In the democracies of DNA: ontological uncertainty and political order in three states

This paper compares the regulation of biotechnology in Britain, Germany and the United States and shows that systematic differences have developed around four issues: abortion, assisted reproduction, stem cells, and genetically modified crops and foods. Policy choices with respect to these issues reflect the capacity of each nation's regulatory institutions to deal with the scientific, social and ethical uncertainties around biotechnology. National regulatory frameworks constitute an apparatus of collective sense-making through which governments and publics interpret biotechnology's risks and promises. Specifically, regulatory choices position the novel ontologies created by biotechnology either on the side of the familiar and manageable or on the side of the unknown and insupportably risky. The comparison shows that public responses to biotechnology are embedded within robust and coherent political cultures and are not ad hoc expressions of concern that very unpredictably from issue to issue.     

Language choices in the teaching of human reproduction

The choice of which language strategies to use in schools in Africa is the subject of much debate. In the Life Sciences, cultural issues associated with the use of biological terminology add to this debate. In our study, we examined the language choices made by Grade 7 Natural Sciences teachers in South Africa during their teaching of human reproduction. A mixed method approach was employed, involving firstly a survey questionnaire amongst 40 teachers in urban schools followed by a multiple case study of 10 of these teachers. Data were collected during classroom observations by means of field notes and audio-recordings followed by interviews which were transcribed and coded. We found that teachers used a variety of language strategies including use of home languages, English or code switching. The teacher’s and/or learners’ fluency in English and the teacher’s perception of the need for learners to feel at ease when discussing human reproduction influenced their choices. In addition, teachers’ belief in the importance of using biological terminology rather than traditional metaphors in order to create a more formal and thus respectful discourse, led them to use the English version of the biological terms. We argue that different language choices are appropriate for different urban contexts, and that teachers should use the language/s in which learners are most comfortable in order to enable deep and rich discussions on the sensitive subject of human reproduction.     

Preimplantation genetic diagnosis

Preimplantation genetic diagnosis (PGD) is an evolving technique that provides a practical alternative to prenatal diagnosis and termination of pregnancy for couples who are at substantial risk of transmitting a serious genetic disorder to their offspring. Samples for genetic testing are obtained from oocytes or cleaving embryos after in vitro fertilization. Only embryos that are shown to be free of the genetic disorders are made available for replacement in the uterus, in the hope of establishing a pregnancy. PGD has provided unique insights into aspects of reproductive genetics and early human development, but has also raised important new ethical issues about assisted human reproduction.     

Consent and confidentiality in the light of recent demands for data sharing

Many attempts have been made to formalize ethical requirements for research. Among the most prominent mechanisms are informed consent requirements and data protection regimes. These mechanisms, however, sometimes appear as obstacles to research. In this opinion paper, we critically discuss conventional approaches to research ethics that emphasize consent and data protection. Several recent debates have highlighted other important ethical issues and underlined the need for greater openness in order to uphold the integrity of health‐related research. Some of these measures, such as the sharing of individual‐level data, pose problems for standard understandings of consent and privacy. Here, we argue that these interpretations tend to be overdemanding: They do not really protect research subjects and they hinder the research process. Accordingly, we suggest another way of framing these requirements. Individual consent must be situated alongside the wider distribution of knowledge created when the actions, commitments, and procedures of researchers and their institutions are opened to scrutiny. And instead of simply emphasizing privacy or data protection, we should understand confidentiality as a principle that facilitates the sharing of information while upholding important safeguards. Consent and confidentiality belong to a broader set of safeguards and procedures to uphold the integrity of the research process.     

