Bill Text: CA AB2531 | 2015-2016 | Regular Session | Amended
Bill Title: Reproductive health and research.
Sponsorship: Partisan Bill (Democrat 1)
Status: (Engrossed - Dead) 2016-11-30 - Died on unfinished business file, concurrence pending. [AB2531 Detail]
Download: California-2015-AB2531-Amended.html
BILL NUMBER: AB 2531 AMENDED
BILL TEXT
AMENDED IN SENATE AUGUST 19, 2016
INTRODUCED BY Assembly Member Burke
FEBRUARY 19, 2016
An act to amend Section 125341 of, and to add Section
125356 to, and to repeal and add Section 125355 of, the Health and
Safety Code, relating to reproductive health.
LEGISLATIVE COUNSEL'S DIGEST
AB 2531, as amended, Burke. Reproductive health and research.
Existing law prohibits 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 prohibits payment in excess of the amount of
reimbursement of direct expenses to be made to any research subject
to encourage her women to produce human
oocytes for the purposes of medical research. Before obtaining
informed consent from a subject for assisted oocyte production (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, existing law requires a physician
and surgeon to provide to the subject a standardized medically
accurate written summary of health and consumer issues associated
with AOP, as specified.
This bill would instead require women providing human oocytes for
research to be compensated for their time, discomfort, and
inconvenience in the same manner as other research subjects, as
prescribed and determined by a human subject research panel or
institutional review board. The bill would make a research
program or project that offers to compensate women for their time,
discomfort, and inconvenience for providing human oocytes for
research subject to specified provisions of existing law relating to
institutional review board requirements and written records.
The bill would require the institutional review board to disregard
the amount of compensation if a woman providing human oocytes for
fertility is compensated, human oocytes or embryos in excess of those
needed for fertility are offered for research, and certain
conditions are met. The bill would additionally require an
institutional review board that reviews and approves medical and
scientific research to require of any research program or project
that comes under its review that involves AOP or any alternative
method of oocyte retrieval to inform the subject that ongoing studies
will continue to assess the long-term health impacts of ovarian
stimulation and oocyte retrieval.
Vote: majority. Appropriation: no. Fiscal committee: no.
State-mandated local program: no.
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 in 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) For all research subjects, there is a concern for exploitation
when subjects are asked to subject themselves to drugs, devices, or
procedures they might not otherwise need to do for their own health
but for the benefit of all. This can range from persons with terminal
illnesses who might be so desperate for help they would subject
themselves to a high-risk procedure with limited benefit, to
otherwise healthy people who might be motivated primarily by a
financial award. To address this concern of exploitation, and to
recognize the need for people to participate in research, mechanisms
were created to balance the need to reward research participants
without creating undue inducement.
(e) In California, the mechanisms dedicated to judging this
balance include human subject research panels, institutional review
boards, and stem cell research organizations.
(f) Concerns that women will be exploited if compensated for
providing human oocytes for research have not borne out in the states
where compensation is allowed.
(g) The ban on compensation for women providing human oocytes for
research was created due to concerns regarding the high volume of
oocytes needed for embryonic stem cell research, but extends to all
research. Without compensation, few women participate in research,
creating barriers to reproductive research that could benefit all
women. As an example, more research could be done on embryo quality
so that women undergoing in vitro fertilization (IVF) can confidently
choose to have a single embryo implanted with a high probability of
achieving a successful pregnancy, instead of multiple embryos.
Lowering the rate of multiple pregnancies in IVF is a high priority
goal that benefits women, parents, the resulting children, and
society. The best source of available embryos for research comes from
embryos created for fertility using a compensated donor, as she is
more likely to produce a higher volume of oocytes and excess viable
embryos than the infertile woman. Due to the ban on compensation,
oocytes and embryos not needed for fertility will be unsuitable for
research and will likely be discarded.
(h) All patients, including those participating in
research research, are due a reasonable duty of
care. In addition, all women undergoing ovarian stimulation and
oocyte retrieval have another layer of regulation as all cycles are
reported to the federal Centers for Disease Control and Prevention.
(i) Sufficient protections are in place to treat women providing
human oocytes for research, similar to any other research subject,
knowing women are competent and able to make decisions for
themselves.
(j) This act repeals the ban on compensation for women providing
human oocytes for research. Compensation amounts will be determined
by human subject research panels and institutional review boards.
SEC. 2. Section 125341 of the Health and
Safety Code is amended to read:
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 inform the subject that ongoing studies will continue
to assess the long-term health impacts of ovarian stimulation and
oocyte retrieval.
(b)
(c) 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)
(d) 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)
(e) 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)
(f) 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)
(g) 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)
(h) 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)
(i) 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.
SEC. 2. SEC. 3. Section 125355 of the
Health and Safety Code is repealed.
SEC. 3. SEC. 4. Section 125355 is
added to the Health and Safety Code, to read:
125355. (a) Notwithstanding Section 125350,
a woman providing human oocytes for research shall be compensated
for her time, discomfort, and inconvenience in the same manner as
other research subjects. Payment pursuant to this section shall not
be for the human oocytes themselves or predicated on the number of
oocytes obtained, including if no human oocytes are obtained. Whether
a proposed compensation amount is appropriate shall be determined by
a human subject research panel or institutional review board. In the
event that a human subject research panel or institutional review
board determines that a proposed compensation amount is
inappropriate, the panel or board shall determine an appropriate
compensation amount.
(b) A woman providing human oocytes for research shall be provided
with a summary of health and consumer issues associated with AOP as
required under Section 125335 and informed consent requirements, as
described in Section 125340.
(c) Any research program that offers compensation to women
providing human oocytes for research pursuant to subdivision (a) is
subject to Sections 125341 and 125342, including, but not limited to,
coverage for medically appropriate medical care that is required as
a direct result of the procedure for research purposes, regardless of
the level of compensation offered.
SEC. 4. SEC. 5. Section 125356 is
added to the Health and Safety Code, to read:
125356. If a woman providing human oocytes for the purposes of
fertility is compensated, and any human oocytes or embryos in excess
of those needed for fertility are offered for research, the
institutional review board shall disregard the amount of compensation
if all of the following conditions are met:
(a) The clinic performing oocyte retrieval is a member of the
Society for Assisted Reproductive Technology.
(b) The procurement and disposition for research purposes of human
oocytes initially provided for reproductive uses, either for use by
the donor or another woman, shall not knowingly compromise the
optimal reproductive success of the woman in the infertility
treatment.
(c) The infertility treatment protocol is established prior to
requesting or obtaining consent for donation for research purposes
and the prospect of donation for research does not alter the timing,
method, or procedures selected for clinical care.
(d) The woman in infertility treatment makes the determination
that she does not want or need the oocytes for her own reproductive
success.
(e) The donation of oocytes for research is done without valuable
consideration as defined in Section 125350.
