89R13815 TYPED
By: Parker S.B. No. 1357
A BILL TO BE ENTITLED
AN ACT
relating to a cancer clinical trial participation program.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. The legislature 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 percent 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 Internet website that reimbursement of direct
subject-incurred expenses is not an inducement, many
organizations, research sponsors, philanthropic individuals,
charitable organizations, governmental entities, and other persons
still operate under the misconception that such reimbursement is an
inducement;
(7) it is the intent of the legislature to enact
legislation to further define and establish a clear difference
between items considered to be an inducement for a subject to
participate in a cancer clinical trial and the reimbursement of
expenses for participating in a cancer clinical trial; and
(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 2. Subtitle B, Title 2, Health and Safety Code, is
amended by adding Chapter 50 to read as follows:
CHAPTER 50. CANCER CLINICAL TRIAL PARTICIPATION PROGRAM
Sec. 50.0001. DEFINITIONS. In this chapter:
(1) "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.
(2) "Inducement" means the payment of money, including
a lump-sum or salary payment, to an individual for the individual's
participation in a cancer clinical trial.
(3) "Program" means the cancer clinical trial
participation program established under this chapter.
(4) "Subject" means an individual who participates in
the program.
Sec. 50.0002. ESTABLISHMENT. A public or private
institution of higher education, as defined by Section 61.003,
Education Code, an independent research organization located in
Texas, or An 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;
(4) meals or groceries;
(5) childcare; and
(4) (6) other costs considered appropriate by the
organization.
Sec. 50.0003. REQUIREMENTS; NOTICE. (a) The program:
(1) must collaborate with physicians and health care
providers to notify a prospective subject about the program when:
(A) the prospective subject provides informed
consent for 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 percent of the federal poverty level;
(3) must provide reimbursement for ancillary costs,
including costs described by Section 50.0002, to eliminate the
financial barriers to enrollment in a clinical trial;
(4) may provide reimbursement for reasonable
ancillary costs, including costs described by Section 50.0002, 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 public or private institution of higher education,
as defined by Section 61.003, Education Code, the independent
research organization located in Texas, or the independent,
third-party organization administering the program shall provide
written notice to prospective subjects of the requirements
described by Subsection (a).
Sec. 50.0004. REIMBURSEMENT REQUIREMENTS; NOTICE. (a) A
reimbursement under the program 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 the program.
(c) The public or private institution of higher education,
as defined by Section 61.003, Education Code, the independent
research organization located in Texas, or 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.
Sec. 50.0005. REIMBURSEMENT STATUS AS INDUCEMENT.
Reimbursement to a subject of ancillary costs under the program:
(1) does not constitute an 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.
Sec. 50.0006. FUNDING. The public or private institution
of higher education, as defined by Section 61.003, Education Code,
the independent research organization located in Texas, or the
independent, third-party organization that administers the program
may accept gifts, grants, and donations from any public or private
source to implement this chapter.
Sec. 50.0007. COLLABORATION. The public or private
institution of higher education, as defined by Section 61.003,
Education Code, the independent research organization located in
Texas, or the independent, third-party organization that
administers the program may collaborate with the Cancer Prevention
and Research Institute of Texas established under Chapter 102 to
provide reimbursement under the program.