Connecticut Stem Cell Legislation - Diabetes and Stem C...

Connecticut Stem Cell Legislation

C.G.S. §19a-32d. Stem Cell Research: Definitions. Prohibition on human cloning. Disposition of embryos or embryonic stem cells following infertility treatment. Written consent required for donations. Penalties. Embryonic stem cell research authorized. Limitations. Regulations. Penalties
(a) As used in sections 19a-32d to 19a-32g, inclusive, and section 4-28e:

(1) “Embryonic stem cell research oversight committee” means a committee established in accordance with the National Academies' Guidelines for Human Embryonic Stem Cell Research, as amended from time to time.

(2) “Cloning of a human being” means inducing or permitting a replicate of a living human being's complete set of genetic material to develop after gastrulation commences.

(3) “Gastrulation” means the process immediately following the blastula state when the hollow ball of cells representing the early embryo undergoes a complex and coordinated series of movements that results in the formation of the three primary germ layers, the ectoderm, mesoderm and endoderm.

(4) “Embryonic stem cells” means cells created through the joining of a human egg and sperm or through nuclear transfer that are sufficiently undifferentiated such that they cannot be identified as components of any specialized cell type.

(5) “Nuclear transfer” means the replacement of the nucleus of a human egg with a nucleus from another human cell.

(6) “Eligible institution” means (A) a nonprofit, tax-exempt academic institution of higher education, (B) a hospital that conducts biomedical research, or (C) any entity that conducts biomedical research or embryonic or human adult stem cell research.

(b) No person shall knowingly (1) engage or assist, directly or indirectly, in the cloning of a human being, (2) implant human embryos created by nuclear transfer into a uterus or a device similar to a uterus, or (3) facilitate human reproduction through clinical or other use of human embryos created by nuclear transfer. Any person who violates the provisions of this subsection shall be fined not more than one hundred thousand dollars or imprisoned not more than ten years, or both. Each violation of this subsection shall be a separate and distinct offense.

(c) (1) A physician or other health care provider who is treating a patient for infertility shall provide the patient with timely, relevant and appropriate information sufficient to allow that person to make an informed and voluntary choice regarding the disposition of any embryos or embryonic stem cells remaining following an infertility treatment.

(2) A patient to whom information is provided pursuant to subdivision (1) of this subsection shall be presented with the option of storing, donating to another person, donating for research purposes, or otherwise disposing of any unused embryos or embryonic stem cells.

(3) A person who elects to donate for stem cell research purposes 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. Consent obtained pursuant to this subsection shall, at a minimum, conform to the National Academies' Guidelines for Human Embryonic Stem Cell Research, as amended from time to time.

(4) Any person who violates the provisions of this subsection shall be fined not more than fifty thousand dollars or imprisoned not more than five years, or both. Each violation of this subsection shall be a separate and distinct offense.

(d) A person may conduct research involving embryonic stem cells, provided (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 documentation to the Commissioner of Public Health in a form and manner prescribed by the commissioner verifying: (A) 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 subsection (c) of this section, or (B) if any embryonic stem cells have been derived outside the state of Connecticut, that such stem cells have been acceptably derived as provided in the National Academies' Guidelines for Human Embryonic Stem Cell Research, as amended from time to time, and (4) all activities involving embryonic stem cells are overseen by an embryonic stem cell research oversight committee.

(e) The Commissioner of Public Health shall enforce the provisions of this section and may adopt regulations, in accordance with the provisions of chapter 54, relating to the administration and enforcement of this section. The commissioner may request the Attorney General to petition the Superior Court for such order as may be appropriate to enforce the provisions of this section.

(f) Any person who conducts research involving embryonic stem cells in violation of the requirements of subdivision (2) of subsection (d) of this section shall be fined not more than fifty thousand dollars, or imprisoned not more than five years, or both.

C.G.S. §19a-32e. Stem Cell Research Fund. Grants-in-aid: Application process and funding
(a) There is established the “Stem Cell Research Fund” which shall be a separate, nonlapsing account within the General Fund. The fund may contain any moneys required or permitted by law to be deposited in the fund and any funds received from any public or private contributions, gifts, grants, donations, bequests or devises to the fund. The Commissioner of Public Health may make grants-in- aid from the fund in accordance with the provisions of subsection (b) of this section.

