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  H.B. No. 3147
 
 
 
 
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.  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.
         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 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 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 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 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.
         SECTION 3.  Section 102.203(b), Health and Safety Code, is
  amended to read as follows:
         (b)  Except as otherwise provided by this section, money
  awarded under this subchapter may be used for authorized expenses,
  including honoraria, salaries and benefits, travel, conference
  fees and expenses, consumable supplies, other operating expenses,
  contracted research and development, capital equipment, [and]
  construction or renovation of state or private facilities, and
  reimbursement for costs of participation incurred by cancer
  clinical trial participants, including transportation, lodging,
  and any costs reimbursed under the cancer clinical trial
  participation program established under Chapter 50.
         SECTION 4.  This Act takes effect September 1, 2019.
 
 
  ______________________________ ______________________________
     President of the Senate Speaker of the House     
 
 
         I certify that H.B. No. 3147 was passed by the House on May
  10, 2019, by the following vote:  Yeas 128, Nays 3, 1 present, not
  voting.
 
  ______________________________
  Chief Clerk of the House   
 
 
         I certify that H.B. No. 3147 was passed by the Senate on May
  22, 2019, by the following vote:  Yeas 31, Nays 0.
 
  ______________________________
  Secretary of the Senate    
  APPROVED:  _____________________
                     Date          
   
            _____________________
                   Governor