The human fetal brain tissues used in this study were obtained from a PCR-confirmed case of congenital ZIKV with a gestational age of 22 weeks, similar to cases that we previously described73. The fetal brain tissues were initially submitted to CDC for diagnostic testing during the Zika response as part of the routine pathology services provided by CDC to state and territorial authorities. Both the initial receipt of human samples [061116SZ] and the secondary use [102517GH] were submitted for review human subjects in accordance with standard NCEZID procedures, and both were determined to be outside the scope of IRB review requirements under 45 CFR 46 [pre-2018 rule] by the NCEZID Senior Human Subjects Advisor, as authorized by CDC institutional policy, as the fetuses are not living individuals [46 CFR 46.102(d), pre-2018 rule].
Do you have any questions about this protocol?
Post your question to gather feedback from the community. We will also invite the authors of this article to respond.