Human genetic engineering may soon be possible. The gathering debate about this prospect already threatens to become mired in irresolvable disagreement. After surveying the scientific and technological developments that have brought us to this pass, _The Ethics of Genetic Engineering_ focuses on the ethical and policy debate, noting the deep divide that separates proponents and opponents. The book locates the source of this divide in differing framing assumptions: reductionist pluralist on one side, holist communitarian on the (...) other. The book argues that we must bridge this divide, drawing on the resources from both encampments, if we are to understand and cope with the distinctive problems posed by genetic engineering. These problems, termed "fractious problems," are novel, complex, ethically fraught, unavoidably of public concern, and unavoidably divisive. Berry examines three prominent ethical and political theories – utilitarianism, Kantianism, and virtue ethics – to consider their competency in bridging the divide and addressing these fractious problems. The book concludes that virtue ethics can best guide parental decision making and that a new policymaking approach sketched here, a "navigational approach," can best guide policymaking. These approaches enable us to gain a rich understanding of the problems posed and to craft resolutions adequate to their challenges. (shrink)

Intrinsic value and animal integrity are two key concepts in the debate on the ethics of the genetic engineering of laboratory animals. These concepts have, on the one hand, a theoretical origin and are, on the other hand, based on the moral beliefs of people not directly involved in the genetic modification of animals. This ‘external’ origin raises the question whether these concepts need to be adjusted or extended when confronted with the moral experiences and (...) opinions of people directly involved in the creation or use of transgenic laboratory animals. To answer this question, 35 persons from the practice of biomedical research who are directly involved in genetic engineering (scientists, biotechnicians, animal caretakers and laboratory animal scientists) were interviewed. They were asked to give their moral opinion on different aspects of the genetic engineering of animals and to react to statements about the concepts of intrinsic value and animal integrity. Analysis of the interviews showed that, contrary to what is often assumed, the respondents embraced these concepts, even those senses that (more) specifically apply to genetic engineering. And although the respondents raised some objections that go beyond issues of animal welfare, these objections could quite well be expressed in terms of the concepts of intrinsic value and animal integrity. In short, the results of the present study strongly suggest that these concepts do not have to be adjusted or extended in the light of the moral experiences and opinions from practice. (shrink)

Intrinsic value and animal integrity are two key concepts in the debate on the ethics of the genetic engineering of laboratory animals. These concepts have, on the one hand, a theoretical origin and are, on the other hand, based on the moral beliefs of people not directly involved in the genetic modification of animals. This ‘external’ origin raises the question whether these concepts need to be adjusted or extended when confronted with the moral experiences and (...) opinions of people directly involved in the creation or use of transgenic laboratory animals. To answer this question, 35 persons from the practice of biomedical research who are directly involved in genetic engineering (scientists, biotechnicians, animal caretakers and laboratory animal scientists) were interviewed. They were asked to give their moral opinion on different aspects of the genetic engineering of animals and to react to statements about the concepts of intrinsic value and animal integrity. Analysis of the interviews showed that, contrary to what is often assumed, the respondents embraced these concepts, even those senses that (more) specifically apply to genetic engineering. And although the respondents raised some objections that go beyond issues of animal welfare, these objections could quite well be expressed in terms of the concepts of intrinsic value and animal integrity. In short, the results of the present study strongly suggest that these concepts do not have to be adjusted or extended in the light of the moral experiences and opinions from practice. (shrink)

Creating Future People offers readers a fast-paced primer on how new genetic technologies will enable parents to influence the traits of their children, including their intelligence, moral capacities, physical appearances, and immune systems. It deftly explains the science of gene editing and embryo selection, and raises the central moral questions with colorful language and a brisk style. Jonathan Anomaly takes seriously the diversity of preferences parents have, and the limits policymakers face in regulating what could soon be (...) a global market for reproductive technology. He argues that once embryo selection for complex traits happens it will change the moral landscape by altering the incentives available to parents. All of us will take an interest in the traits everyone else selects, and this will present coordination problems that previous writers on genetic enhancement have failed to consider. Anomaly navigates difficult ethical issues with vivid language and scientifically-informed speculation about how genetic engineering will transform humanity. Key Features: Offers clear explanations of scientific concepts Explores important moral questions without academic jargon Brings discoveries from different fields together to give us a sense of where humanity is headed. (shrink)

