For several decades now, biologists have been developing digital databanks, which are remarkable scientific instruments allowing scientists to accelerate the development of biological knowledge. From the beginnings of the Human Genome Project (HGP) onwards, genetic databanks have been a major component of current biological knowledge, and biodiversity databanks have also been developed in the wake of the HGP. The purpose of this paper is to identify the specific features of biodiversity data and databanks, and to (...) point out their contribution to biodiversity knowledge. (shrink)

Background Genetic databases are becoming increasingly common as a means of determining the relationship between lifestyle, environmental exposures and genetic diseases. These databases rely on large numbers of research subjects contributing their genetic material to successfully explore the genetic basis of disease. However, as all possible research questions that can be posed of the data are unknown, an unresolved ethical issue is the status of informed consent for future research uses of genetic material. Discussion In (...) this paper, we discuss the difficulties of an informed consent model for future ineffable uses of genetic data. We argue that variations on consent, such as presumed consent, blanket consent or constructed consent fail to meet the standards required by current informed consent doctrine and are distortions of the original concept. In this paper, we propose the concept of an authorization model whereby participants in genetic data banks are able to exercise a certain amount of control over future uses of genetic data. We argue this preserves the autonomy of individuals at the same time as allowing them to give permission and discretion to researchers for certain types of research. Summary The authorization model represents a step forward in the debate about informed consent in genetic databases. The move towards an authorization model would require changes in the regulatory and legislative environments. Additionally, empirical support of the utility and acceptability of authorization is required. (shrink)

Organized into three main parts, this paper examines some challenges for the informed-consent process in medical research where DNA databanks are employed. In Part 1, we briefly describe the principle of informed consent and show why it is ethically important. Part 2 focuses on some specific challenges that that arise for the traditional informed-consent process in population-wide genetics/genomics research, especially where data-mining techniques are used. In the third and final section, we defend a model of consent based on the (...) notion of a "charitable trust," which we believe can help to preserve the integrity of the consent process in the context of medical and genetic research involving DNA databanks. (shrink)

During the past four years, the International Institute for Indigenous Resource Management has sponsored and co-sponsored a series of discursive roundtables on the ethical, legal, social, and cultural implications of genetic research on Indian tribes and Indian people. The deliberations of the tribal leaders, legal scholars, researchers, representatives of non-governmental organizations, and others who participated in these roundtables laid out a range of barriers to informed tribal participation in genetic research and proposed a policy, legal, and scientific research (...) agenda to fill gaps in knowledge and to otherwise support indigenous peoples' decision-making on genetic research issues.An understanding of Native American attitudes toward genetic research on their community cannot be fully understood absent an appreciation of the interrelationship among native peoples, genetic research, and the landscape, contaminated as it is by governmental and other factors. The deliberations described herein present invaluable insights into tribal attitudes toward genetic research that have application to ethical, legal and social aspects of forensic DNA databanks, sample collection and retention, and, in particular, issues of secondary non-forensic uses of such DNA. (shrink)

One interesting aspect of the Hwang-case has been the way in which this affair was assessed by academic journals such as Nature. Initially, Hwang’s success was regarded as evidence for the detrimental effects of research ethics, slowing down the pace of research in Western countries. Eventually, however, Hwang’s debacle was seen as evidence for the importance of ethics in the life sciences. Ironically, it was concluded that the West maintains its prominence in science (as a global endeavour) precisely because it (...) has its ethics in place. Bioethics was now seen as an indispensable part of quality control. In this article, I will claim that the Hwang case rather reveals that there is no reason for complacency and that there are substantial challenges awaiting us. They have to do with major transformations in the way knowledge is produced and research in the life sciences is conducted (such as the increase in pace and scale, globalisation and the growing importance of ICT and bioinformation). These transformations call for a different kind of bioethics. The focus must shift from duties of autonomous researchers concerning visible research subjects (“micro-ethics”) to responsibilities of institutionalised research networks in managing and processing large amounts of bioinformation (“macro-ethics”). Concepts such as transparency, reliability and benefit-sharing will become more important than concepts such as informed consent. Basically, it is a resurgence of the tension between the Kantian and the Hegelian view of ethics. The contours of macro-ethics will be elaborated notably as it is emerging in bioethical debates over biobanking and genetic databanks. (shrink)

