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.