This volume investigates human genetic biobanking and its regulation in various Asian countries and areas, including Japan, Mainland China, Taiwan, Hong Kong, ...

In response to political pressures arising from controversial science policy decisions, the United Kingdom (UK) government conducted a review of its biotechnology governance framework in 1999, identifying best practices of open government and creating strategic bodies to adopt them. Drawing from empirical data on the context and nature of the open government framework, this paper argues that the framework may be interpreted as elasticizing objectivity. Value-neutral scientific objectivity is essentially 'stretched' into a pluralist objectivity that purports (...) to represent a spectrum of interests without privileging any, allowing the policy culture to retain its legitimating objectivity and authority. Governance implications of this analysis are discussed. (shrink)

The production of genetic knowledge -- Scientific and economic strength of genetic reductionism -- Policy implications : discourses of genetic enlightenment as new disciplinary devices -- Genetic conceptualizations of normality and the idea of genetic justice -- Beyond genetic universality and authenticity, the lure of the genetic underclass -- Previews of the future as background -- Economic and actuarial perspective on genetics and insurance -- Practical and normative arguments against genetic exceptionalist legislation -- The changing social role of (...) private insurance : risk as a new representational regime. (shrink)

Informed by a search of the literature about the usage of genetic testing information (GTI) by insurance companies, this paper presents a practical ethical analysis of several distinct public policy options that might be used to govern or constrain GTI usage by insurance providers. As medical research advances and the extension to the Human Genome Project (2016, https://en.wikipedia.org/wiki/human_genome_project_-_write) moves to its fullness over the next decade, such research efforts will allow the full synthesis of human DNA to (...) be connected to predictive health dispositions. As testing costs fall, there will be ever more pressure for citizens to disclose GTI. Genetic testing information is integral to future medical care because it can be used to better assess individually tailored medical therapies as well as to allow a more informed risk analysis by the insurance industry, which in some countries such as the USA underwrites a majority of citizen medical expenses. As discussed in this examination, the revelation of people’s uniquely personal GTI to insurers has enormous societal implications. The major contribution of the paper is to offer policy makers and concerned citizens a nuanced articulation of the basic options to regulate GTI, with a special consideration for ethical fairness and equity. As genetic-based medicine blossoms and pressures to reduce healthcare costs increase, there will be an ever greater impetus for countries to revisit their genetic testing policies. Organizations and policy makers striving to create GTI oversights perceived to be both “fair and effective” need to be aware of the ethical perspectives discussed in this paper. (shrink)

Human body material removed post mortem is a particularly valuable resource for research. Considering the efforts that are currently being made to study the biochemical processes and possible genetic causes that underlie cancer and cardiovascular and neurodegenerative diseases, it is likely that this type of research will continue to gain in importance. However, post mortem procurement of human body material for research raises specific ethical concerns, more in particular with regard to the consent of the research participant. In (...) this paper, we attempt to determine which consent regime should govern the post mortem procurement of body material for research. In order to do so, we assess the various arguments that could be put forward in support of a duty to make body material available for research purposes after death. We argue that this duty does in practice not support conscription but is sufficiently strong to defend a policy of presumed rather than explicit consent. (shrink)

The prospect of using genome technologies to modify the human germline has raised profound moral disagreement but also emphasizes the need for wide-ranging discussion and a well-informed policy response. The Hinxton Group brought together scientists, ethicists, policymakers, and journal editors for an international, interdisciplinary meeting on this subject. This consensus statement formulated by the group calls for support of genome editing research and the development of a scientific roadmap for safety and efficacy; recognizes the ethical challenges involved in (...) clinical reproductive applications of genome editing but, importantly, rejects the idea that human reproductive germline modification is necessarily morally unacceptable; and highlights the importance of meaningful engagement in discussions of genome editing and the development of regulation and oversight mechanisms to govern future uses of such technologies. (shrink)

The governance of human (germline) genome modification at the international and transnational level -- The regulation of human germline genome modification in Canada (E Kleiderman) -- The regulation of human germline genome modification in the United States (Kerry Macintosh) -- The regulation of human germline genome modification in Mexico (M Medina Arellano) -- The regulation of human germline genome modification in Europe (J Almqvist, C Romano) -- The regulation of human germline genome modification in (...) the United Kingdom (J Lawford Davies) -- The regulation of human germline genome modification in Germany (T Faltus). (shrink)

The extent to which society utilises the law to enforce its moral judgments remains a dominant issue in this era of embryonic stem cell research, preimplantation genetic diagnosis, and human reproductive cloning. Balancing the potential health benefits and diverse moral values of society can be a tremendous challenge. In this context, governments often adopt legislative bans and prohibitions and rely on the inflexible and often inappropriate tool of criminal law. Legal prohibitions in the field of reproductive genetics are (...) not likely to reflect adequately the depth and diversity of competing stakeholder positions. Rather, a comprehensive and readily responsive regulatory policy is required. Such a policy must attend to the evolving scientific developments and ethical considerations. We outline a proposal for effective, responsive, and coherent oversight of new reproductive genetic technologies. (shrink)

The sequencing of the entire human genome has opened up unprecedented possibilities for healthcare, but also ethical and social dilemmas about how these can be achieved, particularly in developing countries. UNESCO's Bioethics Programme was established to address such issues in 1993. Since then, it has adopted three declarations on human genetics and bioethics (1997, 2003 and 2005), set up numerous training programmes around the world and debated the need for an international convention on human reproductive cloning. (...) Negotiating Bioethics presents Langlois' research on the negotiation and implementation of the three declarations and the human cloning debate, based on fieldwork carried out in Kenya, South Africa, France and the UK, among policy-makers, geneticists, ethicists, civil society representatives and industry professionals. The book examines whether the UNESCO Bioethics Programme is an effective forum for (a) decision-making on bioethics issues and (b) ensuring ethical practice. Considering two different aspects of the UNESCO Bioethics Programme - deliberation and implementation - at international and national levels, Langlois explores: - how relations between developed and developing countries can be made more equal - who should be involved in global level decision-making and how this should proceed - how overlap between initiatives can be avoided - what can be done to improve the implementation of international norms by sovereign states - how far universal norms can be contextualized - what impact the efficacy of national level governance has at international level Drawing on extensive empirical research, Negotiating Bioethics presents a truly global perspective on bioethics. (shrink)

