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Formulating sound and acceptable embryo research policy remains challenging especially in a pluralistic world. This challenge has acquired a new dimension of complexity with the advent of so-called embryo models, which are derived from stem cells. In this article, we present a normative strategy to facilitate the process of sound policy-making in the field of human embryology. This strategy involves seeking neutral agreements on higher level theories and doctrines as well as seeking agreements on the level of concrete policy proposals. We call this strategy: going high and low. By going high and low, the plurality of reasonable moral and epistemic convictions of stakeholders involved in the domain of human embryology is respected while the process of policy-making in this area is improved., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

The Dutch Health Council has advised to extend the 14-day rule to 28 days and to subsume integrated stem cell-based embryo models under the same legislative regime as natural embryos. Public discussion is necessary due to the ethical issues that may emerge from studying integrated and non-integrated embryo models., Competing Interests: Declaration of interests The authors declare no competing interests., (Copyright © 2024 Elsevier Inc. All rights reserved.)

In order to study early human development while avoiding the burdens associated with human embryo research, scientists are redirecting their efforts towards so-called human embryo-like structures (hELS). hELS are created from clusters of human pluripotent stem cells and seem capable of mimicking early human development with increasing accuracy. Notwithstanding, hELS research finds itself at the intersection of historically controversial fields, and the expectation that it might be received as similarly sensitive is prompting proactive law reform in many jurisdictions, including the Netherlands. However, studies on the public perception of hELS research remain scarce. To help guide policymakers and fill this gap in the literature, we conducted an explorative qualitative study aimed at mapping the range of perspectives in the Netherlands on the creation and research use of hELS. This article reports on a subset of our findings, namely those pertaining to (the degrees of and requirements for) confidence in research with hELS and its regulation. Despite commonly found disparities in confidence on emerging biotechnologies, we also found wide consensus regarding the requirements for having (more) confidence in hELS research. We conclude by reflecting on how these findings could be relevant to researchers and (Dutch) policymakers when interpreted within the context of their limitations., Competing Interests: Declarations. Conflicts of Interest/Competing Interests: Annelien L. Bredenoord is a member of the ISSCR Ethics Committee, the IQVIA’s Ethics Advisory Panel and the Dutch Senate. Ana M. Pereira Daoud, Wybo J. Dondorp and Guido M.W.R. de Wert have no relevant financial or non-financial interests to disclose. Ethics Approval: This study was approved by the Research Ethics Committee (REC) of the Faculty of Health, Medicine, and Life Sciences of Maastricht University (approval number: FHML-REC/2020/018). Consent to Participate: Written informed consent was obtained from all individual participants included in the study., (© 2024. The Author(s).)

Abstract: The paper addresses the issue of the legality and ethical admissi-bility of invasive experiments on embryos and the correlated one of the degree of legal protection and dignity to be recognized for human embryos, particularly in light of the growing importance that scientific research on embryonic stem cells has been gaining from the clinical and biomedical standpoints in the therapeutic treatments of diseases so far considered incurable, in the interest of public health. Furthermore, the issue of experimentation on cryopreserved supernumerary human embryos is still extremely polarizing, which makes it harder to arrive at shared solutions. The author hopes for a broad-ranging debate at the international level, for the ultimate purpose of achieving shared regulatory frameworks.

Programs should create and enforce written policies addressing the designation, retention, and disposal of unclaimed embryos. In the absence of program-specific policies, it is ethically permissible for a program or facility to consider embryos to have been unclaimed if a reasonable period of time has passed since contact with an individual or couple; efforts as outlined in the consent form have been made to contact the individual or couple; and no written instructions from the individual or couple with dispositional control exist concerning disposition. In such cases, programs or facilities may dispose of unclaimed embryos by removing them from storage and thawing without transfer. In the absence of specific written instructions, unclaimed embryos may not be donated to others for reproductive use or be used in research. This statement replaces the American Society for Reproductive Medicine Ethics Committee document "Disposition of Abandoned Embryos" published in 2013., (Copyright © 2021 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

