Human Embryo Research Research Articles

A framework for the responsible reform of the 14-day rule in human embryo research

A framework for the responsible reform of the 14-day rule in human embryo research

'Not birth, marriage or death, but gastrulation': the life of a quotation in biology.

This history of a statement attributed to the developmental biologist Lewis Wolpert exemplifies the making and uses of quotations in recent science. Wolpert's dictum, 'It is not birth, marriage or death, but gastrulation which is truly the most important time in your life', was produced in a series of international shifts of medium and scale. It originated in his vivid declaration in conversation with a non-specialist at a workshop dinner, gained its canonical form in a colleague's monograph, and was amplified as a quotation on a poster derived from an undergraduate project. Although it drew on Wolpert's authority and he accepted his authorship, it thus represents a collective sifting of earlier claims for the significance of prenatal existence through the values of 1980s developmental biology. Juxtaposing a technical term with major life events has let teachers engage students, and researchers entice journalists, while sharing an in-joke that came to mark community identity. Serious applications include arguing for an extension of the fourteen-day limit on human-embryo research. On this evidence, quotations have been kept busy addressing every audience of specialized knowledge.

Can we do that here? An analysis of US federal and state policies guiding human embryo and embryoid research.

Recent technological advances have helped scientists understand early human development. However, scientists’ ability to fully explore their potential comes in conflict with national and state-level policies in the USA. In 2016, for the first time, researchers were able to grow human embryos in culture up to 14 days but stopped because of scientific and legal limits. Other researchers have used stem cells in culture to create organized models of early human development, known as embryoids or cell-based embryo models. In this paper, we review federal and state laws that affect US human embryo and embryoid research. While federal policies focus on funding, state laws are often associated with human embryonic stem cells, abortion, fetal tissue research, and reproductive cloning. Of the 29 states with laws impacting human embryo research, only 11 states ban it, and none address embryoids directly, although five states limit aspects of this research. Overall, this complicated landscape suggests that additional national guidance would help scientists and the public navigate these controversial areas of research, however, it is unlikely to happen, considering the lack of past progress determining embryo research policy.

Evaluation of the knowledge and level of information about stem cells research and therapeutic potential among medical and dental postgraduate students of sumandeep vidyapeeth, Vadodara

Introduction: Stem cells are definite units competent of both self-renewal and differentiation into numerous cells. Embryonic and postnatal tissues are the major sources of stem cells. The aim of the study was to assess the knowledge and level of information about stem cells research and therapeutic potential among Medical and Dental postgraduate students of Sumandeep Vidyapeeth, Vadodara. Materials and Methods: The Medical and Dental postgraduate students of Sumandeep Vidyapeeth, Vadodara, were selected. The questionnaire form was taken to them by the principal investigator personally and explained about the study and asked to fill the questionnaire after obtaining consent. The collected questionnaire was excluded if more than 30% of questions were not filled. Results: A total of 435 medical and dental postgraduate students of Sumandeep Vidyapeeth, Vadodara, were included in the study. 109 dental postgraduates (26.58%), and 301 were medical postgraduates. All participants had a basic knowledge of stem cells (100%), but only a few had specific knowledge (3.90%). Only a few agreed to human embryo research and considered it ethical (0.73%). All agreed to conserve their child's umbilical cord for the child's therapeutic purposes. Conclusion: We can conclude that the knowledge and level of information about stem cells exhibited by most of the participants were minimal. However, all participants expressed a genuine desire to enhance their knowledge regarding stem cells. There is a need for Continuing Medical Education/ Continuing Dental Education (CME/CDE) workshops as well as conferences on this subject to upgrade the knowledge of participants and the community as a whole.

在中國的科研倫理規範體系建設中重視公眾參與

LANGUAGE NOTE | Document text in Chinese; abstract also in English.
 It is an inspiring idea that public participation should be the key factor for determining the human embryo research policy. However, public participation is missing from the Chinese government's vision of an ethics regulation system for scientific research. This article argues that to develop human embryo research policy for China and a new regulation system globally, the most important tasks may be to set rules for public participation and to understand the views on human embryo and cell-based embryo research ethics held by different stakeholders and the Chinese public.

