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IV.09
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Review of Research Involving Pregnant
Women, Fetuses, and Neonates
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Objective
This
Policy/Procedure describes the process by which the Committee for the
Protection of Human Subjects (CPHS) members review
protocols involving pregnant women, human fetuses and neonates. This policy is in effect both for full
Committee reviews and expedited reviews.
Policy/Procedure
I. Pregnant women or fetuses
may be involved in research if all of the following conditions are met.
A.
Where scientifically appropriate, preclinical studies, including studies
on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for
assessing potential risk to pregnant women and fetuses; and
B.
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; or if
there is no such 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; and
C.
Any risk is the least possible for achieving the objectives of the
research; and
D.
If the research holds out the prospect of direct benefit to the pregnant
woman, the prospect of a direct benefit both to the pregnant woman and the
fetus, or no prospect of benefit for the woman nor the fetus when 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, her consent is obtained in accord with the informed consent
provisions according to regulations; and
E.
If the research holds out the prospect of direct benefit solely to the
fetus then the consent of the pregnant woman and the father is obtained in
accord with regulations, 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 from rape or incest; and
F.
Each individual providing consent under paragraph (D) or (E) of this
section is fully informed regarding the reasonably foreseeable impact of the
research on the fetus or neonate; and
G.
For children who are pregnant, assent and permission are obtained
according to regulations; and
H.
No inducements, monetary or otherwise, will be offered to terminate a
pregnancy; and
I.
Individuals engaged in the research will have no part in any decisions as
to the timing, method, or procedures used to terminate a pregnancy; and
J.
Individuals engaged in the research will have no part in determining the
viability of the neonate.
II. Research involving
neonates
A. Neonates of uncertain
viability and nonviable neonates may be involved in research if all of the
following conditions are met:
1. Where scientifically
appropriate, preclinical and clinical studies have been conducted and provide
data for assessing potential risks to neonates; and
2. Each individual providing
consent is fully informed regarding the reasonably foreseeable impact of the
research on the neonate; and
3. Individuals engaged in the
research will have no part in determining the viability of a neonate; and
4. The requirements of
paragraph (B) or (C) of this section have been met as applicable.
B. 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 section unless the following additional
conditions have been met and the CPHS determines that:
1. 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
2. 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.
C. 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 subpart A of 45 CFR §46, except that
the consent of the father or his legally authorized representative need not be
obtained if the pregnancy resulted from rape or incest.
D. Nonviable neonates – After
delivery nonviable neonates may not be involved in research unless all of the
following additional conditions are met:
1. Vital functions of the
neonate will not be artificially maintained; and
2. The research will not
terminate the heartbeat or respiration of the neonate; and
3. There will be no added
risk to the neonate resulting from the research; and
4. The purpose of the
research is the development of important biomedical knowledge that cannot be
obtained by other means; and
5. The legally effective
informed consent of both parents of the neonate is obtained in accord with
subpart A of 45 CFR §46, except that the waiver and alteration provisions of
§46.116(c) and (d) do not apply.
a)
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 45
CFR §46.205(c)(5), except that the consent of the father need not be obtained
if the pregnancy resulted from rape or incest.
b)
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 45 CFR §46.205(c)(5).
III.
Research involving, after delivery, the placenta,
the dead fetus or fetal material.
A. Research involving, after
delivery, the placenta; the dead fetus; macerated fetal material; or cells,
tissue, or organs excised from a dead fetus, shall be conducted only in accord
with any applicable Federal, State, or local laws and regulations regarding
such activities.
IV.
The Secretary of the Department of Health and Human Services (Secretary) will conduct or fund
research that the CPHS does not believe meets the requirements of 45 CFR
§46.204 or 45 CFR §46.205 only if: [45 CFR §46.207]
A. The CPHS 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.
B. The Secretary, after
consultation with a panel of experts in pertinent disciplines (for example:
science, medicine, ethics, law) and following opportunity for public review and
comment, including a public meeting announced in the Federal Register, has
determined either:
1. That the research in fact
satisfies the conditions of §46.204, as applicable; or
2. The following:
a)
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.
b)
The research will be conducted in accord with sound ethical principles.
c)
Informed consent will be obtained in accord with the informed consent
provisions of subpart A and other applicable subparts of this part.
V. Studies in which pregnancy
is coincidental to subject selection
A.
Any study in which women of childbearing potential are possible
participants may inadvertently include pregnant women. Federal regulations
require that, when appropriate, participants be provided a statement that the
particular treatment or procedure may involve risks to the participant (or to
the embryo or fetus, if the participant is or may become pregnant) which are
currently unforeseeable as part of the informed consent process.
1. The CPHS must judge
whether the mother’s participation would pose any risk to the fetus or nursing
infant. In some studies, the CPHS may
need to assure that nonpregnant participants are
advised to avoid pregnancy or nursing for a time during or following the
research. Furthermore, where appropriate, participants should be advised to
notify the PI immediately should they become pregnant. In some instances, there
may be potential risk sufficient to justify requiring that pregnant women
either be specifically excluded from the research or studied separately.
VI.
All of the findings and determinations, including protocol specific
findings, for research involving the above referenced vulnerable populations,
must be 1) stated by the CPHS and included in the minutes or 2) documented in
writing for research undergoing expedited review.
Definitions:
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 - product of conception
from implantation until delivery.
Neonate - a newborn.
Nonviable - neonate means a
neonate after delivery that, although living, is not
viable.
Pregnancy - encompasses the
period of time from implantation until delivery. A woman shall be assumed to be
pregnant if of reproductive potential and exhibiting 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.
The Secretary of Health and Human Services, may from time to time, taking into
account medical advances, publish in the Federal Register guidelines to assist
in determining whether a neonate is viable for purposes of this subpart. If a
neonate is viable then it may be included in research only to the extent
permitted and in accordance with the requirements of subparts A and D of this
part.
Viable neonates – 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 subparts A and D of 45 CFR §46. [45 CFR §46.205(d)]