Bill Text: TX HB3721 | 2017-2018 | 85th Legislature | Comm Sub
Bill Title: Relating to access to and participation in cancer clinical trials.
Spectrum: Partisan Bill (Republican 5-0)
Status: (Introduced - Dead) 2017-05-08 - Placed on General State Calendar [HB3721 Detail]
Download: Texas-2017-HB3721-Comm_Sub.html
85R23634 JG-F | |||
By: Parker | H.B. No. 3721 | ||
Substitute the following for H.B. No. 3721: | |||
By: Price | C.S.H.B. No. 3721 |
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relating to access to and participation in cancer clinical trials. | ||
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: | ||
SECTION 1. (a) This Act shall be known as the "Improving | ||
Patient Access to Cancer Clinical Trials Act." | ||
(b) The legislature finds that: | ||
(1) the ability to translate medical findings from | ||
research to practice relies largely on robust patient participation | ||
and a diverse participation pool in cancer clinical trials; | ||
(2) diverse patient participation in cancer clinical | ||
trials depends partly on whether a participant is able to afford | ||
ancillary costs, including transportation and lodging, during the | ||
course of the patient's participation; | ||
(3) significant health disparities exist among | ||
socioeconomic, racial, ethnic, and regional groups in this state; | ||
and | ||
(4) the health disparities threaten one of the most | ||
basic ethical underpinnings of clinical research: the benefits of | ||
research must be made available equitably among all eligible | ||
individuals. | ||
(c) It is the intent of the legislature to: | ||
(1) provide for a program in this state that | ||
encourages greater patient access to cancer clinical trials; | ||
(2) assist patients who are facing financial barriers | ||
that limit their ability to participate in cancer clinical trials | ||
and patients who have been identified as a priority for health | ||
services in participating in cancer clinical trials by reimbursing | ||
the patients for directly incurred expenses; | ||
(3) ensure that cancer clinical trials are widely | ||
accessible, improve the development of cancer therapy, and enhance | ||
innovation in cancer research and treatment; and | ||
(4) clearly provide that the reimbursement of direct | ||
costs incurred by a cancer clinical trial participant or ancillary | ||
medical costs incurred by a third party does not constitute | ||
coercion or undue influence and instead improves access to cancer | ||
clinical trials as supported by the United States Food and Drug | ||
Administration's draft guidance "Informed Consent Information | ||
Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors," | ||
which provides that the payments made to cancer clinical trial | ||
participants are considered reimbursement for expenses and | ||
inconveniences and not a benefit of participation. | ||
SECTION 2. Section 102.051(a), Health and Safety Code, is | ||
amended to read as follows: | ||
(a) The institute: | ||
(1) may make grants to provide funds to public or | ||
private persons to implement the Texas Cancer Plan, and may make | ||
grants to institutions of learning and to advanced medical research | ||
facilities and collaborations in this state for: | ||
(A) research into the causes of and cures for all | ||
types of cancer in humans; | ||
(B) facilities for use in research into the | ||
causes of and cures for cancer; | ||
(C) research, including translational research, | ||
to develop therapies, protocols, medical pharmaceuticals, or | ||
procedures for the cure or substantial mitigation of all types of | ||
cancer in humans; [ |
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(D) cancer prevention and control programs in | ||
this state to mitigate the incidence of all types of cancer in | ||
humans; and | ||
(E) programs designed to encourage access to and | ||
participation in cancer clinical trials and associated research and | ||
community outreach; | ||
(2) may support institutions of learning and advanced | ||
medical research facilities and collaborations in this state in all | ||
stages in the process of finding the causes of all types of cancer | ||
in humans and developing cures, from laboratory research to | ||
clinical trials and including programs to address the problem of | ||
access to advanced cancer treatment; | ||
(3) may establish the appropriate standards and | ||
oversight bodies to ensure the proper use of funds authorized under | ||
this chapter for cancer research and facilities development; | ||
(4) may employ necessary staff to provide | ||
administrative support; | ||
(5) shall continuously monitor contracts and | ||
agreements authorized by this chapter and ensure that each grant | ||
recipient complies with the terms and conditions of the grant | ||
contract; | ||
(6) shall ensure that all grant proposals comply with | ||
this chapter and rules adopted under this chapter before the | ||
proposals are submitted to the oversight committee for approval; | ||
and | ||
(7) shall establish procedures to document that the | ||
institute, its employees, and its committee members appointed under | ||
this chapter comply with all laws and rules governing the peer | ||
review process and conflicts of interest. | ||
SECTION 3. The heading to Section 102.155, Health and | ||
Safety Code, is amended to read as follows: | ||
Sec. 102.155. AD HOC ADVISORY COMMITTEES [ |
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SECTION 4. Section 102.155(a), Health and Safety Code, is | ||
amended to read as follows: | ||
(a) The oversight committee shall create [ |
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committees [ |
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access to and participation in cancer clinical trials. The | ||
oversight committee, as necessary, may create additional ad hoc | ||
committees of experts to advise the oversight committee on issues | ||
relating to cancer. | ||
SECTION 5. 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, [ |
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construction or renovation of state or private facilities, and | ||
reimbursement for costs incurred by cancer clinical trial | ||
participants that are related to the participation, including | ||
transportation and lodging. | ||
SECTION 6. This Act takes effect September 1, 2017. |