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
A BILL TO BE ENTITLED
AN ACT
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Administration's draft guidance "Informed Consent Information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; [and]
(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 [COMMITTEE].
SECTION 4. Section 102.155(a), Health and Safety Code, is
amended to read as follows:
(a) The oversight committee shall create [an] ad hoc
committees [committee] of experts to address childhood cancers and
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, [and]
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.