Stem Cell Research Act
Summary: The Stem Cell Research Act creates a fund to support stem cell research, administered by an independent Stem Cell Research Commission.
SECTION 1. SHORT TITLE
This Act shall be called the “Stem Cell Research Act.”
SECTION 2. FINDINGS AND PURPOSE
(A) FINDINGS—The legislature finds that:
1. An estimated 128,000,000 Americans suffer from the crippling physical, economic and psychological burdens of chronic, degenerative and acute diseases, including Alzheimer’s disease, heart disease, diabetes, Parkinson’s disease, macular degeneration, amytrophic lateral sclerosis (ALS), multiple sclerosis and cancer.
2. The economic costs of treatment and lost productivity of chronic, degenerative, and acute diseases in the United States amounts to hundreds of billions of dollars every year, and the extreme human loss and suffering associated with these conditions is immeasurable.
3. Stem cell research offers immense promise for the development of new medical therapies and a better understanding of these debilitating diseases and could lead to unprecedented treatments and potential cures for Alzheimer’s disease, heart disease, diabetes, Parkinson’s disease, cancer, and other diseases.
4. Stem cell research, including the use of embryonic stem cells for medical research, raises significant ethical and policy concerns that must be carefully considered.
5. Public policy on stem cell research must balance ethical and medical considerations and must be based on an understanding of the science associated with stem cell research.
6. Stem cell research policy must be carefully crafted to ensure that researchers have the tools necessary to fulfill the promise of stem cell research.
(B) PURPOSE—This law is enacted to ensure the responsible study of stem cells to improve the lives of [State] residents.
SECTION 3. STEM CELL RESEARCH COMMISSION
After section XXX, the following new section XXX shall be inserted:
(A) DEFINITIONS—In this section:
1. “Adult stem cell” means a stem cell that is derived from human tissue that is obtained after birth.
2. “Department” means the Department of [Health].
3. “Human cloning” means the production of a precise genetic copy of nuclear human DNA or any other human molecule, cell, or tissue, in order to create a new human being or to allow development beyond the embryonic stage.
4. “Institutional review board” has the meaning stated in the federal regulations on the protection of human subjects.
6. “Stem cell” means a human cell that has the ability to divide indefinitely, give rise to many other types of specialized cells, and yield new stem cells with identical potential.
(B) ESTABLISHMENT OF STEM CELL RESEARCH FUND
1. There is established a [State] Stem Cell Research Fund.
2. The purpose of the fund is to promote state-funded stem cell research and cures through grants and loans to public and private entities in the state.
3. The fund is a special, non-lapsing fund under the jurisdiction of the [State Treasurer].
4. The proceeds of the fund shall be invested and reinvested in the same manner as other state funds, and any investment earnings shall be paid into the fund.
5. The fund consists of appropriations as provided in the state budget, and any other money from any other source accepted for the benefit of the fund.
6. The fund shall be administered by the [State] Stem Cell Research Commission.
7. Money in the fund may only be expended to:
a. Award grants and loans for state-funded stem cell research, in accordance with the recommendations of the Commission;
b. Award grants and loans for facilities, capital leases and capital equipment where state-funded stem cell research is conducted, in accordance with the recommendations of the Commission; and
c. Pay the costs necessary to administer the fund.
8. The Commission shall establish procedures making the disbursement of a grant contingent on the approval of an institutional review board.
(C) ESTABLISHMENT OF STEM CELL RESEARCH COMMISSION
1. There is established a Stem Cell Research Commission within the Department, which is an independent commission.
2. The Secretary of the Department shall not have the power to disapprove or modify any decision or determination that the Commission makes under authority specifically delegated by law to the commission.
3. The Commission shall consist of the following members:
a. The Attorney General or the Attorney General’s designee.
b. Three patient advocates, one appointed by the governor, one appointed by the President of the Senate, and one appointed by the Speaker of the House.
c. Three individuals with experience in biotechnology, one appointed by the governor, one appointed by the President of the Senate, and one appointed by the Speaker of the House.
d. Two individuals who work as scientists for the state university system and do not engage in stem cell research, appointed by the university system of [State].
e. Two individuals who work as scientists for private universities and do not engage in stem cell research, appointed by the governor.
f. Two bioethicists, one appointed by the university system of [State] and one appointed by the governor.
g. Two individuals with expertise in the field of biomedical ethics as it relates to religion, appointed by the governor.
h. The governor shall designate the Chair of the Commission.
