Maryland Stem Cell Research Fund

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Maryland Stem Cell Research Fund
Act of 2006

§ 5-2B-01. Definitions.

(a) In this subtitle the following words have the meanings indicated.

(b) "Adult stem cell" means a stem cell that:

(1) Is derived from human tissue; and
(2) Is obtained after birth.

(c) "Commission" means the Stem Cell Research Commission.

(d) "Committee" means the independent scientific peer review committee that contracts with the Commission under § 5-2B-06 of this subtitle.

(e) "Corporation" means the Maryland Technology Development Corporation.

(f) "Fund" means the Maryland Stem Cell Research Fund.

(g) "Human cloning" means the replication of a human being through 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 an embryo.

(h) "Institutional review board" has the meaning stated in the federal regulations on the protection of human subjects.

(i) "Oocyte" means a female germ cell or egg.

(j) "State-funded stem cell research" means stem cell research conducted using:

(1) Material obtained in accordance with § 5-2B-10 of this subtitle; or

(2) Adult stem cells.

(k) "Stem cell" means a human cell that has the ability to:

(1) Divide indefinitely;
(2) Give rise to many other types of specialized cells; and
(3) Give rise to new stem cells with identical potential.

(l) "Valuable consideration" means financial gain or advantage in connection with material obtained in accordance with § 5-2B-10 of this subtitle.

§ 5-2B-02. Considerations.

(a) A person who conducts State-funded stem cell research shall conduct the research in a manner that considers the ethical and medical implications of the research.

(b) A person who conducts State-funded stem cell research may not engage in any research that intentionally and directly leads to human cloning.

§ 5-2B-03. Establishment and Purpose of Fund.

(a) There is a Maryland Stem Cell Research Fund.

(b) 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.

(c) The Fund is a special, nonlapsing fund that is not subject to § 7-302 of the State Finance and Procurement Article.

(d) The State Treasurer shall hold the Fund and the Comptroller shall account for the Fund.

(e) The proceeds of the Fund shall be invested and reinvested in the same manner as other State funds.

(f) Any investment earnings shall be paid into the Fund.

(g) The Fund consists of:

(1) Appropriations as provided in the State budget; and
(2) Any other money from any other source accepted for the benefit of the Fund.

(h) Beginning in fiscal year 2008 and in each fiscal year thereafter, the Governor may include in the annual budget bill an appropriation to the Fund.

(i) The Corporation shall administer the Fund.

(j) Money in the Fund may only be expended to:

(1) Award grants and loans for State-funded stem cell research, in accordance with the recommendations of the Commission;
(2) 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
(3) Pay the costs necessary to administer the Fund.

(k) Expenditures from the Fund may only be made in accordance with an appropriation approved by the General Assembly in the annual State budget or by an approved budget amendment.

(l) The Corporation, in consultation with the Commission, shall adopt regulations to establish procedures for making the disbursement of a grant contingent on obtainment of the approval of an institutional review board.

§ 5-2B-04. Commission Established.

(a) There is a Stem Cell Research Commission.

(b) The Commission is an independent commission that functions in the Corporation.

(c) The Commission consists of the following members:

(1) The Attorney General or the Attorney General's designee;
(2) 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 of Delegates;
(3) 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 of Delegates;
(4) Two individuals who work as scientists for the University System of Maryland and do not engage in stem cell research, appointed by the University System of Maryland;
(5) Two individuals who work as scientists for The Johns Hopkins University and do not engage in stem cell research, appointed by The Johns Hopkins University;
(6) Two bioethicists, one appointed by the University System of Maryland and one appointed by The Johns Hopkins University; and
(7) Two individuals with expertise in the field of biomedical ethics as it relates to religion, appointed by the Governor.

(d) The members of the Commission shall elect a chair from among the appointed members of the Commission.

(1) The term of an appointed member is 2 years.
(2) The terms of the appointed members are staggered as required by the terms provided for members on July 1, 2006.
(3) At the end of a term, an appointed member continues to serve until a successor is appointed and qualifies.
(4) An appointed member may not serve more than three consecutive full terms.
(5) An appointed member who is appointed after a term has begun serves only for the rest of the term and until a successor is appointed and qualifies.

(e) A majority of the full authorized membership of the Commission is a quorum.

(f) A member of the Commission:

(1) May not receive compensation as a member of the Commission; but
(2) Is entitled to reimbursement for expenses under the Standard State Travel Regulations, as provided in the State budget.

(g) The Commission may employ a staff, including contractual staff, in accordance with the State budget.

(h) The Commission may consult with experts in performing its duties.

(i) 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.

§ 5-2B-05. Limited Powers of Secretary.

(a) The power of the Secretary over plans, proposals, and projects of units in the Department does not include the power to disapprove or modify any decision or determination that the Commission makes under authority specifically delegated by law to the Commission.

(b) The power of the Secretary to transfer by rule, regulation, or written directive any staff, functions, or funds of units in the Department does not apply to any staff, functions, or funds of the Commission.

§ 5-2B-06. Independent Scientific Peer Review Committee.

