BILL NUMBER: SB 1260 CHAPTERED
BILL TEXT
CHAPTER 483
FILED WITH SECRETARY OF STATE SEPTEMBER 26, 2006
APPROVED BY GOVERNOR SEPTEMBER 26, 2006
PASSED THE SENATE AUGUST 31, 2006
PASSED THE ASSEMBLY AUGUST 28, 2006
AMENDED IN ASSEMBLY AUGUST 21, 2006
AMENDED IN ASSEMBLY AUGUST 8, 2006
AMENDED IN ASSEMBLY AUGUST 7, 2006
AMENDED IN ASSEMBLY JUNE 20, 2006
AMENDED IN SENATE MAY 26, 2006
AMENDED IN SENATE APRIL 26, 2006
AMENDED IN SENATE APRIL 6, 2006
INTRODUCED BY Senators Ortiz and Runner
FEBRUARY 9, 2006
An act to amend Sections 125118, 125119, 125119.3, 125119.5, and
125300 of, and to add Chapter 2 (commencing with Section 125330) to
Part 5.5 of Division 106 of, the Health and Safety Code, relating to
reproductive health.
LEGISLATIVE COUNSEL'S DIGEST
SB 1260, Ortiz Reproductive health and research.
The California Stem Cell Research and Cures Act, an initiative
measure approved by the voters at the November 2, 2004, general
election (Proposition 71), establishes the California Institute for
Regenerative Medicine, the purpose of which is, among other things,
to make grants and loans for stem cell research, for research
facilities, and for other vital research opportunities to realize
therapies, protocols, and medical procedures that will result in the
cure for, or substantial mitigation of, diseases and injuries.
Existing law establishes the Independent Citizen's Oversight
Committee (ICOC), composed of appointed members, that is required to
perform various functions and duties with regard to the operation of
the institute, including, but not limited to, establishing standards
applicable to research funded by the institute.
Existing law prohibits amendment of Proposition 71 by the
Legislature unless the amendment is approved by the voters, or the
amendment is accomplished by a bill introduced after the first 2 full
calendar years and approved by a vote of 70% of both houses.
Existing law, which is not applicable to research funded under
Proposition 71, and which would be repealed on January 1, 2007,
requires the State Department of Health Services to, among other
things, develop guidelines for research involving the derivation or
use of embryonic stem cells, and to report annually to the
Legislature.
This bill would delete the repeal date of those provisions, thus
indefinitely extending their duration. The bill would also revise the
department's reporting duties, by requiring biennial reviews rather
than annual reports to the Legislature.
Existing law requires research projects involving the derivation
or use of human embryonic stem cells to be reviewed and approved by
an institutional review board established in accordance with federal
regulations.
This bill would revise a related declaration of state policy,
would require these research projects to instead be reviewed and
approved by a stem cell research oversight committee established
substantially in accordance with specified guidelines, and would make
these provisions applicable also to research projects involving
human adult stem cells.
Existing law applicable to fertility treatment requires that a
physician and surgeon provide a patient with prescribed information
and obtain the patient's informed consent prior to providing the
fertility treatment.
This bill, with certain exceptions, would require a physician and
surgeon, prior to obtaining informed consent from a subject for
assisted oocyte production, as defined, or other method of ovarian
retrieval for purposes of retrieving eggs for research or for
developing medical therapies, to provide the subject with a
standardized written summary of health and consumer issues and to
obtain the subject's written and oral informed consent for the
procedure.
Existing law prohibits a person from knowingly, for valuable
consideration, purchasing or selling embryonic or cadaveric fetal
tissue for research purposes.
This bill would prohibit human oocytes or embryos from being
acquired, sold, offered for sale, received, or otherwise transferred
for valuable consideration for medical research or development of
medical therapies, and would prohibit payment in excess of the amount
of reimbursement of expenses to be made to any research subject to
encourage her to produce human oocytes for the purposes of medical
research.
The bill would declare that it is not to be construed to amend
Proposition 71.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. The Legislature finds and declares all of the
following:
(a) The purpose of this act is to create protections for research
subjects and it should not be construed to affect any other form of
medical care.
(b) Scientific research can be most effectively achieved by
establishing protocols to protect, respect, and promote human health,
safety, dignity, autonomy, and rights in conducting research.
(c) This act seeks to support the requirements already in current
law upholding the principle of voluntary and informed consent and to
tailor them to this new area of pioneering research that utilizes
human oocytes.