Individual good and common good: a communitarian approach to bioethics

The field of bioethics emerged in the late 1960s and early 1970s. Among its early issues were the protection of human research subjects, the rights of patients, abortion, and reproductive issues. Partly as a reflection of the times, and of those issues, the field became focused on autonomy and individual rights, and liberal individualism came to be the dominant ideology in the 1980s and 1990s. Communitarianism, as an alternative ideology focused more on the common good and the public interest than on autonomy, was a neglected approach. But many bioethical issues can not reasonably be reduced to questions of individualism and choice only. Issues of genetics and reproduction will of necessity touch on the society as a whole, its values, and its social institutions. Serious ethical analysis must take the social implications seriously and not simply assume that they should be left to autonomous choices of individuals. Human beings are social animals and our nature is distorted if we think of ourselves only as co-existing social atoms. Various approaches to communitarianism are outlined, and the question of the relationship between individual good and common good is confronted.     

Reproduction humaine: le point de vue du philosophe

This article discusses and essential aspect of the link between ethics and life, as expressed in the concept of bioethics. It discusses the various issues related to human reproduction from “the philosopher’s point of view”. This discussion is limited to the principles of this field. The author starts by justifying a philosophical approach to ethical problems in the context of medicine in general and reproduction in particular, a field which specialists, theoreticians or practitioners of medicine and legal medicine in particular, appear to have ignored. This leads to a discussion of the human aspects of reproduction, from questions concerning the nature of living beings (individuals and species) to the relationship between nature and culture (symbol and freedom). Although man “reproduces” and “procreates”, he is also technically able to “produce himself”. This shift from biological reproduction to procreation must take into account problems related to technological science in medicine (technical control of living material and so-called “neutrality” of the technique). The main bioethical issues involving an ethics of decision-making in the field of human reproduction (contraception, abortion, status of the embryo, medically-assisted procreation, desire to master the “form” of the “reproduced” human, or even the “product”, cloning) are then discussed. Finally, the author proposes elements of a “philosophy of point of view”, requiring responsibility for each decision in the context of an “ethics of discussion”.     

Ethical Research Issues: Going Beyond the Declaration of Helsinki

La Vaque and Rossiter made a strong, supported argument that it is unethical to use a no treatment control group in a research study if a known, effective treatment is available. Their argument is based on the supposition that the Declaration of Helsinki is the ethical world standard for research with humans. Their argument appears to be straightforward, but is not simple to apply. The issues are very complex, include issues not discussed in their argument, and can lead to a different conclusion as pointed out in this paper. The World Medical Association developed the Declaration of Helsinki as one of their official policies. The Declaration of Helsinki, however, is not accepted as the world ethical standard, as demonstrated by its lack of adoption by many professional associations or even by the United States Federal Government. Perhaps it is not mentioned because its ethical provisions are aspirational rather than mandatory as implied by La Vaque and Rossiter. Researchers and clinicians should also be aware of other ethical issues not directly discussed in the La Vaque and Rossiter paper. The Belmont Report is the basis for the ethical protection of human research subjects for at least 17 federal agencies and does not mention the Declaration of Helsinki. The Belmont Report mentions several ethical principles that form the basis for informed consent, risk/benefit assessment, confidentiality of data, subject selection, Institutional Review Boards, and other protections needed when doing research with human subjects. At least 2 of these core principles have direct implications to the discussion related to the use of placebo controls. The ethical principle of fidelity is also important in guiding research activities with human subjects. Researchers should be familiar with the La Vaque and Rossiter argument, the Belmont Report, and the federal policies developed to implement the provisions of that report, for example, Regulation 45 CFR 46.     

The role of ethics in experimental marine biology and ecology

Although most countries have ethical guidelines for research involving human subjects and other sentient animals, the ethical issues associated with field research have received little attention. Most experimental marine biologists and ecologists operate without ethical guidelines or scrutiny, despite intermittent community concern about their activities. We offer suggestions on how marine biologists and ecologists can protect the future of research involving the field collection and experimental manipulation of organisms by developing mechanisms to address community concerns that such research is ethically responsible. We urge experimental marine biologists and ecologists to take pre-emptive initiatives by encouraging: (1) institutional animal ethics committees to broaden their terms of reference to include environmental ethics; (2) scientific societies to develop codes of ethics to guide the environmental research conducted by their members; (3) editorial boards of journals to require the research they publish to conform to an appropriate code of ethics, and (4) management agencies that issue permits for field research to establish an ethics committee to advise them on the ethical issues raised by specific research proposals. We conclude that the resultant administrative burden on scientists would be low but that the penalties of operating without such protection can be high.     

