Mitochondrial donation or mitochondrial transfer enables a woman with mitochondrial disease to have a genetically related child without transmitting the disease to the child. The techniques used for mitochondrial donation or transfer which are maternal spindle transfer or pro-nuclei transfer, require three gametes to ultimately produce a healthy embryo. Both these techniques result in the child inheriting nuclear DNA from the intending parents and mitochondrial DNA from the female donor. Following the legalisation of (...) mitochondrial donation in the UK, after a rigorous process of scientific and ethical review, and the birth of another baby using the technique, coupled with the fact that there is no cure for mitochondrial disease, suggests that it is prudent for us to consider this reproductive intervention and its application in the South African setting. In addition, the 2019 UNESCO Report of the International Bioethics Committee (IBC) on assisted reproductive technologies (ART) and parenthood, encourages debate on changes in models of parenthood influenced by ART including the emergence of new models of families and forms of parenthood that extend beyond the classical rule of mater semper certa est (the mother is always known). ART, in particular mitochondrial donation, challenges this rule. The aim of this paper is to provide an outline of the legal and ethical positions of mitochondrial donation and resume the discussion with specific focus on the South African context. (shrink)

Recently, Australia became the second jurisdiction worldwide to legalize the use of mitochondrial donation technology. The Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 allows individuals with a family history of mitochondrial disease to access assisted reproductive techniques that prevent the inheritance of mitochondrial disease. Using inductive content analysis, we assessed submissions sent to the Senate Committee as part of a programme of scientific inquiry and public consultation that informed drafting of the Bill. These (...) submissions discussed a range of bioethical and legal considerations of central importance to the political debate. Significantly, submissions from those with a first-hand experience of mitochondrial disease, including clinicians and those with a family history of mitochondrial disease, were in strong support of this legislation. Those in support of the Bill commended the two-staged approach and rigorous licencing requirements as part of the Bill’s implementation strategy. Submissions which outlined arguments against the legislation either opposed the use of these techniques in general or opposed aspects of the implementation strategy in Australia. These findings offer a window into the ethical arguments and perspectives that matter most to those Australians who took part in the Senate inquiry into mitochondrial donation. The insights garnered from these submissions may be used to help refine policy and guidelines as the field progresses. (shrink)

The classification of techniques used in mitochondrial donation, including their role as purported germ-line gene therapies, is far from clear. These techniques exhibit characteristics typical of a variety of classifications that have been used in both scientific and bioethics scholarship. This raises two connected questions, which we address in this paper: how should we classify mitochondrial donation techniques?; and what ethical implications surround such a classification? First, we outline how methods of genetic intervention, such as (...) germ-line gene therapy, are typically defined or classified. We then consider whether techniques of mitochondrial donation fit into these, whether they might do so with some refinement of these categories, or whether they require some other approach to classification. To answer the second question, we discuss the relationship between classification and several key ethical issues arising from mitochondrial donation. We conclude that the properties characteristic of mitochondrial inheritance mean that most mitochondrial donation techniques belong to a new sub-class of genetic modification, which we call ‘conditionally inheritable genomic modification’. (shrink)

BackgroundBiobanking provides exciting opportunities for research on stored biospecimens. However, these opportunities to advance medical science are fraught with challenges including ethical and legal dilemmas. This study was undertaken to establish perspectives of South African stakeholders on the ethico-legal dimensions of biobanking.MethodsAn in-depth exploratory study was conducted with 25 purposively selected biobankers, clinicians, researchers, postgraduate students in biobanking research, and research ethics committee (REC) members in South Africa. Potential study participants were recruited through known hubs for biobanking (...) in the country, online searches and the snowball sampling technique. A semi-structured face-to-face or Skype interview was arranged. Data was analysed using thematic analysis.ResultsThe emergent themes included: inconsistency in understanding consent models, disconnect between biobank researchers and biosample donors, inadequate processes to support re-consenting minors, inconsistent governance processes for biobanking research; challenges with sample and data sharing, and suboptimal strategies for benefit sharing and return of results. Biobanking practice in general appeared to be inconsistent and fragmented. While the need for consent in research is explicitly outlined in legislative documents, some respondents were unclear on the type of consent model to apply in biosample collection. They also reported inconsistencies in research participants’ understanding of consent. Furthermore, these respondents’ own understanding of consent and consent models were dependent on where they were positioned in biobanking practice (roles occupied). Respondents were unsure about the process to follow to re-consent child participants once the age of majority (≥ 18 years) was reached. It was not surprising that consent was identified as one of the major ethical challenges in biobanking practice. In certain settings, some respondents reported suboptimal governance processes for sample collection. Participants were generally unsure about how to operationalise benefit sharing and how to approach the idea of returning results to research participants and biobank donors.ConclusionThe study findings indicated inconsistencies in stakeholder understanding of ethico-legal considerations related to biobanking in South Africa. A need for ongoing ethics capacity development among stakeholders was identified. Improving understanding of the ethics of biobanking could be facilitated by acknowledging the disconnect created by biosamples in the relationship between biobank researchers and donors. (shrink)

