This special issue of the Modern Law Review addresses a range of key issues - conceptual, ethical, political and practical - arising from the regulatory ...

Graphical AbstractRecent waves of controversies surrounding genetic engineering have spilled into popular science in Twitter battles between reputable scientists and their followers. Here, a cautionary perspective on the possible blind spots and risks of CRISPR and related biotechnologies is presented, focusing in particular on the stochastic nature of cellular control processes.

Building on the emerging literature on the ethics of social enterprises (SEs), this paper advances the underexplored role of frontline workers (FLWs) as embedded agents at the interface between communities and SEs. Specifically, we uncover the subjectivity of FLWs as they navigate moral ambiguities while performing their professional roles, dealing with rules and regulations within the organizational hierarchy and living as members of local communities. Based on an inductive case study of a microfinance organization in Cameroon, we find that FLWs (...) engage in three rationalization strategies: cautious disengaging, safeguarding self-interest, and justifying relevance. Our findings offer a better understanding of the ethics of SEs by unpacking the subjectivity of FLWs. We highlight a bottom-up account of caring SEs, identify a boundary condition to subjectivity, and present a nuanced view of FLWs in embedded organizations. We also discuss the practical implications for SEs to improve their compassion and cater for the mental wellbeing of FLWs. (shrink)

This paper deals with the problem of reconstruction of the intergenic interaction graph from the raw data of genetic co-expression coming with new technologies of bio-arrays (DMA-arrays, protein-arrays, etc.). These new imaging devices in general only give information about the asymptotical part (fixed configurations of co-expression or limit cycles of such configurations) of the dynamical evolution of the regulatory networks (genetic and/or proteic) underlying the functioning of living systems. Extracting the casual structure and interaction coefficients of a gene (...) interaction network from the observed configurations is a complex problem. But if all the fixed configurations are supposedly observed and if they are factorizable into two or more subsets of values, then the interaction graph possesses as many connected components as the number of factors and the solution is obtained in polynomial time. This new result allows us for example to partly solve the topology of the genetic regulatory network ruling the flowering in Arabidopsis thaliana. (shrink)

The discovery and ongoing investigation of microRNAs suggest important conceptual and methodological lessons for philosophers and historians of biology. This paper provides an account of miRNA research and the shift from viewing these tiny regulatory entities as minor curiosities to seeing them as major players in the post-transcriptional regulation of genes. Conceptually, the study of miRNAs is part of a broader change in understandings of genetic regulation, in which simple switch-like mechanisms were reinterpreted as aspects of complex cellular and (...) genome-wide processes. Among them are the activities of small RNAs, previously regarded as non-functional. Methodologically, the miRNA story suggests new ways of characterizing biological research that should prove helpful to philosophers of science who seek to develop more pluralistic, pragmatic models of scientific inquiry. miRNA research displays iterative movements between multiple modes of investigation that include not only the proposal and testing of hypotheses but also exploratory, technology-oriented and question-driven modes of research. As an exemplary story of scientific discovery and development, the miRNA case illustrates transitions from genetics to genomics and systems biology, and it shows how diverse configurations of research practice are related to major scientific advances. (shrink)

For the purposes of conservation or suppression of species, gene drive technology has significant potential. Theoretically speaking, with the release of even relatively few animals with gene drive systems in an ecosystem, beneficial or harmful genes could be introduced into the entire wild-type population of that species. Given the profound impact that gene drives could have on species and ecosystems, their use is a highly contentious issue. Communities and groups have differing beliefs about nature and its conservation or preservation, as (...) well as concerns about the ecological safety of the eradication, replacement or enhancement of particular species of animals by means of genetic engineering. For all those reasons, the rigorous regulation of insects and other animals with gene drive systems is crucial. In this paper, we consider the question of whether the United States Food and Drug Administration is prepared to effectively regulate insects and other animals with gene drives. (shrink)

In this article, we address the public issue of mandatory Genetically Modified Organism (GMO) retail food labeling in the U.S., first by reviewing the policy arguments both in support and against labeling food containing GMOs; second, by describing the existing U.S. federal regulatory system pertaining to GMO labeling, and why it does not presently require labeling of food containing GMOs; third, by reviewing and interpreting the results of studies of American consumer attitudes toward mandatory GMO retail food labeling; fourth, by (...) evaluating, through the utilization of issue life cycle analysis in the nonmarket environment, where the issue of GMO retail food labeling stands in the national public policy process; fifth, summarizing the state of scientific evidence addressing the safety of GMO foods and the existing regulatory and public policy environment for this issue; and sixth, offering legislative and litigation strategies for the mainstream food nonmarket strategy framework to formally assess the GMO industry to protect their interests and those of American consumers not concerned with GMO food ingredients, while offering a voluntary labeling strategy for firms responding to and recognizing the “rights” of American consumers who “choose” to purchase non‐GMO food products. (shrink)