論人體胚胎研究“軟法”修改之正當性

LANGUAGE NOTE | Document text in Chinese; abstract also in English.
 This commentary briefly discusses the substantive and procedural justifications for amending the longstanding 14-day rule, a soft-law limitation on the culturing of human embryos. The 14-day rule was established on the basis of general recognition of the human embryo's special status, accompanied by widespread public conversation and engagement. In principle, amending this rule would require the same substantive and procedural justifications. However, such justifications were absent prior to the lifting of the rule by the ISSCR in its 2021 guidelines. This article also discusses the value and importance of the 14-day rule to the development of human embryo research in the last three decades. Discarding the rule without the proper substantive and procedural justifications is likely to damage public trust and confidence in future human embryo research.

生物醫學技術發展應該改變14天法則限制嗎？

LANGUAGE NOTE | Document text in Chinese; abstract also in English.
 Developments in research have made culturing human embryos beyond the 14-day limit seem technologically feasible. In the article “Emerging Human Embryo Research Technologies, the 14-day Rule, and the Special Status of the Embryo,” the authors examine a proposal for new human embryo and embryoid research guidelines by reviewing the history of the 14-day limit and emerging areas of research that are impacted by these guidelines. However, as noted by the authors, changes in science policy should not be developed solely by scientists. Instead, policy development should reflect the reality of science as a public endeavor. After 40 years of consensus, any attempts to revoke the 14-day limit on the in vitro culturing of human embryos should rely on public and stakeholder engagement.

改變“14天規則”：生命倫理學與公眾參與的再平衡

LANGUAGE NOTE | Document text in Chinese; abstract also in English.
 This article argues that the ISSCR's changes to the 14-day rule should be welcomed. In the future of human embryo research oversight in China, bioethics and public engagement should be fully balanced. This is essential to safeguard the public's trust in science.

對〈新興人體胚胎研究技術、 十四天規則和胚胎的特殊地位〉一文的回應

LANGUAGE NOTE | Document text in Chinese; abstract also in English.
 This paper responds to “Emerging Human Embryo Research Technologies, the 14-Day Rule, and the Special Status of the Embryo” by analyzing the moral status of the embryo. We hold that the embryo has a limited moral status that is influenced by local ethical and cultural factors. The moral status of the embryo can be evaluated according to its potential value to and relationship with society within the specific ethical and cultural context. On whether the embryo should be used in research, we recommend that researchers follow the principle of permission, i.e., seek consent from the agents who best represent the interests of the embryo (usually the parents).

論胚胎的道德地位——儒家倫理的視角

LANGUAGE NOTE | Document text in Chinese; abstract also in English.
 For 40 years, international rules have limited human embryo research to the first 14 days of embryonic development. On May 26, 2021, in its latest guidelines for stem cell research and its medical applications, the International Society for Stem Cell Research eased the 14-day restriction. This raises myriad ethical issues. At their core is the debate over the moral status of embryos, which exposes ethical conflicts between cultural perspectives. This article discusses the moral status of embryos and argues from the perspective of Confucian ethics that the 14-day limit should not be waived at the present moment.

14-Day Limit of Human Embryo Research: Moral Issues in the Patent Law in China

Conflicting decisions are made regarding the patentability of inventions related to human embryonic stem cells (hESC) in China based on divergent ethical judgments and arguments. Gaps between patent and health law exist, and inconsistent applications of patentability emerge. The amendment to China's Patent Examination Guidelines regulated that isolating or obtaining stem cells using human embryos which are not undergoing in vivo development and are within 14 days after fertilization could be granted patent. This regulatory scheme that uses the 14-day threshold for patenting hESC-related invention is feasible, transparent, and can be conformed with by researchers and other actors in this field. However, making policy on this matter is not straightforwardly a matter of winning a philosophical argument on moral issues: the moral status of human embryos must be still carefully weighed and balanced in the patent examination process.