The development of any novel reproductive technology involving manipulation of human embryos is almost inevitably going to be controversial and evoke sincerely held, but diametrically opposing views. The plethora of scientific, ethical and legal issues that surround the clinical use of such techniques fuels this divergence of opinion. During the policy change that was required to allow the use of mitochondrial donation in the UK, many of these issues were intensely scrutinised by a variety of people and (...) in multiple contexts. This extensive process resulted in the publication of several reports that informed the recommendations made to government. We have been intrinsically involved in the development of mitochondrial donation, from refining the basic technique for use in human embryos through to clinical service delivery, and have taken the opportunity in this article to offer our own perspective on the issues it raises. (shrink)

Organ donation after a circulatory determination of death is possible in selected patients where consent is given to support donation and the patient has been legally declared dead by two doctors. The National Health Act (61 of 2003) and regulations provide strict controls for the certification of death and the donation of organs and tissues after death. Although the National Health Act expressly recognises that brain death is death, it does not prescribe the medical standards of testing (...) for the determination of brain death (neurological determination of death), circulatory death (circulatory determination of death) or for determination of death based on somatic criteria. However, in all cases of organ donation, including after circulatory death, the National Health Act mandates that two doctors certify the death, with one doctor possessing more than 5 years of experience. Additionally, both doctors must be independent from the transplant team. The standard for such determination, as for brain death, aligns with accepted medical standards. The Critical Care Society of Southern Africa has published South African (SA) Guidelines on Death Determination that outline rigorous standards for death determination in hospital settings by either a neurological or circulatory method. Legislation and the Health Professions Council of SA’s (HPCSA) professional guidance direct clinicians on obtaining informed consent for donation either from the patient or in cases of incapacity from their surrogate decision maker. Collectively, the legislation, regulations and professional guidelines in SA provide a robust ethical framework that supports organ donation after circulatory death. (shrink)

In Islam, one of the core beliefs is in the life of the hereafter. At the end of time and all that exists, all human beings will be resurrected and will face the Day of Judgment. Even their body parts or organs will stand witness against them. Furthermore, in Islamic law, every action or thing is categorized either as legitimate or prohibited. This article explores ethico‐legal opinions on the issues of organ donation and transplantation in the light (...) of these essential Islamic beliefs. (shrink)

Organ donation after cardiac or circulatory death (DCD) has been introduced to increase the supply of transplantable organs. In this paper, we argue that the recovery of viable organs useful for transplantation in DCD is not compatible with the dead donor rule and we explain the consequential ethical and legal ramifications. We also outline serious deficiencies in the current consent process for DCD with respect to disclosure of necessary elements for voluntary informed decision making and respect for (...) the donor's autonomy. We compare two alternative proposals for increasing organ donation consent in society: presumed consent and mandated choice. We conclude that proceeding with the recovery of transplantable organs from decedents requires a paradigm change in the ethics of organ donation. The paradigm change to ensure the legitimacy of DCD practice must include: (1) societal agreement on abandonment of the dead donor rule, (2) legislative revisions reflecting abandonment of the dead donor rule, and (3) requirement of mandated choice to facilitate individual participation in organ donation and to ensure that decisions to participate are made in compliance with the societal values of respect for autonomy and self-determination. (shrink)

This chapter gives a brief overview of the composition of the volume and explains why it is important to undertake a detailed scholarly analysis and comparison of the following ethico-legal regimes of surrogacy and egg donation: the permissive-unregulated but transitory regime of India; the permissive regime of Israel, although highly regulated by professional, medical and religious norms, and the extremely restrictive regime of Germany, being legally permeable for particular forms of cross-border reproductive practice despite the non-permissive national (...) law. It uses an interdisciplinary lens to examine how the ethical, social, legal and cultural issues are interwoven in each regime. Moreover, we highlight the importance of a comparative analysis to understand how local developments cannot be isolated from each other, but deeply influence each other through transnational markets, modern media and the transfer of knowledge, people and body parts. (shrink)

Artificial womb technology for extracorporeal gestation of human offspring (ectogenesis or ectogestation) has profound ethical, sociological and religious implications for Muslim communities. In this article we examine the usage of the technology through the lens of Islamic ethico-legal frameworks specifically the legal maxims (al-Qawaid al-Fiqhiyyah) and higher objectives of Islamic law (Maqaṣid al-Shariah). Our analysis suggests that its application may be contingently permissible (halal) in situations of dire need such as sustaining life and development of extremely premature (...) newborns, for advancing fetal medicine and avoiding maternal co-morbidities during fetal treatment, and for enabling motherhood for women without functional wombs, or who face grave medical risks in pregnancy. However, its application may be proscribed (haram) for enabling healthy women to avoid pregnancy and childbirth, or to achieve parenthood equity. Specification of these views to particular policy, legal contexts and Fatwa will require multidisciplinary Shariah-based bioethical deliberations between jurists, policymakers, and scientists. (shrink)

This paper examines the ethico-legal problems regarding the right to refuse treatment in Turkey's healthcare system. We discuss these problems in the light of a recent case that was directly reported to us. We first summarise the experience of a chronically dependent patient (as recounted by her daughter) and her family during their efforts to refuse treatment and receive palliative care only. This is followed by a summary of the legal framework governing the limits of the right (...) to refuse treatment in Turkey. With the help of this background information on the legal framework, we re-examine the ethico-legal aspects of the case and explain the underlying reasons for the problems the family and the patient experienced. Finally, we conclude that Turkey's legal framework relating to the right to refuse treatment needs to be clarified and amended in accordance with international conventions and fundamental human rights. (shrink)