The ability of medical science to clone and perhaps even predetermine characteristics of certain species conflicts dramatically with many claims of the religious establishment. Opening with a description of various developments in plant, animal, and human genetics, Made in Whose Image? highlights the progress genetic research has achieved, its future promise, and its social impact. The developments are analyzed from the perspective of Christian ethics, as expounded by Roman Catholic and Protestant theorists, to give an overview of crucial (...) class='Hi'>ethical issues. In reviewing the advances of genetic research, noted religion and ethics professor Thomas A. Shannon covers general ethical themes, such as the value of life, materialism, freedom, individuality, the concept of nature, and health and disease. In addition, he discusses problems in genetic engineering and misconceptions of the church. Shannon explores prenatal diagnosis, gene therapy, genes and behavior, freedom and responsibility, and the Human Genome Project. The book concludes with a powerful and groundbreaking methodological discussion of how to approach ethical problems in genetic engineering. (shrink)

Is inheritable genetic modification the new dividing line in gene therapy? The editors of this searching investigation, representing clinical medicine, public health and biomedical ethics, have established a distinguished team of scientists and scholars to address the issues from the perspectives of biological and social science, law and ethics, including an intriguing Foreword from Peter Singer. Their purpose is to consider how society might deal with the ethical concerns raised by inheritable genetic modification, and to re-examine prevailing (...) views about whether these procedures will ever be ethically and socially justifiable. The book also provides background to define the field, and discusses the biological and technological potential for inheritable genetic modification, its limitations, and its connection with gene therapy, cloning, and other reproductive interventions. For scientists, bioethicists, clinicians, counsellors and public commentators, this is an essential contribution to one of the critical debates in current genetics. (shrink)

1. Introduction -- 2. Philosophy of genetic technology and its relation to ethical theories -- 3. Ethics of genetic technology in plants and animals -- 4. Ethics of genetic technology in humans -- 5. Conclusion.

"The patriarch of medical ethics explains why some accepted ethical values need to catch up with the science of human reproduction and why newer reproductive methods can be more "natural" and humane than those they replace." -- from Publisher's site.

The thrilling and terrifying history of genetic engineering. In 2018, scientists manipulated the DNA of human babies for the first time. As biologist and historian Matthew Cobb shows in As Gods, this achievement was one many scientists have feared from the start of the genetic age. Four times in the last fifty years, geneticists, frightened by their own technology, have called a temporary halt to their experiments. They ought to be frightened: Now we have powers that can (...) target the extinction of pests, change our own genes, or create dangerous new versions of diseases in an attempt to prevent future pandemics. Both awe-inspiring and chilling, As Gods traces the history of genetic engineering, showing that this revolutionary technology is far too important to be left to the scientists. They have the power to change life itself, but should we trust them to keep their ingenuity from producing a hellish reality? (shrink)

This study investigates the ethical aspects of deploying and researching into so-called climate engineering methods, i.e. large-scale technical interventions in the climate system with the objective of offsetting anthropogenic climate change. The moral reasons in favour of and against R&D into and deployment of CE methods are analysed by means of argument maps. These argument maps provide an overview of the CE controversy and help to structure the complex debate.

The phenomenon of the New Genetics raises complex social problems, particularly those of privacy. This book offers ethical and legal perspectives on the questions of a right to know and not to know genetic information from the standpoint of individuals, their relatives, employers, insurers and the state. Graeme Laurie provides a unique definition of privacy, including a concept of property rights in the person, and argues for stronger legal protection of privacy in the shadow of developments in human (...) genetics. He challenges the role and the limits of established principles in medical law and ethics, including respect for patient autonomy and confidentiality. This book will interest lawyers, philosophers and doctors concerned both with genetic information and issues of privacy; it will also interest genetic counsellors, researchers, and policy makers worldwide for its practical stance on dilemmas in modern genetic medicine. (shrink)

Reflexión sobre los problemas éticos que plantea la aplicación de la ingeniería genética a los seres humanos, con la intención de conducir a la toma de decisiones prudentes en su utilización.

