BILL NUMBER: AB 926	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  APRIL 23, 2013

INTRODUCED BY   Assembly Member Bonilla
    (   Coauthors:   Assembly Members 
 Atkins,   Garcia,   and Skinner   )


                        FEBRUARY 22, 2013

   An act 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 926, as amended, Bonilla. 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 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 to produce human oocytes for the
purposes of medical research.
   This bill would instead require women providing human oocytes for
research to be compensated for their time, trouble, and inconvenience
in the same manner as other research subjects, as prescribed. The
bill would require an 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.
   Vote: majority. Appropriation: no. Fiscal committee:  yes
  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 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) 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 current 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 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 bill will reverse the current 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 125355 of the Health and Safety Code is repealed.
  SEC. 3.  Section 125355 is added to the Health and Safety Code, to
read:
   125355.  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.

  SEC. 4.  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.