Legal prohibitions on the financial compensation of donors are frequently justified by appealing either to concerns about patient safety or to concerns about the putatively unethical nature of such compensation. But jurisdictions that legally prohibit the financial compensation of donors routinely import plasma that has been collected from financially compensated donors—and they do so knowing its origins. I outline some possible ways in which this puzzle could be resolved and find them all wanting. Focusing on Canada I draw (...) upon public documents to explain how many provinces came to have its apparently puzzling approach to plasma procurement. I then argue that the actions of those who support this approach to plasma procurement are immoral. (shrink)

Reproductive biotechnologies can separate concepts of parenthood into genetic, gestational and social dimensions, often leading to a fragmentation of heteronormative kinship models and posing a challenge to historical methods of establishing legal and/or moral parenthood. Using fictional cases, this article will demonstrate that the issues surrounding the intersection of current and emerging reproductive biotechnologies with definitions of parenthood are already leading to confusion regarding social and legal family ties for offspring, which is only expected to increase as new (...) technologies develop. Rather than opposing these new technologies to reassert traditional concepts of the family, however, this article will explore the opportunities that these technologies represent for re‐imagining various culturally cherished values of family‐making in a way that is inclusive of diverse genders, sexualities and cultures. It will consider IVF, gametogenesis, mitochondrial donation, surrogacy, artificial gestation, CRISPR‐Cas9 gene editing, foster care and adoption as some of many possible pathways to parenthood, including for members of the LGBTIAUQ+ community. (shrink)

The UK-based deliberations that led up to the legalisation of two new ‘mitochondrial donation’ techniques in 2015, and which continued after that time as regulatory details were determined, featured a division of advisory labour that is common when decisions are made about new technologies. An expert panel was convened by the Human Fertilisation and Embryology Authority, charged with assessing the scientific and technical aspects of these techniques. Meanwhile, the Nuffield Council on Bioethics addressed the ethical issues. While this (...) division of labour was undertaken in the name of thoroughness, I argue here that it can have the unintended consequence that hybrid questions that simultaneously involve ethical and technical aspects—especially questions about where to set evidential thresholds for the acceptance of new technology—do not receive enough attention. (shrink)

The UK-based deliberations that led up to the legalisation of two new ‘mitochondrial donation’ techniques in 2015, and which continued after that time as regulatory details were determined, featured a division of advisory labour that is common when decisions are made about new technologies. An expert panel was convened by the Human Fertilisation and Embryology Authority (HFEA), charged with assessing the scientific and technical aspects of these techniques. Meanwhile, the Nuffield Council on Bioethics addressed the ethical issues. While (...) this division of labour was undertaken in the name of thoroughness, I argue here that it can have the unintended consequence that hybrid questions that simultaneously involve ethical and technical aspects—especially questions about where to set evidential thresholds for the acceptance of new technology—do not receive enough attention. (shrink)

Abstract Background The first live birth following the use of a new reproductive technique, maternal spindle transfer (MST), which is a mitochondrial replacement technique (MRT), was accomplished by dividing the execution of the MST procedure between two countries, the USA and Mexico. This was done in order to avoid US legal restrictions on this technique. -/- Sources of data Academic articles, news articles, documents obtained through freedom of information requests, laws, regulations and national reports. -/- Areas of agreement (...) MRTs are new reproductive techniques that present novel ethical and legal challenges, since genetic material from three people is employed to create a child. -/- Areas of controversy Could the first MST procedure that culminated in a live birth negatively impact reproductive medicine in Mexico? -/- Growing points The USA and Mexico need specific and clear legislation on MRTs, in order for such techniques not to be governed by prior existing legislation on assisted reproduction that is inadequate for dealing with the new challenges that these techniques present. -/- Areas timely for developing research There is a pressing need for work to be done on the international governance of new reproductive techniques. (shrink)

This paper provides a justificatory rationale for recommending the inclusion of imagined future use cases in neurotechnology development processes, specifically for legal and policy ends. Including detailed imaginative engagement with future applications of neurotechnology can serve to connect ethical, legal, and policy issues potentially arising from the translation of brain stimulation research to the public consumer domain. Futurist scholars have for some time recommended approaches that merge creative arts with scientific development in order to theorise possible futures toward (...) which current trends in technology development might be steered. Taking a creative, imaginative approach like this in the neurotechnology context can help move development processes beyond considerations of device functioning, safety, and compliance with existing regulation, and into an active engagement with potential future dynamics brought about by the emergence of the neurotechnology itself. Imagined scenarios can engage with potential consumer uses of devices that might come to challenge legal or policy contexts. An anticipatory, creative approach can imagine what such uses might consist in, and what they might imply. Justifying this approach also prompts a co-responsibility perspective for policymaking in technology contexts. Overall, this furnishes a mode of neurotechnology’s emergence that can avoid crises of confidence in terms of ethico-legal issues, and promote policy responses balanced between knowledge, values, protected innovation potential, and regulatory safeguards. (shrink)

