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Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Social, Ethical, and Legal Considerations Raised by IVG

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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This chapter summarizes a panel discussing the social, ethical, and legal implications of in vitro gametogenesis (IVG). The panel was moderated by Glenn Cohen, a professor at Harvard Law School studying the intersection of bioethics and law. The panelists included Michele Goodwin of the University of California, Irvine, a legal expert in health law, novel biotechnologies, reproductive rights, and racial disparities with sociological and anthropological training; Alana Cattapan of the University of Waterloo, Canada, a frontline researcher examining the governance of assisted human reproduction and reproductive biopolitics through a feminist lens; Sonia Suter of George Washington University, a legal expert on genetics and ART with training as a genetic counselor; and Henry (Hank) Greely of Stanford University, a law professor who studies ethical, legal, and social implications of emerging biomedical technologies.

Several panelists noted the importance of holding collective conversations about the potential intended and unintended consequences raised by IVG. Topics discussed were wide ranging, reflecting the many relevant areas when considering novel ART. Some of the questions and discussions revolved around the implications posed by IVG itself to produce human eggs and sperm, such as to enable older or same-sex parents to have genetically related children. The panel also considered the potential of

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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combining IVG and IVF to generate larger numbers of human embryos, facilitate more extensive embryo screening and selection, and further complicate thorny issues about the disposition or continued storage of those excess embryos. Still other important issues mentioned were the broader context of reproductive medicine and the potential role of IVG in increasing demand for services such as gestational surrogates and medical tourism.

“A SOLUTION IN SEARCH OF A PROBLEM?”1

Glenn Cohen opened by prompting panelists to reflect on what need could be served by developing IVG for clinical use. People may disagree over whether the desire to have genetically related children is a want or a need, Greely said, but those faced with infertility undoubtedly suffer both physically and emotionally. Greely suggested that the animating principle behind IVG is relieving this suffering. Society has invested heavily in helping people conceive children via IVF, and Greely argued that it seems unjust not to invest similarly to assist those who cannot be served by traditional ART.

Medical Versus Social Infertility

If ever available clinically, IVG could enable those experiencing medical or social infertility2 to conceive a genetically related child. Glenn Cohen questioned whether distinctions should be drawn between potential clinical uses of IVG depending on the root cause of their infertility.

When considering the value of ART to allow people to have genetically related children, a broad definition of infertility that encompasses both medical and social reasons ought to be used to avoid discrimination, Suter argued. She did not see any distinction between same-sex and opposite-sex couples trying to conceive a child using IVG—if it were ever available clinically. However, Suter suggested that some lines may need to be drawn concerning which social needs could potentially be addressed with IVG. For example, would IVG be used to help couples who struggle with fertility due to their ages? Is solo IVG permissible? As to this latter point, although legitimate arguments could be made for why someone would seek solo IVG if they were planning to parent

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1 A quote from Glenn Cohen on whether there is an unmet need for IVG.

2 Social infertility impacts individuals who do not have a medical condition that prevents them from conceiving a child but instead are above the usual age of reproduction or in a same-sex relationship or desirous of solo parenting.

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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alone, the significant health risks3 may compel regulation prohibiting this avenue, said Suter.

An audience participant challenged any distinctions between medical and social infertility for use of novel ART: “The very definition of infertility is inherently social—that is, trying to get pregnant by having sex for 6 months or a year. The explanation or directive to patients who come in with unexplained infertility—15 to 30 percent of patients—is not go find a different partner. To say that infertility and social infertility are two separate things, I think, is just false.”

Infertility at Advanced Age

Panelists also had a nuanced discussion about whether having children at an advanced age is an unmet need that IVG could or should address. Some people may think it is not for the law to dictate at what age people choose to reproduce, Goodwin said, but serious ethical implications must be considered: “What does it mean very realistically when people decide to become parents at the age of 70?” She also reflected on the social and cultural conditions that shape who society thinks of as good mothers, noting the “tremendous social pressures for women to become mothers later” after they “finish college and finish graduate school and make something of themselves.” She asked who these interests are driven by and if those are the same as the potential mothers.

