[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 363 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                 S. 363

To provide increased Federal funding for stem cell research, to expand 
the number of embryonic stem cell lines available for Federally funded 
  research, to provide ethical guidelines for stem cell research, to 
 derive human pluripotent stem cell lines using techniques that do not 
create an embryo or embryos for research or knowingly harm human embryo 
                  or embryos, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 23, 2007

  Mr. Coleman introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To provide increased Federal funding for stem cell research, to expand 
the number of embryonic stem cell lines available for Federally funded 
  research, to provide ethical guidelines for stem cell research, to 
 derive human pluripotent stem cell lines using techniques that do not 
create an embryo or embryos for research or knowingly harm human embryo 
                  or embryos, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Hope Offered through Principled, 
Ethically-Sound Stem Cell Research Act'' or the ``HOPE Act''.

SEC. 2. PURPOSES.

    It is the purpose of this Act to--
            (1) intensify research that may result in improved 
        understanding of or treatments for diseases and other adverse 
        health conditions; and
            (2) promote the derivation of pluripotent stem cell lines 
        without the creation of human embryos for research purposes or 
        discarding, destroying, or knowingly harming a human embryo.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Altered nuclear transfer.--The term ``altered nuclear 
        transfer'' means a method for obtaining pluripotent stem cells 
        using a modified form of somatic cell nuclear transfer to 
        produce a biological artifact.
            (2) Biological artifact.--The term ``biological artifact'' 
        means an artificially created non-embryonic cellular system, 
        engineered to lack the essential elements of embryogenesis but 
        still capable of some cell division and growth.
            (3) Direct reprogramming of adult cells.--The term ``direct 
        reprogramming of adult cells'' means a procedure whereby 
        differentiated, somatic cells are restored to a more 
        undifferentiated, multipotent condition. Such process is also 
        known as ``dedifferentiation''.
            (4) Embryo adoption.--The term ``embryo adoption'' means 
        the occurrence of a woman receiving into her uterus a human 
        embryo or embryos to which neither she nor her partner has 
        contributed a gamete for the purpose of child bearing.
            (5) Embryonic stem cells.--The term ``embryonic stem 
        cells'' means primitive cells derived from the inner cell mass 
        of the human embryo or embryos, that have the potential to 
        become a wide variety of specialized cell types.
            (6) Human embryo or embryos.--The term ``human embryo or 
        embryos'' includes any organism, not protected as a human 
        subject under part 46 of title 45, Code of Federal Regulations, 
        as of the date of enactment of this section, that is derived by 
        fertilization, parthenogenesis, cloning, or any other means 
        from one or more human gametes or human diploid cells.
            (7) In vitro fertilization.--The term ``in vitro 
        fertilization'' means the union of an egg and sperm, where the 
        event takes place outside the body and in an artificial 
        environment.
            (8) Oocyte.--The term ``oocyte'' means an unfertilized 
        human egg cell.
            (9) Organismically dead embryo.--The term ``organismically 
        dead embryo'' means the irreversible loss of the capacity of 
        continued and integrated cellular division, growth and 
        differentiation.
            (10) Pluripotent cell.--The term ``pluipotent cell'' means 
        a cell that can produce all the cell types of the developing 
        body. Embryonic stem cells, as well as the inner cell mass 
        cells of the blastocyst, are pluripotent cells.
            (11) Pluripotent stem cells.--The term ``pluripotent stem 
        cells'' means precursor cells that are capable both of 
        perpetuating themselves as stem cells and of producing all or 
        almost all the cell types of the developing body, and that have 
        functional capacity (stable pluripotency) as an embryonic stem 
        cell, though not necessarily the same origin.
            (12) Review board.--The term ``Review Board'' means the 
        National Stem Cell Review Board established under section 5.
            (13) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (14) Stem cell line.--The term ``stem cell line'' means 
        stem cells which have been cultured under in vitro conditions 
        that allow proliferation without differentiation from months to 
        years.

SEC. 4. PROVISION OF FEDERAL FUNDING.

