Summary of Federal Provisions Pertaining to Research Use of Human Fetal Tissue by NIH Investigators

(In addition to those required by 45CFR Part 16, Subparts A,C, and/or D)

If you conduct research that involves transplantation of human fetal tissue, you should follow:

http://grants.nih.gov/grants/guide/notice-files/not93-235.html

(NIH Guide, Volume 22 #22, September 3, 1993, "Withdrawal of Interim NIH Guidelines for the Support and Conduct of Therapeutic Human Fetal Tissue Transplantation Research in Light of Superseding Provisions of Public Law 103-43, The NIH Revitalization Act of 1993). This guidance summarizes provisions on the acquisition and use of human fetal tissue for transplantation.

If you conduct basic research that uses human fetal tissue, with no transplantation, the following provisions apply to your acquisition and use of fetal tissue:

• No profits should be involved:

42 USC 289g-2 Provides that it is "unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration in interstate commerce. Human fetal tissue means tissues or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion or after a stillbirth. Valuable consideration does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue."

• Researchers should have no involvement in the termination of pregnancy:

45CFR 46.206(a)(3) Individuals who use fetal tissue in their research "will have no part in (i) any decisions as to the timing, method, and procedures used to terminate the pregnancy, and (ii) determining the viability of the fetus at the termination of the pregnancy" that generates the tissue they use.

http://ohsr.od.nih.gov/guidelines/45cfr46.html#46.206

• The tissue must be obtained in accordance with state and local law:

45CFR 46.210: "Activities involving the dead fetus, macerated fetal material, or cells, tissue, or organs excised from a dead fetus shall be conducted only in accordance with any applicable State or local laws regarding such activities."

http://ohsr.od.nih.gov/guidelines/45cfr46.html#46.206

If you conduct any type of research on human fetal tissue, you should consult with the Office of Human Subjects Research (Charlotte Holden, 301-402-3445) and then with your Institute's Institutional Review Board (IRB).