In re: the disposition of frozen embryos: 2022.

Debates regarding reproductive rights have waxed and waned since the early twentieth century. The current front-and-center debate draws this discussion into tighter focus. Challenges to reproductive rights, changes in definitions of personhood and a pending decision regarding Roe v Wade could change the management and options regarding the disposition of frozen embryos. This commentary outlines how changes in abortion law and reproductive rights could potentially impact the options available to both patients and clinics.

Disposition of unclaimed embryos: an Ethics Committee opinion.

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.

The ethics of human-embryoids model: a call for consistency.

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.

Storage, transport, and disposition of gametes and embryos: legal issues and practical considerations.

Cryopreservation of reproductive material has dramatically improved clinical outcomes for patients all over the world. At the same time the practice has produced significant legal, ethical, and practical challenges to physicians and practices who use this technique. Failing to meet the expectations of patients, for example by losing material because of a freezer failure, has significant implications for the reproductive facility. Similarly, improperly transporting or receiving gametes or embryos can result in substantial risk to a practice. Perhaps the most widely publicized conundrum is how best to manage embryos that are abandoned. This paper will describe the legal principles and best practices that should be incorporated into the management of a fertility cryopreservation program.

New Zealand Policy on Frozen Embryo Disputes.

Disputes between separated couples over whether frozen embryos can be used in an attempt to create a child create a moral dilemma for public policy. When a couple create embryos intending to parent any resulting children, New Zealand's current policy requires the consent of both people at every stage of the ART process. New Zealand's Advisory Committee on Assisted Reproductive Technology has proposed a policy change that would give ex-partners involved in an embryo dispute twelve months to come to an agreement before the embryos are destroyed. New Zealand's current policy and the proposed policy both favour the person who wishes to avoid procreation. Two alternative policy approaches that do not favour procreative avoidance are considered. Using pre-fertilisation contracts to determine the decision reached in embryo disputes allows the couple's wishes at the time the embryos are created to determine what happens to the embryos if they separate. However, pre-fertilisation contracts are agreements about healthcare and personal relationships, and changing circumstances can make enforcing such agreements unjust. Finally, it is argued that New Zealand's Family Court system should be used to reach decisions that balance the interests of those involved in the dispute.

Restatement (Third) of Torts Section 47(b) Bypasses Traditional Barriers and Offers Aspiring Parents a Clear Path to Recover Stand-Alone NIED when Their Cryopreserved Reproductive Material is Lost or Destroyed.

"[T]he tissue or embryo is not the primary victim at all. The victims are the parents who have been deprived of the potential to conceive a child together."1.

Attitudes towards embryo donation among healthcare professionals working in child healthcare: a survey study.

BACKGROUND: The aim of this study was to investigate attitudes towards embryo donation and embryo donation families among professionals working in primary child healthcare, and their experiences of these families. METHODS: A cross-sectional online survey was conducted in Sweden between April and November 2016. A total of 712 primary healthcare physicians, registered nurses and psychologists were approached to participate in this study. The study-specific questionnaire measured attitudes and experiences in the following four domains: legalisation and financing, the family and the child's health, clinical experience of meeting families following embryo donation, and knowledge of embryo donation. RESULTS: Of the 189 women and 18 men who completed the questionnaire (response rate 29%), relatively few (13%) had clinical experience of caring for families following embryo donation. Overall, 69% supported legalisation of embryo donation for infertile couples, and 54% agreed it should be publicly funded. The majority (88%) agreed the child should have the right to know the donors' identity. Respondents did not believe that children conceived through embryo donation are as healthy as other children (50%), citing the risks of poor mental health (17%) and social stigmatization (18%). Approximately half reported low confidence in their own knowledge of embryo donation (47%) and wanted to know more (58%). CONCLUSIONS: These results indicate relatively large support among healthcare professionals in Sweden for the legalisation of embryo donation. In order to provide adequate healthcare to families following embryo donation, there is a need to develop educational resources to increase knowledge about the medical and psychosocial consequences of embryo donation among healthcare professionals working in primary healthcare.

2PN cell donation in Germany. Or: How the German Embryo Protection (Act) undermines itself.

