II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Hope Offered through 

3 Principled, Ethically-Sound Stem Cell Research Act’’ or 

4 the ‘‘HOPE Act’’. 

5 SEC. 2. PURPOSES. 

6 It is the purpose of this Act to— 

7 (1) intensify research that may result in im8 proved understanding of or treatments for diseases 

9 and other adverse health conditions; and 

10 (2) promote the derivation of pluripotent stem 

11 cell lines without the creation of human embryos for 

12 research purposes or discarding, destroying, or 

13 knowingly harming a human embryo. 

14 SEC. 3. DEFINITIONS. 

15 In this Act: 

16 (1) ALTERED NUCLEAR TRANSFER.—The term 

17 ‘‘altered nuclear transfer’’ means a method for ob18 taining pluripotent stem cells using a modified form 

19 of somatic cell nuclear transfer to produce a biologi20 cal artifact. 

21 (2) BIOLOGICAL ARTIFACT.—The term ‘‘biologi22 cal artifact’’ means an artificially created non-em23 bryonic cellular system, engineered to lack the essen24 tial elements of embryogenesis but still capable of 

25 some cell division and growth. 


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1 (3) DIRECT REPROGRAMMING OF ADULT

2 CELLS.—The term ‘‘direct reprogramming of adult 

3 cells’’ means a procedure whereby differentiated, so4 matic cells are restored to a more undifferentiated, 

5 multipotent condition. Such process is also known as 

6 ‘‘dedifferentiation’’. 

7 (4) EMBRYO ADOPTION.—The term ‘‘embryo 

8 adoption’’ means the occurrence of a woman receiv9 ing into her uterus a human embryo or embryos to 

10 which neither she nor her partner has contributed a 

11 gamete for the purpose of child bearing. 

12 (5) EMBRYONIC STEM CELLS.—The term ‘‘em13 bryonic stem cells’’ means primitive cells derived 

14 from the inner cell mass of the human embryo or 

15 embryos, that have the potential to become a wide 

16 variety of specialized cell types. 

17 (6) HUMAN EMBRYO OR EMBRYOS.—The term 

18 ‘‘human embryo or embryos’’ includes any organism, 

19 not protected as a human subject under part 46 of 

20 title 45, Code of Federal Regulations, as of the date 

21 of enactment of this section, that is derived by fer22 tilization, parthenogenesis, cloning, or any other 

23 means from one or more human gametes or human 

24 diploid cells. 


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1 (7) IN VITRO FERTILIZATION.—The term ‘‘in 

2 vitro fertilization’’ means the union of an egg and 

3 sperm, where the event takes place outside the body 

4 and in an artificial environment. 

5 (8) OOCYTE.—The term ‘‘oocyte’’ means an 

6 unfertilized human egg cell. 

7 (9) ORGANISMICALLY DEAD EMBRYO.—The 

8 term ‘‘organismically dead embryo’’ means the irre9 versible loss of the capacity of continued and inte10 grated cellular division, growth and differentiation. 

11 (10) PLURIPOTENT CELL.—The term 

12 ‘‘pluipotent cell’’ means a cell that can produce all 

13 the cell types of the developing body. Embryonic 

14 stem cells, as well as the inner cell mass cells of the 

15 blastocyst, are pluripotent cells. 

16 (11) PLURIPOTENT STEM CELLS.—The term 

17 ‘‘pluripotent stem cells’’ means precursor cells that 

18 are capable both of perpetuating themselves as stem 

19 cells and of producing all or almost all the cell types 

20 of the developing body, and that have functional ca21 pacity (stable pluripotency) as an embryonic stem 

22 cell, though not necessarily the same origin. 

23 (12) REVIEW BOARD.—The term ‘‘Review 

24 Board’’ means the National Stem Cell Review Board 

25 established under section 5. 


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1 (13) SECRETARY.—The term ‘‘Secretary’’ 

2 means the Secretary of Health and Human Services. 

