PART II—RESEARCH ON TRANSPLANTATION OF FETAL TISSUE SEC. 111. ESTABLISHMENT OF AUTHORITIES. 

Part G of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is amended by inserting after section 498 the following section:

‘‘RESEARCH ON TRANSPLANTATION OF FETAL TISSUE ‘‘SEC. 498A. (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), 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);

‘‘(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), 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), 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.

...

‘‘(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) 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) 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) has been conducted in accordance with this section.

‘‘(g) DEFINITION.—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.’’.

SEC. 112. PURCHASE OF HUMAN FETAL TISSUE; SOLICITATION OR ACCEPTANCE OF TISSUE AS DIRECTED DONATION FOR USE IN TRANSPLANTATION. 

Part G of title IV of the Public Health Service Act, as amended by section 111 of this Act, is amended by inserting after section 498A the following section: ‘‘PROHIBITIONS REGARDING HUMAN FETAL TISSUE‘‘

SEC. 498B. (a) PURCHASE OF TISSUE.—It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce.

‘‘(b) SOLICITATION OR ACCEPTANCE OF TISSUE AS DIRECTED DONATION FOR USE IN TRANSPLANTATION.—It shall be unlawful for any person to solicit or knowingly acquire, receive, or accept a donation of human fetal tissue for the purpose of transplantation of such tissue into another person if the donation affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and—

‘‘(1) the donation will be or is made pursuant to a promise to the donating individual that the donated tissue will be transplanted into a recipient specified by such individual;

‘‘(2) the donated tissue will be transplanted into a relative of the donating individual; or

‘‘(3) the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable consideration for the costs associated with such abortion.

‘‘(c) CRIMINAL PENALTIES FOR VIOLATIONS.—

‘‘(1) IN GENERAL.—Any person who violates subsection (a) or (b) shall be fined in accordance with title 18, United States Code, subject to paragraph (2), or imprisoned for not more than 10 years, or both.

‘‘(2) PENALTIES APPLICABLE TO PERSONS RECEIVING CONSIDERATION.— With respect to the imposition of a fine under paragraph

(1), if the person involved violates subsection (a) or

(b)(3), a fine shall be imposed in an amount not less than twice the amount of the valuable consideration received.

‘‘(d) DEFINITIONS.—For purposes of this section:

‘‘(1) The term ‘human fetal tissue’ has the meaning given such term in section 498A(f). 

‘‘(2) The term ‘interstate commerce’ has the meaning given such term in section 201(b) of the Federal Food, Drug, and Cosmetic Act.

‘‘(3) The term ‘valuable consideration’ does not include reasonable payments associated with the transportation, S. 1—11 implantation, processing, preservation, quality control, or storage of human fetal tissue.’’.

SEC. 113. NULLIFICATION OF MORATORIUM.

(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 (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.

(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 (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 (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 (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 (as added by section 111 of this Act).

For purposes of this section, the term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 (the Human Subject Protection regulations) . . . that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes (sperm or egg) or human diploid cells (cells that have two sets of chromosomes, such as somatic cells).

(No funds may be used for)

• (1) the creation of a human embryo or embryos for research purposes; or
• (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498(b) of the Public Health Service Act [1](42 U.S.C. 289g(b)) (Title 42, Section 289g(b), United States Code).

The Office of the General Counsel of the U.S. Department of Health and Human Services (HHS) has prepared the following in response to your request for a legal opinion on whether federal funds may be used for research conducted with human pluripotent stem cells derived from embryos created by in vitro fertilization or from primordial germ cells isolated from the tissue of non-living fetuses. This inquiry arises from the recently reported research of: (1) Dr. James A. Thomson of the University of Wisconsin-Madison,who isolated pluripotent stem cells from embryos donated for research by persons undergoing fertility treatment1; and (2) Dr. Michael Shamblottofthe Johns Hopkins University School ofMedicine, who derived pluripotentstem cells from primordial germ cells from non-living fetuses.2 The research described in these two published reports was not funded by HHS.

Summary Answer

The statutory prohibition on the use offunds appropriated to HHS for human embryo research would not apply to research utilizing human pluripotent stem cells because such cells are not a human embryo within the statutory definition. To the extent human pluripotent stem cells are considered human fetal tissue by law, they are subject to the statutory prohibition on sale for valuable consideration, the restrictions on fetal tissue transplantation research that is conducted or funded by HHS, as well as to the federal criminal prohibition on the directed donation of fetal tissue. Research involving human pluripotent stem cells excised from a non-living fetus may be conducted only in accordance with any applicable state or 10callayJ. Finally, the Presidential Directive banning federal funding of human cloning would apply to pluripotent stem cells, only ifthey were to be used for that purpose.

