Regulating reproductive genetic services: dealing with spiral-shaped processes and techno-scientific imaginaries

Alón, Ido; Urbanos-Garrido, Rosa M.; Guimón, José

doi:10.1007/s10815-020-02017-9

Cited by 5 publications

(3 citation statements)

References 69 publications

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“…For example, the FDA could provide oversight related to the accuracy of results and mosaicism, the indication of PGT-A as a medical necessity vs for personal and social reasons, and provide guidelines for developing and implementing patient education. Oversight from a designated federal agency would include detailed guidance for the selection of appropriate new procedures, methodologies, and laboratory requirements, reducing uncertainty as to the risks and benefits of the procedure [ 35 ]. Additionally, health professional organizations need to produce clear guidelines before a new test can be used in the clinic.…”

Section: Discussionmentioning

confidence: 99%

Preimplantation genetic testing for aneuploidy: challenges in clinical practice

et al. 2022

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Preimplantation genetic testing for aneuploidy (PGT-A) has been used widely during in vitro fertilization procedures in assisted reproductive centers throughout the world. Despite its wide use, concerns arise from the use of PGT-A technology in clinical decision-making. We address knowledge gaps in PGT-A, summarizing major challenges and current professional guidelines. First, PGT-A is a screening test and not a diagnostic test. Second, mosaicism is much higher in the blastocyst stage from PGT-A than had been recognized previously and a mosaic embryo may not accurately represent the genetic disease risk for future fetal disorders. Third, PGT-A was not validated clinically before use in patients; the best use of this technology for selected age-groups remains uncertain. Given these gaps, we believe that current professional policies relying on industry-self-regulation are insufficient. In the USA, the Food and Drug Administration may be the most appropriate agency to provide more definitive guidelines and regulations that are needed for better practice.

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Section: Discussionmentioning

confidence: 99%

Preimplantation genetic testing for aneuploidy: challenges in clinical practice

et al. 2022

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“…The issue of cost-effectiveness has ELSI implications on two distinct levels. First, the use of PGT-A as add-on to increase the chances of a viable pregnancy, which is currently hotly contested from a clinical standpoint [61,173,174] and from an ELSI perspective, since clinics have an inherent conflict of interest in offering pricy services that enhance their profits, with unclear effectiveness for patients' clinical outcomes. Recently, PGT-A has become part of a high percentage of cycles in the U.S. and of an increasing number in Europe, imposing significant costs on patients with unclear effectiveness (A2) [175,176], ESHRE, 2022.…”

Section: Issues That Are Clinically Prevalent and Require More Elsi A...mentioning

confidence: 99%

Mapping ethical, legal, and social implications (ELSI) of preimplantation genetic testing (PGT)

Alon,

Bussod,

Ravitsky

2024

J Assist Reprod Genet

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Purpose Preimplantation Genetic Testing (PGT) has attracted considerable ethical, legal, and social scrutiny, but academic debate often fails to reflect clinical realities. Methods Addressing this disconnect, a review of 506 articles from 1999 to 2019 across humanities and social sciences was conducted to synthesize the Ethical, Legal, and Social Implications (ELSI) of PGT. This review mined PubMed, WoS, and Scopus databases, using both MeSH terms and keywords to map out the research terrain. Results The findings reveal a tenfold increase in global research output on PGT’s ELSI from 1999 to 2019, signifying rising interest and concern. Despite heightened theoretical discourse on selecting “optimal” offspring, such practices were scarcely reported in clinical environments. Conversely, critical issues like PGT funding and familial impacts remain underexplored. Notably, 86% of the ELSI literature originates from just 12 countries, pointing to a research concentration. Conclusion This review underscores an urgent need for ELSI research to align more closely with clinical practice, promoting collaborations among ethicists, clinicians, policymakers, and economists. Such efforts are essential for grounding debates in practical relevance, ultimately steering PGT towards ethical integrity, societal acceptance, and equitable access, aiming to harmonize PGT research with real-world clinical concerns, enhancing the relevance and impact of future ethical discussions.

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“…Therefore, influenced by cross-cultural differences and value-based perspectives, ART regulations vary significantly between states and countries [ 13 ], which was previously described as legal mosaicism [ 37 ]. Moreover, the complexity and weight of regulations increases steadily, due to the growing use of ART, the technical progress, the dissemination of techniques such as gametes cryopreservation, Preimplantation Genetic Testing (PGT), and the emergence of novel possibilities such as Germline Genetic Modification (GGM), among others [ 4 , 5 ].…”

Section: Introductionmentioning

confidence: 99%

Mapping ethical, legal, & social implications (ELSI) of assisted reproductive technologies

Alón

Chebance

Massucci³

et al. 2023

J Assist Reprod Genet

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Purpose A significant portion of the research on assisted reproductive technologies explores ethical, legal, and social implications. It has an impact on social perceptions, the evolution of norms of clinical practices, regulations and public funding. This paper reviews and maps the geographical distribution to test the hypothesis of geographical concentration and classifies the output by fields and topics. Methods We queried PubMed, Scopus and the Web of Science for documents published between 1999 and 2019, excluding clinical trials and medical case reports. Documents were analyzed according to their titles, abstracts and keywords and were classified to assisted reproductive fields and by Topic Modeling. We analyzed geographic distribution. Results Research output increased nearly tenfold. We show a trend towards decentralization of research, although at a slower rate compared with clinical assisted reproduction research. While the U.S. and the U.K.’s share has dropped, North America and Western Europe are still responsible for more than 70%, while China and Japan had limited participation in the global discussion. Fertility preservation and surrogacy have emerged as the most researched categories, while research about genetics was less prominent. Conclusions We call to enrich researchers’ perspectives by addressing local issues in ways that are tailored to local cultural values, social and economic contexts, and differently structured healthcare systems. Researchers from wealthy centers should conduct international research, focusing on less explored regions and topics. More research on financial issues and access is required, especially regarding regions with limited public funding.

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Regulating reproductive genetic services: dealing with spiral-shaped processes and techno-scientific imaginaries

Cited by 5 publications

References 69 publications

Preimplantation genetic testing for aneuploidy: challenges in clinical practice

Preimplantation genetic testing for aneuploidy: challenges in clinical practice

Mapping ethical, legal, and social implications (ELSI) of preimplantation genetic testing (PGT)

Mapping ethical, legal, & social implications (ELSI) of assisted reproductive technologies

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