Texas 2009 - 81st Regular

Texas Senate Bill SB2030 Compare Versions

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

Old	New	Differences
1	1	81R9107 DAK-D
2	2	By: Watson S.B. No. 2030
3	3
4	4
5	5	A BILL TO BE ENTITLED
6	6	AN ACT
7	7	relating to the regulation of certain research.
8	8	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
9	9	SECTION 1. Subtitle G, Title 10, Government Code, is
10	10	amended by adding Chapter 2312 to read as follows:
11	11	CHAPTER 2312. REGULATION OF CERTAIN RESEARCH
12	12	Sec. 2312.001. DEFINITIONS. In this chapter:
13	13	(1) "Institutional review board" includes an
14	14	independent ethics committee or ethical review board designated to
15	15	approve research by the United States Department of Health and
16	16	Human Services, the United States Food and Drug Administration, or
17	17	any other federal agency or entity.
18	18	(2) "Permit" means a license, certificate, approval,
19	19	registration, consent, permit, contract, or other agreement
20	20	related to conducting research in this state or other form of
21	21	authorization required by law, rule, order, or ordinance that a
22	22	person must obtain from a regulatory agency to conduct research in
23	23	this state or initiate, continue, or complete a project for which a
24	24	permit is sought.
25	25	(3) "Project" means research over which a regulatory
26	26	agency exerts its jurisdiction and for which one or more permits are
27	27	required to initiate, continue, or complete the research.
28	28	(4) "Regulatory agency" means this state or a
29	29	political subdivision of this state and includes a bureau,
30	30	department, division, board, commission, or other agency of this
31	31	state or the governing body of that entity.
32	32	(5) "Research" means a scientific endeavor for which
33	33	approval by an institutional review board is required.
34	34	Sec. 2312.002. APPLICABILITY OF CHAPTER. This chapter
35	35	applies only to a project conducted through:
36	36	(1) a public or private institution of higher
37	37	education in this state; or
38	38	(2) a business entity authorized to engage in business
39	39	in this state.
40	40	Sec. 2312.003. DATE OF VESTING OF PROJECT. (a) Subject to
41	41	Subsection (b), a project vests on the date an institutional review
42	42	board issues an initial approval of a project.
43	43	(b) A project for which an institutional review board issues
44	44	an initial approval before September 1, 2009, vests on September 1,
45	45	2009.
46	46	Sec. 2312.004. EFFECT OF VESTING. When a project is vested,
47	47	an applicant for a permit from a regulatory agency in relation to
48	48	the project is entitled to the rights described by this chapter.
49	49	Sec. 2312.005. ENTITLEMENT TO UNIFORMITY OF REQUIREMENTS.
50	50	An applicant for a permit from a regulatory agency for a project
51	51	vested as provided by Section 2312.003, including a permit for a
52	52	part of the project, is entitled to have the regulatory agency
53	53	consider the approval, disapproval, or conditional approval of the
54	54	permit solely on the basis of any order, ordinance, rule,
55	55	expiration date, or other properly adopted requirement in effect on
56	56	the date the project vested.
57	57	Sec. 2312.006. ENTITLEMENT APPLIES TO SUBSEQUENT RESEARCH
58	58	AND COMMERCIALIZATION. The right described by Section 2312.005 in
59	59	relation to a project or a part of a project begins on the date the
60	60	project vests and continues:
61	61	(1) through scientific endeavor subsequent to the
62	62	original research, without regard to whether the endeavor requires
63	63	approval by an institutional review board, if the endeavor
64	64	continues or relates to the purposes of the project; and
65	65	(2) through commercialization efforts subsequent to
66	66	the original research if those efforts continue or relate to the
67	67	purposes of the project.
68	68	Sec. 2312.007. SERIES OF PERMITS. (a) If a series of
69	69	permits from a regulatory agency is required for a project, the
70	70	order, ordinance, rule, expiration date, or other properly adopted
71	71	requirement in effect on the date the original application for the
72	72	first permit in that series is filed shall be the sole basis for
73	73	consideration of all subsequent permits required for completion of
74	74	the project.
75	75	(b) All permits required for a project from a regulatory
76	76	agency are considered to be a single series of permits.
77	77	Sec. 2312.008. CHANGE IN DURATION. On or after the date
78	78	that a project is vested, a regulatory agency may not shorten the
79	79	duration of any permit required for the project.
80	80	Sec. 2312.009. PERMIT CHANGES THAT BENEFIT PROJECT.
81	81	Notwithstanding any other provision of this chapter, a permit
82	82	holder may take advantage of a change to the law relating to a
83	83	regulatory agency or a rule or ordinance of a regulatory agency that
84	84	benefits, enhances, or protects the project, including changes that
85	85	lengthen the effective life of the permit after the date the project
86	86	vested, without forfeiting any right under this chapter.
87	87	Sec. 2312.010. TECHNICAL PERMIT REQUIREMENTS. This chapter
88	88	does not prohibit a regulatory agency from requiring compliance
89	89	with a technical requirement relating to the form and content of an
90	90	application for a permit for a project in effect at the time the
91	91	application is filed, even if the application is filed after the
92	92	date the project is vested.
93	93	Sec. 2312.011. EXEMPTIONS. This chapter does not apply to a
94	94	change relating to a permit for a project that a regulatory agency
95	95	has adopted on or after the date the project vested if the change:
96	96	(1) is enacted solely to address an imminent threat of
97	97	destruction of property or injury to a person; or
98	98	(2) results in an increased fee for the permit if the
99	99	increase is reasonably related to the administrative costs
100	100	associated with issuing the permit.
101	101	Sec. 2312.012. ENFORCEMENT OF CHAPTER. (a) This chapter
102	102	may be enforced only through mandamus or declaratory or injunctive
103	103	relief.
104	104	(b) The immunity of a regulatory agency from suit is waived
105	105	for an action under this chapter.
106	106	SECTION 2. This Act applies to a research project without
107	107	regard to whether the project began before, on, or after the
108	108	effective date of this Act.
109	109	SECTION 3. This Act takes effect September 1, 2009.