TX
Texas House Bill HB3721

Texas 2017 - 85th Regular

Texas House Bill HB3721 Compare Versions

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1-85R23634 JG-F
21 By: Parker H.B. No. 3721
3- Substitute the following for H.B. No. 3721:
4- By: Price C.S.H.B. No. 3721
52
63
74 A BILL TO BE ENTITLED
85 AN ACT
9- relating to access to and participation in cancer clinical trials.
6+ relating to the authority of the Cancer Prevention and Research
7+ Institute of Texas to administer the Texas Cancer Clinical Trials
8+ Program.
109 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
11- SECTION 1. (a) This Act shall be known as the "Improving
12- Patient Access to Cancer Clinical Trials Act."
10+ SECTION 1. (a) This Act shall be known as the Improve
11+ Patient Access to Cancer Clinical Trials Act.
1312 (b) The legislature finds that:
1413 (1) the ability to translate medical findings from
15- research to practice relies largely on robust patient participation
16- and a diverse participation pool in cancer clinical trials;
14+ research to practice relies largely on having robust patient
15+ participation and a diverse participation pool during cancer
16+ clinical trials;
1717 (2) diverse patient participation in cancer clinical
18- trials depends partly on whether a participant is able to afford
19- ancillary costs, including transportation and lodging, during the
20- course of the patient's participation;
21- (3) significant health disparities exist among
22- socioeconomic, racial, ethnic, and regional groups in this state;
23- and
24- (4) the health disparities threaten one of the most
25- basic ethical underpinnings of clinical research: the benefits of
26- research must be made available equitably among all eligible
27- individuals.
18+ trial depends, in part, on whether a participant can afford
19+ ancillary costs like transportation and lodging during the course
20+ of the patient's participation;
21+ (3) there are significant health disparities that
22+ exist among socioeconomic, racial, ethnic, and regional groups in
23+ Texas; and
24+ (4) this disparity threatens one of the most basic
25+ ethical underpinnings of clinical research, the requirements that
26+ the benefits of research be made available equitably among all
27+ eligible individuals.
2828 (c) It is the intent of the legislature to:
29- (1) provide for a program in this state that
30- encourages greater patient access to cancer clinical trials;
31- (2) assist patients who are facing financial barriers
32- that limit their ability to participate in cancer clinical trials
33- and patients who have been identified as a priority for health
34- services in participating in cancer clinical trials by reimbursing
35- the patients for directly incurred expenses;
36- (3) ensure that cancer clinical trials are widely
37- accessible, improve the development of cancer therapy, and enhance
38- innovation in cancer research and treatment; and
39- (4) clearly provide that the reimbursement of direct
40- costs incurred by a cancer clinical trial participant or ancillary
41- medical costs incurred by a third party does not constitute
42- coercion or undue influence and instead improves access to cancer
43- clinical trials as supported by the United States Food and Drug
44- Administration's draft guidance "Informed Consent Information
45- Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors,"
46- which provides that the payments made to cancer clinical trial
47- participants are considered reimbursement for expenses and
48- inconveniences and not a benefit of participation.
49- SECTION 2. Section 102.051(a), Health and Safety Code, is
29+ (1) establish a program in the state that encourages
30+ greater patient access to cancer clinical trials;
31+ (2) assist patients facing financial barriers that
32+ inhibit their participation in cancer clinical trials, or assist
33+ patients who have been identified as priorities for health services
34+ to participate in cancer clinical trials by reimbursing direct
35+ patient incurred expenses; and
36+ (3) ensure these trials are widely accessible, improve
37+ the development of therapies, and enhance innovation.
38+ SECTION 2. Chapter 102.051, Health and Safety Code, is
5039 amended to read as follows:
51- (a) The institute:
40+ Sec. 102.051. POWERS AND DUTIES. (a) The institute:
5241 (1) may make grants to provide funds to public or
5342 private persons to implement the Texas Cancer Plan, and may make
5443 grants to institutions of learning and to advanced medical research
5544 facilities and collaborations in this state for:
5645 (A) research into the causes of and cures for all
5746 types of cancer in humans;
5847 (B) facilities for use in research into the
5948 causes of and cures for cancer;
6049 (C) research, including translational research,
6150 to develop therapies, protocols, medical pharmaceuticals, or
6251 procedures for the cure or substantial mitigation of all types of
63- cancer in humans; [and]
52+ cancer in humans; and
6453 (D) cancer prevention and control programs in
6554 this state to mitigate the incidence of all types of cancer in
6655 humans; and
67- (E) programs designed to encourage access to and
68- participation in cancer clinical trials and associated research and
69- community outreach;
56+ (E) programs to encourage access to and
57+ participation in clinical trials and associated research and
58+ community outreach.
