The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 159
Appendix C Proposition 71 159

OCR for page 159
160 THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE therapies to treat and cure diseases and serious Proposition 71 injuries. This critical funding gap currently prevents the rapid advancement of research that could benefit millions of Californians. This initiative measure is submitted to the people in accordance with the provisions of Section 8 of The California Stem Cell Research and Cures Article II of the California Constitution. Act will close this funding gap by establishing an institute which will issue bonds to support stem cell This initiative measure expressly amends the research, emphasizing pluripotent stem cell and California Constitution by adding an article thereto; progenitor cell research and other vital medical and amends a section of the Government Code, and technologies, for the development of life-saving adds sections to the Health and Safety Code; regenerative medical treatments and cures. therefore, new provisions proposed to be added are printed in italic type to indicate that they are new. SEC. 3. Purpose and Intent PROPOSED LAW It is the intent of the people of California in enacting this measure to: CALIFORNIA STEM CELL RESEARCH AND CURES INITIATIVE Authorize an average of $295 million per year in bonds over a 10-year period to fund stem cell SECTION 1. Title research and dedicated facilities for scientists at This measure shall be known as the “California California’s universities and other advanced medical Stem Cell Research and Cures Act.” research facilities throughout the state. SEC. 2. Findings and Declarations Maximize the use of research funds by giving priority to stem cell research that has the greatest The people of California find and declare the potential for therapies and cures, specifically focused following: on pluripotent stem cell and progenitor cell research Millions of children and adults suffer from among other vital research opportunities that cannot, devastating diseases or injuries that are currently or are unlikely to, receive timely or sufficient federal incurable, including cancer, diabetes, heart disease, funding, unencumbered by limitations that would Alzheimer’s, Parkinson’s, spinal cord injuries, impede the research. Research shall be subject to blindness, Lou Gehrig’s disease, HIV/AIDS, mental accepted patient disclosure and patient consent health disorders, multiple sclerosis, Huntington’s standards. disease, and more than 70 other diseases and injuries. Assure that the research is conducted safely and Recently medical science has discovered a new ethically by including provisions to require way to attack chronic diseases and injuries. The cure compliance with standards based on national models and treatment of these diseases can potentially be that protect patient safety, patient rights, and patient accomplished through the use of new regenerative privacy. medical therapies including a special type of human Prohibit the use of bond proceeds of this cells, called stem cells. These life-saving medical initiative for funding for human reproductive cloning. breakthroughs can only happen if adequate funding is made available to advance stem cell research, Improve the California health care system and develop therapies, and conduct clinical trials. reduce the long-term health care cost burden on California through the development of therapies that About half of California’s families have a child treat diseases and injuries with the ultimate goal to or adult who has suffered or will suffer from a cure them. serious, often critical or terminal, medical condition that could potentially be treated or cured with stem Require strict fiscal and public accountability cell therapies. In these cases of chronic illness or through mandatory independent audits, open when patients face a medical crisis, the health care meetings, public hearings. and annual reports to the system may simply not be able to meet the needs of public. Create an Independent Citizen’s Oversight patients or control spiraling costs, unless therapy Committee composed of representatives of the focus switches away from maintenance and toward University of California campuses with medical prevention and cures. schools; other California universities and California medical research institutions; California disease Unfortunately, the federal government is not advocacy groups; and California experts in the providing adequate funding necessary for the urgent development of medical therapies. research and facilities needed to develop stem cell

OCR for page 159
APPENDIX C 161 Protect and benefit the California budget: by differentiate into multiple adult cell types. Pluripotent postponing general fund payments on the bonds for stem cells may be derived from somatic cell nuclear the first five years; by funding scientific and medical transfer or from surplus products of in vitro research that will significantly reduce state health fertilization treatment when such products are care costs in the future; and by providing an donated under appropriate informed consent opportunity for the state to benefit from royalties, procedures. Progenitor cells are multipotent or patents, and licensing fees that result from the precursor cells that are partially differentiated, but research. retain the ability to divide and give rise to differentiated cells. Benefit the California economy by creating projects, jobs, and therapies that will generate SEC. 6. Notwithstanding any other provision of millions of dollars in new tax revenues in our state. this Constitution or any law, the institute, which is established in state government, may utilize state Advance the biotech industry in California to issues tax-exempt and taxable bonds to fund its world leadership, as an economic engine for operations, medical and scientific research, including California’s future. therapy development through clinical trials, and SEC. 4. Article XXXV is added to the California facilities. Constitution, to read: SEC. 7. Notwithstanding any other provision of Article XXXV. Medical Research this Constitution, including Article VII, or any law, the institute and its employees are exempt from civil SECTION 1. There is hereby established the service. California Institute for Regenerative Medicine. SEC. 5. Chapter 3 (commencing with Section SEC. 2. The Institute shall have the following 125290.10) is added to Part 5 of Division 106 of the purposes: Health and Safety Code, to read: (a) To make grants and loans for stem cell CHAPTER 3. CALIFORNIA STEM CELL RESEARCH AND research, for research facilities, and for other vital CURES BOND ACT research opportunities to realize therapies, protocols, and/or medical procedures that will result in, as Article 1. California Stem Cell Research and Cures speedily as possible, the cure for, and/or substantial Act mitigation of, major diseases, injuries, and orphan 125290.10. General—Independent Citizen’s diseases. Oversight Committee (ICOC) (b) To support all stages of the process of This chapter implements Article XXXV of the developing cures, from laboratory research through California Constitution, which established the successful clinical trials. California Institute for Regenerative Medicine (c) To establish the appropriate regulatory (institute). standards and oversight bodies for research and 125290.15. Creation of the ICOC facilities development. There is hereby created the Independent SEC. 3. No funds authorized for, or made Citizen’s Oversight Committee, hereinafter, the available to, the institute shall be used for research ICOC, which shall govern the institute and is herby involving human reproductive cloning. vested with full power, authority, and jurisdiction SEC. 4. Funds authorized for, or made available over the institute. to, the institute shall be continuously appropriate 125290.20. ICOC Membership; Appointment; without regard to fiscal year, be available and used Terms of Office only for the purposes provided in this article, and shall not be subject to appropriation or transfer by (a) ICOC Membership the Legislature of the Governor for any other The ICOC shall have 29 members, appointed as purpose. follows: SEC. 5. There is herby established a right to (1) The Chancellors of the University of conduct stem cell research which includes research California at San Francisco, Davis, San Diego, Los involving adult stem cells, cord blood stem cells, Angeles, and Irvine, shall each appoint an executive pluripotent stem cells, and/or progenitor stem cells. officer from his or her campus. Pluripotent stem cells are cells that are capable of self-renewal, and have broad potential to

