FIRST REGULAR SESSION
94TH GENERAL ASSEMBLY
INTRODUCED BY REPRESENTATIVES SCHOELLER (Sponsor), FAITH, HARRIS (110), CUNNINGHAM (86), RUESTMAN, NOLTE, DAVIS, ONDER, LEMBKE, SMITH (150), MOORE, CUNNINGHAM (145), PORTWOOD, ICET, SANDER, TILLEY, JONES (89), SATER, EMERY, DIXON, COOPER (158) AND SCHARNHORST (Co-sponsors).
Read 1st time March 29, 2007 and copies ordered printed.
D. ADAM CRUMBLISS, Chief Clerk
AN ACT
To amend chapter 191, RSMo, by adding thereto one new section relating to stem cell research, with penalty provisions.
Be it enacted by the General Assembly of the state of Missouri, as follows:
Section A. Chapter 191, RSMo, is amended by adding thereto one new section, to be known as section 191.1100, to read as follows:
191.1100. 1. The following requirements shall apply to any life sciences conducted in this state:
(1) No blastocysts resulting from the use of donor gametes in the in vitro fertilization process shall be used for research without the consent of the gamete donor;
(2) To facilitate autonomous choice, any decisions regarding the production of embryos for infertility treatment shall be free of the influence of investigators who propose to derive or use stem cells in research. Whenever practicable, the attending physician responsible for the infertility treatment and the investigator deriving or proposing use of stem cells shall not be the same person;
(3) Persons performing human egg extraction for research purposes shall function completely independently of any in vitro fertilization services;
(4) No relatives or coworkers of persons conducting research on human eggs shall be permitted to provide human eggs for research purposes;
(5) No cash or in-kind payments shall be provided to an in vitro fertilization patient for donating blastocysts in excess of clinical need for research purposes;
(6) Any woman who undergoes hormonal induction to generate oocytes specifically for research purposes shall be reimbursed only for direct expenses incurred as a result of the procedure. The expenses shall be documented with receipts, mileage records, and other proof of direct expenses to the oocytes donor. No cash or in-kind payments shall be provided for donating oocytes for research purposes and no payments shall be made for donations of sperm for research purposes or of somatic cells for use in nuclear transfer;
(7) Consent for blastocyst donation shall be obtained from each donor at the time of donation. Any person that has given prior indication of an intent to donate to research any blastocysts that remain after clinical care shall be required to give informed consent at the time of donation;
(8) For donation of gametes or blastocysts for stem cell research, the informed consent process shall, at a minimum, provide the following information:
(a) A statement of the risks involved to the donor, including but not limited to ovarian hyperstimulation syndrome and excessive internal bleeding;
(b) A statement that the blastocysts or gametes will be used to derive stem cells for research that may include research on human transplantation;
(c) A statement that donation is made without any restriction or direction regarding who may be the recipient of transplants of the cells derived, except in the case of autologous donation;
(d) A statement as to whether the identities of the donors will be readily ascertainable to those persons who derive or work with the resulting stem cell lines;
(e) If the identities of the donors are retained, even if coded, a statement as to whether donors wish to be contacted in the future to receive information obtained through studies of the cell lines;
(f) An assurance that participants in research projects will follow applicable and appropriate best practices for donation, procurement, culture, and storage of cells and tissue to ensure the traceability of stem cells;
(g) A statement that derived stem cells and/or cell lines may be kept for many years;
(h) A statement that the stem cells and/or cell lines may be used in research involving genetic manipulation of the cells or the mixing of human and nonhuman cells in animal models;
(i) Disclosure of the possibility that the results of study of the stem cells may have commercial potential and a statement that the donor will not receive financial or any other benefits from any future commercial development;
(j) A statement that the research is not intended to provide direct medical benefit to the donor or donors, except in the case of autologous donation;
(k) A statement that embryos will be destroyed in the process of deriving stem cells; and
(l) A statement that neither consenting nor refusing to donate embryos for research will affect the quality of any future care provided to potential donors;
(9) Consenting or refusing to donate gametes or embryos for research shall not affect or alter in any manner the quality of care provided to prospective donors. Clinical staff shall provide appropriate care to patients without prejudice regarding their decisions about disposition of their embryos;
(10) Clinical personnel who have a conscientious objection to embryonic stem cell research or somatic cell nuclear transfer research shall not be required to participate in providing donor information or securing donor consent for research use of gametes or blastocysts. Such privilege shall not extend to the care of a donor or recipient;
(11) Researchers shall not ask members of the infertility treatment team to generate more oocytes than necessary for the optimal chance of reproductive success. An infertility clinic or other third party responsible for obtaining consent or collecting materials shall not pay for or be paid for the material obtained;
(12) Institutions that are banking or plan to bank stem cells shall establish uniform guidelines to ensure that donors of material provide informed consent through a process approved by an institutional review board, and that meticulous records are maintained regarding all aspects of cell culture. Uniform tracking systems and common guidelines for distribution of cells shall be established;
(13) Before a Missouri-based investigator collaborates with an investigator in another state or country, the institutional review board shall obtain documentation verifying that cell lines or tissues to be used or procured were done in accordance with subdivisions (1) to (6) of this subsection and that procedures prescribed by the collaborating institution afford protections equivalent with such guidelines; and
(14) No research shall be permitted on human eggs or stem cell lines from human eggs procured by any means other than those described in this subsection.
2. Any person who violates the provisions of this section is guilty of a class A misdemeanor. Any second or subsequent violation of this section is a class D felony.
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