S. 363 - HOPE Act: Hope Offered through Principled, Ethically-Sound Stem Cell Research Act

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

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.

END