PARTNERS HUMAN RESEARCH COMMITTEE
ADDITIONAL PROTECTIONS FOR NEONATES OF UNCERTAIN VIABILITY AND
NONVIABLE NEONATES INVOLVED IN RESEARCH
Principal Investigator:
Title of Protocol:
Description of Study Population:
Federal regulations require the IRB to provide additional protections for neonates of uncertain
viability and nonviable neonates involved in research [45 CFR46.205]. For the purposes of research,
a physician independent of the research must determine whether or not the neonate is viable.
Decisions regarding viability, resuscitative efforts and subsequent support of the neonate are complex
and involve anatomic, physiologic, and ethical considerations. While neonatal viability is frequently
determined before delivery, this decision may need to be altered in the delivery room and beyond
depending on the condition of the neonate at birth, the postnatal gestational age assessment, and the
infant’s response to resuscitative and stabilization measures. Reference: Perinatal Care at the
Threshold of Viability, American Academy of Pediatrics Committee on Fetus and Newborn,
Pediatrics 2002; 110 (5), 1024-1027.
Nonviable neonate means a neonate after delivery that, although living, is not viable. In general, and
for the purposes of research conducted at Partners’ institutions, a viable neonate means a neonate that
is likely to survive to the point of independently maintaining circulation and respiration. Although it
may be presumed that an expelled or delivered fetus is nonviable at a gestational age of less than 20
weeks and weight less than 500 grams [Federal Register 40 (August 8, 1975): 33552], a specific
determination as to viability must be made by a physician in each instance. Neonates in the NICU
may be considered nonviable or of uncertain viability when there is a clinical anticipation that the
neonate will not survive (for example: gestational age < 23-24 weeks, significant congenital
pathologies incompatible with life, etc.). The physician making the determination must be
independent of the research.
All viable neonates are considered children and are subject to the additional protections for
children involved in research.
Please complete each section as it applies to your research. Each question must be fully
answered, or the form will be returned and IRB review will be delayed.
RESEARCH INVOLVING NEONATES [45 CFR 46.205]
(a) Neonates of uncertain viability and nonviable neonates may be involved in research when all
of the following conditions are met.
Partners Human Subjects Research Application Form
Version Date: November 4, 2005
Filename: Neonates
Page 1
(1) Where scientifically appropriate, pre-clinical and clinical studies have been conducted and
provide data for assessing potential risks to neonates.
 Provide a brief description of relevant prior pre-clinical and clinical studies, and based on this
information, what you think the risks to the neonate are in your research:
(2) Each individual providing consent is fully informed regarding the reasonably foreseeable
impact of the research on the neonate.
 Explain what reasonably foreseeable impact the research will have on the neonate:
(3) Individuals engaged in the research will have no part in determining the viability of the neonate.
 Provide brief description of how, and by whom viability is determined:
STUDY POPULATION (check all that apply and complete [b] and/or [c])
The research will include:
(b) Neonates of uncertain viability
(c) Nonviable neonates
(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 unless the conditions 1 and 2 below, are met:
(1) The IRB determines that:
(i) The research holds out the prospect of enhancing the probability of survival of the neonate to
the point of viability, and that any risk is the least possible for achieving that objective; or
(ii) 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.
Partners Human Subjects Research Application Form
Version Date: November 4, 2005
Filename: Neonates
Page 2
(2) The legally effective informed consent of either parent of the neonate is obtained 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, except that the consent of the father or his legally authorized representative need not
be obtained if the pregnancy resulted from rape or incest.
 Explain how the research may improve the survivability of the neonate to the point of viability
and address how the risk to the neonate is minimized:
OR
 Explain what important biomedical knowledge is likely to result, and why it cannot be obtained
by other means:
 Explain why you think there will be no added risk to the neonate:
(c) Nonviable neonates. After delivery nonviable neonates may not be involved in research unless
all of the following additional conditions are met:
(1)
(2)
Vital functions of the neonates will not be artificially maintained;
The research will not terminate the heartbeat or respiration of the neonate;
(3)
(4)
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.
(5)
The legally effective informed consent of both parents of the neonate is obtained.
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. Consent of the father need not be obtained if the pregnancy resulted from rape or
incest. NOTE: Consent of a legally authorized representative of either or both of the
parents of a nonviable neonate is not permitted.
 Explain what important biomedical knowledge is likely to result, and why it cannot be obtained
by other means:
 Explain why you think there will be no added risk to the neonate:
Partners Human Subjects Research Application Form
Version Date: November 4, 2005
Filename: Neonates
Page 3
CONFIRMATION OF PRINCIPAL INVESTIGATOR
I confirm that, for research involving neonates of uncertain viability,
 Individuals engaged in the research will have no part in determining the viability of the
neonate; and
 The legally effective informed consent of either parent of the neonate will be obtained 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, except as noted above in (b)(2).
I confirm that, for research involving nonviable neonates,
 Individuals engaged in the research will have no part in determining the viability of the
neonate;
 Vital functions of nonviable neonates will not be artificially maintained;
 The research will not terminate the heartbeat or respiration of nonviable neonates; and
 Legally effective informed consent of both parents of nonviable neonate will be obtained,
except as noted above in (c)(5).
Signature of Principal Investigator
Partners Human Subjects Research Application Form
Version Date: November 4, 2005
Date
Filename: Neonates
Page 4