Technology has provided state and federal governments with huge collections of DNA samples and identifying profiles stored in databanks. That information can be used to solve crimes by matching samples from convicted felons to unsolved crimes, and has aided law enforcement in investigating and convicting suspects, and exonerating innocent felons, even after lengthy incarceration. Rights surrounding the provision of DNA samples, however, remain unclear in light of the constitutional guarantee against unreasonable searches and seizures and privacy concerns. The courts (...) have just begun to consider this issue, and have provided little guidance. It is unclear whether the laws governing protected health information are applicable to the instant situation, and if so, the degree to which they apply. DNA databanks are not uniformly regulated, and it is possible that DNA samples contained in them may be used for purposes unintended by donors of the samples. As people live their lives, they leave bits of their DNA behind. They cannot be assured that these tiny specimens will not be taken or used against their will or without their knowledge for activities such as profiling to measure tendencies such as thrill-seeking, aggressiveness, or crimes with threatening behavior. Existing racial or ethnic discrimination and profiling may also encompass genetic discrimination and profiling, creating societal class distinctions. This article will explore the constitutionality of collecting genetic materials, the ethics of such activities, and balance the social good in solving crime and deterrence against the individual's security, liberty, and privacy. (shrink)

DNA databases have significant commercial value. Direct-to-consumer genetic testing companies have built databanks using samples and information voluntarily provided by customers. As the price of genetic analysis falls, there is growing interest in building such databases by paying individuals for their DNA and personal data. This paper maps the ethical issues associated with private companies paying for DNA. We outline the benefits of building better genomic databases and describe possible concerns about crowding out, undue inducement, exploitation, and (...) commodification. While certain objections deserve more empirical and philosophical investigation, we argue that none currently provide decisive reasons against using financial incentives to secure DNA samples. (shrink)

In this Symposium on the Ethics and Epistemology of Big Data, we present four perspectives on the ways in which the rapid growth in size of research databanks—i.e. their shift into the realm of “big data”—has changed their moral, socio-political, and epistemic status. While there is clearly something different about “big data” databanks, we encourage readers to place the arguments presented in this Symposium in the context of longstanding debates about the ethics, politics, and epistemology of biobank, database, (...) genetic, and epidemiological research. (shrink)

In this Symposium on the Ethics and Epistemology of Big Data, we present four perspectives on the ways in which the rapid growth in size of research databanks—i.e. their shift into the realm of “big data”—has changed their moral, socio-political, and epistemic status. While there is clearly something different about “big data” databanks, we encourage readers to place the arguments presented in this Symposium in the context of longstanding debates about the ethics, politics, and epistemology of biobank, database, (...) genetic, and epidemiological research. (shrink)

Society has historically not taken a benign view of genetic disease. The laws permitting sterilization of the mentally re tarded~ and those proscribing consanguineous marriages are but two examples. Indeed as far back as the 5th-10th centuries, B.C.E., consanguineous unions were outlawed (Leviticus XVIII, 6). Case law has traditionally tended toward the conservative. It is reactive rather than directive, exerting its influence only after an individual or group has sustained injury and brought suit. In contrast, state legislatures have not (...) been inhibited in enacting statutes. Many of their products can be characterized as hasty, unnecessary, ill-conceived, and based on the heart rather than the head. Moreover the lack of expert consultation sought has also been remarkable. One state legislature, for example, has advocated immunization for sickle cell anemia! Many others have enacted laws for the screening of inborn errors of metabolism, e.g., phenylketon uria, but have poorly defined the lines of responsibility to secure compliance. A spate of specific disease-related bills has emerged in the u.S. Congress, each seeking recognition and appropriations. Sickle cell anemia, hemophilia, Cooley's anemia and Tay-Sachs disease have been among the front-runners for support. Finally, in 1975, Congress has begun to examine an omnibus bill concerning all forms of genetic disease. The bill, termed the National Genetic Diseases Act is, however, still far from being enacted. (shrink)