In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools. In August 2016, the US Food and Drug Agency (...) (FDA) approved the uncaged field trial of a GE Aedes aegypti mosquito in Key Haven, Florida. The FDA’s decision was based on its assessment of the risks of the proposed experimental public health research project. The FDA is considered a global regulatory standard setter. So, its approval of the uncaged field trial could be used by proponents of GE mosquitoes to urge countries in the global South to permit the use of those bio-technologies. -/- From a public health ethics perspective, this paper evaluates the FDA’s 2016 risk assessment of the proposed uncaged field trial of the GE mosquito to determine whether it qualified as a realistic risk evaluation. -/- The FDA’s risk assessment of the proposed uncaged field trial did not proximate the conditions under which the GE mosquitoes would be used in regions of the global South where there is a high prevalence of mosquito-borne diseases. -/- Given that health and disease have political-economic determinants, whether a risk assessment of a product is realistic or not particularly matters with respect to interventions meant for public health problems that disproportionately impact socio-economically marginalized populations. If ineffective public health interventions are adopted based on risk evaluations that do not closely mirror the conditions under which those products would actually be used, there could be public health and ethical costs for those populations. (shrink)

The availability of new genetic testing technologies to identify individuals as at risk for a particular disease has inspired tremendous concern that individuals with gene mutations will soon be universally identified, for both insurance and employment purposes, as a genetic underclass. Scholarship in science and technology studies, however, suggests that understandings of genetic knowledge might be locally contingent, while research in comparative politics helps us understand how national context might play an important role in framing approaches to (...) the regulation of genetic information. What role does national context play in defining genetic risk and shaping approaches to the privacy of genetic information? Using data from interviews, document analysis, and ethnographic observation, the author follows debates among advocacy groups, insurers, and governments in the United States and Britain about the appropriate use of genetic information in insurance underwriting to understand how national context frames the definition of genetic risk as well as its regulation. (shrink)

The use of genetic technologies within the equine industries has become increasingly common since the horse genome was published in 2009 (Wade et al. 2009). Testing for genes coding for disease in...

Developments in biotechnology present difficult social and ethical challenges that need to be resolved by regulators among others. One crucial problem for regulators of new technologies is to ensure that regulation is both clear and sufficiently flexible to respond to new developments. This is particularly difficult to achieve in contentious fields such as medical biotechnology. In the European Union there is a divergence in the solutions to this problem which has lead to different regulatory frameworks for medical biotechnology. This paper (...) compares and contrasts the British and Dutch regulatory frameworks for the selection of embryos by preimplantation genetic diagnosis as an example of the regulation of medical biotechnology. Some of the outcomes of the regulatory choices and possible reasons behind the divergent frameworks are discussed, such as the ethical outlooks and political systems in these countries. (shrink)

A discussion of plasticity genes and the genetic architecture of gene-environment interactions.

This paper argues that the “long 1970s” (1969–1983) is an important though often overlooked period in the development of a rich landscape in the research of metabolism, development, and evolution. The period is marked by: shrinking public funding of basic science, shifting research agendas in molecular biology, the incorporation of new phenomena and experimental tools from previous biological research at the molecular level, and the development of recombinant DNA techniques. Research was reoriented towards eukaryotic cells and development, and in particular (...) towards “giant” RNA processing and transcription. We will here focus on three different models of developmental regulation published in that period: the two models of eukaryotic genetic regulation at the transcriptional level that were developed by Georgii P. Georgiev on the one hand, and by Roy Britten and Eric Davidson on the other; and the model of genetic sufficiency and evolution of regulatory genes proposed by Emile Zuckerkandl. These three cases illustrate the range of exploratory hypotheses that characterised the challenging landscape of gene regulation in the 1970s, a period that in hindsight can be labelled as transitional, between the biology at the laboratory bench of the preceding period, and the biology of genetic engineering and intensive data-driven research that followed. (shrink)

According to evolutionary, genetic, and endocrinal perspectives, gender differences are modulated by the interaction between intra-uterine stress, genetic equipments, and the availability of the facilitating environment during the newborn period. The social message of fitness over obstacles during socialization and the discussion of secure/non-secure attachment styles should take into consideration the brain functions, which are altered differently in response to intra- and extra-uterine stress in each gender.