3 (14) STEM CELL LINE.—The term ‘‘stem cell 

4 line’’ means stem cells which have been cultured 

5 under in vitro conditions that allow proliferation 

6 without differentiation from months to years. 

7 SEC. 4. PROVISION OF FEDERAL FUNDING. 

8 (a) BASIC AND APPLIED RESEARCH.— 

9 (1) IN GENERAL.—The Secretary shall conduct 

10 and support basic and applied research to develop 

11 techniques for the isolation, derivation, production, 

12 or testing of pluripotent stem cells that have the 

13 flexibility of embryonic stem cells (whether or not 

14 they have an embryonic source), and may result in 

15 improved understanding of or treatments for dis16 eases and other adverse health conditions, provided 

17 that such isolation, derivation, production, or testing 

18 will not involve— 

19 (A) the creation of a human embryo or em20 bryos for research purposes; or 

21 (B) the destruction or discarding of a 

22 human embryo or embryos, or knowingly sub23 jecting a human embryo or embryos to risk of 

24 injury or death greater than that allowed for re25 search on fetuses in utero under section 498(b) 


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1 of this Act and section 46.204(b) of title 45, 

2 Code of Federal Regulations. 

3 (2) INCLUSIONS.—Research under paragraph 

4 (1) may include— 

5 (A) Methods that use— 

6 (i) cells derived from altered nuclear 

7 transfer; or 

8 (ii) cells derived from organismically 

9 dead embryos; and 

10 (B) the investigation of evidence for 

11 pluripotent potential in adult stem cells from 

12 various sources; or 

13 (C) the direct reprogramming of adult 

14 cells, the derivation of stem cells from human 

15 germ cells, and other methods that do not harm 

16 or destroy a human embryo or embryos and 

17 that are certified by the Review Board. 

18 (b) LIMITATIONS.—If any research described in sub19 section (a) is determined by the Secretary to create an 

20 embryo or embryos for research purposes, or harm or de21 stroy a human embryo or embryos, such research shall im22 mediately be terminated until such determination is re23 viewed and resolved to the satisfaction of the Review 

24 Board. 


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1 (c) GUIDELINES.—Not later than 90 days after the 

2 date of the enactment of this section, the Secretary, after 

3 consultation with the Director, shall issue final guidelines 

4 that— 

5 (1) provide guidance concerning the next steps 

6 required for additional research, which shall include 

7 a determination of the extent to which specific tech8 niques may require additional basic or animal re9 search to ensure that any research involving human 

10 cells using these techniques would clearly be con11 sistent with subsection (a); 

12 (2) prioritize research with the greatest poten13 tial for near-term clinical benefit; and 

14 (3) consistent with subsection (a), take into ac15 count techniques outlined by the President’s Council 

16 on Bioethics and any other appropriate techniques 

17 and research. 

18 (d) REPORTING REQUIREMENTS.—Not later than 

19 January 1 of each year, the Secretary shall prepare and 

20 submit to the appropriate committees of the Congress a 

21 report describing the activities carried out under this sec22 tion during the fiscal year, including a description of the 

23 research conducted under this section. 

24 (e) RULE OF CONSTRUCTION.—Nothing in this sec25 tion shall be construed as altering the policy in effect on 


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1 the date of enactment of this section regarding the eligi2 bility of stem cell lines for funding by the National Insti3 tutes of Health. 

4 SEC. 5. NATIONAL STEM CELL RESEARCH REVIEW BOARD. 

5 (a) IN GENERAL.—There shall be established within 

6 the Department of Health and Human Services a board 

7 to be known as the ‘‘National Stem Cell Research Review 

8 Board’’ which shall be responsible for— 

9 (1) monitoring research to ensure that it is in 

10 compliance with the principles of this Act; 

11 (2) prioritizing research with the greatest po12 tential for near term benefits; 

13 (3) ensuring fair consideration of both embry14 onic stem cell and adult stem cell research for fund15 ing; and 

16 (4) completing their duties under this section in 

17 a timely matter to promote rather than hinder ap18 propriate research. 