OCR for page 159
162 THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE (2) The Governor, the Lieutenant Governor, the regional, state, or national disease advocacy groups, Treasurer, and the Controller shall each appoint an as follows: executive officer from the following three categories: (A) The Governor shall appoint two members, (A) A California university, excluding the five one from each of the following disease advocacy campuses of the University of California described in groups: spinal cord injury and Alzheimer’s disease. paragraph (1), that has demonstrated success and (B) The Lieutenant Governor shall appoint two leadership in stem cell research, and that has: members, one from each of the following disease (i) A nationally ranked research hospital and advocacy groups: type II diabetes and multiple medical school; this criteria will apply to only two of sclerosis or amyotrophic lateral sclerosis. the four appointments. (C) The Treasurer shall appoint two members, (ii) A recent proven history of administering one from each of the following disease groups: type I scientific and/or medical research grants and diabetes and heart disease. contracts in an average annual range exceeding one (D) The Controller shall appoint two members, hundred million dollars ($100,000,000). one from each of the following disease groups: (iii) A ranking, within the past five years, in the cancer and Parkinson’s disease. top 10 United States universities with the highest (4) The Speaker of the Assembly shall appoint a number of life science patents or that has research or member from among California representatives of a clinical faculty who are members of the National California regional, state, or national mental health Academy of Sciences. disease advocacy group. (B) A California nonprofit academic and (5) The President pro Tempore of the Senate research institution that is not a part of the shall appoint a member from among California University of California, that has demonstrated representatives of a California regional, state, or success and leadership in stem cell research, and that national HIV/AIDS disease advocacy group. has: (6) A chairperson and vice chairperson who (i) A nationally ranked research hospital or that shall be elected by the ICOC members. Within 40 has research or clinical faculty who are members of days of the effective date of this act, each the National Academy of Sciences. constitutional officer shall nominate a candidate for (ii) A proven history in the last five years of chairperson and another candidate for vice managing a research budget in the life sciences chairperson. The chairperson and vice chairperson exceeding twenty million dollars ($20,000,000). shall each be elected for a term of six years. The chairperson and vice chairperson of ICOC shall be (C) A California life science commercial entity full or part time employees of the institute and shall that is not actively engaged in researching or meet the following criteria: developing therapies with pluripotent or progenitor stem cells, that has a background in implementing (A) Mandatory Chairperson Criteria successful experimental medical therapies, and that (i) Documented history in successful stem cell has not been awarded, or applied for, funding by the research advocacy. institute at the time of appointment. A board member of that entity with a successful history of developing (ii) Experience with state and federal legislative innovative medical therapies may be appointed in processes that must include some experience with lieu of an executive officer. medical legislative approvals of standards and/or funding. (D) Only one member shall be appointed from a single university, institution, or entity. The executive (iii) Qualified for appointment pursuant to officer of a California university, a nonprofit paragraph (3), (4), or (5) of subdivision (a). research institution or life science commercial entity who is appointed as a member, may from time to time (iv) Cannot be concurrently employed by or on delegate those duties to an executive officer of the leave from any prospective grant or loan recipient entity or to the dean of the medical school, if institutions in California. applicable. (B) Additional Criteria for Consideration: (3) The Governor, the Lieutenant Governor, the (i) Experience with governmental agencies or Treasurer, and the Controller shall appoint members institutions (either executive or board position). from among California representatives of California

OCR for page 159
APPENDIX C 163 (ii) Experience with the process of establishing 125290.30. Public and Financial Accountability government standards and procedures. Standards (iii) Legal experience with the legal review of (a) Annual Public Report proper governmental authority for the exercise of The institute shall issue an annual report to the government agency or government institutional public which sets forth its activities, grants awarded, powers. grants in progress, research accomplishments, and (iv) Direct knowledge and experience in bond future program directions. Each annual report shall financing. include, but not be limited to, the following: the number and dollar amounts of research and facilities The vice chairperson shall satisfy clauses (i), grants; the grantees for the prior year; the institute’s (iii), and (iv) of subparagraph (A). The vice administrative expenses; an assessment of the chairperson shall be selected from among individuals availability of funding for stem cell research from who have attributes and experience complementary sources other than the institute; a summary of to those of the chairperson, preferably covering the research findings, including promising new research criteria not represented by the chairperson’s areas; an assessment of the relationship between the credentials and experience. institute’s grants and the overall strategy of its (b) Appointment of ICOC Members research program; and a report of the institute’s strategic research and financial plans. (1) All appointments shall be made within 40 days of the effective date of this act. In the event that (b) Independent Financial Audit for Review by any of the appointments are not completed within the State Controller permitted timeframe, the ICOC shall proceed to The institute shall annually commission an operate with the appointments that are in place, independent financial audit of its activities from a provided that at least 60 percent of the appointments certified public accounting firm, which shall be have been made. provided to the State Controller, who shall review the (2) Forty-five days after the effective date of the audit and annually issue a public report of that measure adding this chapter, the State Controller review. and the Treasurer, or if only one is available within (c) Citizen’s Financial Accountability Oversight 45 days, the other shall convene a meeting of the Committee appointed members of the ICOC to elect a chairperson and vice chairperson from among the There shall be a Citizen’s Financial individuals nominated by the constitutional officers Accountability Oversight Committee chaired by the pursuant to paragraph (6) of subdivision (a). State Controller. This committee shall review the annual financial audit, the State Controller’s report (c) ICOC Member Terms of Office and evaluation of that audit, and the financial (1) The members appointed pursuant to practices of the institute. The State Controller, the paragraphs (1), (3), (4), and (5) of subdivision (a) State Treasurer, the President pro Tempore of the shall serve eight-year terms, and all other members Senate, the Speaker of the Assembly, and the shall serve six-year terms. Members shall serve a Chairperson of the ICOC shall each appoint a public maximum of two terms. member of the committee. Committee members shall have medical backgrounds and knowledge of relevant (2) If a vacancy occurs within a term, the financial matters. The committee shall provide appointing authority shall appoint a replacement recommendations on the institute’s financial member within 30 days to serve the remainder of the practices and performance. The State Controller term. shall provide staff support. The committee shall hold (3) When a term expires, the appointing a public meeting, with appropriate notice, and with a authority shall appoint a member within 30 days. formal public comment period. The committee shall ICOC members shall continue to serve until their evaluate public comments and include appropriate replacements are appointed. summaries in its annual report. The ICOC shall provide funds for the per diem expenses of the 125290.25. Majority Vote of Quorum committee members and for publication of the annual Actions of the ICOC may be taken only by a report. majority vote of a quorum of the ICOC. (d) Public Meeting Laws

