Safe RESEARCH Act
Bill: H.R.568 | Sponsor: Rep. McClain, Lisa C. (R-MI)
Policy area: Health

Summary:
Safe Responsible Ethical Scientific Endeavors Assuring Research for Compassionate Healthcare Act or the Safe RESEARCH Act
This bill prohibits the National Institutes of Health (NIH) from conducting or supporting research on human fetal tissue obtained from an abortion procedure. It also imposes other restrictions on human fetal tissue research.
Under the bill, the NIH may conduct or support research on human fetal tissue only if it was obtained from a stillbirth. Current law allows research on tissue from stillbirths or from spontaneous or induced abortions.
The bill also applies informed consent and other requirements applicable to research on the transplantation of human fetal tissue for therapeutic purposes to all research with human fetal tissue. This includes research on stem cells and other human fetal tissue alternatives.
Additionally, human fetal tissue used for this research must be obtained in accordance with state anatomical gift laws. These laws govern organ and tissue donation for therapeutic, research, and other purposes. Some states already apply anatomical gift laws to human fetal tissue donation.
Currently, executive branch officials may not prohibit the NIH from conducting or supporting research on the transplantation of human fetal tissue for therapeutic purposes. The bill repeals this limitation on executive branch officials. It also repeals a requirement that the NIH fund certain proposals for this research.

To amend the Public Health Service Act to prohibit research with human 
 fetal tissue obtained pursuant to an abortion, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Safe Responsible Ethical Scientific 
Endeavors Assuring Research for Compassionate Healthcare Act'' or the 
``Safe RESEARCH Act''.

SEC. 2. PROHIBITION ON RESEARCH WITH HUMAN FETAL TISSUE OBTAINED 
              PURSUANT TO AN ABORTION.

    (a) In General.--Section 498A of the Public Health Service Act (42 
U.S.C. 289g-1) is amended--
            (1) in the section heading, by striking ``research on 
        transplantation of fetal tissue'' and inserting ``research with 
        fetal tissue'';
            (2) by amending subsection (a) to read as follows:
    ``(a) Establishment of Program.--
            ``(1) In general.--The Secretary may conduct or support 
        research with human fetal tissue, or research on modern, 
        efficient alternatives to human fetal tissue such as organoids, 
        induced pluripotent stem cells, and adult stem cells. The 
        Secretary shall conduct or support any such research in 
        accordance with this section.
            ``(2) Source of tissue.--Human fetal tissue may be used in 
        research carried out under paragraph (1) only if the tissue is 
        obtained pursuant to a stillbirth.'';
            (3) in subsection (b)(2)--
                    (A) by striking subparagraph (A); and
                    (B) by redesignating subparagraphs (B) and (C) as 
                subparagraphs (A) and (B), respectively;
            (4) in subsection (c)(1)(B), by striking ``may have been 
        obtained pursuant to a spontaneous or induced abortion or 
        pursuant to a stillbirth'' and inserting ``has been obtained 
        pursuant to a stillbirth'';
            (5) in subsection (e), by adding at the end the following 
        new paragraph:
            ``(3) Human fetal tissue obtained for research.--In 
        research carried out under subsection (a), human fetal tissue 
        may be used only if such tissue was obtained in accordance with 
        applicable State law regulating anatomical gifts.''; and
            (6) by amending subsection (g) to read as follows:
    ``(g) Definitions.--In this section:
            ``(1) Human fetal tissue.--The term `human fetal tissue' 
        means tissue or cells obtained from a dead human embryo or 
        fetus after a stillbirth.
            ``(2) Stillbirth.--The term `stillbirth' means a fetal 
        death that occurs as a result of natural causes during a 
        pregnancy, including an ectopic pregnancy.''.
    (b) Technical Amendment.--Paragraph (1) of section 498B(e) of the 
Public Health Service Act (42 U.S.C. 289g-2(e)(1)) is amended to read 
as follows:
            ``(1) The term `human fetal tissue' means tissue or cells 
        obtained from a dead human embryo or fetus after a spontaneous 
        or induced abortion, or after a stillbirth.''.
    (c) Revision of Regulations.--Not later than one year after the 
date of the enactment of this Act, the Secretary of Health and Human 
Services shall revise such regulations as necessary, including section 
46.206 of title 45, Code of Federal Regulations, to incorporate the 
requirements of this section.
    (d) Repeal.--Section 113 of the National Institutes of Health 
Revitalization Act of 1993 (42 U.S.C. 289g-1 note) is hereby repealed.
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