Creating Future People offers readers a fast-paced primer on how advances in genetics will enable parents to influence the traits of their children, including their children's intelligence, moral capacities, physical appearance, and immune system. It explains the science of gene editing and embryo selection, and motivates the moral questions it raises by thinking about the strategic aspects of parental choice. Professor Anomaly takes seriously the diversity of preferences parents have, and the limits policymakers face in regulating what (...) will soon be a global market for reproductive technology. Anomaly argues that once embryo selection for complex traits happens it will change the moral landscape by altering the incentives each person faces. All of us will take an interest in the traits everyone else selects, and this will present coordination problems that previous writers on genetic enhancement have failed to consider. Anomaly ends by considering how genetic engineering will transform humanity. Key Updates to the Second Edition · Significant revisions to the Preface and three separate chapters to include more details about what will be scientifically possible in the coming years and the moral issues these developments will raise · New and substantial coverage of embryo selection (guided by polygenic scores) for minimizing the risk of genetic diseases · Engagement with all important, new publications on the science of genetic enhancement. (shrink)

The ArgumentMuslims share with others both the interest in and the concern about genetic engineering. Naturally their reactions and views stem from general Islamic dogma and from Islamic medical ethics, but they are not unaware of Western scientific data. Particularly relevant is the Islamic religious prohibition against “changing what Allah has created.” Muslim muftis try to offer practical solutions for individuals. Islamic law is concerned about maintaining pure lineage. Consanguineous matings are very common, but induced abortions are usually (...) ruled out. Cloning has reawakened among Muslims an old debate over the positive as well as hazardous aspects of genetic engineering. (shrink)

We humans can enhance some of our mental and physical abilities above the normal upper limits for our species with the use of particular drug therapies and medical procedures. We will be able to enhance many more of our abilities in more ways in the near future. Some commentators have welcomed the prospect of wide use of human enhancement technologies, while others have viewed it with alarm, and have made clear that they find human enhancement morally objectionable. The Ethics of (...) Human Enhancement examines whether the reactions can be supported by articulated philosophical reasoning, or perhaps explained in terms of psychological influences on moral reasoning. An international team of ethicists refresh the debate with new ideas and arguments, making connections with scientific research and with related issues in moral philosophy. (shrink)

This book is a philosophically sophisticated and scientifically well-informed discussion of the moral and social issues raised by genetically engineering animals, a powerful technology which has major implications for society. Unlike other books on this emotionally charged subject, the author attempts to inform, not inflame, the reader about the real problems society must address in order to manage this technology. Bernard Rollin is both a professor of philosophy, and physiology and biophysics, and writes from a uniquely well-informed perspective (...) on this topic. The style is non-technical and anecdotal and will ensure that the book can be used on a wide range of courses on bioethics, biotechnology, veterinary medicine and public policy. The book could also appeal to a general, non-academic reader with a serious interest in genetic engineering. (shrink)

An international team of ethicists refresh the debate about human enhancement by examining whether resistance to the use of technology to enhance our mental and physical capabilities can be supported by articulated philosophical reasoning, or explained away, e.g. in terms of psychological influences on moral reasoning.

Kaum eine zweite moderne Wissenschaft weckt im gleichen Ausmass Hoffnungen und Angste wie die Biotechnologie. Neben der Hoffnung, durch die Entschlusselung des menschlichen genetischen Codes, die Moglichkeit der Veranderung des Erbgutes und Reduplikation von Stammzellen entscheidende Fortschritte in der Diagnostik und Therapie von Krankheiten zu machen, steht die Angst vor einem Missbrauch dieses neuen Wissens. Einer Moralphilosophie, die sich nicht auf die Exegese historischer Texte reduzieren lassen will, bietet sich hier ein wichtiges neues Aufgabenfeld: Sie ist gefordert, vorausschauend die ethischen (...) Grenzen und Notwendigkeiten menschlichen Handelns neu zu beurteilen und zu begrunden. Dieser Sammelband will Diskussionen anregen und vertiefen, indem er unterschiedliche Positionen, konkurrierende philosophische, theologische und naturwissenschaftliche Begrundungs- und Argumentationsmodelle aufzeigt und kritisch aufeinander bezieht.". (shrink)

Biotech Time-Bomb is a probing analysis of the orgins, transformations, and prospects of the Western mentality behind genetic engineering and similar strategies for manipulating the basic elements of life. It is the first media ecology critique of the control paradigm now dominant in developed socities, and a clarion call for a cross-cultural dialogue. Beyond demonstrating how the side-effects of new technologies usually turn out to be their main effects, the book also highlights alternative perspectives from other cultures and (...) urges renewed attention to the inexhaustible resourcefulness of life itself. (shrink)