OCR for page 159
164 THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE (1) The ICOC shall hold at least two public apply to all records of the institute, except as meetings per year, one of which will be designated as otherwise provided in this section. the institute’s annual meeting. The ICOC may hold (2) Nothing in this section shall be construed to additional meetings as it determines are necessary or require disclosure of any records that are any of the appropriate. following: (2) The Bagley-Keene Open Meeting Act, Article (A) Personnel, medical, or similar files, the 9 (commencing with Section 11120) of Chapter 1 of disclosure of which would constitute an unwarranted Part 1 of Division 3 of Title 2 of the Government invasion of personal privacy. Code, shall apply to all meetings of the ICOC, except as otherwise provided in this section. The ICOC shall (B) Records containing or reflecting confidential award all grants, loans, and contracts in public intellectual property or work product, whether meetings and shall adopt all governance, scientific, patentable or not, including, but not limited to, any medical, and regulatory standards in public formula, plan, pattern, process, tool, mechanism, meetings. compound, procedure, production data, or compilation of information, which is not patented, (3) The ICOC may conduct closed sessions as which is known only to certain individuals who are permitted by the Bagley-Keene Open Meeting Act, using it to fabricate, produce, or compound an article under Section 11126 of the Government Code. In of trade or a service having commercial value and addition, the ICOC may conduct closed sessions which gives its user an opportunity to obtain a when it meets to consider or discuss: business advantage over competitors who do not (A) Matters involving information relating to know it or use it. patients or medical subjects, the disclosure of which (C) Prepublication scientific working papers or would constitute an unwarranted invasion of research data. personal privacy. (f) Competitive Bidding (B) Matters involving confidential intellectual property or work product, whether patentable or not, (1) The institute shall, except as otherwise including, but not limited to, any formula, plan, provided in this section, be governed by the pattern, process, tool, mechanism, compound, competitive bidding requirements applicable to the procedure, production data, or compilation of University of California, as set forth in Article 1 information, which is not patented, which is known (commencing with Section 10500) of Chapter 2.1 of only to certain individuals who are using it to Part 2 of Division 2 of the Public Contract Code. fabricate, produce, or compound an article of trade or a service having commercial value and which (2) For all institute contracts, the ICOC shall gives its user an opportunity to obtain a business follow the procedures required of the Regents by advantage over competitors who do not know it or Article 1 (commencing with Section 10500) of use it. Chapter 2.1 of Part 2 of Division 2 of the Public Contract Code with respect to contracts let by the (C) Matters involving prepublication, University of California. confidential scientific research or data. (3) The requirements of this section shall not be (D) Matters concerning the appointment, applicable to grants or loans approved by the ICOC. employment, performance, compensation, or dismissal of institute officers and employees. Action (4) Except as provided in this section, the Public on compensation of the institute’s officers and Contract Code shall not apply to contracts let by the employees shall only be taken in open session. institute. (4) The meeting required by paragraph (2) of (g) Conflicts of Interest subdivision (b) of Section 125290.20 shall be deemed (1) The Political Reform Act, Title 9 to be a special meeting for the purposes of Section (commencing with Section 81000) of the Government 11125.4 of the Government Code. Code, shall apply to the institute and to the ICOC, (e) Public Records except as provided in this section and in subdivision (e) of Section 125290.50. (1) The California Public Records Act, Article 1 (commencing with Section 6250) of Chapter 3.5 of (A) No member of the ICOC shall make, Division 7 of Title 1 of the Government Code, shall participate in making, or in any way attempt to use his or her official position to influence a decision to approve or award a grant, loan, or contract to his or

OCR for page 159
APPENDIX C 165 her employer, but a member may participate in a research is not unreasonably hindered by the decision to approve or award a grant, loan, or intellectual property agreements. contract to a nonprofit entity in the same field as his (i) Preference for California Suppliers or her employer. The ICOC shall establish standards to ensure (B) A member of the ICOC may participate in a that grantees purchase goods and services from decision to approve or award a grant, loan, or California suppliers to the extent reasonably contract to an entity for the purpose of research possible, in a good faith effort to achieve a goal of involving a disease from which a member or his or more than 50 percent of such purchases from her immediate family suffers or in which the member California suppliers. has an interest as a representative of a disease advocacy organization. 125290.35. Medical and Scientific Accountability Standards (C) The adoption of standards is not a decision subject to this section. (a) Medical Standards (2) Service as a member of the ICOC by a In order to avoid duplication or conflicts in member of the faculty or administration of any technical standards for scientific and medical system of the University of California shall not, by research, with alternative state programs, the itself, be deemed to be inconsistent, incompatible, in institute will develop its own scientific and medical conflict with, or inimical to the duties of the ICOC standards to carry out the specific controls and intent member as a member of the faculty or administration of the act, notwithstanding subdivision (b) of Section of any system of the University of California and 125300, Sections 125320, 125118, 125118.5, 125119, shall not result in the automatic vacation of either 125119.3 and 125119.5, or any other current or such office. Service as a member of the ICOC by a future state laws or regulations dealing with the representative or employee of a disease advocacy study and research of pluripotent stem cells and/or organization, a nonprofit academic and research progenitor cells, or other vital research institution, or a life science commercial entity shall opportunities, except Section 125315. The ICOC, its not be deemed to be inconsistent, incompatible, in working committees, and its grantees shall be conflict with, or inimical to the duties of the ICOC governed solely by the provisions of this act in the member as a representative or employee of that establishment of standards, the award of grants, and organization, institution, or entity. the conduct of grants awarded pursuant to this act. (3) Section 1090 of the Government Code shall (b) The ICOC shall establish standards as not apply to any grant, loan, or contract made by the follows: ICOC except where both of the following conditions (1) Informed Consent are met: Standards for obtaining the informed consent of (A) The grant, loan, or contract directly relates research donors, patients, or participants, which to services to be provided by any member of the initially shall be generally based on the standards in ICOC or the entity the member represents or place on January 1, 2003, for all research funded by financially benefits the member or the entity he or she the National Institutes of Health, with modifications represents. to adapt to the mission and objectives of the institute. (B) The member fails to recuse himself or herself (2) Controls on Research Involving Humans from making, participating in making, or in any way attempting to use his or her official position to Standards for the review of research involving influence a decision on the grant loan or contract. human subjects which initially shall be generally based on the Institutional Review Board standards (h) Patent Royalties and License Revenues Paid promulgated by the National Institutes of Health and to the State of California in effect on January 1, 2003, with modifications to The ICOC shall establish standards that require adapt to the mission and objectives of the institute. that all grants and loan awards be subject to (3) Prohibition on Compensation intellectual property agreements that balance the opportunity of the State of California to benefit from Standards prohibiting compensation to research the patents, royalties, and licenses that result from donors or participants, while permitting basic research, therapy development, and clinical reimbursement of expenses. trials with the need to assure that essential medical (4) Patient Privacy Laws

