Texas 2025 - 89th Regular

Texas Senate Bill SB1357 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	89R13815 TYPED
2	2	By: Parker S.B. No. 1357
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7	7	A BILL TO BE ENTITLED
8	8	AN ACT
9	9	relating to a cancer clinical trial participation program.
10	10	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
11	11	SECTION 1. The legislature finds that:
12	12	(1) the ability to translate medical findings from
13	13	research to practice relies largely on robust subject participation
14	14	and a diverse subject participation pool in clinical trials;
15	15	(2) diverse subject participation in cancer clinical
16	16	trials depends significantly on whether an individual is able to
17	17	afford ancillary costs, including transportation and lodging,
18	18	during the course of participation in a cancer clinical trial;
19	19	(3) a national study conducted in 2015 found that
20	20	individuals from households with an annual income of less than
21	21	$50,000 were 30 percent less likely to participate in cancer
22	22	clinical trials;
23	23	(4) direct and indirect costs, including
24	24	transportation, lodging, and child-care expenses, prevent eligible
25	25	individuals from participating in cancer clinical trials according
26	26	to the National Cancer Institute;
27	27	(5) the disparities in subject participation in cancer
28	28	clinical trials threaten the basic ethical underpinning of clinical
29	29	research, which requires the benefits of the research to be made
30	30	available equitably among all eligible individuals;
31	31	(6) while the United States Food and Drug
32	32	Administration recently confirmed to Congress and provided
33	33	guidance on its Internet website that reimbursement of direct
34	34	subject-incurred expenses is not an inducement, many
35	35	organizations, research sponsors, philanthropic individuals,
36	36	charitable organizations, governmental entities, and other persons
37	37	still operate under the misconception that such reimbursement is an
38	38	inducement;
39	39	(7) it is the intent of the legislature to enact
40	40	legislation to further define and establish a clear difference
41	41	between items considered to be an inducement for a subject to
42	42	participate in a cancer clinical trial and the reimbursement of
43	43	expenses for participating in a cancer clinical trial; and
44	44	(8) further clarification of the United States Food
45	45	and Drug Administration's confirmation and guidance is appropriate
46	46	and important to improve subject participation in cancer clinical
47	47	trials, which is the primary intent of this legislation.
48	48	SECTION 2. Subtitle B, Title 2, Health and Safety Code, is
49	49	amended by adding Chapter 50 to read as follows:
50	50	CHAPTER 50. CANCER CLINICAL TRIAL PARTICIPATION PROGRAM
51	51	Sec. 50.0001. DEFINITIONS. In this chapter:
52	52	(1) "Cancer clinical trial" means a research study
53	53	that subjects an individual to a new cancer treatment, including a
54	54	medication, chemotherapy, adult stem cell therapy, or other
55	55	treatment.
56	56	(2) "Inducement" means the payment of money, including
57	57	a lump-sum or salary payment, to an individual for the individual's
58	58	participation in a cancer clinical trial.
59	59	(3) "Program" means the cancer clinical trial
60	60	participation program established under this chapter.
61	61	(4) "Subject" means an individual who participates in
62	62	the program.
63	63	Sec. 50.0002. ESTABLISHMENT. A public or private
64	64	institution of higher education, as defined by Section 61.003,
65	65	Education Code, an independent research organization located in
66	66	Texas, or An an independent, third-party organization may develop
67	67	and implement the cancer clinical trial participation program to
68	68	provide reimbursement to subjects for ancillary costs associated
69	69	with participation in a cancer clinical trial, including costs for:
70	70	(1) travel;
71	71	(2) lodging;
72	72	(3) parking and tolls;
73	73	(4) meals or groceries;
74	74	(5) childcare; and
75	75	(4) (6) other costs considered appropriate by the
76	76	organization.
77	77	Sec. 50.0003. REQUIREMENTS; NOTICE. (a) The program:
78	78	(1) must collaborate with physicians and health care
79	79	providers to notify a prospective subject about the program when:
80	80	(A) the prospective subject provides informed
81	81	consent for a cancer clinical trial; or
82	82	(B) funding is available to provide the program
83	83	for the cancer clinical trial in which the prospective subject
84	84	participates;
85	85	(2) must reimburse subjects based on financial need,
86	86	which may include reimbursement to subjects whose income is at or
87	87	below 700 percent of the federal poverty level;
88	88	(3) must provide reimbursement for ancillary costs,
89	89	including costs described by Section 50.0002, to eliminate the
90	90	financial barriers to enrollment in a clinical trial;
91	91	(4) may provide reimbursement for reasonable
92	92	ancillary costs, including costs described by Section 50.0002, to
93	93	one family member, friend, or other person who attends a cancer
94	94	clinical trial to support a subject; and
95	95	(5) must comply with applicable federal and state
96	96	laws.
97	97	(b) The public or private institution of higher education,
98	98	as defined by Section 61.003, Education Code, the independent
99	99	research organization located in Texas, or the independent,
100	100	third-party organization administering the program shall provide
101	101	written notice to prospective subjects of the requirements
102	102	described by Subsection (a).
103	103	Sec. 50.0004. REIMBURSEMENT REQUIREMENTS; NOTICE. (a) A
104	104	reimbursement under the program must:
105	105	(1) be reviewed and approved by the institutional
106	106	review board associated with the cancer clinical trial for which
107	107	the reimbursement is provided; and
108	108	(2) comply with applicable federal and state laws.
109	109	(b) The independent, third-party organization operating the
110	110	program is not required to obtain approval from an institutional
111	111	review board on the financial eligibility of a subject who is
112	112	medically eligible for the program.
113	113	(c) The public or private institution of higher education,
114	114	as defined by Section 61.003, Education Code, the independent
115	115	research organization located in Texas, or the independent,
116	116	third-party organization operating the program shall provide
117	117	written notice to a subject on:
118	118	(1) the nature and availability of the ancillary
119	119	financial support under the program; and
120	120	(2) the program's general guidelines on financial
121	121	eligibility.
122	122	Sec. 50.0005. REIMBURSEMENT STATUS AS INDUCEMENT.
123	123	Reimbursement to a subject of ancillary costs under the program:
124	124	(1) does not constitute an inducement to participate
125	125	in a cancer clinical trial;
126	126	(2) is not considered coercion or the exertion of
127	127	undue influence to participate in a cancer clinical trial; and
128	128	(3) is meant to accomplish parity in access to cancer
129	129	clinical trials and remove barriers to participation in cancer
130	130	clinical trials for financially burdened subjects.
131	131	Sec. 50.0006. FUNDING. The public or private institution
132	132	of higher education, as defined by Section 61.003, Education Code,
133	133	the independent research organization located in Texas, or the
134	134	independent, third-party organization that administers the program
135	135	may accept gifts, grants, and donations from any public or private
136	136	source to implement this chapter.
137	137	Sec. 50.0007. COLLABORATION. The public or private
138	138	institution of higher education, as defined by Section 61.003,
139	139	Education Code, the independent research organization located in
140	140	Texas, or the independent, third-party organization that
141	141	administers the program may collaborate with the Cancer Prevention
142	142	and Research Institute of Texas established under Chapter 102 to
143	143	provide reimbursement under the program.