The rapid pace of change in the biosciences makes setting biotechnology policies and regulating the sciences difficult for governments, but no less necessary for that. Although government policies around the globe are sometimes classed as ‘pro-science’ or ‘anti-science’, that is a misleading oversimplification. Nurturing the ‘bioeconomy’ is a key goal for most national governments, leading in the UK to a comparatively loose regulatory policy, for example in relation to mitochondrial transfer and germline genetic modification. But in genetic patenting, (...) a recent US court decision has reversed the trend towards privatisation of the human genome, which many scientists perceived as impeding their research. Opposition to permissive regulatory policies thus often comes not only from civic or religious groups, but also from within bioscience itself. In the area of vaccination against infectious disease, governments face an additional challenge from pandemics at the same time that financial austerity has prompted cutbacks in public health funding. (shrink)

Genetically engineered (GE) insects, such as the GE OX513A Aedes aegypti mosquitoes, have been designed to suppress their wild-type populations so as to reduce the transmission of vector-borne diseases in humans. Apart from the ecological and epidemiological uncertainties associated with this approach, such biotechnological approaches may be used by individual governments or the global community of nations to avoid addressing the underlying structural, systemic causes of those infections... We discuss here key ethical questions raised by the use of GE mosquitoes, (...) with the aim of fostering discussion between the public, researchers, policy makers, healthcare organizations, and regulatory agencies at the local, national, and international levels. We affect that goal by outlining a procedural approach to decision-making about the use of the “biotechnology” that goes beyond “community engagement.” The protocol we advocate for entails informed deliberations and decision-making at the community level. It is designed to ensure that the voices of the marginalized and vulnerable groups that would be disproportionately affected by the decision are heard during the community-wide discussions. Moreover, we make the case that the values embedded in the risk assessment should be identified so that the community can make an informed decision about the use of GE insects. In addition, we advocate for the involvement of a variety of actors whose responsibility would be to ensure that the community has the opportunity to make an informed decision based on deliberations about the use of the “biotechnology.”. (shrink)

LeRoy Walters was a central figure in debates about federal policy regarding genetics and biotechnology—a neutral, publicly engaged philosopher and religious studies academic who put his skills to work in national service. His career spanned the emergence of biotechnology as a field in the 1970s until his retirement. His interests reached from moral philosophical theory to Holocaust studies to practical concerns about public policy in genetics. We focus here on the role of bioethics in policy (...) related to the advent of human gene transfer, the Human Genome Project, and the emergence of biotechnology as a commercial enterprise. We focus on his role as an academic influencing the government strand of the “triple helix”... (shrink)

Human Enhancement Technology ranges from the commonplace, such as education, to the futuristic, with possible future developments including genetic modification or direct computer-brain interfaces. Public policies governing the supply of these technologies have the potential to greatly increase or mitigate economic inequality. Due to this potential harm, many have suggested prohibition of further developments of enhancement technologies. However, prohibition would in ineffective at preventing this harm and also would also prevent many positive aspects of enhancement technologies. On the other (...) hand, due to the expected benefits, many have suggested allowing access and development within a free-market system. However, this has the potential to increase inequality beyond acceptable levels. Consequently, Government policies must provide appropriate funding and regulation in order for these technologies to be distributed fairly to provide the most benefits and prevent the worst outcomes. (shrink)

In science policy, public controversy around synthetic biology has often been presented as a major risk because it could deter innovation. The following inter-related strategies for avoiding contestation have been observed: There have been attempts to close down debates by alluding to the importance and legitimacy of reliance on scientific evidence as input to regulatory processes. Scientific policy advice has stressed sufficiency of existing regulation, economic risks of additional regulation and/or suggestions for monitoring that are limited in scope. (...) Initiatives for self-governance have narrowed the scope of topics for consideration. Engagement with humanities, social sciences and arts has been co-opted for legitimisation and science communication. Although such agendas are of course not ubiquitous, in this paper, I criticise that instrumentally motivated engagement has been supported not only by the scientific community but also by policy institutions and funding bodies. I argue that it is good that this now seems to fuel controversy in the academic and policy realms. As synthetic biology is not the only technoscientific field to see such dynamics, this is also part of the broader context of debate about the governance of science, especially the concept of “responsible research and innovation” currently promoted in the EU. (shrink)

Genetic testing has become a vehicle through which basic constitutional relationships between citizens and the state are revisited, reaffirmed, or rearticulated. The interplay between the is of genetic knowledge and the ought of government unfolds in the context of diverse imaginaries of the forms of human well-being, freedom, and flourishing that states have a duty to support. This article examines how the United Kingdom, Germany, and the United States governed testing for Alzheimer’s disease, and how they diverged in (...) defining potential harms, benefits, and objects of regulation. Comparison before and after the arrival of direct-to-consumer genetic tests reveals differences in national understandings of what it means to protect life and citizenship: in the United Kingdom, ensuring physical wellness through clinical utility; in the United States, protecting both citizens’ physical well-being and freedom to choose through a framework of consumer protection; and in Germany, emphasizing individual flourishing and an unburdened sense of human development that is expressed in genetic testing law and policy as a commitment to the stewardship of personhood. Operating with their own visions of what it means to protect life and citizenship, these three states arrived at settlements that coproduced substantially different bioconstitutional regimes around Alzheimer’s testing. (shrink)

This edited collection examines the ethical, legal, social and policy implications of genome editing technologies. Moreover, it offers a broad spectrum of timely legal analysis related to bringing genome editing to the market and making it available to patients, including addressing genome editing technology regulation through procedures for regulatory approval, patent law and competition law. In twelve chapters, this volume offers persuasive arguments for justifying transformative regulatory interventions regarding human genome editing, as well as the various legal venues (...) for introducing necessary or desirable changes needed to create an environment for realizing the potential of genome editing technology for the benefit of patients and society. (shrink)

