Human Fetal Tissue (HFT) Review
Protocols using Human Fetal Tissue (HFT) require ancillary review.
- Review is required for proposed new experiments with human fetal tissue (HFT), defined as tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth, but does not include established human fetal cell lines. RNA, DNA, protein, or subcellular derivatives of HFT, and data derived by others from HFT, do not require HFT review.
- The HFT ancillary review will ensure that HFT is used only when scientifically justifiable, and in the least amount to achieve the scientific outcomes.
- The PI must provide, on the ancillary review form:
- The research goals and anticipated benefits of the research
- Why alternatives to HFT can’t achieve these goals, and how that was determined
- The source of the HFT
- The experimental use of HFT
- Detailed budget information about the acquisition
- Affirmation from the PI that HFT was not acquired for “valuable consideration”
- Detailed vendor information, if acquired from a commercial source
- MTA information, if the HFT was acquired through an agreement
- The ancillary review must be reviewed and “approved” by the HFT Review Committee before the IRBO will act upon the associated IRB protocol.
PROTECT Instructions:
- Attach the completed "Research on HFT Proposal" to your ancillary review when you submit this in PROTECT. This form is also available in the PROTECT IRB Library under the Templates tab: Research on HFT Proposal template
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