Advances in reproductive genetic engineering have the potential to transform human lives. Not only do they promise to allow us to select children free of diseases, they can also enable us to select children with desirable traits. In this paper, I consider two clusters of arguments for the moral permissibility of reproductive genetic engineering, what I call the Perfectionist View and the Libertarian View; and two clusters of arguments against reproductive genetic engineering, what (...) I call the Human Nature View and the Motivation View. I argue that an adequate theory of the ethics of reproductive genetic engineering should take into account insights gained from these views. (shrink)

What makes humans different from other animals, what humans are entitled to do to other species, whether time travel is possible, what limits should be placed on science and technology, the morality and practicality of genetic engineering—these are just some of the philosophical problems raised by Planet of the Apes. Planet of the Apes and Philosophy looks at all the deeper issues involved in the Planet of the Apes stories. It covers the entire franchise, from Pierre Boulle’s 1963 (...) novel Monkey Planet to the successful 2012 reboot Rise of the Planet of the Apes. The chapters reflect diverse points of view, philosophical, religious, and scientific. The ethical relations of humans with animals are explored in several chapters, with entertaining and incisive observations on animal intelligence, animal rights, and human-animal interaction. Genetic engineering is changing humans, animals, and plants, raising new questions about the morality of such interventions. The scientific recognition that humans and chimps share 99 percent of their genes makes a future in which non-human animals acquire greater importance a distinct possibility. Planet of the Apes is the most resonant of all scientific apocalypse myths. (shrink)

Like every major new technology, genetic engineering is affecting the hopes and fears of many people. The risks involved are perceived differently by different groups. One group regards genetic engineering as a simple extension of older techniques with no special risks, e.g. traditional breeding. This conservative denial of special risks is confronted with a different kind of conservatism from a group which, in the name of the preservation of nature, opposes any kind of genetic (...) class='Hi'>engineering. A third group, rooted in the liberal tradition, is prepared to accept the risks of genetic engineering as long as they are outweighed by prospective benefits. The liberal as well as the two conservative approaches, however, face serious difficulties in trying to develop a sound ethical argument concerning genetic engineering. In order to avoid these difficulties, an ethical approach focused on paradigmatic examples of good and evil is proposed. Such examples constitute rules of moral description, much as standards of measurement constitute rules of physical description. These rules are elaborated and interpreted in processes of social learning. In the present state of development of genetic engineering, such social learning requires appropriate institutional procedures. (shrink)

This article is written from within the Catholic, and more particularly the Augustinian/Thomist tradition of moral theology. It analyses the response of the Catholic Magisterium to the prospect of germline-genetic engineering (GGE). This is a very new issue and the Church has little definitive teaching on it. The statements of Popes and Vatican congregations or commissions have not settled the key questions. An analysis of theological themes drawn from secular writers points beyond pragmatic safety considerations toward intrinsic (...) ethical limits to GGE. Given the impossibility of identifying would-have-been-created persons who would be “treated” by this intervention, altering the human genome for the sake of future generations cannot be regarded as “therapy.” Further theological considerations suggest that GGE may not be morally permissible, even in the case of identifiable genetic diseases. This is an area where more theological reflection is needed. (shrink)

First published in 1998, this volume why and how genetic engineering has emerged as the technology most likely to change our lives, for better or worse, in the opening century of the third millennium. Over twenty international experts, including moral philosophers and social scientists, describe the issues and controversies surrounding modern biotechnology and genetic engineering. They explore ways in which lay individuals and groups can join in an effective and constructive dialogue with scientists and industrialists (...) over the assessment, exploitation and safe management of these new and important technologies. Topics covered include a discussion of the issues surrounding 'Dolly', the cloned sheep, the politics and ethics of the international research programme to sequence the entire human genome, the ethical questions raised by the creation of transgenic farm animals, the morality of genetic experimentation on animals, the controversy surrounding the patenting of genetic material and of the transgenic animals themselves, the ethical implications of engineering animals for transplanting their organs into humans, and the environmental hazards of releasing genetically engineered organisms. (shrink)