(b) Not later than June 30, 2006, the Stem Cell Research Advisory Committee established pursuant to section 19a-32f shall develop an application for grants-in-aid under this section for the purpose of conducting embryonic or human adult stem cell research and may receive applications from eligible institutions for such grants-in-aid on and after said date. The Stem Cell Research Advisory Committee shall require any applicant for a grant-in-aid under this section to conduct stem cell research to submit (1) a complete description of the applicant's organization, (2) the applicant's plans for stem cell research and proposed funding for such research from sources other than the state of Connecticut, and (3) proposed arrangements concerning financial benefits to the state of Connecticut as a result of any patent, royalty payment or similar rights developing from any stem cell research made possible by the awarding of such grant-in-aid. Said committee shall direct the Commissioner of Public Health with respect to the awarding of such grants-in-aid after considering recommendations from the Stem Cell Research Peer Review Committee established pursuant to section 19a-32g.

(c) Commencing with the fiscal year ending June 30, 2006, and for each of the nine consecutive fiscal years thereafter, until the fiscal year ending June 30, 2015, not less than ten million dollars shall be available from the Stem Cell Research Fund for grants-in-aid to eligible institutions for the purpose of conducting embryonic or human adult stem cell research, as directed by the Stem Cell Research Advisory Committee established pursuant to section 19a-32f. Any balance of such amount not used for such grants-in-aid during a fiscal year shall be carried forward for the fiscal year next succeeding for such grants-in-aid.

C.G.S. §19a-32f. Stem Cell Research Advisory Committee established. Members deemed public officials. Duties. Report

(a) (1) There is established a Stem Cell Research Advisory Committee. The committee shall consist of the Commissioner of Public Health and eight members who shall be appointed as follows: Two by the Governor, one of whom shall be nationally recognized as an active investigator in the field of stem cell research and one of whom shall have background and experience in the field of bioethics; one each by the president pro tempore of the Senate and the speaker of the House of Representatives, who shall have background and experience in private sector stem cell research and development; one each by the majority leaders of the Senate and House of Representatives, who shall be academic researchers specializing in stem cell research; one by the minority leader of the Senate, who shall have background and experience in either private or public sector stem cell research and development or related research fields, including, but not limited to, embryology, genetics or cellular biology; and one by the minority leader of the House of Representatives, who shall have background and experience in business or financial investments. Members shall serve for a term of four years commencing on October first, except that members first appointed by the Governor and the majority leaders of the Senate and House of Representatives shall serve for a term of two years. No member may serve for more than two consecutive four-year terms and no member may serve concurrently on the Stem Cell Research Peer Review Committee established pursuant to section 19a-32g. All initial appointments to the committee shall be made by October 1, 2005. Any vacancy shall be filled by the appointing authority.

(2) On and after July 1, 2006, the advisory committee shall include eight additional members who shall be appointed as follows: Two by the Governor, one of whom shall be nationally recognized as an active investigator in the field of stem cell research and one of whom shall have background and experience in the field of ethics; one each by the president pro tempore of the Senate and the speaker of the House of Representatives, who shall have background and experience in private sector stem cell research and development; one each by the majority leaders of the Senate and House of Representatives, who shall be academic researchers specializing in stem cell research; one by the minority leader of the Senate, who shall have background and experience in either private or public sector stem cell research and development or related research fields, including, but not limited to, embryology, genetics or cellular biology; and one by the minority leader of the House of Representatives, who shall have background and experience in business or financial investments. Members shall serve for a term of four years, except that (A) members first appointed by the Governor and the majority leaders of the Senate and House of Representatives pursuant to this subdivision shall serve for a term of two years and three months, and (B) members first appointed by the remaining appointing authorities shall serve for a term of four years and three months. No member appointed pursuant to this subdivision may serve for more than two consecutive four-year terms and no such member may serve concurrently on the Stem Cell Research Peer Review Committee established pursuant to section 19a-32g. All initial appointments to the committee pursuant to this subdivision shall be made by July 1, 2006. Any vacancy shall be filled by the appointing authority.

(b) The Commissioner of Public Health shall serve as the chairperson of the committee and shall schedule the first meeting of the committee, which shall be held no later than December 1, 2005.

(c) All members appointed to the committee shall work to advance embryonic and human adult stem cell research. Any member who fails to attend three consecutive meetings or who fails to attend fifty per cent of all meetings held during any calendar year shall be deemed to have resigned from the committee.

(d) Notwithstanding the provisions of any other law, it shall not constitute a conflict of interest for a trustee, director, partner, officer, stockholder, proprietor, counsel or employee of any eligible institution, or for any other individual with a financial interest in any eligible institution, to serve as a member of the committee. All members shall be deemed public officials and shall adhere to the code of ethics for public officials set forth in chapter 10. Members may participate in the affairs of the committee with respect to the review or consideration of grant-in-aid applications, including the approval or disapproval of such applications, except that 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.

