
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC289g-1]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
              SUBCHAPTER III--NATIONAL RESEARCH INSTITUTES
 
                       Part H--General Provisions
 
Sec. 289g-1. Research on transplantation of fetal tissue


(a) Establishment of program

                           (1) In general

        The Secretary may conduct or support research on the 
    transplantation of human fetal tissue for therapeutic purposes.

                        (2) Source of tissue

        Human fetal tissue may be used in research carried out under 
    paragraph (1) regardless of whether the tissue is obtained pursuant 
    to a spontaneous or induced abortion or pursuant to a stillbirth.

(b) Informed consent of donor

                           (1) In general

        In research carried out under subsection (a) of this section, 
    human fetal tissue may be used only if the woman providing the 
    tissue makes a statement, made in writing and signed by the woman, 
    declaring that--
            (A) the woman donates the fetal tissue for use in research 
        described in subsection (a) of this section;
            (B) the donation is made without any restriction regarding 
        the identity of individuals who may be the recipients of 
        transplantations of the tissue; and
            (C) the woman has not been informed of the identity of any 
        such individuals.

                      (2) Additional statement

        In research carried out under subsection (a) of this section, 
    human fetal tissue may be used only if the attending physician with 
    respect to obtaining the tissue from the woman involved makes a 
    statement, made in writing and signed by the physician, declaring 
    that--
            (A) in the case of tissue obtained pursuant to an induced 
        abortion--
                (i) the consent of the woman for the abortion was 
            obtained prior to requesting or obtaining consent for a 
            donation of the tissue for use in such research;
                (ii) no alteration of the timing, method, or procedures 
            used to terminate the pregnancy was made solely for the 
            purposes of obtaining the tissue; and
                (iii) the abortion was performed in accordance with 
            applicable State law;

            (B) the tissue has been donated by the woman in accordance 
        with paragraph (1); and
            (C) full disclosure has been provided to the woman with 
        regard to--
                (i) such physician's interest, if any, in the research 
            to be conducted with the tissue; and
                (ii) any known medical risks to the woman or risks to 
            her privacy that might be associated with the donation of 
            the tissue and that are in addition to risks of such type 
            that are associated with the woman's medical care.

(c) Informed consent of researcher and donee

    In research carried out under subsection (a) of this section, human 
fetal tissue may be used only if the individual with the principal 
responsibility for conducting the research involved makes a statement, 
made in writing and signed by the individual, declaring that the 
individual--
        (1) is aware that--
            (A) the tissue is human fetal tissue;
            (B) the tissue may have been obtained pursuant to a 
        spontaneous or induced abortion or pursuant to a stillbirth; and
            (C) the tissue was donated for research purposes;

        (2) has provided such information to other individuals with 
    responsibilities regarding the research;
        (3) will require, prior to obtaining the consent of an 
    individual to be a recipient of a transplantation of the tissue, 
    written acknowledgment of receipt of such information by such 
    recipient; and
        (4) has had no part in any decisions as to the timing, method, 
    or procedures used to terminate the pregnancy made solely for the 
    purposes of the research.

(d) Availability of statements for audit

                           (1) In general

        In research carried out under subsection (a) of this section, 
    human fetal tissue may be used only if the head of the agency or 
    other entity conducting the research involved certifies to the 
    Secretary that the statements required under subsections (b)(2) and 
    (c) of this section will be available for audit by the Secretary.

                    (2) Confidentiality of audit

        Any audit conducted by the Secretary pursuant to paragraph (1) 
    shall be conducted in a confidential manner to protect the privacy 
    rights of the individuals and entities involved in such research, 
    including such individuals and entities involved in the donation, 
    transfer, receipt, or transplantation of human fetal tissue. With 
    respect to any material or information obtained pursuant to such 
    audit, the Secretary shall--
            (A) use such material or information only for the purposes 
        of verifying compliance with the requirements of this section;
            (B) not disclose or publish such material or information, 
        except where required by Federal law, in which case such 
        material or information shall be coded in a manner such that the 
        identities of such individuals and entities are protected; and
            (C) not maintain such material or information after 
        completion of such audit, except where necessary for the 
        purposes of such audit.

(e) Applicability of State and local law

         (1) Research conducted by recipients of assistance

        The Secretary may not provide support for research under 
    subsection (a) of this section unless the applicant for the 
    financial assistance involved agrees to conduct the research in 
    accordance with applicable State law.

