Decisional authority of gamete donors over embryos created with their gametes.

In the ongoing discussion on the rights and obligations of gamete donors, scant attention has been paid to the decisional authority of gamete donors over the disposition of the embryos created with their gametes. This paper analyses four different positions: three cases relate to the disposition options for surplus or unused embryos by the first recipients, and one case relates to the use of the embryos stored by the first recipients for procreation.We conclude that the gamete donor causally contributes to the creation of the embryos and thus becomes indirectly responsible. To avoid that donors would become accomplices to an activity to which they morally object, a qualified generic consent mentioning types of research should be obtained. No consent from the donor is required for the destruction of the embryos.The cancellation of the agreement by anonymous or identifiable gamete donors should not be possible for embryos in storage for reproduction by the recipients. The interests in not becoming a genetic parent against one's wishes do not outweigh the damage done to recipients who would no longer be able to use their embryos. Known donors, on the contrary, should be able to withdraw their consent up to the moment of transfer of the embryos based on the greater harm caused to them as a consequence of attributional parenthood. They should also be able to veto transfer of the embryos to other people than the original recipients.

Thoughts on the ethics of gestational surrogacy: perspectives from religions, Western liberalism, and comparisons with adoption.

BACKGROUND: In gestational surrogacy, a woman incubates an embryo to which she is not genetically related. Genetic distance from both her and the commissioning parents is increased further when donor gametes are employed. Ethical implications vary depending on the extent to which the parents and surrogates share genetic material with the produced child. PURPOSE: This paper seeks to address two primary questions: What do selected ethical frameworks tell us of (1) the relationship between genetic motherhood, gestational motherhood, social motherhood, and marital fidelity? And (2) the effects of gestational surrogacy and gamete donation on our understanding of lineage and heritability? METHODS: Current literature and thought on these questions were considered through the classical ethics lenses of religion, the adoption standard, and Western liberalism. RESULTS: A genetic link between the parents and the child serves to simplify the adoption process (if one is required) and supports a family's desire to resemble as much as possible a traditional biological family, thus providing a minimum set of challenges to religious or conservative hesitations. CONCLUSION: Inasmuch as gestational surrogacy, with or without donor gametes, is tolerated in a variety of ethical contexts; the basis of its acceptance may be the Western liberal celebration of contractual agreement.

Medical research and reproductive medicine in an ethical context: a critical commentary on the paper dealing with uterine lavage published by Munné et al.

A recent study published in Human Reproduction claimed that uterine lavage offers a non-surgical, minimally invasive strategy for the recovery of human embryos from fertile women who do not want or need IVF for medical reasons but who desire preimplantation genetic testing (PGT) for embryos. To prove this hypothesis, the researchers recruited dozens of young Mexican women. The prospective oocyte donors underwent ovarian stimulation to induce the production of multiple mature oocytes. Subsequently, these women were inseminated by donor semen. A few days later, the developing embryos were collected by uterine lavage (uterine flushing) and subjected to genetic testing for aneuploidies (PGT-A). Oocyte donors with persistently elevated hCG levels, indicating the implantation of one or more embryos after uterine lavage, had to undergo uterine curettage and/or treatment with methotrexate. A critical opinion paper discussing the aforementioned study was published by De Santis and colleagues and has raised critical issues that are largely technical in nature. However, this opinion paper neglects-from our point of view-critical issues of the Mexican study regarding ethical principles and moral standards in human research. These aspects are summarized below.

Regulating assisted reproductive technologies (ART) in Nigeria: lessons from Australia and the United Kingdom.

Assisted reproductive technologies (ART), are innovative, non-coital medical procreative procedures, that have brought respite to a number of childless persons and couples, just as it also raises a number of ethical and medico-legal issues. A number of countries including Nigeria, are still struggling to find the appropriate legal framework to provide guidelines for this reproductive process to curtail inherent unethical practices associated with that development. The paper explores the available regulatory instruments in Nigeria and in cognate jurisdictions such as Australia and the United Kingdom, through a comparative study to ascertain the efficacy of the existing instruments in ensuring that unethical practices and abuses associated with ART are eradicated. The findings indicate that the regulatory instrument in Nigeria requires significant improvement in line with the legal frameworks in operation in the cognate jurisdictions to effectively guard against potential unethical practices and abuses associated with the application of ART.

