General—Independent Citizen’s Oversight Committee (ICOC)

This chapter implements Article XXXV of the California Constitution, which established the California Institute for Regenerative Medicine (institute).

Creation of the ICOC

There is hereby created the Independent Citizen’s Oversight Committee, hereinafter, the ICOC, which shall govern the institute and is hereby vested with full power, authority, and jurisdiction over the institute.

ICOC Membership; Appointments; Terms of Office

The ICOC shall have 35 members, appointed as follows:

and the Controller shall each appoint an executive officer from the following three categories:

(ii) A recent proven history of administering scientific and/or medical research grants and contracts in an average annual range exceeding one hundred million dollars ($100,000,000).

(iii) A ranking, within the past five years, in the top 10 United States

universities with the highest number of life science patents or that has research or clinical faculty who are members of the National Academy of Sciences.

(iv) For purposes of this category, the Governor may appoint an executive officer from the California State University system who has an advanced degree in biological sciences.

(B) A California nonprofit academic and research institution that is not a part of the University of California, that has demonstrated success and leadership in stem cell research, other vital research opportunities, therapy development, or therapy delivery and that has:

(ii) A proven history

in the last five years of managing a research budget in the life sciences exceeding twenty million dollars ($20,000,000) annually.

(C) A California life science commercial entity that is not actively engaged in researching or developing therapies or therapy delivery with pluripotent or progenitor stem cells or genetic medical treatments that has a background in implementing or developing experimental medical therapies, including conducting human clinical trials, and that has not been awarded, or applied for, funding by the institute at the time of appointment. A board member of that entity who generally meets the same qualifications may be appointed in lieu of an executive officer.

(D) Only one member shall be appointed from a single university, institution, or entity for the purposes of paragraph (2). The executive officer of a California university, a nonprofit research

institution or life science commercial entity who is appointed as a member, may from time to time delegate those duties to an executive officer of the entity or to the dean of the medical school, if applicable.

with experience in clinical trial management or stem cell or genetic therapy delivery.

(ii) Experience with state and federal legislative processes that must

include some experience with medical legislative approvals of standards and/or funding.

(iii) Qualified for appointment pursuant to paragraph (3), (4), or (5) of subdivision (a).

(iv) Cannot be concurrently employed by or on leave from any prospective grant or loan recipient institutions in California.

(B) Additional Criteria for Consideration:

(ii) Experience with the process of establishing government standards and procedures.

(iii) Legal experience with the legal review of proper governmental authority for the exercise of

government agency or government institutional powers.

(iv) Direct knowledge and experience in bond financing.

The vice chairperson shall satisfy clauses (i), (iii), and (iv) of subparagraph (A). The vice chairperson shall be selected from among individuals who have attributes and experience complementary to those of the chairperson, preferably covering the criteria not represented by the chairperson’s credentials and experience.

made.

replacement member within 90 days to serve the remainder of the term.

and the vice chairperson, the nominating authority or nominating authorities, if more than one constitutional officer nominated the chairperson or vice chairperson. The appointing authority or nominating authority or authorities in the case of the chairperson and vice chairperson, shall have the authority to remove the member, chairperson, or vice chairperson, respectively, upon receipt of the ICOC’s recommendation. If more than one constitutional officer nominated the chairperson or vice chairperson, each of them must agree in order to remove the chairperson or vice chairperson.

Majority Vote of Quorum

Actions of the ICOC may be taken only by a majority vote of a quorum of the ICOC.

Medical and Scientific Accountability Standards

In order to avoid duplication or conflicts in technical standards for scientific and medical research, with alternative state programs, the institute will develop its own scientific and medical standards to carry out the specific controls and intent of the act, notwithstanding Sections 125300, 125320, 125118, 125119, 125119.3, and 125119.5, or any other current or future state laws or regulations dealing with the study and research of pluripotent stem cells and/or progenitor cells, or other vital research opportunities, except Section 125315. The ICOC, its working committees, and its grantees shall be governed solely by the

provisions of this act in the establishment of standards, the award of grants, and the conduct of grants awarded pursuant to this act.

Standards for obtaining the informed consent of research donors, patients, or participants, which initially shall be generally based on the standards in place on January 1, 2003, for all research funded by the National Institutes of Health, with modifications to adapt to the mission and objectives of the institute.