The struggle over genetically-engineered (GE) maize in Mexico reveals a deep conflict over the criteria used in the governance of agri-food systems. Policy debate on the topic of GE maize has become “scientized,” granting experts a high level of political authority, and narrowing the regulatory domain to matters that can be adjudicated on the basis of scientific information or “managed” by environmental experts. While scientization would seem to narrow opportunities for public participation, this study finds that Mexican activists acting (...) “in defense of maize” engage science in multiple ways, using and producing scientific knowledge as well as treating scientific discussions as a stage for launching complex social critiques. Drawing from research in science and technology studies, this article assesses the impacts and pitfalls of three tactics used by maize activists that respond to the scientization of biotechnology politics: (1) using scientific information as a resource; (2) participating in scientific research; and (3) reframing policy problems as broadly social, rather than as solely scientific or technical. The obstacles that maize activists have faced in carrying out each of these efforts indicate that despite diverse and sophisticated engagements between social movements and the scientific field, scientization remains a significant institutional barrier to democratizing agricultural governance. (shrink)

Over the next 15 years, the government-funded human genome project will map and sequence each of the human cell’s estimated 100,000 genes. The project’s first fruits will be a vast quantity of information about genetic disease. This information will contribute to the design of quicker, cheaper and more accurate tests for identifying deleterious genes in individuals. Because genetic conditions are often regarded as “immutable, heritable taints that intrinsically implicate the bearer’s identity,” overly-deterministic interpretations of genetic information can (...) readily distort genetic risk and become enshrined in institutional policies of social isolation and discrimination. (shrink)

As rapid advances in human genetic research are transferred into new areas of genetic technology, questions relatingto the use of these techniques will escalate. This paper examines some of the policy concerns surrounding recent developments in genetic screening. It discusses the impetus and implications of genetic screening in general, examines various applications, and analyzes the costs and benefits of screening programs currently in existence. Special emphasis is placed on whether or not screening should be considered a matter of (...) public health and mandated on those grounds. This paper argues against any compulsory screening programs except where the disease is easily identified, applicable across social groups, and treatable. While screening services for carriers of genetic disease and prenatal diagnosis should be made available and education programs should be expanded substantially, the burden of proof for involuntary programs is placed on the proponents. There is little public health justification at thb time for mandatory screening though this does not preclude future public health demands. It is argued that the goals and justification of various human genetic technologies must be examined at this time due to the rapid advancement of the research as well as the ultimate benefits promised for humankind. CiteULike Connotea Del.icio.us What's this? (shrink)

This paper reports on a recent symposium seminar series entitled ‘Governing genetic databases – collection, storage and use’ hosted by the Ethox Centre at the University of Oxford. It outlines the inadequacy of the current UK framework for governing genetic databases and biobanks and some of the implications of this. It then briefly describes and reflects on each of the five symposium papers.

Food labels legislated by the U.S. government have been designed to provide information to consumers. It has been asserted that the simple disclosures “produced using genetic engineering” on newly legislated U.S. food labels will send a signal that influences individual preferences rather than providing information. Vermont is the only US state to have experienced mandatory labeling of foods produced using genetic engineering via simple disclosures. Using a representative sample of adults who experienced Vermont’s mandatory GE labeling policy, we (...) examined whether GE labels were seen by consumers and whether the labels provided information or influenced preferences. Nearly one-third of respondents reported seeing a label. Higher income, younger consumers who search for information about GE were more likely to report seeing a label. We also estimated whether labels served as information cues that helped reveal consumer preferences through purchases, or whether labels served as a signal that influenced preferences and purchases. For 50.5% of consumers who saw a label, the label served as an information cue that revealed their preferences. For 13% of those who saw the label, the label influenced preferences and behavior. Overall, for 4% of the total sample, simple GE disclosures influenced preferences. For a slight majority of consumers who used a GE label, simple disclosures were an information signal and not a preference signal. Searching for GE information, classifying as female, older age and opposing GE in food production significantly increased the probability that GE labels served as an information source. Providing such disclosures to consumers may be the least complex and most transparent option for mandatory GE labeling. (shrink)

New techniques for the genetic modification of organisms are creating new strategies for addressing persistent public health challenges. For example, the company Oxitec has conducted field trials internationally—and has attempted to conduct field trials in the United States—of a genetically modified mosquito that can be used to control dengue, Zika, and some other mosquito-borne diseases. In 2016, a report commissioned by the National Academies of Sciences, Engineering, and Medicine discussed the potential benefits and risks of another strategy, using gene drives. (...) Driving a desired genotype through a population of wild animals or insects could lead to irreversible genetic modification of an entire species. The NASEM report recommends community, stakeholder, and public engagement about potential uses of the technology, and it argues that the engagement should occur as research advances, well before gene drives are deployed. Yet what “engagement” means in practice is unclear. This article seeks clarity on this problem by offering a justification for community engagement and drawing out implications of this argument for the implementation and desired outcomes of community engagement. Community engagement is essential when it comes to research that would release genetically modified insects or animals into the environment. By contrast, obtaining informed consent from people who live near such a proposed field trial is neither necessary nor sufficient. Drawing on the epistemic and moral arguments for deliberative democracy, I propose two discrete mechanisms of community engagement: community advisory boards and deliberative forums, neither of which has been systematically incorporated into research governance. The proposed mechanisms would engender respect for persons who live near field trials, even when the results of deliberation override some individuals’ preferences. Community engagement foregrounds the community in our thinking about humans’ relationship to nature, and it implies that deciding to release genetically modified insects or animals into the wild ought to be a collective decision, not one made by product developers, policy-makers, private companies, research funders, or scientists alone. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 11.2 (2001) 205-209 [Access article in PDF] Bioethics Inside the Beltway Banning Human Cloning-Then What? Cynthia B. Cohen The public wonder and concern that accompanied the birth of Dolly, the cloned sheep, four years ago died down soon after her arrival. Little has been heard about human reproductive cloning since then in the public square. This silence was pierced recently when two (...) groups each announced its intention to clone a child from a human being within the next few years.The Raelians, a religious organization, disclosed in October 2000 that they had found a grieving American couple willing to pay $500,000 to clone their deceased child and that they would proceed with cloning in a secret laboratory within the United States. A few months later, an international consortium led by Pavos Zavos, Ph.D., a University of Kentucky emeritus professor of biology, and Severino Antinori, M.D., an Italian infertility specialist, declared that it intended to clone the first human within two years at an undisclosed location outside the United States. These announcements led Representative James Greenwood (R-PA), chair of the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, to convene a hearing on human cloning on 28 March 2001.Why did human reproductive cloning suddenly become of concern to the House of Representatives? What will the federal government do with regard to the development of human cloning at this point in time? And what should it do to address human cloning in the long-term? I will briefly highlight the major controversies that surfaced at the hearing and then consider the broader questions. Scientific Controversies The initial question of concern to the House subcommittee members was whether cloning science has now reached the point of application to humans. Scientists at the hearing offered widely diverging views about this. Zavos testified that only a small number of cloned animals has died after birth and declared that the key to avoiding impaired human clones is to engage in prenatal screening. Consequently, it is now safe to undertake human cloning, he maintained. He was supported in this view by Brigitte Boisselier, Ph.D., visiting assistant professor [End Page 205] of chemistry at Hamilton College and scientific director of the Raelians, who argued that human cloning would not give rise to the problems that have been encountered in nonhuman mammalian cloning.However, professor of veterinary medicine Mark Westhusin, Ph.D., of Texas A&M University, and Massachusetts Institute of Technology researcher Rudolf Jaenisch, Ph.D., maintained that the same sorts of problems that have appeared in nonhuman mammalian cloning would reappear in human cloning. Westhusin stated that mammals have incurred serious defects leading to spontaneous abortion and that mammalian newborns often display severe respiratory and circulatory problems. The most likely explanation for such abnormalities, Jaenisch hypothesized, is that in cloning, the genetic reprogramming that governs the way an organism develops must take place in a much shorter period of time than in coital or in vitro reproduction. This may result in faulty reprogramming leading to dysregulation of gene expression and consequent genetic defects in cloned animals. There is good reason to think that this also would occur in human cloning, Jaenisch maintained. Until reproductive cloning research has been carried out on several generations of primates and is better understood, he argued, human cloning should not be attempted. Even then, several generations of descendants of human clones would have to be observed before scientists could be sure that it would not have a destructive impact on humans. This process could take as long as a century. Ethical Controversy Bioethicists who testified focused on those aspects of the ethical controversy surrounding human cloning that are of particular interest to public policy makers. Thomas Murray, Ph.D., President of The Hastings Center and a member of NBAC, maintained that human cloning is still unsafe, as NBAC had predicted, and that, if carried out, would leave in its wake "damaged women, many dead fetuses, and children born with serious impairments." He expressed particular concern that couples suffering... (shrink)

