Use of Human Fetal Tissue in research

Per NIH Grants Policy Statement Section 4.1.14 (Human Fetal Tissue Research) Human fetal tissue is defined as tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion or stillbirth. This definition does not include established human fetal cell lines.

Sections 498A and 498B of the PHS Act (42 U.S.C. 289g-1 and 289g-2) set forth specific requirements and prohibitions on research involving human fetal tissue. Research involving human fetal tissue is also subject to the HHS Regulations for the Protection of Human Subjects. 45 C.F.R. 46.204 and 46.206 may be specifically relevant.

• See Section 4.1.14.1 for regulations related to research on Transplantation of Human Fetal Tissue
• See Section 4.1.14.2 for regulations related to Non-Transplantation Research on Human Fetal Tissue from Elective Abortions

For NIH supported research that includes human fetal tissue collected after June 5^th, 2019, the definition of fetal tissue includes human extra-embryonic cells and tissue obtained from elective abortions , such as

• • umbilical cord tissue
  • cord blood
  • placenta
  • amniotic fluid
  • 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.]

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 tissue 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 of human fetal tissue.

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.

Per NOT-OD-21-111 "Update on Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research", HHS reversed its 2019 decision that all research applications for NIH grants and contracts proposing the use of human fetal tissue from elective abortions will be reviewed by an Ethics Advisory Board. All other requirements described in NOT-OD-19-128 and updated in NOT-OD-19-137 for extramural research remain unchanged.