42 U.S.C. § 289g — Fetal research

Page 807 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 289g Such appropriations may be expended by con- tract if deemed necessary, without regard to section 6101 of title 41. (b)(1) None of the amounts appropriated under this chapter for the purposes of this subchapter may be obligated for the construction of facili- ties (including the acquisition of land) unless a provision of this subchapter establishes express authority for such purpose and unless the Act making appropriations under such provision specifies that the amounts appropriated are available for such purpose. (2) Any grants, cooperative agreements, or contracts authorized in this subchapter for the construction of facilities may be awarded only on a competitive basis. (July 1, 1944, ch. 373, title IV, § 496, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 877; amended Pub. L. 101–190, § 8, Nov. 29, 1989, 103 Stat. 1695; Pub. L. 103–43, title XX, § 2008(b)(15), June 10, 1993, 107 Stat. 211.) Editorial Notes CODIFICATION In subsec. (a), ‘‘section 6101 of title 41’’ substituted for ‘‘section 3709 of the Revised Statutes (41 U.S.C. 5)’’ on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Con- tracts. AMENDMENTS 1993—Subsec. (a). Pub. L. 103–43 substituted ‘‘Appro- priations to carry out the purposes of this subchapter’’ for ‘‘Such appropriations’’. 1989—Subsec. (a). Pub. L. 101–190 designated existing provisions as subsec. (a), struck out first sentence which read as follows: ‘‘Appropriations to carry out the purposes of this subchapter shall be available for the acquisition of land or the erection of buildings only if so specified.’’, and added subsec. (b). Statutory Notes and Related Subsidiaries CONSTRUCTION OF BIOMEDICAL FACILITIES FOR DEVEL- OPMENT AND BREEDING OF SPECIALIZED STRAINS OF MICE Pub. L. 101–190, §§ 1–7, Nov. 29, 1989, 103 Stat. 1691–1695, as amended by Pub. L. 101–374, § 4(a), (c)(1), Aug. 15, 1990, 104 Stat. 458, 459, authorized a reservation of funds for making a grant to construct facilities for develop- ment and breeding of specialized strains of mice for use in biomedical research, provided for a competitive grant award process, required applicant for the grant to agree to a twenty-year transferable obligation, re- stricted grant applicant to public or nonprofit private status, with assurances of sufficient financial re- sources, set forth other grant requirements, and speci- fied consequences of failure to comply with agreements and violation of the twenty-year obligation. § 289f. Gifts and donations; memorials The Secretary may, in accordance with sec- tion 238 of this title, accept conditional gifts for the National Institutes of Health or a national research institute or for the acquisition of grounds or for the erection, equipment, or main- tenance of facilities for the National Institutes of Health or a national research institute. Dona- tions of $50,000 or over for the National Insti- tutes of Health or a national research institute for carrying out the purposes of this subchapter may be acknowledged by the establishment within the National Institutes of Health or a na- tional research institute of suitable memorials to the donors. (July 1, 1944, ch. 373, title IV, § 497, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 877; amended Pub. L. 99–660, title III, § 311(b)(1), Nov. 14, 1986, 100 Stat. 3779; Pub. L. 100–607, title II, § 204(3), Nov. 4, 1988, 102 Stat. 3079; Pub. L. 100–690, title II, § 2620(b)(2), Nov. 18, 1988, 102 Stat. 4244; Pub. L. 101–381, title I, § 102(5), Aug. 18, 1990, 104 Stat. 586; Pub. L. 103–43, title XX, § 2010(b)(6), June 10, 1993, 107 Stat. 214.) Editorial Notes AMENDMENTS 1993—Pub. L. 103–43 substituted ‘‘section 238’’ for ‘‘section 300aaa’’. 1990—Pub. L. 101–381 made technical amendment to reference to section 300aaa of this title to reflect re- numbering of corresponding section of original act. 1988—Pub. L. 100–690 made technical amendment to reference to section 300aaa of this title to reflect re- numbering of corresponding section of original act. Pub. L. 100–607 substituted ‘‘300aaa’’ for ‘‘300cc’’. 1986—Pub. L. 99–660 substituted ‘‘section 300cc of this title’’ for ‘‘section 300aa of this title’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100–690 effective immediately after enactment of Pub. L. 100–607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out as a note under section 242m of this title. EFFECTIVE DATE OF 1986 AMENDMENT Amendment by Pub. L. 99–660 effective Dec. 22, 1987, see section 323 of Pub. L. 99–660, as amended, set out as an Effective Date note under section 300aa–1 of this title. § 289g. Fetal research (a) Conduct or support by Secretary; restrictions The Secretary may not conduct or support any research or experimentation, in the United States or in any other country, on a nonviable living human fetus ex utero or a living human fetus ex utero for whom viability has not been ascertained unless the research or experimen- tation— (1) may enhance the well-being or meet the health needs of the