Amended in Senate August 19, 2016

California Legislature—2015–16 Regular Session

Assembly BillNo. 2531

Introduced by Assembly Member Burke

February 19, 2016

An act tobegin insert amend Section 125341 of, and toend insert add Section 125356 to, and to repeal and add Section 125355 of, the Health and Safety Code, relating to reproductive health.


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 encouragebegin delete herend deletebegin insert womenend insert to produce human oocytes for the purposes of medical research.begin insert 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.end insert

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.begin insert 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.end insert 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.begin insert 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.end insert

Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no.

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

P2    1


The Legislature finds and declares all of the

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 law upholding
10the principle of voluntary and informed consent and to tailor them
11to this new area of pioneering research that utilizes human oocytes.

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

P3    1(e) In California, the mechanisms dedicated to judging this
2balance include human subject research panels, institutional review
3boards, and stem cell research organizations.

4(f) Concerns that women will be exploited if compensated for
5providing human oocytes for research have not borne out in the
6states where compensation is allowed.

7(g) The ban on compensation for women providing human
8oocytes for research was created due to concerns regarding the
9high volume of oocytes needed for embryonic stem cell research,
10but extends to all research. Without compensation, few women
11participate in research, creating barriers to reproductive research
12that could benefit all women. As an example, more research could
13be done on embryo quality so that women undergoing in vitro
14fertilization (IVF) can confidently choose to have a single embryo
15implanted with a high probability of achieving a successful
16pregnancy, instead of multiple embryos. Lowering the rate of
17multiple pregnancies in IVF is a high priority goal that benefits
18women, parents, the resulting children, and society. The best source
19of available embryos for research comes from embryos created
20for fertility using a compensated donor, as she is more likely to
21produce a higher volume of oocytes and excess viable embryos
22than the infertile woman. Due to the ban on compensation, oocytes
23and embryos not needed for fertility will be unsuitable for research
24and will likely be discarded.

25(h) All patients, including those participating inbegin delete researchend delete
26begin insert research,end insert are due a reasonable duty of care. In addition, all women
27undergoing ovarian stimulation and oocyte retrieval have another
28layer of regulation as all cycles are reported to the federal Centers
29for Disease Control and Prevention.

30(i) Sufficient protections are in place to treat women providing
31human oocytes for research, similar to any other research subject,
32knowing women are competent and able to make decisions for

34(j) This act repeals the ban on compensation for women
35providing human oocytes for research. Compensation amounts
36will be determined by human subject research panels and
37institutional review boards.

38begin insert

begin insertSEC. 2.end insert  

end insert

begin insertSection 125341 of the end insertbegin insertHealth and Safety Codeend insertbegin insert is
39amended to read:end insert

P4    1


An institutional review board (IRB) that reviews and
2approves medical and scientific research shall require all of the
3following of any research program or project that comes under its
4review that involves AOP or any alternative method of oocyte

6(a) That it include a written summary as required under Section
7125335 that would include information on health risks and potential
8adverse consequences of the procedure and describe the manner
9in which the subject will receive and review this written summary.

begin insert

(b) That it inform the subject that ongoing studies will continue
11to assess the long-term health impacts of ovarian stimulation and
12oocyte retrieval.

end insert
begin delete


end delete

14begin insert(c)end insert That it obtain informed consent in compliance with the
15Protection of Human Subjects in Medical Experimentation Act
16(Chapter 1.3 (commencing with Section 24170) of Division 20),
17including informed consent for information obtained pursuant to
18Section 125342.

begin delete


end delete

20begin insert(d)end insert That it provide the subject with an objective and accurate
21statement about the existing state of the research for which the
22subject is providing oocytes.

begin delete


end delete

24begin insert(e)end insert That it perform psychological and physical screening, in
25accordance with the appropriate standard of care, for all subjects
26prior to the oocyte retrieval procedure.

begin delete


end delete

28begin insert(f)end insert That it ensure that after conducting AOP or any alternative
29method of oocyte retrieval on a subject, the subject be given a
30postprocedure medical examination at a time within the standard
31of care to determine if the subject has experienced an adverse
32health effect that is a result of the procedure. The subject shall be
33informed that she has the right to a second opinion if she has any
34medical concerns.

begin delete


end delete

36begin insert(g)end insert That it ensure that the subject has access to and coverage
37for medically appropriate medical care that is required as a direct
38result of the procedure for research purposes. The research program
39or project shall ensure that payment or coverage of resulting
40medical expenses be provided at no cost to the subject and that a
P5    1summary of the arrangements the procuring entity has made for
2coverage or payment for medical care related to AOP or any
3alternative method of oocyte retrieval is provided to the subject
4prior to the procedure.

begin delete


end delete

6begin insert(h)end insert That it provide a summary informing the subject that oocytes
7may not be sold or transferred for valuable consideration except
8as set forth in Section 125350.

begin delete


end delete

10begin insert(i)end insert That it provide disclosure if the physician and surgeon and
11his or her immediate family members have any professional interest
12in the outcome of the research or of the oocyte retrieval procedure
13and, if so, that it provide disclosure that he or she carries the
14interest of both the subject and the success of the research.


begin deleteSEC. 2.end delete
begin insertSEC. 3.end insert  

Section 125355 of the Health and Safety Code is


begin deleteSEC. 3.end delete
begin insertSEC. 4.end insert  

Section 125355 is added to the Health and Safety Code,
20to read:



begin insert(a)end insertbegin insertend insertNotwithstanding Section 125350, a woman
22providing human oocytes for research shall be compensated for
23her time, discomfort, and inconvenience in the same manner as
24other research subjects. Payment pursuant to this section shall not
25be for the human oocytes themselves or predicated on the number
26of oocytes obtained, including if no human oocytes are obtained.
27Whether a proposed compensation amount is appropriate shall be
28determined by a human subject research panel or institutional
29review board. In the event that a human subject research panel or
30institutional review board determines that a proposed compensation
31amount is inappropriate, the panel or board shall determine an
32appropriate compensation amount.

begin insert

(b) A woman providing human oocytes for research shall be
34provided with a summary of health and consumer issues associated
35with AOP as required under Section 125335 and informed consent
36requirements, as described in Section 125340.

end insert
begin insert

(c) Any research program that offers compensation to women
38providing human oocytes for research pursuant to subdivision (a)
39is subject to Sections 125341 and 125342, including, but not limited
40to, coverage for medically appropriate medical care that is
P6    1required as a direct result of the procedure for research purposes,
2 regardless of the level of compensation offered.

end insert

begin deleteSEC. 4.end delete
begin insertSEC. 5.end insert  

Section 125356 is added to the Health and Safety Code,
5to read:



If a woman providing human oocytes for the purposes
7of fertility is compensated, and any human oocytes or embryos in
8excess of those needed for fertility are offered for research, the
9institutional review board shall disregard the amount of
10compensation if all of the following conditions are met:

11(a) The clinic performing oocyte retrieval is a member of the
12Society for Assisted Reproductive Technology.

13(b) The procurement and disposition for research purposes of
14human oocytes initially provided for reproductive uses, either for
15use by the donor or another woman, shall not knowingly
16compromise the optimal reproductive success of the woman in the
17infertility treatment.

18(c) The infertility treatment protocol is established prior to
19requesting or obtaining consent for donation for research purposes
20and the prospect of donation for research does not alter the timing,
21method, or procedures selected for clinical care.

22(d) The woman in infertility treatment makes the determination
23that she does not want or need the oocytes for her own reproductive

25(e) The donation of oocytes for research is done without valuable
26consideration as defined in Section 125350.