For grant and cooperative agreement applications submitted for due dates on or after September 25, 2019, NIH is implementing new requirements on human fetal tissue (HFT) research for scientists applying for grants using human material from elective abortions.
These new requirements apply to a far broader set of materials than what is conventionally considered HFT, to include extra-embryonic cells and tissue, such as umbilical cord tissue, cord blood, placenta, amniotic fluid, and chorionic villi, if obtained from the process of elective abortion as well as animal models incorporating HFT.
Applications that do not address all of the required information will be administratively withdrawn and not reviewed by NIH. For more information on these requirements, including what materials may be subject to them, see NIH’s FAQs or contact Melissa Lopes in OVPR.
The new NIH HFT requirements apply to research involving the study, analysis, or use of primary HFT, cells, and derivatives, and human fetal primary cell cultures obtained from elective abortions and includes the following:
- human fetal primary or secondary cell cultures, whether derived by the investigator or obtained from a vendor.
- animal models incorporating HFT from elective abortions, including obtaining such models from a vendor.
- derivative products from elective abortion tissues or cells such as protein or nucleic acid extracts.
- any human extra-embryonic cells and tissue, such as umbilical cord tissue, cord blood, placenta, amniotic fluid, and chorionic villi, if obtained from the process of elective abortion.
The new NIH HFT requirements do not apply to research involving:
- embryonic stem cells or embryonic cell lines, or
- already-established (as of June 5, 2019) human fetal cell lines
Pursuant to the new NIH requirements, scientists writing grants for experiments that involve HFT as defined above will be subject to review by a federal ethics panel and required to:
- provide a description of the informed consent process,
- explain why other tissue types cannot be used, and
- explain where the researchers plan to get the HFT.