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 women to produce human oocytes for the purposes of medical research. 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.

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 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. 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. 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.

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.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 2531

Author:(Burke)

As Amended Ver:August 19, 2016

Majority vote

Original Committee Reference: HEALTH

SUMMARY: Repeals the ban on compensation for women providing human oocytes (eggs) for research, and instead allows a woman providing eggs for research to be compensated for her time, discomfort, and inconvenience in the same manner as other research subjects.

The Senate amendments require that a woman providing eggs for research be provided with a summary of health and consumer issues associated with assisted oocyte production (AOP) and informed consent requirements, and to be informed that ongoing studies will continue to assess the long-term health impacts of ovarian stimulation and egg retrieval.

FISCAL EFFECT: None.

COMMENTS: According to the author, this bill promotes medical research in California while ensuring research participants are fairly treated by removing the prohibition on compensation for women participating in egg donation for medical research. The author states that we all benefit from those willing to participate in research, and the current processes in place are designed to appropriately reward participants, while protecting them from abusive or coercive practices. The author notes that this bill ensures that women are treated equally to all other research subjects - allowing them to actively evaluate their participation in research studies and be paid for their time, trouble, and inconvenience when they do participate. The author concludes, given that compensation is allowed in 47 other states, and there is no evidence of abuse, it's time to reconsider our ban, just as New York did.

Research using donated eggs. Embryonic stem cells are a unique discovery with the power to unlock causes of and treatments for many human illnesses. Diseases and disabilities such as heart disease, spinal cord injuries, juvenile diabetes (Type I diabetes), amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), Parkinson's disease, and Alzheimer's disease afflict millions of Americans. These are some of the most debilitating diseases known to modern medicine in that they often severely limit the activity of the affected individual, cause painful degeneration of normal bodily functions, bring on premature death, and cause immense suffering for the individual and his or her family.

Potential benefits of embryo research include an improved understanding of fertilization, implantation, and early pregnancy biology and, with this understanding, possibly fewer undesired outcomes, such as miscarriage. For infertile couples, embryo research offers the possibility of more effective therapies: research efforts helped optimize conditions for intracytoplasmic sperm injection, embryo culture, and cryopreservation, for example. For others at risk for heritable genetic disease who feel pregnancy termination is undesirable or inappropriate, embryo research has led to the possibility of early, accurate genetic diagnosis. Preimplantation genetic diagnosis provides diagnostic results at a point before implantation, so pregnancy termination can be avoided. In addition to these benefits of embryo research in general, stem cell research promises additional potential benefits, for such work may lead both to a better understanding of the processes leading to tissue differentiation and function and to possible therapies by creating lines that can replace diseased or nonfunctioning tissues.

SUPPORT. The American Society for Reproductive Medicine (ASRM) is the sponsor of this bill and states, in the United States and California there is a fundamental principle that all research participants deserve just compensation for their contribution to research that entails some risk and much time, trouble, and inconvenience. ASRM contends the lack of compensation deters participants and stalls research. The sponsor notes, women considering ovarian stimulation and oocyte retrieval are capable of informed decision making as to the risks of compensated participation in research, just as they do for now for fertility. ASRM concludes that fairness requires research participants receive the same compensation fertility donors presently receive, and allowing compensation for fertility purposes while banning it for research serves a false value, subordinating research to fertility.

The American Congress of Obstetricians and Gynecologists, District IX – California (ACOG) writes that all other research subjects are compensated for their time, trouble, and inconvenience related to participating in research, except for this population. ACOG notes that this bill ensures that women are treated equal to all other research subjects – allowing them to actively evaluate their participation in research studies.

OPPOSITION. The Center for Genetics and Society (CGS) is opposed to this bill stating, that women providing eggs are not research subjects, and egg retrieval is very different from a clinical trial. CGS notes that, in clinical trial, investigators study the reactions and health outcomes of subjects who take a drug, use a device, or undergo a procedure, however, in the case of egg harvesting, investigators are not studying, or seeking to understand the effects of the procedures on women. CGS also notes that many experts remain concerned about the long-term risks of these drugs, especially their potential impact on infertility and various cancers, and that follow-up research on egg providers, which could establish the frequency and severity of these adverse outcomes, and best protocols for avoiding them, is widely recognized to be grossly inadequate. CGS also references the Institute of Medicine report, "Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research (2006)," and that it concluded that one of the striking facts about ovarian stimulation is just how little is known about long-term health outcomes for women.

We Are Egg Donors indicates that with no provisions in this bill to protect the health of women who would be providing these oocytes, based on their collective experiences as egg providers, they feel it would be imprudent to pass this bill because women cannot give informed consent when there is a lack of information about the risks.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0004769

 THIRD READING  

Bill No: AB 2531

Author:

: in Senate

Vote:

SENATE HEALTH COMMITTEE: 8-1, 6/15/16

AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Pan, Roth, Wolk

NOES: Nielsen

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 65-3, 4/28/16 - See last page for vote

SUBJECT:

SOURCE: American Society for Reproductive Medicine

DIGEST: This bill requires 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.

Senate Floor Amendments of 8/19/16 (1) require that an institutional review board (IRB) to require a research project that includes oocyte retrieval to inform the research subject that ongoing studies will continue to assess the long-term health impacts of ovarian stimulation and oocyte retrieval; (2) require that a woman providing human oocytes for research to be provided with a summary of health and consumer issues associated with assisted oocyte production and informed consent requirements, as specified; (3) make any research program that offers compensation to women providing human oocytes for research subject to specified existing law, including, but not limited to, coverage for medically appropriate medical care that is required as a direct result of the procedure for research purposes, regardless of the level of compensation offered; and (4) make other conforming and technical changes.

ANALYSIS:

Existing law:

1. Prohibits any payment in excess of the amount of reimbursement of direct expenses incurred as a result of the procedure to be made to any subject to encourage her to produce human eggs for purposes of medical research. Prohibits any human egg or embryo from being acquired, sold, offered for sale, received, or otherwise transferred for valuable consideration for the purposes of medical research or development of medical therapies.
2. Requires an IRB to require research programs or projects under its review that involve “assisted oocyte production” to comply with certain requirements, including that the research program perform psychological and physical screening for all subjects, and that subjects be given a post-procedure medical examination.

This bill:

1. Repeals the ban on compensation in excess of the amount of reimbursement of direct expenses incurred, as specified. Requires compensation amounts to be determined by human subject research panels and IRBs.
2. Requires a woman providing human oocytes for research to be compensated for her time, discomfort, and inconvenience in the same manner as other research subjects. Prohibits this payment from being for the human oocytes themselves or predicated on the number of oocytes obtained, including if no human oocytes are obtained.
3. Requires a human subject research panel or IRB to determine whether a proposed compensation amount is appropriate. Requires the panel or IRB, in the event that a proposed compensation amount is determined to be inappropriate, to determine an appropriate compensation amount.
4. Requires the IRB, 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, to disregard the amount of compensation if:
   1. The clinic performing oocyte retrieval is a member of the Society for Assisted Reproductive Technology;
   2. The procurement and disposition for research purposes of human oocytes initially provided for reproductive uses, either for use by the donor or another woman, does not knowingly compromise the optimal reproductive success of the woman in the infertility treatment;
   3. 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;
   4. The woman in infertility treatment makes the determination that she does not want or need the oocytes for her own reproductive success; and,
   5. The donation of oocytes for research is done without valuable consideration, as specified.
5. Requires that an IRB to require a research project that includes oocyte retrieval to inform the research subject that ongoing studies will continue to assess the long-term health impacts of ovarian stimulation and oocyte retrieval.
6. Requires that a woman providing human oocytes for research to be provided with a summary of health and consumer issues associated with assisted oocyte production and informed consent requirements, as specified.
7. Makes any research program that offers compensation to women providing human oocytes for research subject to specified existing law, including, but not limited to, coverage for medically appropriate medical care that is required as a direct result of the procedure for research purposes, regardless of the level of compensation offered.

Background

Over the past two decades, millions of women have had oocytes collected for the purpose of assisted reproduction. Most of these were women undergoing in vitro fertilization (IVF) with their own eggs, but a significant minority donate eggs to help other women get pregnant. During the normal ovulation cycle, 10 or 20 egg follicles will begin to grow, eventually leading to one “dominant follicle” producing a single egg, and the other egg follicles dying off. In the process, hormones are used to basically trick the body into keeping the other follicles alive and also produce eggs. The process involves the woman self-injecting hormones to stimulate the growth of ovarian follicles, plus a gonadotropin-releasing hormone (GnRH) agonist to block the normal surge of luteinizing hormone (LH), which could cause the woman to ovulate before the physician retrieves the eggs. Typically, GnRH agonists are administered a week before stimulation to control the stimulation cycle and avoid a spontaneous LH surge. The woman subsequently self-injects the hormone chorionic gonadotropin (similar to LH) to affect egg maturation. When the eggs are ready, the woman is brought into surgery, where the eggs are harvested via needle aspiration. A woman who has undergone the usual hormone treatment will have a dozen or so eggs that can be collected.

