Source: https://www.law.cornell.edu/uscode/text/42/289g%E2%80%931
Timestamp: 2019-06-18 16:59:30
Document Index: 701171263

Matched Legal Cases: ['§ 289', '§ 289', '§\u202f289', '§\u202f498', '§\u202f111', '§\u202f113', '§\u202f114']

U.S. Code › Title 42 › Chapter 6A › Subchapter III › Part H › § 289g–1
42 U.S. Code § 289g–1 - Research on transplantation of fetal tissue
§ 289g–1.
(1) In generalIn research carried out under subsection (a), 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—
the woman donates the fetal tissue for use in research described in subsection (a);
(2) Additional statementIn research carried out under subsection (a), 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—
(c) Informed consent of researcher and doneeIn research carried out under subsection (a), 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—
(2) Confidentiality of auditAny 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—
(July 1, 1944, ch. 373, title IV, § 498A, as added Pub. L. 103–43, title I, § 111, June 10, 1993, 107 Stat. 129.)
Pub. L. 103–43, title I, § 113, June 10, 1993, 107 Stat. 132, provided that:
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 [42 U.S.C. 289g–1] (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].
“(1)In general.—Subject to subsection (b)(2) of section 492A of the Public Health Service Act [42 U.S.C. 289a–1(b)(2)] (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—
the research has been approved for purposes of subsection (a) of such section 492A;
the research will be carried out in accordance with section 498A of such Act [42 U.S.C. 289g–1] (as added by section 111 of this Act); and
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 [42 U.S.C. 289g–2(a)] (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—
issued by an ethics advisory board pursuant to section 492A(b)(5)(B)(ii) of the Public Health Service Act [42 U.S.C. 289a–1(b)(5)(B)(ii)] (as added by section 101 of this Act); and
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.
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 [42 U.S.C. 289g–1(f)] (as added by section 111 of this Act).”
Pub. L. 103–43, title I, § 114, June 10, 1993, 107 Stat. 132, 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.