Research at the intersections of feminism, biology and philosophy provides dynamic starting grounds for this discussion of genetic technologies and animals. With a focus on animal bodies, I will examine moral implications of the genetic engineering of “domesticated” animals—primarily pigs and chickens—for the purposes of human consumption. Concepts of natural and artificial, contamination and purity, integrity and fragmentation and mind and body will feature in the discussion. In this respect, Margaret Atwood’s novel, Oryx and Crake, serves (...) as a cogent medium for exploring these highly contentious practices and ideas as it provides hypothetical narratives of possibility. Moreover, it is used to highlight contemporary hegemonic assumptions and values in ways that make them visible. Particular attention is paid to issues of growing human organs in pigs for xenotransplantation (resulting, for Atwood, in “pigoons”) and the ultimate end of the intensive factory farming of chickens through the genetic engineering of ‘mindless’ chicken tumours (or, as Atwood calls them, “ChickieNobs”). Integral to these philosophical considerations is the provocative question of the genetic modification of animal bodies as a means to end the suffering of domestic food animals. The ultimate implications of this question include an ongoing sensory and moral deprivation of human experience, potentially resulting in a future mechanomophosis, the extreme manifestation of an existing mechanomorphism. (shrink)

Designer Biology: The Ethics of Intensively Engineering Biological and Ecological Systems consists of thirteen chapters that address the ethical issues raised by technological intervention and design across a broad range of biological and ecological systems. Among the technologies addressed are geoengineering, human enhancement, sex selection, genetic modification, and synthetic biology.

Many people object to genetically engineerehd (GE) food because they believe that it is unnatural or that its creation amounts to playing God. These objections are often referred to as intrinsic objections, and they have been widely criticized in the agricultural bioethics literature as being unsound, incompatible with modern science, religious, inchoate, and based on emotion instead of reason. Many of their critics also argue that even if these objections did have some merit as ethicalobjections, their quasi-religious nature means that (...) they are entirely irrelevant when interpreted aspolitical objections regarding what public policy ought to be. In this paper, we argue that this widespread view is false. Intrinsic objections have much more political import than has previously been recognized, and indeed the requirements of political liberalism and its associated idea of liberal neutrality, once properly understood, protect intrinsic objections from many of the most common objections. That is, policy-makers may not legitimately base public policy on grounds that are inconsistent with intrinsic objections, even when they believe those objections to be flawed in the ways mentioned above. This means that in the context of a political debate about GE food, the discussion should not center on the substantive merits of the intrinsic objections themselves but rather on the appropriate political norms for achieving democratically legitimate policy on issues that touch people’s deepest religious and moral beliefs. (shrink)

Humans living off-world will face numerous physical, psychological and social challenges and are likely to suffer negative health effects due to their lack of evolutionary adaptation to space environments. While some of the necessary adaptations may develop naturally over many generations, genetic technologies could be used to speed this process along, potentially improving the wellbeing of early space settlers and their offspring. With broad support, such a program could lead to significant genetic modification of off-world communities, for example, (...) to limit radiation damage on body systems or prevent bone and muscle loss in reduced gravity conditions. Given the extreme stressors of living off-world, and the need to have a healthy workforce to support a fledgling human settlement, those in favour of using genetic technologies to enhance settlers might even claim there is a moral imperative to protect their health in the face of the unique threats of space travel, especially for children born in settlements who did not take on these risks voluntarily. For some, this might simply be an extension of procreative beneficence. However, ethical concerns arise regarding the risks of embracing a eugenicist agenda and the potential impacts on the rights of future settlers to refuse such genetic enhancements for themselves or their children. (shrink)

In the past fifteen years, there has been a virtual explosion of anthropological literature arguing that morality should be considered central to human practice. Out of this explosion new and invigorating conversations have emerged between anthropologists and philosophers. Moral Engines: Exploring the Ethical Drives in Human Life includes essays from some of the foremost voices in the anthropology of morality, offering unique interdisciplinary conversations between anthropologists and philosophers about the moral engines of ethical life, addressing the (...) question: What propels humans to act in light of ethical ideals? (shrink)

It has been suggested that the era of genetic interventions will sound the death knell for luck egalitarianism, as it will blur the line between chance and choice, on which theories of distributive justice often rest. By examining the threats posed to these theories, a crucial assumption is exposed; it is assumed that a commitment to the neutralisation of the effects of luck implies the endorsement of even the most morally controversial enhancements. In antithesis, I argue that an attractive (...) theory of luck egalitarianism, Dworkinian liberal equality, enables us to deduce plausible implications for genetic engineering. By focusing on the abstract moral commitments at the heart of Dworkin’s theory, a twofold purpose is served. First, they reveal in what ways the criticisms misfire, thereby safeguarding luck egalitarianism. Second, Dworkinian luck egalitarianism is further strengthened, as it produces plausible guidelines for public policy on genetic engineering in liberal societies. (shrink)

