Policies Restricting the Acquisition and Use of Human Fetal Tissue (HFT) for Research Purposes in the Intramural Research Program at NIH
Intramural researchers are prohibited from acquisition of, or new uses of existing Human Fetal Tissue (HFT) from elective abortions, consistent with a June 5, 2019 HHS statement and with extramural requirements found in NOT-OD-19-128. The Deputy Director for Intramural Research (DDIR) is responsible for oversight of all research that uses HFT conducted by intramural scientists at the NIH, whether they are working in NIH facilities or with collaborators outside of NIH. Projects initiated on or before June 5th, 2019 that do not require acquisition of new HFT from elective abortions may continue until such time as the previously acquired tissue is exhausted or until the date of the next BSC review. The use of HFT for research is sensitive and researchers must be mindful of its ethical implications. Researchers must ensure that allowable uses of HFT (including tissue acquired on or before June 5, 2019 or HFT not resulting from elective abortion – i.e., tissue from spontaneous abortion, miscarriage or stillbirth) is in accordance with applicable federal, state, and local laws, regulations and policies. This includes the need for NIH approval prior to acquiring HFT (see Procedures for Obtaining Human Fetal Tissue (HFT) for Research Purposes in the Intramural Research Program at NIH), the need for informed consent from the donor, and the need for continuous oversight review during the performance of the research.
- Acquisition, Use and Storage of HFT
- Prohibited and Permissible HFT Use
- Federal Law, Regulation, and NIH Policy
- Intramural Oversight of HFT
Researchers are prohibited from acquiring HFT (as defined below) from elective abortions, effective June 5th, 2019.
Intramural researchers may use for research purposes, or store HFT that:
- Was acquired on or prior to June 5, 2019 from approved sources (however, existing HFT may not be used in a new project or transferred to others for use); or,
- Was acquired after June 5, 2019 only from sources that verify the tissue was not obtained from an elective abortion.
Acquisition of and new research involving the study, analysis, or use of primary HFT, cells, and derivatives, and human fetal primary cell cultures, from elective abortions, is prohibited. HFT is defined for purposes of this policy as including:
- human fetal primary or secondary cells or cell cultures, whether derived by the investigator or obtained from a vendor, if from elective abortions.
- animal models incorporating HFT from elective abortions, including obtaining such models from a vendor (such as, but not limited to, humanized mouse models created using HFT).
- derivative products from tissues or cells from elective abortions, 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 an elective abortion.
Research involving the study, analysis, or use of the following human materials is permitted (but requires intramural regulatory oversight):
- primary HFT if not derived from an elective abortion.
- human fetal primary or secondary cells or 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.
- human embryonic stem cells or human embryonic cell lines.
- research using (but not creating) cDNA libraries from HFT.
- research with secondary use of data from HFT.
Projects initiated on or before June 5th, 2019, that do not require acquisition of new HFT from elective abortions may continue until such time as the previously acquired tissue is exhausted or until the date of the next BSC review.
Research on transplantation of HFT for therapeutic purposes is permitted but requires additional intramural regulatory oversight because of the statutory provision(s) addressing such research. Please contact the Office of Intramural Research if you are considering research in which HFT or cells would be transplanted as part of clinical research.
- 42 U.S.C. 289g-1 and 289g-2 set forth specific requirements and prohibitions on research involving human fetal tissue. 42 U.S.C. 289g-2 provides that:
- "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 full text of 42 U.S.C. 289g-1 is available at: https://www.gpo.gov/fdsys/pkg/USCODE-2010-title42/html/USCODE-2010-title42-chap6A-subchapIII-partH-sec289g-1.htm.
- The full text of 42 U.S.C. 289g-2 is available at: https://www.gpo.gov/fdsys/pkg/USCODE-2010-title42/html/USCODE-2010-title42-chap6A-subchapIII-partH-sec289g-2.htm.
Research involving human fetal tissue is also subject to the HHS Regulations for the Protection of Human Subjects (45 CFR 46 Subparts A and B).
- §46.204 Research involving pregnant women or fetuses.
- ~ (a) – (g)
- (h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
- (i)Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and
- (j) Individuals engaged in the research will have no part in determining the viability of a neonate.
- §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
- Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs excised from a dead fetus, shall be conducted only in accord with any applicable federal, state, or local laws and regulations regarding such activities.
- If information associated with material described in paragraph (a) of this section is recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.
- The full text of the HHS Regulations for the Protection of Human Subjects is available at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
Research is also subject to NIH policy on informed consent for HFT research, as specified in:
All intramural scientists are informed of the policies and legal requirements applying to human fetal tissue research. Oversight of human fetal tissue research conducted by intramural investigators is summarized below.
- NIH Office of Human Subjects Research Protections (OHSRP). The Office of Human Subjects Research Protections (OHSRP) provides guidance to intramural investigators who are using or contemplate using human fetal tissue. All experiments using human fetal tissue must be reviewed and approved either by the NIH Office of IRBO or the NIH IRP IRB.
- Biospecimen Survey. Intramural investigators with NIH supported projects that entail the acquisition, use or storage of HFT must submit an annual biospecimen survey that tracks this tissue. The Office of Intramural Research and the Scientific Directors of each Institute/Center direct investigators to specifically identify when human fetal tissue is used during the reporting period.
- Clinical and Scientific Directors. The Clinical and Scientific Directors, who provide immediate oversight of intramural research in each institute, are aware of the legal requirements governing acquisition and use of fetal tissue. They are directed to ensure that all scientists who use human fetal tissue in their research assure fetal tissue is used and acquired in accordance with the legal requirements.
- Management Controls. In the annual Management Controls review, each Scientific Director will be asked to verify that he or she has reviewed the legal requirements regarding fetal tissue acquisition and use for research in their intramural program, and to identify and correct any potential problem areas.
The page was last updated on Friday, October 18, 2019 - 10:02am