Policies on the Acquisition and Use of Human Fetal Tissue (HFT) for Research Purposes in the Intramural Research Program at NIH

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 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
• Federal Law, Regulation, and NIH Policy
• Intramural Oversight of HFT

Acquisition, Use and Storage of HFT

Researchers may acquire, use and store HFT (human fetal tissue is defined as tissue or cells obtained from a dead human embryo or fetus, but does not include established human fetal cell lines) for intramural research projects. Acquisition, from either a commercial source or from an academic institution, clinic, or hospital, requires prior approval (see Procedures for Obtaining Human Fetal Tissue (HFT) for Research Purposes in the Intramural Research Program at NIH). Researchers are also required to report annually on their acquisition, use or storage of HFT (see Guide for Human Biospecimen Storage and Tracking). Use of HFT is reported annually on the publicly-facing Research, Condition, and Disease Categories (RCDC) by intramural project number. Intramural researchers with HFT projects are at times required to answer data calls on various aspects of their use of HFT.

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.

Federal Law, Regulation, and NIH Policy

• 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:

• NOT-OD-16-033 NIH Policy on Informed Consent for Human Fetal Tissue Research

Intramural Oversight of HFT

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.