Social policies are used to regulate how members of a society interact and share resources. If we expand our sense of community to include the ecosystem of which we are a part, we begin to develop an ethical obligation to this broader community. This ethic recognizes that the environment has intrinsic value, and each of us, as members of society, are ethically bound to preserve its sustainability. In assessing the environmental risks of new agricultural methods and technologies, society should not (...) freely trade economic gains for ecological damage, but rather seek practices that are compatible with ecosystem health. This approach is used to evaluate the environmental risks associated with genetically engineered insect-resistant trees. The use of insect-resistant trees is a biologically based pest control strategy that has several advantages over pesticide use. However, the use of genetically engineered trees presents particular ecological concerns because the trees are long lived and often are not highly domesticated. The main environmental concerns reviewed include: (1) adaptation of pests to the trees, leading to a non-sustainable agricultural practice, (2) transgenic trees producing environmental toxins, (3) insect resistance enhancing the invasiveness of the tree, causing it to become weedy or invade wild habitats, and (4) transfer of the transgene to wild or feral relatives of the tree, possibly increasing the invasiveness of weeds or wild plants. Some methods are available to offset these risks; however, the environmental risks associated with this technology have been poorly researched and need to be more clearly identified so that when we evaluate the risks, it is based on the best information obtainable. To fulfil an ethical obligation to the environment, public policies and government regulations are needed to preserve the sustainability of both the environment and the future of our production systems. A better understanding of both the ecological issues and of genetic engineering in general are needed on the part of citizens and policy makers alike to ensure that sound environmental decisions are made. Otherwise, the environmental benefits of this technology, mainly decreasing the use of more toxic pesticides in tree crops and forests, will either be lost or traded for other environmental hazards. (shrink)

When intense public controversy erupted around agricultural biotechnology in the late 1990s, critics found opportunities to challenge risk assessment criteria and test methods for genetically modified products. In relation to GM food, they criticized the concept of substantial equivalence, which European Union and United States regulators had adopted as the basis for a harmonized, science-based approach to risk assessment. Competing policy agendas framed scientific uncertainty in different ways. Substantial equivalence was contested and eventually recast to accommodate some criticisms. To (...) explain how the concept changed, this article links two analytical perspectives. Regulatory-science perspectives illuminate how the scientification of politics and politicization of science led to shifts in the boundary between science and policy. Governance perspectives illuminate how the collective problem for policy was redefined to provide a new common ground for some stakeholders. Overall, substantial equivalence was recast to govern the social conflict and address legitimacy problems of regulatory procedures. (shrink)