OCR for page 159
166 THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE Standards to assure compliance with state and (k) Notwithstanding the Administrative federal patient privacy laws. Procedure Act (APA), and in order to facilitate the immediate commencement of research covered by (5) Limitations on Payments for Cells this chapter, the ICOC may adopt interim regulations Standards limiting payments for the purchase of without compliance with the procedures set forth in stem cells or stem cell lines to reasonable payment the APA. The interim regulations shall remain in for the removal, processing, disposal, preservation, effect for 270 days unless earlier superseded by quality control, storage, transplantation, or regulations adopted pursuant to the APA. implantation or legal transaction or other (l) Request the issuance of bonds from the administrative costs associated with these medical California Stem Cell Research and Cures Finance procedures and specifically including any required Committee and loans from the Pooled Money payments for medical or scientific technologies, Investment Board. products, or processes for royalties, patent, or licensing fees or other costs for intellectual property. (m) May annually modify its funding and finance programs to optimize the institute’s ability to achieve (6) Time Limits for Obtaining Cells the objective that its activities be revenue-positive for Standards setting a limit on the time during the State of California during its first five years of which cells may be extracted from blastocysts, which operation without jeopardizing the progress of its shall initially be 8 to 12 days after cell division core medical and scientific research program. begins, not counting any time during which the (n) Notwithstanding Section 11005 of the blastocysts and/or cells have been stored frozen. Government Code, accept additional revenue and 125290.40. ICOC Functions real and personal property, including, but not limited to, gifts, royalties, interest, and appropriations that The ICOC shall perform the following functions: may be used to supplement annual research grant (a) Oversee the operations of the institute. funding and the operations of the institute. (b) Develop annual and long-term strategic 125290.45. ICOC Operations research and financial plans for the institute. (a) Legal Actions and Liability (c) Make final decisions on research standards (1) The institute may sue and be sued. and grant awards in California. (2) Based upon ICOC standards, institute (d) Ensure the completion of an annual financial grantees shall indemnify or insure and hold the audit of the institute’s operations. institute harmless against any and all losses, claims, (e) Issue public reports on the activities of the damages, expenses, or liabilities, including institute. attorneys’ fees, arising from research conducted by the grantee pursuant to the grant, and/or, in the (f) Establish policies regarding intellectual alternative, grantees shall name the institute as an property rights arising from research funded by the additional insured and submit proof of such institute. insurance. (g) Establish rules and guidelines for the (3) Given the scientific, medical, and technical operation of the ICOC and its working groups. nature of the issues facing the ICOC, and (h) Perform all other acts necessary or notwithstanding Section 11042 of the Government appropriate in the exercise of its power, authority, Code, the institute is authorized to retain outside and jurisdiction over the institute. counsel when the ICOC determines that the institute requires specialized services not provided by the (i) Select members of the working groups. Attorney General’s office. (j) Adopt, amend, and rescind rules and (4) The institute may enter into any contracts or regulations to carry out the purposes and provisions obligations which are authorized or permitted by of this chapter, and to govern the procedures of the law. ICOC. Except as provided in subdivision (k), these rules and regulations shall be adopted in accordance (b) Personnel with the Administrative Procedure Act (Government (1) The ICOC shall from time to time determine Code, Title 2, Division 3, Part 1, Chapter 4.5, the total number of authorized employees for the Sections 11371 et seq.). institute, up to a maximum of 50 employees,

OCR for page 159
APPENDIX C 167 excluding members of the working groups, who shall duties, plus reasonable and necessary travel and not be considered institute employees. The ICOC other expenses incurred in the performance of the shall select a chairperson, vice chairperson and member’s duties. president who shall exercise all of the powers (3) The ICOC shall establish daily consulting delegated to them by the ICOC. The following rates and expense reimbursement standards for the functions apply to the chairperson, vice chairperson, non-ICOC members of all of its working groups. and president: (4) Notwithstanding Section 19825 of the (A) The chairperson’s primary responsibilities Government Code, the ICOC shall set compensation are to manage the ICOC agenda and work flow for the chairperson, vice chairperson, and president including all evaluations and approvals of scientific and other officers, and for the scientific, medical, and medical working group grants, loans, facilities, technical, and administrative staff of the institute and standards evaluations, and to supervise all within the range of compensation levels for executive annual reports and public accountability officers and scientific, medical, technical, and requirements; to manage and optimize the institute’s administrative staff of medical schools within the bond financing plans and funding cash flow plan; to University of California system and the nonprofit interface with the California Legislature, the United academic and research institutions described in States Congress, the California health care system, paragraph (2) of subdivision (a) of Section and the California public; to optimize all financial 125290.20. leverage opportunities for the institute; and to lead negotiations for intellectual property agreements, 125290.50. Scientific and Medical Working policies, and contract terms. The chairperson shall Groups-General also serve as a member of the Scientific and Medical Accountability Standards Working Group and the (a) The institute shall have, and there is hereby Scientific and Medical Research Facilities Working established, three separate scientific and medical Group and as an ex-officio member of the Scientific working groups as follows: and Medical Research Funding Working Group. The (1) Scientific and Medical Research Funding vice chairperson’s primary responsibilities are to Working Group. support the chairperson in all duties and to carry out those duties in the chairperson’s absence. (2) Scientific and Medical Accountability Standards Working Group. (B) The president’s primary responsibilities are to serve as the chief executive of the institute; to (3) Scientific and Medical Research Facilities recruit the highest scientific and medical talent in the Working Group. United States to serve the institute on its working (b) Working Group Members groups; to serve the institute on its working groups; to direct ICOC staff and participate in the process of Appointments of scientific and medical working supporting all working group requirements to group members shall be made by a majority vote of a develop recommendations on grants, loans, facilities, quorum of the ICOC, within 30 days of the election and standards as well as to direct and support the and appointment of the initial ICOC members. The ICOC process of evaluating and acting on those working group members’ terms shall be six years recommendations, the implementation of all except that, after the first six-year terms, the decisions on these and general matters of the ICOC; members’ terms will be staggered so that one-third of to hire, direct, and manage the staff of the institute; the members shall be elected for a term that expires to develop the budgets and cost control programs of two years later, one-third of the members shall be the institute; to manage compliance with all rules elected for a term that expires four years later, and and regulations on the ICOC, including the one-third of the members shall be elected for a term performance of all grant recipients; and to manage that expires six years later. Subsequent terms are for and execute all intellectual property agreements and six years. Working group members may serve a any other contracts pertaining to the institute or maximum of two consecutive terms. research it funds. (c) Working Group Meetings (2) Each member of the ICOC except, the Each scientific and medical working group shall chairperson, vice chairperson, and president, shall hold at least four meetings per year, one of which receive a per diem of one hundred dollars ($100) per shall be designated as its annual meeting. day (adjusted annually for cost of living) for each day actually spent in the discharge of the member’s (d) Working Group Recommendations to the ICOC