From a public policy perspective, Cattapan suggested that IVG is a “strange approach” to address the push toward women delaying having children. Having children at advanced ages using IVG would still pose serious health risks related to pregnancy if the genetic mother carried the fetus and/or if this expanded a demand for surrogacy. Cattapan outlined social and economic interventions, including parental leave, funded child care, and reduced student loans, that might be more effective investments “if there is a desire to help people have children.” Suter agreed, noting that “law [shapes] our desires in many ways.” Greely acknowledged that improved parental leave and child care could affect the age at which people desire children. However, he was not convinced that IVG should not be available for those who did wait until an advanced age, for whatever reasons. Ultimately, “people want to have babies. And if people want to have babies, we better have a damn good reason to tell them that they cannot,” he concluded.

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3 Amato outlined solo IVG, a single person reproducing with themselves, and its associated health risks in Chapter 3. Suter notes that extensive genetic testing could enable this but asked “if that is really the path we want to take.”

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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“What Is the Harm in Genetic Parenthood?”4

Glenn Cohen asked panelists to discuss whether the desire to have a genetic connection to their children is “worth the protection of law, worth the protection of future insurance mandates.” Actions can reinforce and privilege these desires as “natural” and “good,” he continued. Whether these desires are natural or good is irrelevant, Greely argued; what is most important is that they are real and not harmful and therefore deserve to be considered.

A participant challenged this notion. Despite no harm in desiring genetic parenthood, the pursuit of those desires may lead to increased costs, fewer options for nongenetic parenthood, and risks to offspring. The participant asked, “how much of an increased risk in chance of abnormalities or other risks to offspring is the desire for genetic parenthood worth?”

Greely responded that someone would have to draw the line on how safe IVG would need to be. “Safety is always going to be in context,” he continued. To reach clinical use, IVG would need to be about as safe as in vitro fertilization (IVF), he said, noting that neither IVF nor naturally conceived pregnancy and childbirth are completely safe.

ETHICAL ISSUES RELATED TO POTENTIAL CLINICAL TRIALS

Lessons Learned from IVF

The trajectory of IVG is often compared to that of IVF. First practiced clinically in the United States in the 1980s, IVF was and still is regulated as the practice of medicine. Many speculate whether it would have been introduced in the United States if it were subjected to the current regulatory hurdles placed on novel ART. Glenn Cohen asked the panelists to reflect on comparisons between IVF and IVG from a regulatory perspective.

Several panelists noted that it would be preferable for IVG not to repeat the path taken by IVF. Examining the dramatic clinical debut of IVF can help reinforce what not to do if IVG is considered for clinical use, Cattapan said. She argued that “we are still in the age of experimentation with IVF,” only now reaching the stage at which adults conceived through it are having children. “It is entirely possible that IVF would have gone through clinical trials, been proven safe enough, and that we would be where we are today in a slower and more measured pace,” she continued.

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4 A quote from a workshop participant.

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Safety as an Ethical Issue

Safety is the most important ethical issue facing reproductive IVG, Greely said, stating that “it is profoundly unethical to do unreasonably unsafe things to people.” He said that IVF was not shown to be appropriately safe when it was first clinically used, but defining and requiring reasonable safety is critical if IVG were ever considered for clinical testing. However, he suggested that an “unreasonable proof of safety” ought not to be demanded of IVG.5 He noted that nothing is without dangers, some of which can take a long time to surface.

Informed Consent

When considering safety and the path forward, Suter drew attention to issues related to informed consent. If there were ever clinical trials for IVG, researchers must inform participants of the risks and uncertainties, she said. Even with appropriate education and counseling for prospective parents, Suter expressed concerns that desperate individuals could act rashly and accept worrying unknowns in the hope of having genetically related children. In addition to initial consent, clinical trials for IVG would necessitate plans for long-term follow-up of the conceived child and potentially their future children. Suter raised the issue of obtaining consent to follow up with the potential progeny. Discussions are needed to determine how such follow-up could be handled.