NOTE: Please see the Senate Health Committee analysis for more detailed background information on this subject.

Comments

Author’s statement. According to the author, AB 2531 promotes medical research in California while ensuring research participants are fairly treated by removing the prohibition on compensation for women participating in oocyte (egg) donation for medical research. We all benefit from those willing to participate in research, and the current processes in place are designed to appropriately reward participants, while protecting them from abusive or coercive practices. AB 2531 ensures that women are treated equally to all other research subjects - allowing them to actively evaluate their participation in research studies and be paid for their time, trouble and inconvenience when they do participate. Given that compensation is allowed in 47 other states, and there is no evidence of abuse, it’s time to reconsider our ban, just as New York did. Lifting the ban will allow women providing oocytes, just as any other research subject, to make an informed decision as to participation, and justly compensate them for doing so. We should no longer deny a woman’s fundamental ability to make informed decisions or think for herself, or tell her if she wants to participate, she can only participate on terms different than for any other procedure.

FISCAL EFFECT: Appropriation: Fiscal Com.: Local:

SUPPORT: (Verified 8/22/16)

American Society for Reproductive Medicine (source)

Adventist Health

Alliance for Fertility Preservation

American Association of University Women

American Congress of Obstetricians and Gynecologists

California Chronic Care Coalition

California Cryobank

California Hepatitis C Task Force

California Life Sciences Association

California National Organization for Women

Equality California

Fair Allocation in Research Foundation

Fertile Action

Loma Linda University Health

National Association of Hepatitis Task Forces

National Center for Lesbian Rights

Resolve: The National Infertility Association

Secular Coalition for California

OPPOSITION: (Verified 8/22/16)

Alliance for Humane Biotechnology

Black Women for Wellness

Black Women’s Health Imperative

Breast Cancer Action

California Catholic Conference, Inc.

California Nurses for Ethical Standards

California Right to Life Committee, Inc.

Center for Genetics and Society

Friends of the Earth

Forward Together

Life Priority Network

National Women’s Health Network

Our Bodies Ourselves

Pro-Choice Alliance for Responsible Research

We Are Egg Donors

Seven Individuals

ARGUMENTS IN SUPPORT: The American Association of University Women and the American Congress of Obstetricians and Gynecologists, District IX (California) (AAUW/ACOG) state that all other research subjects can be compensated for their time, trouble, and inconvenience related to participating in research, except for this population. AAUW/ACOG contend that this bill ensures that women are treated equally to all other research subjects - allowing them to actively evaluate their participation in research studies, and that it will remove barriers to women participating in research that could result in improvement in care for reproductive health, including infertility and cancer care. AAUW/ACOG state that this research could benefit untold numbers of women in the future. The California Life Sciences Association states that California is one of three states banning compensation for oocytes, which ultimately deters participation among women who are willing donors and stalls research excellence. California Cryobank states that to single out egg donors is inherently discriminatory so few, if any women, participate in oocyte research in California, creating barriers to reproductive and other biomedical research that could result in major medical advancements in cancer and degenerative diseases. The National Association of Hepatitis Task Forces, the California Hepatitis C Task Force, and the Fair Allocation in Research Foundation state that the gender inequality regarding women and research will be resolved by having a requirement for women providing human oocytes for research to be compensated. Equality California writes that despite all of the protections to guard against the dangers of exploitation in laws and informed consent procedures, women are the only ones singled out and prohibited from being compensated for research purposes in cases of oocyte donation and that as a result of the prohibition, all research is suffering due to lack of needed tissues. Resolve states that while some fear potential exploitation of women for their oocytes, in the 47 other states which permit compensation there is no evidence of exploitation or abuse. The National Center for Lesbian Rights states that if paying for oocyte donors is an acceptable practice for infertility treatment, it should also be acceptable to compensate donors who provide their eggs for research. The California Chronic Care Coalition writes that this bill will ensure that women are treated equally to all other research subjects, allowing them to actively evaluate their participation in research studies and be paid for their time, trouble, and inconvenience when they do participate.

ARGUMENTS IN OPPOSITION: Former California State Senator Deborah Ortiz, who authored the legislation that this bill seeks to repeal, states that in 2006, she stood alongside women’s health and reproductive rights advocates to call for more studies on the long-term health outcomes for women undergoing egg retrieval. Senator Ortiz states that the health risks to women are not only significant, but there is wide recognition that they are understudied and that the many reports of harm to women who provide eggs in the fertility context should not be ignored. Senator Ortiz further states that the research has advanced very little in the last 10 years, reinforcing the need for more data before expanding the market in eggs and that the absence of data should urge caution, not serve as a rationale to support inducements for medical procedures that carry risks. A number of organizations, including Breast Cancer Action, Black Women for Wellness, Friends of the Earth, and National Women’s Health Network write that while they support reimbursing women for the reasonable expenses of egg donation, they oppose paying women over and above those amounts because women providing eggs are not research subjects, and egg harvesting is very different from a clinical trial and the health risks of egg harvesting are substantial, but there is insufficient evidence about their extent and severity to be able to provide true informed consent. These opponents further state that this bill conflicts with recommendations by the National Academy of Sciences, and with policies that apply to California Institute for Regenerative Medicine-funded researchers and are part of the California Constitution. Black Women for Wellness also writes that they are concerned about the lack of oversight to protect vulnerable women from being preyed upon for research purposes, especially with the lack of clarity around the longer term health consequences of egg harvesting. We Are Egg Donors states that they understand that research with human oocytes can contribute to important knowledge that can be used for the greater good, but with no provision in this bill to protect the health of women who would be providing these oocytes, based on their collective experiences as egg providers, feel it would be imprudent to pass it. The Alliance for Humane Biotechnology states that in clinical trials, investigators study the reactions and health outcomes of subjects who take a drug, use a device, or undergo a procedure and that in a case of egg harvesting, investigators are not studying, or seeking to understand, the effects of the procedures on women. The Alliance for Humane Biotechnology states that egg providers are thus quite different from research subjects. The California Catholic Conference states that this bill puts women’s health in jeopardy by creating and, in effect, resulting in a marketing dynamic designed to exploit women who are most in need of resources, including college students, immigrants and women with economic challenges.

ASSEMBLY FLOOR: 65-3, 4/28/16

AYES: Achadjian, Alejo, Arambula, Atkins, Baker, Bloom, Bonilla, Bonta, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dodd, Eggman, Frazier, Beth Gaines, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mayes, McCarty, Medina, Mullin, Nazarian, Obernolte, O'Donnell, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Weber, Wilk, Williams, Wood, Rendon

NOES: Grove, Harper, Mathis

NO VOTE RECORDED: Travis Allen, Bigelow, Brough, Dahle, Daly, Gallagher, Gray, Hadley, Melendez, Olsen, Patterson, Waldron

Prepared by:

8/22/16 23:18:48

**** END ****

 THIRD READING  

Bill No: AB 2531

Author:

:

Vote:

SENATE HEALTH COMMITTEE: 8-1, 6/15/16

AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Pan, Roth, Wolk

NOES: Nielsen

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 65-3, 4/28/16 - See last page for vote

SUBJECT:

SOURCE: American Society for Reproductive Medicine

DIGEST: This bill requires 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.

ANALYSIS:

Existing law:

1. Prohibits any payment in excess of the amount of reimbursement of direct expenses incurred as a result of the procedure to be made to any subject to encourage her to produce human eggs for purposes of medical research. Prohibits any human egg or embryo from being acquired, sold, offered for sale, received, or otherwise transferred for valuable consideration for the purposes of medical research or development of medical therapies.
2. Requires an institutional review board (IRB) to require research programs or projects under its review that involve “assisted oocyte production” to comply with certain requirements, including that the research program perform psychological and physical screening for all subjects, and that subjects be given a post-procedure medical examination.

This bill:

1. Repeals the ban on compensation in excess of the amount of reimbursement of direct expenses incurred, as specified. Requires compensation amounts to be determined by human subject research panels and IRBs.
2. Requires a woman providing human oocytes for research to be compensated for her time, discomfort, and inconvenience in the same manner as other research subjects. Prohibits this payment from being for the human oocytes themselves or predicated on the number of oocytes obtained, including if no human oocytes are obtained.
3. Requires a human subject research panel or IRB to determine whether a proposed compensation amount is appropriate. Requires the panel or IRB, in the event that a proposed compensation amount is determined to be inappropriate, to determine an appropriate compensation amount.
4. Requires the IRB, 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, to disregard the amount of compensation if:
   1. The clinic performing oocyte retrieval is a member of the Society for Assisted Reproductive Technology;
   2. The procurement and disposition for research purposes of human oocytes initially provided for reproductive uses, either for use by the donor or another woman, does not knowingly compromise the optimal reproductive success of the woman in the infertility treatment;
   3. 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;
   4. The woman in infertility treatment makes the determination that she does not want or need the oocytes for her own reproductive success; and,
   5. The donation of oocytes for research is done without valuable consideration, as specified.