OCR for page 159
168 THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE Recommendations of each of the working groups (2) Nine scientists and clinicians nationally may be forwarded to the ICOC only by a vote of a recognized in the field of pluripotent and progenitor majority of a quorum of the members of each working cell research. group. If 35 percent of the members of any working (3) Four medical ethicists. group join together in a minority position, a minority report may be submitted to the ICOC. The ICOC (4) The Chairperson of the ICOC. shall consider the recommendations of the working groups in making its decisions on applications for (b) Functions research and facility grants and loan awards and in The Scientific and Medical Accountability adopting regulatory standards. Each working group Standards Working Group shall have the following shall recommend to ICOC rules, procedures, and functions: practices for that working group. (1) To recommend to the ICOC scientific, (e) Conflict of Interest medical, and ethical standards. (1) The ICOC shall adopt conflict of interest (2) To recommend to the ICOC standards for all rules, based on standards applicable to members of medical, socioeconomic, and financial aspects of scientific review committees of the National Institutes clinical trials and therapy delivery to patients, of Health, to govern the participation of non-ICOC including, among others, standards for safe and working group members. ethical procedures for obtaining materials and cells (2) The ICOC shall appoint an ethics officer for research and clinical efforts for the appropriate from among the staff of the institute. treatment of human subjects in medical research consistent with paragraph (2) of subdivision (b) of (3) Because the working groups are purely Section 125290.35, and to ensure compliance with advisory and have no final decisionmaking authority, patient privacy laws. members of the working groups shall not be considered public officials, employees, or consultants (3) To recommend to the ICOC modification of for purposes of the Political Reform Act (Title 9 the standards described in paragraphs (1) and (2) as (commencing with Section 81000) of the Government needed. Code), Sections 1090 and 19990 of the Government (4) To make recommendations to the ICOC on Code, and Sections 10516 and 10517 of the Public the oversight of funded research to ensure Contract Code. compliance with the standards described in (f) Working Group Records paragraphs (1) and (2). All records of the working groups submitted as (5) To advise the ICOC, the Scientific and part of the working groups’ recommendations to the Medical Research Funding Working Group, and the ICOC for approval shall be subject to the Public Scientific and Medical Research Facilities Working Records Act. Except as provided in this subdivision, Group, on an ongoing basis, on relevant ethical and the working groups shall not be subject to the regulatory issues. provisions of Article 9 (commencing with Section 125290.60. Scientific and Medical Research 11120) of Chapter 1 of Part 1 of Division 3 of Title 2 Funding Working Group of the Government Code, or Article 1 (commencing with Section 6250) of Chapter 3.5 of Division 7 of (a) Membership Title 1 of the Government Code. The Scientific and Medical Research Funding 125290.55. Scientific and Medical Working Group shall have 23 members as follows: Accountability Standards Working Group (1) Seven ICOC members from the 10 disease (a) Membership advocacy group members described in paragraphs (3), (4), and (5) of subdivision (a) of Section The Scientific and Medical Accountability 125290.20. Standards Working Group shall have 19 members as follows: (2) Fifteen scientists nationally recognized in the field of stem cell research. (1) Five ICOC members from the 10 groups that focus on disease-specific areas described in (3) The Chairperson of the ICOC. paragraphs (3), (4), and (5) of subdivision (a) of (b) Functions Section 125290.20.

OCR for page 159
APPENDIX C 169 The Scientific and Medical Research Funding objectives, and the innovativeness of the proposed Working Group shall perform the following research. functions: (C) In order to ensure that institute funding does (1) Recommend to the ICOC interim and final not duplicate or supplant existing funding, a high criteria, standards, and requirements for considering priority shall be placed on funding pluripotent stem funding applications and for awarding research cell and progenitor cell research that cannot, or is grants and loans. unlikely to, receive timely or sufficient federal funding, unencumbered by limitations that would (2) Recommend to the ICOC standards for the impede the research. In this regard, other research scientific and medical oversight of awards. categories funded by the National Institutes of Health (3) Recommend to the ICOC any modifications shall not be funded by the institute. of the criteria, standards, and requirements (D) Notwithstanding subparagraph (C), other described in paragraphs (1) and (2) above as needed. scientific and medical research and technologies (4) Review grant and loan applications based on and/or any stem cell research proposal not actually the criteria, requirements, and standards adopted by funded by the institute under subparagraph (C) may the ICOC and make recommendations to the ICOC be funded by the institute if at least two-thirds of a for the award of research, therapy development, and quorum of the members of the Scientific and Medical clinical trial grants and loans. Research Funding Working Group recommend to the ICOC that such a research proposal is a vital (5) Conduct peer group progress oversight research opportunity. reviews of grantees to ensure compliance with the terms of the award, and report to the ICOC any 125290.65. Scientific and Medical Facilities recommendations for subsequent action. Working Group (6) Recommend to the ICOC standards for the (a) Membership evaluation of grantees to ensure that they comply The Scientific and Medical Research Facilities with all applicable requirements. Such standards Working Group shall have 11 members as follows: shall mandate periodic reporting by grantees and shall authorize the Scientific and Medical Research (1) Six members of the Scientific and Medical Funding Working Group to audit a grantee and Research Funding Working Group. forward any recommendations for action to the (2) Four real estate specialists. To be eligible to ICOC. serve on the Scientific and Medical Research (7) Recommend its first grant awards within 60 Facilities Working Group, a real estate specialist days of the issuance of the interim standards. shall be a resident of California, shall be prohibited from receiving compensation from any construction (c) Recommendations for Awards or development entity providing specialized services Award recommendations shall be based upon a for medical research facilities, and shall not provide competitive evaluation as follows: real estate facilities brokerage services for any applicant for, or any funding by the Scientific and (1) Only the 15 scientist members of the Medical Research Facilities Working Group and Scientific and Medical Research Funding Working shall not receive compensation from any recipient of Group shall score grant and loan award applications institute funding grants. for scientific merit. Such scoring shall be based on scientific merit in three separate classifications— (3) The Chairperson of the ICOC. research, therapy development, and clinical trials, on (b) Functions criteria including the following: The Scientific and Medical Research Facilities (A) A demonstrated record of achievement in the Working Group shall perform the following areas of pluripotent stem cell and progenitor cell functions: biology and medicine, unless the research is determined to be a vital research opportunity. (1) Make recommendations to the ICOC on interim and final criteria requirements, and (B) The quality of the research proposal, the standards for applications for, and the awarding of, potential for achieving significant research, or grants and loans for buildings, building leases, and clinical results, the timetable for realizing such capital equipment; those standards and requirements significant results, the importance of the research shall include, among others:

OCR for page 159
170 THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE (A) Facility milestones and timetables for (a) Moneys in the California Stem Cell Research achieving such milestones. and Cures Fund shall be allocated as follows: (B) Priority for applications that provide for (1) (A) No less than 97 percent of the proceeds of facilities that will be available for research no more the bonds authorized pursuant to Section 125291.30, than two years after the grant award. after allocation of bond proceeds to purposes described in paragraphs (4) and (5) of subdivision (C) The requirement that all funded facilities and (a) of Section 125291.20, shall be used for grants and equipment be located solely within California. grant oversight as provided in this chapter. (D) The requirement that grantees comply with (B) Not less than 90 percent of the amount used reimbursable building cost standards, competitive for grants shall be used for research grants, with no building leasing standards, capital equipment cost more than the following amounts as stipulated below standards, and reimbursement standards and terms to be committed during the first 10 years of grant recommended by the Scientific and Medical Facilities making by the institute, with each year’s Funding Working Group, and adopted by the ICOC. commitments to be advanced over a period of one to (E) The requirement that grantees shall pay all seven years, except that any such funds that are not workers employed on construction or modification of committed may be carried over to one or more the facility funded by facilities grants or loans of the following years. The maximum amount of research institute, the general prevailing rate of per diem funding to be allocated annually as follows: Year 1, wages for work of a similar character in the locality 5.6 percent; Year 2, 9.4 percent; Year 3, 9.4 percent; in which work on the facility is performed, and not Year 4, 11.3 percent; Year 5, 11.3 percent; Year 6, less than the general prevailing rate of per diem 11.3 percent; Year 7, 11.3 percent; Year 8, 11.3 wages for holiday and overtime work fixed as percent; Year 9, 11.3 percent; and Year 10, 7.5 provided in Chapter 1 (commencing with Section percent. 1720) of Part 7 of Division 2 of the Labor Code. (C) Not more than 3 percent of the proceeds of (F) The requirement that grantees be not-for- bonds authorized by Section 125291.30 may be used profit entities. by the institute for research and research facilities implementation costs, including the development, (G) The requirement that awards be made on a administration, and oversight of the grant making competitive basis, with the following minimum process and the operations of the working groups. requirements: (2) Not more than 3 percent of the proceeds of (i) That the grantee secure matching funds from the bonds authorized pursuant to Section 125291.30 sources other than the institute equal to at least 20 shall be used for the costs of general administration percent of the award. Applications of equivalent of the institute. merit, as determined by the Scientific and Medical Research Funding Working Group, considering (3) In any single year any new research funding research opportunities to be conducted in the to any single grantee for any program year is limited proposed research facility, shall receive priority to to no more than 2 percent of the total bond the extent that they provide higher matching fund authorization under this chapter. This limitation shall amounts. The Scientific and Medical Research be considered separately for each new proposal Facilities Working Group may recommend waiving without aggregating any prior year approvals that the matching fund requirement in extraordinary may fund research activities. This requirement shall cases of high merit or urgency. be determinative, unless 65 percent of a quorum of the ICOC approves a higher limit for that grantee. (ii) That capital equipment costs and capital equipment loans be allocated when equipment costs (4) Recognizing the priority of immediately can be recovered in part by the grantee from other building facilities that ensure the independence of the users of the equipment. scientific and medical research of the institute, up to 10 percent of the proceeds of the bonds authorized (2) Make recommendations to the ICOC on pursuant to Section 125291.30, net of costs described oversight procedures to ensure grantees’ compliance in paragraphs (2), (4), and (5) of subdivision (a) of with the terms of an award. Section 125291.20 shall be allocated for grants to 125290.70. Appropriation and Allocation of build scientific and medical research facilities of Funding nonprofit entities which are intended to be constructed in the first five years.

OCR for page 159
APPENDIX C 171 (5) The institute shall limit indirect costs to 25 125291.20. (a) Notwithstanding Section 13340 of percent of a research award, excluding amounts the Government Code or any other provision of law, included in a facilities award, except that the indirect moneys in the fund are appropriated without regard cost limitation may be increased by that amount by to fiscal years to the institute for the purpose of (1) which the grantee provides matching funds in excess making grants or loans to fund research and of 20 percent of the grant amount. construct facilities for research, all as described in and pursuant to the act, (2) paying general (b) To enable the institute to commence administrative costs of the institute (not to exceed 3 operating during the first six months following the percent of the net proceeds of each sale of bonds), (3) adoption of the measure adding this chapter, there is paying the annual administration costs of the interim hereby appropriated from the General Fund as a debt or bonds after December 31 of the fifth full temporary start-up loan to the institute three million calendar year after this article takes effect, (4) dollars ($3,000,000) for initial administrative and paying the costs of issuing interim debt, paying the implementation costs. All loans to the institute annual administration costs of the interim debt until pursuant to this appropriation shall be repaid to the and including December 31 of the fifth full calendar General Fund within 12 months of each loan draw year after this article takes effect, and paying interest from the proceeds of bonds sold pursuant to Section on interim debt, if such interim debt is incurred or 125291.30. issued on or prior to December 31 of the fifth full (c) The institute’s funding schedule is designed calendar year after this article takes effect, and (5) to create a positive tax revenue stream for the State paying the costs of issuing bonds, paying the annual of California during the institute’s first five calendar administration costs of the bonds until and including years of operations, without drawing funds from the December 31 of the fifth full calendar year after this General Fund for principal and interest payments for article takes effect, and paying interest on bonds that those first five calendar years. accrues on or prior to December 31 of the fifth full calendar year after this article takes effect (except Article 2. California Stem Cell Research and Cures that such limitation does not apply to premium and Bond Act of 2004 accrued interest as provided in Section 125291.70). 125291.10. This article shall be known, and may In addition, moneys in the fund or other proceeds of be cited, as the California Stem Cell Research and the sale of bonds authorized by this article may be Cures Bond Act of 2004. used to pay principal of or redemption premium on any interim debt issued prior to the issuance of bonds 125291.15. As used in this article, the following authorized by this article. Moneys deposited in the terms have the following meaning: fund from the proceeds of interim debt may be used (a) “Act” means the California Stem Cell to pay general administrative costs of the institute Research and Cures Bond Act constituting Chapter 3 without regard to the 3 percent limit set forth in (2) (commencing with Section 125290.10) of Part 5 of above, so long as such 3 percent limit is satisfied for Division 106. each issue of bonds. (b) “Board” or “institute” means the California (b) Repayment of principal and interest on any Institute for Regenerative Medicine designated in loans made by the institute pursuant to this article accordance with subdivision (b) of Section shall be deposited in the fund and used to make 125291.40. additional grants and loans for the purposes of this act or for paying continuing costs of the annual (c) “Committee” means the California Stem Cell administration of outstanding bonds. Research and Cures Finance Committee created pursuant to subdivision (a) of Section 125291.40. 125291.25. The proceeds of interim debt and bonds issued and sold pursuant to this article shall be (d) “Fund” means the California Stem Cell deposited in the State Treasury to the credit of the Research and Cures Fund created pursuant to California Stem Cell Research and Cures Fund, Section 125291.25. which is hereby created in the State Treasury, except (e) “Interim debt” means any interim loans to the extent that proceeds of the issuance of bonds pursuant to subdivision (b) of Section 125290.70, and are used directly to repay interim debt. Sections 125291.60 and 125291.65, bond 125291.30. Bonds in the total amount of three anticipation notes or commercial paper notes issued billion dollars ($3,000,000,000), not including the to make deposits into the fund and which will be paid amount of any refunding bonds issued in accordance from the proceeds of bonds issued pursuant to this with Section 125291.75, or as much thereof as is article.

