BILL NUMBER: AB 2531	INTRODUCED
	BILL TEXT


INTRODUCED BY   Assembly Member Burke

                        FEBRUARY 19, 2016

   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 2531, as introduced, 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 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, 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 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.
   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 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 125355 of the Health and Safety Code is repealed.

   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. 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.