(e) The Stem Cell Research Advisory Committee shall (1) develop, in consultation with the Commissioner of Public Health, a donated funds program to encourage the development of funds other than state appropriations for embryonic and human adult stem cell research in this state, (2) examine and identify specific ways to improve and promote for-profit and not-for-profit embryonic and human adult stem cell and related research in the state, including, but not limited to, identifying both public and private funding sources for such research, maintaining existing embryonic and human adult stem-cell-related businesses, recruiting new embryonic and human adult stem-cell-related businesses to the state and recruiting scientists and researchers in such field to the state, (3) establish and administer, in consultation with the Commissioner of Public Health, a stem cell research grant program which shall provide grants-in-aid to eligible institutions for the advancement of embryonic or human adult stem cell research in this state pursuant to section 19a-32e, and (4) monitor the stem cell research conducted by eligible institutions that receive such grants-in-aid.

(f) Connecticut Innovations, Incorporated shall serve as administrative staff of the committee and shall assist the committee in (1) developing the application for the grants-in-aid authorized under subsection (e) of this section, (2) reviewing such applications, (3) preparing and executing any assistance agreements or other agreements in connection with the awarding of such grants-in-aid, and (4) performing such other administrative duties as the committee deems necessary.

(g) Not later than June 30, 2007, and annually thereafter until June 30, 2015, the Stem Cell Research Advisory Committee shall report, in accordance with section 11-4a, to the Governor and the General Assembly on (1) the amount of grants-in-aid awarded to eligible institutions from the Stem Cell Research Fund pursuant to section 19a-32e, (2) the recipients of such grants-in-aid, and (3) the current status of stem cell research in the state.

C.G.S. §19a-32g. Stem Cell Research Peer Review Committee established. Additional members. Members deemed public officials. Duties

(a) (1) There is established a Stem Cell Research Peer Review Committee. The committee shall consist of five members appointed by the Commissioner of Public Health. All members appointed to the committee shall (A) have demonstrated knowledge and understanding of the ethical and medical implications of embryonic and human adult stem cell research or related research fields, including, but not limited to, embryology, genetics or cellular biology, (B) have practical research experience in human adult or embryonic stem cell research or related research fields, including, but not limited to, embryology, genetics or cellular biology, and (C) work to advance embryonic and human adult stem cell research. Members shall serve for a term of four years commencing on October first, except that three members first appointed by the Commissioner of Public Health shall serve for a term of two years. No member may serve for more than two consecutive four-year terms and no member may serve concurrently on the Stem Cell Research Advisory Committee established pursuant to section 19a-32f. All initial appointments to the committee shall be made by October 1, 2005. Any member who fails to attend three consecutive meetings or who fails to attend fifty per cent of all meetings held during any calendar year shall be deemed to have resigned from the committee.

(2) On and after July 1, 2007, the Commissioner of Public Health may appoint such additional members to the Stem Cell Research Peer Review Committee as the commissioner deems necessary for the review of applications for grants-in-aid, provided the total number of Stem Cell Research Peer Review Committee members does not exceed fifteen. Such additional members shall be appointed as provided in subdivision (1) of this subsection, except that such additional members shall serve for a term of two years from the date of appointment.

(b) All members shall be deemed public officials and shall adhere to the code of ethics for public officials set forth in chapter 10. 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 which such member engages in any business, employment, transaction or professional activity.

(c) Prior to the awarding of any grants-in-aid for embryonic or human adult stem cell research pursuant to section 19a-32e, the Stem Cell Research Peer Review Committee shall review all applications submitted by eligible institutions for such grants-in-aid and make recommendations to the Commissioner of Public Health and the Stem Cell Research Advisory Committee established pursuant to section 19a-32f with respect to the ethical and scientific merit of each application.

(d) The Peer Review Committee shall establish guidelines for the rating and scoring of such applications by the Stem Cell Research Peer Review Committee.

(e) All members of the committee shall become and remain fully cognizant of the National Academies' Guidelines for Human Embryonic Stem Cell Research, as amended from time to time, and shall utilize said guidelines to evaluate each grant-in-aid application. The committee may make recommendations to the Stem Cell Research Advisory Committee and the Commissioner of Public Health concerning the adoption of said guidelines, in whole or in part, in the form of regulations adopted pursuant to chapter 54.

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