POTENTIAL IMPLICATIONS OF EMBRYO CREATION VIA IVG

If IVG to create human eggs and sperm were successfully developed, it could lead to producing many more gametes (especially eggs) than can currently be obtained. These gametes could then be used to create many more embryos than is possible with other forms of ART. Several panelists reflected on the potential consequences of creating larger numbers of embryos, including the ability to facilitate embryo selection and the problem of embryo disposition.

Embryo Selection

Combining IVG with polygenic risk screening could revolutionize the ability to select embryos.6 As IVG advances, so too could the capacity

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5 Were a translational pathway toward IVG clinical use to be defined, it would need to better articulate what would constitute reasonable proof of safety and plans for long-term follow-up. These issues are highlighted but not defined at this workshop.

6 See Chapter 3 for further discussion.

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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to test for and interpret genetic variation. For polygenic conditions, such as heart disease, multiple gene variants contribute to disease risk. Multiple embryos could be needed to screen for many genetic variants and still be able to identify one or more embryos that may have the desired combination.7 IVG development potentially opens the door to creating significantly more embryos than ovarian stimulation and IVF. As a result, it both enables new types of screening and selection before using an embryo to establish a pregnancy and raises difficult ethical issues. Panelists discussed how IVG could enable embryo selection and shape public attitudes about reproductive testing and parenting.

In her opening remarks, Cattapan challenged the notion that IVG is destined for clinical use for purely reproductive purposes. Limiting its use is possible within regulatory frameworks, she suggested, but unlikely. If ever available clinically, Cattapan agreed with other participants that IVG would likely permit more large-scale PGT to select against certain genetic diseases than is currently possible. “We should approach that with skepticism and caution as the lines between medicine and so-called enhancement are not clear,” she said. Cattapan referenced phrases such as “‘choose the best embryo’” and warned that the implications of normalizing genetic screening may be that the lives of people with certain disabilities and conditions are seen to have lesser value.

Along those lines, Suter examined how IVG could shape public attitudes and societal values around parenting, family, and disability. For example, for-profit ART providers could leverage societal norms around what it means to be a good parent8 to encourage increased prenatal genetic testing and embryo selection before transfer. Communities that can pay for tools that enable embryo selection are more likely to think that good parents are informed parents and that part of being informed is “do[ing] reproductive testing of all sorts.” Noting how overwhelmed parents could be by the deluge of information and the prospect of selecting an embryo, Suter asked participants to consider whether more choice and more information is always better.

Regulating Embryo Selection

A virtual participant asked panelists to reflect on the ethics of state involvement in regulating and setting limits on embryo selection.

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7 According to Amato and others, the utility and validity of polygenic risk screening are unclear.

8 Marketing for noninvasive prenatal testing plays on societal norms of informed parenthood, Suter said.

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Suter, Goodwin, and Greely shared concerns about whether governments should be drawing lines on when and for what purpose embryo selection could be allowed. Suter recalled efforts in the United States to enact laws that ban abortions on the basis of the fetus’ sex or medical diagnosis; supporters of those bans seem to have no problem using IVF followed by PGT (usually used to identify chromosomal issues or single-gene diseases), which represents a type of selection. “We need to be having very serious conversations as a society about what it means to do this different kind of selection,” Suter said. Goodwin highlighted the history of eugenics policies that affected those with disabilities, deemed to be socially and morally unfit, or from lower socioeconomic status. Although the federal government has been quiet in the reproductive technology space, Goodwin speculated that this could change with the significant political shifts occurring. Given this history and the current moment, states may develop regulations on embryo selection, she said. Despite a potential role for regulation, Greely said that, in general, it is better to rely on parental choices to make decisions about how people wish to create families. Ultimately, different prospective parents and societies will make different choices on how to approach embryo selection, as they already do for embryos created by other ARTs, Greely said.

