OLR Bill Analysis

sSB 934 (File 446, as amended by Senate “A”)*

AN ACT PERMITTING STEM CELL RESEARCH AND BANNING THE CLONING OF HUMAN BEINGS

SUMMARY:

This bill permits research in the state involving human embryonic stem cells if (1) it is conducted with full consideration of its medical and ethical implications and before gastrulation; (2) before beginning the research, the researcher provides documentation to the public health commissioner, on a form and in a way he prescribes, verifying that any human embryos, embryonic stem cells, human unfertilized eggs, or human sperm used were donated voluntarily; (3) the general research program under which the stem cell research is conducted is reviewed and approved by an institutional review committee as required by federal law; and (4) the specific protocol used to derive stem cells from an embryo is reviewed and approved by an institutional review committee. “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 resulting in the formation of the three primary germ layers (ectoderm, mesoderm and endoderm).

The bill also:

1. requires physicians or other health care providers treating a patient for infertility to provide the patient with timely, relevant, and appropriate information sufficient to allow her to make an informed and voluntary choice about the disposition of any embryos or embryonic stem cells remaining after an infertility treatment;

2. prohibits a person from knowingly (a) engaging or assisting, directly or indirectly, in cloning a human being, (b) implanting human embryos created by nuclear transfer into a uterus or device similar to a uterus (“nuclear transfer” means replacing the nucleus of a human egg with the nucleus from another human cell); and (c) facilitating human reproduction through clinical or other use of human embryos created by nuclear transfer (violating any of these provisions results in a fine of up to $ 100,000, imprisonment up to 10 years, or both, with each violation a separate offense);

3. requires the Department of Public Health (DPH) to enforce the provisions on information for infertility patients, cloning prohibitions, nuclear transfer, informed consent for donations, and research procedures and standards; allows the commissioner to adopt regulations to administer and enforce them; and allows him to ask the attorney general to petition the Superior Court for appropriate enforcement orders;

4. establishes a “Stem Cell Research Fund,” appropriates $ 20 million from the General Fund to it for FY 05, and directs that $ 10 million be disbursed from the Tobacco Settlement Fund to the Stem Cell Research Fund for each of FYs 08 to 15;

5. requires that for each of FYs 06 to 15, at least $ 10 million be available from the research fund for grants to eligible institutions for embryonic or human adult stem cell research, with any balance remaining in a fiscal year carried forward to the next year;

6. establishes a nine-member Stem Cell Research Advisory Committee responsible for (a) establishing and administering, in consultation with the DPH commissioner, a program to provide stem cell research grants to eligible institutions; (b) directing the commissioner on awarding grants; (c) monitoring the grant-funded research; (d) developing, in consultation with DPH, a donated funds program for stem cell research; and (e) reporting to the governor and General Assembly on stem cell research in the state; and

7. establishes a five-member Stem Cell Research Peer Review Committee responsible for reviewing all applications for grants and making recommendations to DPH and the advisory committee on the ethical and scientific merits of applications.

*Senate Amendment “A” (1) adds the concept and definition of “gastrulation; ” (2) establishes the Stem Cell Research Fund and appropriates $ 20 million to it from the General Fund in FY 05; (3) requires that stem cell research grants be made from the research fund instead of from the Biomedical Research Trust Fund as in the original bill (File 446) and requires that $ 10 million be disbursed from the Tobacco Settlement Fund to the research fund through FY 15; (4) changes some of the membership criteria for the Stem Cell Research Advisory and Peer Review committees; (5) requires the Peer Review Committee members to have knowledge of the National Academies guidelines; (6) specifies that those donating unfertilized human eggs or human sperm, as well as embryos or embryonic stem cells, must give their written consent and cannot receive any payment for them; and (7) makes technical changes.

EFFECTIVE DATE: Upon passage

DEFINITIONS

Embryonic Stem Cells

The bill defines embryonic stem cells as cells created by joining a human egg and sperm or through nuclear transfer that are sufficiently undifferentiated so that they cannot be identified as components of any specialized cell type.

Institutional Review Committee

Under the bill, an institutional review committee is (1) the local institutional review committee established according to federal law to supervise the clinical testing of devices in facilities where clinical testing is to be conducted and (2) where applicable, an “institutional review board” (IRB), which, under federal law, is responsible for ensuring that human subjects engaged in research are treated with dignity, are protected from harm, and have given informed consent to participation in research. An IRB reviews and approves research protocols before any work is started and reviews ongoing research periodically to ensure the protection of subjects.

Cloning of a Human Being

The bill defines cloning of a human being as inducing or permitting a replicate of a living human being’s complete set of genetic material to develop after gastrulation begins.

PATIENTS UNDERGOING FERTILITY TREATMENT

Under the bill, a patient undergoing infertility treatment who receives the required information on the disposition of remaining human embryos or embryonic stem cells must be given the option of storing them, donating them to another person, donating them for research purposes, or otherwise disposing of them. People choosing to donate for research purposes any embryos or embryonic stem cells remaining after infertility treatment, or unfertilized human eggs or human sperm must give written consent and cannot receive any direct or indirect payment for them.

Anyone violating these provisions, or a health care provider who fails to give the required information, is subject to a fine of up to $ 50,000, a prison term of up to five years, or both. Each violation is a separate offense.

STEM CELL RESEARCH FUND AND RESEARCH GRANTS

The bill establishes a Stem Cell Research Fund as a separate, nonlapsing General Fund account. It can hold any funds required or allowed by law to be deposited in it and any public or private contributions, gifts, grants, donations, bequests, or devises made to it. The DPH commissioner can make grants from the fund to eligible institutions for embryonic and human adult stem research (see below).