Background

Over the past two decades, millions of women have had oocytes collected for the purpose of assisted reproduction. Most of these were women undergoing in vitro fertilization (IVF) with their own eggs, but a significant minority donate eggs to help other women get pregnant. During the normal ovulation cycle, 10 or 20 egg follicles will begin to grow, eventually leading to one “dominant follicle” producing a single egg, and the other egg follicles dying off. In the process, hormones are used to basically trick the body into keeping the other follicles alive and also produce eggs. The process involves the woman self-injecting hormones to stimulate the growth of ovarian follicles, plus a gonadotropin-releasing hormone (GnRH) agonist to block the normal surge of luteinizing hormone (LH), which could cause the woman to ovulate before the physician retrieves the eggs. Typically, GnRH agonists are administered a week before stimulation to control the stimulation cycle and avoid a spontaneous LH surge. The woman subsequently self-injects the hormone chorionic gonadotropin (similar to LH) to affect egg maturation. When the eggs are ready, the woman is brought into surgery, where the eggs are harvested via needle aspiration. A woman who has undergone the usual hormone treatment will have a dozen or so eggs that can be collected.

Compensation of oocyte donors. Under California law, the prohibition against compensation to oocyte donors applies only to donors for research purposes, not to assist someone else get pregnant (fertility purposes). According to a March 2010 report by the Hastings Center, a research institution focusing on bioethics, entitled “Self-Regulation, Compensation, and the Ethical Recruitment of Oocyte Donors,” the fertility industry in the United States relies heavily on self-regulation, which generally takes the form of guidelines issued by the American Society for Reproductive Medicine (ASRM - the sponsor of this bill) and its affiliated organization, the Society for Assisted Reproductive Technology. The report looked at egg donor recruitment advertisements on college campuses, and found that nearly half offered compensation that exceeded recommended levels. The average compensation offered was approximately $9,000, with a maximum offer of $50,000. ASRM’s 2007 donor compensation guidelines state that compensation should be structured to acknowledge the time, inconvenience, and discomfort associated with the process, and should not vary according to the planned use of the oocytes, the number or quality retrieved, or the donor’s ethnic or other personal characteristics. The guidelines state that total payments to donors in excess of $5,000 require justification, and sums above $10,000 are not appropriate.

Institute of Medicine report. Following passage of Proposition 71 in 2004, the Institute of Medicine and the National Research Council convened a committee of experts to ascertain the medical risks of oocyte donation for stem cell research. The committee issued a report in 2007 entitled “Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research” (IMR report), which stated that years of experience with assisted reproduction have identified a number of potential risks associated with egg donation, falling into three main categories: (1) the potential risks arising from the hormone regimen that women are given to stimulate egg production, including ovarian hyperstimulation syndrome, perhaps problems with long-term fertility, and breast, ovarian, and endometrial cancers; (2) the risks associated with the surgical procedure, including the anesthesia, which involves many of the same issues that anyone having surgery faces; and (3), the potential risks that are psychological in nature, including anxiety, mood swings, and post-donation adjustment. However, the IMR Report stated that there was a need for more and better data and that one of the most striking facts about IVF is just how little is known for sure about the long term health outcomes for the women who undergo the procedures. The IMR Report notes that there are no registries that track the health of the people who have taken part, and without such registries to draw from, most of the studies have focused on relatively small groups of people. The IMR Report did acknowledge that the available data come primarily from IVF patients and not from healthy subjects, yet it is healthy women and not those coping with infertility who will be donating eggs for research, which raises the possibility that the existing data overstates the potential risks for healthy donors. The bottom line, according to the IMR Report, is that there is a great deal of uncertainty about the potential risks for oocyte donation for research.

National Academy of Sciences. The National Academy of Sciences’ (NAS) Guidelines for Human Embryonic Stem Cell Research states that women who undergo hormonal induction to generate oocytes specifically for research purposes should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an IRB. The Guidelines go on to state that “no payments beyond reimbursements, cash or in-kind, should be provided for donating oocytes for research purposes. Similarly, no payments beyond reimbursements should be made for donations of sperm for research purposes.” When developing the 2010 amendments to these guidelines (the most recent update), NAS noted that since the prior update in 2008, the ethics committee of the State of New York’s Empire State Stem Cell Board adopted a resolution allowing New York State-funded stem cell researchers to compensate women who donate their oocytes directly and solely to research for the time, risk and burden involved in donating. Amounts of compensation are to be comparable to those received by women in New York State for similar donations for reproductive purposes. NAS stated that while it “acknowledges that the circumstances surrounding the issue of compensation to oocyte donors continues to evolve, it chose not to change the National Academies’ Guidelines.” NAS went on to state that while it was leaving its guideline on no payments in place, it recognized that “other states and entities may choose to set their own policies, as New York has done.”

Comments

Author’s statement. According to the author, AB 2531 promotes medical research in California while ensuring research participants are fairly treated by removing the prohibition on compensation for women participating in oocyte (egg) donation for medical research. We all benefit from those willing to participate in research, and the current processes in place are designed to appropriately reward participants, while protecting them from abusive or coercive practices. AB 2531 ensures that women are treated equally to all other research subjects - allowing them to actively evaluate their participation in research studies and be paid for their time, trouble and inconvenience when they do participate. Given that compensation is allowed in 47 other states, and there is no evidence of abuse, it’s time to reconsider our ban, just as New York did. Lifting the ban will allow women providing oocytes, just as any other research subject, to make an informed decision as to participation, and justly compensate them for doing so. We should no longer deny a woman’s fundamental ability to make informed decisions or think for herself, or tell her if she wants to participate, she can only participate on terms different than for any other procedure.

FISCAL EFFECT: Appropriation: Fiscal Com.: Local:

SUPPORT: (Verified 8/1/16)

American Society for Reproductive Medicine (source)

Adventist Health

Alliance for Fertility Preservation

American Association of University Women

American Congress of Obstetricians and Gynecologists

California Chronic Care Coalition

California Cryobank

California Hepatitis C Task Force

California Life Sciences Association

Equality California

Fair Allocation in Research Foundation

Fertile Action

Loma Linda University Health

National Association of Hepatitis Task Forces

National Center for Lesbian Rights

Resolve: The National Infertility Association

OPPOSITION: (Verified 8/1/16)

Alliance for Humane Biotechnology

Black Women for Wellness

Black Women’s Health Imperative

Breast Cancer Action

California Catholic Conference, Inc.

California Nurses for Ethical Standards

California Right to Life Committee, Inc.

Center for Genetics and Society

Friends of the Earth

Forward Together

Life Priority Network

National Women’s Health Network

Our Bodies Ourselves

Pro-Choice Alliance for Responsible Research

We Are Egg Donors

Seven Individuals

ARGUMENTS IN SUPPORT: The American Association of University Women and the American Congress of Obstetricians and Gynecologists, District IX (California) (AAUW/ACOG) state that all other research subjects can be compensated for their time, trouble, and inconvenience related to participating in research, except for this population. AAUW/ACOG contend that this bill ensures that women are treated equally to all other research subjects - allowing them to actively evaluate their participation in research studies, and that it will remove barriers to women participating in research that could result in improvement in care for reproductive health, including infertility and cancer care. AAUW/ACOG state that this research could benefit untold numbers of women in the future. The California Life Sciences Association states that California is one of three states banning compensation for oocytes, which ultimately deters participation among women who are willing donors and stalls research excellence. California Cryobank states that to single out egg donors is inherently discriminatory so few, if any women, participate in oocyte research in California, creating barriers to reproductive and other biomedical research that could result in major medical advancements in cancer and degenerative diseases. The National Association of Hepatitis Task Forces, the California Hepatitis C Task Force, and the Fair Allocation in Research Foundation state that the gender inequality regarding women and research will be resolved by having a requirement for women providing human oocytes for research to be compensated. Equality California writes that despite all of the protections to guard against the dangers of exploitation in laws and informed consent procedures, women are the only ones singled out and prohibited from being compensated for research purposes in cases of oocyte donation and that as a result of the prohibition, all research is suffering due to lack of needed tissues. Resolve states that while some fear potential exploitation of women for their oocytes, in the 47 other states which permit compensation there is no evidence of exploitation or abuse. The National Center for Lesbian Rights states that if paying for oocyte donors is an acceptable practice for infertility treatment, it should also be acceptable to compensate donors who provide their eggs for research. The California Chronic Care Coalition writes that this bill will ensure that women are treated equally to all other research subjects, allowing them to actively evaluate their participation in research studies and be paid for their time, trouble, and inconvenience when they do participate.

