Use of Human Fetal Tissue in research

Definitions:

Per US Federal regulation 42 U.S. Code § 289g–1 - Research on transplantation of fetal tissue, the term “human fetal tissue” means tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth.

For NIH supported research that includes human fetal tissue obtained from elective abortions collected after June 5th, 2019 from elective abortions, the definition of fetal tissue includes human extra-embryonic cells and tissue, such as umbilical cord tissue, cord blood, placenta, amniotic fluid, and chorionic villi.

Note: if isolated postnatally (following birth), ‘human extra-embryonic cells and tissue, such as umbilical cord tissue, cord blood, placenta, amniotic fluid, and chorionic villi’ are NOT considered FETAL tissue per NIH definition mentioned above.

NIH published specific requirements applicable to human fetal tissue obtained from elective abortions NIH research* submitted after 08/23/2019 per NOT-OD-19-137

The new requirements apply only to research that involves 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 definition of research involving HFT does not include the following materials (if the research includes ONLY the following materials – the new requirements do not apply):

  • human fetal primary or secondary cell cultures, if cells were not derived from an elective abortion
  • already-established (as of June 5, 2019) human fetal cell lines (e.g. induced pluripotent stem cell lines from human fetal tissue, immortalized cell lines, differentiated cell lines).
  • derivative products from human fetal tissue or cells (e.g. DNA, RNA, protein) if not derived from elective abortion.
  • human extra-embryonic cells and tissue, including, but not limited to, umbilical cord tissue, cord blood, placenta, amniotic fluid, and chorionic villi if not derived from elective abortion.
  • human fetal cells present in maternal blood or other maternal sources
  • embryonic stem cells or embryonic cell lines.
  • research on transplantation of HFT for therapeutic purposes.

The following prohibitions regarding ALL human fetal tissue apply per US federal regulations 42 U.S. Code § 289g–2:

  • Purchase of tissue

It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce.

  • The term “valuable consideration” does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage ofhuman fetal tissue.
  • The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
  • The term “human fetal tissue” means tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth.
  • Solicitation or acceptance of tissue as directed donation for use in transplantation

It shall be unlawful for any person to solicit or knowingly acquire, receive, or accept a donation of human fetal tissue for the purpose of transplantation of such tissue into another person if the donation affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and—

(1) the donation will be or is made pursuant to a promise to the donating individual that the donated tissue will be transplanted into a recipient specified by such individual;

(2) the donated tissue will be transplanted into a relative of the donating individual; or

(3) the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable consideration for the costs associated with such abortion.

(c)Solicitation or acceptance of tissue from fetuses gestated for research purposes

It shall be unlawful for any person or entity involved or engaged in interstate commerce to—

(1) solicit or knowingly acquire, receive, or accept a donation of human fetal tissue knowing that a human pregnancy was deliberately initiated to provide such tissue; or

(2) knowingly acquire, receive, or accept tissue or cells obtained from a human embryo or fetus that was gestated in the uterus of a nonhuman animal.