81R9107 DAK-D
By: Watson S.B. No. 2030
A BILL TO BE ENTITLED
AN ACT
relating to the regulation of certain research.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle G, Title 10, Government Code, is
amended by adding Chapter 2312 to read as follows:
CHAPTER 2312. REGULATION OF CERTAIN RESEARCH
Sec. 2312.001. DEFINITIONS. In this chapter:
(1) "Institutional review board" includes an
independent ethics committee or ethical review board designated to
approve research by the United States Department of Health and
Human Services, the United States Food and Drug Administration, or
any other federal agency or entity.
(2) "Permit" means a license, certificate, approval,
registration, consent, permit, contract, or other agreement
related to conducting research in this state or other form of
authorization required by law, rule, order, or ordinance that a
person must obtain from a regulatory agency to conduct research in
this state or initiate, continue, or complete a project for which a
permit is sought.
(3) "Project" means research over which a regulatory
agency exerts its jurisdiction and for which one or more permits are
required to initiate, continue, or complete the research.
(4) "Regulatory agency" means this state or a
political subdivision of this state and includes a bureau,
department, division, board, commission, or other agency of this
state or the governing body of that entity.
(5) "Research" means a scientific endeavor for which
approval by an institutional review board is required.
Sec. 2312.002. APPLICABILITY OF CHAPTER. This chapter
applies only to a project conducted through:
(1) a public or private institution of higher
education in this state; or
(2) a business entity authorized to engage in business
in this state.
Sec. 2312.003. DATE OF VESTING OF PROJECT. (a) Subject to
Subsection (b), a project vests on the date an institutional review
board issues an initial approval of a project.
(b) A project for which an institutional review board issues
an initial approval before September 1, 2009, vests on September 1,
2009.
Sec. 2312.004. EFFECT OF VESTING. When a project is vested,
an applicant for a permit from a regulatory agency in relation to
the project is entitled to the rights described by this chapter.
Sec. 2312.005. ENTITLEMENT TO UNIFORMITY OF REQUIREMENTS.
An applicant for a permit from a regulatory agency for a project
vested as provided by Section 2312.003, including a permit for a
part of the project, is entitled to have the regulatory agency
consider the approval, disapproval, or conditional approval of the
permit solely on the basis of any order, ordinance, rule,
expiration date, or other properly adopted requirement in effect on
the date the project vested.
Sec. 2312.006. ENTITLEMENT APPLIES TO SUBSEQUENT RESEARCH
AND COMMERCIALIZATION. The right described by Section 2312.005 in
relation to a project or a part of a project begins on the date the
project vests and continues:
(1) through scientific endeavor subsequent to the
original research, without regard to whether the endeavor requires
approval by an institutional review board, if the endeavor
continues or relates to the purposes of the project; and
(2) through commercialization efforts subsequent to
the original research if those efforts continue or relate to the
purposes of the project.
Sec. 2312.007. SERIES OF PERMITS. (a) If a series of
permits from a regulatory agency is required for a project, the
order, ordinance, rule, expiration date, or other properly adopted
requirement in effect on the date the original application for the
first permit in that series is filed shall be the sole basis for
consideration of all subsequent permits required for completion of
the project.
(b) All permits required for a project from a regulatory
agency are considered to be a single series of permits.
Sec. 2312.008. CHANGE IN DURATION. On or after the date
that a project is vested, a regulatory agency may not shorten the
duration of any permit required for the project.
Sec. 2312.009. PERMIT CHANGES THAT BENEFIT PROJECT.
Notwithstanding any other provision of this chapter, a permit
holder may take advantage of a change to the law relating to a
regulatory agency or a rule or ordinance of a regulatory agency that
benefits, enhances, or protects the project, including changes that
lengthen the effective life of the permit after the date the project
vested, without forfeiting any right under this chapter.
Sec. 2312.010. TECHNICAL PERMIT REQUIREMENTS. This chapter
does not prohibit a regulatory agency from requiring compliance
with a technical requirement relating to the form and content of an
application for a permit for a project in effect at the time the
application is filed, even if the application is filed after the
date the project is vested.
Sec. 2312.011. EXEMPTIONS. This chapter does not apply to a
change relating to a permit for a project that a regulatory agency
has adopted on or after the date the project vested if the change:
(1) is enacted solely to address an imminent threat of
destruction of property or injury to a person; or
(2) results in an increased fee for the permit if the
increase is reasonably related to the administrative costs
associated with issuing the permit.
Sec. 2312.012. ENFORCEMENT OF CHAPTER. (a) This chapter
may be enforced only through mandamus or declaratory or injunctive
relief.
(b) The immunity of a regulatory agency from suit is waived
for an action under this chapter.
SECTION 2. This Act applies to a research project without
regard to whether the project began before, on, or after the
effective date of this Act.
SECTION 3. This Act takes effect September 1, 2009.