California Cancer Clinical Trials Program - Administration Of Public Health - CA Health And Safety

Section § 101990

This law section defines terms used in relation to the California Cancer Clinical Trials Program. It explains that the 'Board' refers to the Board of Trustees for this program, and an 'eligible cancer clinical trial' is one conducted in California targeting cancer and regulated by the FDA. It also defines the 'Fund' as a source of financial support for the program, and the 'Program' itself as the California Cancer Clinical Trials initiative. The 'Program administrator' is appointed by the University of California, which is also referred to as the 'University'. Lastly, a 'Program grant recipient' is an organization that receives funding to help achieve the program's goals.

For purposes of this part, the following definitions shall apply:

(a) “Board” means the Board of Trustees of the California Cancer Clinical Trials Program.

(b) “Eligible cancer clinical trial” means a clinical trial, as defined in Section 300gg-8(d) of Title 42 of the United States Code, that is conducted in the state, that targets cancer, and that is regulated by the United States Food and Drug Administration.

(c) “Fund” or “clinical trials fund” refers to a fund established by or on behalf of the program administrator to support the program.

(d) “Program” means the California Cancer Clinical Trials Program.

(e) “Program administrator” means the institute or office designated by the University of California pursuant to subdivision (a) of Section 101991.

(f) “Program grant recipient” means an organization that receives support from the fund to carry out the purposes of this part.

(g) “University” means the University of California.

California Cancer Clinical Trials Program Board of Trustees eligible cancer clinical trial FDA regulation clinical trials fund program administrator University of California program grant recipient cancer research clinical trial support program definitions healthcare funding clinical trial regulation cancer treatment medical research support

(Added by Stats. 2016, Ch. 661, Sec. 2. (AB 1823) Effective January 1, 2017.)

Section § 101991

This law section asks the university to create a special office or institute to oversee a program aimed at increasing participation in cancer clinical trials in California. It requires forming a board with at least five members who have diverse backgrounds and expertise in clinical trials, and who care about improving access and diversity in these trials. Board members should represent a variety of institutions and organizations and work for no pay, though they can get reimbursed for their related expenses. The law allows some flexibility with program administrative costs, especially in the first year, so no more than 20% of funds should ordinarily go to these costs unless it's the inaugural year. The university must also promote the opportunity for board nominations and the availability of grants to relevant organizations.

The university is hereby requested to do all of the following:

(a) Establish or designate an institute or office within the university to administer the program.

(b) Establish the board, to consist of at least five members, appointed by the president of the university to represent institutions and individuals performing, participating in, and supporting eligible cancer clinical trials in California.

(1) The members shall have varying backgrounds to promote the purposes of this part.

(2) The board shall be qualified through the experience, expertise, and diversity of its members in the design, implementation, and support of clinical trials, and through studying and addressing socioeconomic, ethnic or racial, regional, and other barriers to participation and interventions to remove those barriers.

(3) Efforts shall be made to include representatives of a range of public and private research institutions, health care providers, health care foundations, and patient advocacy organizations.

(4) All persons appointed to the board shall have an interest in increasing and diversifying access to eligible cancer clinical trials and the ability and desire to solicit funds for the purpose of increasing and diversifying access to clinical trials as provided in this part.

(5) Members of the board shall serve without compensation. A board member shall be reimbursed for any actual, necessary, and reasonable expenses incurred in connection with his or her duties as a board member.

(6)

(A) The program administrator may adjust administrative costs available for use in the program based on the size of the program and the funds that are received.

(B) Notwithstanding subparagraph (A), the program administrator shall use no more than 20 percent of the funds that are made available for the program for administrative costs.

(C) Notwithstanding subparagraph (B), in the first year of the program, the program administrator may use more than 20 percent of the funds for administrative costs, in order to fund the costs of establishing the program.

(c) Publicize to National Cancer Institute-Designated Cancer Centers, community organizations, hospitals, hospital associations, industry, health care foundations, and government agencies, the opportunity to submit nominations for board membership to the president of the university.

(d) Publicize the availability of grants made available through the program to organizations described in subdivision (a) of Section 101994.5.

cancer clinical trials university institute board membership diverse backgrounds barriers to participation public and private institutions patient advocacy clinical trial access diversify clinical trials fund solicitation program administrator administrative costs grant availability National Cancer Institute Centers community organizations

(Added by Stats. 2016, Ch. 661, Sec. 2. (AB 1823) Effective January 1, 2017.)

Section § 101992

This law allows the university to take part in a program as either an administrator, a participant, or both. Before starting the program, it can seek necessary approvals from federal, state, or its own internal bodies. The university also has the option to opt-out of starting or joining the program entirely. Additionally, if the program doesn't seem feasible, the university can choose to end it.

