______
NEBRASKA’S HEALTH SCIENCE CENTER OFFICE OF REGULATORY AFFAIRS (ORA)
Institutional Review Board (IRB)
Addendum B
Biomedical Research Involving Pregnant Women, Fetuses
and Neonates of Uncertain Viability or Non-Viable
DATE:
IRB#:
TITLE OF PROTOCOL:
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
PRINCIPLE INVESTIGATOR:
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Instructions: HHS and non-HHS funded biomedical research involving pregnant women, human fetuses, and neonates (nonviable and uncertain viability) must comply with HHS regulations at 45 CFR 46, Subpart B in accordance with HRPP policy. Subpart B provides additional protections for these subjects because they are considered to be a vulnerable subject population.
This addendum application is designed to assist the investigator in developing the documentation necessary to verify compliance with Subpart B. All questions should, therefore, be completely addressed by consulting this section of the regulations and HRPP policy which can be accessed at the IRB website (http://www.unmc.edu/irb.) The exact subheadings as well as numbered and sequenced sections on this form should be maintained.
This addendum should be submitted with the IRB application. Information should be provided by site for all studies involving more than one site for which the UNMC IRB or PedsIRB is the only IRB of record.
The italicized, educational information may be deleted. These instructions may also be deleted from the final completed application.
PRECLINICAL STUDIES AND STUDIES ON NON-PREGNANT WOMEN
[45 CFR 46.204(A)]
1. Have scientifically appropriate preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, been conducted?
No
Yes. Provide a brief description of the studies.
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
2. Do these studies provide data for assessing potential risks to pregnant women and fetuses?
Yes
No
RISKS AND BENEFITS TO THE PREGNANT WOMAN OR FETUS WHICH ARE ASSOCIATED WITH THE RESEARCH [45 CFR 46.204(B)]
1. If there is any prospect of direct benefit for the woman or the fetus, respond to the following:
A. Describe the anticipated benefit(s), if any, to the pregnant woman.
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
B. Describe the potential benefit(s), if any, to the fetus.
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
C. Describe any risks to the fetus and/or the pregnant woman.
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
D. Are there any risks to the fetus which are caused by interventions or procedures that do not hold out the prospect of direct benefit for the pregnant woman or the fetus?
No
Yes. Describe.
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
2. If there is no prospect of direct benefit to the pregnant woman or fetus, respond to the following:
A. Describe any risks to the fetus.
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
B. Describe how the research could lead to the development of important biomedical knowledge.
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
C. Could the research be conducted without involvement of pregnant women?
Yes
No. Provide the rationale.
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
MINIMIZATION OF RISKS TO THE PREGNANT WOMAN AND FETUS
[45 CFR 46.204(c)]
Describe how the risks to the pregnant woman and fetus are minimized to the greatest extent possible consistent with the objectives of the research.
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
PREGNANCY TERMINATION AND DETERMINATION OF VIABILITY
[45 CFR 46.204(H-J)]
1. Will the research involve termination of a pregnancy?
No
Yes
requirements for consent of the pregnant woman and father
[45 CFR 46.204b]
Consent of the pregnant woman and, in some cases the father, is required as indicated below, unless the father is not reasonably available.
Note: 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.
Check off ONE of the following categories as it applies to this research:
Benefit to the pregnant woman ONLY ® Consent of pregnant woman alone required
Benefit to both the pregnant woman and fetus ® Consent of pregnant woman alone required
Benefit to the fetus ONLY ® Consent of pregnant woman and the father required
No benefit to the pregnant woman or fetus, but minimal risk to the fetus ® Consent of pregnant woman alone required
Other ® may not be approvable under 45 CFR 46 subpart B. Consult IRB Office.
Research involving neonates of uncertain viability [45 CFR 46.205]
1. Will the research involve neonates of uncertain viability?
No
Yes. Respond to the following:
A. Have scientifically appropriate preclinical and clinical studies been conducted?
No
Yes.
B. Do the preclinical and clinical studies provide data for assessing potential risks to neonates?
No
Yes.
C. How will viability of the neonate be determined?
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
D. Will this research have the potential of helping the neonate reach the point of viability?
No
Yes.
E. Describe any risks to the neonate.
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
F. Describe how the risks to the neonate are minimized to the greatest extent possible consistent with the objectives of the research.
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
G. Describe how the research could lead to the development of important biomedical knowledge.
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Requirements for consent of the parents of the neonate
[45 CFR 46.205(b)(2)]
Research involving nonviable neonates [45 CFR 46.205(c)]
1. Will the research involve nonviable neonates?
No
Yes. Respond to the following:
A. Have scientifically appropriate preclinical and clinical studies been conducted?
No
Yes
B. Do the preclinical and clinical studies provide data for assessing potential risks to neonates?
No
Yes
C. How will viability status of the neonate be determined?
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
D. Describe any risks to the neonate.
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
E. Describe how the research could lead to the development of important biomedical knowledge.
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)
Requirement for consent of the parents of nonviable neonates
[45 CFR 46.205(c)(5)]
Page 1 of 4
Addendum B-Pregnant Women, Fetuses & Neonates (07-27-10)