(d) The potential for exploitation of the reproductive
capabilities of women for commercial gain raises health and ethical
concerns that justify the prohibition of payment for human oocytes.
SEC. 2. Section 125118 of the Health and Safety Code is amended to
read:
125118. (a) The State Department of Health Services shall develop
guidelines for research involving the derivation or use of human
embryonic stem cells in California.
(b) In developing the guidelines specified in subdivision (a), the
department may consider other applicable guidelines developed or in
use in the United States and in other countries, including, but not
limited to, the Guidelines for Research Using Human Pluripotent Stem
Cells developed by the National Institutes of Health and published in
August 2000, and corrected in November 2000, and the Guidelines for
Human Embryonic Stem Cell Research issued by the National Research
Council and Institute of Medicine of the National Academies in 2005.
SEC. 3. Section 125119 of the Health and Safety Code is amended to
read:
125119. (a) (1) All research projects involving the derivation or
use of human embryonic stem cells shall be reviewed and approved by
a stem cell research oversight committee prior to being undertaken.
Any stem cell research oversight committee shall, in its review of
human embryonic stem cell research projects, consider and apply the
guidelines developed by the department pursuant to Section 125118. A
stem cell research oversight committee may require modifications to
the plan or design of a proposed human embryonic stem cell research
project as a condition of approving the research project.
(2) A stem cell research oversight committee for purposes of this
article shall be established substantially in accordance with
Guidelines for Human Embryonic Stem Cell Research issued by the
National Research Council and the Institute of Medicine of the
National Academies in 2005. This committee shall be established in
accordance with standards issued by the California Institute for
Regenerative Medicine (CIRM) as authorized by Article XXXV of the
California Constitution. The intent of the Legislature is to avoid
inconsistencies for stem cell research oversight committees
established pursuant to this article with other existing standards
for research conducted in California.
(b) Not less than once per year, a stem cell research oversight
committee shall conduct continuing review of human embryonic stem
cell research projects reviewed and approved under this section in
order to ensure that the research continues to meet the standards for
stem cell research oversight committee approval. Pursuant to its
review in accordance with this subdivision, a stem cell research
oversight committee may revoke its prior approval of research under
this section and require modifications to the plan or design of a
continuing research project before permitting the research to
continue.
(c) A stem cell research oversight committee may provide
scientific and ethical review of research consistent with this
article.
SEC. 4. Section 125119.3 of the Health and Safety Code is amended
to read:
125119.3. (a) Each stem cell research oversight committee that
has reviewed human embryonic stem cell research pursuant to Section
125119 shall report to the department, annually, on the number of
human embryonic stem cell research projects that the stem cell
research oversight committee has reviewed, and the status and
disposition of each of those projects, including the information
collected pursuant to Section 125342.
(b) Each stem cell research oversight committee shall also report
to the department regarding unanticipated problems, unforeseen
issues, or serious continuing investigator noncompliance with the
requirements or determinations of the stem cell research oversight
committee with respect to the review of human embryonic stem cell
research projects, and the actions taken by the stem cell research
oversight committee to respond to these situations.
SEC. 5. Section 125119.5 of the Health and Safety Code is amended
to read:
125119.5. (a) The department shall at least annually review
reports from stem cell research oversight committees, and may revise
the guidelines developed pursuant to Section 125118, as it deems
necessary.
(b) The department shall provide a biennial review to the
Legislature on human embryonic stem cell research activity. These
biennial reviews shall be compiled from the reports from stem cell
research oversight committees.
SEC. 6. Section 125300 of the Health and Safety Code is amended to
read:
125300. The policy of the State of California shall be that
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, shall be reviewed by
a stem cell research oversight committee.
SEC. 7. Chapter 2 (commencing with Section 125330) is added to
Part 5.5 of Division 106 of the Health and Safety Code, to read:
CHAPTER 2. Procuring of Oocytes for Research
125330. The following definitions shall apply to this chapter:
(a) "Assisted oocyte production" or "AOP" means surgical
extraction of oocytes following pharmaceutically induced manipulation
of oocyte production through the use of ovarian stimulation.
(b) "Oocyte" means a female egg or egg cell of a human female.
(c) "Subject" means any person undergoing AOP or any alternative
method of ovarian retrieval for research or for the development of
medical therapies, including those who would not meet the definition
of "subject" under 45 C.F.R. 46.102.
