Vulnerable Populations - Pregnant Women, Fetuses, Neonates
Research Involving Pregnant Women, Fetuses, and/or Neonates
When research involving pregnant women, fetal material, and/or neonates is proposed, the IRB must determine that certain criteria are met [45 CFR 46 Subpart B]. If your research involves recruitment of pregnant women, neonates, and/or collection of fetal material, check mark the "Pregnant Women/Neonates/Fetal Material" attribute in the Subject Demographics section of your E-IRB application, and complete the questions as prompted under the Pregnant Women/Neonates/Fetuses subsection.
If your study is Department of Health and Human Services (HHS) funded, or funding by HHS is sought, and category (section) 4 in the Pregnant Women/Neonates/Fetuses subsection is applicable, the IRB must determine that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or neonates. The Office of Research Integrity will prepare and submit a report of IRB review to the appropriate HHS institutional official. The research may not commence until IRB approval is issued.