    (a) Basic and Applied Research.--
            (1) In general.--The Secretary shall conduct and support 
        basic and applied research to develop techniques for the 
        isolation, derivation, production, or testing of pluripotent 
        stem cells that have the flexibility of embryonic stem cells 
        (whether or not they have an embryonic source), and may result 
        in improved understanding of or treatments for diseases and 
        other adverse health conditions, provided that such isolation, 
        derivation, production, or testing will not involve--
                    (A) the creation of a human embryo or embryos for 
                research purposes; or
                    (B) the destruction or discarding of a human embryo 
                or embryos, or knowingly subjecting a human embryo or 
                embryos to risk of injury or death greater than that 
                allowed for research on fetuses in utero under section 
                498(b) of this Act and section 46.204(b) of title 45, 
                Code of Federal Regulations.
            (2) Inclusions.--Research under paragraph (1) may include--
                    (A) Methods that use--
                            (i) cells derived from altered nuclear 
                        transfer; or
                            (ii) cells derived from organismically dead 
                        embryos; and
                    (B) the investigation of evidence for pluripotent 
                potential in adult stem cells from various sources; or
                    (C) the direct reprogramming of adult cells, the 
                derivation of stem cells from human germ cells, and 
                other methods that do not harm or destroy a human 
                embryo or embryos and that are certified by the Review 
                Board.
    (b) Limitations.--If any research described in subsection (a) is 
determined by the Secretary to create an embryo or embryos for research 
purposes, or harm or destroy a human embryo or embryos, such research 
shall immediately be terminated until such determination is reviewed 
and resolved to the satisfaction of the Review Board.
    (c) Guidelines.--Not later than 90 days after the date of the 
enactment of this section, the Secretary, after consultation with the 
Director, shall issue final guidelines that--
            (1) provide guidance concerning the next steps required for 
        additional research, which shall include a determination of the 
        extent to which specific techniques may require additional 
        basic or animal research to ensure that any research involving 
        human cells using these techniques would clearly be consistent 
        with subsection (a);
            (2) prioritize research with the greatest potential for 
        near-term clinical benefit; and
            (3) consistent with subsection (a), take into account 
        techniques outlined by the President's Council on Bioethics and 
        any other appropriate techniques and research.
    (d) Reporting Requirements.--Not later than January 1 of each year, 
the Secretary shall prepare and submit to the appropriate committees of 
the Congress a report describing the activities carried out under this 
section during the fiscal year, including a description of the research 
conducted under this section.
    (e) Rule of Construction.--Nothing in this section shall be 
construed as altering the policy in effect on the date of enactment of 
this section regarding the eligibility of stem cell lines for funding 
by the National Institutes of Health.

SEC. 5. NATIONAL STEM CELL RESEARCH REVIEW BOARD.

    (a) In General.--There shall be established within the Department 
of Health and Human Services a board to be known as the ``National Stem 
Cell Research Review Board'' which shall be responsible for--
            (1) monitoring research to ensure that it is in compliance 
        with the principles of this Act;
            (2) prioritizing research with the greatest potential for 
        near term benefits;
            (3) ensuring fair consideration of both embryonic stem cell 
        and adult stem cell research for funding; and
            (4) completing their duties under this section in a timely 
        matter to promote rather than hinder appropriate research.
    (b) Composition.--
            (1) In general.--The Review Board shall be composed of 11 
        individuals, to be appointed by the Secretary.
            (2) Requirements.--The members appointed under paragraph 
        (1) shall include--
                    (A) scientists or physicians with relevant 
                expertise (including areas of assisted reproduction, 
                developmental biology, and clinical medicine), 
                including scientists that are not directly engaged in 
                the research considered by the Board;
                    (B) ethicists or professionals from other 
                disciplines with a specialized ability to interpret the 
                moral justifications and implications of the research 
                considered by the Board;
                    (C) members or advisors familiar with relevant 
                national legal statutes governing the research 
                considered by the Board; and
                    (D) community members, unaffiliated with the 
                institutions involved through employment or other 
                remunerative relationships, who are objective and 
                reasonably familiar with the views and needs of 
                research subjects, patients and patient communities who 
                could be benefitted or harmed by stem cell research, 
                and community standards.
            (3) Terms of office.--
                    (A) In general.--The term of office of a member of 
                a the Review Board appointed under paragraph (1) shall 
                be 4 years, except that any member appointed to fill a 
                vacancy for an unexpired term shall serve for the 
                remainder of such term. The Secretary shall ensure that 
                appointments are made to the Board in such a manner as 
                to ensure that the terms of the members not all expire 
                in the same year and that not all members' terms concur 
                with the 4-year Presidential term. A member of the 
                Board may serve after the expiration of such member's 
                term until a successor has been appointed and taken 
                office.
                    (B) Time for appointment.--If a vacancy occurs 
                among the members of the Review Board, the Secretary 
                shall ensure that an appointment to fill such vacancy 
                occurs within 90 days from the date the vacancy occurs.
    (c) Limitation.--The Review Board shall not be responsible for 
dispersing funds. The Board shall ensure that funds which are to be 
provided by the Federal Government are being used appropriately and 
under the provisions of this Act.
    (d) Additional Administrative Provisions.--
            (1) Compensation.--Members of the Review Board who are 
        officers or employees of the United States shall not receive 
        any compensation for service on the Board. The remaining 
        members of the Board shall receive, for each day (including 
        travel time) they are engaged in the performance of the 
        functions of the advisory council, compensation at rates not to 
        exceed the daily equivalent to the annual rate in effect for 
        grade GS-15 of the General Schedule.
            (2) Executive secretary and staff.--The Review Board may 
        appoint an individual to serve as the Executive Secretary of 
        the Board. The Secretary shall make available to the Board such 
        staff, information, and other assistance as it may require to 
        carry out its functions.