Requires the Secretary of Health and Human Services to contract with qualified cord blood stem cell banks to assist in the collection and maintenance of 150,000 new units of high-quality cord blood to be made available for transplantation through the C.W. Bill Young Cell Transplantation Program.

Requires the Secretary to require that contract recipients:

• acquire, tissue-type, test, cryopreserve, and store donated units of human cord blood acquired with the informed consent of the donor in a manner that complies with federal and state regulations
• encourage donation from a genetically diverse population
• make collected cord blood units available for stem cell transplantation or, if not appropriate for clinical use, available for peer-reviewed research
• make data available in a standardized electronic format for the Program
• and submit data in a standardized format for inclusion in the stem cell therapeutics outcome database.

Requires the Secretary to establish a three-year demonstration project under which qualified cord blood banks may use a portion of the funding received under a contract for the collection and storage of cord blood units for a family where a relative has been diagnosed with a condition that will benefit from transplantation at no cost to such family.

Excludes cord blood collected under such project from the 150,000 units to be collected for the Program. Sets forth reporting requirements. Establishes ten years as the term of such Program contracts. Requires the Secretary to give preference to qualified cord blood banks that have demonstrated a superior ability to satisfy the requirements and achieve the contract goals.

Amends the Public Health Service Act to require the Secretary of Health and Human Services to conduct and support research that utilizes human embryonic stem cells, regardless of the date on which the stem cells were derived from a human embryo, provided such embryos

• have been donated from in vitro fertilization clinics
• were created for the purposes of fertility treatment
• were in excess of the needs of the individuals seeking such treatment and would never be implanted in a woman and would otherwise be discarded (as determined in consultation with the individuals seeking fertility treatment)
• were donated by such individuals with written informed consent and without any financial or other inducements

Amends the Public Health Service Act to require the Secretary of Health and Human Services to conduct and support research that utilizes human embryonic stem cells, regardless of the date on which the stem cells were derived from a human embryo. Limits such research to stem cells that meet the following ethical requirements:

• (1) the stem cells were derived from human embryos donated from in vitro fertilization clinics for the purpose of fertility treatment and were in excess of the needs of the individuals seeking such treatment;
• (2) the embryos would never be implanted in a woman and would otherwise be discarded;
• (3) such individuals donate the embryos with written informed consent and receive no financial or other inducements.

Amends the Public Health Service Act to require the Secretary of Health and Human Services to develop techniques for the isolation, derivation, production, or testing of stem cells, including pluripotent stem cells that have the flexibility of embryonic stem cells (whether or not they have an embryonic source), that may result in improved understanding of or treatments for diseases and other adverse health conditions, provided that such techniques do not involve:

• (1) the creation of a human embryo or embryos for research purposes; or
• (2) the destruction or discarding of, or risk of injury to, a human embryo of embryos other than those that are naturally dead.

Expanding Approved Stem Cell Lines in Ethically Responsible Ways 

By the authority vested in me as President by the Constitution and the laws of the United States of America, and to provide leadership with respect to research on pluripotent stem cells derived by ethically responsible techniques so that the potential of pluripotent stem cells can be explored without violating human dignity or demeaning human life, it is hereby ordered as follows:

Section 1. Research on Alternative Sources of Pluripotent Stem Cells.

(a) The Secretary of Health and Human Services (Secretary) shall conduct and support research on the isolation, derivation, production, and testing of stem cells that are capable of producing all or almost all of the cell types of the developing body and may result in improved understanding of or treatments for diseases and other adverse health conditions, but are derived without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus.

(b) Within 90 days of this order, the Secretary, after such consultation with the Director of the National Institutes of Health (Director), shall issue a plan, including such mechanisms as requests for proposals, requests for applications, program announcements and other appropriate means, to implement subsection (a) of this section, that:

• (i) specifies and reflects 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 is clearly consistent with the standards established under this order and applicable law;
• (ii) prioritizes research with the greatest potential for clinical benefit;
• (iii) takes into account techniques outlined by the President’s Council on Bioethics, and any other appropriate techniques and research, provided they clearly meet the standard set forth in subsection (a) of this section;
• (iv) renames the ‘‘Human Embryonic Stem Cell Registry’’ the ‘‘Human Pluripotent Stem Cell Registry;’’ and
• (v) adds to the registry new human pluripotent stem cell lines that clearly meet the standard set forth in subsection (a) of this section. 

