Public Act 101-0619
Public Act 0619 101ST GENERAL ASSEMBLY
|Public Act 101-0619|
|SB1711 Enrolled||LRB101 09730 RLC 54830 b|
AN ACT concerning health.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
This Act may be cited as the
Clinical Trial Participation Program Act.
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
(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
(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
(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
(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
(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
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
"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
"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.
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:
(3) parking and tolls; and
(4) other costs considered appropriate by the
(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
(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
(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).
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
Reimbursement status as undue inducement.
Reimbursement to a subject of ancillary costs under the
(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.
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.
This Act takes effect upon
Effective Date: 12/20/2019