Public Act 101-0619
 
SB1711 EnrolledLRB101 09730 RLC 54830 b


  
    AN ACT concerning health.
  
 
    Be it enacted by the People of the State of Illinois,
 
represented in the General Assembly:
  



 
 
    Section 1. Short title. This Act may be cited as the Cancer 
Clinical Trial Participation Program Act.
 
    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.
        (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.
 
    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 
are not in his or her best interests.
 
    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.
 
    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;
        (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).
 
    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:
        (1)  the nature and availability of the ancillary 
    financial support under the program; and
        (2)  the program's general guidelines on financial 
    eligibility.
 
    Section 30. Reimbursement status as undue inducement. 
Reimbursement to a subject of ancillary costs under the 
program:
 
        (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.

 
    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.
 
 
    Section 99. Effective date. This Act takes effect upon 
becoming law.