SB3176 94TH GENERAL ASSEMBLY

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94TH GENERAL ASSEMBLY
State of Illinois
2005 and 2006
SB3176

Introduced 3/2/2006, by Sen. Dale A. Righter

SYNOPSIS AS INTRODUCED:

New Act

Creates the Public Support Standards for Biomedical Research Act. Provides that the State, units of local government, school districts, and community college districts may not use or allow the use of public funds, property, or credit for certain human cloning activities. Prohibits grant recipients from acquiring, receiving, or otherwise transferring any human fetal tissue for valuable consideration. Requires the Department of Public Health to report to the General Assembly concerning grants for biomedical and stem cell research. Sets forth informed consent and other research requirements for grant recipients. Sets forth eligibility requirements for grants. Sets forth penalties for violations of the Act.

CORRECTIONAL BUDGET AND IMPACT NOTE ACT MAY APPLY

FISCAL NOTE ACT MAY APPLY

A BILL FOR

AN ACT concerning biomedical research.

Be it enacted by the People of the State of Illinois, represented in the General Assembly:

Section 1. Short title. This Act may be cited as the Public Support Standards for Biomedical Research Act.

Section 3. Legislative findings.

(a) The General Assembly finds that:

(1) at least one organization has announced that it has successfully cloned a human being at the early embryonic stage of life, using the technique known as somatic cell nuclear transfer;

(2) efforts to create human beings by cloning mark a new and decisive step toward turning human reproduction into a manufacturing process in which human beings are made in laboratories to preordained specifications and, potentially, in multiple copies;

(3) creating cloned live-born human children, "cloning-to-produce-children", begins by creating cloned human beings at the embryonic stage of life, a process which some also propose as a way of creating human embryos for destructive research as sources of stem cells and tissues for possible treatment of other humans, "cloning-for-biomedical-research";

(4) many scientists agree that attempts at "cloning-to-produce-children" pose a massive risk of producing children who are stillborn, unhealthy, or severely disabled, and that attempts at "cloning-for-biomedical-research" always result in the destruction of human beings at the embryonic stage of life when their stem cells are harvested;

(5) the prospect of creating new human life solely to be exploited ("cloning-to-produce-children") or destroyed ("cloning-for-biomedical-research") in these ways has been condemned on moral grounds by many, as displaying a profound disrespect for life;

(6) the distinction between "therapeutic" and "reproductive" cloning is a false distinction scientifically because both begin with the reproduction of a human being at the embryonic stage of life, one destined for implantation in a womb, one destined for destructive farming of its stem cells, and regardless of their ultimate destiny, all human embryos are human beings; and

(7) it will be nearly impossible to ban only attempts at "cloning-to-produce-children" if "cloning for-biomedical-research" is allowed because (i) cloning would take place within the privacy of a doctor-patient relationship; (ii) the implantation of embryos to begin a pregnancy is a simple procedure; and (iii) any government effort to prevent the implantation of an existing cloned embryo, or to prevent birth once implantation has occurred, would raise substantial moral, legal, and practical issues.

(b) Based on the findings specified in subsection (a), it is the purpose of this Act to prohibit the use of public funds, property, or credit to support cloning technology to initiate the development of new human beings at the embryonic stage of life for any purpose.

Section 5. Definitions. In this Act:

"Department" means the Department of Public Health, which administers funding programs for biomedical and stem cell research.

"Applicant" means an applicant for public funds and grants from the Department for biomedical and stem cell research purposes.

"Human cloning" means the asexual production of a new human organism that is, at all stages of development, genetically virtually identical to a currently existing or previously existing human being, which is achieved through somatic cell nuclear transfer. This includes the production of a cloned human embryo, formed for the purpose of initiating a pregnancy, with the ultimate goal of producing a child who will be genetically virtually identical to a currently existing or previously existing individual and the production of a cloned human embryo, formed for the purpose of using it in research or for extracting its stem cells, with the ultimate goals of gaining scientific knowledge of normal and abnormal development and of developing cures for human diseases.

"Somatic cell nuclear transfer" means the introduction of nuclear material of a human somatic cell into an oocyte, which has had its own nucleus removed or deactivated, yielding a product that has a human genetic constitution virtually identical to the donor of the somatic cell.

"Embryonic stem cells" means primitive, undifferentiated cells, derived from the inner cell mass of the embryo that have the potential to become a wide variety of specialized cell types.

"Human embryo" means a human organism from the single cell stage of development through 8 weeks development.

"Institutional review committee" means the local institutional review committee specified in 21 U.S.C. Sec. 360j(g)(3)(A)(i), as amended from time to time, and, when applicable, an institutional review board established in accordance with the requirements of 45 C.F.R. 46, Subpart A, as amended from time to time.

"Recipient" means a recipient of public funds and grants for biomedical and stem cell research from the Department.

Section 10. Ban on the use of State assets in human cloning activities.

(a) Notwithstanding any other provision of law, the State, units of local government, school districts, and community college districts may not use or allow the use of public funds, property, or credit for any of the following human cloning activities:

(1) the production of human embryos for the purpose of implanting them into the uterus of a woman or the production of human embryos for the purpose of biomedical research;

(2) the creation of a chimera or hybrid;

(3) the transfer of a human embryo into any non-human life form or artificial device;

(4) the transfer of a sperm, ovum, embryo, or fetus of a non-human life form into the uterus of a woman; and

(5) the creation of a she-male.

No recipient of public funds pursuant to Executive Order 2005-6 may offer to do or advertise the performance of any of the prohibited activities listed in this Section.

No person shall compensate or offer to compensate any individual or entity for performing any of the prohibited activities listed in this Section.