fetus or enhance the prob- ability of its survival to viability; or (2) will pose no added risk of suffering, in- jury, or death to the fetus and the purpose of the research or experimentation is the devel- opment of important biomedical knowledge which cannot be obtained by other means. (b) Risk standard for fetuses intended to be aborted and fetuses intended to be carried to term to be same In administering the regulations for the pro- tection of human research subjects which— (1) apply to research conducted or supported by the Secretary; (2) involve living human fetuses in utero; and (3) are published in section 46.208 of part 46 of title 45 of the Code of Federal Regulations; or any successor to such regulations, the Sec- retary shall require that the risk standard (pub- Page 808 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 289g–1 lished in section 46.102(g) of such part 46 or any successor to such regulations) be the same for fetuses which are intended to be aborted and fetuses which are intended to be carried to term. (July 1, 1944, ch. 373, title IV, § 498, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 877; amended Pub. L. 100–607, title I, §§ 156, 157(b), Nov. 4, 1988, 102 Stat. 3059; Pub. L. 103–43, title I, § 121(b)(1), June 10, 1993, 107 Stat. 133.) Editorial Notes AMENDMENTS 1993—Subsec. (c). Pub. L. 103–43 struck out subsec. (c) which directed Biomedical Ethics Advisory Committee to conduct a study of the nature, advisability, and bio- medical and ethical implications of exercising any waiver of the risk standard published in section 46.102(g) of part 46 of title 45 of the Code of Federal Reg- ulations and to report its finding to the Biomedical Ethics Board not later than 24 months after Nov. 4, 1988, which report was to be then transmitted to speci- fied Congressional committees. 1988—Subsec. (c)(1). Pub. L. 100–607, § 157(b), sub- stituted ‘‘24 months after November 4, 1988’’ for ‘‘thirty months after November 20, 1985’’. Subsec. (c)(2). Pub. L. 100–607, § 156(1), substituted ‘‘24- month period beginning on November 4, 1988’’ for ‘‘thir- ty-six month period beginning on November 20, 1985’’. Subsec. (c)(3). Pub. L. 100–607, § 156(2), substituted ‘‘1990’’ for ‘‘1988’’. Statutory Notes and Related Subsidiaries NULLIFICATION OF CERTAIN PROVISIONS Pub. L. 103–43, title I, § 121(c), June 10, 1993, 107 Stat. 133, provided that: ‘‘The provisions of Executive Order 12806 (57 Fed. Reg. 21589 (May 21, 1992)) [formerly set out below] shall not have any legal effect. The provisions of section 204(d) of part 46 of title 45 of the Code of Federal Regulations (45 CFR 46.204(d)) shall not have any legal effect.’’ Executive Documents EXECUTIVE ORDER NO. 12806. ESTABLISHMENT OF FETAL TISSUE BANK Ex. Ord. No. 12806, May 19, 1992, 57 F.R. 21589, which established a human fetal tissue bank, was nullified by Pub. L. 103–43, title I, § 121(c), June 10, 1993, 107 Stat. 133, set out above. FEDERAL FUNDING OF FETAL TISSUE TRANSPLANTATION RESEARCH Memorandum of President of the United States, Jan. 22, 1993, 58 F.R. 7457, provided: Memorandum for the Secretary of Health and Human Services On March 22, 1988, the Assistant Secretary for Health of Health and Human Services (‘‘HHS’’) imposed a tem- porary moratorium on Federal funding of research in- volving transplantation of fetal tissue from induced abortions. Contrary to the recommendations of a Na- tional Institutes of Health advisory panel, on Novem- ber 2, 1989, the Secretary of Health and Human Services extended the moratorium indefinitely. This morato- rium has significantly hampered the development of possible treatments for individuals afflicted with seri- ous diseases and disorders, such as Parkinson’s disease, Alzheimer’s disease, diabetes, and leukemia. Accord- ingly, I hereby direct that you immediately lift the moratorium. You are hereby authorized and directed to publish this memorandum in the Federal Register. WILLIAM J. CLINTON. § 289g–1. Research on transplantation of fetal tis- sue (a) Establishment of program (1) In general The Secretary may conduct or support re- search 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), human fetal tissue may be used only if the woman providing the tissue makes a state- ment, 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); (B) the donation is made without any re- striction regarding the identity of individ- uals 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), human fetal tissue may be used only if the at- tending 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 preg- nancy was made solely for the purposes of obtaining the tissue; and (iii) the abortion was performed in ac- cordance 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 tis- sue; and (ii) any known medical risks to the woman or risks to her privacy that might be associated with the donation of the tis- sue 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), human fetal tissue may be used only if the indi- vidual with the principal responsibility for con- ducting the research involved makes a state-