Legal regimes for using human embryos for scientific purposes in the light of the international bodies’ practice

The research on human embryos evolves rapidly, raising a number of ethical and legal issues and directly affecting human rights. Approaches to the legal regulation of human embryo research differ significantly from country to country. Some of them employ prohibitive practices (e.g. Switzerland and Italy), and the others have a regime that allows using embryos for scientific purposes with restrictions of different extent (e.g. the UK and Japan). There is no the international consensus on the issue of human embryo research. The objective of the article is to find out whether there are positions of the international bodies that may become or have already become the general guidance for different countries, allowing therefore to regulate effectively the use of human embryos for scientific purposes.The conclusion is drawn that there are positions of international bodies that may serve as the guidance within the regulation of the area concerned. States may enjoy a wide margin of appreciation within the framework of human embryo research regulation, considering the need to update their regulations regularly to harmonize them with the development of human rights and scientific progress and also to ensure a certain level of the embryo protection.

The closer the knit, the tighter the fit: conceptual and ethical issues of human embryo modelling

Recent publications reporting the generation of human blastocyst-like structures (also known as ‘blastoids’; Liu et al., 2021; Yu et al., 2021) mark an important further step in the modelling of human embryogenesis. This emerging field of research uses advanced (stem) cell technologies and culture systems to enable new insights into early human development and reproductive health. Moreover, it promises to do so in a way that overcomes current limitations on human embryo research. Unlike human embryos, stem cell-based ‘embryo-like structures’ (ELS) – such as ‘blastoids’ or ‘gastruloids’ – can be created and modified ad libitum, enabling studies that require large numbers of genetically identical entities, while bypassing the need for oocyte donation.

O-096 The ethics of stem cell-based embryo-like structures: a focus group study on the attitudes of Dutch professionals and lay citizens

Abstract Study question What are main themes guiding the attitudes of Dutch professionals and lay citizens with regard to the creation and research use of embryo-like structures? Summary answer The attitudes of Dutch citizens indicate feelings of trust and distrust, distinct ‘embryo’ conceptualizations, competing moral values and beliefs, and criteria for adequate regulatory safeguards. What is known already Researchers are hopeful that the creation and research use of so-called embryo-like structures (ELS), i.e., stem cell-based models that can mimic (parts of) early (human) embryogenesis, may provide a morally less controversial way of studying the period during which most human etiologies rise while also reducing and replacing the use of animals and/or human embryos in research. Scholars in the humanities and social sciences underline that public engagement and support will be essential in harvesting this presumed moral advantage. Studies on the public endorsement of and attitudes towards synthetic embryology remain nevertheless significantly scarce. Study design, size, duration For this qualitative study with a cross-sectional design, data were collected through four semi-structured focus group discussions (N = 33) between August and September 2020. Participants/materials, setting, methods The focus group interviews consisted of one pilot interview (n = 5), two interviews with lay citizens (n = 21), and one interview with professionals (n = 7). The pilot participants and lay citizens were invited based on sociodemographic characteristics of the Dutch public. Professionals were selected from the networks of the authors based on their experience and affinity with ethical and legal debates on emerging biotechnologies. The transcriptions were analyzed using inductive thematic analysis. Main results and the role of chance From our analysis emerged four themes: (1) trust, distrust and ambivalence in synthetic embryology, mainly due to concerns about scientific compliance with societal norms, also in view of a projected future ability of using ELS for reproductive ends; (2) diversity of ELS-conceptualizations, also in terms of their (non-)distinction from ‘natural’ human embryos; (3) grounds for moral value and moral standing, in which a possible potential to grow into a human being and perceived tinkering with nature were considered key issues of moral concern; and (4) conditions for responsible embryo-like research, with an emphasis on legally binding the use of ELS to non-reproductive research purposes. Interestingly, whereas questions on the developmental potential of ELS were critical for both the attitudes of professionals and those of lay citizens, lay citizens were much more concerned that synthetic embryology could fundamentally change human existence for the worse. In particular, lay citizens worried that synthetic embryology could lead to dystopian futures, for instance, because it stimulates a ‘makeable human existence’ or because of a presumed inability to monitor and control scientific progress. These findings may imply a correlation between fear of research and degrees of (un)familiarity with the governance systems of science. Limitations, reasons for caution Qualitative research methods provide rich and in-depth data for an ethical analysis of motivations and intuitions, but do not allow generalizations of the findings to broader publics. Wider implications of the findings The results may provide a useful starting point for further discussion and analysis of adequate regulatory parameters for the creation and research use of ELS. The findings also show that societal dialogue and public consultation can play a significant role in addressing concerns about emerging (bio)technologies. Trial registration number not applicable

Human embryo research, stem cell-derived embryo models and invitro gametogenesis: Considerations leading to the revised ISSCR guidelines.