Abstract:There is a role for regulatory oversight over new genetic technologies. Research must ensure the rights of human subjects, and all medical products and techniques should be ensured to be safe and effective. In the United States, these forms of regulation are largely the purview of the National Institutes of Health and the Food and Drug Administration. Some have argued, however, that human genetic therapies require new regulatory agencies empowered to enforce cultural norms, protect against hypothetical social harms, (...) or ensure that the human genome remains unchanged. Focusing on the United States, this essay will briefly review these arguments and argue that the current limited regulatory role over human gene therapies is sufficient to protect public health, bodily autonomy, and reproductive freedom. (shrink)

Uncoupling proteins (UCPs) regulate mitochondrial function, and thus cellular metabolism. Angiotensin‐converting enzyme (ACE) is the central component of endocrine and local tissue renin–angiotensin systems (RAS), which also regulate diverse aspects of whole‐body metabolism and mitochondrial function (partly through altering mitochondrial UCP expression). We show that ACE expression also appears to be regulated by mitochondrial UCPs. In genetic analysis of two unrelated populations (healthy young UK men and Scandinavian diabetic patients) serum ACE (sACE) activity was significantly higher amongst UCP3‐55C (rather (...) than T) and UCP2 I (rather than D) allele carriers. RNA interference against UCP2 in human umbilical vein endothelial cells reduced UCP2 mRNA sixfold (P < 0·01) whilst increasing ACE expression within a physiological range (<1·8‐fold at 48 h; P < 0·01). Our findings suggest novel hypotheses. Firstly, cellular feedback regulation may occur between UCPs and ACE. Secondly, cellular UCP regulation of sACE suggests a novel means of crosstalk between (and mutual regulation of) cellular and endocrine metabolism. This might partly explain the reduced risk of developing diabetes and metabolic syndrome with RAS antagonists and offer insight into the origins of cardiovascular disease in which UCPs and ACE both play a role. (shrink)

This paper explores the analytical relevance of Foucault's notion of biopower in the context of regulating and managing non-human lives and populations, specifically those animals that are the focus of livestock breeding based on genetic techniques. The concept of biopower is seen as offering theoretical possibilities precisely because it is concerned with the regulation of life and of populations. The paper approaches the task of testing the 'analytic mettle' of biopower through an analysis of four policy documents concerned with (...) farm animal genetics: the UK's National Scrapie Plan (2003); the UK National Action Plan on Farm Animal Genetic Resources (2006); the Agriculture and Environment Biotechnology Committee's report on Animals and Biotechnology (2002); and the Farm Animal Welfare Council's report on the Welfare Implications of Animal Breeding and Breeding Technologies in Commercial Agriculture (2004). Of interest is whether and how the four policy case studies articulate a form of biopower in relation to human-livestock animal relations in the context of genetic approaches to livestock breeding, and how biopower is variably expressed in relation to the different policy issues addressed. In concluding, the paper considers the overall applicability and relevance of biopower in the context of regulating animal lives within livestock breeding, highlighting both possibilities and limitations, and offers suggestions for taking forward research on livestock populations from a neo-Foucaultian perspective. (shrink)

