86R12085 JG-D
By: Parker H.B. No. 3147
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 partly 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 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 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 believe 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 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 nonprofit 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) child care; and
(4) other costs considered appropriate by the
organization.
Sec. 50.0003. REQUIREMENTS; NOTICE. (a) The program:
(1) 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;
(2) must provide reimbursement for ancillary costs,
including costs described by Section 50.0002, to eliminate the
financial barriers to enrollment in a clinical trial;
(3) 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
(4) must comply with applicable federal and state
laws.
(b) The nonprofit 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 nonprofit 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 nonprofit 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 through the program does not constitute
an inducement or coercion to participate in a cancer clinical
trial.
Sec. 50.0006. FUNDING. The nonprofit organization that
administers the program may accept gifts, grants, and donations
from any public or private source to implement this chapter.
SECTION 3. This Act takes effect September 1, 2019.