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SECTION 1. (a) This Act
shall be known as the Improve 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 having robust
patient participation and a diverse participation pool during cancer
clinical trials;
(2) diverse patient
participation in cancer clinical trial depends, in part, on whether a
participant can afford ancillary costs like transportation and lodging
during the course of the patient's participation;
(3) there are significant
health disparities that exist among socioeconomic, racial, ethnic, and
regional groups in Texas; and
(4) this disparity threatens
one of the most basic ethical underpinnings of clinical research, the
requirements that the benefits of research be made available equitably
among all eligible individuals.
(c) It is the intent of the
legislature to:
(1) establish a program in
the state that encourages greater patient access to cancer clinical trials;
(2) assist patients facing
financial barriers that inhibit their participation in cancer clinical
trials, or assist patients who have been identified as priorities for
health services to participate in cancer clinical trials by reimbursing
direct patient incurred expenses; and
(3) ensure these trials are
widely accessible, improve the development of therapies, and enhance
innovation.
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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.
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SECTION 2. Chapter 102.051,
Health and Safety Code, is amended to read as follows:
Sec. 102.051. POWERS AND
DUTIES. (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 to encourage
access to and participation in 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.
(b) The institute shall work
to implement the Texas Cancer Plan and continually monitor and revise the
Texas Cancer Plan as necessary.
(c) The institute shall
employ a chief compliance officer to monitor and report to the oversight
committee regarding compliance with this chapter and rules adopted under
this chapter.
(d) The chief compliance
officer shall:
(1) 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
(2) attend and observe the
meetings of the program integration committee to ensure compliance with
this chapter and rules adopted under this chapter.
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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.
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SECTION 3. Chapter 102.155,
Health and Safety Code, is amended to read as follows:
Sec. 102.155. AD HOC
ADVISORY COMMITTEE.
(a) The oversight committee
shall create an ad hoc committees of experts to address issues including childhood cancers and
access to 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.
(b) Ad hoc committee members
shall serve for a period determined by the oversight committee.
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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 [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.
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SECTION 4. Chapter 102.203,
Health and Safety Code, is amended to read as follows:
Sec. 102.203. AUTHORIZED USE
OF FUNDS. (a) A person awarded money from the cancer prevention and
research fund or from bond proceeds under this subchapter may use the money
for research consistent with the purpose of this chapter and in accordance
with a contract between the person and the institute.
(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 financial assistance for costs related
to participation in clinical trials such as transportation and lodging.
(c) A person receiving money
under this subchapter for cancer research may not spend more than five
percent of the money for indirect costs. For purposes of this subsection,
"indirect costs" means the expenses of doing business that are
not readily identified with a particular grant, contract, project,
function, or activity, but are necessary for the general operation of the
organization or the performance of the organization's activities.
(d) Not more than five
percent of the money awarded under this subchapter may be used for facility
purchase, construction, remodel, or renovation purposes during any year.
Expenditures of money awarded under this subchapter for facility purchase,
construction, remodel, or renovation projects must benefit cancer
prevention and research.
(e) Not more than 10 percent
of the money awarded under this subchapter may be used for cancer prevention
and control programs during any year.
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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.
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