Reminder for Intramural Investigators of Legal Requirements Regarding Acquisition and Use of Human Fetal Tissue for Research Purposes

Purpose

This Notice is intended to remind NIH-intramural investigators and contractors that research involving human fetal tissue must be conducted in accordance with applicable Federal, State and local laws, regulations, and policies, including the NIH Sourcebook.

Selected Federal statutes, regulations, and policies are provided below:

• 42 U.S.C. 289g-1 and 289g-2 set forth specific requirements and prohibitions on research involving human fetal tissue. For example, among other prohibitions, 42 U.S.C. 289g-2 provides:
  • "Prohibitions regarding human fetal tissue
    • (a) 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 full text of 42 U.S.C. 289g-1 is available at: http://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: http://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). The following provisions may be specifically relevant:

• §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.
  • (a) 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.
  • (b) 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: http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf.