ICOC Functions
The ICOC shall perform the following functions:
(a)Oversee the operations of the institute.
(b)Develop annual and long-term strategic research and financial plans for the institute.
(c)Make final decisions on research standards and grant awards in California across the research and therapy development and delivery spectrum, from stem cell discovery research and early development to clinical trials and therapy delivery.
(d)Ensure the completion of an annual financial audit of the institute’s operations.
(e)Issue public reports on the activities of the institute.
(f)Develop and implement programs to enhance patient access to affordable stem cell and related treatments and cures through public hospitals and clinics and establish policies regarding intellectual property ri
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ICOC Functions
The ICOC shall perform the following functions:
(a)
Oversee the operations of the institute.
(b)
Develop annual and long-term strategic research and financial plans for the institute.
(c)
Make final decisions on research standards and grant awards in California across the research and therapy development and delivery spectrum, from stem cell discovery research and early development to clinical trials and therapy delivery.
(d)
Ensure the completion of an annual financial audit of the institute’s operations.
(e)
Issue public reports on the activities of the institute.
(f)
Develop and implement programs to enhance patient access to affordable stem cell and related treatments and cures through public hospitals and clinics and establish policies regarding intellectual property rights arising from research funded by the institute.
(g)
Establish and oversee the institute’s research, therapy development, and therapy delivery programs, including, but not limited to, the Alpha Stem Cell Clinics and Community Care Centers of Excellence, training and fellowship, and shared research laboratory programs.
(h)
Establish and oversee the development of policies and programs to help make treatments and cures arising from institute-funded research available and affordable for
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.
(i)
Establish rules and guidelines for the operation of the ICOC and its working groups.
(j)
Perform all other acts necessary or appropriate in the exercise of its power, authority, and jurisdiction over the institute.
(k)
Select members of the working groups.
(l)
Adopt, amend, and rescind rules and regulations to carry out the purposes and provisions of this chapter, and to govern the procedures of the ICOC. Except as provided in
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.).
(m)
Notwithstanding the Administrative Procedure Act (APA), and in order to facilitate the immediate commencement of research covered by this chapter, the ICOC may adopt interim regulations without compliance with the procedures set forth in the APA. The interim regulations shall remain in effect for 270 days unless earlier superseded by regulations adopted pursuant to the APA. For purposes of subdivision (l), requests for applications, program announcements, and notices of award shall not be considered regulations.
(n)
Request the issuance of bonds from the California Stem Cell Research and Cures Finance Committee and loans from the Pooled Money Investment Board.
(o)
May annually modify its funding and finance programs to optimize the institute’s ability to achieve the objective that its activities be revenue-positive for the State of California during its first five years of operation without jeopardizing the progress of its core medical and scientific research program.
(p)
Notwithstanding Section 11005 of the Government Code, accept additional revenue and real and personal property, including, but not limited to, gifts, royalties, interest, and appropriations that may be used to supplement annual research grant funding and the operations of the institute.
(q)
Subject to the restrictions set forth in this article, develop conflict of interest standards, and at its discretion, consult with the National Academy of Sciences and the Scientific and Medical Accountability Standards
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.