In a first major study, the UK’s Royal Society found that 76% of people in the UK are in favour of therapeutic germline genomic editing to correct genetic diseases in human embryos, but found there was little appetite for germline genomic editing for non‐therapeutic purposes. Assuming the UK and other governments acted on these findings, can lawmakers and policymakers coherently regulate the use of biomedical innovations by permitting their use for therapeutic purposes but prohibiting their use for enhancement purposes? (...) This paper examines the very common claim in the enhancement literature that the therapy v enhancement distinction does little meaningful work in helping us think through the ethical issues, a claim that has significant implications for these lawmakers and policymakers who may wish to regulate genomic editing techniques to reflect the findings of this important study. The focus of this paper is on germline genomic editing as one of the main themes in this special issue. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Human Genome Project and BioethicsEric T. Juengst, Ph.D. (bio)The fifteen-year "human genome project" at the National Institutes of Health and the Department of Energy officially began on October 1, 1990. With it began a new dimension in federally supported scientific research: concurrent funding for work to anticipate the social consequences of the project's research and to develop policies to guide the use of the knowledge it (...) produces. As a result, the National Center for Human Genome Research (NCHGR) at NIH will support the largest public investment in bioethical analysis to date.NCHGR was established to work with other federal, private, and international organizations on the scientific effort to characterize the form and content of the human genome. The research will yield information—high-resolution genetic linkage and physical maps of all the human chromosomes as well as human DNA sequence data—that will be a resource for studies of gene structure and function. It will greatly increase our understanding of the genetic aspects of human health and disease. That increased understanding will eventually provide insights into the prevention and treatment of the 3,000 known inherited disorders, and of conditions caused by our (gene-governed) physiological reactions to pathogens, toxins, and mutagens of external origin.It has been clear since the conception of the human genome project, however, that professional and public deliberations concerning the responsible use of genetic information must be a part of the process. The most immediate consequence of genome research will be the development of new diagnostic and predictive tests, well in advance of corresponding therapeutic or curative advances. The implications of acquiring and using that knowledge about individuals raise policy questions at many levels within society. The primary purpose of the Ethical, Legal and Social Implications Program at the NCHGR is to anticipate and address these questions early in the life of the scientific project, to help optimize the [End Page 71] benefits to human welfare and opportunity from the new knowledge, and to guard against its misuses.The program has identified three sets of questions as particularly important to pursue as the genome initiative proceeds:1.Issues involved in the integration of new genetic tests into medical practice. Human genome research is expected to increase greatly the number of gene-based diagnostic and prognostic tests available to health professionals. The bioethical policy problems involved in integrating those tests effectively into medical practice include developing standards for:— accuracy and quality control of genetic tests;— medical indications for testing and design of testing protocols;— professional responsibilities of clinicians who perform tests;— confidentiality of information obtained from testing;— access to and use of test results by third parties, such as health insurers; and— reimbursement for testing and test-related counseling.These are problems for both those charged with regulating the use of new genetic tests and for those establishing the standards of practice within the health professions. Thus, in addition to soliciting and funding scholarly research proposals on both the factual and normative questions raised by these problems, the program is commissioning a major new study by the National Academy of Sciences/Institute of Medicine aimed at providing professional guidelines for the integration of genetic services into mainstream medical practice.2. Issues involved in educating and counseling individuals about genetic test results. The primary risk that health professionals will face in using genetic tests is the misinterpretation of their findings and the resulting potential for psychological trauma, stigmatization, and discrimination. Sometimes, out of ignorance, patients, families, and social institutions already stigmatize genetic disorders and treat those with them unfairly. This risk broadens as the genetic elements of more health problems are uncovered and gene-based tests for susceptibilities and carrier states are developed.To protect against these risks, NCHGR is soliciting and supporting projects aimed at improving professional and public understanding of these tests and their implications. For example, a philosopher is leading a team of geneticists and physicians in a scholarly effort to clarify [End Page 72] concepts of genetic susceptibility and draw out the social meaning of their different interpretations. Other projects involve social scientific studies of genetic risk perceptions, stigmatization, and discrimination. The conclusions of these studies, and... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Human Gene TherapyMary Carrington Coutts (bio)On September 14, 1990, researchers at the U.S. National Institutes of Health (NIH) performed the first approved gene therapy procedure on a four-year-old girl named Ashanti DeSilva. Born with a rare genetic disease, severe combined immune deficiency (SCID), Ashanti lacked a healthy immune system and was extremely vulnerable to infection. Children with SCID usually develop overwhelming infections and rarely survive to adulthood; even (...) a common childhood illness like chicken pox is life-threatening. Ashanti led a cloistered existence, avoiding contact with people outside her family, remaining in the sterile environment of her home, and battling frequent illnesses with massive amounts of antibiotics.In Ashanti's gene therapy procedure, her own white blood cells were genetically modified and then infused back into her bloodstream. Laboratory tests show that the therapy has strengthened Ashanti's immune system. She no longer has recurrent colds, has been allowed to attend school, and has been immunized against whooping cough. This gene therapy procedure is not a cure, however. The genetically-treated white blood cells only survive for a few months and must then be replaced, but Ashanti's future is much brighter because of the new therapy (VI, Thompson [The First] 1993).Although this simplified description of Ashanti's gene therapy procedure sounds like a happy ending, it is little more than an optimistic chapter in a long story. The road to the first approved gene therapy procedure was rocky and fraught with controversy. The biology of human gene therapy is very complex, and there are still many techniques that need to be developed and diseases that need to be understood more fully before gene therapy is well established. The public policy debate surrounding the possible use of genetically engineered material in human subjects is equally complex. Major participants in the debate come from the fields of biology, government, law, medicine, philosophy, politics, and religion, each bringing different views to the discussion.In studying the ethics of gene therapy, one should draw a distinction between [End Page 63] therapy on somatic (non-reproductive) cells and germ (reproductive) cells. Only the germ cells carry the genes that will be passed on to the next generation. Reactions to gene therapy have varied widely. Some commentators on gene therapy object to any form of genetic manipulation, no matter how well-intentioned (VI, Rifkin 1983). Another reaction is to allow the use of somatic-cell therapy, but not to approve the use of germ-line therapy, which could have unforeseeable effects on future generations. A different stance is that, with proper regulation and safeguards, germ-line gene therapy is a logical extension of the progress made to date and that it is an ethically acceptable procedure.TechniquesTo date, 43 research protocols have been approved for somatic-cell gene therapy in the United States. The techniques employed in each protocol vary, but in general a virus is used as a "vector" to insert the desired gene into the DNA of the patient's cells, in order to compensate for a defective gene. For Ashanti's gene therapy, this technique involved obtaining white blood cells and introducing properly functioning genes into as many of the cells as possible. The normal genes were delivered through the use of a specially-engineered virus.Although similar techniques are used in germ-line gene therapy, the procedure is more difficult. There are two basic ways to perform germ-line gene therapy: (1) to treat a preimplantation embryo that carries a serious genetic defect before its implantation in the mother, which necessitates the use of in vitro fertilization techniques; or (2) to treat the germ cells (sperm or egg cells) of afflicted adults so that the genetic defects would not be passed on to their offspring, which requires the technical expertise to delete the defective gene and insert a properly functioning replacement. Because of the complexity of the procedures involved and the attendant ethical controversy, germ-line therapy is not currently performed.Candidate Diseases for Gene TherapyAt present, gene therapy is likely to be most successful in treating diseases that are caused by single-gene defects and has been approved for treating diseases such... (shrink)

During the past 20 years, the importance of human genetic information has exploded. Whether sought for medical treatment, disease prediction studies, cultural studies, or the general study of human origins, human genetic information is now viewed as crucial for scientific research and general attempts at human understanding.With the importance of genetic information have come bitter battles over its control. The demonstrated power of human genetic information has moved the issue of its “ownership” from the realm (...) of musty academic musings to protracted political and legal battles among “source” individuals, researchers, commercial concerns, government agencies, and others. Whether collected through targeted scientific studies, “discarded” biological tissue, initial charitable bequest, or other means, genetic information and the biological materials in which it is contained have become the subject of protracted legal battles for control and intense social and ethical controversy. (shrink)

