Amended in Assembly April 23, 2013

California Legislature—2013–14 Regular Session

Assembly BillNo. 926


Introduced by Assembly Member Bonilla

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(Coauthors: Assembly Members Atkins, Garcia, and Skinner)

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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: begin deleteyes end deletebegin insertnoend insert. State-mandated local program: no.

The people of the State of California do enact as follows:

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SECTION 1.  

The Legislature finds and declares all of the
2following:

3(a) The purpose of this act is to create protections for research
4subjects and it should not be construed to affect any other form of
5medical care.

6(b) Scientific research can be most effectively achieved by
7establishing protocols to protect, respect, and promote human
8health, safety, dignity, autonomy, and rights in conducting research.

9(c) This act seeks to support the requirements in current law
10upholding the principle of voluntary and informed consent and to
11tailor them to this new area of pioneering research that utilizes
12human oocytes.

13(d) For all research subjects, there is a concern for exploitation
14when subjects are asked to subject themselves to drugs, devices,
15or procedures they might not otherwise need to do for their own
16health but for the benefit of all. This can range from persons with
17terminal illnesses who might be so desperate for help they would
18subject themselves to a high-risk procedure with limited benefit,
19to otherwise healthy people who might be motivated primarily by
20a financial award. To address this concern of exploitation, and to
21recognize the need for people to participate in research,
22mechanisms were created to balance the need to reward research
23participants without creating undue inducement.

24(e) In California, the mechanisms dedicated to judging this
25balance include human subject research panels, institutional review
26boards, and stem cell research organizations.

27(f) Concerns that women will be exploited if compensated for
28providing human oocytes for research have not borne out in the
29states where compensation is allowed.

30(g) The current ban on compensation for women providing
31human oocytes for research was created due to concerns regarding
32the high volume of oocytes needed for embryonic stem cell
33research, but extends to all research. Without compensation, few
34women participate in research, creating barriers to reproductive
35research that could benefit all women. As an example, more
36research could be done on embryo quality so that women
37undergoing in vitro fertilization (IVF) can confidently choose to
38have a single embryo implanted with a high probability of
P3    1achieving a successful pregnancy, instead of multiple embryos.
2Lowering the rate of multiple pregnancies in IVF is a high priority
3goal that benefits women, parents, the resulting children, and
4society. The best source of available embryos for research comes
5from embryos created for fertility using a compensated donor, as
6she is more likely to produce a higher volume of oocytes and excess
7viable embryos than the infertile woman. Due to the ban on
8compensation, oocytes and embryos not needed for fertility will
9be unsuitable for research and will likely be discarded.

10(h) All patients, including those participating in research are
11due a reasonable duty of care. In addition, all women undergoing
12ovarian stimulation and oocyte retrieval have another layer of
13regulation as all cycles are reported to the federal Centers for
14Disease Control and Prevention.

15(i) Sufficient protections are in place to treat women providing
16human oocytes for research, similar to any other research subject,
17knowing women are competent and able to make decisions for
18 themselves.

19(j) This bill will reverse the current ban on compensation for
20women providing human oocytes for research. Compensation
21amounts will be determined by human subject research panels and
22institutional review boards.

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SEC. 2.  

Section 125355 of the Health and Safety Code is
24repealed.

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SEC. 3.  

Section 125355 is added to the Health and Safety Code,
26to read:

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125355.  

Notwithstanding Section 125350, a woman providing
28human oocytes for research shall be compensated for her time,
29discomfort, and inconvenience in the same manner as other
30research subjects. Payment pursuant to this section shall not be for
31the human oocytes themselves or predicated on the number of
32oocytes obtained, including if no human oocytes are obtained.
33begin insert Whether a proposed compensation amount is appropriate shall
34be determined by a human subject research panel or institutional
35review board. In the event that a human subject research panel or
36institutional review board determines that a proposed
37compensation amount is inappropriate, the panel or board shall
38determine an appropriate compensation amount.end insert

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SEC. 4.  

Section 125356 is added to the Health and Safety Code,
40to read:

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125356.  

If a woman providing human oocytes for the purposes
2of fertility is compensated, and any human oocytes or embryos in
3excess of those needed for fertility are offered for research, the
4institutional review board shall disregard the amount of
5compensation if all of the following conditions are met:

6(a) The clinic performing oocyte retrieval is a member of the
7Society for Assisted Reproductive Technology.

8(b) The procurement and disposition for research purposes of
9human oocytes initially provided for reproductive uses, either for
10use by the donor or another woman, shall not knowingly
11compromise the optimal reproductive success of the woman in the
12infertility treatment.

13(c) The infertility treatment protocol is established prior to
14requesting or obtaining consent for donation for research purposes
15and the prospect of donation for research does not alter the timing,
16method, or procedures selected for clinical care.

17(d) The woman in infertility treatment makes the determination
18that she does not want or need the oocytes for her own reproductive
19success.

20(e) The donation of oocytes for research is done without valuable
21consideration as defined in Section 125350.



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