Bill Amendment: IL SB1711 | 2019-2020 | 101st General Assembly
NOTE: For additional amemendments please see the Bill Drafting List
Bill Title: CANCER TRIAL PARTICIPATION PGM
Status: 2019-12-20 - Public Act . . . . . . . . . 101-0619 [SB1711 Detail]
Download: Illinois-2019-SB1711-House_Amendment_001.html
Bill Title: CANCER TRIAL PARTICIPATION PGM
Status: 2019-12-20 - Public Act . . . . . . . . . 101-0619 [SB1711 Detail]
Download: Illinois-2019-SB1711-House_Amendment_001.html
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1 | AMENDMENT TO SENATE BILL 1711
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2 | AMENDMENT NO. ______. Amend Senate Bill 1711 by replacing | ||||||
3 | everything after the enacting clause with the following:
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4 | "Section 1. Short title. This Act may be cited as the | ||||||
5 | Cancer Clinical Trial Participation Program Act.
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6 | Section 5. Findings. The General Assembly finds that: | ||||||
7 | (1) The ability to translate medical findings from | ||||||
8 | research to practice relies largely on robust subject | ||||||
9 | participation and a diverse subject participation pool in | ||||||
10 | clinical trials. | ||||||
11 | (2) Diverse subject participation in cancer clinical | ||||||
12 | trials depends significantly on whether an individual is | ||||||
13 | able to afford ancillary costs, including transportation | ||||||
14 | and lodging, during the course of participation in a cancer | ||||||
15 | clinical trial. | ||||||
16 | (3) A national study conducted in 2015 found that |
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1 | individuals from households with an annual income of less | ||||||
2 | than $50,000 were 30% less likely to participate in cancer | ||||||
3 | clinical trials. | ||||||
4 | (4) Direct and indirect costs, including | ||||||
5 | transportation, lodging, and child-care expenses, prevent | ||||||
6 | eligible individuals from participating in cancer clinical | ||||||
7 | trials according to the National Cancer Institute. | ||||||
8 | (5) The disparities in subject participation in cancer | ||||||
9 | clinical trials threaten the basic ethical underpinning of | ||||||
10 | clinical research, which requires the benefits of the | ||||||
11 | research to be made available equitably among all eligible | ||||||
12 | individuals. | ||||||
13 | (6) While the United States Food and Drug | ||||||
14 | Administration recently confirmed to Congress and provided | ||||||
15 | guidance on its website that reimbursement of direct | ||||||
16 | subject-incurred expenses is not an undue inducement, many | ||||||
17 | organizations, research sponsors, philanthropic | ||||||
18 | individuals, charitable organizations, governmental | ||||||
19 | entities, and other persons still operate under the | ||||||
20 | misconception that such reimbursement is an undue | ||||||
21 | inducement. | ||||||
22 | (7) It is the intent of the General Assembly to enact | ||||||
23 | legislation to further define and establish a clear | ||||||
24 | difference between items considered to be an undue | ||||||
25 | inducement for a subject to participate in a cancer | ||||||
26 | clinical trial and the reimbursement of expenses for |
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1 | participating in a cancer clinical trial. | ||||||
2 | (8) Further clarification of the United States Food and | ||||||
3 | Drug Administration's confirmation and guidance is | ||||||
4 | appropriate and important to improve subject participation | ||||||
5 | in cancer clinical trials, which is the primary intent of | ||||||
6 | this legislation.
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7 | Section 10. Definitions. In this Act: | ||||||
8 | "Cancer clinical trial" means a research study that | ||||||
9 | subjects an individual to a new cancer treatment, including a | ||||||
10 | medication, chemotherapy, adult stem cell therapy, or other | ||||||
11 | treatment. | ||||||
12 | "Cancer clinical trial sponsor" means a person, physician, | ||||||
13 | professor, or researcher who initiates a cancer clinical trial; | ||||||
14 | a government entity or agency that initiates a cancer clinical | ||||||
15 | trial; or an industry, including, but not limited to, a | ||||||
16 | pharmaceutical, biotechnology, or medical device company, that | ||||||
17 | initiates a cancer clinical trial. | ||||||
18 | "Independent third-party organization" means an entity or | ||||||
19 | organization, whether public or private, that is not a sponsor | ||||||
20 | or host of a cancer clinical trial, or in any way directly | ||||||
21 | affiliated with a sponsor or host of a cancer clinical trial, | ||||||
22 | and has experience in patient advocacy and direct patient | ||||||
23 | reimbursement of cancer clinical trial participation costs. | ||||||
24 | "Inducement" means providing a person something of value, | ||||||
25 | including money, as part of participation in a clinical trial. |
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1 | "Program" means the cancer clinical trial participation | ||||||
2 | program established under this Act. | ||||||
3 | "Subject" means an individual who participates in the | ||||||
4 | program. | ||||||
5 | "Undue inducement" means the value of something received by | ||||||
6 | a potential clinical trial research subject, which value is so | ||||||
7 | large that it causes the research subject to take risks that | ||||||
8 | are not in his or her best interests.
