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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 significantly on whether an individual is able to |
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afford ancillary costs, including transportation and lodging, |
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during the 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 30 percent less likely to participate in cancer |
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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 and provided |
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guidance on its Internet website that reimbursement of direct |
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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 operate under the misconception that such reimbursement is an |
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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 and guidance is appropriate |
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and 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. An independent, third-party |
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organization may develop and implement the cancer clinical trial |
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participation program to provide reimbursement to subjects for |
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ancillary costs associated with participation in a cancer clinical |
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trial, including costs for: |
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(1) travel; |
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(2) lodging; |
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(3) parking and tolls; 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 collaborate with physicians and health care |
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providers to notify a prospective subject about the program when: |
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(A) the prospective subject provides informed |
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consent for a cancer clinical trial; or |
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(B) funding is available to provide the program |
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for the cancer clinical trial in which the prospective subject |
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participates; |
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(2) 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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(3) 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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(4) 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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(5) must comply with applicable federal and state |
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laws. |
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(b) The independent, third-party organization |
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administering the program shall provide written notice to |
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prospective subjects of the requirements described by Subsection |
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(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 independent, third-party organization operating the |
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program is not required to obtain approval from an institutional |
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review board on the financial eligibility of a subject who is |
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medically eligible for the program. |
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(c) The independent, third-party organization operating the |
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program shall 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 of ancillary costs under the program: |
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(1) does not constitute an inducement to participate |
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in a cancer clinical trial; |
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(2) is not considered coercion or the exertion of |
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undue influence to participate in a cancer clinical trial; and |
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(3) is meant to accomplish parity in access to cancer |
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clinical trials and remove barriers to participation in cancer |
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clinical trials for financially burdened subjects. |
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Sec. 50.0006. FUNDING. The independent, third-party |
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organization that administers the program may accept gifts, grants, |
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and donations from any public or private source to implement this |
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chapter. |
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Sec. 50.0007. COLLABORATION. The independent, third-party |
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organization that administers the program may collaborate with the |
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Cancer Prevention and Research Institute of Texas established under |
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Chapter 102 to provide reimbursement under the program. |
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SECTION 3. Section 102.203(b), Health and Safety Code, is |
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amended to read as follows: |
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(b) Except as otherwise provided by this section, money |
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awarded under this subchapter may be used for authorized expenses, |
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including honoraria, salaries and benefits, travel, conference |
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fees and expenses, consumable supplies, other operating expenses, |
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contracted research and development, capital equipment, [and] |
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construction or renovation of state or private facilities, and |
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reimbursement for costs of participation incurred by cancer |
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clinical trial participants, including transportation, lodging, |
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and any costs reimbursed under the cancer clinical trial |
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participation program established under Chapter 50. |
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SECTION 4. This Act takes effect September 1, 2019. |
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______________________________ |
______________________________ |
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President of the Senate |
Speaker of the House |
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I certify that H.B. No. 3147 was passed by the House on May |
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10, 2019, by the following vote: Yeas 128, Nays 3, 1 present, not |
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voting. |
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______________________________ |
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Chief Clerk of the House |
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I certify that H.B. No. 3147 was passed by the Senate on May |
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22, 2019, by the following vote: Yeas 31, Nays 0. |
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______________________________ |
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Secretary of the Senate |
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APPROVED: _____________________ |
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Date |
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_____________________ |
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Governor |