In 2015 the United Kingdom (UK) became the first nation to legalize egg and zygotic nuclear transfer procedures using mitochondrial replacement techniques (MRTs) to prevent the maternal transmission of serious mitochondrial DNA diseases to offspring. These techniques are a form of human germline genetic modification and can happen intentionally if female embryos are selected during the MRT clinical process, either through sperm selection or preimplantation genetic diagnosis (PGD). In the same year, an MRT was performed by a United (...) States (U.S.)-based physician team. This experiment involved a cross-border effort: the MRT procedure per se was carried out in the US, and the embryo transfer in Mexico. The authors examine the ethics of MRTs from the standpoint of genetic relatedness and gender implications, in places that lack adequate laws and regulation regarding assisted reproduction. Then, we briefly examine whether MRTs can be justified as a reproductive option in the US and Mexico, after reassessing their legalization in the UK. We contend that morally inadequate and ineffective regulations regarding egg donation, PGD, and germline genetic modifications jeopardize the ethical acceptability of the implementation of MRTs, suggesting that MRTs are currently difficult to justify in the US and Mexico. In addition to relevant regulation, the initiation and appropriate use of MRTs in a country require a child-centered follow-up policy and more evidence for its safety. (shrink)

Currently in the United Kingdom, anyone donating gametes has the status of an open-identity donor. This means that, at the age of 18, persons conceived with gametes donated since April 1, 2005 have a right to access certain pieces of identifying information about their donor. However, in early 2015, the UK Parliament approved new regulations that make mitochondrial donors anonymous. Both mitochondrial donation and gamete donation are similar in the basic sense that they involve the contribution (...) of gamete materials to create future persons. Given this similarity, this paper presumes that both types of donor should be treated the same and made open-identity under the law, unless there is a convincing argument for treating them differently. I argue that none of the existing arguments that have been made so far in favor of mitochondrial donor anonymity are convincing and mitochondrial donors should therefore be treated as open-identity donors under UK law. (shrink)

BackgroundThe nursing profession requires ethical and legal regulations to guide nurses’ performance. Ethical climate plays a part in shaping nurses’ ethical practice. Therefore, ethico-legal aspects and ethical climate contribute to improving nurses’ ethical practice and competencies with reducing medical errors in hospital settings.ObjectiveThis study examined the effect of ethico-legal aspects and ethical climate on managing safe patient care and medical errors among nurses.Materials and methodsA cross-sectional correlational study was carried out on 548 nurses. Data were (...) collected through self-administered questionnaires about nurses’ knowledge in both ethical and legal aspects, ethical practice, competencies, ethical climate and experience with medical error.ResultsThe main sources of nurses’ knowledge of ethical and legal aspects were undergraduate lectures, job experience and colleagues. Nurses’ knowledge in both ethical and legal aspects, nurses’ ethical practice and competencies were insufficient. Nurses fairly perceived their ethical climate. Also, nurses experienced medical errors about 22.6% in their units. Nurses’ knowledge of ethical and legal aspects, as well as the ethical climate were positive predictors of inadequate nurses’ ethical practice and competencies. Additionally, nurses’ knowledge in both ethical and legal aspects, ethical climate and practice had a negative influence on the occurrence of medical errors.ConclusionEnhancing nurses’ knowledge in both ethical and legal aspects as well as ethical climate could significantly influence improving nurses’ ethical practice, competencies and reducing medical errors in the study units. Therefore, planning for enhancing the nurses’ ethico-legal learning and ethical climate seems to be mandatory. (shrink)

In 2015 the UK became the first country in the world to legalise mitochondrial donation, a controversial germ line reproductive technology to prevent the transmission of mitochondrial disease. Dimond and Stephens track the intense period of scientific and ethical review, public consultation and parliamentary debates preceeding the decision. They draw on stakeholder accounts and public documents to explore how patients, professionals, institutions and publics mobilised within ‘for’ and ‘against’ clusters, engaging in extensive promissory, emotional, bureaucratic, ethical, embodied (...) and clinical labour to justify competing visions of an ethical future. They describe how this decision is the latest iteration of a UK sociotechnical imaginary in which the further liberalization of human embryo research and use is rendered legitimate and ethical through modes of consultation and permissive but strictly regulated licensing. Overall, this book presents a timely, multi-dimensional, and sociological account of a globally significant landmark in the history of human genetics, and will be relevant to those with an interest in genetics, Science, Technology and Society, the sociology of medicine, reproductive technology, and public policy debate. (shrink)