For the purposes of this Section:

"Chimera" means the individual produced by grafting an embryonic part of one animal onto the embryo of another, either of the same or of another species.

"Hybrid" means (i) a human ovum that has been fertilized by a sperm of a non-human life form; (ii) an ovum of a non-human life form that has been fertilized by a human sperm; (iii) a human ovum into which the nucleus of a cell of a non-human life form has been introduced; (iv) an ovum of a non-human life form into which the nucleus of a human cell has been introduced; or (v) a human ovum or an ovum of a non-human life form that otherwise contains haploid sets of chromosomes from both a human being and a non-human life form.

"She-male" means a human embryo that has been purposefully genetically engineered to produce mixed sexual characteristics.

Section 15. Purchase of tissue; solicitation or acceptance of tissue for donation and transplantation. Any recipient is prohibited from knowingly acquiring, receiving, or otherwise transferring any human fetal tissue for valuable consideration. For the purposes of this Section, "valuable consideration" does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.

Any recipient is further prohibited from knowingly acquiring, receiving, or accepting a donation of human fetal tissue for the purpose of transplantation of such tissue into another human being. The donation may not be received from any of the following sources:

(1) an induced abortion;

(2) a donation made with the promise to the donating individual that the donated tissue will be transplanted into a recipient specified by such individual or a relative of that individual;

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

(4) the person who solicits or knowingly acquires, receives, or accepts the donation knows the pregnancy was initiated in order to provide such tissue.

Section 20. Public report of Department administration of funding and grants for biomedical and stem cell research. Within 30 days after the end of each fiscal year beginning with fiscal year 2006, the Department shall deliver to members of the General Assembly a comprehensive report regarding the implementation and administration of all grant programs for biomedical and stem cell research. The report shall further be posted prominently, and maintained permanently, on the website of the Department.

The report shall include (1) the name and address of all applicants for funding for biomedical and stem cell research purposes, (2) the amount of grants-in-aid awarded to recipients for biomedical and stem cell research purposes, (3) the name and address of the recipients of such grants-in-aid, (4) the current status of research conducted by such recipients, and (5) whether the recipients are involved in any clinical trials and the status of those clinical trials.

Section 25. Informed consent and other protections for women.

(a) A person who elects to donate for publicly funded stem cell research any human embryos or embryonic stem cells remaining after receiving infertility treatment, or unfertilized human eggs or human sperm, shall provide written consent for that donation and shall not receive direct or indirect payment for such human embryos, embryonic stem cells, unfertilized human eggs or human sperm. The Department shall verify that such informed consent has been provided.

(b) Any recipient of public funds for biomedical and stem cell research shall demonstrate that (1) the research is conducted with full consideration for the ethical and medical implications of such research, (2) the research is conducted before gastrulation occurs, (3) prior to conducting such research, the person provides to the Department documentation verifying that any human embryos, embryonic stem cells, unfertilized human eggs or human sperm used in such research have been donated voluntarily in accordance with the provisions of this Section, on a form and in the manner prescribed by the Department, (4) the general research program under which such research is conducted is reviewed and approved by an institutional review committee, as required under federal law, and (5) the specific protocol used to derive embryonic stem cells is reviewed and approved by an institutional review committee.

(c) The Department shall enforce the provisions of this Section and may adopt regulations relating to the administration and enforcement of this Section. The Director of the Department may request the Attorney General to petition the circuit court for such order as may be appropriate to enforce the provisions of this Section.

Section 30. Requirements for grants for biomedical and stem cell research.

(a) The Director of the Department may make grants-in-aid for biomedical and stem cell research purposes in accordance with the provisions of this Section.

(b) No later than June 30, 2006, the Department shall develop an application for grants-in-aid for the purpose of conducting embryonic stem cell research. The Department shall require any applicant for a grant-in-aid to submit (1) a complete description of the applicant's organization, (2) the applicant's plans for research and proposed funding for such research from sources other than the State of Illinois, and (3) proposed arrangements concerning financial benefits to the State of Illinois as a result of any patent, royalty payment or similar right developing from any stem cell research made possible by the awarding of such grant-in-aid.

(c) Consideration shall be given to grant applicants that can demonstrate that Type 1 clinical trials will commence within 365 days of the receipt of public funds from the Department.

(d) Among the members of the Department that review and approve grants for public funding for biomedical and stem cell research, the Director of the Department shall include at least one active investigator in the field of adult stem cell research.

(e) All members of the Department shall be deemed public officials and shall adhere to the code of ethics for public officials set forth in the general statutes. No member shall participate in the affairs of the committee with respect to the review or consideration of any grant-in-aid application filed by such member or by any eligible institution in which such member has a financial interest, or with whom such member engages in any business, employment, transaction or professional activity.

(f) The Department shall monitor the stem cell research conducted by eligible institutions that receive such grants-in-aid.

(g) Prior to the awarding of any grants-in-aid for embryonic stem cell research, the Department shall review all applications submitted for such grants-in-aid and make recommendations to the Director of the Department with respect to the ethical and scientific merit of each application. Written conclusions regarding the ethical and scientific merit of each application shall be included in the annual report to the General Assembly pursuant to Section 20.

(h) The Department shall establish and publish guidelines for the rating and scoring of all applications for funding for biomedical and stem cell research purposes. Such guidelines shall be utilized in the review of all applications.

Section 35. Penalties.

(a) Any recipient who violates the provisions of this Act shall be permanently disqualified from receiving any public funding from the State of Illinois.

(b) A person who knowingly engages or assists, directly or indirectly, in the cloning of a human being is guilty of a Class 1 felony.

(c) A person who knowingly purchases or sells embryonic tissue for research purposes is guilty of a Class A misdemeanor for the first conviction and a Class 4 felony for subsequent violations.