From the U.S. Code Online via GPO Access
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[Laws in effect as of January 1, 1994]
[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 June 10, 1993,
Pub. L. 103-43, title I, Sec. 111, 107 Stat. 129.)
Change of Name
Committee on Energy and Commerce of House of Representatives changed
to Committee on Commerce of House of Representatives by House Resolution
No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
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:
``(a) In General.--With respect to research on the transplantation
of human fetal tissue for therapeutic purposes, the Comptroller General
of the United States shall conduct an audit for the purpose of
determining--
``(1) whether and to what extent such research conducted or
supported by the Secretary of Health and Human Services has been
conducted in accordance with section 498A of the Public Health
Service Act [this section] (as added by section 111 of this Act);
and
``(2) whether and to what extent there have been violations of
section 498B of such Act [section 289g-2 of this title] (as added by
section 112 of this Act).
``(b) Report.--Not later than May 19, 1995, the Comptroller General
of the United States shall complete the audit required in subsection (a)
and submit to the Committee on Energy and Commerce [now Committee on
Commerce] of the House of Representatives, and to the Committee on Labor
and Human Resources of the Senate, a report describing the findings made
pursuant to the audit.''
Section Referred to in Other Sections
This section is referred to in section 289g-2 of this title.
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