Embryo selection affects the disability community.9 Greely said, “To the extent that parental selection is allowed … many parents will select against having children with disabilities, and that has effects on people with disabilities.”10 Permitting embryo selection against disabilities can feel like a societally sanctioned statement that such lives are less worth living, he continued, noting the immense psychological toll this can have on individuals with disabilities. In addition, fewer people born with a given disability leads to less visibility, fewer physicians, less social support, and other concrete, negative consequences for those with that disability. Greely concluded that addressing embryo selection vis-à-vis disability justice is difficult both practically and theoretically, and he does not expect to reach a satisfactory answer.

Cattapan said that there are ways that communities can come together to develop regulations on embryo selection in a democratic context. These regulations need to include input from diverse stakeholders, especially “people with disabilities who have important stakes in this,” she said.

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9 Several participants identified the need to include voices from the disability community in future discussions. With that in mind, Goodwin noted several people whose work attends to those concerns including Michael Stine, Ruth Kocher, Jamelia Morgan, and Jasmine Harris.

10 Both Greely and Suter mentioned the deaf community as a counterexample. Some deaf parents use PGT to select for having a deaf child.

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×

Cattapan pointed to Canada as an example of a country in which legislation on embryo selection already exists; it is regulated by the Assisted Human Reproduction Act insofar as it prohibits selection based on sex except in the cases of certain sex-linked diseases.11 In the United States, embryo selection, including based on sex, is legal.

Embryo Disposition

Glenn Cohen asked the panelists to imagine a future in which IVG produces three times the number of embryos created by IVF. Panelists reflected on how embryo disposition and cryopreservation could be handled legally, ethically, practically, and politically.

Cattapan discussed how many people do not know what to do with their embryos and have fraught feelings about disposition. She noted that it is possible that these feelings could change if IVG were available for clinical use due to decreased physiological and time investments by prospective parents to create embryos. However, she speculated that it is more likely that people will continue to have complicated feelings about embryo disposition no matter how many are in storage. Due to liability concerns, fertility clinics currently struggle to dispose of embryos when users are not paying their storage fees or giving consent to ongoing storage. It is important to consider the impact of “having millions and millions of embryos sitting around in storage” without clear ways to handle them, she concluded.

Several panelists discussed the potential impact of the 2022 U.S. Supreme Court’s decision on Dobbs v. Jackson Women’s Health Organization (an overturning of Roe v. Wade that returns the ability to regulate abortion back to the states) and ongoing debates and legislation on the definition of personhood. Suter said that the legal expansion of personhood to embryos could remove rights from parents and lead to requirements that unused embryos must be put up for adoption in certain states. In Louisiana, laws have forbidden the destruction of viable embryos for several decades.12 Greely noted that despite this law, IVF clinics remain in Louisiana and costs have not skyrocketed. Therefore, he suggested that a threefold increase in the number of embryos would likely not be a practical hurdle as much as an ethical and political one. A potential next

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11 Cattapan noted ongoing debates in Canada about the list of diseases for which sex selection is permitted.

12 During Hurricane Katrina, which killed nearly 1,200 people in Louisiana, resources were used to dispatch a boat to save ~1,200 embryos belonging to 485 couples. (https://money.cnn.com/2015/08/14/news/hurricane-katrina-embryos-twins/index.html [accessed August 8, 2023]).

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×

step in expanding embryo legislation could be for more states to pass laws prohibiting the disposition of unused embryos resulting from fertility treatment. However, Greely said that laws that could significantly affect the practice of IVF are unlikely because “IVF is politically popular.” If IVG were shown to be safe and effective, it would likely be viewed in the same light as IVF regarding laws limiting its practice, including around embryo disposition, he concluded.

REPRODUCTIVE INEQUITIES

Goodwin asked participants to consider, “Is [IVG] liberation or liability?” Referencing the work of Martha Ertman, a U.S. law professor and expert in family law at the University of Maryland School of Law, she noted that ART can be viewed as “a curative for mother nature’s discrimination against individuals who are LGBTQ.” Furthermore, these novel technologies can address other reproductive inequities, including allowing those of advanced age to generate eggs. With these potential benefits come questions regarding who would be able to access and afford IVG if it were available clinically, where it could be successfully implemented, and how people would support the progeny.

