UK Office of Research Integrity

IRB Application: Vulnerable Populations

Section 5
FORM U.   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, complete Form U for inclusion with your IRB application submission.

If you are proposing research involving pregnant women, fetuses, and/or neonates, please mark the appropriate selection(s) in the space provided on the General Information Sheet [Section 1, Form A].

If your study is Department of Health and Human Services (HHS) funded, or funding by HHS is sought, and category 4 on Form U 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.

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