Principal Investigator:
Study Title:
Version Date:
Vanderbilt University Institutional Review Board
Vulnerable Populations:
PREGNANT WOMEN, HUMAN FETUSES, NEONATES, OR FETAL
MATERIAL
Use this form if you plan to include one of the following groups of individuals in your study:
Pregnant women or fetuses

Pregnant women or fetuses may be involved in research if all of the conditions under 45 CFR 46.204 are
met (complete all questions under checkbox #1).
Neonates (viable, nonviable or uncertain viability)

Neonates of uncertain viability may be involved in research if all the conditions under 45 CFR 46.205(a)
and 45 CFR 46.205(b) are met

Nonviable neonates may be involved in research if all the conditions under 45 CFR 46.205(a) and 45
CFR 46.205(c) are met.

Viable neonates may be involved in research if the conditions in 45 CFR 46 Subpart A and D are met.
The placenta, the dead fetus or fetal material obtain after delivery

Research involving, after delivery, the placenta, the dead fetus or fetal material must be conducted in
accordance with 45 CFR 46.206 (complete all questions under checkbox #2).
§ 46.204 Research Involving Pregnant Women or Fetuses Address all items listed below.
1. Provide information to describe the pre-clinical studies on pregnant animals and clinical studies on pregnant
or non-pregnant women that have been conducted (when scientifically appropriate) to provide data for
assessing the potential risks to pregnant women and fetuses. (attach as a separate document if needed and
provide references)
2. One of the following must apply:
The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct
benefit for the woman or the fetus.
a) Describe the benefits to the woman/fetus:
OR
There is no prospect of direct benefit for the woman or the fetus but 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.
a) Describe how the research involves no more than minimal risk for participants:
b) Describe how this study may provide important biomedical knowledge that cannot otherwise be
obtained:
Vulnerable Populations: Pregnant Women, Fetuses and Neonates (Form#1116)
Form Revision Date: February 3, 2010
Replaces Form Dated: January 2, 2007
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Principal Investigator:
Study Title:
Version Date:
3. Explain why any risk is the least possible for achieving the objectives of the research.
4. Mark “yes” or “no” to the following questions
a) Will any inducements, monetary or otherwise, be offered to terminate a pregnancy?
No
Yes
b) Will individuals engaged in the research have any part in any decisions as to the timing, method, or
procedures used to terminate a pregnancy? No Yes
c) Will individuals engaged in the research have any part in determining the viability of a fetus?
No
Yes
If you marked “yes” to any of the questions above, then this study protocol does not meet the requirements for
approval under 45 CFR 46.204. Please contact the IRB for assistance.
5. Informed Consent must be obtained as required in 45 CFR 46.116 and 117. The informed consent process
should include a clear explanation regarding the reasonably foreseeable impact of the research on the fetus.
a) In some circumstances waiver of consent/authorization may be applicable.
No
Yes Is a waiver of the informed consent process being sought?
If “yes”, complete Form 1112. And skip to item 6.
No
Yes Is an alteration of the consent process or a waiver of the documentation of informed
consent being sought?
If “yes”, complete Form 1112 and continue below.
b) Informed Consent is required from the pregnant woman only or her legally authorized representative
when one of the conditions is met:
No
No
No
Yes The research holds out the prospect of a direct benefit to the pregnant woman.
Yes The research holds out the prospect of a direct benefit both to the pregnant woman
and the fetus.
Yes The research does not hold out the prospect a of direct benefit for the woman or the
fetus, but the risk to the fetus is not greater than minimal and the purpose of the
research is the development of important biomedical knowledge that cannot be
obtained by any other means.
c) Informed Consent is required from both the pregnant woman and the father when:
No
Yes The research holds out the prospect of a direct benefit solely to the fetus.
**NOTE: The father's informed 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.
Vulnerable Populations: Pregnant Women, Fetuses and Neonates (Form#1116)
Form Revision Date: February 3, 2010
Replaces Form Dated: January 2, 2007
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Principal Investigator:
Study Title:
Version Date:
d) Assent from the pregnant child and permission from her parent or legal guardian must be obtained in
accordance with the provisions of 45 CFR 46, Subpart D when:
No
Yes The research involves participants who are pregnant and meet the definition of
“children” as defined in 45 CFR 46.402. (Note: Children are persons who have not
attained the legal age to consent to treatments or procedures involved in the
research, under the applicable law of jurisdiction in which the research will be
conducted. In Tennessee, the legal age for consent is 18 years of age.) Please
complete the Vulnerable Population Form for Children (Form 1117)
In certain circumstances, mature or emancipated minors may be considered as
individuals who can provide consent. Please see IRB Policy IV.A Informed Consent
Process for guidance.
§ 46.205 Research Involving Neonates