ARGUMENTS IN OPPOSITION: Former California State Senator Deborah Ortiz, who authored the legislation that this bill seeks to repeal, states that in 2006, she stood alongside women’s health and reproductive rights advocates to call for more studies on the long-term health outcomes for women undergoing egg retrieval. Senator Ortiz states that the health risks to women are not only significant, but there is wide recognition that they are understudied and that the many reports of harm to women who provide eggs in the fertility context should not be ignored. Senator Ortiz further states that the research has advanced very little in the last 10 years, reinforcing the need for more data before expanding the market in eggs and that the absence of data should urge caution, not serve as a rationale to support inducements for medical procedures that carry risks. A number of organizations, including Breast Cancer Action, Black Women for Wellness, Friends of the Earth, and National Women’s Health Network write that while they support reimbursing women for the reasonable expenses of egg donation, they oppose paying women over and above those amounts because women providing eggs are not research subjects, and egg harvesting is very different from a clinical trial and the health risks of egg harvesting are substantial, but there is insufficient evidence about their extent and severity to be able to provide true informed consent. These opponents further state that this bill conflicts with recommendations by the National Academy of Sciences, and with policies that apply to California Institute for Regenerative Medicine-funded researchers and are part of the California Constitution. Black Women for Wellness also writes that they are concerned about the lack of oversight to protect vulnerable women from being preyed upon for research purposes, especially with the lack of clarity around the longer term health consequences of egg harvesting. We Are Egg Donors states that they understand that research with human oocytes can contribute to important knowledge that can be used for the greater good, but with no provision in this bill to protect the health of women who would be providing these oocytes, based on their collective experiences as egg providers, feel it would be imprudent to pass it. The Alliance for Humane Biotechnology states that in clinical trials, investigators study the reactions and health outcomes of subjects who take a drug, use a device, or undergo a procedure and that in a case of egg harvesting, investigators are not studying, or seeking to understand, the effects of the procedures on women. The Alliance for Humane Biotechnology states that egg providers are thus quite different from research subjects. The California Catholic Conference states that this bill puts women’s health in jeopardy by creating and, in effect, resulting in a marketing dynamic designed to exploit women who are most in need of resources, including college students, immigrants and women with economic challenges.

ASSEMBLY FLOOR: 65-3, 4/28/16

AYES: Achadjian, Alejo, Arambula, Atkins, Baker, Bloom, Bonilla, Bonta, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dodd, Eggman, Frazier, Beth Gaines, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mayes, McCarty, Medina, Mullin, Nazarian, Obernolte, O'Donnell, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Weber, Wilk, Williams, Wood, Rendon

NOES: Grove, Harper, Mathis

NO VOTE RECORDED: Travis Allen, Bigelow, Brough, Dahle, Daly, Gallagher, Gray, Hadley, Melendez, Olsen, Patterson, Waldron

Prepared by:

8/3/16 19:10:59

**** END ****

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: AB 2531

SUBJECT: Reproductive health and research

SUMMARY:

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.

Existing law:

1. Defines “oocyte” as a female egg or egg cell of a human female, and defines “assisted oocyte production” (AOP) as surgical extraction of oocytes following pharmaceutically induced manipulation of oocyte production through the use of ovarian stimulation.
2. Prohibits any payment in excess of the amount of reimbursement of direct expenses incurred as a result of the procedure to be made to any subject to encourage her to produce human eggs for purposes of medical research.
3. Prohibits any human egg or embryo from being acquired, sold, offered for sale, received, or otherwise transferred for valuable consideration for the purposes of medical research or development of medical therapies.
4. Requires a physician, prior to providing AOP for the purposes of medical research, to obtain written and oral informed consent for the procedure from the subject, and requires this informed consent to comply with the requirements of the Protection of Human Subjects in Medical Experimentation Act (Act), as specified.
5. Requires a physician, prior to obtaining informed consent from a subject for AOP for the purpose of procuring eggs for research, to provide to the subject a standardized medically accurate written summary of health and consumer issues associated with AOP. Requires this summary to include medically accurate disclosures concerning the potential risks of AOP, including the risks associated with the surgical procedure and with using the drugs, medications, and hormones prescribed for ovarian stimulation during the AOP process.
6. Requires an institutional review board (IRB) to require research programs or projects under its review that involve AOP to comply with certain requirements, including that the research program perform psychological and physical screening for all subjects, and that subjects be given a post-procedure medical examination.
7. Requires a research program that involves AOP to ensure that a written record is maintained that includes specified components, including the demographics of subjects, information regarding every egg that has been donated or used, and a record of all adverse health outcomes resulting from the AOP.
8. Prohibits a physician performing the AOP from having a financial interest in the outcome of the research.
9. Establishes the Act, which provides various statutory protections for Californians involved in medical experiments, including a detailed requirement for what constitutes voluntary informed consent, and includes penalties for violations of this Act.
10. Establishes, in the California Constitution, via the passage of Proposition 71 in 2004, the California Stem Cell Research and Cures Act and the California Institute for Regenerative Medicine (CIRM), to provide $3 billion in bond funding over a period of 10 years to fund stem cell research. Requires the Independent Citizens Oversight Committee of CIRM to establish certain standards for the use of the funds provided by the Act, including a prohibition against compensation to donors or participants of the research, beyond reimbursement of expenses.

This bill:

1. Repeals the ban on compensation in excess of the amount of reimbursement of direct expenses incurred as a result of the procedure for women providing human oocytes for the purposes of medical research. Compensation amounts will be determined by human subject research panels and institutional review boards.
2. Requires a woman providing human oocytes for research to be compensated for her time, discomfort, and inconvenience in the same manner as other research subjects. Prohibits this payment from being for the human oocytes themselves or predicated on the number of oocytes obtained, including if no human oocytes are obtained.
3. Requires a human subject research panel or IRB to determine whether a proposed compensation amount is appropriate. Requires the panel or board, in the event that a proposed compensation amount is determined to be inappropriate, to determine an appropriate compensation amount.
4. Requires the IRB, 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, to disregard the amount of compensation if:
   1. The clinic performing oocyte retrieval is a member of the Society for Assisted Reproductive Technology;
   2. The procurement and disposition for research purposes of human oocytes initially provided for reproductive uses, either for use by the donor or another woman, does not knowingly compromise the optimal reproductive success of the woman in the infertility treatment;
   3. 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;
   4. The woman in infertility treatment makes the determination that she does not want or need the oocytes for her own reproductive success; and,
   5. The donation of oocytes for research is done without valuable consideration, as specified.
5. Makes a number of findings and declarations.

FISCAL EFFECT:

This bill is keyed non-fiscal.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, AB 2531 promotes medical research in California while ensuring research participants are fairly treated by removing the prohibition on compensation for women participating in oocyte (egg) donation for medical research. We all benefit from those willing to participate in research, and the current processes in place are designed to appropriately reward participants, while protecting them from abusive or coercive practices. AB 2531 ensures that women are treated equally to all other research subjects - allowing them to actively evaluate their participation in research studies and be paid for their time, trouble and inconvenience when they do participate. Given that compensation is allowed in 47 other states, and there is no evidence of abuse, it’s time to reconsider our ban, just as New York did. Lifting the ban will allow women providing oocytes, just as any other research subject, to make an informed decision as to participation, and justly compensate them for doing so. We should no longer deny a woman’s fundamental ability to make informed decisions or think for herself, or tell her if she wants to participate, she can only participate on terms different than for any other procedure.
   
2. Background on oocyte production and retrieval for donation. Over the past two decades, millions of women have had oocytes collected for the purpose of assisted reproduction. Most of these were women undergoing in vitro fertilization (IVF) with their own eggs, but a significant minority were donating their eggs to help other women get pregnant. During the normal ovulation cycle, 10 or 20 egg follicles will begin to grow, eventually leading to one “dominant follicle” producing a single egg, and the other egg follicles dying off. In the oocyte or egg donation process, hormones are used to basically trick the body into keeping the other follicles alive and also produce eggs. The donation process involves the woman self-injecting hormones to stimulate the growth of ovarian follicles, plus a gonadotropin-releasing hormone (GnRH) agonist to block the normal surge of luteinizing hormone (LH), which could cause the woman to ovulate before the physician retrieves the eggs. Typically, GnRH agonists are administered a week before stimulation to control the stimulation cycle and avoid a spontaneous LH surge. The woman subsequently self-injects the hormone chorionic gonadotropin (hCG, similar to LH) to affect egg maturation. When the eggs are ready, the woman is brought into surgery, where she receives intravenous sedation, and the eggs are harvested via needle aspiration. A woman who has undergone the usual hormone treatment will have a dozen or so eggs that can be collected.
3. Background on compensation of oocyte donors. Under California law, the prohibition against compensation to oocyte donors applies only to donors for research purposes, not to assist someone else get pregnant (fertility purposes). According to a March 2010 report by the Hastings Center, a research institution focusing on bioethics, entitled “Self-Regulation, Compensation, and the Ethical Recruitment of Oocyte Donors,” the fertility industry in the United States relies heavily on self-regulation, which generally takes the form of guidelines issued by the American Society for Reproductive Medicine (the sponsor of this bill) and its affiliated organization, the Society for Assisted Reproductive Technology. The report looked at egg donor recruitment advertisements on college campuses, and found that nearly half offered compensation that exceeded recommended levels. The average compensation offered was approximately $9,000, with a maximum offer of $50,000.
   