Although IVG could address certain reproductive inequities, Suter discussed how it also perpetuates the notion that genetic connection is paramount for family building. Investing significant resources into IVG could exacerbate and heighten these attitudes and desires. Privileging genetic connection risks invalidating many families formed without these ties, Suter concluded.

Greely and Cattapan both discussed reproductive inequities relating to socioeconomic status. Greely identified low socioeconomic status as “the most important and most shameful of the social infertilities we have in the U.S.” He cited Judith Daar’s book The New Eugenics, where she argues that structural barriers disproportionately prevent people with low socioeconomic status from having babies. Because IVG would represent a new and likely expensive type of ART, it could exacerbate reproductive stratification, Cattapan said, such that “those with financial resources are given nearly limitless options about how to reproduce so long as they can pay for it, while others are forced to carry pregnancies to term.”

The future of IVG must be considered against the backdrop of the U.S. reproductive health care system, Goodwin asserted, one marred by high rates of maternal mortality and morbidity and deep racial inequities. Conversations need to consider whether and how IVG could perpetuate or mitigate these inequalities, she said.

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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SOCIETAL STRUCTURES IMPACTING HUMAN REPRODUCTION

Goodwin examined the arc of reproductive rights in the United States. She drew connections from the coerced reproduction of enslaved people during the period of American slavery to the forced sterilization of those deemed to be unfit, often individuals with disabilities, during the 20th century.13 How, then, should legal concerns about reproduction post-Dobbs be considered, she continued, when the decisions of both the Supreme Court and federal district courts affect our reproductive lives and the potential use of ART. “Where law has intervened over time in matters of reproduction, it has served to undermine civil liberties and civil rights,” often of the most vulnerable people in our society, Goodwin concluded.

A participant commented on current ways the state affects reproductive bodies.14 State mandates on insurance coverage for fertility services and other measures use limited state resources to reify genetic ties through access to ART, she said, but the state itself may have created the necessity for such technologies by contributing to infertility through structural barriers. The participant asked panelists to reflect on this notion and the commitment to advancing IVG and other reproductive technologies through a reproductive justice framework.

Suter and Cattapan both agreed that conversations need to be had concerning the potential roles the government simultaneously plays in contributing to infertility through societal structures and reifying genetic connection. Suter said that it is important to consider how governmental policies could affect the presence or absence of factors that can contribute to infertility. “We are focusing on the end game of creating a genetically related child when we are not doing all the things that we possibly can to help people have the families they want in other ways,” Cattapan added. She concluded that legal and regulatory reforms need to be considered to enable people to conceive children earlier, adopt, or prevent infertility in the first place.

Greely acknowledged ongoing societal and ethical factors contributing to infertility and thus to a potential desire for IVG. However, he disagreed with the idea that IVG must not be pursued until the other ills of the world are addressed, “and therefore, we should not pursue [IVG] until we fixed everything else?” He suggested that development of IVG could be pursued even as these other issues are addressed.

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13 Goodwin referenced Buck v. Bell (1927), in which the Supreme Court ruled that state laws permitting compulsory sterilization did not violate the Due Process Clause of the Fourteenth Amendment to the Constitution.

14 The participant cited how incarceration can delay the age at which men have children and environmental justice issues, including how Black women are more likely to be exposed to an environment that compromises fertility.

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×

PRIVATE INVESTMENT IN IVG

The lack of federal funding and varied state policies on research conducted in human embryos has driven advancement of IVG for potential clinical use into the private sector, especially in the United States. In her opening remarks, Cattapan noted with concern that private industry operates outside of some of the traditional research oversight mechanisms found in academia, such as requirements from federal and philanthropic funders and publication of results in peer-reviewed journals. She urged careful consideration of who could benefit from these advancements and might make money from these endeavors. Who advances IVG is intimately connected to who makes decisions about it, including when and if it safe enough for a clinical trial. Ultimately, Cattapan said, “It matters who gets to make the decisions here.... It should not be a combination of scientists committed to ‘progress’ and private capital alone. We are all invested, all committed to our collective genetic futures.”