We respond to Morgan and Feeley’s critique on our article “Mass Media in Organ Donation: Managing Conflicting Messages and Interests.” We noted that Morgan and Feeley agree with the position that the primary aims of media campaigns are: “to educate the general public about organ donation process” and “help individuals make informed decisions” about organ donation. For those reasons, the educational messages in media campaigns should not be restricted to “information from pilot work or focus groups” but (...) should include evidence-based facts resulting from a comprehensive literature research. We consider the controversial aspects about organ donation to be relevant, if not necessary, educational materials that must be disclosed in media campaigns to comply with the legal and moral requirements of informed consent. With that perspective in mind, we address the validity of Morgan and Feeley’s claim that media campaigns have no need for informing the public about the controversial nature of death determination in organ donation. Scientific evidence has proven that the criteria for death determination are inconsistent with the Uniform Determination of Death Act and therefore potentially harmful to donors. The decision by campaign designers to use the statutory definition of death without disclosing the current controversies surrounding that definition does not contribute to improved informed decision making. We argue that if Morgan and Feeley accept the important role of media campaigns to enhance informed decision making, then critical controversies should be disclosed. In support of that premise, we will outline: (1) the wide-spread scientific challenges to brain death as a concept of death; (2) the influence of the donor registry and team-huddling on the medical care of potential donors; (3) the use of authorization rather than informed consent for donor registration; (4) the contemporary religious controversy; and (5) the effects of training desk clerks as organ requestors at the Department of Motor Vehicles offices. We conclude that organ donation is a medical procedure subject to all the ethical obligations that the medical profession must uphold including that of transparency and truthfulness. (shrink)

Many if not most sperm donors in the early years of IVF donated under conditions of anonymity. There is, however, a growing awareness of the ethical cost of withholding identifying parental information from donor children. Today, anonymous donation is illegal in many jurisdictions, and some jurisdictions have gone as far as retrospectively invalidating contracts whereby donors were guaranteed anonymity. This article provides a critical evaluation of the ethics and legality of anonymous donation. We defend Australian and British legislation (...) that has outlawed donor anonymity, and we argue for the establishment of a central registry that provides donor children with the ability to easily and reliably access identifying information about their donor parents. (shrink)

Given the dramatic shortage of transplantable organs, demand cannot be met by established and envisioned organ procurement policies targeting postmortem donation. Live organ donation is a medically attractive option, and ethically permissible if informed consent is given and donor beneficence balances recipient non-maleficence. Only a few legal and regulatory frameworks incentivise LOD, with the key exception of Israel’s Organ Transplant Law, which has produced significant improvements in organ donation rates. Therefore, I propose an organ procurement system (...) that incentivises LOD by allocating additional priority points to the living donor on any transplant waiting list. I outline benefits and challenges for potential recipients, donors and society at large, and suggest measures to ensure medical protection of marginalised patient groups. (shrink)

The existing ethico-legal regulation of adolescent children's participation in health research in South Africa is currently unclear. The article interrogates the existing framework governing children's consent to research participation, with specific emphasis on discrepancies in consent norms in law and ethical guidelines. Against the backdrop of the constitutional directive that requires that a child's best interests are of paramount importance in every matter concerning the child, the article assesses whether sufficient consideration is given to children's evolving maturity and (...) capacities when consent to their participation in health research is sought. The article provides specific recommendations and proposes a legislative change to consent provisions in the National Health Act 61 of 2003 in order to address the existing lacunae and to align the framework with constitutional imperatives and international fundamental rights considerations. (shrink)

Over the last two decades, the ethical implications of patents for biological materials and processes have been the subject of spirited public debate between the many individuals and groups on which the patent system impacts. Whereas copyright, trade marks, and other species of Intellectual Property Rights (IPR) are widely acceptable, the patent system evokes criticism from many quarters, especially in relation to the legal protection of inventions in the Life Sciences. Some of these criticisms expressed by prestigious public organisations (...) are addressed here from the patent professional standpoint. (shrink)

In Religion within the Bounds of Bare Reason Kant speaks of an ethical state of nature and of an ethico-civil condition, with explicit reference to the juridical state of nature and the juridico-civil condition he discusses at length in his legal-political writings. Given that the Religion is the only work where Kant introduces a parallel between these concepts, one might think that this is only a loose analogy, serving a merely illustrative function. The paper provides a first (...) class='Hi'>outline of the similarities and the differences between the state of nature and the civil condition in Right and in ethics. The comparison points to a deeper, structural relation between the two pairs of concepts. By doing so, it makes room for developing a unitary conception of the state of nature and of the civil condition, which would underlie both the ethical and the juridical version. (shrink)

PrécisThe administration of Pre-Mortem Interventions (PMIs) to preserve the opportunity to donate, to assess the eligibility to donate, or to optimize the outcomes of donation and transplantation are controversial as they offer no direct medical benefit and include at least the possibility of harm to the still-living patient. In this article, we describe the legal analysis surrounding consent to PMIs, drawing on existing legal commentary and identifying key legal problems. We provide an overview of the approaches (...) in several jurisdictions that have chosen to explicitly address PMIs within codified law. We then provide, as an example, a detailed exploration of how PMIs are likely to be addressed in one jurisdiction where general medical consent law applies because there is no specific legislation addressing PMIs — the province of Ontario in Canada. (shrink)

