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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 Submission to NIH must include all of the following information:

    • Justification for why the research goals cannot be accomplished using an alternative to HFT
    • Indicate the methods used (e.g. literature review, preliminary data) to determine that alternatives could not be used
    • Results from a literature review used to provide justifications
    • Plans for the treatment of HFT and the disposal of HFT when research is complete
    • A description of planned written, voluntary, informed consent process for cell/tissue donation, or description and documentation of process if cells/tissue were already obtained.
    • Include a sample of the IRB approved consent form with the application or during the JIT process.
      1. The PDF-formatted form must be a blank sample and named ‘HFTSampleIRBConsentForm.pdf’.
      2. Include an assurance letter indicating that this is the correct consent document.
        Applications proposing HFT research that do not include this assurance will be administratively withdrawn and not reviewed.
    • The informed consent for use of HFT from elective abortion requires:
      1. Language that acknowledges informed consent for donation of HFT was obtained by someone other than the person who obtained the informed consent for abortion,
      2. Language that the consent for use of HFT from an elective abortion occurred after the informed consent for abortion,
      3. Language that consent for use of HFT from an elective abortion will not affect the method of abortion,
      4. No enticements, benefits, or financial incentives were used at any level of the process to incentivize the elective abortion or the donation of HFT,
      5. The consent for use of HFT from the elective abortion is signed by both the woman and the person who obtains the informed consent.
      6. HFT Compliance Assurance: The applicant institution must provide a letter signed by the PD/PI assuring the HFT donating organization or clinic adheres to the requirements of the informed consent process and documentation that HFT was not obtained or acquired for valuable consideration.
        1. The PDF-formatted letter must be named ‘HFTComplianceAssurance.pdf’.
      Applications proposing HFT research that do not include this assurance will be administratively withdrawn and not reviewed.

In addition, the following federal and state requirements apply to all human fetal tissue (including tissue not obtained from elective abortions or collected prior to June 5th, 2019) defined as “tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth”:

The woman who donates the fetal tissue must sign a statement declaring  that

  • the donation is being made for research purposes,
  • the donation is made without any restriction regarding who may be the recipient(s) of materials derived from the tissue and
  • the woman has not been informed of the identity of any such individuals

The attending physician must sign a statement that

  • he or she has obtained the tissue in accordance with the donor’s signed statement.

In the case of tissue obtained pursuant to an induced abortion, the physician must sign a statement stating that

  • he or she obtained the woman’s consent for the abortion before requesting or obtaining consent for the tissue to be used for research;
  • he or she  did not alter the timing, method, or procedures used to terminate the pregnancy solely for the purpose of obtaining the tissue for research; and
  • performed the abortion in accordance with applicable state law.
  • The attending physician must disclose to the donor any financial interest that the attending physician has in the research to be conducted with the tissue.
  • The attending physician must disclose any known medical risks to the donor or risks to her privacy that might be associated with the donation of the tissue and that are in addition to risks of such type that are associated with the woman's medical care.

The principal investigator of the research project must sign a statement certifying that he/she:

  • is aware that the tissue is human fetal tissue obtained in a spontaneous or induced abortion or pursuant to a stillbirth;
  • is aware that the tissue was donated for research purposes;
  • had no part in any decisions as to the timing, method, or procedures used to terminate the pregnancy; and 
  • is not the donor’s attending physician.
  • has provided such information to other individuals with responsibilities regarding the research [i.e. PI has provided the information listed under point (1) above to their research team which are listed on the protocol that includes the use of this tissue].
  • will require, prior to obtaining the consent of an individual to be a recipient of a transplantation of the tissue, written acknowledgment of receipt of such information by such recipient [if the PI is the person obtaining consent from the recipient of the tissue, the PI will inform the recipient of the tissue about the information listed under point (1) above]

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

  1. Purchase of tissue
    • The term “valuable consideration” does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human 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.
  2. 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.
  3. 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.