Foundations of modeling in cryobiology—I: Concentration,Gibbs energy,and chemical potential relationships

Mathematical modeling plays an enormously important role in understanding the behavior of cells, tissues, and organs undergoing cryopreservation. Uses of these models range from explanation of phenomena, exploration of potential theories of damage or success, development of equipment, and refinement of optimal cryopreservation/cryoablation strategies. Over the last half century there has been a considerable amount of work in bio-heat and mass-transport, and these models and theories have been readily and repeatedly applied to cryobiology with much success. However, there are significant gaps between experimental and theoretical results that suggest missing links in models. One source for these potential gaps is that cryobiology is at the intersection of several very challenging aspects of transport theory: it couples multi-component, moving boundary, multiphase solutions that interact through a semipermeable elastic membrane with multicomponent solutions in a second time-varying domain, during a two-hundred Kelvin temperature change with multi-molar concentration gradients and multi-atmosphere pressure changes. In order to better identify potential sources of error, and to point to future directions in modeling and experimental research, we present a three part series to build from first principles a theory of coupled heat and mass transport in cryobiological systems accounting for all of these effects. The hope of this series is that by presenting and justifying all steps, conclusions may be made about the importance of key assumptions, perhaps pointing to areas of future research or model development, but importantly, lending weight to standard simplification arguments that are often made in heat and mass transport. In this first part, we review concentration variable relationships, their impact on choices for Gibbs energy models, and their impact on chemical potentials.     

Generating a taxonomy of regulatory responses to emerging issues in biomedicine

In the biomedical field, calls for the generation of new regulations or for the amendment of existing regulations often follow the emergence of apparently new research practices (such as embryonic stem cell research), clinical practices (such as facial transplantation) and entities (such as Avian Influenza/'Bird Flu'). Calls for regulatory responses also arise as a result of controversies which bring to light longstanding practices, such as the call for increased regulation of human tissue collections that followed the discovery of unauthorised post-mortem organ retention. Whilst it seems obvious that new regulations should only be generated if existing regulations are inadequate (a practice referred to in this paper as 'regulatory syncretism'), this does not always occur in practice. This paper examines the conceptual steps involved in generating regulatory responses to emerging phenomena. Two decision points are identified. First, a stance is taken as to whether the emerging phenomenon raises unique ethical or legal issues (exceptionalism versus non-exceptionalism). Second, the decision is made as to whether new regulation should be generated only for truly unique phenomena (syncretism versus asyncretism). It is argued here that it is important to make a careful assessment of novelty, followed by a reflective and deliberative choice of regulatory syncretism or asyncretism, since each type of regulatory response has advantages which need to be harnessed and disadvantages which need to be managed--something that can only occur if regulators are attentive to the choices they are making.     

Engineering-Based Contributions in Cryobiology

Over the past three decades there has been an increasing number of engineering-trained researchers who have made the field of cryobiology a primary focus of their work. In prior times the advances in cryobiology were accomplished nearly exclusively by members of the life and medical science communities. In general, the practice of engineering may be distinguished by two features: an emphasis on rigorous quantitative measurement and analysis of processes and the synthesis of an understanding of fundamental principles of nature into the design of novel devices and processes for specific applications. One area of focus in cryobiology that engineers have emphasized is the design of new apparatus, including both experimental instrumentation and clinical diagnostic and therapeutic devices. There has been a broad spectrum of new apparatus invented to enable the quantitative control and measurement of the fundamental phenomena that govern processes in cryobiology. Among these are low-temperature cryomicroscopy stages and mass diffusion chambers, which now are often used in conjunction with digital image analysis algorithms to quantify changes to individual cells and tissues elicited during the process being studied. Other applications include the development of novel measurement techniques for assessing system properties and states during freezing and thawing. In cryosurgery and in cryopreservation new probes and apparatus have been designed to provide more accurate and effective processes to achieve clinical objectives. Equally important and complementary to the design of hardware is the development of analytical models which can be applied to understand and interpret experimental data and to predict the behavior of systems for operation in domains beyond those for which empirical data are available. Perhaps the most critical role of these models is for inverse solution techniques with experimental data to obtain values for the intrinsic constitutive properties of tissues which govern their response to freezing and thawing processes.     

