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| Public Act 101-0619
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| SB1711 Enrolled | LRB101 09730 RLC 54830 b |
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AN ACT concerning health.
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Be it enacted by the People of the State of Illinois,
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represented in the General Assembly:
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Section 1. Short title. This Act may be cited as the Cancer |
Clinical Trial Participation Program Act.
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Section 5. Findings. The General Assembly finds that: |
(1) The ability to translate medical findings from |
research to practice relies largely on robust subject |
participation and a diverse subject participation pool in |
clinical trials. |
(2) Diverse subject participation in cancer clinical |
trials depends significantly on whether an individual is |
able to afford ancillary costs, including transportation |
and lodging, during the course of participation in a cancer |
clinical trial. |
(3) A national study conducted in 2015 found that |
individuals from households with an annual income of less |
than $50,000 were 30% less likely to participate in cancer |
clinical trials. |
(4) Direct and indirect costs, including |
transportation, lodging, and child-care expenses, prevent |
eligible individuals from participating in cancer clinical |
trials according to the National Cancer Institute. |
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(5) The disparities in subject participation in cancer |
clinical trials threaten the basic ethical underpinning of |
clinical research, which requires the benefits of the |
research to be made available equitably among all eligible |
individuals. |
(6) While the United States Food and Drug |
Administration recently confirmed to Congress and provided |
guidance on its website that reimbursement of direct |
subject-incurred expenses is not an undue inducement, many |
organizations, research sponsors, philanthropic |
individuals, charitable organizations, governmental |
entities, and other persons still operate under the |
misconception that such reimbursement is an undue |
inducement. |
(7) It is the intent of the General Assembly to enact |
legislation to further define and establish a clear |
difference between items considered to be an undue |
inducement for a subject to participate in a cancer |
clinical trial and the reimbursement of expenses for |
participating in a cancer clinical trial. |
(8) Further clarification of the United States Food and |
Drug Administration's confirmation and guidance is |
appropriate and important to improve subject participation |
in cancer clinical trials, which is the primary intent of |
this legislation.
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Section 10. Definitions. In this Act: |
"Cancer clinical trial" means a research study that |
subjects an individual to a new cancer treatment, including a |
medication, chemotherapy, adult stem cell therapy, or other |
treatment. |
"Cancer clinical trial sponsor" means a person, physician, |
professor, or researcher who initiates a cancer clinical trial; |
a government entity or agency that initiates a cancer clinical |
trial; or an industry, including, but not limited to, a |
pharmaceutical, biotechnology, or medical device company, that |
initiates a cancer clinical trial. |
"Independent third-party organization" means an entity or |
organization, whether public or private, that is not a sponsor |
or host of a cancer clinical trial, or in any way directly |
affiliated with a sponsor or host of a cancer clinical trial, |
and has experience in patient advocacy and direct patient |
reimbursement of cancer clinical trial participation costs. |
"Inducement" means providing a person something of value, |
including money, as part of participation in a clinical trial. |
"Program" means the cancer clinical trial participation |
program established under this Act. |
"Subject" means an individual who participates in the |
program. |
"Undue inducement" means the value of something received by |
a potential clinical trial research subject, which value is so |
large that it causes the research subject to take risks that |
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are not in his or her best interests.
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Section 15. Establishment. An independent third-party |
organization may develop and implement the cancer clinical |
trial participation program to provide reimbursement to |
subjects for ancillary costs associated with participation in a |
cancer clinical trial, including costs for: |
(1) travel; |
(2) lodging; |
(3) parking and tolls; and |
(4) other costs considered appropriate by the |
organization.
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Section 20. Requirements; notice. |
(a) The program: |
(1) must collaborate with physicians, health care |
providers, and cancer clinical trial sponsors to notify a |
prospective subject about the program when: |
(A) the prospective subject consents to a cancer |
clinical trial; or |
(B) funding is available to provide the program for |
the cancer clinical trial in which the prospective |
subject participates; |
(2) must reimburse subjects based on financial need, |
which may include reimbursement to subjects whose income is |
at or below 700% of the federal poverty level; |
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(3) must provide reimbursement for ancillary costs, |
including costs described under Section 15, to eliminate |
the financial barriers to enrollment in a cancer clinical |
trial; |
(4) may provide reimbursement for reasonable ancillary |
costs, including costs described under Section 15, to one |
family member, friend, or other person who attends a cancer |
clinical trial to support a subject; and |
(5) must comply with applicable federal and State laws. |
(b) The independent third-party organization administering |
the program shall provide written notice to prospective |
subjects of the requirements described under subsection (a).
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Section 25. Reimbursement requirements; notice. |
(a) A reimbursement under the program at a trial site that |
conducts cancer clinical trials must: |
(1) be reviewed and approved by the institutional |
review board associated with the cancer clinical trial for |
which the reimbursement is provided; and |
(2) comply with applicable federal and State laws. |
(b) The independent third-party organization operating the |
program is not required to obtain approval from an |
institutional review board on the financial eligibility of a |
subject who is medically eligible for a cancer clinical trial. |
(c) The independent third-party organization operating the |
program shall provide written notice to a subject on: |
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(1) the nature and availability of the ancillary |
financial support under the program; and |
(2) the program's general guidelines on financial |
eligibility.
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Section 30. Reimbursement status as undue inducement. |
Reimbursement to a subject of ancillary costs under the |
program:
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(1) does not constitute an undue inducement to |
participate in a cancer clinical trial; |
(2) is not considered coercion or the exertion of undue |
influence to participate in a cancer clinical trial; and |
(3) is meant to accomplish parity in access to cancer |
clinical trials and remove barriers to participation in |
cancer clinical trials for financially burdened subjects.
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Section 35. Funding. The independent third-party |
organization that administers the program may accept gifts, |
grants, and donations from any public or private source to |
implement this Act.
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Section 99. Effective date. This Act takes effect upon |
becoming law.
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