   The oocyte donor compensation guidelines of the American Society for Reproductive Medicine, adopted in 2007, state that compensation should be structured to acknowledge the time, inconvenience, and discomfort associated with the process, and should not vary according to the planned use of the oocytes, the number or quality retrieved, or the donor’s ethnic or other personal characteristics. The guidelines stated that total payments to donors in excess of $5,000 require justification, and sums above $10,000 are not appropriate.
   
   According to the author, besides California, only Massachusetts and South Dakota specifically prohibit compensation for oocyte donors.
4. Institutional Review Boards. An IRB is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans conducted under the auspices of the institution with which it is affiliated. IRBs are regulated by the federal Office for Human Research Protection, and are required to have at least five members, including at least one member who is not otherwise affiliated with the institution. IRBs have the authority to approve, require modifications in, or disapprove all research activities under its review. Under California law, regarding any research project involving AOP, the IRB is required to ensure that the research program comply with specified requirements, including the following:
   1. That the research program provide the subject with an objective and accurate statement about the existing state of the research for which the subject is providing oocytes;
   2. That the research program performs psychological and physical screening for all subjects prior to the oocyte retrieval procedure;
   3. That the research program ensure, after conducting AOP retrieval on a subject, that the subject be given a post-procedure medical examination at a time within the standard of care to determine if the subject has experienced an adverse health effect that is a result of the procedure, and to inform the subject of the right to a second opinion if she has any medical concerns;
   4. That the research program ensure that the subject has access to and coverage for medically appropriate medical care that is required as a direct result of the procedure , and to ensure that payment or coverage of resulting expenses is provided at no cost to the subject; and,
   5. That the research program provide disclosure if the physician and his or her immediate family members have any professional interest in the outcome of the research or of the oocyte retrieval procedure.
5. Institute of Medicine report. Following passage of Proposition 71 in 2004, CIRM asked the Institute of Medicine and the National Research Council to convene a committee of experts to ascertain the medical risks of oocyte donation for stem cell research. A workshop was convened in 2006, and issued a report in 2007 entitled “Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research” (IMR report). According to the IMR Report, years of experience with assisted reproduction have identified a number of potential risks associated with egg donation, falling into three main categories: (1) the potential risks arising from the hormone regimen that women are given to stimulate egg production, including ovarian hyperstimulation syndrome (OHSS), perhaps problems with long-term fertility, and breast, ovarian, and endometrial cancers; (2) the risks associated with the surgical procedure, including the anesthesia, which involves many of the same issues that anyone having surgery faces; and (3), the potential risks that are psychological in nature, including anxiety, mood swings, and post-donation adjustment. These risks are summarized below. However, the IMR Report stated that there was a need for more and better data. According to the report, one of the most striking facts about in vitro fertilization is just how little is known for sure about the long term health outcomes for the women who undergo the procedures. The IMR Report notes that there are no registries that track the health of the people who have taken part, and without such registries to draw from, most of the studies have focused on relatively small groups of people. The IMR Report did acknowledge that the available data come primarily from IVF patients and not from healthy subjects, yet it is healthy women and not those coping with infertility who will be donating eggs for research, which raises the possibility that the existing data overstates the potential risks for healthy donors. The bottom line, according to the IMR Report, is that there is a great deal of uncertainty about the potential risks for oocyte donation for research.
   1. Risk of Ovarian Hyperstimulation Syndrome. OHSS is the most common side effect of the use of fertility drugs, and is described in the IMR Report as an “exaggeration of a desired response” – which is to override the female body’s natural mechanism of getting a single egg during an ovulation cycle. The administration of the ovulation-inducing hormone hCG is a key factor in the development of OHSS. OHSS symptoms include enlarged ovaries, an accumulation of fluid in the abdomen. Moderate cases of OHSS are characterized by more than minimal discomfort, a significant fluid buildup in the abdomen, leading to shortness of breath, nausea and vomiting. These cases can normally be handled on an outpatient basis. Serious cases are rare – about 100 to 200 cases for every 100,000 stimulation cycles, but they can have serious complications, including blood clots or kidney failure in the most severe cases, requiring hospitalizations.
   2. Risk of cancer. The IMR Report noted that because women with infertility itself are at higher risk for cancer, it is more difficult to ascertain the extent to which egg donation increases cancer risk, because many of the women undergoing egg harvesting are doing so because of infertility problems. Taking this into consideration, the IMR Report stated that there was no evidence that fertility drugs elevate the risk of breast cancer, and that there was no systematic evidence at this point that fertility drugs elevate the risk for invasive ovarian cancer. But for uterine cancer, the IMR Report stated that while the data are too sparse to lead to any conclusion, there is greater concern. The IMR Report also noted a concern that these effects may not be evident until a longer period of time has elapsed between the exposure, the assisted reproduction therapy, and the cancer. According to the report, one study in particular found that as time elapsed since the treatment, there did seem to be an increased risk for breast, ovarian, and endometrial cancers, stating that this study raised the possibility that many studies have missed the increased cancer risk because they haven’t followed their subjects for enough years.
   3. Risk of long-term fertility effects. The IMR Report stated that one of the concerns that had been raised was that the retrieval of up to 20 eggs instead of the normal ovulation of one egg per cycle could hasten the onset of age-related infertility. However, based on both ovarian physiology and clinical experience, the report stated that is no reason to think that repeated ovarian stimulation poses a risk to a woman’s long-term fertility. The IMR Report acknowledged, however, that not everything is known on the subject, and there are several important questions that have not yet been answered. The IMR Report stated that it would be helpful, for example, to have a longitudinal study that followed woman who had ovarian stimulation all the way to menopause to find out what their reproduction future holds.
   4. Risk of surgery. The potential risk of surgical complications from oocyte retrieval is generally very small. A related concern is whether the trauma applied to the ovary by the needle during harvesting could increase the risk of infertility. The IMR reports that several studies have found that women who have undergone oocyte retrievals have a greater prevalence of antibodies to ovarian tissue, and these antibodies have been shown to be associated with IVF failures, but it is difficult to know whether antibodies play any role at all in infertility.
   5. Psychological risks. One form of psychological risk associated with donating eggs is that the screening process may reveal some previously unknown psychological or medical condition that disqualifies the woman from donating and that is uncomfortable or psychologically threatening to the patient. After the eggs have been donated, the main psychological issues that donors experience are related to worries about future fertility, about which the IMR Report states that more and better research should be done on the risks of oocyte donation so that these risks can be reported to the donors and they can be clear about what they are getting themselves into.
6. National Academy of Sciences. The National Academy of Sciences’ (NAS) Guidelines for Human Embryonic Stem Cell Research states that women who undergo hormonal induction to generate oocytes specifically for research purposes should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an IRB. The Guidelines go on to state that “no payments beyond reimbursements, cash or in-kind, should be provided for donating oocytes for research purposes. Similarly, no payments beyond reimbursements should be made for donations of sperm for research purposes.” When developing the 2010 amendments to these guidelines (the most recent update), NAS noted that since the prior update in 2008, the ethics committee of the State of New York’s Empire State Stem Cell Board adopted a resolution allowing New York State-funded stem cell researchers to compensate women who donate their oocytes directly and solely to research for the time, risk and burden involved in donating. Amounts of compensation are to be comparable to those received by women in New York State for similar donations for reproductive purposes. NAS stated that while it “acknowledges that the circumstances surrounding the issue of compensation to oocyte donors continues to evolve, it chose not to change the National Academies’ Guidelines.” NAS went on to state that while it was leaving its guideline on no payments in place, it recognized that “other states and entities may choose to set their own policies, as New York has done.”
7. Prior legislation. AB 926 (Bonilla), vetoed by Governor Brown in 2013, was substantially similar to this bill. AB 926 would have lifted the prohibition on compensation for egg donations for medical research, and would have established guidelines for the use of IRBs relative to egg donations and compensation. Governor Brown's veto message read:

Not everything in life is for sale nor should it be.

This bill would legalize the payment of money in exchange for a woman submitting to invasive procedures to stimulate, extract and harvest her eggs for scientific research.

The questions raised here are not simple; they touch matters that are both personal and philosophical.

