Section 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.
Section 289g-2. Prohibitions regarding human fetal tissue
(a) Purchase of tissue
It shall be unlawful for any person to knowingly acquire,
receive, or otherwise transfer any human fetal tissue for valuable
consideration if the transfer affects interstate commerce.
(b) Solicitation or acceptance of tissue as directed donation for
use in transplantation
It shall be unlawful for any person to solicit or knowingly
acquire, receive, or accept a donation of human fetal tissue for
the purpose of transplantation of such tissue into another person
if the donation affects interstate commerce, the tissue will be or
is obtained pursuant to an induced abortion, and -
(1) the donation will be or is made pursuant to a promise to
the donating individual that the donated tissue will be
transplanted into a recipient specified by such individual;
(2) the donated tissue will be transplanted into a relative of
the donating individual; or
(3) the person who solicits or knowingly acquires, receives, or
accepts the donation has provided valuable consideration for the
costs associated with such abortion.
(c) Criminal penalties for violations
(1) In general
Any person who violates subsection (a) or (b) of this section
shall be fined in accordance with title 18, subject to paragraph
(2), or imprisoned for not more than 10 years, or both.
(2) Penalties applicable to persons receiving consideration
With respect to the imposition of a fine under paragraph (1),
if the person involved violates subsection (a) or (b)(3) of this
section, a fine shall be imposed in an amount not less than twice
the amount of the valuable consideration received.
(d) Definitions
For purposes of this section:
(1) The term ''human fetal tissue'' has the meaning given such
term in section 289g-1(f) (FOOTNOTE 1) of this title.
(FOOTNOTE 1) So in original. Probably should be section
''289g-1(g)''.
(2) The term ''interstate commerce'' has the meaning given such
term in section 321(b) of title 21.
(3) The term ''valuable consideration'' does not include
reasonable payments associated with the transportation,
implantation, processing, preservation, quality control, or
storage of human fetal tissue.
May the President instruct the Secretary to block the use of these funds? Or does he have no option?
The language sounds permissive, not mandatory, to me. But perhaps there is other legislation, or other EO's. But then, perhaps the President could countermand EO's.
Still in the dark ...
Richard F.
SEC. 113. NULLIFICATION OF MORATORIUM.
(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 (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 .
(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 (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 (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 (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 (as added by section 111 of this Act ).