(c) Not later than December 31 of each year, the Secretary shall report to the President on the activities carried out under this order during the past fiscal year, including a description of the research carried out or supported by the Department of Health and Human Services, including the National Institutes of Health, and other developments in the science of pluripotent stem cells not derived from human embryos.

Sec. 2. Policy. The activities undertaken and supported by and under the direction of the Secretary shall be clearly consistent with the following policies and principles:

• (a) the purposes of this order are (i) to direct the Department of Health and Human Services, including the National Institutes of Health, to intensify peer reviewed research that may result in improved understanding of or treatments for diseases and other adverse health conditions, and (ii) to promote the derivation of human pluripotent stem cell lines from a variety of alternative sources while clearly meeting the standard set forth in section 1(a) of this order;
• (b) it is critical to establish moral and ethical boundaries to allow the Nation to move forward vigorously with medical research, while also maintaining the highest ethical standards and respecting human life and human dignity;
• (c) the destruction of nascent life for research violates the principle that no life should be used as a mere means for achieving the medical benefit of another;
• (d) human embryos and fetuses, as living members of the human species, are not raw materials to be exploited or commodities to be bought and sold; and
• (e) the Federal Government has a duty to exercise responsible stewardship of taxpayer funds, both supporting important medical research and respecting ethical and moral boundaries.

Sec. 3. Interpretation of this Order.

• (a) For purposes of this order, the term ‘‘human embryo’’ shall mean any organism, not protected as a human subject under 45 CFR 46 as of the date of this order, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.
• (b) For purposes of this order, the term ‘‘subjecting to harm a human embryo’’ shall mean subjecting such an embryo to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)) as of the date of this order.
• (c) Nothing in this order shall be construed to affect any policy, guideline, or regulation regarding embryonic stem cell research, human cloning by somatic cell nuclear transfer, or any other research not specifically authorized by this order, or to forbid the use of existing stem cell lines deemed eligible for other federally funded research in accordance with the presidential policy decision of August 9, 2001, for research specifically authorized by this order.

Sec. 4. General Provisions.

• (a) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
• (b) This order is not intended to, and does not, create any right, benefit, or privilege, substantive or procedural, enforceable at law or in equity, by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

REMOVING BARRIERS TO RESPONSIBLE SCIENTIFIC RESEARCH INVOLVING HUMAN STEM CELLS

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

Section 1. Policy. Research involving human embryonic stem cells and human non-embryonic stem cells has the potential to lead to better understanding and treatment of many disabling diseases and conditions. Advances over the past decade in this promising scientific field have been encouraging, leading to broad agreement in the scientific community that the research should be supported by Federal funds.

For the past 8 years, the authority of the Department of Health and Human Services, including the National Institutes of Health (NIH), to fund and conduct human embryonic stem cell research has been limited by Presidential actions. The purpose of this order is to remove these limitations on scientific inquiry, to expand NIH support for the exploration of human stem cell research, and in so doing to enhance the contribution of America's scientists to important new discoveries and new therapies for the benefit of humankind.

Sec. 2. Research. The Secretary of Health and Human Services (Secretary), through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.

Sec. 3. Guidance. Within 120 days from the date of this order, the Secretary, through the Director of NIH, shall review existing NIH guidance and other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and issue new NIH guidance on such research that is consistent with this order. The Secretary, through NIH, shall review and update such guidance periodically, as appropriate.

Sec. 4. General Provisions.

• (a) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
• (b) Nothing in this order shall be construed to impair or otherwise affect:rn
  • (i) authority granted by law to an executive department, agency, or the head thereof; or
  • (ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
• (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity, by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

Sec. 5. Revocations. (a) The Presidential statement of August 9, 2001, limiting Federal funding for research involving human embryonic stem cells, shall have no further effect as a statement of governmental policy.

(b) Executive Order 13435 of June 20, 2007, which supplements the August 9, 2001, statement on human embryonic stem cell research, is revoked.

BARACK OBAMA

THE WHITE HOUSE,
March 9, 2009.