Since the 1980s, Islamic scholars and medical experts have used the tools of Islamic law to formulate ethico-legal opinions on brain death. These assessments have varied in their determinations and remain controversial. Some juridical councils such as the Organization of Islamic Conferences' Islamic Fiqh Academy (OIC-IFA) equate brain death with cardiopulmonary death, while others such as the Islamic Organization of Medical Sciences (IOMS) analogize brain death to an intermediate state between life and death. Still other councils have repudiated (...) the notion entirely. Similarly, the ethico-legal assessments are not uniform in their acceptance of brain-stem or whole-brain criteria for death, and consequently their conceptualizations of, brain death. Within the medical literature, and in the statements of Muslim medical professional societies, brain death has been viewed as sanctioned by Islamic law with experts citing the aforementioned rulings. Furthermore, health policies around organ transplantation and end-of-life care within the Muslim world have been crafted with consideration of these representative religious determinations made by transnational, legally-inclusive, and multidisciplinary councils. The determinations of these councils also have bearing upon Muslim clinicians and patients who encounter the challenges of brain death at the bedside. For those searching for ‘Islamically-sanctioned’ responses that can inform their practice, both the OIC-IFA and IOMS verdicts have palpable gaps in their assessments and remain clinically ambiguous. In this paper we analyze these verdicts from the perspective of applied Islamic bioethics and raise several questions that, if answered by future juridical councils, will better meet the needs of clinicians and bioethicists. (shrink)

Jürgen Habermas is regarded as a central bioconservative commentator in the debate on the ethics of human prenatal genetic manipulations. While his main work on this topic, The Future of Human Nature, has been widely examined in regard to his position on prenatal genetic enhancement, his arguments regarding prenatal genetic therapeutic interventions have for the most part been overlooked. In this work I do two things. First, I present the three necessary conditions that Habermas establishes for a prenatal genetic manipulation (...) to be regarded as morally permissible. Second, I examine if mitochondrial replacement techniques meet these necessary conditions. I investigate, specifically, the moral permissibility of employing pronuclear transfer and maternal spindle transfer. I conclude that, according to a Habermasian perspective on prenatal genetic manipulation, maternal spindle transfer and pronuclear transfer are morally impermissible. Maternal spindle transfer is, in principle, morally permissible, but only when we have beforehand preselected a sperm and an egg for our reproductive purpose. These findings are relevant for bioconservatives, both for those who hold a Habermasian stance and for those who hold something akin to a Habermasian stance, because they answer the question: what should bioconservatives do regarding mitochondrial replacement techniques? In fact, the answer to this question does not only normatively prescribe what bioconservatives should do in terms of their personal morality, but it also points towards what kind of legislation regulating mitochondrial replacement techniques they should aim at. (shrink)

Although the concept of biobanking is not new, the open and evolving nature of biobanks has created profound ethical, legal, and social implications, including issues around informed consent, community engagement, secondary uses of materials over time, ownership of materials, data sharing, and privacy. Complexities also emerge because of increasing international collaborations and differing national positions. In addition, the degrees and topics of concern vary as legislative, ethical, and social frameworks differ across developed and developing countries. Implementing national laws in (...) an internationally consistent manner is also problematic. However, these concerns should not cause countries, especially developing countries, to lag behind as this novel wave of research gains momentum, particularly while several biobank initiatives are already underway in the developing world. As the law has always struggled to keep up with the fast-evolving scientific arena, this article seeks to identify the ethico-legal frameworks in place in the United Kingdom, Australia, Uganda, and South Africa, for human biobank research, in an attempt to compare and contextualize the approaches to human biobanking in specific developed and developing countries. (shrink)

In 2017 and 2019, two research teams claimed ‘proof of principle’ for artificial womb technology (AWT). AWT has long been a subject of speculation in bioethical literature, with broad consensus that it is a welcome development. Despite this, little attention is afforded to more immediate ethical problems in the development of AWT, particularly as an alternative to neonatal intensive care. To start this conversation, I consider whether experimental AWT is innovative treatment or medical research. The research–treatment distinction, pervasive in regulation (...) worldwide, is intended to isolate research activities and subject them to a greater degree of oversight. I argue that there is a tendency in the literature to conceptualize AWT for partial ectogenesis as innovative treatment. However, there are sufficiently serious ethical concerns with experimental AWT that mean that it must not be first used on humans on the basis that it is a ‘beneficial treatment’. First, I outline the prospects for translation of AWT animal studies into treatment for human preterms. Second, I challenge the conceptualizations of experimental AWT as innovative treatment. It must be considered medical research to reflect the investigatory nature of the process and guarantee sufficient protections for subjects. Identifying that AWT is research is crucial in formulating further ethico‐legal questions regarding the experimental use of AWT. Third, I demonstrate that clinical trials will be a necessary part of the clinical translation of AWT because of requirements laid out by regulators. I consider the justification for clinical trials and highlight some of the crucial ethical questions about the conditions under which they should proceed. (shrink)

Nearly a million Indian women lack access to safe and dignified abortion services from public healthcare facilities and instead opt to induce abortions by themselves or with the help from unskilled and unauthorized practitioners. Unsafe abortions account for an estimated 9% of all maternal deaths in India despite the legalization of abortion on all grounds since 1971 via the MTP Act. However, the Act technically does not make any provision for abortion based on a woman’s request alone, subjecting her decision (...) to the approval of her healthcare provider, limiting reproductive autonomy. Moreover, the problem of female feticide through sex‐selective abortions has also contributed to a conflicting public agenda that prioritizes preventing the former over allowing women access to abortion services for other reasons. Women who are socio‐economically, culturally, and educationally vulnerable and minors may experience further abortion related stigmatization. These ethico‐legal considerations highlight the need for transition from a provider‐centered to a woman‐centered abortion service model. (shrink)