The cryobiology of spermatozoa

The impact of successful cryopreservation of spermatozoa can be found in many fields, including agriculture, laboratory animal medicine, and human assisted reproduction, providing a cost-effective and efficient method to preserve genetic material for decades. The success of any cryobiologic protocol depends critically on understanding the fundamentals that underlie the process. In this review, we summarize the biophysical fundamentals critical to much of the research in sperm cryobiology, provide a synopsis of the development of sperm cryobiology as a discipline, and present the current state and directions for future research in sperm cryobiology in the three major areas outlined above—agriculture, laboratory animal medicine, and human clinical assisted reproduction. There is much room for new research, both empiric and fundamental, in all areas, including refinement of mathematical models, optimization of cryoprotective agent addition and removal procedures for spermatozoa from many species, development of effective, efficient, and facile cryopreservation protocols and freezing containers for agricultural sperm cryopreservation, and tailoring cryopreservation protocols for individual human samples.     

Getting personal: ethics and identity in global health research

'Researcher identity' affects global health research in profound and complex ways. Anthropologists in particular have led the way in portraying the multiple, and sometimes tension-generating, identities that researchers ascribe to themselves, or have ascribed to them, in their places of research. However, the central importance of researcher identity in the ethical conduct of global health research has yet to be fully appreciated. The capacity of researchers to respond effectively to the ethical tensions surrounding their identities is hampered by lack of conceptual clarity, as to the nature and scope of the issues involved. This paper strives to provide some clarification of these ethical tensions by considering researcher identity from the perspective of (1) Guillemin and Heggen's (2009) key distinction between procedural ethics and ethics in practice, and (2) our own distinction between perceptions of identity that are either symmetrical or asymmetrical, with the potential to shift research relationships toward greater or lesser ethical harmony. Discussion of these concepts is supported with ethnographic examples from relevant literature and from our own (United States (US) Government-funded) research in South Africa. A preliminary set of recommendations is provided in an effort to equip researchers with a greater sense of organization and control over the ethics of researcher identity. The paper concludes that the complex construction of researcher identity needs to be central among the ethical concerns of global health researchers, and that the conceptual tools discussed in the paper are a useful starting point for better organizing and acting on these ethical concerns.     

STEM CELL TREATMENTS IN CHINA: RETHINKING THE PATIENT ROLE IN THE GLOBAL BIO‐ECONOMY

The paper looks in detail at patients that were treated at one of the most discussed companies operating in the field of untried stem cell treatments, Beike Biotech of Shenzhen, China. Our data show that patients who had been treated at Beike Biotech view themselves as proactively pursuing treatment choices that are not available in their home countries. These patients typically come from a broad variety of countries: China, the United Kingdom, the United States, South Africa and Australia. Among the patients we interviewed there seemed to be both an awareness of the general risks involved in such experimental treatments and a readiness to accept those risks weighed against the possible benefits. We interpret this evidence as possibly reflecting the emergence of risk‐taking patients as ‘consumers’ of medical options as well as the drive of patients to seek treatment options in the global arena, rather than being hindered by the ethical and regulatory constraints of their home countries. Further, we found that these patients tend to operate in more or less stable networks and groups in which they interact and cooperate closely and develop opinions and assessments of available treatment options for their ailments. These patients also perform a multiple role as patients, research subjects, and research funders because they are required to pay their way into treatment and research activities. This new social dynamics of patienthood has important implications for the ethical governance of stem cell treatments.     

