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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 1. Short title. This Act may be cited as the Cancer
5Clinical Trial Participation Program Act.
 
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
17    individuals from households with an annual income of less
18    than $50,000 were 30% less likely to participate in cancer
19    clinical trials.
20        (4) Direct and indirect costs, including
21    transportation, lodging, and child-care expenses, prevent
22    eligible individuals from participating in cancer clinical
23    trials according to the National Cancer Institute.

 

 

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1        (5) The disparities in subject participation in cancer
2    clinical trials threaten the basic ethical underpinning of
3    clinical research, which requires the benefits of the
4    research to be made available equitably among all eligible
5    individuals.
6        (6) While the United States Food and Drug
7    Administration recently confirmed to Congress and provided
8    guidance on its website that reimbursement of direct
9    subject-incurred expenses is not an undue inducement, many
10    organizations, research sponsors, philanthropic
11    individuals, charitable organizations, governmental
12    entities, and other persons still operate under the
13    misconception that such reimbursement is an undue
14    inducement.
15        (7) It is the intent of the General Assembly to enact
16    legislation to further define and establish a clear
17    difference between items considered to be an undue
18    inducement for a subject to participate in a cancer
19    clinical trial and the reimbursement of expenses for
20    participating in a cancer clinical trial.
21        (8) Further clarification of the United States Food and
22    Drug Administration's confirmation and guidance is
23    appropriate and important to improve subject participation
24    in cancer clinical trials, which is the primary intent of
25    this legislation.
 

 

 

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1    Section 10. Definitions. In this Act:
2    "Cancer clinical trial" means a research study that
3subjects an individual to a new cancer treatment, including a
4medication, chemotherapy, adult stem cell therapy, or other
5treatment.
6    "Cancer clinical trial sponsor" means a person, physician,
7professor, or researcher who initiates a cancer clinical trial;
8a government entity or agency that initiates a cancer clinical
9trial; or an industry, including, but not limited to, a
10pharmaceutical, biotechnology, or medical device company, that
11initiates a cancer clinical trial.
12    "Independent third-party organization" means an entity or
13organization, whether public or private, that is not a sponsor
14or host of a cancer clinical trial, or in any way directly
15affiliated with a sponsor or host of a cancer clinical trial,
16and has experience in patient advocacy and direct patient
17reimbursement of cancer clinical trial participation costs.
18    "Inducement" means providing a person something of value,
19including money, as part of participation in a clinical trial.
20    "Program" means the cancer clinical trial participation
21program established under this Act.
22    "Subject" means an individual who participates in the
23program.
24    "Undue inducement" means the value of something received by
25a potential clinical trial research subject, which value is so
26large that it causes the research subject to take risks that

 

 

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1are not in his or her best interests.
 
2    Section 15. Establishment. An independent third-party
3organization may develop and implement the cancer clinical
4trial participation program to provide reimbursement to
5subjects for ancillary costs associated with participation in a
6cancer clinical trial, including costs for:
7        (1) travel;
8        (2) lodging;
9        (3) parking and tolls; and
10        (4) other costs considered appropriate by the
11    organization.
 
12    Section 20. Requirements; notice.
13    (a) The program:
14        (1) must collaborate with physicians, health care
15    providers, and cancer clinical trial sponsors to notify a
16    prospective subject about the program when:
17            (A) the prospective subject consents to a cancer
18        clinical trial; or
19            (B) funding is available to provide the program for
20        the cancer clinical trial in which the prospective
21        subject participates;
22        (2) must reimburse subjects based on financial need,
23    which may include reimbursement to subjects whose income is
24    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 cancer
8    clinical trial to support a subject; and
9        (5) must comply with applicable federal and State laws.
10    (b) The independent third-party organization administering
11the program shall provide written notice to prospective
12subjects of the requirements described under subsection (a).
 
13    Section 25. Reimbursement requirements; notice.
14    (a) A reimbursement under the program at a trial site that
15conducts cancer clinical trials must:
16        (1) be reviewed and approved by the institutional
17    review board associated with the cancer clinical trial for
18    which the reimbursement is provided; and
19        (2) comply with applicable federal and State laws.
20    (b) The independent third-party organization operating the
21program is not required to obtain approval from an
22institutional review board on the financial eligibility of a
23subject who is medically eligible for a cancer clinical trial.
24    (c) The independent third-party organization operating the
25program shall provide written notice to a subject on:

 

 

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1        (1) the nature and availability of the ancillary
2    financial support under the program; and
3        (2) the program's general guidelines on financial
4    eligibility.
 
5    Section 30. Reimbursement status as undue inducement.
6Reimbursement to a subject of ancillary costs under the
7program:
8        (1) does not constitute an undue inducement to
9    participate in a cancer clinical trial;
10        (2) is not considered coercion or the exertion of undue
11    influence to participate in a cancer clinical trial; and
12        (3) is meant to accomplish parity in access to cancer
13    clinical trials and remove barriers to participation in
14    cancer clinical trials for financially burdened subjects.
 
15    Section 35. Funding. The independent third-party
16organization that administers the program may accept gifts,
17grants, and donations from any public or private source to
18implement this Act.
 
19    Section 99. Effective date. This Act takes effect upon
20becoming law.