OCR for page 159
172 THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE necessary, may be issued and sold to provide a fund federal income tax purposes if the committee to be used for carrying out the purposes expressed in determines that such treatment is necessary in order this article and to be used and sold for carrying out to provide funds for the purposes of the act. the purposes of Section 125291.20 and to reimburse (b) The total amount of the bonds authorized by the General Obligation Bond Expense Revolving Section 125291.30 which may be issued in any Fund pursuant to Section 16724.5 of the Government calendar year, commencing in 2005, shall not exceed Code. The bonds, when sold, shall be and shall three hundred fifty million dollars ($350,000,000). If constitute a valid and binding obligation of the State less than this amount of bonds is issued in any year, of California, and the full faith and credit of the State the remaining permitted amount may be carried over of California is hereby pledged for the punctual to one or more subsequent years. payment of both the principal of, and interest on, the bonds as the principal and interest become due and (c) An interest-only floating rate bond structure payable. will be implemented for interim debt and bonds until at least December 31 of the fifth full calendar year 125291.35. The bonds authorized by this article after this article takes effect, with all interest to be shall be prepared, executed, issued, sold, paid, and paid from proceeds from the sale of interim debt or redeemed as provided in the State General bonds, to minimize debt service payable from the Obligation Bond Law (Chapter 4 (commencing with General Fund during the initial period of basic Section 16720) of Part 3 of Division 4 of Title 2 of research and therapy development, if the committee the Government Code), and all of the provisions of determines, with the advice of the Treasurer, that this that law except Section 16727 apply to the bonds and structure will result in the lowest achievable to this article and are hereby incorporated in this borrowing costs for the state during that five-year article as though set forth in full in this article. period considering the objective of avoiding any 125291.40. (a) Solely for the purpose of bond debt service payments, by the General Fund, authorizing the issuance and sale, pursuant to the during that period. Upon such initial determination, State General Obligation Bond Law, of the bonds and the committee may delegate, by resolution, to the interim debt authorized by this article, the California Treasurer such authority in connection with issuance Stem Cell Research and Cures Finance Committee is of bonds as it may determine, including, but not hereby created. For purposes of this article, the limited to, the authority to implement and continue California Stem Cell Research and Cures Finance this bond financing structure (including during any Committee is “the committee” as that term is used in time following the initial five-year period) and to the State General Obligation Bond Law. The determine that an alternate financing plan would committee consists of the Treasurer, the Controller, result in significant lower borrowing costs for the the Director of Finance, the Chairperson of the state consistent with the objectives related to the California Institute for Regenerative Medicine, and General Fund and to implement such alternate two other members of the Independent Citizens financing plan. Oversight Committee (as created by the act) chosen 125291.50. There shall be collected each year by the Chairperson of the California Institute for and in the same manner and at the same time as Regenerative Medicine, or their designated other state revenue is collected, in addition to the representatives. The Treasurer shall serve as ordinary revenues of the state, a sum in an amount chairperson of the committee. A majority of the required to pay the principal of, and interest on, the committee may act for the committee. bonds maturing each year. It is the duty of all officers (b) For purposes of the State General Obligation charged by law with any duty in regard to the Bond Law, the California Institute for Regenerative collection of the revenue to do and perform each and Medicine is designated the “board.” every act that is necessary to collect that additional sum. 125291.45. (a) The committee shall determine whether or not it is necessary or desirable to issue 125291.55. Notwithstanding Section 13340 of bonds authorized pursuant to this article in order to the Government Code, there is hereby appropriated carry out the actions specified in this article and, if from the General Fund in the State Treasury, for the so, the amount of bonds to be issued and sold. purposes of this article, an amount that will equal the Successive issues of bonds may be authorized and total of the following: sold to carry out those actions progressively, and it is (a) The sum annually necessary to pay the not necessary that all of the bonds authorized to be principal of, and interest on, bonds issued and sold issued be sold at any one time. The bonds may bear interest which is includable in gross income for

OCR for page 159
APPENDIX C 173 pursuant to this article, as the principal and interest separate accounts for the investment of bond become due and payable. proceeds and the investment earnings on those proceeds. The Treasurer may use or direct the use of (b) The sum necessary to carry out Section those proceeds or earnings to pay any rebate, 125291.60 appropriated without regard to fiscal penalty, or other payment required under federal law years. or to take any other action with respect to the 125291.60. The Director of Finance may investment and use of bond proceeds required or authorize the withdrawal from the General Fund of desirable under federal law to maintain the tax- an amount or amounts, not to exceed the amount of exempt status of those bonds and to obtain any other the unsold bonds that have been authorized by the advantage under federal law on behalf of the funds of committee, to be sold for the purpose of carrying out this state. this article. Any amount withdrawn shall be 125291.85. Inasmuch as the proceeds from the deposited in the fund. Any money made available sale of bonds authorized by this article are not under this section shall be returned to the General “proceeds of taxes” as that term is used in Article Fund, plus an amount equal to the interest that the XIII B of the California Constitution, the money would have earned in the Pooled Money disbursement of these proceeds is not subject to the Investment Account, from money received from the limitations imposed by that article. sale of bonds for the purpose of carrying out this article. Article 3. Definitions 125291.65. The institute may request the Pooled 125292.10. As used in this chapter and in Article Money Investment Board to make a loan from the XXXV of the California Constitution, the following Pooled Money Investment Account in accordance terms have the following meanings: with Section 16312 of the Government Code for the (a) “Act” means the California Stem Cell purposes of carrying out this article. The amount of Research and Cures Bond Act constituting Chapter 3 the request shall not exceed the amount of the unsold (commencing with Section 125290.10) of Part 5 of bonds that the committee, by resolution, has Division 106 of the Health and Safety Code. authorized to be sold for the purpose of carrying out this article. The institute shall execute any documents (b) “Adult stem cell” means an undifferentiated required by the Pooled Money Investment Board to cell found in a differentiated tissue in an adult obtain and repay the loan. Any amounts loaned shall organism that can renew itself and may, with certain be deposited in the fund to be allocated by the limitations, differentiate to yield all the specialized institute in accordance with this article. cell types of the tissue from which it originated. 125291.70. All money deposited in the fund that (c) “Capitalized interest” means interest funded is derived from premium and accrued interest on by bond proceeds. bonds sold shall be reserved in the fund and shall be available for transfer to the General Fund as a credit (d) “Committee” means the California Stem Cell to expenditures for bond interest. Research and Cures Finance Committee created pursuant to subdivision (a) of Section 125291.40. 125291.75. The bonds may be refunded in accordance with Article 6 (commencing with Section (e) “Constitutional officers” means the 16780) of Chapter 4 of Part 3 of Division 4 of Title 2 Governor, Lieutenant Governor, Treasurer, and of the Government Code, which is a part of the State Controller of California. General Obligation Bond Law. Approval by the (f) “Facilities” means buildings, building leases, voters of the state for the issuance of the bonds or capital equipment. described in this article includes the approval of the issuance of any bonds issued to refund any bonds (g) “Floating-rate bonds” means bonds which originally issued under this article or any previously do not bear a fixed rate of interest until their final issued refunding bonds. maturity date, including commercial paper notes. 125291.80. Notwithstanding any provision of (h) “Fund” means the California Stem Cell this article or the State General Obligation Bond Research and Disease Cures Fund created pursuant Law, if the Treasurer sells bonds pursuant to this to Section 125291.25. article that include a bond counsel opinion to the (i) “Grant” means a grant, loan, or guarantee. effect that the interest on the bonds is excluded from gross income for federal tax purposes, subject to (j) “Grantee” means a recipient of a grant from designated conditions, the Treasurer may maintain the institute. All University of California grantee

