Last Revised: 10.2015
Prior Version: 7.2007
Special Populations in Research
Pregnant Women 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). The CWRU
IRB does not review or approve biomedical protocols involving fetuses or neonates.
Investigators must submit their study to a hospital IRB such as University Hospitals of
Cleveland.
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).
Neonate means a newborn. (45 CFR 46.202, Subpart B). Investigators must submit their study
to a hospital IRB such as University Hospitals of Cleveland. Non-biomedical protocols
involving neonates may be reviewed by the CWRU IRB.
The CWRU SBER IRB does not review or approve biomedical protocols involving
pregnant women or neonates.
Policy
A research protocol is considered to include pregnant women, human fetuses, and/or neonates
when:

Any of the above are target populations about which data are collected; 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.
II.
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 (please keep in mind that the
following conditions apply most often in biomedical research and do not fall under the
purview of the CWRU SBER IRB).

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,
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CWRU SBER IRB Policies and Procedures
Last Revised: 10.2015
Prior Version: 7.2007
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
scientific knowledge which cannot be obtained by any other means.
Any risk is the least possible for achieving the objectives of the research.
When research involves pregnant women, the IRB determines that the consent of
the pregnant women is required if the research holds out:
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 development of
important knowledge that cannot be obtained by any other means.
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(s) or legal guardian(s). Please see the CWRU IRB
policy on Special Population in Research: Children.
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 regulations, including 45 CFR 46 Subpart B, are applicable. This includes
obtaining informed consent from the pregnant partner for participation.
III.
Additional Considerations when the Pregnant Subject is a Child
In addition to the regulations under 45 CFR 46 Subpart B, if the pregnant subject is also a
child, there are additional considerations that must be accounted for under 45 CFR 46
Subpart D, Additional Protections for Children Involved as Research Subjects.
Prior to inclusion of pregnant children 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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CWRU SBER IRB Policies and Procedures
Last Revised: 10.2015
Prior Version: 7.2007
In research protocols that involve pregnancy testing of subjects who are under the age of
18, the following is required:

If the female is 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. 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 child. 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.
References and/or Regulatory Citations
45 CFR 46, Subpart B
45 CFR 46.204
45 CFR 46.205
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CWRU SBER IRB Policies and Procedures