Assessment of Turkey IVF (In Vitro Fertilization) websites according to the American Society for Reproductive Medicine (ASRM)/Society for Assisted Reproductive Technology (SART) guidelines.

OBJECTIVE: To evaluate websites of in-vitro fertilisation centres in terms of standardised ethical guidelines for advertising. METHODS: The cross-sectional study was conducted in Turkey from February to April 2017. A total of 148 IVF centre websites were evaluated in terms of objective criteria in accordance with American Medical Association, American College of Obstetricians and Gynaecologists, American Society for Reproductive Medicine / Society for Assisted Reproductive. Technology guidelines for advertising. Websites were surveyed with attention paid to success rates, testimonials, sales promotions, price, psychological support offered as part of the service, regulating / certifying bodies, misleading language, and the ethical principles of autonomy, beneficence, non-maleficence and justice. Data was analysed using SPSS 23. RESULTS: Out of 193 centres, 148(76.7%) had active websites; 104(70.3%) private, 38(25.7%) in university hospitals and 6(4%) in state hospitals. Of them, 103(69.6%) centres used at least one example of misleading language when compared to the relevant guidelines. Among these centres, 82(79.6%) were private, 18(17.5%) university hospitals and 3(2.9%) were state hospitals. CONCLUSIONS: A massive majority of websites related to in-vitro fertilisation centres did not follow standardised guidelines for advertising.

'Compassionate transfer': an alternative option for surplus embryo disposition.

Compassionate transfer is a procedure wherein in vitro-created embryos are placed in a patient's cervix, vagina or uterus at an infertile period in the menstrual cycle where they are expected to perish. Patients report that they feel this procedure is a more natural means of disposition and provides them with the opportunity to grieve the loss of a potential child. However, some have argued that the procedure is an unnecessary, and illogical, addition to fertility treatment and that it detracts resources from medical care. Here, we introduce compassionate transfer as an alternative disposition option and argue that, for certain patients, it may constitute an ethical extension of fertility care that respects patient autonomy and psychosocial health.

Preimplantation genetic testing for more than one genetic condition: clinical and ethical considerations and dilemmas.

STUDY QUESTION: Which clinical and ethical aspects of preimplantation genetic testing for monogenic disorders or structural rearrangements (PGT-M, PGT-SR) should be considered when accepting requests and counselling couples for PGT when applied for more than one condition (combination-PGT; cPGT-M/SR)? SUMMARY ANSWER: cPGT is a feasible extension of the practice of PGT-M/SR that may require adapting the criteria many countries have in place with regard to indications-setting for PGT-M/SR, while leading to complex choices that require timely counselling and information. WHAT IS KNOWN ALREADY: Although PGT-M/SR is usually performed to prevent transmission of one disorder, requests for PGT-M/SR for more than one condition (cPGT-M/SR) are becoming less exceptional. However, knowledge about implications for a responsible application of such treatments is lacking. STUDY DESIGN, SIZE, DURATION: Retrospective review of all (40) PGT-M/SR applications concerning more than one genetic condition over the period 1995-2018 in the files of the Dutch national PGT centre. This comprises all relevant national data since the start of PGT in the Netherlands. PARTICIPANTS/MATERIALS, SETTING AND METHODS: Data regarding cPGT-M/SR cases were collected by means of reviewing medical files of couples applying for cPGT-M/SR. Ethical challenges arising with cPGT-M/SR were explored against the background of PGT-M/SR regulations in several European countries, as well as of relevant ESHRE-guidance regarding both indications-setting and transfer-decisions. MAIN RESULTS AND THE ROLE OF CHANCE: We report 40 couples applying for cPGT-M/SR of which 16 couples started their IVF treatment. Together they underwent 39 IVF cycles leading to the birth of five healthy children. Of the couples applying for cPGT, 45% differentiated between a primary and secondary condition in terms of perceived severity. In the light of an altered balance of benefits and drawbacks, we argue the 'high risk of a serious condition' standard that many countries uphold as governing indications-setting, should be lowered for secondary conditions in couples who already have an indication for PGT-M/SR. As a consequence of cPGT, professionals will more often be confronted with requests for transferring embryos known to be affected with a condition that they were tested for. In line with ESHRE guidance, such transfers may well be acceptable, on the condition of avoiding a high risk of a child with a seriously diminished quality of life. LIMITATIONS, REASONS FOR CAUTION: We are the first to give an overview of cPGT-M/SR treatments. Retrospective analysis was performed using national data, possibly not reflecting current trends worldwide. WIDER IMPLICATIONS OF THE FINDINGS: Our observations have led to recommendations for cPGT-M/SR that may add to centre policy making and to the formulation of professional guidelines. Given that the introduction of generic methods for genomic analysis in PGT will regularly yield incidental findings leading to transfer requests with these same challenges, the importance of our discussion exceeds the present discussion of cPGT. STUDY FUNDING/COMPETING INTEREST(S): The research for this publication was funded by the Dutch Organization for Health Research and Development (ZonMw), project number: 141111002 (Long term safety, quality and ethics of Preimplantation Genetic Diagnosis). None of the authors has any competing interests to declare.