In contrast to embryo donation, the permissibility of 2PN cell donation is highly controversial in Germany. This article is based on there being a legal loophole with respect to 2PN cell donation, which results from an inconsistency within the Embryo Protection Act on the normative status of 2PN cells. Following that thesis, the article argues that, on the basis of the normative criterion totipotency (i.e. the capacity to develop into a born human being), 2PN cells should also be considered human embryos within the meaning of the Act and thereby be protected by that Act in the same way as embryos. However, the normative assumption that 2PN cells should already be endowed with human dignity and the right to life has absurd consequences. Moreover, the consistent continuation of the Embryo Protection Act, as well as of the underlying ethical position or argumentation (i.e. the potentiality argument), leads to the even more absurd consequence of having to place every human somatic cell under the protection of human dignity and the right to life. As totipotency or the developmental potential therefore cannot delimit entities considered worthy of protection (i.e. human embryos) from entities considered not worthy of protection (i.e. 2PN cells, gametes, hESC, hiPSC and human somatic cells), it is not a suitable normative criterion. As a paradigmatic case, 2PN cell donation demonstrates that by retaining this normative criterion the now obsolete German Embryo Protection (Act) ultimately undermines itself.

The point of no return: Up to what point should we be allowed to withdraw consent to the storage and use of embryos and gametes?

This article discusses when it is ethically acceptable to withdraw consent for the storage and use of embryos and gametes. Currently, the law in the UK states that consent to use of a gamete or embryo can be withdrawn up to the point of the embryo's transfer to the recipient's uterus or when the gamete is used in providing treatment services; that is, the 'point of no return'. In this article, we will consider other points of no return and argue that having a single point of no return, a one size fits all form of consent can, in some cases, lead to restrictions on individuals' autonomy and cause particular types of harm. Therefore, having different points of no return that fit different circumstances could extend autonomy and allow people to enter into agreements that are tailored more to their own particular needs and circumstances.

[Regulación de la donación de gametos y embriones en las técnicas de reproducción humana asistida: ¿anónima o abierta?]

The use of donated gametes and embryos in assisted reproduction techniques (ART) makes it necessary to examine interests that involve relevant ethical and legal considerations, which include the autonomy and privacy rights of the intended parents, donors' right to privacy and the right of the minors to know their genetic origin. This article presents arguments to consider policies of more openness to obtain information from donors in order to protect the child's best interest in knowing his/her genetic origins. It concludes with the situation in Mexico, where ART has been carried out with donated gametes since several years ago; however, due to the absence of regulations to control these procedures, each establishment imposes its own criteria for the operation of its programs.

El uso de gametos y embriones donados en técnicas de reproducción humana asistida hace necesario examinar intereses que implican consideraciones éticas y jurídicas relevantes, y estos incluyen los derechos de autonomía y privacidad de los padres de intención, el derecho a la privacidad de los donantes y el derecho de los menores a conocer su origen genético. En este artículo se exponen argumentos para considerar políticas de mayor apertura para la obtención de información de los donantes en aras de proteger el interés superior del niño y la niña a conocer sus orígenes genéticos. Concluye con la problemática en México, donde desde hace varios años se realizan técnicas de reproducción humana asistida con gametos donados, sin embargo, debido a la ausencia de una normatividad que regule estos procedimientos, cada establecimiento impone sus criterios para el funcionamiento de sus programas.

Abandoned frozen embryos in Argentina: a committee opinion.

Argentina, like many other countries in the region, faces the dilemma of what to do with the increasing accumulation of frozen embryos, which are often abandoned. This report aims to address the issue of abandoned frozen embryos, following the main concerns: 1) when is an embryo considered abandoned, according to regulatory documents; 2) how can the number of cryopreserved abandoned embryos be decreased; and 3) what are the current available options for discarding these abandoned embryos. Issues concerning the fate of abandoned embryos call for a revision of the technical aspects, as well as the symbolic aspects associated with the embryos and their options for discarding. Embryo disposal is a complex and intimate decision, which depends not only, on the quality of the cryopreserved embryo, but also on the social, cultural, economic, labor and health insurance aspects. In the absence of a formal regulatory framework for such decisions in Argentina, current practices and standard procedures face significant developmental hurdles. Among future actions to be developed in the short, medium and long term by this committee are building interdisciplinary teams, fostering patient-awareness, devising guidelines, and enforcing policies regarding embryo abandonment.

[Chapter 7. The frozen embryo in the light of a jurist : beyond qualification]. / Chapitre 7. L?embryon congelé sous le regard d?un juriste : au delà de la qualification.

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.

[Chapter 10. The embryo, a particular thing]. / Chapitre 10. L?embryon, une chose particulière.