The rapidly changing field of genetics affects society through advances in health-care and through implications of genetic research. This study addresses the impacts of new genetic discoveries and technologies on different segments of today's society. The book begins with a chapter on genetic complexity, and subsequent chapters discuss moral and ethical questions arising from today's genetics from the perspectives of health care professionals, the media, the general public, special interest groups and commercial interests.

The role of fixed charges present at the surface of biological membranes is usually described by the Gouy-Chapman-Grahame theory of the electric double-layer where the Grahame equation is applied independently on each side of the membrane and where the capacitive charges are disregarded. In this article, we generalize the Gouy-Chapman-Grahame theory by taking into account both intrinsic charges and capacitive charges, in the density value of the membrane surface charges. In the first part, we show that capacitive charges couple electrostatic (...) potentials present on both sides of the membrane. The intensity of this coupling depends both on the value of the membrane specific capacitance and the transmembrane electric potential difference. In the second part, we suggest some physiological implications of membrane electric double-layers. (shrink)

The Epic of Evolution is a course taught at Northern Arizona University. It engages the task of formulating a new epic myth that is based on the physical, natural, social, and cultural sciences. It aims to serve the need of providing meaning for human living in the vast and complex universe that the sciences now depict for us. It is an interdisciplinary effort in an academic setting that is often divided by specializations; it focuses on values in a climate of (...) relativism; and it concentrates on an enterprise for which there are few textbooks at hand. The course is presented in three segments: the cosmos before humans appeared, the human phenomenon, and scenarios for the future of evolution. (shrink)

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

The physician-patient relationship has changed over the last several decades, requiring a systematic reevaluation of the competing demands of patients, physicians, and families. In the era of genetic testing, using a model of patient care known as the family covenant may prove effective in accounting for these demands. The family covenant articulates the roles of the physician, patient, and the family prior to genetic testing, as the participants consensually define them. The initial agreement defines the boundaries of autonomy (...) and benefit for all participating family members. The physician may then serve as a facilitator in the relationship, working with all parties in resolving potential conflicts regarding genetic information. The family covenant promotes a fuller discussion of the competing ethical claims that may come to bear after genetic test results are received. (shrink)

Investigators and institutional review boards should integrate plans about the appropriate disclosure of individual genetic results when designing research studies. The ethical principles of beneficence, respect, reciprocity, and justice provide justification for routinely offering certain results to research participants. We propose a result-evaluation approach that assesses the expected information and the context of the study in order to decide whether results should be offered. According to this approach, the analytic validity and the clinical utility of a specific result determine (...) whether it should be offered routinely. Different results may therefore require different decisions even within the same study. We argue that the threshold of clinical utility for disclosing a result in a research study should be lower than the threshold used for clinical use of the same result. The personal meaning of a result provides additional criteria for evaluation. Finally, the context of the study allows for a more nuanced analysis by addressing the investigators' capabilities for appropriate disclosure, participants' alternative access to the result, and their relationship with the investigators. This analysis shows that the same result may require different decisions in different contexts. (shrink)

Genetic modification of crop plants is frequently described by its proponents as a continuation of the ancient process of domestication. While domestication, crop breeding, and GM all modify the genomes and phenotypes of plants, GM fundamentally differs from domestication in terms of the biological and sociopolitical processes by which change occurs, and the subsequent impacts on agrobiodiversity and seed sovereignty. We review the history of domestication, crop breeding, and GM, and show that crop breeding and GM are continuous with (...) each other in many important ways, but represent a momentous break from domestication because they move plant evolution off of farms and into centralized institutions. The social contexts in which these processes unfold dictate who holds rights to germplasm and agricultural knowledge, shape incentives to effect particular kinds of changes in our crops, and create or constrict biodiversity. Presenting GM as a continuation of domestication puts forward a false equivalency that fundamentally misrepresents how domestication, crop breeding, and GM occur. In doing so, this narrative diminishes public understanding of these important processes and obscures the effects of industrial agriculture on in situ biodiversity and the practice of farming. This misrepresentation is used in public-facing science communication by representatives of the biotechnology industry to silence meaningful debate on GM by convincing the public that it is the continuation of an age-old process that underlies all agricultural societies. (shrink)

