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Texas Senate Bill SB73

Texas 2009 - 81st Regular

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11 By: Nelson, Patrick S.B. No. 73
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44 A BILL TO BE ENTITLED
55 AN ACT
66 relating to the establishment of an adult stem cell research
77 program and to certain reporting requirements with regard to
88 research involving human stem cells or human cloning.
99 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1010 SECTION 1. Subtitle H, Title 3, Education Code, is amended
1111 by adding Chapter 156 to read as follows:
1212 CHAPTER 156. ADULT STEM CELL RESEARCH PROGRAM
1313 Sec. 156.001. DEFINITIONS. In this chapter:
1414 (1) "Adult stem cell" means an undifferentiated cell
1515 that is:
1616 (A) found among differentiated cells in tissues
1717 or fluids; and
1818 (B) able to renew itself and differentiate to
1919 yield all or nearly all of the specialized cell types needed for
2020 clinical applications.
2121 (2) "Advisory committee" means the advisory committee
2222 appointed under Section 156.006.
2323 (3) "Consortium" means the Texas Adult Stem Cell
2424 Research Consortium.
2525 (4) "Coordinating board" means the Texas Higher
2626 Education Coordinating Board.
2727 (5) "Institution of higher education" means an
2828 institution of higher education as defined by Section 61.003 or a
2929 private college or university that receives state funds.
3030 (6) "Multi-institutional, multi-investigator
3131 research project" means a research project conducted by two or more
3232 cooperating members of the consortium involving one or more
3333 researchers from each member of the consortium conducting the
3434 research project.
3535 (7) "Program" means the adult stem cell research
3636 program established under this chapter.
3737 (8) "Research oversight committee" means the Texas
3838 Adult Stem Cell Research Oversight Committee.
3939 Sec. 156.002. PURPOSE. The Texas Adult Stem Cell Research
4040 Consortium is established to create and expedite innovation in the
4141 area of adult stem cell research and to enhance the potential for a
4242 medical or scientific breakthrough in treatment for diseases or
4343 disorders.
4444 Sec. 156.003. COMPOSITION OF RESEARCH OVERSIGHT COMMITTEE.
4545 (a) The research oversight committee is composed of:
4646 (1) two members representing the coordinating board,
4747 each of whom is appointed by the commissioner of higher education;
4848 (2) two members representing the Health and Human
4949 Services Commission, each of whom is appointed by the executive
5050 commissioner of the Health and Human Services Commission;
5151 (3) one member who is an interested person appointed
5252 by the governor; and
5353 (4) seven professional members with special training
5454 and interest in:
5555 (A) adult stem cell research;
5656 (B) clinical applications involving adult stem
5757 cells; or
5858 (C) commercialization of products or technology
5959 involving adult stem cell research and treatments.
6060 (b) The governor shall appoint five of the professional
6161 members, two of whom must be selected from a list of candidates
6262 prepared by the speaker of the house of representatives, and the
6363 lieutenant governor shall appoint two of the professional members.
6464 (c) The governor shall designate a member of the research
6565 oversight committee as the presiding officer of the research
6666 oversight committee. The presiding officer serves in that capacity
6767 at the will of the governor.
6868 (d) The members of the research oversight committee serve
6969 staggered six-year terms, with four members' terms expiring
7070 February 1 of each odd-numbered year. If a vacancy occurs on the
7171 research oversight committee, the appropriate appointing authority
7272 shall appoint, in the same manner as the original appointment,
7373 another person to serve for the remainder of the unexpired term.
7474 (e) A research oversight committee member is not entitled to
7575 compensation but is entitled to reimbursement for necessary
7676 expenses, including travel expenses, incurred in performing the
7777 duties of a research oversight committee member.
7878 Sec. 156.004. CONFLICT OF INTEREST. (a) In this section,
7979 "Texas trade association" means a cooperative and voluntarily
8080 joined association of business or professional competitors in this
8181 state designed to assist its members and its industry or profession
8282 in dealing with mutual business or professional problems and in
8383 promoting their common interest.
8484 (b) A person may not be a member of the research oversight
8585 committee if:
8686 (1) the person is an officer, employee, or paid
8787 consultant of a Texas trade association in the field of medicine; or
8888 (2) the person's spouse is an officer, manager, or paid
8989 consultant of a Texas trade association in the field of medicine.
9090 (c) A person may not be a member of the research oversight
9191 committee if the person is required to register as a lobbyist under
9292 Chapter 305, Government Code, because of the person's activities
9393 for compensation on behalf of a profession related to the operation
9494 of the research oversight committee.