In this article, we discuss the ethics of human embryoids, i.e., embryo-like structures made from pluripotent stem cells for modeling natural embryos. We argue that defining our social priorities is critical to design a consistent ethical guideline for research on those new entities. The absence of clear regulations on these emerging technologies stems from an unresolved debate surrounding natural human embryo research and one common opinion that one needs to solve the question of the moral status of the human embryo before regulating their surrogate. The recent NIH funding restrictions for research on human embryoids have made scientists even more unlikely to raise their voices. As a result, the scientific community has maintained a low profile while longing for a more favorable socio-political climate for their research. This article is a call for consistency among biomedical research on human materials, trying to position human embryoids within a spectrum of existing practice from stem cell research or IVF to research involving human subjects. We specifically note that the current practices in infertility clinics of freezing human embryos or disposing of them without any consideration for their potential benefits contradicts the assumption of special consideration for human material. Conversely, creating human embryoids for research purposes could ensure that no human material be used in vain, always serving humankind. We argue here that it is time to reconsider the full ban on embryo research (human embryos and embryoids) beyond the 14-day rule and that research on those entities should obey a sliding scale combining the completeness of the model (e.g., complete vs. partial) and the developmental stage: with more advanced completeness and developmental stage of the considered entity, being associated with more rigorous evaluation of societal benefits, statements of intention, and necessity of such research.

The paper addresses the issues of admissibility of human embryo research and the legal protection to be recognized, in light of the growing importance that scientific research has been gaining in the clinical and biomedical fields of embryonic stem cells for therapeutic purposes. As for human embryo experimentation, particularly on cryopreserved supernumerary embryos, European legislation varies, since the European Court has granted member States a wide margin of appreciation. Some countries, including Italy, have strict legislation protecting embryos from the fertilisation stage, whereas others have taken permissive approaches, allowing experimentation until 14 days after fertilisation. Science, however, has shown that the 14-day limit can be moved. The author finds it necessary to achieve broad international consensus and shared regulations. Lawmakers, however, need to balance respect for the principle of life, represented by the embryo, against scientific needs, in order to devise sound regulations safeguarding both apparently conflicting fundamental values.