In medical procedures of this kind, genuinely informed consent is difficult because the long-term risks are not adequately known. Putting thousands of dollars on the table only compounds the problem.

Six years ago the Legislature, by near unanimity, enacted the prohibition that this bill now seeks to reverse. After careful review of the materials which both supporters and opponents submitted, I do not find sufficient reason to change course.

I am returning this bill without my signature.

AB 1317 (Block, Chapter 523, Statutes of 2009), required that all advertisements for egg donations for fertility (non-research) purposes to include a warning that there is a screening process, that not all potential donors are selected, and that not all selected donors receive the compensation amount advertised. AB 1317 also requires the advertisement to include a warning that there may be risks involved, and required egg donors for fertility purposes to be provided with the same risk information required to be provided to donors for research purposes, and to comply with the same informed consent requirements.

SB 1260 (Ortiz, Chapter 483, Statutes of 2006), established various requirements related to the donation of eggs for research. The prohibition against compensating donors beyond reimbursement of direct costs, which this bill is seeking to repeal, was among the provisions established by SB 1260.

1. Support. The American Association of University Women and the American Congress of Obstetricians and Gynecologists, District IX (California) (AAUW/ACOG) state that all other research subjects can be compensated for their time, trouble, and inconvenience related to participating in research, except for this population. AAUW/ACOG contend that this bill ensures that women are treated equally to all other research subjects - allowing them to actively evaluate their participation in research studies, and that it will remove barriers to women participating in research that could result in improvement in care for reproductive health, including infertility and cancer care. AAUW/ACOG state that this research could benefit untold numbers of women in the future. The California Life Sciences Association states that California is one of three states banning compensation for oocytes, which ultimately deters participation among women who are willing donors and stalls research excellence. California Cryobank states that to single out egg donors is inherently discriminatory so few, if any women, participate in oocyte research in California, creating barriers to reproductive and other biomedical research that could result in major medical advancements in cancer and degenerative diseases. The National Association of Hepatitis Task Forces, the California Hepatitis C Task Force, and the Fair Allocation in Research Foundation state that the gender inequality regarding women and research will be resolved by having a requirement for women providing human oocytes for research to be compensated. Equality California writes that despite all of the protections to guard against the dangers of exploitation in laws and informed consent procedures, women are the only ones singled out and prohibited from being compensated for research purposes in cases of oocyte donation and that as a result of the prohibition, all research is suffering due to lack of needed tissues. RESOLVE states that while some fear potential exploitation of women for their oocytes, in the 47 other states which permit compensation there is no evidence of exploitation or abuse. The National Center for Lesbian Rights states that if paying for oocyte donors is an acceptable practice for infertility treatment, it should also be acceptable to compensate donors who provide their eggs for research. The California Chronic Care Coalition writes that this bill will ensure that women are treated equally to all other research subjects, allowing them to actively evaluate their participation in research studies and be paid for their time, trouble, and inconvenience when they do participate.
2. Opposition. Former California State Senator Deborah Ortiz, who authored the legislation that this bill seeks to repeal, states that In 2006, she stood alongside women’s health and reproductive rights advocates to call for more studies on the long-term health outcomes for women undergoing egg retrieval. Senator Ortiz states that the health risks to women are not only significant, but there is wide recognition that they are understudied and that the many reports of harm to women who provide eggs in the fertility context should not be ignored. Senator Ortiz further states that the research has advanced very little in the last 10 years, reinforcing the need for more data before expanding the market in eggs and that the absence of data should urge caution, not serve as a rationale to support inducements for medical procedures that carry risks. A number of organizations, including Breast Cancer Action, Black Women for Wellness, Friends of the Earth, and National Women’s Health Network write that while they support reimbursing women for the reasonable expenses of egg donation, they oppose paying women over and above those amounts because women providing eggs are not research subjects, and egg harvesting is very different from a clinical trial and the health risks of egg harvesting are substantial, but there is insufficient evidence about their extent and severity to be able to provide true informed consent. These supporters further state that this bill conflicts with recommendations by the National Academy of Sciences, and with policies that apply to CIRM-funded researchers and are part of the California constitution. Black Women for Wellness also writes that they are concerned about the lack of oversight to protect vulnerable women from being preyed upon for research purposes, especially with the lack of clarity around the longer term health consequences of egg harvesting. We Are Egg Donors states that they understand that research with human oocytes can contribute to important knowledge that can be used for the greater good, but with no provision in this bill to protect the health of women who would be providing these oocytes, based on their collective experiences as egg providers, feel it would be imprudent to pass it. The Alliance for Humane Biotechnology states that in clinical trials, investigators study the reactions and health outcomes of subjects who take a drug, use a device, or undergo a procedure and that in a case of egg harvesting, investigators are not studying, or seeking to understand, the effects of the procedures on women. The Alliance for Humane Biotechnology states that egg providers are thus quite different from research subjects. The California Catholic Conference states that this bill puts women’s health in jeopardy by creating and, in effect, result in a marketing dynamic designed to exploit women who are most in need of resources, including college students, immigrants and women with economic challenges.

SUPPORT AND OPPOSITION:

Support: Alliance for Fertility Preservation

American Association of University Women

American Congress of Obstetricians and Gynecologists

American Society for Reproductive Medicine

California Chronic Care Coalition

California Cryobank

California Hepatitis C Task Force

California Life Sciences Association

Equality California

Fair Allocation in Research Foundation

Fertile Action

National Association of Hepatitis Task Force

National Center for Lesbian Rights

Resolve: The National Infertility Association

Oppose: Alliance for Humane Biotechnology

Black Women for Wellness

Black Women’s Health Imperative

Breast Cancer Action

California Catholic Conference, Inc.

California Nurses for Ethical Standards

California Right to Life Committee, Inc.

Center for Genetics and Society

Friends of the Earth

Forward Together

National Women’s Health Network

Our Bodies Ourselves

Pro-Choice Alliance for Responsible Research

We Are Egg Donors

Five Individuals

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 2531

Author:(Burke)

As Introduced Ver:February 19, 2016

Majority vote

SUMMARY: Repeals the ban on compensation for women providing human oocytes (eggs) for research, and instead allows a woman providing eggs for research to be compensated for her time, discomfort, and inconvenience in the same manner as other research subjects. Specifically, this bill:

1. Prohibits payment received for providing eggs for research from being for the eggs themselves, or predicated on the number obtained, including if none are obtained.
2. Requires the proposed compensation amount to be determined by a human subject research panel or institutional review board (IRB).
3. Specifies, in the event that a human subject research panel or IRB determines that a proposed compensation amount is inappropriate, the panel or board to determine an appropriate compensation amount.
4. Requires the IRB, if a woman is compensated for providing eggs for the purpose of infertility treatment, and any eggs or embryos in excess of those needed for fertility are offered for research, to disregard the amount of compensation if all of the following conditions are met:
   1. The clinic performing egg retrieval is a member of the Society for Assisted Reproductive Technology;
   2. The procurement and disposition for research purposes of eggs 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;
   3. 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;
   4. The woman in infertility treatment makes the determination that she does not want or need the eggs for her own reproductive success; and,
   5. The donation of eggs for research is done without valuable consideration. Valuable consideration does not include reasonable payment for the removal, processing, disposal, preservation, quality control, and storage of eggs or embryos.
5. Makes various legislative findings and declarations, stating that concerns that women will be exploited if compensated for providing human eggs for research have not been borne out in the states where compensation is allowed, and that sufficient protections are in place to treat women providing human eggs for research, similar to any other research subject, and that women are competent and able to make decisions for themselves.

FISCAL EFFECT: None.

COMMENTS: According to the author, this bill promotes medical research in California while ensuring research participants are fairly treated by removing the prohibition on compensation for women participating in egg donation for medical research. The author states that we all benefit from those willing to participate in research, and the current processes in place are designed to appropriately reward participants, while protecting them from abusive or coercive practices. The author notes that this bill ensures that women are treated equally to all other research subjects - allowing them to actively evaluate their participation in research studies and be paid for their time, trouble, and inconvenience when they do participate. The author concludes, given that compensation is allowed in 47 other states, and there is no evidence of abuse, it's time to reconsider our ban, just as New York did.

Research using donated eggs. Embryonic stem cells are a unique discovery with the power to unlock causes of and treatments for many human illnesses. Diseases and disabilities such as heart disease, spinal cord injuries, juvenile diabetes (Type I diabetes), amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), Parkinson's disease, and Alzheimer's disease afflict millions of Americans. These are some of the most debilitating diseases known to modern medicine in that they often severely limit the activity of the affected individual, cause painful degeneration of normal bodily functions, bring on premature death, and cause immense suffering for the individual and his or her family.