7059 (2) may support institutions of learning and advanced
7160 medical research facilities and collaborations in this state in all
7261 stages in the process of finding the causes of all types of cancer
7362 in humans and developing cures, from laboratory research to
7463 clinical trials and including programs to address the problem of
7564 access to advanced cancer treatment;
7665 (3) may establish the appropriate standards and
7766 oversight bodies to ensure the proper use of funds authorized under
7867 this chapter for cancer research and facilities development;
7968 (4) may employ necessary staff to provide
8069 administrative support;
8170 (5) shall continuously monitor contracts and
8271 agreements authorized by this chapter and ensure that each grant
8372 recipient complies with the terms and conditions of the grant
8473 contract;
8574 (6) shall ensure that all grant proposals comply with
8675 this chapter and rules adopted under this chapter before the
8776 proposals are submitted to the oversight committee for approval;
8877 and
8978 (7) shall establish procedures to document that the
9079 institute, its employees, and its committee members appointed under
9180 this chapter comply with all laws and rules governing the peer
9281 review process and conflicts of interest.
93- SECTION 3. The heading to Section 102.155, Health and
94- Safety Code, is amended to read as follows:
95- Sec. 102.155. AD HOC ADVISORY COMMITTEES [COMMITTEE].
96- SECTION 4. Section 102.155(a), Health and Safety Code, is
82+ (b) The institute shall work to implement the Texas Cancer
83+ Plan and continually monitor and revise the Texas Cancer Plan as
84+ necessary.
85+ (c) The institute shall employ a chief compliance officer to
86+ monitor and report to the oversight committee regarding compliance
87+ with this chapter and rules adopted under this chapter.
88+ (d) The chief compliance officer shall:
89+ (1) ensure that all grant proposals comply with this
90+ chapter and rules adopted under this chapter before the proposals
91+ are submitted to the oversight committee for approval; and
92+ (2) attend and observe the meetings of the program
93+ integration committee to ensure compliance with this chapter and
94+ rules adopted under this chapter.
95+ SECTION 3. Chapter 102.155, Health and Safety Code, is
9796 amended to read as follows:
98- (a) The oversight committee shall create [an] ad hoc
99- committees [committee] of experts to address childhood cancers and
100- access to and participation in cancer clinical trials. The
101- oversight committee, as necessary, may create additional ad hoc
97+ Sec. 102.155. AD HOC ADVISORY COMMITTEE. (a) The oversight
98+ committee shall create an ad hoc committees of experts to address
99+ issues including childhood cancers and access to clinical trials.
100+ The oversight committee, as necessary, may create additional ad hoc
102101 committees of experts to advise the oversight committee on issues
103102 relating to cancer.
104- SECTION 5. Section 102.203(b), Health and Safety Code, is
103+ (b) Ad hoc committee members shall serve for a period
104+ determined by the oversight committee.
105+ SECTION 4. Chapter 102.203, Health and Safety Code, is
105106 amended to read as follows:
107+ Sec. 102.203. AUTHORIZED USE OF FUNDS. (a) A person
108+ awarded money from the cancer prevention and research fund or from
109+ bond proceeds under this subchapter may use the money for research
110+ consistent with the purpose of this chapter and in accordance with a
111+ contract between the person and the institute.
106112 (b) Except as otherwise provided by this section, money
107113 awarded under this subchapter may be used for authorized expenses,
108114 including honoraria, salaries and benefits, travel, conference
109115 fees and expenses, consumable supplies, other operating expenses,
110- contracted research and development, capital equipment, [and]
116+ contracted research and development, capital equipment, and
111117 construction or renovation of state or private facilities, and
112- reimbursement for costs incurred by cancer clinical trial
113- participants that are related to the participation, including
114- transportation and lodging.
115- SECTION 6. This Act takes effect September 1, 2017.
118+ financial assistance for costs related to participation in
119+ clinical trials such as transportation and lodging.
120+ (c) A person receiving money under this subchapter for
121+ cancer research may not spend more than five percent of the money
122+ for indirect costs. For purposes of this subsection, "indirect
123+ costs" means the expenses of doing business that are not readily
124+ identified with a particular grant, contract, project, function, or
125+ activity, but are necessary for the general operation of the
126+ organization or the performance of the organization's activities.
127+ (d) Not more than five percent of the money awarded under
128+ this subchapter may be used for facility purchase, construction,
129+ remodel, or renovation purposes during any year. Expenditures of
130+ money awarded under this subchapter for facility purchase,
131+ construction, remodel, or renovation projects must benefit cancer
132+ prevention and research.
133+ (e) Not more than 10 percent of the money awarded under this
134+ subchapter may be used for cancer prevention and control programs
135+ during any year.
136+ SECTION 5. This Act takes effect September 1, 2017.