79R4520 JTS-F
By: Thompson H.B. No. 2469
A BILL TO BE ENTITLED
AN ACT
relating to research using human cells and tissues.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle H, Title 2, Health and Safety Code, is
amended by adding Chapter 168 to read as follows:
CHAPTER 168. TEXAS INSTITUTE FOR REGENERATIVE MEDICINE
Sec. 168.001. DEFINITIONS. In this chapter:
(1) "Committee" means the Independent Citizens'
Oversight Committee established by Section 168.002.
(2) "Financial accountability oversight committee"
means the financial accountability oversight committee established
by Section 168.009.
(3) "Institute" means the Texas Institute for
Regenerative Medicine established by Section 73, Article XVI, Texas
Constitution.
Sec. 168.002. INDEPENDENT CITIZENS' OVERSIGHT COMMITTEE.
(a) The committee is the governing body of the institute.
(b) The committee is composed of nine members appointed as
follows:
(1) one member appointed by the chancellor of The
University of Texas System to represent:
(A) The University of Texas Medical Branch at
Galveston;
(B) The University of Texas at San Antonio;
(C) The University of Texas at Dallas; or
(D) The University of Texas Health Science
Center;
(2) one member appointed by the governor to represent:
(A) The Texas A&M University System;
(B) the Texas Tech University System;
(C) the University of Houston System;
(D) the Texas State University System; or
(E) the University of North Texas System;
(3) two members appointed by the governor, one of whom
must be selected from a list submitted by the speaker of the house
of representatives, one member appointed by the lieutenant
governor, and one member appointed by the comptroller from any of
the following categories:
(A) a representative of a university in this
state other than the universities listed in Subdivisions (1) and
(2) that has demonstrated success and leadership in regenerative
medical research and that has:
(i) a research hospital and medical school;
(ii) a recent proven history of
administering scientific or medical research grants or contracts in
an average annual range of more than $20 million; and
(iii) a ranking, in the past five years, in
the top 50 universities in the United States with the highest number
of life science patents or that has research or clinical faculty who
are members of the National Academy of Sciences;
(B) a representative from a nonprofit academic
and research institution in this state that is not a part of The
University of Texas System that has:
(i) demonstrated success and leadership in
stem cell research; and
(ii) a nationally ranked research hospital
or research or clinical faculty who are members of the National
Academy of Sciences;
(C) a resident of this state who has a background
in medical ethics; and
(D) a resident of this state with a background in
finance; and
(4) two members appointed by the governor, one of whom
must be selected from a list submitted by the speaker of the house
of representatives, and one member appointed by the lieutenant
governor to represent a disease advocacy group, which may include
an advocacy group for any of the following diseases:
(A) spinal cord injury;
(B) Alzheimer's disease;
(C) diabetes;
(D) multiple sclerosis;
(E) amyotropic lateral sclerosis;
(F) HIV or AIDS;
(G) mental health diseases;
(H) heart disease;
(I) cancer; or
(J) Parkinson's disease.
Sec. 168.003. OFFICERS. (a) The committee shall elect from
among its members a presiding officer and an assistant presiding
officer.
(b) The officers serve a term of three years and shall be
part-time or full-time employees of the institute.
(c) The presiding officer:
(1) must have been appointed under Section 168.002(3)
or (4) and have the following qualifications:
(A) documented history in successful stem cell
research advocacy; and
(B) experience with state and federal
legislative processes, including experience with medical
legislative approvals of standards or funding; and
(2) may not concurrently be employed by or on leave
from an institution that seeks or receives state grants or loans.
(d) In electing a presiding officer the committee may also
consider:
(1) executive experience with governmental agencies
or institutions;
(2) experience with the process of establishing
government standards and procedures;
(3) experience with the legal review of proper
governmental authority for the exercise of government agency or
government institutional powers; and
(4) direct knowledge and experience in bond financing.
(e) The assistant presiding officer must:
(1) meet the requirements of Subsections (c)(1)(A) and
(2); and
(2) have attributes and experience complementary to
those of the presiding officer, preferably meeting criteria not met
by the presiding officer's credentials and experience.
Sec. 168.004. TERMS. (a) Committee members serve
staggered six-year terms, with as near as possible to one-third of
the members' terms expiring on February 1 of each odd-numbered
year.
(b) A committee member may not serve more than one term.
(c) If a vacancy occurs on the committee during a term, the
appointing authority shall appoint a successor to serve for the
unexpired portion of the term not later than 30 days after the
vacancy occurs.
(d) On the expiration of a committee member's term, the
appointing authority must make a replacement appointment not later
than 30 days after the date that a term expires. The member whose
term expires continues to serve on the committee until a
replacement is made.
Sec. 168.005. POWERS AND DUTIES. The institute has the
powers conferred under Section 73, Article XVI, Texas Constitution.
Sec. 168.006. STEM CELL RESEARCH ACCOUNT. The stem cell
research account is an account in the general revenue fund. The
account may be used only as provided by Section 73, Article XVI,
Texas Constitution.