Please place a check in the box beside the population/s that best fits your proposed research and answer the
questions that immediately follow:
A.
Viable Neonates (i.e. neonate able to survive given the benefit of available medical treatment, by
independently maintaining heartbeat and respiration after delivery).
1) Please complete the “Vulnerable Population Supplemental Form for Children” (IRB Form #1117).
Please note, for viable neonates to participate in research the requirement of 45 CFR 46 Subparts A and D
must be met.
2) Explain the procedures that will be used to obtain 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 will be
obtained as required by 45 CFR 46.116 & 117.
NOTE: These procedures must assure that each individual providing informed consent will be fully
informed regarding the reasonably foreseeable impact of the research on the neonate.
B.
Research involving neonates of uncertain viability and nonviable neonates may be included in
research if all of the following conditions are satisfied:
Until it has been ascertained whether or not a neonate is viable, a neonate may not be involved in research
covered by Subpart B unless the following conditions are met:
1) Explain why the proposed research is scientifically appropriate and provide a description of any preclinical and clinical studies that have been conducted which provide data for assessing potential risks to
neonates.
2) Will individuals engaged in the research have any part in determining the viability of a neonate?
No
Yes
(If “yes” neonates of uncertain viability and nonviable neonates may NOT be included in this research)
Neonates of Uncertain Viability - Additional Requirements
1) Place a check in the appropriate box as it applies to this research:
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 research has the main purpose of 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.
Vulnerable Populations: Pregnant Women, Fetuses and Neonates (Form#1116)
Form Revision Date: February 3, 2010
Replaces Form Dated: January 2, 2007
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Principal Investigator:
Study Title:
Version Date:
2) Explain the procedures that will be used to obtain 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 will be obtained as required by 45 CFR 46.116 & 117.
NOTE: These procedures must assure that each individual providing informed consent
will be fully informed regarding the reasonably foreseeable impact of the research on the
neonate.
Nonviable Neonates – Additional Requirements
After delivery, a nonviable neonate may not be involved in research covered by Subpart B unless all
of the following additional conditions are met:
1) Will the vital functions of the neonate be artificially maintained?
No
Yes
2) Does the research include procedures to terminate the heartbeat or respiration of the neonate?
No
Yes
3) Will there be any added risk to the neonate resulting from this research?
No
Yes
4) Can the knowledge gained from this research be obtained by other means?
No
Yes
Note: If the answer to any of the four questions above is “yes,” nonviable neonates may NOT
be included in this research.
5) Please describe the informed consent process. Please note, 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 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.
NOTE: The process must assure that each individual providing informed consent will be fully
informed regarding the reasonably foreseeable impact of the research on the neonate.
§ 46.206 Research Involving, After Delivery, The Placenta, The Dead Fetus, Or Fetal Material
1) This research proposes to use the following: (Check all that apply)
placenta
the dead fetus
macerated fetal material
cells excised from dead
tissue excised from dead
organs excised from dead
fetus
fetus
fetus
NOTE: The use of any of the above must be conducted in accordance with any applicable Federal,
State, or local laws, regulations, and institutional policies regarding such activities (See IRB Policy
IX.C for further details).
2) Will any information associated with the material identified above be recorded for research purposes in such
a manner that living individuals can be identified, directly or through identifiers linked to those individuals?
No
Yes
NOTE: If “Yes”, those individuals are considered to be research subjects and all pertinent human
subject regulations are applicable to their participation.
Vulnerable Populations: Pregnant Women, Fetuses and Neonates (Form#1116)
Form Revision Date: February 3, 2010
Replaces Form Dated: January 2, 2007
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Principal Investigator:
Study Title:
Version Date:
§ 46.207 Research that does NOT meet § 46.204 or § 46.205 Above BUT not Otherwise Approvable Which
Presents an Opportunity to Understand, Prevent, or Alleviate a Serious Problem Affecting the Health or
Welfare of Pregnant Women, Human Fetuses, or Neonates.
This requires review by the Secretary of the Department of Health and Human Services (DHHS) and posting in the
Federal Register for public comments and review.
1) Please provide justification 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.
2) Please describe how the research will be conducted in accord with sound ethical principles.
3) Explain how informed consent will be obtained.
Vulnerable Populations: Pregnant Women, Fetuses and Neonates (Form#1116)
Form Revision Date: February 3, 2010
Replaces Form Dated: January 2, 2007
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