By: Nelson, Patrick S.B. No. 73
A BILL TO BE ENTITLED
AN ACT
relating to the establishment of an adult stem cell research
program and to certain reporting requirements with regard to
research involving human stem cells or human cloning.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle H, Title 3, Education Code, is amended
by adding Chapter 156 to read as follows:
CHAPTER 156. ADULT STEM CELL RESEARCH PROGRAM
Sec. 156.001. DEFINITIONS. In this chapter:
(1) "Adult stem cell" means an undifferentiated cell
that is:
(A) found among differentiated cells in tissues
or fluids; and
(B) able to renew itself and differentiate to
yield all or nearly all of the specialized cell types needed for
clinical applications.
(2) "Advisory committee" means the advisory committee
appointed under Section 156.006.
(3) "Consortium" means the Texas Adult Stem Cell
Research Consortium.
(4) "Coordinating board" means the Texas Higher
Education Coordinating Board.
(5) "Institution of higher education" means an
institution of higher education as defined by Section 61.003 or a
private college or university that receives state funds.
(6) "Multi-institutional, multi-investigator
research project" means a research project conducted by two or more
cooperating members of the consortium involving one or more
researchers from each member of the consortium conducting the
research project.
(7) "Program" means the adult stem cell research
program established under this chapter.
(8) "Research oversight committee" means the Texas
Adult Stem Cell Research Oversight Committee.
Sec. 156.002. PURPOSE. The Texas Adult Stem Cell Research
Consortium is established to create and expedite innovation in the
area of adult stem cell research and to enhance the potential for a
medical or scientific breakthrough in treatment for diseases or
disorders.
Sec. 156.003. COMPOSITION OF RESEARCH OVERSIGHT COMMITTEE.
(a) The research oversight committee is composed of:
(1) two members representing the coordinating board,
each of whom is appointed by the commissioner of higher education;
(2) two members representing the Health and Human
Services Commission, each of whom is appointed by the executive
commissioner of the Health and Human Services Commission;
(3) one member who is an interested person appointed
by the governor; and
(4) seven professional members with special training
and interest in:
(A) adult stem cell research;
(B) clinical applications involving adult stem
cells; or
(C) commercialization of products or technology
involving adult stem cell research and treatments.
(b) The governor shall appoint five of the professional
members, two of whom must be selected from a list of candidates
prepared by the speaker of the house of representatives, and the
lieutenant governor shall appoint two of the professional members.
(c) The governor shall designate a member of the research
oversight committee as the presiding officer of the research
oversight committee. The presiding officer serves in that capacity
at the will of the governor.
(d) The members of the research oversight committee serve
staggered six-year terms, with four members' terms expiring
February 1 of each odd-numbered year. If a vacancy occurs on the
research oversight committee, the appropriate appointing authority
shall appoint, in the same manner as the original appointment,
another person to serve for the remainder of the unexpired term.
(e) A research oversight committee member is not entitled to
compensation but is entitled to reimbursement for necessary
expenses, including travel expenses, incurred in performing the
duties of a research oversight committee member.
Sec. 156.004. CONFLICT OF INTEREST. (a) In this section,
"Texas trade association" means a cooperative and voluntarily
joined association of business or professional competitors in this
state designed to assist its members and its industry or profession
in dealing with mutual business or professional problems and in
promoting their common interest.
(b) A person may not be a member of the research oversight
committee if:
(1) the person is an officer, employee, or paid
consultant of a Texas trade association in the field of medicine; or
(2) the person's spouse is an officer, manager, or paid
consultant of a Texas trade association in the field of medicine.
(c) A person may not be a member of the research oversight
committee if the person is required to register as a lobbyist under
Chapter 305, Government Code, because of the person's activities
for compensation on behalf of a profession related to the operation
of the research oversight committee.
Sec. 156.005. COMPOSITION OF CONSORTIUM. (a) The research
oversight committee shall establish the Texas Adult Stem Cell
Research Consortium.