This essay analyzes one of Germany's former premier research institutions for biomedical research, the Kaiser Wilhelm Institute for Anthropology, Human Heredity and Eugenics (KWIA) as a test case for the way in which politics and human heredity served as resources for each other during the Third Reich. Examining the KWIA from this perspective brings us a step closer to answering the questions at the heart of most recent scholarship concerning the biomedical community under the swastika: (1) How do (...) we explain why the vast majority of German human geneticists and eugenicists were willing to work for the National Socialist state and, at the very least, legitimized its exterminationist racial policy; and (2) what accounts for at least some of Germany's most renowned medically trained professionals' involvement in forms of morally compromised science that wholly transcend the bounds of normal scientific practice? Although a complete answer to this question must await an examination of other German biological research centers, the present study suggests that during the Nazi period the symbiotic relationship between human genetics and politics served to radicalize both. The dynamic between the science of human heredity and Nazi politics changed the research practice of some of the biomedical sciences housed at the KWIA. It also simultaneously made it easier for the Nazi state to carry out its barbaric racial program leading, finally, to the extermination of millions of so-called racial undesirables. (shrink)

The centerpiece of Aldous Huxley's Brave New World is state control of the human reproduction process as a means of ensuring social stability. Although written as fiction, recent advances in human genetic and reproductive technology promise to give us more control over our biological destiny, including procreation. Concurrently, they create new social policy dilemmas, challenge prevailing "givens" of the human condition, and, technologically, increase the possibility of centralized control over reproduction. After reviewing the current status of (...) human genetic technology and discussing its use in the United States, this article analyzes the implications of these innovations for the future. (shrink)

This paper seeks to expand our appreciation of the gene editing tool, clustered regularly interspaced short palindromic repeats‐associated protein 9 (CRISPR‐Cas9), its function, its benefits and risks, and the challenges of regulating its use. I frame CRISPR's emergence and its current use in the context of 150 years of formal exploration of heredity and genetics. I describe CRISPR's structure and explain how it functions as a useful engineering tool. The contemporary international and domestic regulatory environment governing human genetic (...) interventions is reviewed and shown to be increasingly ineffective in its ability to restrain, guide, and optimize the emerging use of CRISPR. Several reasons for this lack of consensus are discussed. In conclusion, I suggest a number of public policy recommendations that might allow us to simultaneously embrace our most important moral values and manage the inevitable power CRISPR will come to have in our lives. (shrink)

Until recently, scientific consensus held firm that genetically manipulated embryos created through methods including Mitochondrial Replacement Therapy or human germline genome editing should not be used to initiate a pregnancy. In countries that have relevant laws pertaining to heritable human germline modifications, the vast majority prohibit or restrict this practice. In the last several years, scholars have observed a transformation of scientific and policy restrictions with insistent calls for creating a regulatory pathway. Multiple stakeholders highlight the role (...) of social consensus and public engagement for governance of heritable human germline modifications. However, in the drive to gain public acceptance and lift restrictions, some proponents provide distorted or misleading narratives designed to influence public perception and incrementally shift the consensus. This article describes eight discrete strategies that proponents employ to influence framing, sway public opinion, and revise policymaking of human germline modifications in a manner that undermines honest engagement. (shrink)

Human rights legislation pertaining to applications of human genetic science is still lacking at an international level. Three international human rights documents now serve as guidelines for countries wishing to develop such legislation. These were drafted and adopted by the United Nations Educational, Scientific and Cultural Organization, the Human Genome Organization, and the Council of Europe. It is critically important that the international nursing community makes known its philosophy and practice-based knowledge relating to ethics and (...) class='Hi'>human rights, and contributes to the globalization of genetics. Nurses have particular expertise because they serve in a unique role at grass roots level to mediate between genetic science and its application to public health policies and medical interventions. As a result, nurses worldwide need to focus a constant eye on human rights ideals and interpret these within social, cultural, economic and political contexts at national and local levels. The purpose of this article is to clarify and legitimate the need for an international declaration on nursing, human rights, human genetics and public health policy. Because nurses around the world are the professional workforce by which genetic health care services and genetic research protocols will be delivered in the twenty-first century, members of the discipline of nursing need to think globally while acting locally. Above all other disciplines involved in genetics, nursing is in a good position to articulate an expanded theory of ethics beyond the principled approach of biomedical ethics. Nursing is sensitive to cultural diversity and community values; it is sympathetic to and can introduce an ethic of caring and relational ethics that listen to and accommodate the needs of local people and their requirements for public health. (shrink)

Today it is possible to screen for mutated DNA sequences which do not induce any diseases but predispose to develop diseases under certain environmental condition. These latter disorders are called multifactorial since they result from the interplay of genetic and environmental factors. Among multifactorial disorders there are job-related diseases whose genetic component can be identified by genetic screening tests. The use of these tests to predict occupational disorders, to cut down on them, and to save costs—in particular for absenteeism, health (...) care, and lawsuits—is of interest to employers and insurers. As for employees, it could entail an extremely deep invasion of privacy, economic problems and, very likely, a jeopardy of the present position of the individual who may be screened even if his/her potential disease is never developed. (shrink)

_One of the enduring queries in the development of human intellectual thought is, "What is human nature?" What does it mean to be a human tends to be defined by all disciplines, including religion? We all need theories about what makes people tick in order to predict how they will respond to their environment in various situations. Indeed, how we view human nature affects a number of things. People utilize it in their private lives to govern (...) their daily routines, manage their relationships, raise their children, and influence others. Additionally, our policies in areas of collective social life like politics, law, and education are influenced by how we view human nature. Steven Pinker critically explains the modern view of human nature and its theoretical presuppositions in his widely read book The Blank Slate: The Modern Denial of Human Nature. Pinker contends that this contemporary account of human nature faces significant challenges in light of recent developments in the fields of biology, genetics, evolution, and the brain sciences. Because it is built on axioms that we cannot accept in light of the advancements in science over the past few decades, the current theory of human nature is conceptually unsound. This research performs a comparative analysis between Pinker’s View of Human Nature and Dupré’s Critique of Evolutionary Psychology on the principles which serve as the foundation for the influential idea of human nature, and contributes significantly in our contemporary intellectual life._. (shrink)

