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1    AN ACT concerning health.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Cancer Clinical Trial Participation Program
5Act is amended by changing Sections 1, 5, 10, 15, 20, 25, and
630 as follows:
 
7    (410 ILCS 416/1)
8    Sec. 1. Short title. This Act may be cited as the Cancer
9Clinical Trial Participation Program Act.
10(Source: P.A. 101-619, eff. 12-20-19.)
 
11    (410 ILCS 416/5)
12    Sec. 5. Findings. The General Assembly finds that:
13        (1) The ability to translate medical findings from
14    research to practice relies largely on robust subject
15    participation and a diverse subject participation pool in
16    clinical trials.
17        (2) Diverse subject participation in cancer clinical
18    trials depends significantly on whether an individual is
19    able to afford ancillary costs, including transportation
20    and lodging, during the course of participation in a
21    cancer clinical trial.
22        (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
3    and 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.
7(Source: P.A. 101-619, eff. 12-20-19.)
 
8    (410 ILCS 416/10)
9    Sec. 10. Definitions. In this Act:
10    "Clinical Cancer clinical trial" means (i) a research
11study that subjects an individual to a new cancer treatment,
12including a medication, chemotherapy, adult stem cell therapy,
13or other treatment or (ii) a voluntary research study
14conducted on people and designed to answer specific questions
15about the safety or effectiveness of a drug, vaccine, therapy,
16medical device, medical diagnostic, or new way of using an
17existing treatment to treat or diagnose a condition.
18    "Clinical Cancer clinical trial sponsor" means a person,
19physician, professor, or researcher who initiates a cancer
20clinical trial; a government entity or agency that initiates a
21cancer clinical trial; or an industry, including, but not
22limited to, a pharmaceutical, biotechnology, or medical device
23company, that initiates a cancer clinical trial.
24    "Condition" means a disease, disorder, syndrome, illness,
25or injury, including, but not limited to, cancer,

 

 

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1cardiovascular disease, circulatory disease, infectious
2disease, digestive disease, musculoskeletal disease, nervous
3system disease, endocrinological disease, metabolic disease,
4mental health and behavioral disorder, blood disease, and rare
5diseases.
6    "Independent third-party organization" means an entity or
7organization, whether public or private, that is not a sponsor
8or host of a cancer clinical trial, or that is not in any way
9directly affiliated with a sponsor or host of a cancer
10clinical trial, and has experience in patient advocacy and
11direct patient reimbursement of cancer clinical trial
12participation costs.
13    "Inducement" means providing a person something of value,
14including money, as part of participation in a clinical trial.
15    "Program" means the cancer clinical trial participation
16program established under this Act.
17    "Subject" means an individual who participates in the
18program.
19    "Undue inducement" means the value of something received
20by a potential clinical trial research subject, which value is
21so large that it may reasonably cause causes the research
22subject to take risks that are not in his or her best
23interests.
24(Source: P.A. 101-619, eff. 12-20-19.)
 
25    (410 ILCS 416/15)

 

 

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1    Sec. 15. Establishment. An independent third-party
2organization may develop and implement the cancer clinical
3trial participation program to provide reimbursement to
4subjects for ancillary costs associated with participation in
5a cancer clinical trial, including costs for:
6        (1) travel;
7        (2) lodging;
8        (3) parking and tolls; and
9        (4) other related costs considered appropriate by the
10    organization.
11(Source: P.A. 101-619, eff. 12-20-19.)
 
12    (410 ILCS 416/20)
13    Sec. 20. Requirements; notice.
14    (a) The program:
15        (1) must collaborate with physicians, health care
16    providers, and cancer clinical trial sponsors to notify a
17    prospective subject about the program when:
18            (A) the prospective subject consents to a cancer
19        clinical trial; or
20            (B) funding is available to provide the program
21        for the cancer clinical trial in which the prospective
22        subject participates;
23        (2) must reimburse subjects based on financial need,
24    which may include reimbursement to subjects whose income
25    is at or below 700% of the federal poverty level;

 

 

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1        (3) must provide reimbursement for ancillary costs,
2    including costs described under Section 15, to eliminate
3    the financial barriers to enrollment in a cancer clinical
4    trial;
5        (4) may provide reimbursement for reasonable ancillary
6    costs, including costs described under Section 15, to one
7    family member, friend, or other person who attends a
8    cancer clinical trial to support a subject; and
9        (5) must comply with applicable federal and State
10    laws.
11    (b) The independent third-party organization administering
12the program shall provide written notice to prospective
13subjects of the requirements described under subsection (a).
14(Source: P.A. 101-619, eff. 12-20-19.)
 
15    (410 ILCS 416/25)
16    Sec. 25. Reimbursement requirements; notice.
17    (a) A reimbursement under the program at a trial site that
18conducts cancer clinical trials must:
19        (1) be reviewed and approved by the institutional
20    review board associated with the cancer clinical trial for
21    which the reimbursement is provided; and
22        (2) comply with applicable federal and State laws.
23    (b) The independent third-party organization operating the
24program is not required to obtain approval from an
25institutional review board with respect to on the financial

 

 

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1eligibility of a subject who is medically eligible for a
2cancer clinical trial.
3    (c) The independent third-party organization operating the
4program shall provide written notice to a subject on:
5        (1) the nature, and availability, and scope of the
6    ancillary financial support under the program; and
7        (2) the program's general guidelines on financial
8    eligibility.
9(Source: P.A. 101-619, eff. 12-20-19.)
 
10    (410 ILCS 416/30)
11    Sec. 30. Reimbursement status as undue inducement.
12Reimbursement of ancillary costs incurred by to a subject of
13ancillary costs under the program:
14        (1) does not constitute an undue inducement to
15    participate in a cancer clinical trial;
16        (2) is not considered coercion or the exertion of
17    undue influence to participate in a cancer clinical trial;
18    and
19        (3) shall be deemed is meant to accomplish parity in
20    access to cancer clinical trials and remove barriers to
21    participation in cancer clinical trials for financially
22    burdened subjects.
23(Source: P.A. 101-619, eff. 12-20-19.)
 
24    Section 99. Effective date. This Act takes effect upon
25becoming law.