19 (b) COMPOSITION.— 

20 (1) IN GENERAL.—The Review Board shall be 

21 composed of 11 individuals, to be appointed by the 

22 Secretary. 

23 (2) REQUIREMENTS.—The members appointed 

24 under paragraph (1) shall include— 


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1 (A) scientists or physicians with relevant 

2 expertise (including areas of assisted reproduc3 tion, developmental biology, and clinical medi4 cine), including scientists that are not directly 

5 engaged in the research considered by the 

6 Board; 

7 (B) ethicists or professionals from other 

8 disciplines with a specialized ability to interpret 

9 the moral justifications and implications of the 

10 research considered by the Board; 

11 (C) members or advisors familiar with rel12 evant national legal statutes governing the re13 search considered by the Board; and 

14 (D) community members, unaffiliated with 

15 the institutions involved through employment or 

16 other remunerative relationships, who are objec17 tive and reasonably familiar with the views and 

18 needs of research subjects, patients and patient 

19 communities who could be benefitted or harmed 

20 by stem cell research, and community stand21 ards. 

22 (3) TERMS OF OFFICE.— 

23 (A) IN GENERAL.—The term of office of a 

24 member of a the Review Board appointed under 

25 paragraph (1) shall be 4 years, except that any 


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1 member appointed to fill a vacancy for an unex2 pired term shall serve for the remainder of such 

3 term. The Secretary shall ensure that appoint4 ments are made to the Board in such a manner 

5 as to ensure that the terms of the members not 

6 all expire in the same year and that not all 

7 members’ terms concur with the 4-year Presi8 dential term. A member of the Board may serve 

9 after the expiration of such member’s term 

10 until a successor has been appointed and taken 

11 office. 

12 (B) TIME FOR APPOINTMENT.—If a va13 cancy occurs among the members of the Review 

14 Board, the Secretary shall ensure that an ap15 pointment to fill such vacancy occurs within 90 

16 days from the date the vacancy occurs. 

17 (c) LIMITATION.—The Review Board shall not be re18 sponsible for dispersing funds. The Board shall ensure 

19 that funds which are to be provided by the Federal Gov20 ernment are being used appropriately and under the provi21 sions of this Act. 

22 (d) ADDITIONAL ADMINISTRATIVE PROVISIONS.— 

23 (1) COMPENSATION.—Members of the Review 

24 Board who are officers or employees of the United 

25 States shall not receive any compensation for service 


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1 on the Board. The remaining members of the Board 

2 shall receive, for each day (including travel time) 

3 they are engaged in the performance of the functions 

4 of the advisory council, compensation at rates not to 

5 exceed the daily equivalent to the annual rate in ef6 fect for grade GS–15 of the General Schedule. 

7 (2) EXECUTIVE SECRETARY AND STAFF.—The 

8 Review Board may appoint an individual to serve as 

9 the Executive Secretary of the Board. The Secretary 

10 shall make available to the Board such staff, infor11 mation, and other assistance as it may require to 

12 carry out its functions. 

13 SEC. 6. INFORMED CONSENT PROVISIONS. 

14 (a) PURPOSE.—It is the purpose of this section to 

15 ensure that individuals are empowered to make voluntary 

16 and informed decisions regarding the use of human em17 bryo or embryos created using their biological materials 

18 or their oocytes. 

19 (b) TIMING OF CONSENT.—Consent from an indi20 vidual for the donation of materials for research described 

21 in this Act shall be obtained from such individual, in writ22 ing, at the time of the proposed transfer of the donated 

23 materials from the storage site to the research team. 

24 (c) PROVISION OF INFORMATION TO DONORS.—At 

25 the time that the consent described in subsection (b) is 


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1 given, the donor shall be informed, verbally and in writing, 

2 that the donor retains the right to withdraw such consent 

3 until such time as the donated materials involved are actu4 ally utilized in research. 