A lot of interest has been generated by the possibility of deriving gametes from embryonic stem cells and bone marrow stem cells. These stem cell derived gametes may become useful for research and for the treatment of infertility. In this article we consider prospectively the ethical issues that will arise if stem cell derived gametes are used in the clinic, making a distinction between concerns that only apply to embryonic stem cell derived gametes and concerns that are also relevant (...) for gametes derived from adult stem cells. At present, it appears preferable to use non-embryonic stem cells for the derivation of gametes. Adult stem cell derived gametes do not present any problems with regard to the moral status of the human embryo, bypass the safety risks linked to SCNT and do not present any ambiguity or novel problems with regard to informed consent, psychological consequences for the child or genetic parenthood. A remaining ethical concern, however, regards the safety of the procedure in terms of the welfare of the resulting children. This should spark a thorough reflection on how far one must go to accommodate a person’s wish to have a genetically related child. (shrink)

Background: A predictive genetic test for Huntington’s disease can be used before any symptoms are apparent, but there is only sparse knowledge about the long-term consequences of a positive test result. Such knowledge is important in order to gain a deeper understanding of families’ experiences. Objectives: The aim of the study was to describe a young couple’s long-term experiences and the consequences of a predictive test for Huntington’s disease. Research design: A descriptive case study design was used with a (...) longitudinal narrative life history approach. Participants and research context: The study was based on 18 interviews with a young couple, covering a period of 2.5 years; starting 6 months after the disclosure of the test results showing the woman to be a carrier of the gene causing Huntington’s disease. Ethical considerations: Even though the study was extremely sensitive, where potential harm constantly had to be balanced against the benefits, the couple had a strong wish to contribute to increased knowledge about people in their situation. The study was approved by the ethics committee. Findings: The results show that the long-term consequences were devastating for the family. This 3-year period was characterized by anxiety, repeated suicide attempts, financial difficulties and eventually divorce. Discussion: By offering a predictive test, the healthcare system has an ethical and moral responsibility. Once the test result is disclosed, the individual and the family cannot live without the knowledge it brings. Support is needed in a long-term perspective and should involve counselling concerning the families’ everyday life involving important decision-making, reorientation towards a new outlook of the future and the meaning of life. Conclusion: As health professionals, our ethical and moral responsibility thus embraces not only the phase in direct connection to the actual genetic test but also a commitment to provide support to help the family deal with the long-term consequences of the test. (shrink)

For elite athletes seeking a winning advantage, manipulation of their own genetic code has become a realistic possibility. In Genetic Technology and Sport, experts from sports science, genetics, philosophy, ethics, and international sports administration describe the potential applications of the new technology and debate the questions surrounding its use.

Should we make people healthier, smarter, and longer-lived if genetic and medical advances enable us to do so? Matti Häyry asks this question in the context of genetic testing and selection, cloning and stem cell research, gene therapies and enhancements. The ethical questions explored include parental responsibility, the use of people as means, the role of hope and fear in risk assessment, and the dignity and meaning of life. Taking as a starting point the arguments presented by (...) Jonathan Glover, John Harris, Ronald M. Green, Jürgen Habermas, Michael J. Sandel, and Leon R. Kass, who defend a particular normative view as the only rational or moral answer, Matti Häyry argues that many coherent rationalities and moralities exist in the field, and that to claim otherwise is mistaken"--Provided by publisher. (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)

How long new biomedical technologies are welcome paths for treatment of diseases or reduction of sufferings and where does the aspiration of human enhancement start? Are there basic criteria and standards for a demarcation or has this question to be answered pragmatically, based on a deliberated experience, open for the respective situation? In any case, a common understanding about boundary lines between elemental self-development and forced self-optimization is essential. The volume contains contributions to this burning issue given and debated during (...) the Berlin conference of the Protestant Research Academy (Evangelische Forschungsakademie) in January 2018 to stimulate a public discourse beyond pure scientific discussions. (shrink)