4. The term of an appointed member is two years, with terms staggered so that half of the initial appointees shall serve an initial term of one year and are then eligible for reappointment. An appointed member may not serve more than three consecutive full terms.
5. A member of the Commission may not receive compensation as a member of the commission, but is entitled to reimbursement for expenses under the standard state travel regulations, as provided in the state budget.
6. The Commission shall meet at least twice a year.
7. The Commission may employ a staff, including contractual staff, in accordance with the state budget.
8. Each member of the Commission shall disclose to the [state commission on ethics] whether the member is employed by or has a financial interest in an entity that may apply to conduct state-funded stem cell research.
(D) DUTIES OF THE COMMISSION
1. The Commission shall contract with an independent scientific peer review committee composed of scientifically-recognized experts in the field of stem cell research. The peer review committee shall:
a. Review, evaluate, rank and rate research proposals for state-funded stem cell research based on the procedures and guidelines established by the Commission, and in a manner that gives due consideration to the scientific, medical and ethical implications of the research.
b. Make recommendations to the Commission, based on the rankings and ratings awarded to research proposals, for the award and disbursement of grants under the fund.
2. A member of the peer review committee is not eligible to receive a grant or loan for state-funded stem cell research from the fund. Members of the peer review committee shall be subject to conflict of interest standards that are at least as stringent as the standards on conflict of interest adopted by the National Institutes of Health.
3. The Commission shall:
a. Develop criteria, standards and requirements for the review of grant and loan applications.
b. Establish procedures and guidelines to be used for the peer review, evaluation, ranking and rating of research proposals for state-funded stem cell research.
c. Ensure that the procedures and guidelines established under this subsection are based on the guidelines of the National Institutes of Health Center for Scientific Review.
d. Establish criteria, standards and requirements for consideration of grant and loan applications based on the rankings and ratings of the committee.
e. Establish standards for the oversight and use of awards.
f. Develop guidelines on disclosure and recusal to be followed by members of the Commission when considering grant and loan applications.
4. A grant shall be contingent on the submission by a grantee to the Commission of approval from an institutional review board, and entrance into a memorandum of understanding between the grantee and the Commission that establishes the scope of the state’s ownership or other financial interest in the commercialization and other benefits of the results, products, inventions and discoveries of state-funded stem cell research, and to the extent consistent with federal and state law, reflects the intellectual property policies of the institution.
(E) RESPONSIBILITY OF PRACTITIONERS
1. A licensed health care practitioner who treats individuals for infertility shall:
a. Provide individuals with information sufficient to enable them to make an informed and voluntary choice regarding the disposition of any unused material; and
b. Present to individuals the options of storing or discarding any unused material, donating any unused material for clinical purposes in the treatment of infertility, and donating any unused material for research purposes.
2. An individual who donates any unused material for research purposes under this section shall provide the health care practitioner with written consent for the donation.
3. Nothing in this subtitle shall be construed to prohibit the creation of stem cell lines to be used for therapeutic research purposes.
(F) PROHIBITIONS
1. A person who conducts state-funded stem cell research may not engage in any research that intentionally and directly leads to human cloning.
2. A person may not purchase, sell, transfer or obtain any material donated in accordance with this subtitle for valuable consideration.
3. A person may not give valuable consideration to another person to encourage the production of material donated in accordance with this subtitle for the sole purpose of medical research.
4. A person who violates this section is guilty of a misdemeanor and on conviction is subject to imprisonment not exceeding three years, a fine not exceeding $50,000 or both.
5. A person may not conduct or attempt to conduct human cloning. A person who violates this paragraph is guilty of a felony and on conviction is subject to imprisonment not exceeding ten years or a fine not exceeding $200,000 or both.
(G) REPORT
1. On or before January 1 of each year, the commission shall report to the governor and legislature on the progress of state-funded stem cell research conducted in accordance with this subtitle.
2. The report shall identify each grantee that received funding from the fund, the amount of funding awarded to each grantee, and a description of the type of stem cell research performed by the grantee.
SECTION 4. EFFECTIVE DATE—This Act shall take effect on July 1, 2007.