Is it ethical to provide IVF add-ons when there is no evidence of a benefit if the patient requests it?

In vitro fertilisation (IVF) 'add-ons' are therapeutic or diagnostic tools developed in an endeavour to improve the success rate of infertility treatment. However, there is no conclusive evidence that these interventions are a beneficial or effective adjunct of assisted reproductive technologies. Additionally, IVF add-ons are often implemented in clinical practice before their safety can be thoroughly ascertained. Yet, patients continue to request and pay large sums for such additional IVF tools. Hence, this essay set out to examine if it is ethical to provide IVF add-ons when there is no evidence of a benefit if the patient requests it. In order to determine what is ethical-namely, morally good and righteous, the question was considered in relation to three key values of medical ethics-autonomy, beneficence and non-maleficence. It was determined that providing IVF add-ons might be morally acceptable in specific circumstances, if true informed consent can be given, there is a potential of cost-effective physiological or psychological benefit and the risk of harm is minimal, particularly with regard to the unborn child.

Embryo donation or embryo adoption? Conceptual and normative issues.

A central question in the ethical debate on the practice of relinquishing in vitro fertilization surplus embryos for family building is whether we ought to think of it more in terms of donating these embryos or in terms of having them adopted. Deciding between these two alternatives is more than a matter of mere terminology. It has an impact on normative questions, e.g., on the question of what criteria for parent selection ought to be applied to the recipients of the embryos, and on the moral evaluation of the act of 'donating' the embryo or 'having it adopted'. In this article, I defend the view that we should conceptualize the relinquishment of spare embryos according to the adoption model, not as a donation. Section 2 sketches the outline of the argument by making clear how we may ground a defense of the adoption model in a theory of parental responsibility without implicitly elevating the moral status of the embryo. Section 3 contains a preliminary defense of the adoption model that draws on geneticism as what seems to me the most persuasive theory of parental responsibility. In section 4, I examine three objections to geneticism and either rebut them or, insofar as they are justified, try to accommodate them into my view. In section 5, I point out some features that distinguish embryo adoption from the adoption of (born) children. I contend, however, that these differences are compatible with the adoption model. Section 6 is concerned with the normative ramifications of this view.

Overcoming bioethical, legal, and hereditary barriers to mitochondrial replacement therapy in the USA.

The purpose of the paper is to explore novel means to overcome the controversial ban in the USA against mitochondrial replacement therapy, a form of IVF, with the added step of replacing a woman's diseased mutated mitochondria with a donor's healthy mitochondria to prevent debilitating and often fatal mitochondrial diseases. Long proven effective in non-human species, MRT recently performed in Mexico resulted in the birth of a healthy baby boy. We explore the ethics of the ban, the concerns over hereditability of mitochondrial disease and its mathematical basis, the overlooked role of Mitochondrial Eve, the financial burden of mitochondrial diseases for taxpayers, and a woman's reproductive rights. We examine applicable court cases, particularly protection of autonomy within the reproductive rights assured by Roe v Wade. We examine the consequences of misinterpreting MRT as genetic engineering in the congressional funding prohibitions causing the MRT ban by the FDA. Allowing MRT to take place in the USA would ensure a high standard of reproductive medicine and safety for afflicted women wishing to have genetically related children, concurrently alleviating the significant financial burden of mitochondrial diseases on its taxpayers. Since MRT does not modify any genome, it falls outside the "heritable genetic modification" terminology of concern to Congress and the FDA. Correcting this terminology, the IOM's conclusion that MRT is ethical, the continuing normalcy of the first MRT recipient, and increasing public awareness of the promising benefits might be all that is required to modify the FDA's position on MRT.