(d) "Alternate method of oocyte retrieval" means a method of
oocyte retrieval that does not involve the pharmaceutically induced
manipulation of oocyte production.
(e) "Institutional review board" means a body established in
accordance with federal regulations, including Part 46 (commencing
with Section 46.101) of Subchapter A of Subtitle A of Title 45 of the
Code of Federal Regulations.
125335. (a) Prior to obtaining informed consent from a subject
for AOP or any alternative method of ovarian retrieval on a subject
for the purpose of procuring oocytes for research or the development
of medical therapies, a physician and surgeon shall provide to the
subject a standardized medically accurate written summary of health
and consumer issues associated with AOP and any alternative methods
of oocyte retrieval. The failure to provide to a subject this
standardized medically accurate written summary constitutes
unprofessional conduct within the meaning of Chapter 5 (commencing
with Section 2000) of Division 2 of the Business and Professions
Code.
(b) The summary shall include, but not be limited to, medically
accurate disclosures concerning the potential risks of AOP or any
alternative method of oocyte retrieval, including the risks
associated with the surgical procedure and with using the drugs,
medications, and hormones prescribed for ovarian stimulation during
the AOP process or any alternative method of oocyte retrieval.
(c) For purposes of subdivision (a), "written summary of health
and consumer issues" means the guide published and updated by the
American Society for Reproductive Medicine entitled, "Assisted
Reproductive Technology: A Guide for Patients" or an alternative
written medically accurate document prepared by a recognized
authority on oocyte retrieval for medical research that also meets
the criteria included in this section. This alternative document may
be one that has been approved and recommended by the State Department
of Health Services pursuant to Section 125118 and shall include all
of the following:
(1) The document shall adhere to simplified reading standards,
including, but not limited to, those generally accepted and required
for government publications. The document shall be written in
layperson's language and shall be made available in languages spoken
by subjects in the study if their proficiency is largely in a
language other than English. All information in the document shall be
conveyed to the subject orally in easy to understand and
nontechnical terms.
(2) The document shall include additional resources for, or list
additional sources of, medical information on health and safety
issues surrounding oocyte retrieval.
125340. (a) Prior to providing AOP or any alternative method of
ovarian retrieval to a subject for the purposes of medical research
or development of medical therapies, a physician and surgeon shall
obtain written and oral informed consent for the procedure from the
subject. Informed consent for the purposes of this chapter shall
comply with the informed consent requirements of the Protection of
Human Subjects in Medical Experimentation Act (Chapter 1.3
(commencing with Section 24170) of Division 20).
(b) The failure to obtain written informed consent from the
subject constitutes unprofessional conduct within the meaning of
Chapter 5 (commencing with Section 2000) of Division 2 of the
Business and Professions Code. Nothing in this section shall be
construed to relieve the physician and surgeon from other existing
duties under the law, including, but not limited to, the duty to
obtain a subject's informed consent after fully explaining the
proposed procedure. The requirement that a physician and surgeon
provide the standardized written summary pursuant to Section 125335
is in addition to, and does not supplant, other existing legal
requirements regarding informed consent, including, but not limited
to, compliance with the Protection of Human Subjects in Medical
Experimentation Act (Chapter 1.3 (commencing with Section 24170) of
Division 20.
(c) This chapter shall not affect the suitability or availability
of oocytes procured for research before January 1, 2007, if the
oocytes were donated pursuant to protocols or standards that are
generally recognized and accepted by national or international
scientific bodies.
(d) Any written document required pursuant to this section shall
adhere to simplified reading standards, including, but not limited
to, those generally accepted and required for government
publications, and in layperson's language. The document shall be made
available in languages spoken by subjects in the study if their
proficiency is largely in a language other than English. All
information in the written informed consent document shall also be
conveyed to the subject orally in easy to understand and nontechnical
terms.
125341. An institutional review board (IRB) that reviews and
approves medical and scientific research shall require all of the
following of any research program or project that comes under its
review that involves AOP or any alternative method of oocyte
retrieval:
(a) That it include a written summary as required under Section
125335 that would include information on health risks and potential
adverse consequences of the procedure and describe the manner in
which the subject will receive and review this written summary.
(b) That it obtain informed consent in compliance with the
Protection of Human Subjects in Medical Experimentation Act (Chapter
1.3 (commencing with Section 24170) of Division 20), including
informed consent for information obtained pursuant to Section 125342.