9595 Sec. 156.005. COMPOSITION OF CONSORTIUM. (a) The research
9696 oversight committee shall establish the Texas Adult Stem Cell
9797 Research Consortium.
9898 (b) The consortium is composed of:
9999 (1) participating institutions of higher education
100100 that:
101101 (A) accept public money for adult stem cell
102102 research; or
103103 (B) otherwise agree to participate in the
104104 consortium;
105105 (2) nonprofit entities that conduct adult stem cell
106106 research in affiliation with an institution of higher education
107107 and:
108108 (A) accept public money for adult stem cell
109109 research; or
110110 (B) otherwise agree to participate in the
111111 consortium; and
112112 (3) the following umbilical cord blood banks:
113113 (A) the Texas Cord Blood Bank;
114114 (B) the M. D. Anderson Cord Blood Bank; and
115115 (C) any not-for-profit umbilical cord blood bank
116116 operating in this state that:
117117 (i) stores umbilical cord blood for public
118118 use; and
119119 (ii) agrees to participate in the
120120 consortium.
121121 Sec. 156.006. ADVISORY COMMITTEE. (a) An advisory
122122 committee is established to make recommendations based on
123123 prevailing international best practices in adult stem cell research
124124 to assist the research oversight committee in performing its
125125 duties. The research oversight committee shall consult with the
126126 advisory committee to develop grant and loan application procedures
127127 for research proposals submitted by consortium participants.
128128 (b) The advisory committee is composed of:
129129 (1) a member representing each institution of higher
130130 education participating in the consortium, appointed by the
131131 president of the institution;
132132 (2) a member representing each nonprofit entity
133133 participating in the consortium, appointed by the director of the
134134 nonprofit entity; and
135135 (3) a member representing each umbilical cord blood
136136 bank participating in the consortium, appointed by the chief
137137 executive officer of the bank.
138138 (c) A member of the advisory committee is not entitled to
139139 compensation and is not entitled to reimbursement for expenses.
140140 (d) Chapter 2110, Government Code, does not apply to the
141141 advisory committee.
142142 Sec. 156.007. PEER REVIEW PROCEDURES AND CRITERIA.
143143 (a) The advisory committee shall establish procedures and
144144 criteria for peer review of applications for grants and loans for
145145 proposed research projects consistent with national and
146146 international standards, including the enhanced review criteria
147147 for the evaluation of research applications received for potential
148148 funding in fiscal year 2010 and the associated scoring procedures
149149 used by the National Institutes of Health. The advisory committee
150150 shall establish conflict of interest standards regarding peer
151151 reviewers consistent with 42 C.F.R. Section 52h.5.
152152 (b) The advisory committee shall select reviewers for the
153153 peer review process based on a reviewer's training and experience
154154 in relevant scientific, medical, or technical fields, taking into
155155 account:
156156 (1) the formal scientific or technical education
157157 completed;
158158 (2) relevant research engaged in by the person,
159159 including whether the person was the principal researcher;
160160 (3) any awards, honors, or other recognition received
161161 from scientific, professional, and medical organizations; and
162162 (4) the need to include experts from various areas of
163163 specialization within relevant scientific, medical, or technical
164164 fields.
165165 (c) Notwithstanding Subsection (b), not more than 50
166166 percent of the peer reviewers for an application may be residents of
167167 this state.
168168 (d) A peer reviewer is not an officer or employee of this
169169 state.
170170 Sec. 156.008. ADMINISTRATION OF PROGRAM; GUIDELINES AND
171171 PROCEDURES. (a) The research oversight committee shall
172172 administer the program to:
173173 (1) make grants and loans on a competitive, peer
174174 review basis to consortium participants for:
175175 (A) multi-institutional, multi-investigator
176176 research projects involving adult stem cells, including projects to
177177 develop therapies, protocols, or medical procedures involving
178178 adult stem cells; and
179179 (B) the commercialization of products or
180180 technology involving adult stem cell research and treatments;
181181 (2) support consortium participants in all stages of
182182 the process of developing treatments and cures based on adult stem
183183 cell research, beginning with initial laboratory research through
184184 successful clinical trials; and
185185 (3) establish appropriate regulatory standards and
186186 oversight bodies for adult stem cell research conducted by
187187 consortium participants.
188188 (b) The research oversight committee shall refer all grant
189189 and loan applications to the advisory committee for competitive,
190190 peer review evaluation of the medical, scientific, and technical
191191 merits of the proposed research project. The advisory committee
192192 shall, giving consideration to the substance and results of peer
193193 review of individual research project proposals, recommend to the
194194 research oversight committee acceptance or rejection of an
195195 individual grant or loan application.
196196 (c) Money awarded under this chapter may not be used for
197197 research using stem cells obtained after an induced abortion.
198198 (d) The research oversight committee shall follow the
199199 recommendations of the advisory committee in performing its duties.
200200 If the research oversight committee does not carry out a
201201 recommendation of the advisory committee, the research oversight
202202 committee shall provide a reason to the advisory committee in
203203 writing not later than the 14th day after the date of the decision
204204 and include the reason in its biennial report.
