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A neonate, after delivery, that has been determined to be viable may be included in the research only to the extent permitted by and in accord with the requirements for children involved in research.
1) Research not otherwise approvable will only be allowed in this vulnerable population if:
a. The IRB finds 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; AND
b. The Secretary of DHHS, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, ethics, law) and following an opportunity for public review and comment, including a public meeting announced in the Federal Register has determined that the research may take place.
2) Research involving human fetal tissue (placenta, or tissue from a spontaneous or induced abortion or from a stillbirth) is evaluated as tissue specimen research, using the guidelines for research involving specimens.
Studies using human fetal tissue for transplantation research and studies of human embryos involve very explicit regulations concerning consent and study procedures. Investigators wishing to conduct transplantation research with human fetal tissue should contact the Human Subjects Office well in advance of IRB application submission to discuss applicable regulations.