Regulierung ist ein Kennzeichen für Rationalität bei dem Versuch, Verhaltensweisen im Lichte von Normen zu leiten. Ihre Funktion ist es, sowohl das Verhalten der Individuen in einem bestimmten Bereich ihres Handelns zu koordinieren als auch dieses Verhalten auf wünschenswerte Ziele hin auszurichten. Nach Regulierung wird insbesondere auf neuartigen Feldern sozialen Verhaltens gerufen, so vor allem im Hinblick auf gentechnische Forschung und Praxis. Aber die Genetik ist deshalb ein schwieriger Fall, weil sie Ziele und Werte betrifft, die in hohem Maße kontrovers (...) sind. Darüberhinaus ist schon die Frage, ob und, wenn ja, in welchem Maße der Bereich der Genetik einer Regulierung unterworfen werden sollte, diskussionswürdig. Als ein wissenschaftliches Projekt verlangt die Genetik nach maximaler Freiheit; als eine potentiell gefährliche Praxis erfordert sie gesellschaftliche Eingrenzung. Im vorliegenden Artikel werden die vier Ebenen einer möglichen Regulierung von Genetik diskutiert: die institutionelle, die gouvernementale, die legislative und die internationale. Dabei wird Israel als Testfall für die komplexe Beziehung zwischen diesen Ebenen der Regulierung herangezogen. Aus einer philosophischen Perspektive wird die inhärente Spannung untersucht, die einerseits zwischen der Kraft der theoretischen Argumentation, die oftmals den Gedanken der Freiheit unterstützt, und andererseits dem Druck der praktischen und gesellschaftlichen &UUML;berlegungen besteht, die regelmäßig nach einer begrenzenden Regulierung rufen. Diese Spannung wird typischerweise in den verschiedensten Formen von nicht prinzipiengeleiteten Kompromissen aufgelöst, die aus teilweisen Regulierungen, ministeriellen Entscheidungen, zeitweiligen Richtlinien, institutionellen Selbstbeschränkungen und der Unterscheidung zwischen legitimer und illegitimer gentechnischer Praxis bestehen. Damit wird die Regulierung der gentechnischen Praxis zugleich zu einem erhellenden Beispiel für die prekäre Lage der "Angewandten Ethik" zwischen Theorie und gesellschaftlicher Praxis.Regulation is a hallmark of rationality in the attempt to guide behavior in the light of norms. Its function is both to coordinate individuals' behavior in a particular field of action and to subject it to desirable goals. Regulation is called for especially in new realms of social conduct, such as genetic research and practice. Yet genetics is a difficult case since it involves goals and values that are highly controversial. Furthermore, the question whether and to what extent the sphere of genetics should be at all regulated is debatable. As a scientific project it calls for maximal freedom; as a potentially harmful practice it calls for social restraint. The paper discusses the four levels of genetic regulation: the institutional, the governmental, the legislative, and the international. It takes Israel as a test case for the complex inter-relation between these regulative levels. On the philosophical level it demonstrates the inherent tension between the force of theoretical arguments and the pressure of practical and social considerations . This tension is typically resolved in various forms of unprincipled compromise, consisting of partial regulation, ministerial discretion, temporary guidelines, institutional self-restraint and distinctions between legitimate and illegitimate genetic practices. Thus, regulation of genetic practice is an illuminating case of the precarious position of "applied ethics" between philosophical theory and social practice. (shrink)

Novel targeted genetic modification (TagMo) techniques for plants have the potential to increase the speed and ease of genetic modification and fall outside existing regulatory authority. We conducted 31 interviews with expert-stakeholders to explore the differing visions they have for the future of plant TagMo environmental regulation. To guide our analysis we review the tenets of anticipatory governance in light of future studies literature on emerging technology, focusing on how to contribute to reflexivity by making explicit the assumptions (...) within envisioned futures. Our findings reveal that the environmental regulation futures articulated by expert-stakeholders could be classified into three categories—optimistic, pragmatic, and critical—based on their differing underlying assumptions concerning what constitutes environmental risk and the adequacy of existing U.S. genetically modified plant regulations. By gathering these diverse perspectives on the future and studying how they differ, we hope to further the anticipatory governance-informed engagement with regulation and foster a more productive discussion of plant TagMo regulation. (shrink)

The logic of genetic discovery has changed little over time, but the focus of biology is shifting from simple genotype–phenotype relationships to complex metabolic, physiological, developmental, and behavioral traits. In light of this, the traditional reductionist view of individual genes as privileged difference‐making causes of phenotypes is re‐examined. The scope and nature of genetic effects in complex regulatory systems, in which dynamics are driven by regulatory feedback and hierarchical interactions across levels of organization are considered. This review argues (...) that it is appropriate to treat genes as specific actual difference‐makers for the molecular regulation of gene expression. However, they are often neither stable, proportional, nor specific as causes of the overall dynamic behavior of regulatory networks. Dynamical models, properly formulated and validated, provide the tools to probe cause‐and‐effect relationships in complex biological systems, allowing to go beyond the limitations of genetic reductionism to gain an integrative understanding of the causal processes underlying complex phenotypes. (shrink)

The background of this paper is the ongoing dismantling of the social insurance systems in favour of commercialisation and privatisation of insurances needed for illness, old age and premature death. This combined with the increased possibility of using genetic testing for differentiating personal insurance premiums has the potentiality of creating a ‘genetic proletariat’ — an uninsurable high-risk population. The common way of handling this problem in Sweden, and many other developed countries around the North Atlantic, has been to (...) regulate insurance companies’ right to ask for and use genetic information in various ways. There is a distinction between partial regulation (that allows insurance companies access to genetic information from genetic tests already made, sometimes only above a specified amount, but not to demand new tests) and total regulation (that forbids insurance companies to ask for or use any genetic information). I will argue that these forms of regulation probably will have adverse consequences given the dismantling of collective social insurance systems. If this is convincing, a better way to solve the problem of an uninsurable high-risk population (and other problems) is to resurrect the collective, obligatory insurance systems in which the individual risk profile does not constitute a basis for premium determination. Both arguments cast in terms of consequences and justice render support for this conclusion. (shrink)

We report here on recent developments in Israel on the issue of sex selection for nonmedical reasons by preimplantation genetic diagnosis. Sex selection for medical reasons is generally viewed as uncontroversial and legal in European and American law. Its use for nonmedical reasons is generally illegal in European countries. In the United States, it is not illegal, although in the opinion of the Ethics Committee of the American Society for Reproductive Medicine, it is problematic. This position is undergoing reconsideration, (...) albeit in a limited way. (shrink)

Prospective parents have long been interested in knowing as much information about their children as early as possible. This interest is not—and never has been—strictly limited to significant “medi...