                 (2) Research conducted by Secretary

        The Secretary may conduct research under subsection (a) of this 
    section only in accordance with applicable State and local law.

(f) Report

    The Secretary shall annually submit to the Committee on Energy and 
Commerce of the House of Representatives, and to the Committee on Labor 
and Human Resources of the Senate, a report describing the activities 
carried out under this section during the preceding fiscal year, 
including a description of whether and to what extent research under 
subsection (a) of this section has been conducted in accordance with 
this section.

(g) ``Human fetal tissue'' defined

    For purposes of this section, 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.

(July 1, 1944, ch. 373, title IV, Sec. 498A, as added Pub. L. 103-43, 
title I, Sec. 111, June 10, 1993, 107 Stat. 129.)

                         Change of Name

    Committee on Energy and Commerce of House of Representatives treated 
as referring to Committee on Commerce of House of Representatives by 
section 1(a) of Pub. L. 104-14, set out as a note preceding section 21 
of Title 2, The Congress.


                       Nullification of Moratorium

    Section 113 of Pub. L. 103-43 provided that:
    ``(a) In General.--Except as provided in subsection (c), no official 
of the executive branch may impose a policy that the Department of 
Health and Human Services is prohibited from conducting or supporting 
any research on the transplantation of human fetal tissue for 
therapeutic purposes. Such research shall be carried out in accordance 
with section 498A of the Public Health Service Act [this section] (as 
added by section 111 of this Act), without regard to any such policy 
that may have been in effect prior to the date of the enactment of this 
Act [June 10, 1993].
    ``(b) Prohibition Against Withholding of Funds in Cases of Technical 
and Scientific Merit.--
        ``(1) In general.--Subject to subsection (b)(2) of section 492A 
    of the Public Health Service Act [section 289a-1(b)(2) of this 
    title] (as added by section 101 of this Act), in the case of any 
    proposal for research on the transplantation of human fetal tissue 
    for therapeutic purposes, the Secretary of Health and Human Services 
    may not withhold funds for the research if--
            ``(A) the research has been approved for purposes of 
        subsection (a) of such section 492A;
            ``(B) the research will be carried out in accordance with 
        section 498A of such Act [this section] (as added by section 111 
        of this Act); and
            ``(C) there are reasonable assurances that the research will 
        not utilize any human fetal tissue that has been obtained in 
        violation of section 498B(a) of such Act [section 289g-2(a) of 
        this title] (as added by section 112 of this Act).
        ``(2) Standing approval regarding ethical status.--In the case 
    of any proposal for research on the transplantation of human fetal 
    tissue for therapeutic purposes, the issuance in December 1988 of 
    the Report of the Human Fetal Tissue Transplantation Research Panel 
    shall be deemed to be a report--
            ``(A) issued by an ethics advisory board pursuant to section 
        492A(b)(5)(B)(ii) of the Public Health Service Act (as added by 
        section 101 of this Act); and
            ``(B) finding, on a basis that is neither arbitrary nor 
        capricious, that the nature of the research is such that it is 
        not unethical to conduct or support the research.
    ``(c) Authority for Withholding Funds From Research.--In the case of 
any research on the transplantation of human fetal tissue for 
therapeutic purposes, the Secretary of Health and Human Services may 
withhold funds for the research if any of the conditions specified in 
any of subparagraphs (A) through (C) of subsection (b)(1) are not met 
with respect to the research.
    ``(d) Definition.--For purposes of this section, the term `human 
fetal tissue' has the meaning given such term in section 498A(f) of the 
Public Health Service Act [subsec. (f) of this section] (as added by 
section 111 of this Act).''


     Report by General Accounting Office on Adequacy of Requirements

    Section 114 of Pub. L. 103-43 provided that, with respect to 
research on the transplantation of human fetal tissue for therapeutic 
purposes, the Comptroller General of the United States was to conduct an 
audit for the purpose of determining whether and to what extent such 
research conducted or supported by Secretary of Health and Human 
Services had been conducted in accordance with this section and whether 
and to what extent there have been violations of section 289g-2 of this 
title and directed the Comptroller General to complete the audit and 
report the findings to Congress, not later than May 19, 1995.

                  Section Referred to in Other Sections

    This section is referred to in section 289g-2 of this title.
