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A BILL TO BE ENTITLED
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AN ACT
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relating to access to and participation in cancer clinical trials. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. (a) This Act shall be known as the "Improving |
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Patient Access to Cancer Clinical Trials Act." |
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(b) 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 patient participation |
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and a diverse participation pool in cancer clinical trials; |
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(2) diverse patient participation in cancer clinical |
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trials depends partly on whether a participant is able to afford |
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ancillary costs, including transportation and lodging, during the |
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course of the patient's participation; |
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(3) significant health disparities exist among |
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socioeconomic, racial, ethnic, and regional groups in this state; |
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and |
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(4) the health disparities threaten one of the most |
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basic ethical underpinnings of clinical research: the benefits of |
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research must be made available equitably among all eligible |
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individuals. |
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(c) It is the intent of the legislature to: |
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(1) provide for a program in this state that |
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encourages greater patient access to cancer clinical trials; |
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(2) assist patients who are facing financial barriers |
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that limit their ability to participate in cancer clinical trials |
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and patients who have been identified as a priority for health |
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services in participating in cancer clinical trials by reimbursing |
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the patients for directly incurred expenses; |
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(3) ensure that cancer clinical trials are widely |
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accessible, improve the development of cancer therapy, and enhance |
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innovation in cancer research and treatment; and |
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(4) clearly provide that the reimbursement of direct |
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costs incurred by a cancer clinical trial participant or ancillary |
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medical costs incurred by a third party does not constitute |
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coercion or undue influence and instead improves access to cancer |
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clinical trials as supported by the United States Food and Drug |
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Administration's draft guidance "Informed Consent Information |
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Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors," |
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which provides that the payments made to cancer clinical trial |
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participants are considered reimbursement for expenses and |
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inconveniences and not a benefit of participation. |
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SECTION 2. Section 102.051(a), Health and Safety Code, is |
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amended to read as follows: |
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(a) The institute: |
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(1) may make grants to provide funds to public or |
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private persons to implement the Texas Cancer Plan, and may make |
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grants to institutions of learning and to advanced medical research |
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facilities and collaborations in this state for: |
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(A) research into the causes of and cures for all |
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types of cancer in humans; |
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(B) facilities for use in research into the |
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causes of and cures for cancer; |
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(C) research, including translational research, |
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to develop therapies, protocols, medical pharmaceuticals, or |
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procedures for the cure or substantial mitigation of all types of |
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cancer in humans; [and] |
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(D) cancer prevention and control programs in |
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this state to mitigate the incidence of all types of cancer in |
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humans; and |
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(E) programs designed to encourage access to and |
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participation in cancer clinical trials and associated research and |
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community outreach; |
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(2) may support institutions of learning and advanced |
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medical research facilities and collaborations in this state in all |
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stages in the process of finding the causes of all types of cancer |
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in humans and developing cures, from laboratory research to |
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clinical trials and including programs to address the problem of |
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access to advanced cancer treatment; |
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(3) may establish the appropriate standards and |
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oversight bodies to ensure the proper use of funds authorized under |
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this chapter for cancer research and facilities development; |
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(4) may employ necessary staff to provide |
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administrative support; |
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(5) shall continuously monitor contracts and |
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agreements authorized by this chapter and ensure that each grant |
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recipient complies with the terms and conditions of the grant |
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contract; |
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(6) shall ensure that all grant proposals comply with |
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this chapter and rules adopted under this chapter before the |
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proposals are submitted to the oversight committee for approval; |
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and |
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(7) shall establish procedures to document that the |
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institute, its employees, and its committee members appointed under |
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this chapter comply with all laws and rules governing the peer |
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review process and conflicts of interest. |
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SECTION 3. The heading to Section 102.155, Health and |
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Safety Code, is amended to read as follows: |
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Sec. 102.155. AD HOC ADVISORY COMMITTEES [COMMITTEE]. |
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SECTION 4. Section 102.155(a), Health and Safety Code, is |
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amended to read as follows: |
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(a) The oversight committee shall create [an] ad hoc |
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committees [committee] of experts to address childhood cancers and |
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access to and participation in cancer clinical trials. The |
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oversight committee, as necessary, may create additional ad hoc |
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committees of experts to advise the oversight committee on issues |
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relating to cancer. |
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SECTION 5. 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 incurred by cancer clinical trial |
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participants that are related to the participation, including |
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transportation and lodging. |
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SECTION 6. This Act takes effect September 1, 2017. |