The “Lošinj Declaration on Biotic Sovereignty” is a novelty in the consideration of the environment and life in general and a unique document on a global scale. Until the advent of the Declaration, the environment was usually considered in an instrumentalist way, following the prevailing techno-scientific paradigm. The Declaration introduces biotic sovereignty as the starting point for the debate on GMOs, from which the harmfulness or potential benefits of genetic engineering can be assessed. The protection of biotic sovereignty should (...) be one of the crucial values that European and Croatian citizens should defend in the upcoming struggle to change and probably drastically reduce the regulatory regime for genetically modified crops in the European Union and thus also in Croatia. In this paper, we highlight the importance of the “Lošinj Declaration on Biotic Sovereignty” in the context of the emergence of new gene regulation techniques that are becoming a threat to biotic sovereignty. We analyse the lobbying process against the ruling C-528/16 using the example of the scientists united in the network EU-SAGE. The central part of the paper analyses the controversy over a new European Commission study on new genetic techniques and the political context of the conflict between the European Commission and the European Parliament over the authorisation of new seed varieties of genetically modified crops. (shrink)

-/- Policy regulations of ethically controversial genetic technologies should, on the one hand, be based on ethical principles. On the other hand, they should be socially acceptable to ensure implementation. In addition, they should align with ethical theory. Yet to date we lack a reliable and valid scale to measure the relevant ethical judgements in laypeople. We target this lacuna. -/- We developed a scale based on ethical principles to elicit lay judgments: the Genetic Technologies Questionnaire (GTQ). In (...) two pilot studies and a pre-registered main study, we validated the scale in a representative sample of the US population. -/- The final version of the scale contains 20 items but remains highly reliable even when reduced to five. It also predicts behaviour; for example, ethical judgments as measured by the GTQ predicted hypothetical donations and grocery shopping. In addition, the GTQ may be of interest to policymakers and ethicists because it reveals coherent and ethically justified judgments in laypeople. For instance, the GTQ indicates that ethical judgments are sensitive to possible benefits and harms (in line with utilitarian ethics), but also to ethical principles such as the value of consent-autonomy. -/- In conclusion, the GTQ can be recommended for research in both experimental psychology and applied ethics, as well as a tool for ethically and empirically informed policymaking. (shrink)

Aufgrund der Erfahrung mit der genetischen Manipulation von nicht-menschlichen Organismen, glauben wir, dass die Risiken einer gezielten Manipulation der menschlichen Erbinformation zum Zwecke der vermeintlichen Verbesserung des Menschen in absehbarer Zukunft zu hoch und die erhofften Vorteile einer solchen Manipulation zu ungewiß bleiben werden, um Eingriffe dieser Art zu rechtfertigen. In diesem Aufsatz erklären wir, warum wir meinen, dass gesetzliche Verbote solcher Experimente mit Menschen gegenwärtig gerechtfertigt wären, und warum wir gleichwohl meinen, dass solche Verbote nicht die wichtigsten Strategien zur (...) Steuerung dieser allmählich auch wirtschaftlich sehr signifikanten Forschungsrichtung darstellen. Wir argumentieren dafür, dass die Furcht vor zivilrechtlicher Haftung für die durchaus nicht auszuschließenden Schäden solcher Versuche und der bewußte Einsatz von staatlichen Forschungsgeldern nicht nur zur Entwicklung neuer genmanipulativer Techniken, sondern auch für die gründliche und unabhängige Beurteilung der Risiken solcher Techniken viel probatere und realistischere Reaktionen auf dieses neue Phänomen darstellen. (shrink)

Genetic engineering in general, and human genetic editing in particular, is revolutionizing humankind’s self-understanding: an evolved organism taking ever greater control of its own evolution. This Anthropocenic phenomenon is deeply equivocal (Gregg B. Human genetic engineering: biotic justice in the anthropocene? In: DellaSala D, Goldstein M (eds) Encyclopedia of the Anthropocene, vol 4. Elsevier, Oxford, pp 351–359, 2018). While delivering humans from some risks, it renders them vulnerable to unintended consequences as well. Even in the face of (...) seemingly intractable differences of opinion about how best to understand genetic manipulation culturally, and how to evaluate it ethically, political communities and international organizations alike must address its possible future legal regulation. Governments and other elite institutions would do well to include the general public, to the extent possible, in deliberations about regulation, even as genetic engineering is based on highly specialized knowledge. (shrink)