A large body of literature considers the ethico-legal and regulatory issues surrounding assisted conception. Surrogacy, however, within this body of literature is an odd-fit. It involves a unique demand of another person—a form of reproductive labour—that many other aspects of assisted conception, such as gamete donation do not involve. Surrogacy is a form of assisted gestation. The potential alternatives for individuals who want a genetically related child but who do not have the capacity to gestate are ever (...) increasing: with the advent of uterus transplantation, and the anticipated development of artificial placentas.In this paper, I highlight the pertinent conceptual differences between technologies assisting conception and those assisting gestation to demonstrate that distinct issues arise when assisted gestative technologies are used. I argue that there is utility in considering AGTs as a genus of technologies. These technologies perform the same function from the perspective of putative parents and might exist on a spectrum of alternatives when they become more available. Moreover, since many of the same or very similar ethical, social and legal issues are raised by surrogacy, UTx and ectogestation, analysis of these issues will be better contextualised by considering these technologies together. Many of the matters currently being highlighted for reform in the context of surrogacy will inevitably impact on how other forms of assisted gestation are governed. The conversation should be broadened; we should consider how far other emerging technologies might be accommodated in revised regulatory schemes. (shrink)

Autopoiesis and systems theory are terms often treated as synonymous by lawyers. This sleight‐of‐phrase elides the space between autopoiesis and systems theory, removing its content. Within this eliminated space there exist numerous understandings of systems approaches in law; one such understanding is complexity theory. Complexity theory entails a very different systems view of law to that of autopoiesis. In this paperIexplore the concepts of complexity and their relevance to law. In tracing an outline of complexity, a number of contradictions, (...) paradoxes, and additional questions are exposed which require further detailed analysis in the future. (shrink)

After having accomplished an observation of the different problematic that affect the daily life of our city, as reflect of what happens in the rest of the national territory, we have been attracted to implement a juridical analysis to the situation of the donation and organ transplantation in the legal ambit of our country, with the objective to identify the level of efficacy and the normative scope with respect to the situation of people who need a transplant. This (...) restlessness born from the analysis of the law 1716 and its regulation, which ambiguously delimits the functions of the centers of health in what respect to this topic, also to establish the creation of a waiting list and a record, tool which objective would be norm the permanent supply of organs through donation programs. These do not accomplish their objective or being attached to a public policy in the ambit that allow the continuity of the institutions and benefit of the people in need. (shrink)

There is a substantial shortage of organs available for transplantation in Bangladesh. This has resulted in the commodification of organs. This study analyzes the religious, cultural, and legal barriers to organ donation in Bangladesh. It is based on the examination of available literature and primary sources i.e. religious decrees and opinions of religious leaders of faith traditions, and the Bangladesh Organ Donation Act, 1999. The literature was retrieved from databases, such as PubMed, BioMed, and Google Scholar using (...) the key words: organ donation in Islam, organ donation in Bangladesh, organ donation and religions. The study found that although many Islamic scholars accept organ donation, both living and cadaveric, under some conditions, some Bangladeshi Muslim clerics oppose donation. They argue that organ retrieval violates the sanctity of the human body and retrieval of organs may harm a living donor or lead to death, and organ donation may encourage the commercialization of body parts. Both commercialization and harming oneself are considered sins. Thus, the divergent views of Muslim clerics are a major barrier to organ donation among the Bangladeshi Muslims. Cultural and social factors also have a negative impact. Most people desire to be buried with their bodies intact. Although the Bangladesh government promulgated the Bangladesh Organ Donation Act, 1999, and amended it in 2018, it restricted donors and recipients to members of the extended family, which also reduced the donor pool. This study argues that the Muslim Orthodox clerics’ stand against organ donation and other cultural and legal issues are the major obstacles to organ donation in Bangladesh. (shrink)

Health care decision making for patients without decisional capacity is ethically and legally challenging. Advance directives (living wills) have proved to be of limited usefulness in clinical practice. Therefore, academic attention should focus more on substitute decision making by the next of kin. In this article, we comparatively analyse the legal approaches to substitute medical decision making in England and Germany. Based on the current ethico-legal discourse in both countries, three aspects of substitute decision making will be (...) highlighted: (1) Should there be a legally predefined order of relatives who serve as health care proxies? (2) What should be the respective roles and decisional powers of patient-appointed versus court-appointed substitute decision-makers? (3) Which criteria should be determined by law to guide substitute decision-makers? (shrink)

There is burgeoning interest in the field of “Islamic” bioethics within public and professional circles, and both healthcare practitioners and academic scholars deploy their respective expertise in attempts to cohere a discipline of inquiry that addresses the needs of contemporary bioethics stakeholders while using resources from within the Islamic ethico-legal tradition. This manuscript serves as an introduction to the present thematic issue dedicated to Islamic bioethics. Using the collection of papers as a guide the paper outlines several critical (...) questions that a comprehensive and cohesive Islamic bioethical theory must address: (i) What are the relationships between Islamic law (Sharīʿah), moral theology (uṣūl al-Fiqh), and Islamic bioethics? (ii) What is the relationship between an Islamic bioethics and the lived experiences of Muslims? and (iii) What is the relationship between Islamic bioethics and the state? This manuscript, and the papers in this special collection, provides insight into how Islamic bioethicists and Muslim communities are addressing some of these questions, and aims to spur further dialogue around these overaching questions as Islamic bioethics coalesces into a true field of scholarly and practical inquiry. (shrink)

As rational adults, we are free to elect what is (or is not) done to our bodies. However, this strong freedom does not extend to the borders of life. Control over the uses of our biological material is constrained and uncertain at law. Our article examines the legal condition of embryos and organs: how law conceptualises them and regulates their uses.

