Appendix: GCRC-Specific Information

(Appendix: Pregnant Women, Fetuses and Neonates) NYU School of Medicine IRB HRPP

1. Appendix: Pregnant Women, Fetuses and Neonates This research is funded by the US Yes; contact the Office This research poses a greater than Yes; specify: Department of Health and Human of the IRB with regard to minimal risk to the woman or fetus No; this form is Services the inclusion of pregnant complete (you do not women in your study have to answer any No further questions) The risk to the fetus is caused Where scientifically appropriate, solely by interventions or have preclinical studies, including procedures that hold out the studies on pregnant animals, and prospect of direct benefit for the Yes* clinical studies, including studies Yes woman or the fetus No; explain: on non-pregnant women, been No; explain: conducted to provide data for assessing potential risks to pregnant women and fetuses? * if the research holds out the prospect of direct benefit solely to the fetus, then the consent of the pregnant woman and the father must be obtained, 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. Otherwise, the consent of the mother is sufficient. Explain why the level of risk is the least possible for achieving the objectives of the research and provide justification for your explanation Describe how you will ensure that individuals providing consent are fully informed regarding the reasonably foreseeable impact of the research on the fetus The Principle Investigator assures No inducements, monetary or otherwise, will be offered to terminate a pregnancy that (all 3 must be checked) Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy Individuals engaged in the research will have no part in determining the viability of a neonate

Risk Please note, newborns are only considered neonates until they are determined to be viable. Once they are determined to be viable, they are considered children; Appendix: Children should be completed for viable newborns. When neonates of uncertain viability and nonviable neonates are to be involved in research please answer the following questions. There will be any added risk to the Where scientifically appropriate, neonate resulting from the research preclinical and clinical studies Yes; explain: Yes have been conducted to provide No data for assessing potential risks to No; explain: neonates The research holds out the The purpose of the research is the prospect of enhancing the development of important probability of survival of the Yes biomedical knowledge that cannot Yes neonate to the point of viability, No; explain: be obtained by other means and No; explain: and is the least possible risk for will there be no added risk to the achieving that objective neonate as a result of the research Legally effective informed consent Legally effective informed consent from either parent* will be Yes from both parents* will be Yes obtained in the case of a neonate of No; explain: obtained in the case of nonviable No; explain: uncertain viability neonates *The legally effective informed consent of either parent may be waived because of unavailability, incompetence, or temporary incapacity, in which case the legally effective informed consent of either parent's legally authorized representative is obtained in accord with subpart A of CFR 45 part 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. In the case of nonviable neonates, In the case on nonviable neonates, vital functions of the neonate will Yes; explain: the research will terminate the Yes; explain: be artificially maintained No heartbeat or respiration of the No neonate

version 2011.08.02 | email [email protected] | phone 212.263.4110 | page 1 of 2 (Appendix: Pregnant Women, Fetuses and Neonates) NYU School of Medicine IRB HRPP

version 2011.08.02 | email [email protected] | phone 212.263.4110 | page 2 of 2