42 U.S.C. § 289g–1 — Research on transplantation of fetal tissue

(a) Establishing the program. The Secretary may conduct or support research that transplants human fetal tissue into patients for therapeutic purposes. The tissue can be used no matter how it was obtained — whether from a spontaneous abortion, an induced abortion, or a stillbirth. (b) Informed consent of the donor. Before researchers can use the tissue, the woman who provided it must sign a written statement. In it, she must declare that she is donating the tissue for this research, that she placed no restriction on who could receive the tissue, and that she has not been told who any recipient is. The attending physician who obtained the tissue must also sign a written statement. If the tissue came from an induced abortion, the physician must declare that the woman consented to the abortion before anyone asked her to donate the tissue, that no part of how or when the abortion was performed was changed just to get the tissue, and that the abortion followed state law. The physician must also declare that the woman donated the tissue the way subsection (b)(1) requires, and that the physician fully told the woman about any personal interest in the research and about any medical or privacy risks tied to the donation, beyond the normal risks of her medical care. (c) Informed consent of the researcher and the recipient. The lead researcher must also sign a written statement. The researcher must declare awareness that the tissue is human fetal tissue, that it may have come from a spontaneous abortion, an induced abortion, or a stillbirth, and that it was donated for research. The researcher must have shared this information with everyone else working on the research who needs it. Before getting a recipient's consent to receive a transplant of the tissue, the researcher must get the recipient's written acknowledgment that they received this information. And the researcher must have had no role in deciding the timing or method of the abortion, where that decision was made solely to benefit the research. (d) Keeping the statements available for audit. Researchers can use the tissue only if the head of the research agency or entity certifies to the Secretary that the statements required under (b) and (c) will be available for the Secretary to audit. Any audit the Secretary conducts must be kept confidential, to protect the privacy of everyone involved, including those who donated, transferred, received, or transplanted the tissue. The Secretary can use audit material only to check compliance with this section. The Secretary generally cannot publish or disclose it, except when federal law requires disclosure — and even then, the material must be coded so no one's identity is exposed. The Secretary cannot keep the material after the audit ends, except as needed for that audit. (e) Following state and local law. If the Secretary is giving financial assistance for this research, the recipient must agree to follow the state law that applies. If the Secretary is directly conducting the research, the Secretary must follow the applicable state and local law too. (f) Annual report. Each year, the Secretary must report to the House Committee on Energy and Commerce and the Senate Committee on Labor and Human Resources. The report must describe the activities carried out under this section in the prior fiscal year, including whether and how well the research followed this section's rules. (g) Definition. In this section, "human fetal tissue" means tissue or cells taken from a dead human embryo or fetus, after a spontaneous abortion, an induced abortion, or a stillbirth.