USING IVG TO ANSWER RESEARCH QUESTIONS

A participant asked the panelists to reflect on questions that could be studied using IVG as a research tool in the laboratory, including exploring causes of infertility or congenital conditions that arise during gamete development, fertilization, and early embryo development. What questions can scientists consider now, they wondered, “not just in terms of the speculative future of this technology.”

Suter discussed how the development and use of IVG in the laboratory has the real potential to help scientists better understand the fundamentals of reproduction and developmental biology. Under current guidelines, human embryos can be cultured only to 14 days, which limits the bounds of what can be discovered about early human development. Further conversations that consider how long embryos could be cultured are needed, she suggested. Suter noted that experiments beyond 14 days could reveal valuable information for both those who wish to become pregnant and those who do not but could also raise scientific, ethical, and legal concerns.

Greely noted that many of the scientists who presented during the State of the Science sessions do not research IVG itself. Rather than seeking to develop eggs or sperm from stem cells, they study basic issues around mammalian gamete formation and reproductive biology, including meiosis, epigenetics, germline mutations, and tissue environment. This knowledge is needed to make progress in developing and validating IVG but can also address other questions. Increased investment by the NIH could further research on reproduction more broadly, he added.

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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GLOBAL PERSPECTIVE

Ogbogu noted that the panelists generally framed the discussion of social, ethical, and legal considerations raised by IVG against the backdrop of Western society, specifically the United States, and a Western vision of ethics, law, and policy. He pressed the panel to consider relevant ethical issues from an international perspective inclusive of the Global South. Goodwin identified the potential for IVG biotourism as a major ethical concern, including whether prospective parents might travel to clinics in countries with less stringent regulatory oversight and availability of IVG might increase the use of gestational surrogates from the Global South.15 She reflected on the long-standing tradition of the West using neocolonialism to export its demands, including reproductive needs, which “we are still struggling to address.”

The remaining panelists raised several additional points. Greely and Suter both identified the health of any babies born from IVG as a universal issue for any country that considers permitting it for reproductive use. Suter also expressed that it is critical to address unmet societal needs, including parental leave and subsidized daycare, that may encourage the perception that IVG is needed. These unmet needs are different in different countries, she continued, depending on their resources and issues. Cattapan expressed concern about how emerging ARTs could move people toward an increasing acceptance of genetic selection across the world.

BREAKOUT GROUP DISCUSSION

A breakout group moderated by Katherine Kraschel (Yale Law School) discussed “Social, Ethical, and Legal Implications of IVG.” In anticipation of continued research developments, the group proactively considered ramifications of this disruptive technology, including possible societal, ethical, and legal issues raised by potential clinical use. Key points from participants in the breakout group discussion were reported to workshop attendees by the rapporteur, Kraschel.

Intergenerational Consent

Data collected about the health of children conceived via IVG would be key for demonstrating its safety, several participants suggested. The participants debated how to handle the potential necessity of data col-

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15 Goodwin referenced a 2016 VICE documentary featured on HBO, “Outsourcing Embryos,” that examined gestational surrogacy as a booming industry in India.

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×

lection from individuals not yet born. How would consent be handled for someone who does not yet exist? Furthermore, participants discussed how far this tracking would need to go: children, grandchildren, great-grandchildren?

Participants asked about examples in public health or FDA regulations in which this type of follow-up or monitoring has been mandated. During the report-out, Glenn Cohen said that organ transplant candidates who initially consent to sharing their personal health information with stakeholders in medicine and research cannot withdraw that consent after receiving a transplant. He raised concerns about how enforceable such mandates would be for children conceived via IVG, if people were reluctant to participate or chose to withdraw from follow-up. Several participants felt that mandatory reporting would be impractical and unenforceable, emphasizing that participation needs to be voluntary. Kraschel noted that individuals from historically marginalized groups would be rightfully suspicious of formats such as national registries, and she worried that this would further ostracize them from fertility care were IVG ever to be available clinically.

