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A BILL TO BE ENTITLED
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AN ACT
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relating to a cancer clinical trial participation program. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. The legislature finds that: |
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(1) the ability to translate medical findings from |
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research to practice relies largely on robust subject participation |
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and a diverse subject participation pool in clinical trials; |
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(2) diverse subject participation in cancer clinical |
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trials depends partly on whether an individual is able to afford |
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ancillary costs, including transportation and lodging, during the |
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course of participation in a cancer clinical trial; |
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(3) a national study conducted in 2015 found that |
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individuals from households with an annual income of less than |
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$50,000 were less likely to participate in cancer clinical trials; |
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(4) direct and indirect costs, including |
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transportation, lodging, and child-care expenses, prevent eligible |
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individuals from participating in cancer clinical trials according |
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to the National Cancer Institute; |
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(5) the disparities in subject participation in cancer |
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clinical trials threaten the basic ethical underpinning of clinical |
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research, which requires the benefits of the research to be made |
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available equitably among all eligible individuals; |
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(6) while the United States Food and Drug |
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Administration recently confirmed to Congress that reimbursement |
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of direct subject-incurred expenses is not an inducement, many |
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organizations, research sponsors, philanthropic individuals, |
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charitable organizations, governmental entities, and other persons |
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still believe that such reimbursement is an inducement; |
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(7) it is the intent of the legislature to enact |
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legislation to further define and establish a clear difference |
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between items considered to be an inducement for a subject to |
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participate in a cancer clinical trial and the reimbursement of |
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expenses for participating in a cancer clinical trial; and |
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(8) further clarification of the United States Food |
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and Drug Administration's confirmation is appropriate and |
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important to improve subject participation in cancer clinical |
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trials, which is the primary intent of this legislation. |
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SECTION 2. Subtitle B, Title 2, Health and Safety Code, is |
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amended by adding Chapter 50 to read as follows: |
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CHAPTER 50. CANCER CLINICAL TRIAL PARTICIPATION PROGRAM |
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Sec. 50.0001. DEFINITIONS. In this chapter: |
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(1) "Cancer clinical trial" means a research study |
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that subjects an individual to a new cancer treatment, including a |
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medication, chemotherapy, adult stem cell therapy, or other |
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treatment. |
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(2) "Inducement" means the payment of money, including |
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a lump-sum or salary payment, to an individual for the individual's |
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participation in a cancer clinical trial. |
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(3) "Program" means the cancer clinical trial |
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participation program established under this chapter. |
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(4) "Subject" means an individual who participates in |
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the program. |
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Sec. 50.0002. ESTABLISHMENT. A nonprofit organization may |
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develop and implement the cancer clinical trial participation |
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program to provide reimbursement to subjects for ancillary costs |
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associated with participation in a cancer clinical trial, including |
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costs for: |
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(1) travel; |
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(2) lodging; |
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(3) child care; and |
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(4) other costs considered appropriate by the |
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organization. |
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Sec. 50.0003. REQUIREMENTS; NOTICE. (a) The program: |
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(1) must reimburse subjects based on financial need, |
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which may include reimbursement to subjects whose income is at or |
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below 700 percent of the federal poverty level; |
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(2) must provide reimbursement for ancillary costs, |
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including costs described by Section 50.0002, to eliminate the |
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financial barriers to enrollment in a clinical trial; |
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(3) may provide reimbursement for reasonable |
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ancillary costs, including costs described by Section 50.0002, to |
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one family member, friend, or other person who attends a cancer |
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clinical trial to support a subject; and |
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(4) must comply with applicable federal and state |
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laws. |
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(b) The nonprofit organization administering the program |
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shall provide written notice to prospective subjects of the |
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requirements described by Subsection (a). |
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Sec. 50.0004. REIMBURSEMENT REQUIREMENTS; NOTICE. (a) A |
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reimbursement under the program must: |
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(1) be reviewed and approved by the institutional |
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review board associated with the cancer clinical trial for which |
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the reimbursement is provided; and |
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(2) comply with applicable federal and state laws. |
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(b) The nonprofit organization operating the program is not |
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required to obtain approval from an institutional review board on |
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the financial eligibility of a subject who is medically eligible |
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for the program. |
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(c) The nonprofit organization operating the program shall |
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provide written notice to a subject on: |
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(1) the nature and availability of the ancillary |
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financial support under the program; and |
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(2) the program's general guidelines on financial |
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eligibility. |
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Sec. 50.0005. REIMBURSEMENT STATUS AS INDUCEMENT. |
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Reimbursement to a subject through the program does not constitute |
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an inducement or coercion to participate in a cancer clinical |
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trial. |
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Sec. 50.0006. FUNDING. The nonprofit organization that |
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administers the program may accept gifts, grants, and donations |
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from any public or private source to implement this chapter. |
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SECTION 3. This Act takes effect September 1, 2019. |