205205 Sec. 156.009. FUNDING; SUPPORT. (a) The program may be
206206 funded by:
207207 (1) gifts, grants, or donations described by Section
208208 156.010.
209209 (b) The coordinating board shall provide administrative
210210 support and resources necessary for the research oversight
211211 committee to perform its duties under this chapter.
212212 Sec. 156.010. GIFTS AND GRANTS. The consortium shall
213213 solicit, and the research oversight committee may accept on behalf
214214 of the consortium, a gift, grant, or donation made from any public
215215 or private source for the purpose of promoting adult stem cell
216216 commercialization or multi-institutional, multi-investigator
217217 research projects.
218218 Sec. 156.011. BIENNIAL REPORT. Not later than September 1
219219 of each even-numbered year, the research oversight committee shall
220220 submit a report of the research oversight committee's activities
221221 and recommendations to the coordinating board and to the governor,
222222 the lieutenant governor, the speaker of the house of
223223 representatives, and the presiding officer of each legislative
224224 standing committee or subcommittee with jurisdiction over higher
225225 education.
226226 SECTION 2. Subtitle H, Title 2, Health and Safety Code, is
227227 amended by adding Chapter 172 to read as follows:
228228 CHAPTER 172. BIOMEDICAL RESEARCH
229229 Sec. 172.001. DEFINITION. In this chapter, "state agency"
230230 means a department, commission, board, office, or other agency in
231231 the executive branch of state government created by the state
232232 constitution or a state statute, including an institution of higher
233233 education as defined by Section 61.003, Education Code.
234234 Sec. 172.002. ANNUAL REPORT. (a) Not later than December
235235 1 of each year, a state agency that conducts, funds, or supports
236236 biomedical research shall submit to the governor, the Legislative
237237 Budget Board, and the commissioner of state health services a
238238 report, in the format established by the commissioner, on whether
239239 the agency conducted, funded, or supported during the preceding
240240 state fiscal year any research that involves human stem cells or
241241 human cloning.
242242 (b) A state agency that conducts, funds, or supports any
243243 research that involves human stem cells or human cloning must
244244 include in the report submitted under Subsection (a) information
245245 on:
246246 (1) the type of research conducted, funded, or
247247 supported by the state agency that involves:
248248 (A) human stem cells; and
249249 (B) human cloning, including therapeutic and
250250 reproductive cloning;
251251 (2) the process through which the human stem cells and
252252 stem cell lines were derived, if applicable;
253253 (3) the amount and source of state and federal money,
254254 private grants, and other funding used to conduct, fund, or support
255255 the research;
256256 (4) the use of state facilities to conduct or support
257257 the research; and
258258 (5) the goals, progress, and results of the research.
259259 (c) A state agency shall not include in the report:
260260 (1) proprietary, competitive, and other information
261261 that the agency is not required to publicly disclose under Chapter
262262 552, Government Code; or
263263 (2) the name, address, or other personal identifying
264264 information of an individual conducting or otherwise participating
265265 in research that is the subject of the report.
266266 SECTION 3. Not later than December 1, 2009, a state agency
267267 that conducts, funds, or supports biomedical research shall submit
268268 the initial report required under Chapter 172, Health and Safety
269269 Code, as added by this Act.
270270 SECTION 4. (a) As soon as possible after the effective
271271 date of this Act, the governor, lieutenant governor, executive
272272 commissioner of the Health and Human Services Commission, and
273273 commissioner of higher education shall appoint members to the Texas
274274 Adult Stem Cell Research Oversight Committee in accordance with
275275 Chapter 156, Education Code, as added by this Act.
276276 (b) In making initial appointments to the Texas Adult Stem
277277 Cell Research Oversight Committee:
278278 (1) the governor shall appoint:
279279 (A) two members to serve a term expiring February
280280 1, 2011, one member to serve a term expiring February 1, 2013, and
281281 one member to serve a term expiring February 1, 2015; and
282282 (B) from a list of candidates prepared by the
283283 speaker of the house of representatives, one member to serve a term
284284 expiring February 1, 2011, and one member to serve a term expiring
285285 February 1, 2015;
286286 (2) the lieutenant governor shall appoint one member
287287 to serve a term expiring February 1, 2011, and one member to serve a
288288 term expiring February 1, 2013;
289289 (3) the executive commissioner of the Health and Human
290290 Services Commission shall appoint one member to serve a term
291291 expiring February 1, 2013, and one member to serve a term expiring
292292 February 1, 2015; and
293293 (4) the commissioner of higher education shall appoint
294294 one member to serve a term expiring February 1, 2013, and one member
295295 to serve a term expiring February 1, 2015.
296296 SECTION 5. Not later than September 1, 2010, the Texas Adult
297297 Stem Cell Research Oversight Committee shall submit the first
298298 report of the committee's activities and recommendations as
299299 required by Chapter 156, Education Code, as added by this Act.
300300 SECTION 6. This Act takes effect September 1, 2009.