Potential benefits of embryo research include an improved understanding of fertilization, implantation, and early pregnancy biology and, with this understanding, possibly fewer undesired outcomes, such as miscarriage. For infertile couples, embryo research offers the possibility of more effective therapies: research efforts helped optimize conditions for intracytoplasmic sperm injection, embryo culture, and cryopreservation, for example. For others at risk for heritable genetic disease who feel pregnancy termination is undesirable or inappropriate, embryo research has led to the possibility of early, accurate genetic diagnosis. Preimplantation genetic diagnosis provides diagnostic results at a point before implantation, so pregnancy termination can be avoided. In addition to these benefits of embryo research in general, stem cell research promises additional potential benefits, for such work may lead both to a better understanding of the processes leading to tissue differentiation and function and to possible therapies by creating lines that can replace diseased or nonfunctioning tissues.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0002697

Date of Hearing: April 5, 2016

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 2531

Author:(Burke) – As Introduced Ver:February 19, 2016

SUBJECT: Reproductive health and research.

SUMMARY: Repeals the ban on compensation for women providing human oocytes (eggs) for research, and instead allows a woman providing eggs for research to be compensated for her time, discomfort, and inconvenience in the same manner as other research subjects. Specifically, this bill:

1. Prohibits payment received for providing eggs for research from being for the eggs themselves, or predicated on the number obtained, including if none are obtained.
2. Requires the proposed compensation amount to be determined by a human subject research panel or institutional review board (IRB).
3. Specifies, in the event that a human subject research panel or IRB determines that a proposed compensation amount is inappropriate, the panel or board to determine an appropriate compensation amount.
4. Requires the IRB, if a woman is compensated for providing eggs for the purpose of infertility treatment, and any eggs or embryos in excess of those needed for fertility are offered for research, to disregard the amount of compensation if all of the following conditions are met:
   1. The clinic performing egg retrieval is a member of the Society for Assisted Reproductive Technology;
   2. The procurement and disposition for research purposes of eggs 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;
   3. 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;
   4. The woman in infertility treatment makes the determination that she does not want or need the eggs for her own reproductive success; and,
   5. The donation of eggs for research is done without valuable consideration. Valuable consideration does not include reasonable payment for the removal, processing, disposal, preservation, quality control, and storage of eggs or embryos.
5. Makes various legislative findings and declarations, stating that concerns that women will be exploited if compensated for providing human eggs for research have not been borne out in the states where compensation is allowed, and that sufficient protections are in place to treat women providing human eggs for research, similar to any other research subject, and that women are competent and able to make decisions for themselves.

EXISTING LAW:

1. Defines “oocyte” as a female egg or egg cell of a human female, and defines “assisted oocyte production” (AOP) as surgical extraction of oocytes following pharmaceutically induced manipulation of oocyte production through the use of ovarian stimulation.
2. Prohibits any payment in excess of the amount of reimbursement of direct expenses incurred as a result of the procedure to be made to any subject to encourage her to produce human eggs for purposes of medical research.
3. Prohibits any human egg or embryo from being acquired, sold, offered for sale, received, or otherwise transferred for valuable consideration for the purposes of medical research or development of medical therapies.
4. Requires a physician, prior to providing AOP for the purposes of medical research, to obtain written and oral informed consent for the procedure from the subject, and requires this informed consent to comply with the requirements of the Protection of Human Subjects in Medical Experimentation Act (Act), as specified.
5. Requires a physician, prior to obtaining informed consent from a subject for AOP for the purpose of procuring eggs for research, to provide to the subject a standardized medically accurate written summary of health and consumer issues associated with AOP. Requires this summary to include medically accurate disclosures concerning the potential risks of AOP, including the risks associated with the surgical procedure and with using the drugs, medications, and hormones prescribed for ovarian stimulation during the AOP process.
6. Requires an IRB to require research programs or projects under its review that involve AOP to comply with certain requirements, including that the research program perform psychological and physical screening for all subjects, and that subjects be given a post-procedure medical examination.
7. Requires a research program that involves AOP to ensure that a written record is maintained that includes specified components, including the demographics of subjects, information regarding every egg that has been donated or used, and a record of all adverse health outcomes resulting from the AOP.
8. Prohibits a physician performing the AOP from having a financial interest in the outcome of the research.
9. Establishes the Act, which provides various statutory protections for Californians involved in medical experiments, including a detailed requirement for what constitutes voluntary informed consent, and includes penalties for violations of this Act.
10. Establishes, in the California Constitution, via the passage of Proposition 71 in 2004, the California Stem Cell Research and Cures Act and the California Institute for Regenerative Medicine (CIRM), to provide $3 billion in bond funding over a period of 10 years to fund stem cell research. Requires the Independent Citizens Oversight Committee of CIRM to establish certain standards for the use of the funds provided by the Act, including a prohibition against compensation to donors or participants of the research, beyond reimbursement of expenses.

FISCAL EFFECT: None.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, this bill promotes medical research in California while ensuring research participants are fairly treated by removing the prohibition on compensation for women participating in egg donation for medical research. The author states that we all benefit from those willing to participate in research, and the current processes in place are designed to appropriately reward participants, while protecting them from abusive or coercive practices. The author notes that this bill ensures that women are treated equally to all other research subjects - allowing them to actively evaluate their participation in research studies and be paid for their time, trouble, and inconvenience when they do participate.
   
   The author continues, given that compensation is allowed in 47 other states, and there is no evidence of abuse, it’s time to reconsider our ban, just as New York did. Lifting the ban will allow women providing eggs, just as any other research subject, to make an informed decision as to participation, and justly compensate them for doing so. The author concludes we should no longer deny a woman’s fundamental ability to make informed decisions or think for herself, or tell her if she wants to participate, she can only participate on terms different than for any other procedure.
2. BACKGROUND.
   1. Egg production, retrieval, and donation. Over the past two decades, millions of women have had eggs collected for the purpose of assisted reproduction.  Most of these were women undergoing in vitro fertilization (IVF) with their own eggs; however, a significant minority were donating their eggs to help other women get pregnant.  In the egg donation process, hormones are used to basically trick the body into producing many mature eggs, instead of the normal single egg per menstrual cycle.  The donation process involves the woman self-injecting a mix of hormones over the span of a month that stimulate the growth of ovarian follicles, stop the normal ovulation cycle, and affect egg maturation. When the eggs are ready, the woman is brought into surgery, where she receives intravenous sedation, and the eggs are harvested via needle aspiration. A woman who has undergone the usual hormone treatment will have a dozen or so eggs that can be collected.
   2. Compensation of egg donors. Under California law, the prohibition against compensation to egg donors applies only to donors for research purposes, not to assist someone else in getting pregnant. According to a March 2010 report by the Hastings Center, a research institution focusing on bioethics, entitled “Self-Regulation, Compensation, and the Ethical Recruitment of Oocyte Donors,” the fertility industry in the United States relies heavily on self-regulation, which generally takes the form of guidelines issued by the American Society for Reproductive Medicine (ASRM, the sponsor of this bill) and its affiliated organization, the Society for Assisted Reproductive Technology. The report looked at egg donor recruitment advertisements on college campuses, and found that nearly half offered compensation that exceeded recommended levels. The average compensation offered was approximately $9,000, with a maximum offer of $50,000. The oocyte donor compensation guidelines of the ASRM, adopted in 2007, state that compensation should be structured to acknowledge the time, inconvenience, and discomfort associated with the process, and should not vary according to the planned use of the eggs, the number or quality retrieved, or the donor’s ethnic or other personal characteristics. The guidelines stated that total payments to donors in excess of $5,000 require justification, and sums above $10,000 are not appropriate.

According to the author, besides California, only Massachusetts and South Dakota specifically prohibit compensation for egg donors.

• 1. Institutional Review Boards. An IRB is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans conducted under the auspices of the institution with which it is affiliated. IRBs are regulated by the federal Office for Human Research Protection, and are required to have at least five members, including at least one member who is not otherwise affiliated with the institution. IRBs have the authority to approve, require modifications in, or disapprove all research activities under its review. Under California law, regarding any research project involving AOP, the IRB is required to ensure that the research program comply with specified requirements, including the following:
     
     1. That the research program provide the subject with an objective and accurate statement about the existing state of the research for which the subject is providing oocytes;
        
     2. That the research program performs psychological and physical screening for all subjects prior to the oocyte retrieval procedure;
        
     3. That the research program ensures, after conducting AOP retrieval on a subject, that the subject be given a post-procedure medical examination at a time within the standard of care to determine if the subject has experienced an adverse health effect that is a result of the procedure, and to inform the subject of the right to a second opinion if she has any medical concerns;
        
     4. That the research program ensures that the subject has access to and coverage for medically appropriate medical care that is required as a direct result of the procedure, and to ensure that payment or coverage of resulting expenses is provided at no cost to the subject; and,
        
     5. That the research program provides disclosure if the physician and his or her immediate family members have any professional interest in the outcome of the research or of the oocyte retrieval procedure.
        
