Direct-to-Consumer Genetic Testing: Value and Risk.

Although the explosive growth of direct-to-consumer (DTC) genetic testing has moderated, a substantial number of patients are choosing to undergo genetic testing outside the purview of their regular healthcare providers. Further, many industry leaders have been expanding reports to cover many more genes, as well as partnering with employers and others to expand access. This review addresses continuing concerns about DTC genetic testing quality, psychosocial impact, integration with medical practice, effects on the healthcare system, and privacy, as well as emerging concerns about third-party interpretation services and non-health-related uses such as investigative genetic genealogy. It concludes with an examination of two possible futures for DTC genetic testing: merger with traditional modes of healthcare delivery or continuation as a parallel system for patient-driven generation of health-relevant information. Each possibility is associated with distinctive questions related to value and risk.

Knowledge development, technology and questions of nursing ethics.

This article explores emerging ethical questions that result from knowledge development in a complex, technological age. Nursing practice is at a critical ideological and ethical precipice where decision-making is enhanced and burdened by new ways of knowing that include artificial intelligence, algorithms, Big Data, genetics and genomics, neuroscience, and technological innovation. On the positive side is the new understanding provided by large data sets; the quick and efficient reduction of data into useable pieces; the replacement of redundant human tasks by machines, error reduction, pattern recognition, and so forth. However, these innovations require skepticism and critique from a profession whose mission is to care for and protect patients. The promise of technology and the new biological sciences to radically and positively transform healthcare may seem compelling when couched in terms of safety, efficiency, and effectiveness but their role in the provision of ethical nursing care remains uncertain. Given the profound moral and clinical implications of how today's knowledge is developed and utilized, it is time to reconsider the relationship between ethics and knowledge development in this new uncharted area.

Epigenetics and the environment in bioethics.

A rich literature in public health has demonstrated that health is strongly influenced by a host of environmental factors that can vary according to social, economic, geographic, cultural or physical contexts. Bioethicists should, we argue, recognize this and--where appropriate--work to integrate environmental concerns into their field of study and their ethical deliberations. In this article, we present an argument grounded in scientific research at the molecular level that will be familiar to--and so hopefully more persuasive for--the biomedically-inclined in the bioethics community. Specifically, we argue that the relatively new field of molecular epigenetics provides novel information that should serve as additional justification for expanding the scope of bioethics to include environmental and public health concerns. We begin by presenting two distinct visions of bioethics: the individualistic and rights-oriented and the communitarian and responsibility-oriented. We follow with a description of biochemical characteristics distinguishing epigenetics from genetics, in order to emphasize the very close relationship that exists between the environment and gene expression. This then leads to a discussion of the importance of the environment in determining individual and population health, which, we argue, should shift bioethics towards a Potterian view that promotes a communitarian-based sense of responsibility for the environment, in order to fully account for justice considerations and improve public health.

Playing God: the rock opera that endeavors to become a bioethics education tool.

This article describes and introduces a new innovative tool for bioethics education: a rock opera on the ethics of genetics written by two academics and a drummer legend. The origin of the idea, the characters and their development, and the themes and approaches as well as initial responses to the music and the show are described, and the various educational usages are explored.

Introducing "Precision Health Promotion": The Convergence of Genomics, Health Education, and Lived Experience.

The prospect that modifying just one mutated letter in a genomic sequence could save millions of lives has spawned a growing discipline called personalized medicine (PM). Where PM focuses on bringing greater precision to individual treatments, the genetics revolution also invites questions about how genetics testing and genetics reference panels can be applied in a public health context. Some voice concerns that the growth of PM will shift us back to an emphasis on the medical model for health advancement with undue focus and investment on individual rather than societal solutions. This editorial introduces precision health promotion and defines it as "the personalized design of lived experiences that foster improved health and well-being for individuals within the context of their families, organizations and communities."

[Neuroethics in clinical practice]. / Neuroethische Verantwortung in der nervenärztlichen Praxis.

In recent years the ability of neuroscience to identify and intervene in mental functions has progressed immensely, which raises several anthropologic and ethical questions. Meanwhile neuroethics arose as a new interdisciplinary field for critical analysis of neuroscientific actions and ethical reflection on the increasing knowledge of the human brain, with regard to society and politics. This article provides a survey of neuroethical implications for clinical practice.

A legal duty to disclose individual research findings to research subjects?