(a) The Commission shall contract with an independent scientific peer review committee composed of scientifically recognized experts in the field of stem cell research.

(b) The committee shall review, evaluate, rank, and rate research proposals for State-funded stem cell research:

(1) Based on the procedures and guidelines established by the Commission; and
(2) In a manner that gives due consideration to the scientific, medical, and ethical implications of the research.

(c) The committee shall make recommendations to the Commission, based on the rankings and ratings awarded to research proposals by the committee, for the award and disbursement of grants under the Fund.

(d) A member of the committee:

(1) Is not eligible to receive a grant or loan for State-funded stem cell research from the Fund; and
(2) May not reside in the State.

(e) Members of the 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.

§ 5-2B-07. Duties.

(a) The Commission shall:

(1) Adopt regulations that ensure that adult stem cell and stem cell research financed by the Fund complies with State law;
(2) Develop criteria, standards, and requirements for the initial review of grant and loan applications by the Commission;
(3) Review grant and loan applications to ensure that each application is complete and satisfies the criteria, standards, and requirements developed by the Commission, including approval by an institutional review board;
(4) Establish procedures and guidelines to be used by the committee for the review, evaluation, ranking, and rating of research proposals for State-funded stem cell research;
(5) Ensure that the procedures and guidelines established under item (4) of this subsection are based on the guidelines of the National Institutes of Health Center for Scientific Review;
(6) Establish criteria, standards, and requirements for consideration of grant and loan applications based on the rankings and ratings of the committee;
(7) Make recommendations consistent with the criteria, standards, and requirements established by the Commission and based on the rankings and ratings of the committee regarding the award of grants and loans from the Fund;
(8) Establish standards for the oversight and use of awards;
(9) Conduct progress oversight reviews of grantees;
(10) Notify the Corporation regarding the submission by a grantee, or failure of a grantee, to submit institutional review board approval for a grant awarded under this subtitle; and
(11) Develop guidelines on disclosure and recusal to be followed by members of the Commission when considering grant and loan applications.

(b) The Commission shall meet at least twice a year.

§ 5-2B-08. Grant Contingencies.

(a) A grant awarded under this subtitle shall be contingent on:

(1) The submission by a grantee to the Commission of approval from an institutional review board; and
(2) Entrance into a memorandum of understanding between the grantee and the Corporation that:

(i) 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
(ii) To the extent consistent with federal and State law, reflects the intellectual property policies of the institution.

(b) A grantee shall submit the approval required under subsection (a)(1) of this section within 6 months of the award of the grant.

(c) The Corporation may not disburse grant money to a grantee until:

(1) The approval required under subsection (a)(1) of this section has been obtained; and
(2) The memorandum of understanding required under subsection (a)(2) of this section has been obtained.

§ 5-2B-09. Annual Report.

(a) On or before January 1 of each year, the Corporation and the Commission shall report to the Governor and, in accordance with § 2-1246 of the State Government Article, to the General Assembly on the progress of State-funded stem cell research conducted in accordance with this subtitle.

(b) The report shall identify:

(1) Each grantee that received funding from the Fund;
(2) The amount of funding awarded to each grantee; and
(3) A description of the type of stem cell research performed by the grantee.

§ 5-2B-10. Heath Care Practitioner - Unused Material.

(a) A health care practitioner licensed under the Health Occupations Article who treats individuals for infertility shall:

(1) Provide individuals with information sufficient to enable them to make an informed and voluntary choice regarding the disposition of any unused material; and
(2) Present to individuals the option of:

(i) Storing or discarding any unused material;
(ii) Donating any unused material for clinical purposes in the treatment of infertility;
(iii) Except as provided in subsection (b) of this section, donating any unused material for research purposes; and
(iv) Donating any unused material for adoption purposes.

(b) Any unused material donated for State-funded stem cell research may not be an oocyte.

(c) An individual who donates any unused material for research purposes under subsection (a)(2) of this section shall provide the health care practitioner with written consent for the donation.

§ 5-2B-11. Creation of Stem Cell Lines Not Prohibited.

Nothing in this subtitle shall be construed to prohibit the creation of stem cell lines to be used for therapeutic research purposes.

§ 5-2B-12. Restrictions and Penalties of Donated Material.

(a) A person may not purchase, sell, transfer, or obtain any material donated in accordance with § 5-2B-10 of this subtitle for valuable consideration.

(b) A person may not give valuable consideration to another person to encourage the production of material donated in accordance with § 5-2B-10 of this subtitle for the sole purpose of medical research.

(c) A person who violates this section is guilty of a misdemeanor and on conviction is subject to imprisonment not exceeding 3 years or a fine not exceeding $50,000 or both.

§ 5-2B-13. Prohibition on Human Cloning.

(a) A person may not conduct or attempt to conduct human cloning.

(b) A person who violates this section is guilty of a felony and on conviction is subject to imprisonment not exceeding 10 years or a fine not exceeding $200,000 or both.

Dan Gincel, Ph.D.
Director
(410) 715-4172
dgincel@marylandtedco.org