5 SEC. 7. PRIVACY. 

6 Provisions protecting individually identifiable infor7 mation under the regulations promulgated under section 

8 264(c) of the Health Insurance Portability and Account9 ability Act of 1996 (42 U.S.C. 1320d-2 note) shall apply 

10 to donors under this Act. 

11 SEC. 8. PROHIBITION ON PROFITEERING FROM COMMERCE 

12 IN EMBRYOS, HUMAN OVUMS, OR EMBRYONIC 

13 STEM CELL LINES. 

14 (a) NO VALUABLE CONSIDERATION.—Section 301 of 

15 the National Organ Transplant Act (42 U.S.C. 274e) is 

16 amended— 

17 (1) in subsection (a), by inserting ‘‘, human 

18 ovum, human blastocyst, human embryo, or stem 

19 cell derived from a human embryo’’ after ‘‘any 

20 human organ’’; and 

21 (2) in subsection (c)(2)— 

22 (A) by striking ‘‘human organ’’ each place 

23 the term appears and inserting ‘‘human organ, 

24 human ovum, human blastocyst, human emVerDate Aug 31 2005 21:28 Jan 26, 2007 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S363.IS S363

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1 bryo, or stem cell derived from a human em2 bryo’’; and 

3 (B) by inserting ‘‘, ovum, blastocyst, em4 bryo, or stem cell’’ after ‘‘the organ’’. 

5 (b) NO PROFITS FROM THERAPIES THAT DESTROY

6 HUMAN EMBRYOS.—Part H of title IV of the Public 

7 Health Service Act (42 U.S.C. 289 et seq.) is amended 

8 by adding at the end the following: 

9 ‘‘SEC. 498D. REQUIREMENTS FOR RESEARCH INVOLVING 

10 HUMAN EMBRYOS. 

11 ‘‘(a) ENSURING ACCESS TO AFFORDABLE TREAT12 MENTS.— 

13 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

14 person to knowingly receive any valuable consider15 ation for any therapy that— 

16 ‘‘(A) affects interstate commerce or is 

17 funded, in full or in part, by Federal assistance; 

18 and 

19 ‘‘(B) utilizes cells from a human embryo, 

20 if the process of deriving such cells destroyed 

21 the embryo. 

22 ‘‘(2) DEFINITION OF VALUABLE CONSIDER23 ATION.—In this subsection, the term ‘valuable con24 sideration’ does not include the reasonable producVerDate Aug 31 2005 21:28 Jan 26, 2007 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S363.IS S363

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1 tion and administrative costs associated with devel2 oping a therapy described in paragraph (1).’’. 

3 SEC. 9. FUNDING FOR STEM CELL RESEARCH. 

4 (a) IN GENERAL.—There is authorized to be appro5 priated to carry out this Act, $5,000,000,000 for the pe6 riod beginning with fiscal year 2008 and ending with fiscal 

7 year 2017. 

8 (b) DISTRIBUTION OF FUNDS.— 

9 (1) IN GENERAL.—Not less than 90 percent of 

10 the amount appropriated in each fiscal year under 

11 subsection (a) shall be allocated by the Secretary for 

12 the research and administrative costs described in 

13 this Act. 

14 (2) REMAINDER.—Not more than 10 percent of 

15 the amount appropriated in each fiscal year under 

16 subsection (a) shall be allocated by the Secretary 

17 for— 

18 (A) the Federal promotion of human em19 bryo or embryos adoption from in vitro fertiliza20 tion clinics; 

21 (B) research towards prevention and med22 ical treatment of genetic conditions consistent 

23 with this Act that do not involve harming or de24 stroying human embryos in order to promote 

25 the health of the population; and 


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1 (C) research to advance the understanding 

2 of clinical techniques to minimize the creation 

3 of human embryo or embryos that remain 

4 unimplanted after clinical in vitro fertilization 

5 treatments. 

Æ 


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