Parents make lots of decisions that could affect their children, their grandchildren, and perhaps even future generations, several participants indicated. What is it about IVG that makes many feel that compulsory health and safety reporting by progeny is warranted? Furthermore, what is it about IVG that makes many consider that consent by a parent on behalf of their child for monitoring and reporting of health effects might warrant legal intervention? This same line of thinking also led to questions about liability if a child conceived using IVG were to develop issues. Would the laboratory or company that created the in vitro gamete be responsible, the fertility clinic that performed IVF or the embryo transfer, or the parents who chose this method of reproduction? Children do not generally sue their parents over parental decision making, and many participants suspected that the decision to conceive using IVG would not be an exception. Other participants suggested that this choice would necessitate accepting certain risks, with the knowledge that making babies is always risky.

Revisiting Safety in Other Accepted Reproductive Practices

Participants discussed how assessing safety for new technologies provides an opportunity to revisit best practices, including safety and validation in the context of other accepted interventions. For example, freezing and thawing gametes may create epigenetic changes. Many participants said that this issue could be considered and that markers for epigenetic toxicity could be included when assessing the safety of IVG. They dis-

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×

cussed whether this issue and others ought to be revisited for other forms of ART. Conversely, they asked if similar risks could be accepted for IVG as for other types of ART.

Embryo Disposition with IVG

Participants discussed how IVF is considered by many people to be a viable clinical option and that it can lead to destroying embryos that are not transferred to establish a pregnancy. There are varied views on the morality and ethics of such destruction. Participants asked how attitudes toward IVF might influence public views on creating and using IVG-derived gametes. The pathway to developing, testing, and validating IVG would likely involve generating and then destroying embryos in the laboratory. Similarly, if IVG were ever available clinically, it would most likely be used in conjunction with IVF to create embryos, some of which would also need to be stored or destroyed. Participants reflected on whether those on the fence about the ethics of embryo destruction would be willing accept IVG when it could result in many more embryos being created and potentially destroyed than current ARTs.

Potential for Creating More Embryos with IVG

Conversations during the workshop focused on the potential of IVG to generate many gametes, particularly many more oocytes than currently available, and of IVG being used in combination with IVF to create many embryos, for both research and clinical purposes. During the report-out, Clark noted that the ISSCR publishes human stem cell and embryo research guidelines, which state that the minimum number of embryos should be used to achieve the scientific objectives. She said that this serves as a framework for developing norms around responsible practices in IVG and that scientists are not going to suddenly generate 20-fold more human embryos.

In response, Kraschel noted that the participants in her breakout group were particularly concerned about IVG’s potential to facilitate mass creation of embryos for polygenic risk screening. Clark recognized this possibility but emphasized that scientists developing these techniques are not aiming to create embryos at this scale. As a fertility doctor, Amato shared her view that the number of embryos generated by IVG could be far greater than via ovarian stimulation, egg harvesting, and IVF. This increase would be due, in part, to the demand for polygenic risk screening, she speculated. Clark noted that experiments are needed to establish the utility and efficacy of polygenic risk screening before even discussing the worth of generating embryos at this scale.

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×

Clark concluded by suggesting that the number of embryos generated as a result of IVG be regulated, potentially at a similar volume as IVF. Assays to screen for gamete quality, followed by using only selected gametes to create resulting embryos, would assist with this goal, she said.

Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 51
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 52
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 53
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 54
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 55
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 56
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 57
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 58
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 59
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 60
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 61
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 62
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 63
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 64
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 65
Suggested Citation:"4 Social, Ethical, and Legal Considerations Raised by IVG." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
×
Page 66
Next: 5 Equity, Access, and Cost Considerations Associated with IVG »
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Current assisted reproductive technologies such as in vitro fertilization (IVF) do not enable all prospective parents to have genetically related children. The National Academies Board on Health Sciences Policy hosted a workshop in April 2023 to explore the development of in vitro-derived human eggs and sperm from pluripotent stem cells through a process known as in vitro gametogenesis (IVG). Speakers emphasized the impacts of the potential biotechnology on research and reproductive medicine should clinical IVG ever be approved, along with the many social, ethical, legal, and technical considerations its development raises. This proceedings document summarizes workshop discussions.

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