(a) The university may participate in the program as the program administrator, a beneficiary, or both.

(b) Prior to establishing the program, the university may pursue any federal, state, or internal approvals, authorizations, or advice it deems necessary to the university’s participation.

(c) The university may decline to establish or participate in the program.

(d) The university may terminate the program if it determines that the program is not viable.

university program participation program administrator program beneficiary federal approvals state approvals internal approvals program viability program termination university discretion program establishment university opt-out

(Added by Stats. 2016, Ch. 661, Sec. 2. (AB 1823) Effective January 1, 2017.)

Section § 101993

This section explains that a program administrator can collect funds from various sources like businesses, foundations, and government agencies to support a program that aims to increase patient access to cancer clinical trials. The funds collected are used to manage the program and award grants.

Only federal or private funds can be used for running the program and awarding grants, except the university can use state funds just for initial start-up costs, as long as these are later reimbursed by federal or private funds.

(a) The program administrator, directly or through a university-affiliated foundation, may solicit funds from business, industry, foundations, research organizations, federal government agencies, individuals, and other private sources for the purpose of administering the program and awarding grants to increase patient access to clinical trials targeting cancer, consistent with guidelines established by the board.

(b)

(1) Subject to paragraph (2), only funds from federal or private sources may be used to administer the program or award grants.

(2) The university may use its own state source funds for oversight and administration of the program relating to the initial start-up costs of the program only, provided the university is reimbursed from federal or private sources of funds.

program administrator fund solicitation cancer clinical trials patient access grant awards federal funding private funding university oversight university-affiliated foundation start-up costs fund reimbursement business and industry funding research organizations foundation donations guidelines by the board

(Amended by Stats. 2017, Ch. 561, Sec. 126. (AB 1516) Effective January 1, 2018.)

Section § 101993.5

This law section explains that any resources the university uses to set up and run a specific program should be paid back to the university. This repayment must come from donations to a specific fund and has to happen before the program gives out any grants to organizations identified in another law section.

Any funds, personnel, facility, equipment, or other resources that are allocated by the university to establish and operate the program shall be reimbursed to the university, from moneys donated to the fund, prior to distribution by the program of any grants to any entity that is designated under subdivision (a) of Section 101994.5.

university reimbursement program operation costs donation fund grant distribution resource allocation funding repayment financial management university resources donor fund allocation program grants Section 101994.5 subdivision (a) university funding recovery program setup costs financial priority

(Added by Stats. 2016, Ch. 661, Sec. 2. (AB 1823) Effective January 1, 2017.)

Section § 101994

This law requires that once there is at least $500,000 in funding, a program administrator must create a fund and a Cancer Clinical Trials Grant Program. The main goal of this program is to help more patients from underserved or disadvantaged communities, like women and minority populations, gain access to cancer clinical trials.

Upon the program administrator’s receipt of at least five hundred thousand dollars ($500,000) in funding for the program, the program administrator shall establish the fund and the Cancer Clinical Trials Grant Program to increase patient access to eligible cancer clinical trials in underserved or disadvantaged communities and populations, including among women and patients from racial and ethnic minority communities and socioeconomically disadvantaged communities.

Cancer Clinical Trials Patient Access Underserved Communities Disadvantaged Populations Funding Requirements Women in Clinical Trials Minority Patient Access Socioeconomic Barriers Healthcare Access Racial and Ethnic Minority Communities Cancer Research Funding Clinical Trial Grants

(Added by Stats. 2016, Ch. 661, Sec. 2. (AB 1823) Effective January 1, 2017.)

Section § 101994.5

This law establishes guidelines for awarding grants to support cancer clinical trials. The board can give grants to research institutions, hospitals, and nonprofit organizations focusing on patient support and health disparities in clinical trials. These grants aim to improve patient access, enrollment, and retention in cancer clinical trials.

Funds can be used for services like patient navigation, education, technical tools, counseling, well-being services, and covering patient and caregiver costs like travel, lodging, meals, and childcare during trials. Special consideration is given to applicants addressing health disparities or with experience improving trial participation among underserved populations.

(a) The board shall determine the criteria to award and administer grants to support program grant recipients. The board may award grants to any or all of the following:

(1) Public and private research institutions and hospitals that conduct eligible cancer clinical trials.

(2) Nonprofit organizations that are exempt from taxation under Section 501(c) of the Internal Revenue Code and that do either of the following:

(A) Specialize in direct patient support for improved clinical trial enrollment and retention.