Mesenchymal stem cells in neurodegenerative diseases: Opinion review on ethical dilemmas

The treatment of neurodegenerative diseases presents a growing need for innovation in relation to recent evidence in the field of reconstructive therapy using stem cells. Understanding the molecular mechanisms underlying neurodegenerative disorders, and the advent of methods able to induce neuronal stem cell differentiation allowed to develop innovative therapeutic approaches offering the prospect of healthy and perfectly functional cell transplants, able to replace the sick ones. Hence the importance of deepening the state of the art regarding the clinical applications of advanced cell therapy products for the regeneration of nerve tissue. Besides representing a promising area of tissue transplant surgery and a great achievement in the field of neurodegenerative disease, stem cell research presents certain critical issues that need to be carefully examined from the ethical perspective. In fact, a subject so complex and not entirely explored requires a detailed scientific and ethical evaluation aimed at avoiding improper and ineffective use, rather than incorrect indications, technical inadequacies, and incongruous expectations. In fact, the clinical usefulness of stem cells will only be certain if able to provide the patient with safe, long-term and substantially more effective strategies than any other treatment available.The present paper provides an ethical assessment of tissue regeneration through mesenchymal stem cells in neurodegenerative diseases with the aim to rule out the fundamental issues related to research and clinical translation.     

DIAGNOSTIC SELF‐TESTING: AUTONOMOUS CHOICES AND RELATIONAL RESPONSIBILITIES

Diagnostic self‐testing devices are being developed for many illnesses, chronic diseases and infections. These will be used in hospitals, at point‐of‐care facilities and at home. Designed to allow earlier detection of diseases, self‐testing diagnostic devices may improve disease prevention, slow the progression of disease and facilitate better treatment outcomes. These devices have the potential to benefit both the individual and society by enabling individuals to take a more proactive role in the maintenance of their health and by helping society improve health and reduce health costs. However, the full implications of future home‐based diagnostic technology for individuals and society remain unclear due to their novelty. We argue that the development of diagnostic tools, especially for home use, will heighten a number of ethical challenges. This paper will explore some of the ethical implications of home‐based self‐testing diagnostic devices for the autonomous and relational dimensions of the person. This will be facilitated by examining the impact of diagnostic devices for individual autonomy, for the delivery of accurate diagnosis and for the personal significance of the information for the user. The latter will be examined using Charles Taylor's view of personhood and his emphasis on human agency and interpretation. While the ethical issues are not necessarily new, the development of home‐based self‐testing diagnostic devices will make issues regarding autonomy, accuracy of information and personal significance more and more demanding. This will be the case particularly when an individual's autonomous choices come into conflict with the person's relational responsibilities.     

THE ETHICS OF INTERCOUNTRY ADOPTION: WHY IT MATTERS TO HEALTHCARE PROVIDERS AND BIOETHICISTS

The goal of this paper is both modest and ambitious. The modest goal is to show that intercountry adoption should be considered by ethicists and healthcare providers. The more ambitious goal is to introduce the many ethical issues that intercountry adoption raises. Intercountry adoption is an alternative to medical, assisted reproduction option such as in vitro fertilization (IVF), intracytoplasmic sperm injection, third party egg and sperm donation and surrogacy. Health care providers working with assisted reproduction are in a unique position to introduce their clients to intercountry adoption; however, providers should only do so if intercountry adoption is ethically equal or superior to the alternatives. This paper first presents a brief history of intercountry adoption. The second section compares intercountry adoption with medical alternatives. The third section examines the unique ethical challenges that are not shared by other medical alternatives. The final section concludes that it is simplistic for a healthcare provider to promote intercountry adoption unconditionally; however, in situation where intercountry adoption is practiced conscientiously it poses no greater ethical concern than several medical alternatives. This conclusion is preliminary and is intended as a start for further discussion.     