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9 | Section 15. Establishment. An independent third-party | ||||||
10 | organization may develop and implement the cancer clinical | ||||||
11 | trial participation program to provide reimbursement to | ||||||
12 | subjects for ancillary costs associated with participation in a | ||||||
13 | cancer clinical trial, including costs for: | ||||||
14 | (1) travel; | ||||||
15 | (2) lodging; | ||||||
16 | (3) parking and tolls; and | ||||||
17 | (4) other costs considered appropriate by the | ||||||
18 | organization.
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19 | Section 20. Requirements; notice. | ||||||
20 | (a) The program: | ||||||
21 | (1) must collaborate with physicians, health care | ||||||
22 | providers, and cancer clinical trial sponsors to notify a | ||||||
23 | prospective subject about the program when: | ||||||
24 | (A) the prospective subject consents to a cancer |
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1 | clinical trial; or | ||||||
2 | (B) funding is available to provide the program for | ||||||
3 | the cancer clinical trial in which the prospective | ||||||
4 | subject participates; | ||||||
5 | (2) must reimburse subjects based on financial need, | ||||||
6 | which may include reimbursement to subjects whose income is | ||||||
7 | at or below 700% of the federal poverty level; | ||||||
8 | (3) must provide reimbursement for ancillary costs, | ||||||
9 | including costs described under Section 15, to eliminate | ||||||
10 | the financial barriers to enrollment in a cancer clinical | ||||||
11 | trial; | ||||||
12 | (4) may provide reimbursement for reasonable ancillary | ||||||
13 | costs, including costs described under Section 15, to one | ||||||
14 | family member, friend, or other person who attends a cancer | ||||||
15 | clinical trial to support a subject; and | ||||||
16 | (5) must comply with applicable federal and State laws. | ||||||
17 | (b) The independent third-party organization administering | ||||||
18 | the program shall provide written notice to prospective | ||||||
19 | subjects of the requirements described under subsection (a).
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20 | Section 25. Reimbursement requirements; notice. | ||||||
21 | (a) A reimbursement under the program at a trial site that | ||||||
22 | conducts cancer clinical trials must: | ||||||
23 | (1) be reviewed and approved by the institutional | ||||||
24 | review board associated with the cancer clinical trial for | ||||||
25 | which the reimbursement is provided; and |
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1 | (2) comply with applicable federal and State laws. | ||||||
2 | (b) The independent third-party organization operating the | ||||||
3 | program is not required to obtain approval from an | ||||||
4 | institutional review board on the financial eligibility of a | ||||||
5 | subject who is medically eligible for a cancer clinical trial. | ||||||
6 | (c) The independent third-party organization operating the | ||||||
7 | program shall provide written notice to a subject on: | ||||||
8 | (1) the nature and availability of the ancillary | ||||||
9 | financial support under the program; and | ||||||
10 | (2) the program's general guidelines on financial | ||||||
11 | eligibility.
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12 | Section 30. Reimbursement status as undue inducement. | ||||||
13 | Reimbursement to a subject of ancillary costs under the | ||||||
14 | program:
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15 | (1) does not constitute an undue inducement to | ||||||
16 | participate in a cancer clinical trial; | ||||||
17 | (2) is not considered coercion or the exertion of undue | ||||||
18 | influence to participate in a cancer clinical trial; and | ||||||
19 | (3) is meant to accomplish parity in access to cancer | ||||||
20 | clinical trials and remove barriers to participation in | ||||||
21 | cancer clinical trials for financially burdened subjects.
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22 | Section 35. Funding. The independent third-party | ||||||
23 | organization that administers the program may accept gifts, | ||||||
24 | grants, and donations from any public or private source to |
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1 | implement this Act.
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2 | Section 99. Effective date. This Act takes effect upon | ||||||
3 | becoming law.".
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