SEC. 6. INFORMED CONSENT PROVISIONS.

    (a) Purpose.--It is the purpose of this section to ensure that 
individuals are empowered to make voluntary and informed decisions 
regarding the use of human embryo or embryos created using their 
biological materials or their oocytes.
    (b) Timing of Consent.--Consent from an individual for the donation 
of materials for research described in this Act shall be obtained from 
such individual, in writing, at the time of the proposed transfer of 
the donated materials from the storage site to the research team.
    (c) Provision of Information to Donors.--At the time that the 
consent described in subsection (b) is given, the donor shall be 
informed, verbally and in writing, that the donor retains the right to 
withdraw such consent until such time as the donated materials involved 
are actually utilized in research.

SEC. 7. PRIVACY.

    Provisions protecting individually identifiable information under 
the regulations promulgated under section 264(c) of the Health 
Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 
note) shall apply to donors under this Act.

SEC. 8. PROHIBITION ON PROFITEERING FROM COMMERCE IN EMBRYOS, HUMAN 
              OVUMS, OR EMBRYONIC STEM CELL LINES.

    (a) No Valuable Consideration.--Section 301 of the National Organ 
Transplant Act (42 U.S.C. 274e) is amended--
            (1) in subsection (a), by inserting ``, human ovum, human 
        blastocyst, human embryo, or stem cell derived from a human 
        embryo'' after ``any human organ''; and
            (2) in subsection (c)(2)--
                    (A) by striking ``human organ'' each place the term 
                appears and inserting ``human organ, human ovum, human 
                blastocyst, human embryo, or stem cell derived from a 
                human embryo''; and
                    (B) by inserting ``, ovum, blastocyst, embryo, or 
                stem cell'' after ``the organ''.
    (b) No Profits From Therapies That Destroy Human Embryos.--Part H 
of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is 
amended by adding at the end the following:

``SEC. 498D. REQUIREMENTS FOR RESEARCH INVOLVING HUMAN EMBRYOS.

    ``(a) Ensuring Access to Affordable Treatments.--
            ``(1) In general.--It shall be unlawful for any person to 
        knowingly receive any valuable consideration for any therapy 
        that--
                    ``(A) affects interstate commerce or is funded, in 
                full or in part, by Federal assistance; and
                    ``(B) utilizes cells from a human embryo, if the 
                process of deriving such cells destroyed the embryo.
            ``(2) Definition of valuable consideration.--In this 
        subsection, the term `valuable consideration' does not include 
        the reasonable production and administrative costs associated 
        with developing a therapy described in paragraph (1).''.

SEC. 9. FUNDING FOR STEM CELL RESEARCH.

    (a) In General.--There is authorized to be appropriated to carry 
out this Act, $5,000,000,000 for the period beginning with fiscal year 
2008 and ending with fiscal year 2017.
    (b) Distribution of Funds.--
            (1) In general.--Not less than 90 percent of the amount 
        appropriated in each fiscal year under subsection (a) shall be 
        allocated by the Secretary for the research and administrative 
        costs described in this Act.
            (2) Remainder.--Not more than 10 percent of the amount 
        appropriated in each fiscal year under subsection (a) shall be 
        allocated by the Secretary for--
                    (A) the Federal promotion of human embryo or 
                embryos adoption from in vitro fertilization clinics;
                    (B) research towards prevention and medical 
                treatment of genetic conditions consistent with this 
                Act that do not involve harming or destroying human 
                embryos in order to promote the health of the 
                population; and
                    (C) research to advance the understanding of 
                clinical techniques to minimize the creation of human 
                embryo or embryos that remain unimplanted after 
                clinical in vitro fertilization treatments.
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