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.