(c) That it provide the subject with an objective and accurate
statement about the existing state of the research for which the
subject is providing oocytes.
(d) That it perform psychological and physical screening, in
accordance with the appropriate standard of care, for all subjects
prior to the oocyte retrieval procedure.
(e) That it ensure that after conducting AOP or any alternative
method of oocyte retrieval on a subject, the subject be given a
postprocedure medical examination at a time within the standard of
care to determine if the subject has experienced an adverse health
effect that is a result of the procedure. The subject shall be
informed that she has the right to a second opinion if she has any
medical concerns.
(f) That it ensure that the subject has access to and coverage for
medically appropriate medical care that is required as a direct
result of the procedure for research purposes. The research program
or project shall ensure that payment or coverage of resulting medical
expenses be provided at no cost to the subject and that a summary of
the arrangements the procuring entity has made for coverage or
payment for medical care related to AOP or any alternative method of
oocyte retrieval is provided to the subject prior to the procedure.
(g) That it provide a summary informing the subject that oocytes
may not be sold or transferred for valuable consideration except as
set forth in Section 125350.
(h) That it provide disclosure if the physician and surgeon and
his or her immediate family members have any professional interest in
the outcome of the research or of the oocyte retrieval procedure
and, if so, that it provide disclosure that he or she carries the
interest of both the subject and the success of the research.
125342. (a) A research program or project that involves AOP or
any alternative method of oocyte retrieval shall ensure that a
written record is established and maintained to include, but not be
limited to, all of the following components:
(1) The demographics of subjects, including, but not limited to,
their age, race, primary language, ethnicity, income bracket,
education level, and the first three digits of the ZIP Code of
current residence.
(2) Information regarding every oocyte that has been donated or
used. This record should be sufficient to determine the provenance
and disposition of those materials.
(3) A record of all adverse health outcomes, including, but not
limited to, incidences and degrees of severity, resulting from the
AOP or any alternative method of oocyte retrieval.
(b) (1) The information included in the written record pursuant to
subdivision (a) shall not disclose personally identifiable
information about subjects, and shall be confidential and is deemed
protected by subject privacy provisions of law. This information
shall be reported to the State Department of Health Services, which
shall aggregate the data and make it publicly available, as set forth
in paragraph (2), in a manner that does not reveal personally
identifiable information about the subjects.
(2) The department shall provide public access to information
which it is required to release pursuant to the California Public
Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7
of Title 1 of the Government Code). The department shall disseminate
the information to the general public via governmental and other Web
sites in a manner that is understandable to the average person. The
information shall be made available to the public when the biennial
review pursuant to Section 125119.5 is provided to the Legislature.
125343. Any employee who works in the unit conducting stem cell
research using human oocytes, persons who report to, or are
supervised by, the principal investigator or key personnel of the
project, or both, along with the principal investigator and the key
personnel of the project, and the immediate family members of any of
the above persons are prohibited from being a subject in the
research.
125344. The physician and surgeon performing the AOP or any
alternative method of oocyte retrieval shall not have a financial
interest in the outcome of the research.
125345. Pursuant to guidelines adopted by the Research Council
and Institute of Medicine of the National Academies, researchers
shall offer subjects an opportunity to document their preferences
regarding future uses of their donated materials. The consent process
shall fully explore whether subjects have objections to any specific
forms of research to ensure that their wishes are honored.
125346. Any procedures for procuring oocytes in this state for
research or the development of medical therapies shall meet all of
the standards for subjects included in this chapter. All oocytes
procured outside of this state for research taking place in this
state shall meet these same standards. All egg extractions for
research shall be approved by an institutional review board pursuant
to Section 125341.
125350. No human oocyte or embryo shall be acquired, sold,
offered for sale, received, or otherwise transferred for valuable
consideration for the purposes of medical research or development of
medical therapies. For purposes of this section, "valuable
consideration" does not include reasonable payment for the removal,
processing, disposal, preservation, quality control, and storage of
oocytes or embryos.
125355. No payment in excess of the amount of reimbursement of
direct expenses incurred as a result of the procedure shall be made
to any subject to encourage her to produce human oocytes for the
purposes of medical research.
SEC. 8. This act shall not be construed to amend Proposition 71,
approved by the voters at the November 2, 2004, general election.