(B) Engage in research on health disparities and their relationship to clinical trial enrollment.

(b) Grants awarded pursuant to subdivision (a) shall be used for activities to increase patient access to eligible cancer clinical trials, including, but not limited to, any of the following:

(1) Patient navigator services or programs.

(2) Education and community outreach.

(3) Patient-friendly technical tools to assist patients in identifying available clinical trials.

(4) Counseling services for clinical trial participants.

(5) Well-being services for clinical trial participants, including, but not limited to, physical therapy, pain management, stress management, and nutrition management.

(6) Payment of ancillary costs for patients and caregivers, including, but not limited to, all of the following during and related to participation in the clinical trial:

(A) Airfare.

(B) Lodging.

(C) Rental automobile and fuel for the automobile.

(D) Local public transportation by bus, train, or other public transportation.

(E) Meals.

(F) Dependent child care.

(7) Research on the effectiveness of these and other measures to increase patient access to clinical trials.

(c) When determining program grant recipients pursuant to subdivision (a), the board is encouraged to grant special consideration to public or nonprofit applicants that provide patient services related to cancer clinical trials that address health disparities or that possess two or more years’ experience in the improvement of enrollment, retention, or participation in cancer clinical trial participation with an emphasis on underserved populations.

cancer clinical trials patient support grant criteria research institutions nonprofit organizations patient navigator services community outreach health disparities trial enrollment technical tools for patients counseling services well-being services ancillary costs underserved populations patient access to trials

(Added by Stats. 2016, Ch. 661, Sec. 2. (AB 1823) Effective January 1, 2017.)

Section § 101995

This law requires that grantees, or those receiving funds, must provide reports to ensure money is used properly. The reports must align with the program's goals and meet grant award terms. In addition, the university can request the board to submit reports to the University of California Regents, which may include financial summaries, program evaluations, and improvement suggestions.

(a) The program administrator shall require grantees to submit any reports it deems necessary to ensure the appropriate use of funds consistent with the purposes of this part and the terms of any grant awards.

(b) The university may require the board to submit reports pertaining to the program’s and the board’s activities to the Regents of the University of California, including, but not limited to, the following information:

(1) An accounting of funds collected and expended.

(2) An evaluation of the program.

(3) Recommendations regarding the program.

grantees' reports fund usage grant awards program evaluations financial accounting university requirements board activities University of California Regents program recommendations fund monitoring use of funds grant compliance

(Added by Stats. 2016, Ch. 661, Sec. 2. (AB 1823) Effective January 1, 2017.)

Section § 101996

This law allows a university to end a program if the funding is not enough to start or continue it. If the program fund doesn't get at least $500,000 by January 1, 2021, or if administrative costs become too high, the program administrator can choose to end the program. After paying all expenses, any leftover money should be given to certain organizations specified by law before closing the program.

(a) If the university determines at any time that the moneys in the fund are insufficient to establish or sustain the program, the university may terminate the program.

(b) If the fund does not receive five hundred thousand dollars ($500,000) or more by January 1, 2021, or, if at any time, the program administrator determines that the 20-percent limit on administrative costs set forth in subparagraph (B) of paragraph (6) of subdivision (b) of Section 101991 is inadequate to support the cost of administering the program authorized pursuant to this part, the program administrator may elect to dissolve the program.

(c) All moneys in the fund remaining after expenses are paid shall, prior to dissolution, be allocated to one or more organizations described in subdivision (a) of Section 101994.5.

university program termination insufficient funding program dissolution administrative cost limit fund allocation remaining funds organization allocation program fund minimum requirement program administrator decision program expenses payment program sustainability termination conditions

(Amended by Stats. 2017, Ch. 561, Sec. 127. (AB 1516) Effective January 1, 2018.)

Section § 101997

This section allows universities to set up and run programs that help people take part in clinical trials, without facing any legal restrictions from this part of the law.

This part does not preclude the university from establishing or operating one or more similar programs to facilitate participation in any clinical trials, as defined in Section 300gg-8(d) of Title 42 of the United States Code.

university programs clinical trial participation facilitating clinical trials Section 300gg-8(d) Title 42 United States Code research facilitation operating similar programs establishing clinical trial programs legal permissions for universities healthcare research support university research initiatives facilitating medical studies

(Added by Stats. 2016, Ch. 661, Sec. 2. (AB 1823) Effective January 1, 2017.)

Administration Of Public Health

Part 7California Cancer Clinical Trials Program

Section § 101990

Section § 101991

Section § 101992

Section § 101993

Section § 101993.5

Section § 101994

Section § 101994.5

Section § 101995

Section § 101996

Section § 101997

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