OCR for page 159
174 THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE institutions shall be considered as separate and retain the ability to divide and give rise to individual grantee institutions. differentiated cells. (k) “Human reproductive cloning” means the (s) “Quorum” means at least 65 percent of the practice of creating or attempting to create a human members who are eligible to vote. being by transferring the nucleus from a human cell (t) “Research donor” means a human who into an egg cell from which the nucleus has been donates biological materials for research purposes removed for the purpose of implanting the resulting after full disclosure and consent. product in a uterus to initiate a pregnancy. (u) “Research funding” includes (l) “Indirect costs” mean the recipient’s costs in interdisciplinary scientific and medical funding for the administration, accounting, general overhead, basic research, therapy development, and the and general support costs for implementing a grant development of pharmacologies and treatments or loan of the institute. NIH definitions of indirect through clinical trials. When a facility’s grant or costs will be utilized as one of the bases by the loan has not been provided to house all elements of Scientific and Medical Research Standards Working the research, therapy development, and/or clinical Group to create a guideline for recipients on this trials, research funding shall include an allowance definition, with modifications to reflect guidance by for a market lease rate of reimbursement for the the ICOC and this act. facility. In all cases, operating costs of the facility, (m) “Institute” means the California Institute for including, but not limited to, library and Regenerative Medicine. communication services,utilities, maintenance, janitorial, and security, shall be included as direct (n) “Interim standards” means temporary research funding costs. Legal costs of the institute standards that perform the same function as incurred in order to negotiate standards with federal “emergency regulations” under the Administrative and state governments and research institutions; to Procedure Act (Government Code, Title 2, Division implement standards or regulations; to resolve 3, Part 1, Chapter 4.5, Sections 11371 et seq.) except disputes; and/or to carry out all other actions that in order to provide greater opportunity for necessary to defend and/or advance the institute’s public comment on the permanent regulations, mission shall be considered direct research funding remain in force for 270 days rather than 180 days. costs. (o) “Life science commercial entity” means a (v) “Research participant” means a human firm or organization, headquartered in California, enrolled with full disclosure and consent, and whose business model includes biomedical or participating in clinical trials. biotechnology product development and commercialization. (w) “Revenue positive” means all state tax revenues generated directly and indirectly by the (p) “Medical ethicist” means an individual with research and facilities of the institute are greater advanced training in ethics who holds a Ph.D., MA, than the debt service on the state bonds actually paid or equivalent training and who spends or has spent by the General Fund in the same year. substantial time (1) researching and writing on ethical issues related to medicine, and (2) (x) “Stem cells” mean nonspecialized cells that administering ethical safeguards during the clinical have the capacity to divide in culture and to trial process, particularly through service on differentiate into more mature cells with specialized institutional review boards. functions. (q) “Pluripotent cells” means cells that are (y) “Vital research opportunity” means scientific capable of self-renewal, and have broad potential to and medical research and technologies and/or any differentiate into multiple adult cell types. Pluripotent stem cell research not actually funded by the institute stem cells may be derived from somatic cell nuclear under subparagraph (C) of paragraph (1) of transfer or from surplus products of in vitro subdivision (c) of Section 125290.60 which provides fertilization treatments when such products are a substantially superior research opportunity vital to donated under appropriate informed consent advance medical science as determined by at least a procedures. These excess cells from in vitro two-thirds vote of a quorum of the members of the fertilization treatments would otherwise be intended Scientific and Medical Research Funding Working to be discarded if not utilized for medical research. Group and recommended as such by that working group to the ICOC. Human reproductive cloning (r) “Progenitor cells” means multipotent or shall not be a vital research opportunity. precursor cells that are partially differentiated but

OCR for page 159
APPENDIX C 175 SEC. 6. Section 20069 of the Government Code is amended to read: (a) “State service” means service rendered as an employee or officer (employed, appointed or elected) of the state, the California Institute for Regenerative Medicine and the officers and employees of its governing body, the university, a school employer, or a contracting agency, for compensation, and only while he or she is receiving compensation from that employer therefor, except as provided in Article 4 (commencing with Section 20990) of Chapter 11. (b) “State service,” solely for purposes of qualification for benefits and retirement allowances under this system, shall also include service rendered as an officer or employee of a county if the salary for the service constitutes compensation earnable by a member of this system under Section 20638. SEC. 7. Severability If any provision of this act, or part thereof, is for any reason held to be invalid or unconstitutional, the remaining provisions shall not be affected, but shall remain in full force and effect, and to this end the provisions of this act are severable. SEC. 8. Amendments The statutory provisions of this measure, except the bond provisions, may be amended to enhance the ability of the institute to further the purposes of the grant and loan programs created by the measure, by a bill introduced and passed no earlier than the third full calendar year following adoption, by 70 percent of the membership of both houses of the Legislature and signed by the Governor, provided that at least 14 days prior to passage in each house, copies of the bill in final form shall be made available by the clerk of each house to the public and news media.

OCR for page 159