Standards for the review of research involving human subjects which initially shall be generally based on the Institutional Review Board standards promulgated by the National

Institutes of Health and in effect on January 1, 2003, with modifications to adapt to the mission and objectives of the institute.

Standards prohibiting compensation to research donors or participants, while permitting reimbursement of expenses.

Standards permitting reimbursement for expenses, including, but not limited to, medical expenses and lodging, meals, and travel expenses, for research participants and caregivers in order to ensure functional access to clinical trials. For purposes of this paragraph, “caregivers” includes family members, friends, and professional caregivers providing supportive care.

Standards to assure compliance with state and federal patient privacy laws.

Standards limiting payments for the purchase of stem cells or stem cell lines to reasonable payment for the removal, processing, disposal, preservation, quality control, storage, transplantation, or implantation or legal costs or other administrative costs associated with these medical procedures and specifically including any required payments for medical or scientific technologies, products, or processes for royalties, patent, or licensing fees or other costs for intellectual property.

Standards setting a limit on the time during which cells may be extracted from blastocysts, which shall initially be up to

12 days after cell division begins, not counting any time during which the blastocysts and/or cells have been stored frozen.

Standards for research involving genetic medical treatments that shall, in the ICOC’s discretion, generally be based on the standards adopted by the National Academy of Sciences.

ICOC Functions

The ICOC shall perform the following functions:

California patients, through engagement with health care providers, research and therapy development institutions, businesses, governmental agencies, philanthropists, foundations, and patient advocacy groups, and based on recommendations made by the Treatments and Cures Accessibility and Affordability Working Group.

subdivision (m), these rules and regulations shall be adopted in accordance with the Administrative Procedure Act (Government Code, Title 2, Division 3, Part 1, Chapter 3.5, Sections 11340 et seq.).

Working Group, for the consideration of funding awards based on best practices established by the National Academy of Sciences to prevent conflicts of interest in the award of research funding and update those standards no less than every four years to be, at the ICOC’s discretion, generally aligned with standards adopted by the National Academy of Sciences, subject to the constitutional and statutory requirements applicable to the institute.

ICOC Operations

Section 11042 of the Government Code, the institute is authorized to retain outside counsel when the ICOC determines that the institute requires specialized services not provided by the Attorney General’s office.

available and affordable for Californians. The cap on employees shall not apply to employees funded through sources other than bond proceeds or the General Fund. The ICOC shall select a chairperson, vice chairperson, and president who shall exercise all of the powers delegated to them by the ICOC. The following functions apply to the chairperson, vice chairperson, and president:

the institute, including, without limitation, generating matching or supplemental funds through collaborations with other states, nations, territories, or institutions; and to lead negotiations for intellectual property agreements, policies, and contract terms. The chairperson shall also serve as a member of the Treatments and Cures Accessibility and Affordability Working Group, the Scientific and Medical Accountability Standards Working Group, and the Scientific and Medical Research Facilities Working Group and as an ex officio member of the Scientific and Medical Research Funding Working Group. The vice chairperson’s primary responsibilities are to support the chairperson in all duties and to carry out those duties in the chairperson’s absence.

its working groups; to serve the institute on its working groups; to direct ICOC staff and participate in the process of supporting all working group requirements to develop recommendations on grants, loans, facilities, and standards as well as to direct and support the ICOC process of evaluating and acting on those recommendations, the implementation of all decisions on these and general matters of the ICOC; to hire, direct, and manage the staff of the institute; to develop the budgets and cost control programs of the institute; to manage compliance with all rules and regulations of the ICOC, including the performance of all grant recipients; and to manage and execute all intellectual property agreements and any other contracts pertaining to the institute or research it funds.

Section 125290.20, who shall be compensated pursuant to paragraph (3), shall receive a per diem of one hundred dollars ($100) per day (adjusted annually for cost of living) for each day actually spent in the discharge of the member’s duties, plus reasonable and necessary travel and other expenses incurred in the performance of the member’s duties.

Scientific and Medical Accountability Standards Working Group

The Scientific and Medical Accountability Standards Working Group shall have 19 members as follows:

The Scientific and Medical Accountability Standards Working Group shall have the following functions:

125290.35, and to ensure compliance with patient privacy laws.

Scientific and Medical Research Funding Working Group

The Scientific and Medical Research Funding Working Group shall have at least 23 members as follows:

The Scientific and Medical Research Funding Working Group shall perform the following functions:

criteria, requirements, and standards adopted by the ICOC and make recommendations to the ICOC for the award of research, therapy development, clinical trial, and therapy delivery grants and loans.

