Child
Abuse and Neglect”
UHCMC IRB Policies and Procedures