Irresponsibly Infertile? Obesity, Efficiency, and Exclusion from Treatment.

Many countries tightly ration access to publicly funded fertility treatments such as in vitro fertilisation (IVF). One basis for excluding people from access to IVF is their body mass index. In this paper, I consider a number of potential justifications for such a policy, based on claims about effectiveness and cost-efficiency, and reject these as unsupported by available evidence. I consider an alternative justification: that those whose subfertility results from avoidable behaviours for which they are responsible are less deserving of treatment. I ultimately stop short of endorsing or rejecting such a justification, though highlight some reasons for thinking it is unlikely to be practicable.

In Vitro Gametogenesis and the Creation of 'Designer Babies'.

Research into the development of stem cell-derived (SCD) gametes in humans, otherwise known as in vitro gametogenesis (IVG), is largely motivated by reproductive aims. Especially, the goal of establishing genetic parenthood by means of SCD-gametes is considered an important aim. However, like other applications in the field of assisted reproduction, this technology evokes worries about the possibility of creating so-called 'designer babies.' In this paper, we investigate various ways in which SCD-gametes could be used to create such preference-matched offspring, and what this would mean for the acceptability of IVG, if it is premised that it is morally problematic to 'design' offspring. We argue that IVG might facilitate the creation of preference-matched offspring, but conclude that this should not undermine the moral acceptability of IVG altogether-even if one concedes the premise that creating 'designer babies' is morally problematic. In the light of this, we also point at a possible inconsistency for a position that condemns the creation of 'designer offspring,' while accepting the various endeavors to have genetically related offspring.

The American Democratic Deficit in Assisted Reproductive Technology Innovation.

In many areas of innovation, the United States is a leader, but this characterization does not apply to the United States' position in assisted reproductive technology innovation and clinical use. This article uses a political science concept, the idea of the "democratic deficit" to examine the lack of American public discourse on innovations in ART. In doing so, the article focuses on America's missing public consultation in health care innovation. This missing discourse is significant, as political and ethical considerations may impact regulatory decisions. Thus, to the extent that these considerations are influencing the decisions of federal agency employees, namely those who work within the U.S. Food and Drug Administration, the public is unable to participate in the decision-making process. This lack of a public discourse undermines the goals of the administrative state, which include democratic participation, transparency, and accountability. The United Kingdom, on the other hand, has had a markedly divergent experience with assisted reproductive technology innovation. Instead of ignoring the various ethical, social, and legal issues surrounding assisted reproductive technology innovation, the United Kingdom engaged in a five-strand public consultation on the topic of mitochondrial transfer, a form of assisted reproductive technology that uses genetic modification in order to prevent disease transmission. This article argues that after a multi-decade standstill in terms of the public discourse related to ethical issues associated with assisted reproductive technology and germline modification, it is time for the United States to institute a more democratic inquiry into the scientific, ethical, and social implications of new forms of assisted reproductive technology and ultimately, forthcoming medical innovations that involve genetic modification.

The Ethics of the Societal Entrenchment-approach and the case of live uterus transplantation-IVF.

In 2014, the first child in the world was born after live uterus transplantation and IVF (UTx-IVF). Before and after this event, ethical aspects of UTx-IVF have been discussed in the medical and bioethical debate as well as, with varying intensity, in Swedish media and political fora. This article examines what comes to be identified as important ethical problems and solutions in the media debate of UTx-IVF in Sweden, showing specifically how problems, target groups, goals, benefits, risks and stakes are delineated and positioned. It also demonstrates how specific assumptions, norms and values are expressed and used to underpin specific positions within this debate, and how certain subjects, desires and risks become shrouded or simply omitted from it. This approach-which we label the Ethics of the Societal Entrenchment-approach, inspired by Koch and Stemerding (1994)-allows us to discuss how the identification of something as the problem helps to shape what gets to be described as a solution, and how specific solutions provide frameworks within which problems can be stated and emphasised. We also offer a critical discussion of whether some of these articulations and formations should be seen as ethically troubling, and if so, why.

