Illinois General Assembly

  Bills & Resolutions  
  Compiled Statutes  
  Public Acts  
  Legislative Reports  
  IL Constitution  
  Legislative Guide  
  Legislative Glossary  

 Search By Number
 (example: HB0001)
Search Tips

Search By Keyword

Public Act 101-0619


 

Public Act 0619 101ST GENERAL ASSEMBLY

  
  
  

 


 
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.

Effective Date: 12/20/2019