SummaryThe ISSCR Guidelines for Stem Cell Research and Clinical Translation were last revised in 2016. Since then, rapid progress has been made in research areas related to in vitro culture of human embryos, creation of stem cell-based embryo models, and in vitro gametogenesis. Therefore, a working group of international experts was convened to review the oversight process and provide an update to the guidelines. This report captures the discussion and summarizes the major recommendations made by this working group, with a specific emphasis on updating the categories of review and engagement with the specialized scientific and ethical oversight process.

Naive stem cell blastocyst model captures human embryo lineage segregation.

SummaryHuman naive pluripotent cells can differentiate into extraembryonic trophectoderm and hypoblast. Here we describe a human embryo model (blastoid) generated by self-organization. Brief induction of trophectoderm leads to formation of blastocyst-like structures within 3 days. Blastoids are composed of three tissue layers displaying exclusive lineage markers, mimicking the natural blastocyst. Single-cell transcriptome analyses confirm segregation of trophectoderm, hypoblast, and epiblast with high fidelity to the human embryo. This versatile and scalable system provides a robust experimental model for human embryo research.

A Letter to President Biden and Secretary Designate of HHS Xavier Becerra: Remove Barriers to Federal Funding of Human Embryo and Fetal Tissue Research.

Human fetal tissue (HFT) has been used in biomedical research for nearly a century and has led to extraordinarily valuable discoveries that have benefitted humankind. Politicization of the use of HFT over recent years has led to the creation of numerous obstacles to scientific progress in this field. In July 2019, the imposition of redundant ethics policies was supplemented with the creation of the Human Fetal Tissue Ethics Advisory Board, which withheld funding of 13 out of 14 NIH grants that were favorably peer reviewed in the Summer of 2020. We believe that these new sets of restrictions are harmful to the goals of scientific progress and call upon the new administration of our government to allow peer review, not politics, to determine scientific merit and to reinstitute the previously existing ethics policies that were more than adequate to assure the appropriateness of human fetal tissue research.

After He Jianku: China's biotechnology regulation reforms

The unveiling of the world’s first gene-edited twins by biophysics researcher He Jiankui generated much discussion about Chinese legal and ethical frameworks for biotechnology. In response, the highest Chinese legislative body, the National People’s Congress, and the two responsible departments for biotechnology, the Ministry of Science and Technology and the National Health Committee, have undertaken a seemingly far-reaching regulatory reform. The most salient step of this reform is to regulate genetic research and human embryo research in the Chinese Civil Code. This article overviews recent policy developments in China and their respective importance for promoting a governance framework for biomedical research that meets the expectations of the international community. However, this regulatory reform could also set stricter administrative procedures in place for Chinese institutions and their foreign partners, which may impede scientific progress. The concrete impact of this reform on the practice of Chinese scientists will need to be closely scrutinised by Chinese authorities and the international community.

Parthenogenesis: New Conflicts and Opportunities for Fecundity and Reproductive Freedom

This Monograph examines, critically, a phenomenon of nature termed parthenogenesis, or asexual reproduction. The potential for adapting this occurrence to humans, especially transsexual women, is not only intriguing as a form of assisted reproductive technology, but holds great promise as a source for human embryo research and regenerative medicine. Parthenogenetic embryos would be derived from unfertilized human eggs and, thus, blunt – if not resolve – ethical concerns over experimentation of human embryos. These research embryos would, in turn, be a valuable source for producing stem cells which could then be used to facilitate growth of tissues for organ transplants. As a tool for expanding human fecundity, however, uses of this nature would be little more than a vainglorious and dangerous scientific achievement.

Freedom of Scientific Research and Embryo Protection Under Italian and European Court of Human Rights' Jurisprudence. Brief European Legislation Overview.

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.