Does egg donation for mitochondrial replacement techniques generate parental responsibilities?

Children created through mitochondrial replacement techniques (MRTs) are commonly presented as possessing 50% of their mother's nuclear DNA, 50% of their father's nuclear DNA and the mitochondrial DNA of an egg donor. This lab-engineered genetic composition has prompted two questions: Do children who are the product of an MRT procedure have three genetic parents? And, do MRT egg donors have parental responsibilities for the children created? In this paper, I address the second question and in doing so I also address the first one. First, I present a brief account of mitochondrial diseases and MRTs. Second, I examine how MRTs affect the numerical identity of eggs and zygotes. Third, I investigate two genetic accounts of parenthood and MRT egg donation. Fourth, I explore three causal accounts of parenthood and MRT egg donation. My conclusion is that, under the appropriate circumstances, MRT egg donors are parentally responsible for the children created under genetic accounts of parenthood and under causal accounts of parenthood.

Challenges, Dilemmas and Factors Involved in PGD Decision-Making: Providers' and Patients' Views, Experiences and Decisions.

Providers and patients are considering and pursuing PGD for ever-more conditions, but questions arise concerning how they make, view and experience these decisions, and what challenges they may face. Thirty-seven in-depth semi-structured interviews were conducted (with 27 IVF providers and 10 patients). Patients and providers struggled with challenges and dilemmas about whether to pursue PGD in specific cases, and how to decide. Respondents varied in how they viewed, experienced and made these choices, and for which conditions to pursue PGD (from lethal, childhood-onset conditions to milder, treatable, or adult-onset disorders). Several factors were involved, including differences in gene penetrance, predictability, and phenotypic expression, and disease severity, age of onset, treatability, stigma and degree of disability. Providers and patients face questions regarding possibilities of screening for more than one condition in one set of embryos, and limitations of PGD (e.g., inaccurate results). Characteristics of providers (e.g., amount of PGD experience, understandings of genetics, and use of genetic counselors), and of patients (e.g., related to broader moral and social attitudes) can also affect these decisions. These data, the first to examine several key questions concerning PGD, suggest that providers and patients confront several dilemmas. These findings have critical implications for future practice, guidelines, education and research.

Ethical Issues in the Practice of Assisted Reproductive Technologies in Nigeria: Empirical Data from Fertility Practitioners.

The need to formulate practice guidelines and ethical framework to guide the practice of assisted conception in Nigeria has been highlighted severally. The Association for Fertility and Reproductive Health (AFRH) ethics committee is charged with the objective of producing ethical guidelines that would govern the practice of assisted conception in Nigeria. This study was a survey of attendees at the AFRH international conference that held in Abuja in September 2017. The aim of the study was to generate empirical data that would form the drafting of ethical practice guidelines in Nigeria. Ninety-seven (50%) of the respondents were of the view that performing IVF for unmarried couples was ethical while about 70 (36%) were of the contrary opinion. Respondents were equally divided (45.26% versus 44.21%) on the ethical standing of performing IVF for single ladies. About 128 (70.33%) of respondents agree that egg donors should be paid more in compensation besides reimbursement for personal expenditure incurred during the process of egg donation and that they should be an upper age limit for clients requesting ART with donor eggs. Several unethical practices ongoing in Nigeria were highlighted including inadequate provision of information and counselling and exploitation of egg donors. Majority agreed on the need for a regulatory framework to govern the practice of ART in Nigeria. The diverse range of views and ethical issues concerning ART practice in Nigeria obtained from this study demonstrates the need to recognise the local context in Nigeria when applying universal principles of ethics.

Defending eugenics : From cryptic choice to conscious selection.

For most of human history children have been a byproduct of sex rather than a conscious choice by parents to create people with traits that they care about. As our understanding of genetics advances along with our ability to control reproduction and manipulate genes, prospective parents have stronger moral reasons to consider how their choices are likely to affect their children, and how their children are likely to affect other people. With the advent of cheap and effective contraception, and the emergence of new technologies for in vitro fertilization, embryo selection, and genetic engineering, it is becoming increasingly difficult to justify rolling the genetic dice by having children without thinking about the traits they will have. It is time to face up to the awesome responsibilities that accompany our reproductive choices.