Background: Studying the human peri-implantation period remains hindered by the limited accessibility of the in vivo environment and scarcity of research material. As such, continuing efforts have been directed towards developing embryo-like structures (ELS) from pluripotent stem cells (PSCs) that recapitulate aspects of embryogenesis in vitro. While the creation of such models offers immense potential for studying fundamental processes in both pre- and early post-implantation development, it also proves ethically contentious due to wide-ranging views on the moral and legal reverence due to human embryos. Lack of clarity on how to qualify and regulate research with ELS thus presents a challenge in that it may either limit this new field of research without valid grounds or allow it to develop without policies that reflect justified ethical concerns., Objective and Rationale: The aim of this article is to provide a comprehensive overview of the existing scientific approaches to generate ELS from mouse and human PSCs, as well as discuss future strategies towards innovation in the context of human development. Concurrently, we aim to set the agenda for the ethical and policy issues surrounding research on human ELS., Search Methods: The PubMed database was used to search peer-reviewed articles and reviews using the following terms: 'stem cells', 'pluripotency', 'implantation', 'preimplantation', 'post-implantation', 'blastocyst', 'embryoid bodies', 'synthetic embryos', 'embryo models', 'self-assembly', 'human embryo-like structures', 'artificial embryos' in combination with other keywords related to the subject area. The PubMed and Web of Science databases were also used to systematically search publications on the ethics of ELS and human embryo research by using the aforementioned keywords in combination with 'ethics', 'law', 'regulation' and equivalent terms. All relevant publications until December 2019 were critically evaluated and discussed., Outcomes: In vitro systems provide a promising way forward for uncovering early human development. Current platforms utilize PSCs in both two- and three-dimensional settings to mimic various early developmental stages, including epiblast, trophoblast and amniotic cavity formation, in addition to axis development and gastrulation. Nevertheless, much hinges on the term 'embryo-like'. Extension of traditional embryo frameworks to research with ELS reveals that (i) current embryo definitions require reconsideration, (ii) cellular convertibility challenges the attribution of moral standing on the basis of 'active potentiality' and (iii) meaningful application of embryo protective directives will require rethinking of the 14-day culture limit and moral weight attributed to (non-)viability. Many conceptual and normative (dis)similarities between ELS and embryos thus remain to be thoroughly elucidated., Wider Implications: Modelling embryogenesis holds vast potential for both human developmental biology and understanding various etiologies associated with infertility. To date, ELS have been shown to recapitulate several aspects of peri-implantation development, but critically, cannot develop into a fetus. Yet, concurrent to scientific innovation, considering the extent to which the use of ELS may raise moral concerns typical of human embryo research remains paramount. This will be crucial for harnessing the potential of ELS as a valuable research tool, whilst remaining within a robust moral and legal framework of professionally acceptable practices., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Discussions and debates about the governance of human germline and heritable genome editing should be informed by a clear and accurate understanding of the global policy landscape. This policy survey of 106 countries yields significant new data. A large majority of countries (96 out of 106) surveyed have policy documents-legislation, regulations, guidelines, codes, and international treaties-relevant to the use of genome editing to modify early-stage human embryos, gametes, or their precursor cells. Most of these 96 countries do not have policies that specifically address the use of genetically modified in vitro embryos in laboratory research (germline genome editing); of those that do, 23 prohibit this research and 11 explicitly permit it. Seventy-five of the 96 countries prohibit the use of genetically modified in vitro embryos to initiate a pregnancy (heritable genome editing). Five of these 75 countries provide exceptions to their prohibitions. No country explicitly permits heritable human genome editing. These data contrast markedly with previously reported findings.

Research using human embryos and embryoids has expanded in recent years due to technological advances. Surveying laws and guidelines among the top research and development (R&D) investing nations highlights existing barriers to expanding this area of research. Of the 22 nations surveyed, we found 12 countries with a 14-day limit, one with a seven-day limit, five with prohibitions and four without national laws or guidelines that limit or prohibit human embryo research. Sixteen national laws or guidelines define an embryo or related entities, with five nations limiting human embryoid research. Other laws are ambiguous in relation to embryoid research, leave unanswered questions regarding what research is permitted or restricted and need additional clarity for researchers.

For the better part of a dozen years and over 3 US presidential terms, heated debates about the ethics of cloning and embryonic stem cell research helped to define the American political landscape. Current lack of public controversy about regulation of human genome editing does not signal that ethical issues about engineering human embryos have been settled. Rather, while genome editing raises old ethical questions about the value of human life, eugenics, and the weight of unintended consequences, it also came into being in a political landscape that vastly differs from the early aughts when bioethics was last a major topic of political controversy., (© 2019 American Medical Association. All Rights Reserved.)

The paper relates to the actual extent of the "margin of appreciation" of national law-making power in Europe when it takes ethical issues into consideration. This occurs when the use of technoscience may affect fundamental interests. The discretion of the legislature is limited, particularly by the transnational system arising from the European legal integration within both the European Union and the Council of Europe. The two schemes of integration, although there are differences between them, converge to put national legislation under pressure, particularly when it considers ethical matters. As a matter of fact, ethical issues cannot be approached at the national level alone but must be addressed at least at the continental level. An important role in the work of shaping the ethical rules from a continental perspective is played not by the national legislatures, but by the dialogue between the different levels of the judiciary. This role is inescapable and cannot be replaced by legislation, even if it is approved in a transnational plan. The function of the case law in regulating phenomena with ethical implications is studied, taking into consideration the case of Italian Law no. 40 of 2004 concerning medically assisted reproduction. Over the last 15 years, this law, which is inconsistent with many fundamental ethical principles, but has not been amended by the legislature, has been in the process of being corrected by the dialogue between European and national case law.

