Federal

Safe RESEARCH Act

Source: Congress.gov · 800 words in original text

What This Bill Does

This bill changes federal law to restrict how human fetal tissue can be used in research. The bill allows research with human fetal tissue only if the tissue comes from a stillbirth (a fetal death from natural causes during pregnancy). The bill also allows the government to fund research using alternatives to fetal tissue, such as organoids (miniature lab-grown organs), induced pluripotent stem cells (adult cells reprogrammed to act like embryonic cells), and adult stem cells.

Who It Affects

The Secretary of Health and Human Services (the federal official who oversees health policy) is directly affected. Researchers who conduct or receive federal funding for fetal tissue research are affected. Any institution receiving federal money for this type of research must follow the new rules.

Key Provisions

• The government may conduct or support research with human fetal tissue or with modern alternatives like organoids, induced pluripotent stem cells, and adult stem cells (Sec. 2(a)(1)) • Human fetal tissue used in federally-funded research must come only from a stillbirth, not from an abortion (Sec. 2(a)(2)) • Human fetal tissue used in research must be obtained according to applicable state law that regulates anatomical gifts (the legal transfer of body parts) (Sec. 2(a)(5)) • The Secretary of Health and Human Services must revise regulations within one year to include these new requirements (Sec. 2(c)) • Section 113 of the National Institutes of Health Revitalization Act of 1993 is repealed (Sec. 2(d))

What Changes

Federal law will no longer allow research using human fetal tissue obtained from abortion. Only fetal tissue from stillbirths may be used in federally-funded research. The definition of "human fetal tissue" changes to mean tissue from a dead embryo or fetus after a stillbirth only. Federal regulations governing this research must be updated within one year to reflect these restrictions.

Important Definitions

• "Human fetal tissue" means tissue or cells obtained from a dead human embryo or fetus after a stillbirth • "Stillbirth" means a fetal death that occurs from natural causes during pregnancy, including an ectopic pregnancy (a pregnancy that develops outside the uterus)

Effective Date

Not specified in bill text

I 118TH CONGRESS 1ST SESSION H. R. 1466 To amend the Public Health Service Act to prohibit research with human fetal tissue obtained pursuant to an abortion, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MARCH 8, 2023 Mrs. MCCLAIN (for herself, Mr. NORMAN, Mr. JOHNSON of Louisiana, Mr. GRAVES of Louisiana, Mr. HARRIS, Mr. ALLEN, Mrs. MILLER of Illinois, Mr. GROTHMAN, Mr. GOOD of Virginia, Mr. C. SCOTT FRANKLIN of Flor- ida, Mr. BIGGS, Mr. DUNCAN, Mr. POSEY, Mr. STEUBE, Mr. FEENSTRA, Mr. JOYCE of Pennsylvania, Mr. BOST, Mr. MOORE of Alabama, and Mr. GOSAR) introduced the following bill; which was referred to the Com- mittee on Energy and Commerce A BILL To amend the Public Health Service Act to prohibit research with human fetal tissue obtained pursuant to an abor- tion, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Safe Responsible Eth- 4 ical Scientific Endeavors Assuring Research for Compas- 5 sionate Healthcare Act’’ or the ‘‘Safe RESEARCH Act’’. 6 VerDate Sep 11 2014 23:43 Mar 21, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1466.IH H1466 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 1466 IH SEC. 2. PROHIBITION ON RESEARCH WITH HUMAN FETAL 1 TISSUE OBTAINED PURSUANT TO AN ABOR- 2 TION. 3 (a) IN GENERAL.—Section 498A of the Public 4 Health Service Act (42 U.S.C. 289g–1) is amended— 5 (1) in the section heading, by striking ‘‘RE- 6 SEARCH ON TRANSPLANTATION OF FETAL TISSUE’’ 7 and inserting ‘‘RESEARCH WITH FETAL TISSUE’’; 8 (2) by amending subsection (a) to read as fol- 9 lows: 10 ‘‘(a) ESTABLISHMENT OF PROGRAM.— 11 ‘‘(1) IN GENERAL.—The Secretary may conduct 12 or support research with human fetal tissue, or re- 13 search on modern, efficient alternatives to human 14 fetal tissue such as organoids, induced pluripotent 15 stem cells, and adult stem cells. The Secretary shall 16 conduct or support any such research in accordance 17 with this section. 18 ‘‘(2) SOURCE OF TISSUE.—Human fetal tissue 19 may be used in research carried out under para- 20 graph (1) only if the tissue is obtained pursuant to 21 a stillbirth.’’; 22 (3) in subsection (b)(2)— 23 (A) by striking subparagraph (A); and 24 VerDate Sep 11 2014 23:43 Mar 21, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1466.IH H1466 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •HR 1466 IH (B) by redesignating subparagraphs (B) 1 and (C) as subparagraphs (A) and (B), respec- 2 tively; 3 (4) in subsection (c)(1)(B), by striking ‘‘may 4 have been obtained pursuant to a spontaneous or in- 5 duced abortion or pursuant to a stillbirth’’ and in- 6 serting ‘‘has been obtained pursuant to a stillbirth’’; 7 (5) in subsection (e), by adding at the end the 8 following new paragraph: 9 ‘‘(3) HUMAN FETAL TISSUE OBTAINED FOR RE- 10 SEARCH.—In research carried out under subsection 11 (a), human fetal tissue may be used only if such tis- 12 sue was obtained in accordance with applicable State 13 law regulating anatomical gifts.’’; and 14 (6) by amending subsection (g) to read as fol- 15 lows: 16 ‘‘(g) DEFINITIONS.—In this section: 17 ‘‘(1) HUMAN FETAL TISSUE.—The term 18 ‘human fetal tissue’ means tissue or cells obtained 19 from a dead human embryo or fetus after a still- 20 birth. 21 ‘‘(2) STILLBIRTH.—The term ‘stillbirth’ means 22 a fetal death that occurs as a result of natural 23 causes during a pregnancy, including an ectopic 24 pregnancy.’’. 25 VerDate Sep 11 2014 23:43 Mar 21, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1466.IH H1466 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •HR 1466 IH (b) TECHNICAL AMENDMENT.—Paragraph (1) of 1 section 498B(e) of the Public Health Service Act (42 2 U.S.C. 289g–2(e)(1)) is amended to read as follows: 3 ‘‘(1) The term ‘human fetal tissue’ means tis- 4 sue or cells obtained from a dead human embryo or 5 fetus after a spontaneous or induced abortion, or 6 after a stillbirth.’’. 7 (c) REVISION OF REGULATIONS.—Not later than one 8 year after the date of the enactment of this Act, the Sec- 9 retary of Health and Human Services shall revise such 10 regulations as necessary, including section 46.206 of title 11 45, Code of Federal Regulations, to incorporate the re- 12 quirements of this section. 13 (d) REPEAL.—Section 113 of the National Institutes 14 of Health Revitalization Act of 1993 (42 U.S.C. 289g– 15 1 note) is hereby repealed. 16 Æ VerDate Sep 11 2014 23:43 Mar 21, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H1466.IH H1466 pbinns on DSKJLVW7X2PROD with $$_JOB

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