By allowing a woman to terminate the life of the embryo, the law of 17 January 1975 leads us to ask the question about how to qualify the embryo. Is it a thing or a person ? Subordinate to the birth of a viable, living being, the embryo can have no acknowledged legal personality. Its particularity must nevertheless be noted : it is the only thing in law that is likely to become a person. So, conjugated in the present (The reality of the present : the embryo is a thing), the embryo is without doubt a thing.This qualification is implicit and results from an a contrario interpretation of article 16 CC. By not qualifying the human being from the start of his life as a person, the legislator treats him as a thing. That explains why the term homicide cannot be used against someone whose fault has provoked the termination of the pregnancy of a pregnant woman.The qualification as a thing does not prevent the protection of the embryo, attached to its quality as a human being. This protection is different from that applied to a person. In fact, it does not present an obstacle to the destruction of the embryo. It only consists in providing a framework for any violations that the embryo might suffer. The protection is variable according to whether it applies to the embryo in vitro or in utero and increases as the parental project progresses.Conjugated in the future, the embryo will become a person (The fiction taken from the future : the embryo is a person). This perspective allows us to qualify it fictitiously as a person, from conception, by means of an analysis, either retrospective or prospective.The retrospective analysis allows, once the child is born alive, a ?return to the future? by recognising that the embryo has rights, from conception, by applying the adage infans conceptus.The prospective analysis leads to anticipating the future and the quality as a person that will be acknowledged for the embryo at birth. Inspired by the law of goods and in particular the notion of thing by anticipation, the embryo can thus be qualified as ?person by? : this is a ?thing by nature? fictitiously qualified as a person because of the perspective of his birth. The interest of this qualification is that it explains the exceptional application of the legal regime of persons to the embryo, which limits the powers of the woman over her embryo. Indeed, the woman without doubt has absolute power to dispose of her body materially during the first weeks of the pregnancy, which confers on her the ability to destroy the embryo which is an element of her body. However, if she should wish to give birth to the child, the woman is deprived of the power to conclude legal acts of disposition by which she would commit herself to transfer the child to someone else at birth.

[Chapter 11. The impossible status of the embryo or the state withdrawal to the profit of vested interests]. / Chapitre 11. L?impossible statut de l?embryon ou le désengagement de l?État au profit des intérêts particuliers.

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.

Beyond Balancing: Rethinking the Law of Embryo Disposition.

Actress Sofia Vergara became the center of a new round of conflict about the disposition of embryos created using assisted reproductive technologies (ART): the conflict about the difference that abortion jurisprudence should make to case law on ART. This Article argues that the history of abortion jurisprudence sheds light on the problems with the leading approach to embryo-disposition cases like Vergara's. In many instances, courts first look for a clear, binding agreement and look to a balancing analysis if no such agreement exists. As this Article shows, this is not the first time that courts have applied a balancing analysis to deal with clashing rights to seek and avoid genetic parenthood. The Article explores the history of two balancing approaches that have played a pivotal role in abortion law. These approaches have led to inconsistent results and cater to the prejudices of judges who are asked to weigh the relative merits of individual parties' views on reproduction. This Article recommends that states adopt legislation detailing the requirements of an enforceable embryo disposition similar to the Uniform Premarital and Marital Agreements Act (UPMAA). In the embryo-disposition context, states should require parties to disclose legal rights and responsibilities rather than only finances. These disclosures should cover the preservation, implantation, or destruction of the embryos and the financial and legal responsibility for any resulting child. States should enforce an embryo-disposition agreement if it is voluntary, if the parties had counsel or the opportunity to access counsel, and if the parties had a full disclosure of the constitutional and common law rights implicated by the agreement.

The Legalisation of Gamete Donation in Italy.

Since 2004, the regulation of assisted reproduction in Italy has undergone substantial reform as an effect of key judicial intervention. Limitations on embryo production, screening and transfer, the prohibition against engaging in preimplantation genetic diagnosis (PGD) and embryo selection, and the ban on gamete donation have all been removed by courts. In this article, I discuss how judicial intervention has improved the ability of Italian couples to access assisted reproduction technologies (ARTs), and how the expansion of reproductive rights is, however, still incomplete. In particular, I discuss the challenges in implementing the liberalisation of gamete donation, and identify the practical, political and cultural reasons for limited access to gamete donation. I also discuss the future of the prohibitions and restrictions that still exist in Law 40/2004.

Embryo donation and understanding of kinship: the impact of law and policy.