The disciplines of ethics, science, and the law often conflict when it comes to determining the limits and boundaries of embryo research. Under current Australian law and regulations, and in various other jurisdictions, research conducted on the embryo in vitro is permitted up until day fourteen, after which, the embryo must be destroyed. Reproductive technology and associated research is rapidly advancing at a rate that contests current societal and ethical limits surrounding the treatment of the embryo. This has brought about the question of the adequacy of the fourteen-day rule and whether it is necessary for it be reconsidered and reformed. This paper will highlight some of the tensions that exist in ethics, science, and the law in relation to the extension of the rule. It will be concluded that any move to extend the rule must be accompanied by close consultation with the public as the ultimate stakeholders in how the future of reproductive technology is created, constructed, and contested.

Recent developments in gene-editing technology have enabled scientists to manipulate the human genome in unprecedented ways. One technology in particular, Clustered Regularly Interspaced Short Pallindromic Repeat (CRISPR), has made gene editing more precise and cost-effective than ever before. Indeed, scientists have already shown that CRISPR can eliminate genes linked to life-threatening diseases from an individual's genetic makeup and, when used on human embryos, CRISPR has the potential to permanently eliminate hereditary diseases from the human genome in its entirety. These developments have brought great hope to individuals and their families, who suffer from genetically linked diseases. But there is a dark side: in the wrong hands, CRISPR could negatively impact the course of human evolution or be used to create biological weaponry. Despite these possible consequences, CRISPR remains largely unregulated due to the United States's outdated regulatory scheme for biotechnology. Moreover, human embryo research, which is likely critical to maximizing the therapeutic applications of CRISPR, is not easily undertaken by scientists due to a number of federal and state restrictions aimed at preventing such research. This Note examines the possible benefits and consequences of CRISPR and discusses the current regulations in both the fields of biotechnology and human embryo research that hamper the government's ability to effectively regulate this technology. Ultimately, this Note proposes a new regulatory scheme for biotechnology that focuses on the processes used to create products using CRISPR, rather than the products themselves, with a focus on enabling ethical research using human embryos to maximize the potential benefits of CRISPR.

Purpose of Review: The present study briefly reviews the history of mitochondrial replacement therapy (MRT); however, the focus is on recent advancements and future directions of the field. Specifically addressing societal and legal concerns and advances in MRT., Recent Findings: There continue to be new ethical debates surrounding MRT. In addition, there have been advancements in MRT techniques which could improve potential outcomes. Furthermore, advances in genetics continue to provide alternative approaches to treatment of many diseases, including alternatives to MRT., Summary: MRT may be beneficial to eradicate a severely debilitating and often fatal disease. Despite significant supporting safety and efficacy, there are still many social and legal barriers to instituting MRT to clinical practice.

Aims: Successive New Zealand Health Ministers have failed to approve guidelines for research using viable human embryos, which effectively places a blanket ban on all research that "uses" viable human embryos in this country. This includes research that aims to improve currently available reproductive technologies, illustrated by a failed application to ministerial ethics committees for a clinical research project investigating the efficacy of in vitro fertilisation procedures. However, no data currently exists describing the degree to which these restrictions are inhibiting reproductive research in this country., Methods: We have conducted a qualitative survey of New Zealand researchers from 20 major academic, clinical and governmental institutes to qualify the impact these restrictions are having on New Zealand's research outputs., Results: The results suggest dissatisfaction with the current guidelines, and the lack of guidance from the Ministry of Health and associated ethics committees regarding what constitutes embryo research and therefore what research can be performed., Conclusions: The lack of current guidelines regarding the use of embryos for research is restricting improvements to established reproductive technologies, and any future research. We suggest that the Minister of Health instructs ministerial advisory and ethics committees to review the current guidelines and to define the term "use of embryos"., Competing Interests: CF is the principle investigator for the “Day of Embryo Transfer” study described in the introduction. Authors CF, AS, LC, and ML participated in this survey.