It is important to talk about corporations as a class, about trade agreements, and about government policy; but without examining specific examples of how real corporations actually shape the world to suit their purposes, we stand little chance of understanding the determinative forces behind government policy and trade agreements, and even less chance of affecting them. This article uses the metaphor of “genetics” (inherent character) to examine two major transnational corporations operating at the extremes of (...) restructuring life. (shrink)

In its governance activities for genetic resources, the international community has adopted various approaches to their ownership, including: free access; common heritage of mankind; intellectual property rights; and state sovereign rights. They have also created systems which combine elements of these approaches. While governance of plant and animal genetic resources is well-established internationally, there has not yet been a clear approach selected for human genetic resources. Based on assessment of the goals which international governance of human genetic resources (...) ought to serve, and the implications for how they will be accessed and utilised, it is argued that common heritage of mankind will be the most appropriate approach to adopt to their ownership/control. It does this with the aim of stimulating discussion in this area and providing a starting point for deeper consideration of how a common heritage of mankind, or similar, regime for human genetic resources would function and be implemented. (shrink)

For the first time in the history of civilization, humans have procured the power to rewrite nature's book of life. Following the discovery of CRISPR and other key scientific developments at the dawn of the twenty-first century, humankind has-for better or worse-reached the Rubicon of precise genetic manipulation, which existed only in science fiction until now. Those familiar with genome editing understand its colossal power and potential to become a global transformative agent that surpasses the impact of electricity, the atomic (...) bomb, or the Internet. REWRITING NATURE is an interdisciplinary odyssey through the law, science, and policy of genome editing-the most significant breakthrough of our generation. The volume addresses a critical need to bridge gaps between law, science, and policy, and challenges the conventional, false dichotomy frequently associated with mutually exclusive normative roles for science and law. Through exploration of heuristic inquiries into an array of interdisciplinary fields, the book seeks to ignite thoughtful dialogues about authentic-rather than manufactured or sensationalized-issues raised by the technology. This timely resource is intended for keen audiences focused on venturing beyond the headlines and talking points to develop a deeper understanding of the prospects and challenges of genome editing. (shrink)

In many parts of sub-Saharan Africa, mothers impacted by the genetic condition of albinism, whether as mothers of children with albinism or themselves with albinism, are disproportionately impacted by a constellation of health-related stigma, social determinants of health, and human rights violations. In a critical ethnographic study in Tanzania, we engaged with the voices of mothers impacted by albinism and key stakeholders to elucidate experiences of stigma. Their narratives revealed internalized subjective stigma, social stigma such as being ostracized by (...) family and community, and structural stigma on account of lack of access to SDH. An analysis of health systems as SDH revealed stigmatizing attitudes and behaviours of healthcare providers, especially at the time of birth; a lack of access to timely quality health services, in particular skin and eye care; and a lack of health-related education about the cause and care of albinism. Gender inequality as another SDH featured prominently as an amplifier of stigma. The findings pose implications for research, policy, and practice. A concrete avenue to de-stigmatization of mothers impacted by albinism exists by the application of principles of human rights, particularly equality and non-discrimination; contextual analysis of cultural dynamics including relevant ontology; meaningful participation of rights-claimants, such as peer groups of mothers; and accountability of governments and their obligation to ensure access to health information as a key social determinant of the right to health. (shrink)

The ethical issues associated with germline gene modification and embryo research are some of the most contentious in current international science policy debates. In this paper, we argue that new genetic techniques, such as CRISPR, demonstrate that there is an urgent need for China to develop its own regulatory and ethical framework governing new developments in genetic and embryo research. While China has in place a regulatory framework, it needs to be strengthened to include better compliance oversight and explicit (...) criteria for how different types of research should be reviewed by regulatory authorities. We also document a variety of opinions about the new technologies among the public, scholars, and policy makers. China needs to develop its own regulations in coordination with other countries; but it is unlikely that an international consensus will be achieved in this area, given the existing differences in regulations between countries. We should aim at harmonization, not necessarily complete consensus, and the perspective from China is vital when international norms are developed and harmonized. Chinese policy makers and researchers need to be aware of the international discussions, at the same time as the international community is aware of, and accommodates, Chinese positions on important policy options. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Ethical, Legal, and Social Implications Research Program at the National Human Genome Research InstituteEric M. Meslin (bio), Elizabeth J. Thomson (bio), and Joy T. Boyer (bio)Organizers of the Human Genome Project (HGP) understood from the beginning that the scientific activities of mapping and sequencing the human genome would raise ethical, legal, and social issues that would require careful attention by scientists, health care professionals, (...) class='Hi'>government officials, and the public. The establishment of the ELSI (ethical, legal, and social implications) programs at the National Human Genome Research Institute (NHGRI) and the Department of Energy (DOE) was thought to be vital to the success of the HGP in the United States. It also provided a novel approach to the simultaneous study of ethical, legal, and social issues and basic scientific issues. Eric Juengst, the first director of the ELSI program, described its origins in a previous issue of the Kennedy Institute of Ethics Journal (Juengst 1991). Now in its seventh year, the ELSI program has accomplished much. This article summarizes the evolution and goals of the ELSI program at NHGRI, outlines the program’s current research priorities with examples of activities within each priority area, and provides a look to the future, including the initiation of a strategic planning process.Evolution and Goals of the ELSI Research ProgramThe HGP’s “genomic” goals are unique: to map and sequence the entire human genome—some 3 billion base pairs that make up approximately 80–100,000 genes—and the genomes of related model organisms by the year 2005. This goal was particularly ambitious since, when it was proposed, the technologies for mapping and sequencing had yet to be developed. When the HGP was first established, its organizers also elaborated a set of ELSI goals, which they saw as vital to the success of the genome project. The original ELSI goals were: (1) to anticipate and address the implications of the HGP for individuals and society and (2) to examine the ELSI consequences of mapping and sequencing the human genome in order to stimulate public discussion. To meet these goals, the NHGRI created its ELSI research program in 1990. Along with mapping, sequencing, [End Page 291] and mammalian genetics, ELSI was one of four original branches in the NHGRI Division of Extramural Research that funded research in those areas. Although the individual “branches” no longer exist, the mechanisms for funding research remain much the same. While the overall goals of the program have not changed, the specific ways of achieving the goals have continued to evolve. The importance of the ELSI program lies not in the collection of a full set of data that will be valuable in and of itself, but in the value of using and interpreting this new set of information.Early on, the NHGRI described a set of somewhat more specific goals: (1) to develop a program to help understand the ethical, legal, and social implications of the human genome project and (2) to identify and define the major issues of concern and develop policy options to address them. These more specific goals have been largely met. As the most recent biennial NHGRI Progress Report notes, “a robust ELSI research and education program has been established, many of the most urgent ELSI issues have been identified, and many policy options to address these issues have been proposed” (NCHGR 1995, p. 21). Between 1990 and 1996, ELSI provided more than $32.5 million in funding through 128 research and education grants in more than 30 states and in Canada (Table 1). The ELSI research budget is unique in that when originally created, it was specifically tied to the amount of money provided for the overall NHGRI budget. The NHGRI originally devoted 3 percent of its extramural budget to fund ELSI projects, but in FY 1991, it increased the ELSI budget to 5 percent, a figure that remains today. Table 2 lists the expenditures for each fiscal year since 1990 and the cumulative expenditures to date. The ELSI research budget at NHGRI this year will be about $7 million. When other sources of funding—e.g., co-funding arrangements with other institutes and agencies and the funding of ELSI... (shrink)

