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