Source: https://uscode.house.gov/view.xhtml?path=&req=%28title%3A42+section%3A289g-1+edition%3Aprelim%29&f=&fq=&num=0&hl=false&edition=prelim
Timestamp: 2019-11-22 10:54:29
Document Index: 290810408

Matched Legal Cases: ['§ 289', '§289', '§498', '§111', '§113', '§114']

[USC02] 42 USC 289g-1: Research on transplantation of fetal tissue
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42 USC 289g-1: Research on transplantation of fetal tissue Text contains those laws in effect on November 21, 2019
From Title 42-THE PUBLIC HEALTH AND WELFARECHAPTER 6A-PUBLIC HEALTH SERVICESUBCHAPTER III-NATIONAL RESEARCH INSTITUTESPart H-General Provisions
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§289g–1. Research on transplantation of fetal tissue
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
In 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-
(2) Additional statement
In 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-
(A) in the case of tissue obtained pursuant to an induced abortion-
(C) full disclosure has been provided to the woman with regard to-
(c) Informed consent of researcher and donee
In 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-
(1) is aware that-
(d) Availability of statements for audit
In research carried out under subsection (a), 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) 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) 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) only in accordance with applicable State and local law.
(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, §498A, as added Pub. L. 103–43, title I, §111, June 10, 1993, 107 Stat. 129 .)
Nullification of Moratorium
Pub. L. 103–43, title I, §113, June 10, 1993, 107 Stat. 132 , 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 [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].
"(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 [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-
"(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 [42 U.S.C. 289g–1] (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 [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-
"(A) 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
"(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 [42 U.S.C. 289g–1(f)] (as added by section 111 of this Act)."
Report by General Accounting Office on Adequacy of Requirements
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.