Challenges Faced by Behavioral Genetic Studies: Researchers Perspective from the MENA Region

BackgroundBehavioral genetic studies are important for the understanding of the contribution of genetic variations to human behavior. However, such studies might be associated with some ethical concerns.MethodsIn the current study, ethical challenges related to studies of genetic variations contributing to human behavior were examined among researchers. To achieve the study purpose, the Middle East and North Africa (MENA) region researchers were taken as an example, where the after- mentioned ethical challenges were discussed among a group of researchers, who were the participants of an online forum. Discussions and responses of the participants were monitored and were later qualitatively analyzed.ResultsDiscussions revealed that several ethical challenges, including subjects’ recruitment, the difficulty of obtaining informed consents, and issues of privacy and confidentiality of obtained data as information leakage, in this case, will lead to social stigma and isolation of the participants and their immediate family members. Jordanian social and cultural norms, faith, and the tribal nature of the population were raised as a major challenge that might face conducting behavioral genetic studies in the Arab populations of the MENA. The lack of regulation related to the conduction of genetic studies, misunderstanding, and misuse of genetic information are other challenges. A full explanation of genetic research and the current and future possible benefits/risks of such research could be potential solutions.ConclusionIn conclusion, the MENA populations are tackled with major challenges in relation to conducting research studies in genetics/antisocial behavior field/s. Establishment of guidelines related to genetic studies, capacity building, increasing public awareness about the importance of genetic testing, and enhancing responsible conduct of research will facilitate the conduct of such sensitive studies in the future in the region.     

Rethinking parenthood within assisted reproductive technology: The need for regulation in Nigeria

In Nigeria, reproduction is highly valued, with many people desiring to produce a child ‘in their own image and likeness’. Previously, aspiring parents often resorted to adoption. Today, the availability of assisted reproductive technologies (ARTs) has provided options other than adoption for those desiring to procreate. Through ARTs, aspirations for a family may be attained through an exchange of reproductive goods and services, and not necessarily through traditional heterosexual relationships. ARTs have altered the perception of parenthood as it exists in Nigeria, and courts face a difficult task in defining parenthood within Nigerian jurisprudence, as they can only adjudicate based on extant law. Although ARTs provide greater individual choices for fulfilling the desire to procreate, they raise a number of ethical and legal issues that evolving legal systems, such as that in Nigeria, are ill-equipped to manage. This paper describes the traditional assignment of parenthood under indigenous laws and other sources of law within the Nigerian jurisprudence. We carried out an in-depth study of the Nigerian legislative framework and found that there are no laws directly regulating parenthood, procreation and ARTs in Nigeria. We also found that the extant laws are only tangentially related and do not answer the relevant questions sufficiently well, especially concerning succession, nationality and assignment of responsibility in collaborative reproduction. We conclude by highlighting the need for and recommending a regulatory framework on ARTs with a particular focus on providing a definition for parenthood achieved through ARTs in Nigeria.     

Human cloning: category, dignity, and the role of bioethics

Human cloning has been simultaneously a running joke for massive worldwide publicity of fringe groups like the Raelians, and the core issue of an international movement at the United Nations in support of a treaty to ban the use of cloning techniques to produce a child (so called reproductive cloning). Yet, even though debates on human cloning have greatly increased since the birth of Dolly, the clone sheep, in 1997, we continue to wonder whether cloning is after all any different from other methods of medically assisted reproduction, and what exactly makes cloning an 'affront to the dignity of humans.' Categories we adopt matter mightily as they inform but can also misinform and lead to mistaken and unproductive decisions. And thus bioethicists have a responsibility to ensure that the proper categories are used in the cloning debates and denounce those who try to win the ethical debate through well-crafted labels rather than well-reasoned argumentations. But it is as important for bioethicists to take a position on broad issues such as human cloning and species altering interventions. One 'natural question' would be, for example, should there be an international treaty to ban human reproductive cloning?