Research that utilizes human subjects is a large and growing enterprise. Tens of millions of individuals have already participated as subjects in one or more research protocols, and millions more participate each year. Government and industry combined spend billions annually to support as many as 20,000 research studies, many of which are individually large and complex enterprises in their own right.These numbers are, if anything, likely to increase even further. Besides the growth in research, two other trends are apparent. First, research-related litigation is on the rise and appears likely to become even more widespread. Sparked at least in part by recent widely publicized instances of harm befalling research subjects, plaintiffs' attorneys are suing both more often and more creatively. Related to this is the second trend: public trust in research is declining and, as a result, at least some types of research are struggling to find adequate numbers of human subjects.As a result of these trends, exposure to potential liability and public perception are both increasingly important. Concomitant with all of this research is the discovery and generation of tremendous quantities of data specific to individual subjects, including--but not limited to--genetic information. Much of this data is irrelevant to subjects' interests because it lacks predictive value, has uncertain meaning, or is otherwise uninformative. Some, however, is different--some of the personal data learned during the course of research with human subjects bears directly on individuals' health. Despite the fact that much individual data has already been generated and that both the quantity and the quality of data generated seem likely to increase, there is a lack of clear guidance for researchers regarding whether and when such information should be divulged to the subjects on whom it bears.In this environment, the potential exists for litigation alleging that a researcher was negligent for failure to disclose to a subject an individual research finding of medical significance. Such litigation would raise a heretofore-unanswered question: should a researcher have a legal duty to disclose medically significant individual research findings to a subject?

Assisted procreation and its relationship to genetics and eugenics.

The article below is intended to reflect on whether or not a eugenic tendency constitutes an intrinsic element of human fertilization in vitro. The author outlines ideas and circumstances which characterized the foundation and propagation of eugenics between the eighteenth and nineteenth centuries. A brief discussion follows on some of the standard procedures of in vitro fertilization, and in particular, those which manifest a trace or hint of eugenics--heterologous fertilization and sperm banking, preimplantation genetic diagnosis (PGD) and embryo selection--practices which, nonetheless, are used on a large scale and shed light on both the essence of procreative medicine and on the current cultural environment. The objective of the article is to explore whether it is possible to eliminate the eugenic connotations without foregoing the benefits of technical and scientific progress.

LeRoy Walters's Legacy of Bioethics in Genetics and Biotechnology Policy.

LeRoy Walters was at the center of public debate about emerging biological technologies, even as "biotechnology" began to take root. He chaired advisory panels on human gene therapy, the human genome project, and patenting DNA for the congressional Office of Technology Assessment. He chaired the subcommittee on Human Gene Therapy for NIH's Recombinant DNA Advisory Committee. He was also a regular advisor to Congress, the executive branch, and academics concerned about policy governing emerging biotechnologies. In large part due to Prof. Walters, the Kennedy Institute of Ethics was one of the primary sources of talent in bioethics, including staff who populated policy and science agencies dealing with reproductive and genetic technologies, such as NIH and OTA. His legacy lies not only in his writings, but in those people, documents, and discussions that guided biotechnology policy in the United States for three decades.

Stroke genetic research and adults with impaired decision-making capacity: a survey of IRB and investigator practices.

BACKGROUND AND PURPOSE: In stroke and other brain disorders, severely affected phenotypes often impair decision-making capacity. Severity is in part under genomic control. Therefore, scientifically valid research into genetic risk may require inclusion of such impaired individuals. U.S. Federal regulations do not detail rules governing enrollment of adults with impaired decision-making capacity into genetic research. Rather, policy and practice are locally determined. This study was conducted to obtain data on how investigators and IRBs handle surrogate authorization to enroll probands into a genetic study where some may lack capacity because of ischemic stroke. METHODS: Sequential surveys of sites from an ongoing North American study investigating genetic risks for ischemic stroke (2003: 49 sites, response rate=100%; 2007: 53 sites; response rate=91%) assessed whether and how investigators enroll adults with impaired decision-making capacity and determined frequency of IRB approval for enrollment by surrogate authorization. RESULTS: Approximately 40% of sites report that their IRBs do not approve surrogate authorization to enroll stroke patients-43% (21/49) in 2003 and 35% (17/48) in 2007. Thirty-three percent of sites report evaluating eligible adults who lacked capacity to provide their own informed consent; 18% (9/49) in 2003 and 15% (7/48) in 2007 have enrolled these individuals. Surrogate enrollment is the most common method used. Most sites have not enrolled any individual lacking capacity to give his or her own consent. CONCLUSIONS: Our study suggests that enrollment by surrogate authorization into stroke genetic research is often not approved by IRBs, and even when allowed is frequently not used. For disorders like stroke, this situation has significant implications for scientific validity.