The main purpose of The NorwegianGene Technology Act (1993) is to enforcecontainment of genetically modified organisms(GMOs) and control of GMO releases.Furthermore, the Act intends to ensure that``production and use of GMOs should take placein an ethically and socially justifiable way,in accordance with the principle of sustainabledevelopment and without detrimental effects tohealth and the environment.'' Hence it isobvious that, for the Norwegian authorities,sustainable development is a normativeguideline when evaluating acceptableconsequences of GMO use and production. Inaccordance with this, we have investigated theextent (...) to which the sustainability criteriawere decisive for the destiny of one approvedand one declined application of geneticallymodified plant release. The presentunderstanding of the ecological,socio-economical, and cultural consequences ofGMO use and release is fragmentary anduncertain. We consider the PrecautionaryPrinciple and the notion of equitabledistribution as key issues within thesustainable development framework, henceconstituting important foundations for ouranalyses. The Act is legitimizingsustainability criteria, but does not seem tosecure their conversion into concrete action.We envisage a more conscious implementation ofthe Norwegian Gene Technology Act.Sustainability concerns ecological, economical,and social values, and these can only beensured through long-term thinking, initiationof independent risk-associated research, andbroad involvement of all stakeholders in theevaluation of GMO issues and concerns. (shrink)

Should significant enhancement of human capacities using genetic technologies become possible, each generation will have an unprecedented power over the next. I argue that it is implausible to leave decisions about the genetic traits of children entirely up to individuals and that communities will sometimes be justified in intervening to protect the interests of children against their parents. While a number of influential authors have suggested that the primary interest that the community should aim to protect is the (...) child’s right to “an open future”, when we examine closely what we desire for our children, it is clear that sometimes we have good reasons to try to restrict their opportunities to pursue dangerous, corrupting, or meaningless projects. Rather than maximise the openness of their future, then, we should strive to ensure that children have access to sufficient opportunities to make available a reasonable range of valuable life-choices. Importantly, both the assessment of what counts as a reasonable range and our judgements about which forms of life are valuable must inevitably make reference to substantive notions about the nature of human flourishing. A more appropriate formulation, then, of what should be protected by law and/or regulation, is the child’s right to a “decent future”, understood as a future which promises a reasonable range of opportunities to lead a life of human flourishing. I then proceed to highlight the challenge posed by the task of settling upon an idea of what counts as a decent future, for multicultural societies wherein ideas about the standards against which we should evaluate human flourishing are likely to be highly contested. (shrink)

The science of genetics is undergoing a paradigm shift. Recent discoveries, including the activity of retrotransposons, the extent of copy number variations, somatic and chromosomal mosaicism, and the nature of the epigenome as a regulator of DNA expressivity, are challenging a series of dogmas concerning the nature of the genome and the relationship between genotype and phenotype. According to three widely held dogmas, DNA is the unchanging template of heredity, is identical in all the cells and tissues of the body, (...) and is the sole agent of inheritance. Rather than being an unchanging template, DNA appears subject to a good deal of environmentally induced change. Instead of identical DNA in all the cells of the body, somatic mosaicism appears to be the normal human condition. And DNA can no longer be considered the sole agent of inheritance. We now know that the epigenome, which regulates gene expressivity, can be inherited via the germline. These developments are particularly significant for behavior genetics for at least three reasons: First, epigenetic regulation, DNA variability, and somatic mosaicism appear to be particularly prevalent in the human brain and probably are involved in much of human behavior; second, they have important implications for the validity of heritability and gene association studies, the methodologies that largely define the discipline of behavior genetics; and third, they appear to play a critical role in development during the perinatal period and, in particular, in enabling phenotypic plasticity in offspring. I examine one of the central claims to emerge from the use of heritability studies in the behavioral sciences, the principle of minimal shared maternal effects, in light of the growing awareness that the maternal perinatal environment is a critical venue for the exercise of adaptive phenotypic plasticity. This consideration has important implications for both developmental and evolutionary biology. (shrink)