Award recommendations shall be based upon a competitive evaluation as follows:

An expert peer review panel shall consist of both scientists and patient advocates. There shall be 15 scientists on each expert peer review panel. Only the scientist members of the Scientific and Medical Research Funding Working Group shall score grant and loan award applications for scientific merit. Such scoring shall be based on scientific merit in three separate classifications—research, therapy development, and clinical trials, on criteria including the following:

research proposal not actually funded by the institute under paragraph (3) may be funded by the institute if at least two-thirds of a quorum of the members of the Scientific and Medical Research Funding Working Group recommend to the ICOC, or if a majority of a quorum of the members of the ICOC determine, that such a research proposal is a vital research opportunity.

Scientific and Medical Facilities Working Group

The Scientific and Medical Research Facilities Working Group shall have 11 members as follows:

The Scientific and Medical Research Facilities Working Group shall perform the following functions:

(ii) That capital equipment costs and capital equipment loans be allocated when equipment costs can be recovered in part by the grantee from other users of the equipment.

Appropriation and Allocation of Funding

Under the guidance of the ICOC, the institute shall, by January 31, 2012, create a transition plan addressing the expiration of current bond funding. A copy of the transition plan shall be transmitted to the Governor, the Controller, and the Legislature within 30 days of its completion.

Expand Alpha Stem Cell Clinic Program and Establish Community Care Centers of Excellence Program

resulting treatments and cures broadly available to California patients.

research more widely available to California patients, including addressing how the applicant will support the ancillary hospital and access costs of patients participating in clinical trials to enhance access to trials for California patients, regardless of their economic means and geographical location.

Scientific and Medical Training and Fellowship Programs

research opportunities and in the development and delivery of treatments and cures.

other vital research opportunities and in the development and delivery of treatments and cures. Direct patient engagement and outreach activities that engage California’s diverse communities to ensure that all communities are aware of, and have access to, institute-funded treatments and cures shall be a priority outcome of this program. The institute shall prioritize the funding of applications from institutions that enhance the geographic distribution of training across the state and socio-economic diversity and applications that offer matching funds or verified in-kind support.

(B) The institute may establish coinvestment, sponsored apprenticeships as part of the training program in order to leverage the institute’s funding and create employment opportunities for students in technical positions that advance the fields of stem cell and other vital research opportunities and the development and delivery of treatments and cures.

with Section 125290.10) of Chapter 3 of Part 5 of Division 106.

Shared Research Laboratory Program

Treatments and Cures Accessibility and Affordability Working Group

The Treatments and Cures Accessibility and Affordability Working Group shall have 17 members, nominated by the chairperson or vice chairperson and approved by the board, as follows:

for reimbursement, including, if possible, experience with coverage negotiations with private insurers, health management organizations, or corporate self-insurance health plans.

or genetic therapies.

The Treatments and Cures Accessibility and Affordability Working Group shall have the following functions:

Californians and to enhance access to clinical trials, including reimbursement alternatives for patient-qualified costs to help achieve the objective that reimbursement covers patient expenses, including, but not limited to, medical expenses, lodging, meals, and travel for research participants and their caregivers.

Advisory Task Forces

The chairperson and the president may appoint one or more advisory task forces to provide expert guidance to address specific objectives in areas under the institute’s jurisdiction, including scientific, policy, ethical, financial, and technical matters. The chairperson and president shall each appoint an equal number of members with expertise in the area or areas for which advice is sought, including at least one member who has a patient advocate perspective.

The advisory task forces shall advise the board through the chairperson and the president, regarding

scientific, policy, financial, ethical, and technical matters under the institute’s jurisdiction.

The intellectual property standards that the ICOC develops shall include:

extension from CIRM, or notify CIRM of its intention to seek a waiver, within 10 business days following final approval of the drug by the federal Food and Drug Administration. If the grantee seeks an extension, the plan must be submitted within 30 business days following final approval of the drug by the federal Food and Drug Administration. The plan shall be subject to the approval of CIRM, after a public hearing and opportunity for public comment.

for a minimum of 10 business days in advance of the public hearing and that CIRM shall notify the Legislature if the ICOC grants a waiver request, including the reasons that justified the waiver request.