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In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop (2023)

Chapter: 8 Looking Ahead

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Previous Chapter: 7 Participatory Public Engagement Around Reproductive Science Advances

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Suggested Citation: "8 Looking Ahead." 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.

8

Looking Ahead

Key Considerations and Cautions Discussed by Individual Speakers and Participants*

There is no consensus that IVG should be used clinically in humans—this collective conversation must continue and needs to include diverse stakeholders, including those outside of science and industry. (Cattapan, Pande)
Balancing scientific progress, patient safety and autonomy, safety of the future child, human dignity, equality, and nondiscrimination, among many other considerations—including cost, access, and social necessity—are important when determining whether or how to pursue IVG. (Amato, Crockin, Serour, Kraschel, Ikemoto)
Public engagement is critical at every step of IVG development, including in shaping research agendas, and therefore, such conversations ought to begin in earnest now with diverse voices and international perspectives. (Marsh, Gray Valbrun, Landecker, Ogbogu)
Failures in professional self-regulation could lead to a chilling effect on IVG research. (Serour) Appropriate oversight

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* This list reflects the rapporteurs’ summary of points made by identified speakers, and the statements have not been endorsed or verified by the National Academies of Sciences, Engineering, and Medicine. They are not intended to reflect a consensus among workshop participants.

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and regulation would be critical for its ethical advancement. (Charo, Clark, Krisiloff)

Without discussing all possibilities posed by IVG, such oversight and regulation cannot be effectively developed. (Taylor)
The animating principle behind the potential development of human reproductive IVG is relieving the suffering of those yearning to have genetically related children who otherwise cannot. (Greely)
At the same time, IVG could lead to an emphasis on the importance of genetic relatedness in family building and may undermine work performed to expand legal definitions of family. (Crockin, Kraschel, Suter)
When considering potential clinical use cases for IVG, a broad definition of infertility that encompasses both medical and social reasons ought to be used to avoid discrimination. However, societies may need to draw some lines concerning the social needs permissible to address with IVG (e.g., solo IVG). (Suter)
Reproductive choices are not only based on individual desire, but deeply rooted in social and societal contexts. (Pande)
Policies on ART can also influence how people choose to build their families. (Mathews)
The potential for IVG to greatly expand embryo screening raises concerns about routinizing prenatal selection and exacerbating inequalities for those living with disabilities. (Cattapan)
It is important to consider the future of IVG against the backdrop of the U.S. reproductive health care system where debate continues about appropriate protections and limits on reproductive choices. Further, the system is marred by deep inequities where vulnerable populations experience disproportionately high rates of maternal mortality and morbidity. (Goodwin, Kraschel)
The regulatory framework for biologic cell therapies could be useful to consider when imagining a potential translational and regulatory path for IVG. (Krisiloff)
Regulating any potential clinical use of in vitro–derived gametes or resulting human embryos may require adapting an existing pathway or identifying a new pathway. (Marks)
FDA has limited capacity to consider regulatory frameworks for technologies that would result in the creation of human embryos. (Greely, Marks)

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This final chapter highlights overall messages, directions for potential future work, and key considerations associated with in vitro gametogenesis (IVG) and assisted reproductive technologies (ARTs) more broadly that were discussed by participants.

KEY MESSAGES

In presentations and discussions throughout the workshop, speakers and participants noted multiple scientific, ethical, social, and governance considerations associated with the research and development of IVG. During the final session, Amander Clark (University of California, Los Angeles) also presented take-away messages she identified throughout the workshop, in addition to inviting speakers and participants to share their thoughts:

Advancements in IVG are progressing; however, a lack of consensus remains on the time line for successfully reconstituting human gametogenesis, with some participants estimating as few as 2 years and others as many as 10 or more. (Clark)
Scientific and technical roadblocks to achieving IVG in humans include accurate recapitulation of meiosis, achieving epigenetic resetting, minimizing mutations, refining and optimizing culture conditions, and developing nondestructive assays to assess gamete quality. (Clark, Cohen, Goriely, Hajkova, Landecker, Mathews)
Though still undergoing scientific development and ethical discussion, IVG could overcome limitations for having genetically related children in a variety of circumstances. (Adashi, Marks)
Although IVG may hold promise as a potential new means of family formation, it could also strengthen the notion that genetic connection is the most important component of family building. (Kraschel, Suter)
If ever available clinically, IVG could expand the use of prenatal selection. Such a capacity raises concerns about the possibility of eugenic practices and potential implications for disability communities. Therefore, future discussions on continued development and potential use of IVG ought to be grounded in a disability justice framework. (Ikemoto, Pande)
IVG could permit creating more embryos than previously possible with other forms of ART. Regulation to govern how many embryos could be created may be needed. (Clark)

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IVG could exacerbate existing inequities in fertility care both in the United States and globally if ever available clinically. (Cattapan, Ikemoto, Pande)
If IVG were considered for potential clinical trials, safety would be a key ethical concern for both the babies conceived and the pregnant individuals. Future conversations could help delineate how much risk, if any, society is willing to accept. (Amato, Gamal, Kahn, Mathews, Suter)
In addition to safety, any clinical trial of IVG would need to address concerns related to protecting human subjects, including establishing appropriate oversight, equitably selecting trial participants, designing and handling informed consent, and conducting follow-up. (Cohen, Marks, Marsh, Suter)
“First-in-human” does not accurately capture how a potential trial of IVG would differ from typical clinical trials. Given its potential to create a new life, “first-to-human” may be more accurate and nuanced. (Kahn)
Based on its regulatory mandate from Congress, FDA would have jurisdiction over IVG if it ever progresses to clinical trials or use. However, the current U.S. legal and policy landscape may preclude any IVG clinical trials. If this were to change, FDA may need to develop a novel regulatory framework using a humanist lens. (Charo, Marks)
The patient community and the public need to be involved, engaged, and empowered from early stages of technological development. Furthermore, conversations on identifying and prioritizing which prospective parents might be selected to participate in any first-to-human trial of IVG would need to be conducted equitably and center the patient community, because people with many different diseases and conditions could benefit from or have concerns about its use. (Gray Valbrun, Marsh)

POTENTIAL FUTURE DIRECTIONS AND ACTIVITIES

Participants then had a conversation, led by Clark, about potential future directions and activities revolving around reproductive health and ART, which included engaging international stakeholders in conversations (Ogbogu), addressing disparities in equity and accessibility of fertility care grounded in reproductive justice (Amato, Mathews), engaging the public around ART (Mathews, Marsh), and discussing federal funding for embryonic research (Taylor, Suter).

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Marsh and Clark noted the importance of developing health literacy in members of the public, particularly on reproductive health. Developing reproductive health literacy could serve as a platform to help the public interpret ART developments, including IVG, and feel more empowered to participate in conversations about their development, uses, implications, and limits. Marsh noted that educational materials ought to be developed in multiple languages and for people with differing levels of education. Clark suggested that one form of outreach could be science museum exhibits on gametogenesis, embryology, and ART.

Clark noted that future discussions could also include nonreproductive uses of IVG, such as how it could be used for research to improve human health, which was outside the scope of the workshop. Such conversations would need to be approached with care given the differing views about whether even nonheritable uses ought to be advanced, Cattapan noted, because “the legitimation of IVG for nonheritable purposes might end up being one pathway to clinical use.”

WORKSHOP WRAP-UP

Presentations and discussions over the course of the 3-day workshop brought together scientists, clinicians, sociologists, psychologists, ethicists, lawyers, patient advocates, and others. Eli Y. Adashi (Brown University) thanked speakers and participants and noted that this diverse group came together to discuss scientific, ethical, social, and legal issues for a technology not yet practiced. He expressed the hope that these discussions may lay the groundwork for future, global conversations on IVG, which has multiple potential uses and could change the landscape of fertility care across the world.