The adequacy of Elliott Sober’s analogy between classical mechanics and evolutionary theory—according to which both theories explain via a zero-force law and a set of forces that alter the zero-force state—has been criticized from various points of view. I focus here on McShea and Brandon’s claim that drift shouldn’t be considered a force because it is not directional. I argue that there are a number of different theses that could be meant by this, and show that one of those theses—the (...) idea that drift cannot bias populations to be taken somewhere in the evolutionary space from one generation to the next—is actually false. Not only has this thesis been implicitly assumed in the discussion of the force analogy thus far, but it is also commonly found in a wider range of philosophical and biological texts. I argue that correcting this view, and the usual images associated with it, will thereby bring heuristic benefits that impact the force analogy discussion, but that also go beyond it. (shrink)

In March 1996, the General Accounting Office (GAO) issued the reportScientific Research: Continued Vigilance Critical to Protecting Human Subjects.It stated that “an inherent conflict of interest exists when physician-researchers include their patients in research protocols. If the physicians do not clearly distinguish between research and treatment in their attempt to inform subjects, the possible benefits of a study can be overemphasized and the risks minimized.” The report also acknowledged that “the line between research and treatment is not always cleartoclinicians. Controversy (...) exists regarding whether certain medical procedures should be categorized as research.”This problem currently plagues gene transfer research. A few months prior to the GAO report, an ad hoc committee appointed by National Institutes of Health (NIH) Director Harold Varmus expressed similar concerns in its assessment of NIH investment in research on gene therapy. (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)

Successful preimplantation genetic diagnosis to avoid creating a child affected by a genetically-based disorder was reported in 1989. Since then PGD has been used to biopsy and analyze embryos created through in viuo fertilization to avoid transferring to the mother’s uterus an embryo affected by a mutation or chromosomal abnormality associated with serious illness. PGD to avoid serious and early-onset illness in the child-to-be is widely accepted. PGD prevents gestation of an affected embryo and reduces the chance that the (...) parents will be faced with a difficult decision of whether to terminate the pregnancy. More controversial have been PGD to select the sex of the child-to-be for “family balancing”, PGD for mere susceptibility to disease and for late-onset disorders such as Alzheimer diseas, and most controversially, PGD to create a donor child who is Human Leukocyte Antigen (HLA-matched with a preexisting sibling in need of stem cell transplant. (shrink)

The term “exceptionalism” was introduced into health care in 1991 when Bayer described “HIV exceptionalism” as the policy of treating the human immunodeficiency virus different from other infectious diseases, particularly other sexually transmitted diseases. It was reflected in the following practices: pre- and post-HIV test counseling, the development of specific separate consent forms for HIV testing, and stringent requirements for confidentiality of HIV test results. The justification for these practices was the belief that testing was essential for prevention and that (...) patients might not seek HIV testing if confidentiality were not guaranteed. Confidentiality was believed to be particularly important given the degree of discrimination and stigmatization associated with the illness. Anonymous testing was a further step in ensuring strict confidentiality, even though such a practice prevented public officials from contacting partners and others who were at risk. (shrink)