(b) The consortium is composed of:
(1) participating institutions of higher education
that:
(A) accept public money for adult stem cell
research; or
(B) otherwise agree to participate in the
consortium;
(2) nonprofit entities that conduct adult stem cell
research in affiliation with an institution of higher education
and:
(A) accept public money for adult stem cell
research; or
(B) otherwise agree to participate in the
consortium; and
(3) the following umbilical cord blood banks:
(A) the Texas Cord Blood Bank;
(B) the M. D. Anderson Cord Blood Bank; and
(C) any not-for-profit umbilical cord blood bank
operating in this state that:
(i) stores umbilical cord blood for public
use; and
(ii) agrees to participate in the
consortium.
Sec. 156.006. ADVISORY COMMITTEE. (a) An advisory
committee is established to make recommendations based on
prevailing international best practices in adult stem cell research
to assist the research oversight committee in performing its
duties. The research oversight committee shall consult with the
advisory committee to develop grant and loan application procedures
for research proposals submitted by consortium participants.
(b) The advisory committee is composed of:
(1) a member representing each institution of higher
education participating in the consortium, appointed by the
president of the institution;
(2) a member representing each nonprofit entity
participating in the consortium, appointed by the director of the
nonprofit entity; and
(3) a member representing each umbilical cord blood
bank participating in the consortium, appointed by the chief
executive officer of the bank.
(c) A member of the advisory committee is not entitled to
compensation and is not entitled to reimbursement for expenses.
(d) Chapter 2110, Government Code, does not apply to the
advisory committee.
Sec. 156.007. PEER REVIEW PROCEDURES AND CRITERIA.
(a) The advisory committee shall establish procedures and
criteria for peer review of applications for grants and loans for
proposed research projects consistent with national and
international standards, including the enhanced review criteria
for the evaluation of research applications received for potential
funding in fiscal year 2010 and the associated scoring procedures
used by the National Institutes of Health. The advisory committee
shall establish conflict of interest standards regarding peer
reviewers consistent with 42 C.F.R. Section 52h.5.
(b) The advisory committee shall select reviewers for the
peer review process based on a reviewer's training and experience
in relevant scientific, medical, or technical fields, taking into
account:
(1) the formal scientific or technical education
completed;
(2) relevant research engaged in by the person,
including whether the person was the principal researcher;
(3) any awards, honors, or other recognition received
from scientific, professional, and medical organizations; and
(4) the need to include experts from various areas of
specialization within relevant scientific, medical, or technical
fields.
(c) Notwithstanding Subsection (b), not more than 50
percent of the peer reviewers for an application may be residents of
this state.
(d) A peer reviewer is not an officer or employee of this
state.
Sec. 156.008. ADMINISTRATION OF PROGRAM; GUIDELINES AND
PROCEDURES. (a) The research oversight committee shall
administer the program to:
(1) make grants and loans on a competitive, peer
review basis to consortium participants for:
(A) multi-institutional, multi-investigator
research projects involving adult stem cells, including projects to
develop therapies, protocols, or medical procedures involving
adult stem cells; and
(B) the commercialization of products or
technology involving adult stem cell research and treatments;
(2) support consortium participants in all stages of
the process of developing treatments and cures based on adult stem
cell research, beginning with initial laboratory research through
successful clinical trials; and
(3) establish appropriate regulatory standards and
oversight bodies for adult stem cell research conducted by
consortium participants.
(b) The research oversight committee shall refer all grant
and loan applications to the advisory committee for competitive,
peer review evaluation of the medical, scientific, and technical
merits of the proposed research project. The advisory committee
shall, giving consideration to the substance and results of peer
review of individual research project proposals, recommend to the
research oversight committee acceptance or rejection of an
individual grant or loan application.
(c) Money awarded under this chapter may not be used for
research using stem cells obtained after an induced abortion.
(d) The research oversight committee shall follow the
recommendations of the advisory committee in performing its duties.
If the research oversight committee does not carry out a
recommendation of the advisory committee, the research oversight
committee shall provide a reason to the advisory committee in
writing not later than the 14th day after the date of the decision
and include the reason in its biennial report.
Sec. 156.009. FUNDING; SUPPORT. (a) The program may be
funded by:
(1) gifts, grants, or donations described by Section
156.010.
