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:
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
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.
23(e) In California, the mechanisms dedicated to judging this
24balance include human subject research panels, institutional review
25boards, and stem cell research organizations.
26(f) Concerns that women will be exploited if compensated for
27providing human oocytes for research have not borne out in the
28states where compensation is allowed.
29(g) The ban on compensation for women providing human
30oocytes for research was created due to concerns regarding the
31high volume of oocytes needed for embryonic stem cell research,
32but extends to all research. Without compensation, few women
33participate in research, creating barriers to reproductive research
34that could benefit all women. As an example, more research could
35be done on embryo quality so that women undergoing in vitro
36fertilization (IVF) can confidently choose to have a single embryo
37implanted with a high probability of achieving a successful
38pregnancy, instead of multiple embryos. Lowering the rate of
P3 1multiple pregnancies in IVF is a high priority goal that benefits
2women, parents, the resulting children, and society. The best source
3of available embryos for research comes from embryos created
4for fertility using a compensated donor, as she is more likely to
5produce a higher volume of oocytes and excess viable embryos
6than the infertile woman. Due to the ban on compensation, oocytes
7and embryos not needed for fertility will be unsuitable for research
8and will likely be discarded.
9(h) All patients, including those participating in research are
10due a reasonable duty of care. In addition, all women undergoing
11ovarian stimulation and oocyte retrieval have another layer of
12regulation as all cycles are reported to the federal Centers for
13Disease Control and Prevention.
14(i) Sufficient protections are in place to treat women providing
15human oocytes for research, similar to any other research subject,
16knowing women are competent and able to make decisions for
18(j) This act repeals the ban on compensation for women
19providing human oocytes for research. Compensation amounts
20will be determined by human subject research panels and
21institutional review boards.
Section 125355 of the Health and Safety Code is
No payment in excess of the amount of reimbursement
25of direct expenses incurred as a result of the procedure shall be
26made to any subject to encourage her to produce human oocytes
27for the purposes of medical research.
Section 125355 is added to the Health and Safety Code,
Notwithstanding Section 125350, a woman providing
31human oocytes for research shall be compensated for her time,
32discomfort, and inconvenience in the same manner as other
33research subjects. Payment pursuant to this section shall not be for
34the human oocytes themselves or predicated on the number of
35oocytes obtained, including if no human oocytes are obtained.
36Whether a proposed compensation amount is appropriate shall be
37determined by a human subject research panel or institutional
38review board. In the event that a human subject research panel or
39institutional review board determines that a proposed compensation
P4 1amount is inappropriate, the panel or board shall determine an
2appropriate compensation amount.
Section 125356 is added to the Health and Safety Code,
If a woman providing human oocytes for the purposes
6of fertility is compensated, and any human oocytes or embryos in
7excess of those needed for fertility are offered for research, the
8institutional review board shall disregard the amount of
9compensation if all of the following conditions are met:
10(a) The clinic performing oocyte retrieval is a member of the
11Society for Assisted Reproductive Technology.
12(b) The procurement and disposition for research purposes of
13human oocytes initially provided for reproductive uses, either for
14use by the donor or another woman, shall not knowingly
15compromise the optimal reproductive success of the woman in the
17(c) The infertility treatment protocol is established prior to
18requesting or obtaining consent for donation for research purposes
19and the prospect of donation for research does not alter the timing,
20method, or procedures selected for clinical care.
21(d) The woman in infertility treatment makes the determination
22that she does not want or need the oocytes for her own reproductive
24(e) The donation of oocytes for research is done without valuable
25consideration as defined in Section 125350.