  2. Institute of Medicine Report. Following passage of Proposition 71 in 2004, CIRM asked the Institute of Medicine (IOM) and the National Research Council to convene a committee of experts to ascertain the medical risks of oocyte donation for stem cell research. A workshop was convened in 2006, and issued a report in 2007 entitled “Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research” (IOM Report). According to the IOM Report, years of experience with assisted reproduction have identified a number of potential risks associated with egg donation, falling into three main categories: i) the potential risks arising from the hormone regimen that women are given to stimulate egg production, including ovarian hyper-stimulation syndrome (OHSS), problems with long-term fertility, breast, ovarian, and endometrial cancers; ii) the risks associated with the surgical procedure, including the anesthesia, which involves many of the same issues that anyone having surgery faces; and, iii), the potential risks that are psychological in nature, including anxiety, mood swings, and post-donation adjustment.
     

However, the IOM Report stated that there was a need for more and better data. According to the report, one of the most striking facts about IVF is just how little is known for sure about the long-term health outcomes for the women who undergo the procedures. The IOM Report notes that there are no registries that track the health of the people who have taken part, and without such registries to draw from, most of the studies have focused on relatively small groups of people. The IOM Report did acknowledge that the available data come primarily from IVF patients and not from healthy subjects, yet it is healthy women and not those coping with infertility who will be donating eggs for research, which raises the possibility that the existing data overstates the potential risks for healthy donors. The bottom line, according to the IOM Report, is that there is a great deal of uncertainty about the potential health risks for egg donation.

• 1. National Academy of Sciences. The National Academy of Sciences’ (NAS) Guidelines for Human Embryonic Stem Cell Research state that women who undergo hormonal induction to generate eggs specifically for research purposes should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an IRB. The Guidelines go on to state that “no payments beyond reimbursements, cash or in-kind, should be provided for donating oocytes for research purposes. Similarly, no payments beyond reimbursements should be made for donations of sperm for research purposes.” When developing the 2010 amendments to these guidelines (the most recent update), NAS noted that since the prior update in 2008, the ethics committee of the State of New York’s Empire State Stem Cell Board adopted a resolution allowing New York State-funded stem cell researchers to compensate women who donate their eggs directly and solely to research for the time, risk, and burden involved in donating. Amounts of compensation are to be comparable to those received by women in New York State for similar donations for reproductive purposes. NAS stated that while it “acknowledges that the circumstances surrounding the issue of compensation to oocyte donors continues to evolve, it chose not to change the National Academies’ Guidelines.” NAS went on to state that while it was leaving its guideline on no payments in place, it recognized that “other states and entities may choose to set their own policies, as New York has done.”
     
  2. Research using donated eggs. Embryonic stem cells are a unique discovery with the power to unlock causes of and treatments for many human illnesses. Diseases and disabilities such as heart disease, spinal cord injuries, juvenile diabetes (Type I diabetes), amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), Parkinson's disease, and Alzheimer's disease afflict millions of Americans. These are some of the most debilitating diseases known to modern medicine in that they often severely limit the activity of the affected individual, cause painful degeneration of normal bodily functions, bring on premature death, and cause immense suffering for the individual and his or her family.
     
     Potential benefits of embryo research include an improved understanding of fertilization, implantation, and early pregnancy biology and, with this understanding, possibly fewer undesired outcomes, such as miscarriage. For infertile couples, embryo research offers the possibility of more effective therapies: research efforts helped optimize conditions for intracytoplasmic sperm injection, embryo culture, and cryopreservation, for example. For others at risk for heritable genetic disease who feel pregnancy termination is undesirable or inappropriate, embryo research has led to the possibility of early, accurate genetic diagnosis. Preimplantation genetic diagnosis provides diagnostic results at a point before implantation, so pregnancy termination can be avoided. In addition to these benefits of embryo research in general, stem cell research promises additional potential benefits, for such work may lead both to a better understanding of the processes leading to tissue differentiation and function and to possible therapies by creating lines that can replace diseased or nonfunctioning tissues.

1. SUPPORT. ASRM is the sponsor of this bill and states, in the United States and California there is a fundamental principle that all research participants deserve just compensation for their contribution to research that entails some risk and much time, trouble, and inconvenience. ASRM contends the lack of compensation deters participants and stalls research. The sponsor notes, women considering ovarian stimulation and oocyte retrieval are capable of informed decision making as to the risks of compensated participation in research, just as they do for now for fertility. ASRM concludes that fairness requires research participants receive the same compensation fertility donors presently receive, and allowing compensation for fertility purposes while banning it for research serves a false value, subordinating research to fertility.
   
   The American Congress of Obstetricians and Gynecologists, District IX – California (ACOG) writes that all other research subjects are compensated for their time, trouble, and inconvenience related to participating in research, except for this population. ACOG notes that this bill ensures that women are treated equal to all other research subjects – allowing them to actively evaluate their participation in research studies.
   
   The National Center for Lesbian Rights (NCLR) asserts that only through research – through translating science from the laboratory to clinical practice – can treatment options and patient outcomes be improved. NCLR states that without compensation for oocyte donations, few women participate in research, creating barriers to reproductive and other biomedical research that could benefit all women. NCLR concludes a lack of fertility research affect LGBT people in particular because assisted reproduction is essential for many LGBT people to become parents and build families.
2. OPPOSITION. The Center for Genetics and Society (CGS) is opposed to this bill stating, that women providing eggs are not research subjects, and egg retrieval is very different from a clinical trial. CGS notes that, in clinical trial, investigators study the reactions and health outcomes of subjects who take a drug, use a device, or undergo a procedure, however, in the case of egg harvesting, investigators are not studying, or seeking to understand the effects of the procedures on women. CGS also notes that many experts remain concerned about the long-term risks of these drugs, especially their potential impact on infertility and various cancers, and that follow-up research on egg providers, which could establish the frequency and severity of these adverse outcomes, and best protocols for avoiding them, is widely recognized to be grossly inadequate. CGS also references the IOM report, “Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research (2006),” and that it concluded that one of the striking facts about ovarian stimulation is just how little is known about long-term health outcomes for women.
   
   We Are Egg Donors indicates that with no provisions in this bill to protect the health of women who would be providing these oocytes, based on their collective experiences as egg providers, they feel it would be imprudent to pass this bill because women cannot give informed consent when there is a lack of information about the risks.
   
   The California Catholic Conference, Inc. opposes this bill stating that it would put women's health in jeopardy by creating and, in effect, result in a marketing dynamic designed to exploit women who are most in need of resources – including college students, immigrants, and women with economic challenges.
3. PREVIOUS LEGISLATION.
   1. AB 926 (Bonilla), vetoed by Governor Brown in 2013, was substantially similar to this bill. AB 926 would have lifted the prohibition on compensation for egg donations for medical research, and would have established guidelines for the use of IRBs relative to egg donations and compensation. Governor Brown's veto message read:

Not everything in life is for sale nor should it be.

This bill would legalize the payment of money in exchange for a woman submitting to invasive procedures to stimulate, extract and harvest her eggs for scientific research.

The questions raised here are not simple; they touch matters that are both personal and philosophical.

In medical procedures of this kind, genuinely informed consent is difficult because the long-term risks are not adequately known. Putting thousands of dollars on the table only compounds the problem.

Six years ago the Legislature, by near unanimity, enacted the prohibition that this bill now seeks to reverse. After careful review of the materials which both supporters and opponents submitted, I do not find sufficient reason to change course.

I am returning this bill without my signature.

• 1. AB 1317 (Block), Chapter 523, Statutes of 2009, required that all advertisements for egg donations for fertility (non-research) purposes to include a warning that there is a screening process, that not all potential donors are selected, and that not all selected donors receive the compensation amount advertised. AB 1313also requires the advertisement to include a warning that there may be risks involved, and required egg donors for fertility purposes to be provided with the same risk information required to be provided to donors for research purposes, and to comply with the same informed consent requirements.
  2. SB 1260 (Ortiz), Chapter 483, Statutes of 2006, establishes various requirements related to the donation of eggs for research. The prohibition against compensating donors beyond reimbursement of direct costs, which this bill is seeking to repeal, was among the provisions established by SB 1260.

1. POLICY COMMENT. In 2013 the Governor vetoed AB 926 which included similar provisions to those contained in this bill. The Committee may wish to ask the author her plans to address the Governor's veto message.

REGISTERED SUPPORT / OPPOSITION:

Support

American Society for Reproductive Medicine (sponsor)

American Congress of Obstetricians and Gynecologists, District IX – California

California Chronic Care Coalition
California Cryobank
Equality California
Fertile Action

National Center for Lesbian Rights
RESOLVE: The National Infertility Association

Opposition

California Catholic Conference, Inc.

California Right to Life Committee, Inc.
Center for Genetics and Society
We Are Egg Donors
Several individuals

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097