The science and technology of genetic testing is rapidly advancing with the consequences that genetic testing may well offer the prospect of being able to detect the onset of future disabilities. Some recent research also indicates that certain behavioural profiles may have a strong genetic basis, such as the determination to succeed and win or the propensity for risk-taking, which may be of interest to third parties. However, as this technology becomes more prevalent there is a danger (...) that the genetic information may be misused by entities such as employers, insurance companies, educational facilities, and finance companies and that people with particular genetic profiles may be discriminated against.This book explores the different types and the potential uses of genetic testing. The book highlights the ethical and legal dilemmas and the challenges arising as a result of emerging and rapidly advancing genetic science. Chapters in the book assess the importance and impact of the US Genetic Information Non-Discrimination Act (GINA) in the employment and health insurance contexts asking whether it is proving to be an effective tool in addressing the issue of genetic discrimination and alleviating individuals' fears of discrimination. The book then goes on to make the case for regulation at the European Union level in order to protect the privacy of genetic information and to prevent the discriminatory use of genetic information in Europe. It considers what can be learnt from the experience of the US in addressing ethical and legal issues as well as the impact that the UN Convention on the Rights of Persons with Disabilities is having on this debate within the EU. (shrink)

The article proposes to further develop the ideas of the Extended Evolutionary Synthesis by including into evolutionary research an analysis of phenomena that occur above the organismal level. We demonstrate that the current Extended Synthesis is focused more on individual traits (genetically or non-genetically inherited) and less on community system traits (synergetic/organizational traits) that characterize transgenerational biological, ecological, social, and cultural systems. In this regard, we will consider various communities that are made up of interacting populations, and for which the (...) individual members can belong to the same or to different species. Examples of communities include biofilms, ant colonies, symbiotic associations resulting in holobiont formation, and human societies. The proposed model of evolution at the level of communities revises classic theorizing on the major transitions in evolution by analyzing the interplay between community/social traits and individual traits, and how this brings forth ideas of top-down regulations of bottom-up evolutionary processes (collaboration of downward and upward causation). The work demonstrates that such interplay also includes reticulate interactions and reticulate causation. In this regard, we exemplify how community systems provide various non-genetic ‘scaffoldings’, ‘constraints’, and ‘affordances’ for individual and sociocultural evolutionary development. Such research complements prevailing models that focus on the vertical transmission of heritable information, from parent to offspring, with research that instead focusses on horizontal, oblique and even reverse information transmission, going from offspring to parent. We call this reversed information transfer the ‘offspring effect’ to contrast it from the ‘parental effect’. We argue that the proposed approach to inheritance is effective for modelling cumulative and distributed developmental process and for explaining the biological origins and evolution of language. (shrink)

Background Investigative genetic genealogy (IGG) is a technique that involves uploading genotypes developed from perpetrator DNA left at a crime scene, or DNA from unidentified remains, to public genetic genealogy databases to identify genetic relatives and, through the creation of a family tree, the individual who was the source of the DNA. As policymakers demonstrate interest in regulating IGG, it is important to understand public perspectives on IGG to determine whether proposed policies are aligned with public attitudes.Methods (...) We conducted eight focus groups with members of the public (N = 72), sampled from four geographically diverse US regions, to explore general attitudes and perspectives regarding aspects of IGG practices, applications, and policies. Five major topics were explored in each focus group: when IGG should be used; who should perform IGG; how to approach consent for genetic database users; what systems of oversight should govern IGG practitioners; and whether to notify database users if their data are involved in law enforcement (LE) matching.Results Participants were supportive of IGG in most scenarios, especially for cold and violent cases. The favorable attitudes toward IGG were, however, tempered by distrust of law enforcement among some participants. All participants agreed that databases must inform users if IGG is allowed, but they did not agree on how individual database users should be allowed to opt out or whether to notify them if their data are involved in specific investigations. All participants agreed that IGG should be subject to some prescriptive guidelines, regulations, or accountability mechanisms.Conclusions These findings suggest broad public support for IGG, and interest in developing systems of accountability for its practice. Our study provides useful insight for policy makers, genomic database stewards, law enforcement, and other stakeholders in IGG’s practice, and suggests multiple directions for future research. (shrink)

The concept of regulation pervades biology, for example in models of genetic regulatory networks and the endocrine system. Regulation has a normative opposite, dysregulation, which figures prominently in biomedical models of disease. The use of normative concepts in biology, however, has been thought to present some challenges for the physicalist view of the world, and various resolutions have been proposed. Up to now the problem of biological normativity has been debated largely in connection with the concept of biological information. (...) In this paper we shift focus to the concept of biological regulation, proposing that it provides a promising new approach to these issues. Models of regulatory systems have several features: they are causal, but they do not deal with the energy exchanges and transformations covered by physics and chemistry; further, and entirely connected, regulatory systems can break down, and this is because they and their causal-regulatory properties are dependent on fragile molecular structures. Biological regulatory systems exhibit normativity, because they are not determined by physical and chemical laws, but their close relationship with physical laws and physicalist ontology is transparent. (shrink)