Sec. 168.007. ANNUAL PUBLIC REPORT. The institute shall
issue an annual public report outlining the institute's activities,
grants awarded, grants in progress, research accomplishments, and
future program directions. The report should include:
(1) the number and dollar amounts of research and
facilities grants;
(2) identification of the grantees for the reported
year;
(3) the institute's administrative expenses;
(4) an assessment of the availability of funding for
stem cell research from sources other than the institute;
(5) a summary of research findings, including
promising new research areas;
(6) an assessment of the relationship between the
institute's grants and the overall strategy of its research
program; and
(7) a report of the institute's strategic research and
financial plans.
Sec. 168.008. INDEPENDENT FINANCIAL AUDIT FOR REVIEW BY
COMPTROLLER. The institute shall annually commission an
independent financial audit of its activities from a certified
public accounting firm that shall be provided to the comptroller,
who shall review the audit and annually issue a public report of
that review.
Sec. 168.009. FINANCIAL ACCOUNTABILITY OVERSIGHT
COMMITTEE. (a) The comptroller shall be the presiding officer of a
financial accountability oversight committee that:
(1) reviews the annual financial audit, the
comptroller's report and evaluation of that audit, and the
financial practices of the institute; and
(2) provides recommendations on the institute's
financial practices and performance.
(b) The governor shall appoint one public member of the
financial accountability oversight committee from a list submitted
by the speaker of the house of representatives. The lieutenant
governor, the comptroller, and the presiding officer of the
committee shall each appoint a public member of the financial
accountability oversight committee. Financial accountability
oversight committee members must have medical backgrounds and
knowledge of relevant financial matters.
(c) The comptroller shall provide staff support for the
financial accountability oversight committee.
(d) The financial accountability oversight committee shall
hold an annual public meeting, with appropriate notice and with a
formal public comment period. The committee shall evaluate public
comments and include appropriate summaries in its annual report.
(e) The committee shall provide funds for the per diem
expenses of the financial accountability oversight committee
members and for publication of the annual report.
SECTION 2. Subtitle H, Title 2, Health and Safety Code, is
amended by adding Chapter 169 to read as follows:
CHAPTER 169. RESEARCH USING HUMAN CELLS AND TISSUE
Sec. 169.001. USE OF HUMAN CELLS PERMITTED. (a) A person
may conduct research involving the derivation and use of human
embryonic stem cells, human embryonic germ cells, and human adult
stem cells, including somatic cell nuclear transplantation.
(b) The research authorized by this section:
(1) must be conducted with full consideration for the
ethical and medical implications of the research; and
(2) must be reviewed by an institutional review board.
Sec. 169.002. DUTY OF HEALTH CARE PROVIDER. A physician or
other health care provider who is delivering fertility treatment
shall provide the patient with timely, relevant, and appropriate
information sufficient to allow the patient to make an informed and
voluntary choice regarding the disposition of any human embryos
remaining following the infertility treatment in accordance with
Section 169.003.
Sec. 169.003. PATIENT OPTIONS. (a) The information given
to the patient under Section 169.002 must inform the patient of the
patient's options to:
(1) store any unused embryos;
(2) donate the unused embryos to another person for
use;
(3) discard the unused embryos; or
(4) donate the unused embryos for research purposes.
(b) A patient who donates, for research purposes, embryos
remaining after infertility treatment must consent in writing to
the donation.
SECTION 3. Section 48.02(c), Penal Code, is amended to read
as follows:
(c) It is an exception to the application of this section
that the valuable consideration is: (1) a fee paid to a physician or
to other medical personnel for services rendered in the usual
course of medical practice or a fee paid for hospital or other
clinical services; (2) reimbursement of legal or medical expenses
incurred for the benefit of the ultimate receiver of the organ; (3)
reasonable payment for removal, processing, disposal,
preservation, quality control, storage, transplantation, or
implantation of embryonic or cadaveric fetal tissue for research
conducted in compliance with Chapter 169, Health and Safety Code;
or (4) [(3)] reimbursement of expenses of travel, housing, and
lost wages incurred by the donor of a human organ in connection with
the donation of the organ.
SECTION 4. (a) Subject to Section 6(b) of this Act, not
later than December 1, 2005, the chancellor of The University of
Texas System, the governor, the lieutenant governor, and the
comptroller of public accounts shall appoint members to the
Independent Citizens' Oversight Committee as required by Section
168.002, Health and Safety Code, as added by this Act.
(b) Subject to Section 6(b) of this Act, not later than
January 1, 2006, the members of the Independent Citizens' Oversight
Committee shall elect a presiding officer and assistant presiding
officer as required by Section 168.003, Health and Safety Code, as
added by this Act.
SECTION 5. (a) The change in law made by this Act to Section
48.02(c), Penal Code, applies only to an offense committed on or
after the effective date of this Act. For purposes of this section,
an offense is committed before the effective date of this Act if any
element of the offense occurs before that date.
(b) An offense committed before the effective date of this
Act is covered by the law in effect when the offense was committed,
and the former law is continued in effect for that purpose.
SECTION 6. (a) Except as provided by Subsection (b), this
Act takes effect September 1, 2005.
(b) Section 1 of this Act takes effect on the date on which
the constitutional amendment proposed by the 79th Legislature,
Regular Session, 2005, establishing the Texas Institute for
Regenerative Medicine and prohibiting the legislature from
prohibiting stem cell research is approved by the voters. If that
amendment is not approved by the voters, Section 1 of this Act has
no effect.