The sustainable development of rural areas involves guaranteeing the quality of life and well-being of people who live in those areas. Existing studies on farmer health and well-being have revealed high levels of stress and low well-being, with government regulations emerging as a key stressor. This ethnographic study takes smallholder farmers in two rural mountain areas of Italy, one in the central Alps and one in the northwest Apennines, as its focus. It asks how and why the current (...) class='Hi'>policy and regulatory context of agriculture affects farmer well-being. Interviews and participant observation were conducted with 104 farmers. Three common scenarios emerged that negatively affect farmer well-being. First, policies and regulations designed for lowland areas do not always make sense when applied in the mountains. Second, when subsidies are put into effect at the local level, the reality of their implementation can veer away from the original goals of the funding program and have unintended effects on farmer well-being, agricultural practices, and the environment. Finally, when regulations are implemented on farms in rural mountain areas, the primacy of a techno-scientific knowledge system over other, local and place-based knowledge systems is exposed. These three scenarios affect well-being by eliciting feelings of stress, frustration, and disillusionment; by reducing farmer control over their work; and by fostering the perception that farming is not valued by society. They also create conditions of inequality and insecurity. The ways in which government policies and regulations play out on mountain farms can erode trust in government institutions, lead to an us versus them mentality, and contribute to the further abandonment of agriculture and rural areas. (shrink)

During the 1920s and 1930s geneticist L. C. Dunn of Columbia University cautioned Americans against endorsing eugenic policies and called attention to eugenicists' less than rigorous practices. Then, from the mid-1940s to early 1950s he attacked scientific racism and Nazi Rassenhygiene by co-authoring Heredity, Race and Society with Theodosius Dobzhansky and collaborating with members of UNESCO on their international campaign against racism. Even though shaking the foundations of scientific discrimination was Dunn's primary concern during the interwar and post-World War II (...) years, his campaigns had ancillary consequences for the discipline. He contributed to the professionalization of genetics during the 1920s and 1930s and sought respectability for human genetics in the 1940s and 1950s. My article aims to elucidate the activist scientist's role in undermining scientific discrimination by exploring aspects of Dunn's scientific work and political activism from the 1920s to 1950s. Definitions are provided for scientific discrimination and activist scientist. (shrink)

So-called ‘anonymous’ tissue samples are widely used in research. Because they lack externally identifying information, they are viewed as useful in reconciling conflicts between the control, privacy and confidentiality interests of those from whom the samples originated and the public (or commercial) interest in carrying out research, as reflected in ‘consent or anonymise’ policies. High level guidance documents suggest that withdrawal of consent and samples and the provision of feedback are impossible in the case of anonymous samples. In view of (...) recent developments in science and consumer-driven genomics the authors argue that such statements are misleading and only muddle complex ethical questions about possible entitlements to control over samples. The authors therefore propose that terms such as ‘anonymised’, ‘anonymous’ or ‘non-identifiable’ be removed entirely from documents describing research samples, especially from those aimed at the public. This is necessary as a matter of conceptual clarity and because failure to do so may jeopardise public trust in the governance of large scale databases. As there is wide variation in the taxonomy for tissue samples and no uniform national or international standards, the authors propose that a numeral-based universal coding system be implemented that focuses on specifying incremental levels of identifiability, rather than use terms that imply that the reidentification of research samples and associated actions are categorically impossible. (shrink)

Heredity and reproduction have always been matters of concern. Eugenics is a story that began well before the Holocaust, but the Holocaust completely changed the way eugenics was perceived at that time. What began with Galton as a scientific movement aimed at the improvement of the human race based on the theories and principles of heredity and statistics became by the beginning of the 20th century an international movement that sought to engineer human supremacy. Eugenic ideas, however, trace (...) back to ancient Greek aristocratic ideas exemplified in Plato’s Republic, which played an important role in shaping modern eugenic social practices and government policies. Both positive and negative eugenics focused on the encouragement of healthy and discouragement of unhealthy reproduction. All these practices were often based on existing prejudices about race and disability. In this article, we will focus on the rise of eugenics, starting with the publication of Origin of Species to the Holocaust. This examination will be multidisciplinary, utilizing genetics, legal history and bioethical aspects. Through this examination, we will discuss how provisional understandings of genetics influenced eugenics-based legislation. We will also discuss the rise of biopolitics, the change of medical ethos and stance towards negative eugenics policies, and the possible power of bioethical principles to prevent such phenomena. (shrink)

Human genetic enhancement, examined from the standpoint of the new field of political bioethics, displaces the age-old question of truth: What is human nature? This book displaces that question with another: What kind of human nature should humans want to create for themselves? To answer that question, this book answers two others: What constraints should limit the applications of rapidly developing biotechnologies? What could possibly form the basis for corresponding public policy in a democratic society? Benjamin (...) Gregg focuses on the distinctly political dimensions of human nature, where politics refers to competition among competing values on which to base public policy, legislation, and political culture. This book offers citizens of democratic communities a broad perspective on how they together might best approach urgent questions of how to deal with the socially and morally challenging potential for human genetic engineering. (shrink)