UNIVERSITY OF COLORADO COLORADO SPRINGS
INSTITUTIONAL REVIEW BOARD (IRB)
ADDENDUM:
RESEARCH INVOLVING PREGNANT WOMEN, HUMAN FETUSES, AND NEONATES
For IRB Use Only
IRB#________________ Date Received _____________________
Date Approved ___________
Please use this addendum to address the regulatory requirements for conducting any research
procedures while conducting research with pregnant women, human fetuses, and neonates.
The UCCS IRB requires that investigators plan for the inclusion of these populations as early in
the protocol planning process as possible. The UCCS IRB also requires that all submissions
specify the inclusion of pregnant women, fetuses, and/or neonates.
Definitions pertaining to this addendum can be referenced in 45 CFR 46.201-207 subpart B and
the IRB Standard Operating Procedures Special Topics: XXIV.
Will the protocol include only de-identified secondary data analysis?
If so, please disregard remaining questions.
Yes
No
Questions involving Pregnant Women or Fetuses
1. Are you targeting pregnant women for enrollment?
Yes
No
2. What is your reasoning for including this vulnerable population (pregnant
women/fetus/placental tissue)?
3. For the research procedures indicated in the application, describe scientifically appropriate
clinical and pre-clinical studies, including studies involving pregnant women and nonpregnant animals that provide data for assessing potential risks to pregnant women and
fetuses. If prior research is not necessary to understand the fetal risks for the procedures
listed above, enter “N/A” and explain why no prior research is needed.
4. Do the procedures discussed in the application provide the least possible risk for achieving
the objectives of the research?
5. The interventions or procedures indicated in the application have prospect for direct benefits
for
The pregnant woman only
The fetus only
Both the pregnant woman and the fetus
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Neither the pregnant woman nor the fetus
6. Who will provide informed consent, if required?
a. Are they fully informed regarding the reasonably foreseeable
impact of the research on the fetus? If N/A/, please explain:
Yes
No
7. Will any researchers engaged in research have any part in any decision
with regards to terminating the pregnancy?
Yes
No
8. Will any researchers engaged in the research have any part in
determining the viability of the neonate?
Yes
No
9. Does the proposed research involve, after delivery, the placenta, the
dead fetus, or fetal material?
Yes
No
10. Will any inducements, monetary or otherwise, be offered to terminate a
pregnancy for the purpose of this research?
Yes
No
Questions involving Neonates
11. Are you targeting neonates for enrollment? If no, you are finished.
Yes
No
12. What is your reasoning for including neonates?
13. What are the risks involved to the neonates due to being enrolled in this study?
14. What are the benefits to the neonates due to being enrolled in this study?
15. Describe the appropriate pre-clinical and clinical studies that have been conducted that
provide data for assessing potential risks (answer “N/A” if no studies are needed to
determine neonatal risks):
16. Who will obtain parental permission, their level of experience and understanding of the
potential impact on the neonates:
17. Will neonates that have been determined to be viable be included in
the study?
Yes
No
18. Does the proposed research involve neonates of Uncertain Viability?
Yes
No
19. Does the proposed research involve Non-Viable Neonates?
Yes
No
Viable: Being able, after delivery, to survive (given benefit of the available medical therapy) to the
point of independently maintaining heartbeat and respiration.
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Non-Viable: a neonate after delivery that although living, has futility of care concerns. Examples
of futility of care are lethal congenital genetic defects, extreme prematurity, or other lethal
abnormalities.
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