Should we make a fuss? A case for social responsibility in science.

If society is to remain in step with new technology, the scientific community needs to be better educated about the social and ethical implications of its research.

Somatic individuality in context, a comparative case study.

Scholars have challenged the totalizing nature of the "geneticization thesis," arguing that its brushstrokes are too broad to capture the complicated nature of the new genetics. One such challenge has come from Nikolas Rose's argument that genetic medicine is governed by a new biopolitics in which patients understand themselves as "somatic individuals" who treat their bodies as an "ethical substance" to be worked on in order to secure a healthier future. I argue that Rose's argument, while compelling, paints the new genetics in equally broad brushstrokes and that in order for a concept like somatic individuality to become useful, we must study its manifestation across different communities of at-risk individuals. I undertake such a study by analyzing discourse use in two online biosocial communities, showing how the decision-making situations specific to each affect representations of somatic individuality, often creating opportunities for the rhetorical repurposing of older discourses of genetic determinism.

What Should a Psychiatrist Know About Genetics? Review and Recommendations From the Residency Education Committee of the International Society of Psychiatric Genetics.

The International Society of Psychiatric Genetics (ISPG) created a Residency Education Committee with the purpose of identifying key genetic knowledge that should be taught in psychiatric training programs. Thirteen committee members were appointed by the ISPG Board of Directors, based on varied training, expertise, gender, and national origin. The Committee has met quarterly for the past 2 years, with periodic reports to the Board and to the members of the Society. The information summarized includes the existing literature in the field of psychiatric genetics and the output of ongoing large genomics consortia. An outline of clinically relevant areas of genetic knowledge was developed, circulated, and approved. This document was expanded and annotated with appropriate references, and the manuscript was developed. Specific information regarding the contribution of common and rare genetic variants to major psychiatric disorders and treatment response is now available. Current challenges include the following: (1) Genetic testing is recommended in the evaluation of autism and intellectual disability, but its use is limited in current clinical practice. (2) Commercial pharmacogenomic testing is widely available, but its utility has not yet been clearly established. (3) Other methods, such as whole exome and whole genome sequencing, will soon be clinically applicable. The need for informed genetic counseling in psychiatry is greater than ever before, knowledge in the field is rapidly growing, and genetic education should become an integral part of psychiatric training.

Ethnography/ethics.

This paper situates discussion of the ethics of ethnographic research against the background of a theoretical and methodological debate about the relationship between ethics and method, and about the relationships between research methods and their objects. In particular, the paper investigates the implications of folding together the ethical and the empirical in research and argues that this requires the development of new ethico-ethnographic methods for the investigation of ethico-moral objects. The paper falls into three main parts. The first considers calls for what has come to be known as empirical ethics, that is, for a more empirically informed bioethics, by way of an exploration of the integration of ethnographic methods in bioethics, and concludes that approaches which see the ethical and the empirical as 'complementary' do not do justice to the methodological implications of enfolding the ethical and the ethnographic. The second part juxtaposes this with calls for the integration of ethics in ethnography and, similarly, argues that the enfolding of the ethical and the empirical in ethnography calls for the development of new methods. The paper goes on to problematise the 'negotiational' approaches to informed consent preferred by many ethnographers, arguing that the concept of negotiation, rather than offering a solution to the problem of consent, is itself ethically complex and in need of analysis. The paper argues that, in the context of ethnographic research, the possibility of negotiational forms of consent depends upon engagement between researchers and researched, with unavoidably 'ethical' concepts such as 'respect', 'recognition', 'dignity', 'justice' and so on, and that this poses methodological challenges to ethnography. The paper's third section explores the implications of these arguments for research practice, using The Genethics Club as an example.

Genetics and right: a methodology.

The theme of the free availability of genetic information is, by its nature, the heart of attention in most areas of investigation. From biology to medicine, from philosophy to law, from theology to biotechnology there isn't an area of science that cannot be said to be interested in the subject, nor has not, in recent years, tried to deepen it.