The bill appropriates $ 20 million to the research fund in FY 05 from the General Fund for FY 05 and requires that $ 10 million be disbursed for each of FYs 08 to 15 from the Tobacco Settlement Fund to the Stem Cell Research Fund. Beginning with FY 06 and continuing through FY 15, it requires at least $ 10 million be available each year from the fund for grants to eligible institutions for embryonic or human adult stem cell research. Any balance left in a fiscal year must be carried forward to the next fiscal year. An “eligible institution” is (1) a nonprofit, tax-exempt academic institution of higher education, (2) a hospital conducting biomedical research, or (3) any entity conducting biomedical research or embryonic or human adult stem cell research.

STEM CELL RESEARCH ADVISORY COMMITTEE

Membership

This nine-member committee includes the DPH commissioner and eight other members appointed as follows: (1) two by the governor, one who is a nationally recognized active investigator in stem cell research and one with background and experience in bioethics; (2) one each by the Senate president pro tempore and the House speaker with background and experience in private sector stem cell research and development; (3) one each by the House and Senate majority leaders who must be academic researchers specializing in stem cell research; (4) one by the Senate minority leader with background and experience in public or private sector research and development or related research fields including embryology, genetics, or cellular biology; and (5) one by the House minority leader with background and experience in business or financial investments.

Members serve staggered four-year terms beginning on October 1, with the members first appointed by the governor and majority leaders serving for two years. Members cannot serve more than two consecutive four-year terms and no member can serve concurrently on the Stem Cell Research Peer Review Committee (see below). All initial appointments must be made by October 1, 2005, and the appointing authority must fill any vacancy. The first meeting must be held by December 1, 2005. The members must work to advance embryonic and human adult stem cell research in the state. A member missing three consecutive meetings or failing to attend 50% of the meetings in a calendar year is deemed to have resigned.

Members are considered public officials and must follow the Code of Ethics for Public Officials. The bill prohibits members from reviewing or considering any grant application filed by himself or any applicant in which he has a financial interest or with whom he engages in any business, employment, transaction, or professional activity.

Grants and Grant Applications

By June 30, 2006, the advisory committee must develop a grants application for conducting embryonic or human adult stem cell research. It may receive applications after that date from eligible institutions. A grant applicant must submit (1) a complete description of its organization; (2) its plans for stem cell research and proposed funding from non-state sources; and (3) proposed arrangements concerning financial benefits the state will receive as a result of any patent, royalty payments, or similar rights resulting from any stem cell research made possible by the grant.

The committee is responsible for directing the DPH commissioner on awarding the grants and monitoring the research conducted by those receiving the grants.

Connecticut Innovations, Inc. serves as administrative staff for the committee and must assist in (1) developing the grants application, (2) reviewing applications, (3) preparing and executing any assistance or other agreements concerning grant awards, and (4) performing other necessary duties.

Other Committee Responsibilities

The bill directs the committee to (1) develop, in consultation with DPH, a program to encourage development of funds other than state appropriations for such research and (2) identify ways to improve and promote for-profit and not-for-profit stem cell and related research in the state. The latter can include identifying public and private funding sources, maintaining existing embryonic and adult stem cell-related business in the state, and recruiting new business, scientists and researchers to the state.

Report

Beginning June 30, 2007 and annually through June 30, 2015, the advisory committee must report to the governor and the General Assembly on (1) the amount of grants awarded from the research fund, (2) grant recipients, and (3) the current status of stem cell research in the state.

STEM CELL RESEARCH PEER REVIEW COMMITTEE

The bill creates a five-member Stem Cell Research Peer Review Committee appointed by the DPH commissioner. All members must (1) have demonstrated knowledge and understanding of the ethical and medical implications of embryonic and human adult stem cell research or related research fields such as embryology, genetics or cellular biology; (2) have practical research experience in these research areas; and (3) work to advance embryonic and human adult stem cell research.

Members serve staggered four-year terms beginning on October 1, with three members first appointed serving a two-year term. No member can serve more than two consecutive four-year terms or concurrently serve on the Stem Cell Research Advisory Committee. Initial appointments must be made by October 1, 2005. Members are subject to the same attendance requirements as the advisory committee. Also, they are subject to the same ethics and conflict of interest standards as advisory committee members.

The peer review committee must review all applications for grants and make recommendations to DPH and the advisory committee concerning the ethical and scientific merit of each application. It must establish guidelines for the rating and scoring of the applications.

Peer review committee members must become aware of the National Academies for Human Embryonic Stem Cell Research (see BACKGROUND). They may also make recommendations to the advisory committee and the DPH commissioner concerning adoption of these guidelines, in whole or in part, as state regulations.

BACKGROUND

National Academies Guidelines

The National Academies is an independent organization chartered by Congress to advise the government on scientific, engineering, and health matters. In April 2005, it released guidelines and recommendations for human embryonic stem cell research to advance the science in a responsible manner. These guidelines are intended for use by the scientific community, including researchers in academic, industry, or other private sector organizations.

Legislative History

The Senate referred the bill to the (1) Appropriations Committee, which reported it favorably on May 2; (2) Commerce Committee, which reported it favorably on May 11; (3) Government Administration and Elections Committee, which reported it favorably on May 17; and (4) the Higher Education and Employment Advancement Committee, which reported it favorably on May 24.

COMMITTEE ACTION

Public Health Committee

Joint Favorable Substitute Change of Reference

Yea

18

Nay

5

Judiciary Committee

Joint Favorable Report

Yea

28

Nay

8

Appropriations Committee

Joint Favorable Report

Yea

37

Nay

10

Commerce Committee

Joint Favorable Report

Yea

16

Nay

6

Government Administration and Elections Committee

Joint Favorable Report

Yea

18

Nay

2

Higher Education and Employment Advancement Committee

Joint Favorable Report

Yea

14

Nay

0