Institutional Review Board

Research Involving Pregnant Women, Fetuses and Neonates

This application should be completed when the research will involve Pregnant Women, Fetuses and Neonates.

Definitions:
Viable Neonate means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.
Non-Viable Neonate means a neonate after delivery that, although living, is not viable.

Study Information
IRB Number:
Protocol Title:
Principal Investigator:
Pregnant Women and Fetuses
  1. If scientifically appropriate, have
a)preclinical studies (including studies on pregnant animals) been conducted that provide data for assessing potential risks to pregnant women and fetuses?
Yes No N/A – not scientifically appropriate
b)clinical studies, including studies on non-pregnant women, been conducted that provide data for assessing potential risks to pregnant women and fetuses?
Yes No N/A – not scientifically appropriate
  1. Is the risk to the fetus caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus?
Yes No N/A – No risk to the fetus
  1. Are the study risks to both the pregnant woman and fetus the least possible for achieving the objectives of the research?
Yes No N/A – There are no risks
  1. Does the research hold out:
a) the prospect of direct benefit solely to the pregnant woman?
b) the prospect of direct benefit both to the pregnant woman and the fetus?
c) no prospect of benefit for the woman nor the fetus?
If (c), is the risk to the fetus no greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means?
Yes No
d) The prospect of direct benefit solely to the fetus?
If (d), is the consent of the pregnant woman and the father to be obtained?
Yes, consent of both the mother and father will be obtained unless the father's is unavailable, incompetent, or temporarily incapacitated or the pregnancy resulted from rape or incest.
No, consent will not be obtained.
  1. Will each individual providing consent be fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate?
Yes No
  1. Will inducements, monetary or otherwise, be offered to terminate a pregnancy?
Yes No
  1. Will the individuals engaged in the research have any part in decisions as to the timing, method, or procedures used to terminate a pregnancy?
Yes No
  1. Will individuals engaged in the research have any part in determining the viability of a neonate?
Yes No
Neonates
  1. Will the research involve the following (check all that apply)
Viable Neonates
Non-viable Neonates
Neonates of Uncertain Viability

Principal Investigator’s SignatureDate

Research With Pregnant Women, Fetuses and NeonatesPage 1 of 2

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