(b) The coordinating board shall provide administrative
support and resources necessary for the research oversight
committee to perform its duties under this chapter.
Sec. 156.010. GIFTS AND GRANTS. The consortium shall
solicit, and the research oversight committee may accept on behalf
of the consortium, a gift, grant, or donation made from any public
or private source for the purpose of promoting adult stem cell
commercialization or multi-institutional, multi-investigator
research projects.
Sec. 156.011. BIENNIAL REPORT. Not later than September 1
of each even-numbered year, the research oversight committee shall
submit a report of the research oversight committee's activities
and recommendations to the coordinating board and to the governor,
the lieutenant governor, the speaker of the house of
representatives, and the presiding officer of each legislative
standing committee or subcommittee with jurisdiction over higher
education.
SECTION 2. Subtitle H, Title 2, Health and Safety Code, is
amended by adding Chapter 172 to read as follows:
CHAPTER 172. BIOMEDICAL RESEARCH
Sec. 172.001. DEFINITION. In this chapter, "state agency"
means a department, commission, board, office, or other agency in
the executive branch of state government created by the state
constitution or a state statute, including an institution of higher
education as defined by Section 61.003, Education Code.
Sec. 172.002. ANNUAL REPORT. (a) Not later than December
1 of each year, a state agency that conducts, funds, or supports
biomedical research shall submit to the governor, the Legislative
Budget Board, and the commissioner of state health services a
report, in the format established by the commissioner, on whether
the agency conducted, funded, or supported during the preceding
state fiscal year any research that involves human stem cells or
human cloning.
(b) A state agency that conducts, funds, or supports any
research that involves human stem cells or human cloning must
include in the report submitted under Subsection (a) information
on:
(1) the type of research conducted, funded, or
supported by the state agency that involves:
(A) human stem cells; and
(B) human cloning, including therapeutic and
reproductive cloning;
(2) the process through which the human stem cells and
stem cell lines were derived, if applicable;
(3) the amount and source of state and federal money,
private grants, and other funding used to conduct, fund, or support
the research;
(4) the use of state facilities to conduct or support
the research; and
(5) the goals, progress, and results of the research.
(c) A state agency shall not include in the report:
(1) proprietary, competitive, and other information
that the agency is not required to publicly disclose under Chapter
552, Government Code; or
(2) the name, address, or other personal identifying
information of an individual conducting or otherwise participating
in research that is the subject of the report.
SECTION 3. Not later than December 1, 2009, a state agency
that conducts, funds, or supports biomedical research shall submit
the initial report required under Chapter 172, Health and Safety
Code, as added by this Act.
SECTION 4. (a) As soon as possible after the effective
date of this Act, the governor, lieutenant governor, executive
commissioner of the Health and Human Services Commission, and
commissioner of higher education shall appoint members to the Texas
Adult Stem Cell Research Oversight Committee in accordance with
Chapter 156, Education Code, as added by this Act.
(b) In making initial appointments to the Texas Adult Stem
Cell Research Oversight Committee:
(1) the governor shall appoint:
(A) two members to serve a term expiring February
1, 2011, one member to serve a term expiring February 1, 2013, and
one member to serve a term expiring February 1, 2015; and
(B) from a list of candidates prepared by the
speaker of the house of representatives, one member to serve a term
expiring February 1, 2011, and one member to serve a term expiring
February 1, 2015;
(2) the lieutenant governor shall appoint one member
to serve a term expiring February 1, 2011, and one member to serve a
term expiring February 1, 2013;
(3) the executive commissioner of the Health and Human
Services Commission shall appoint one member to serve a term
expiring February 1, 2013, and one member to serve a term expiring
February 1, 2015; and
(4) the commissioner of higher education shall appoint
one member to serve a term expiring February 1, 2013, and one member
to serve a term expiring February 1, 2015.
SECTION 5. Not later than September 1, 2010, the Texas Adult
Stem Cell Research Oversight Committee shall submit the first
report of the committee's activities and recommendations as
required by Chapter 156, Education Code, as added by this Act.
SECTION 6. This Act takes effect September 1, 2009.