While 23andMe aspires to be “the world's trusted source of personal genetic information,” the U.S. Food and Drug Administration (FDA) believes that the company's advertising practices have been anything but trustworthy. Last November, a harshly worded FDA “warning letter” demanded that the direct‐to‐consumer genetic testing company immediately discontinue marketing its unapproved “medical device.” The tussle between 23andMe and the FDA has attracted more attention than a typical disagreement between a company and a government agency. Larry Downes and Paul (...) Nunes identify 23andMe as a “Big Bang Disruption”: an invention that revolutionizes the existing market, foiling both industry incumbents and unprepared regulators. The outcome of the FDA's current review to hold the answer to the million‐dollar question: how will DTC genetic testing be regulated in the future? Ideally, the FDA's regulations should not pose undue burdens on consumers seeking personal genetic information but, rather, help consumers make a transition out of the consumer setting and into the medical setting. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:FDA Releases Draft Guidance on Regulation of Genetically Engineered AnimalsJohn P. Gluck (bio) and Mark T. Holdsworth (bio)On 18 September 2008, the U.S. Food and Drug Administration (FDA) issued a draft set of guidelines for those involved in developing genetically engineered animals with heritable recombinant DNA (rDNA) constructs and is requesting comment from industry and the public about their content. The document does not impose new regulations but details (...) how existing laws and regulations apply to genetically engineered (GE) animals and offers advice to developers on how to negotiate the laws in the most efficient and productive manner. The draft guidance document is not legally enforceable at this juncture, but the guidelines are recommendations reflecting the FDA's "current thinking on a topic."The modification of GE animals being developed for commercialization, which are the focus of the document, fall into six categories: modifications intended to (1) enhance food quality—e.g., faster growing fish and meats with better nutritional profiles; (2) improve animal health via increased resistance to disease—e.g., mastitis in dairy cattle and Bovine Spongiform Encephalopathy (BSE); (3) create so-called "biopharm" animals capable of producing therapeutic products such as insulin, clotting factors, and tissues for human transplantation; (4) reduce the barriers to human animal interaction—e.g., hypoallergenic pets; (5) develop valid animal models of human disease—e.g., Parkinson's disease, Lesh-Nyhan's syndrome, and cancer; and (6) improve production of industrial or consumer products such as fiber. The timing of the guidelines coincides with the FDA's belief in an expected boon in the number of GE animals approaching the stage of commercialization.The FDA's involvement in the approval process emerges from the new animal drug provisions of the Federal Food Drug and Cosmetic Act and the definition of what constitutes a drug. The Act defines a new animal drug as "an article (other than food) intended to affect the structure or any function of the body of... animals." A rDNA construct intended to affect the structure or function of an animal meets the definition of a new animal drug, regardless of whether the resulting GE animals are intended for human food or the production of pharmaceuticals or any other substances. [End Page 393]Before proceeding to a review of the draft guidelines, it is important briefly to set the controversies around GE animals in historical and ethical context.The Ethical DebateFrom its inception, the intentional genetic modification or genetic engineering of molecules, plants, and animals by the techniques of gene splicing has consistently elicited strong responses from both the scientific community and the public. There are some data to suggest that although the concerns of scientists fall primarily into the category of possible biohazards, those of the public also reflect great concern about the intrinsic moral issues, such as whether there is something fundamentally wrong with this line of work, making it a form of forbidden knowledge (see, e.g., Gaskell 1997). When news of Paul Berg's attempts in 1970 to graft the primate tumor virus (SV 40) onto the intestinal tract bacteria Escherichia coli for the purpose of studying how normal cells may be transformed into cancerous cells was shared with colleagues, he was strongly encouraged to reflect on the potential public health risks if somehow the altered bacteria broke containment and entered the environment. Thanks to Berg's leadership, these concerns soon resulted in conferences held in Asilomar, California, and New Hampton, New Hampshire, where the ethical responsibilities of microbiologists involved in this research were discussed. These initial discussions resulted in what has come to be known as "The Moratorium Letter" (Shattuck 1996) published in the journal Science in 1974. This letter, signed by 11 leaders in the field, actually recommended restrictions on several types of experiments that were considered to be particularly risky and stated "that adherence to our major recommendations will entail postponement or possibly abandonment of certain types of scientifically worthwhile experiments" (Berg 1974). An international conference on the issues came to similar conclusions about the need for a research moratorium for the sake of public safety. Recommendations arising from conference participants led to the formation of the National Institutes... (shrink)