By: Parker H.B. No. 3721
A BILL TO BE ENTITLED
AN ACT
relating to the authority of the Cancer Prevention and Research
Institute of Texas to administer the Texas Cancer Clinical Trials
Program.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
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.
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.
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.
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.
SECTION 5. This Act takes effect September 1, 2017.