For a long time, the legal condition of the child conceived, the embryo or the human fœtus, to use the language of biomedicine, was dominated by two main principles : one, having its roots in Roman law, made it possible to count it, by anticipation, among beings with a legal existence, so as to grant it its rights, as if it was already born (the infans conceptus maxim) : the other, protecting its life in utero, and so its chances of being born, by the penal incrimination of abortion. The legalisation of abortion by the ?Veil? law of 17 January 1975 upset this traditional approach of the law. The subsequent evolution of the legislation has accentuated the phenomenon. The promotion of the freedom of women to obtain an abortion has been accompanied by a correlated decline in the protection of the embryo. At the same time, abortion resting on medical techniques has become a means, precious for research, to obtain embryo or foetal cells or tissues. Eliminated on the one hand, the embryo has finally become on the other hand the object of medical and scientific stakes.

Although research on human biological material has long been the subject of much controversy, the question of the embryo is an extremely delicate subject.Concerns are strong about the possibilities of conducting research on embryonic matter, and the difficulties in defining the legal rules applicable to the embryo are also found in research and intellectual property. The field of patentability depends on the notion retained about the embryo because of a principle prohibiting the use of human embryos for industrial or commercial purposes.This study is devoted to the evolution of the concept on a European scale, particularly via the decisions made by the CJEU : by adopting an evolutionary notion of the embryo according to scientific progress, the field of patentability extends and offers new perspectives in research.

In criminal law the embryo is not assimilated to a person. It is therefore not protected in relation to offences against persons. However, the embryo does enjoy a certain, very relative and unapplied, protection through specific offences.

The bioethics laws since their first adoption in 1994 until the latest proposals, have been widely commented and analyzed, regarding the provisions related to the legal qualification and the legal status of the embryo and of the embryonic stem cells. The legal issues raised by these hesitations imply instability for both researchers and health professionals about what they can and cannot do when it comes to the embryo and its cells. Thus, while the protection of the embryo was the subject of a consensus until the end of the 2000s, it now appears as the object of a political will, from researchers and state agencies, to support this research. The legal frameworks have been modified step by step leading to an administrative police that reconciles freedom of research and ethical issues whose legal enforcement remains weak and uncertain. It will therefore be important to highlight the legal and institutional milestones that led to the acceptance of embryo research and to the liberalization of the legal framework. Some doubts will then be expressed about the benefits of this liberalization notably because cases law on the patentability of inventions resulting from this research are a bit of a threat to encourage development perspectives and because embryonic stem cells could remain marginal because of the economic and scientific contexts.

The legal qualification of the embryo does not pose any particular difficulties : this human being is a bodily thing of human nature, devoid of legal personality.However the freezing affects its humanity : it is no more than a thing made in laboratory, out of time. Stored in liquid nitrogen, it does not die, so storage must be ended.As long as they respond to a specific parental project, the one for which they were made and kept, the frozen embryos are identified by this given project.They are unique and not interchangeable. On the other hand, without a parental project, frozen embryos that can be accommodated by any infertile couple or those given to research, become interchangeable gender things.Although human beings, they are treated as the elements and products of the human body, human things.

The hesitations on the legal classification of the embryo lead to the doctrinal realization, that there is a certainty about its status, or, that it hasn't got any which allows the creator of the standard to reify it.The access to the claims which are based on specific interests seem to be at the heart of justifications to new legal rules concerning the embryo, even if It seems there are underlying specific interests.Confronted to the state disengagement in favour of these interests, the embryo, as far as French law is concerned, the embryo falls only under a limited protection which is destined to lose authority.