By exploring whether nanotechnologies have the potential to generate green innovations, we consider the paradox between the negative and positive side-effects that could come with the development of nanotechnologies. Starting from the conceptual framework of green product innovation, the potential green innovation activity of more than 14,000 firms of the nanotech sector is investigated. Using a query-search method, their patenting activity is explored. Results first show that there is an increasing trend toward the creation of fundamental green knowledge by firms (...) involved in nanotechnologies; second, they demonstrate that energy efficiency is the main driver of green knowledge creation in the sector and third they reveal the main characteristics of nanotech firms creating green knowledge. Beyond their contribution to the debate between positive and negative outcomes of nanotechnology developments, these results also enrich the conceptual framework of green product innovation—a key route to achieving sustainability at the same time as growth. (shrink)

The concept of a communal type of privacy shared by interconnected social groups has wide applications in the healthcare field, specifically in genetic testing and genetic data privacy (Pyrrho, Cam...

Given the rise of genetic etiological beliefs regarding psychiatric disorders, a growing body of research has focused on trying to elucidate the effects that such explanatory frameworks might be having on how mental disorders are perceived by patients, clinicians, and the general public. Genetic and other biomedical explanations of mental disorders have long been seen as a potential tool in the efforts to destigmatize mental disorders, given the harshness of the widespread negative attitudes about them and the important (...) negative clinical and social impacts of this stigma. The conventional wisdom has appeared to be that because the effects of genes are seen as falling outside individual control, conceiving of mental disorders as caused by genes casts patients as blameless, thereby reducing stigmatization. Indeed, the results of experimental and correlational research have now robustly linked genetic and other biomedical explanations for mental disorders with reductions in the extent to which people are blamed for their psychiatric symptoms. However, research examining the impact of genetic and other biomedical explanations of mental disorders has also suggested that they can have significant downsides. The most consistently observed negative effect of these kinds of explanations is that they can apparently lead to the assumption that mental disorders are unlikely to improve or abate. Genetic and other biomedical explanations of mental disorders can also increase people’s confidence in the effectiveness of biomedical treatments (such as pharmacotherapy) but decrease their confidence in the effectiveness of “nonbiomedical” treatments (such as psychotherapy). (shrink)

Loi recently proposed a libertarian right to direct to consumer genetic testing — independent of autonomy or utility—reflecting Cohen’s work on self-ownership and Hohfeld’s model of jural relations. Cohen’s model of libertarianism dealt principally with self-ownership of the physical body. Although Loi adequately accounts for the physical properties of DNA, DNA is also an informational substrate, highly conserved within families. Information about the genome of relatives of the person undergoing testing may be extrapolated without requiring direct engagement with their (...) personal physical copy of the genome, triggering rights and interests of relatives that may differ from the rights and interests of others, that is, individual consumers, testing providers and regulators. Loi argued that regulatory interference with exercise of the right required justification, whereas prima facie exercise of the right did not. Justification of regulatory interference could include ‘conflict with other people’s rights’, ‘aggressive’ use of the genome and ‘harming others’. Harms potentially experienced by relatives as a result of the individual’s exercise of a right to test include breach of genetic privacy, violation of their right to determine when, and if, they undertake genetic testing and discrimination. Such harms may justify regulatory intervention, in the event they are recognised; motives driving ‘aggressive’ use of the genome may also be relevant. Each of the above criteria requires clarification, as potential redundancies and tensions exist between them, with different implications affecting different groups of rights holders. (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)

This article seeks to reframe the ethical discussion of genetic enhancement, which is the use of genetic engineering to supply a characteristic that a parent might want in a child that does not involve the treatment or prevention of disease. I consider whether it is likely that enhancement can be successfully prohibited. If genetic enhancement is feasible, it is likely that there will be demand for it because parents compete to produce able children and nations compete to (...) accumulate human capital in skilled workers. If some parents or nations begin using genetic enhancement, this will change these competitions in ways that increase the incentives for others to use it. Therefore, a ban on genetic enhancement would be unstable, because once the ban was breached by defectors the motivation of others to uphold it would weaken, making the ban liable to collapse. The argument provides a new perspective on slippery slopes to dangerous technology. Keywords: genetic enhancement, slippery slope argumentation CiteULike Connotea Del.icio.us What's this? (shrink)