STUDY QUESTION: What is the impact of law and policy upon the experience of embryo donation for reproductive use? SUMMARY ANSWER: Access to, and experience of, embryo donation are influenced by a number of external factors including laws that impose embryo storage limits, those that frame counselling and approval requirements and allow for, or mandate, donor identity disclosure. WHAT IS KNOWN ALREADY: To date only three qualitative studies in Australia and New Zealand have been completed on the experience of embryo donation for reproductive purposes, each with a small cohort of interviewees and divergent findings. STUDY DESIGN, SIZE, DURATION: Embryo donors, recipients, and would-be donors were interviewed between July 2010 and July 2012, with three additional interviews between September 2015 and September 2016, on their experiences of embryo donation. The sampling protocol had the advantage of addressing donation practices across multiple clinical sites under distinct legal frameworks. PARTICIPANTS/MATERIALS, SETTINGS, METHODS: Participants were recruited from five Australian jurisdictions and across 11 clinical sites. Twenty-six participants were interviewed, comprising: 11 people who had donated embryos for the reproductive use of others (nine individuals and one couple), six recipients of donated embryos (four individuals and one couple) and nine individuals who had attempted to donate, or had a strong desire to donate, but had been prevented from doing so. In total, participants reported on 15 completed donation experiences; of which nine had resulted in offspring to the knowledge of the donor. MAIN RESULTS AND THE ROLE OF CHANCE: Donors positively desired donation and did not find the decision difficult. Neither donors nor recipients saw the donation process as akin to adoption . The process and practice of donation varied considerably across different jurisdictions and clinical sites. LIMITATIONS, REASONS FOR CAUTION: Because the pool of donors and recipients is small, caution must be exercised over drawing general conclusions. Saturation was not reached on themes of counselling models and future contact. WIDER IMPLICATIONS OF THE FINDINGS: The differences between our findings and those of a previous study are attributable to varied legal and counselling regimes. Therefore, law and policy governing embryo storage limits, counselling protocols and identity disclosure shape the donation experience and how it is described. STUDY FUNDING/COMPETING INTERESTS: This research was supported by Discovery Project Grants DP 0986213 and 15010157 from the Australian Research Council and additional funding from UTS: Law. There are no conflicts of interest to declare. TRIAL REGISTRATION NUMBER: Not applicable.

Donation of surplus frozen pre-embryos to research in Israel: underlying motivations.

BACKGROUND: The high number of IVF procedures performed in Israel has had an unforeseen consequence: accumulation of large amounts of surplus frozen embryos. After five years that the frozen embryos are kept for free, patients need to make an embryo disposition decision. One option is donation for research. The donation rate in Israel is very low. Our aim was to understand the attitudes, values and perceptions of female IVF patients that decided to donate their surplus frozen embryos to research. METHODS: The study setting was a tertiary IVF unit which during the 2000-2009 period treated 241 patients who had their frozen pre-embryos stored for more than five years. The study population consists of the 12 patients (from among the 241) who had decided to donate their excess frozen pre-embryos to research. In-depth interviews were carried out with 8 of those 12 patients. RESULTS: IVF patients who donated their surplus frozen pre-embryos to research viewed the frozen embryo as a valuable resource that does not have human identity yet. The majority expressed a gradualist approach to the human status of the embryo as requiring successful implantation and development in the uterus. All the respondents chose donation to research not because it was their first choice but because they did not want or were unable to use the pre-embryos in the future, in addition to not willing to thaw them. For many of the respondents, donation to research was accompanied by a sense of uncertainty. All would have preferred to donate their pre-embryos to infertile women or couples, an option which is currently prohibited in Israel. CONCLUSIONS: The moral reasoning behind decisions that patients make regarding excess pre-embryos is important for health care practitioners to consider when offering decision-making alternatives and counseling. For our respondents, the scarcity of donating excess frozen pre-embryos to research may reflect patients' preference for embryo donation to infertile couples. Recommended ways to increase donation to research may include public education and awareness, as well as targeted communication with IVF patients by multi-professional IVF unit teams comprised of a medical doctor and a professional trained in bioethics.

Embryo Disposition Disputes: Controversies and Case Law.

When prospective parents use in vitro fertilization, many of them hope to generate more embryos than they intend to implant immediately. The technology often requires multiple attempts to reach a successful pregnancy, and couples can cryopreserve any excess embryos so that they have them on hand for later attempts. As part of obtaining informed consent for IVF or cryopreservation, clinics typically ask patients to specify their preferences for the embryos in the event of divorce or death, offering options such as use of the embryos by a specified partner, donation to research, or discarding the remaining embryos. Still, many courts face a recurring problem: the partners dissolve their relationship (typically through divorce), and one party wants to use the frozen embryos over the objections of the other. Courts and legislatures have struggled with how to handle these cases, which seem to pit one partner's right to procreate against the other's right not to procreate. In this essay, we use one of the most recent decisions in this line of cases-the Appellate Court of Illinois's decision in Szafranski v. Dunston-to explain the current state of the law and make recommendations for changes. The issue is ripe for revisiting because in the last year, embryo disputes have become a battlefront for larger conflagrations over the moral status of embryos.