The “dead-donor rule” states that, in any case of vital organ donation, the potential donor should be determined to be dead before transplantation occurs. In many countries around the world, neurological criteria can be used to legally determine death (also referred to as brain death). Nevertheless, there is considerable controversy in the bioethics literature over whether brain death is the equivalent of biological death. This international legal review demonstrates that there is considerable variability in how different jurisdictions have (...) evolved to justify the legal status of brain death and its relationship to the dead-donor rule.In this article, we chose to review approaches that are representative of many different jurisdictions—the United States takes an approach similar to that of many European countries; the United Kingdom’s approach is followed by Canada, India, and influences many other Commonwealth countries; Islamic jurisprudence is applicable to several different national laws; the Israeli approach is similar to many Western countries, but incorporates noteworthy modifications; and Japan’s relatively idiosyncratic approach has received some attention in the literature. Illuminating these different justifications may help develop respectful policies regarding organ donation within countries with diverse populations and allow for more informed debate about brain death and the deaddonor rule. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:152 BOOK REVIEWS with Weinrih's theory of formalism which Joseph Raz points out in his essay. One of the most serious of these deficiencies in my opinion is the role that is accorded to the judiciary. Weinrih's theory, as Raz shows, requires that when positive law is in conflict with the " form of law," positive law should he disregarded by the courts, and the courts in these cases (...) not only have the legal right to disregard the statutes of law hut even the moral duty to do so. To give such total discretionary power to the courts is certainly to offer an invitation impossible to re· sist, as the recent judicial history of the United States Supreme Court clearly shows, to autocratic and politically motivated judicial activism. The above remarks, inadequate as they are because of the constraints of space, may offer some indication of the rich diversity of natural law theories currently offering themselves for our consideration. Those interested in natural law theory either within the framework of moral theory, or legal theory, or both, will surely find that a careful reading of this volume will amply reward their efforts. St. John's University Jamaica, New York THOMAS A. FAY Metaphysics: An Outline of the History of Being. By MIECZYSLAW ALBERT KRAPIEC, O.P., translated by Theresa Sandok. New York: Peter Lang, 1991. Pp. 539. $69.95 (cloth). This volume is the second in Lang's Catholic Thought from Lublin series edited by Andrew Woznicki. Krapiec's work is a tour de force of Gilsonian Thomism as it founds metaphyscis upon a judgmental grasp of the act of existence in sensible things. The hook is unrelentingly Krapiec. Though there are abundant historical descriptions, there is a minimum of textual citation. Also, the reader can plainly see that Krapiec is intent upon presenting his understanding of metaphysics ad mentem Thomae. Three main parts comprise the hook. Part One is on the object of metaphysics-being as being (as existing). Part One contains the most crucial pages of the hook, viz., pp. 86-100. There Krapiec explains the attainment of this object. This portion is obviously the heart of the hook, and I will treat it in detail later. Part One also includes a lengthy exposition of the transcendentals. Part Two focuses on the structure of being and elaborates the following : act and potency, substance and accidents, matter and form, essence and existence, and the causes of being. There are two noteworthy points here. First, Krapiec's lengthy inclusion (pp. 313-374) of BOOK REVIEWS 153 matter and form within his metaphysics seems to have metaphysics swallowing up natural philosophy. One's misgivings are not assuaged by Krapiec's presentation of the division of the speculative sciences hack in his General Introduction. There the first degree of abstraction is no longer the home of natural philosophy hut the home of the modern humanistic and natural sciences (p. 28). The second degree harbors mathematics, while the third degree is home not only to metaphysics hut "philosophy" (pp. 28-9). The reader is left wondering what has happened to natural philosophy. I see no exigency' for Krapiec's metaphysics to eclipse natural philosophy. Moreover, for some Thomists, the move will create an unfortunate distraction from the good points of Krapiec's metaphysics. Second, by this reader's count, Krapiec presents no less than nine arguments for the real distinction between essence and existence. These arguments include the following: Aquinas's De Ente et Essentia argument that one can know what a phoenix is without knowing that one exists; the necessary character of existence as an essence vs. contingent realities; the monism of existence as an essence vs. the plurality of beings ; the infinity of existence as an essence vs. finite realities; and the reality of the potency/act distinction applied to essence-as·potency and existence-as-act. I cannot engage this involved topic in the short space of a review. I will say, however, that with Joseph Owens, I fail to see why a conceptual distinction between essence and existence is insufficient to deal with the above facts and problems. Underwriting my skepticism is the understanding that meanings can remain... (shrink)