Actor-Network Theory: a tool to support ethical analysis of commercial genetic testing

Social, ethical and policy analysis of the issues arising from gene patenting and commercial genetic testing is enhanced by the application of science and technology studies, and Actor-Network Theory (ANT) in particular. We suggest the potential for transferring ANT's flexible nature to an applied heuristic methodology for gathering empirical information and for analysing the complex networks involved in the development of genetic technologies. Three concepts are explored in this paper—actor-networks, translation, and drift—and applied to the case of Myriad Genetics and their commercial BRACAnalysis genetic susceptibility test for hereditary breast cancer. Treating this test as an active participant in socio-technical networks clarifies the extent to which it interacts with, shapes and is shaped by people, other technologies, and institutions. Such an understanding enables more sophisticated and nuanced technology assessment, academic analysis, as well as public debate about the social, ethical and policy implications of the commercialization of new genetic technologies.|spagf|ro|epagf|     

Looking back, looking beyond: revisiting the ethics of genome generation

This paper will explore some of the ethical imperatives that have shaped strategic and policy frameworks for the use of new genetic technologies and how these play a role in shaping the nature of research and changing attitudes; with an attempt to conceptualize some theories of genetic determinism. I analyse why there is a need to put bioethical principles within a theoretical framework in the context of new technologies, and how, by doing so, their practical applications for agriculture, environment medicine and health care can be legitimized. There are several theories in favour of and against the use of genetic technologies that focus on genes and their role in our existence. In particular the theory of geneticisation is commonly debated. It highlights the conflicting interests of science, society and industry in harnessing genetic knowledge when the use of such knowledge could challenge ethical principles. Critics call it a ‘reductionist’ approach, based on arguments that are narrowed down to genes, often ignoring other factors including biological, social and moral ones. A parallel theory is that there is something special about genes, and it is this “genetic exceptionalism” that creates hopes and myths. Either way, the challenging task is to develop a common ground for understanding the importance of ethical sensitivities. As research agendas become more complex, ethical paradigms will need to be more influential. New principles are needed to answer the complexities of ethical issues as complex technologies develop. This paper reflects on global ethical principles and the tensions between ethical principles in legitimizing genetic technologies at the social and governance level.     

Risk assessment for inherited susceptibility to cancer: a review of the psychosocial and ethical dimensions

The objective of this study was to conduct a broad-based systematic review of social, ethical, and legal considerations associated with genetic cancer risk assessment technologies (CaRATs). This paper focuses on psychosocial and ethical issues. Search results were limited to papers published in English, French, or German from January, 1990, to May, 2003. A quality assessment tool was developed and applied to retrieved papers. Application of the quality assessment tool resulted in 77 of 247 qualitative and quantitative primary research papers being reviewed and synthesized. A broad range of issues were addressed and grouped into content areas. Despite a large literature addressing psychosocial and ethical issues associated with CaRATs, many existing studies are not adequate to inform decision-makers and stakeholders. Careful policy analysis, as in some of the economic analyses reviewed here, is important to bridge this gap.     

Governing genetics: reifying choice and progress

The governance of genetics involves a wide range of policy networks and covers a considerable array of genetic technoscience. Despite this apparent diversity, the uniformity of some genetic governance requires investigation. Reviewing policy documents on genetic patenting and embryonic stem cell research, I shall argue that policy networks often conceive of the ethical aspects of these practices in similar ways. In particular, I shall argue that individual choice and medico-scientific progress are common rhetorical devices in their frameworks. I shall end by commenting upon the implications of these trends for the future.     

Contemplating choice: attitudes towards intervening in human reproduction in Sri Lanka

To date, relatively little is known about the ethical, legal and social responses to recent advances in reproductive and genetic technology outside Europe and North America. This article reports on a survey carried out among doctors (n=278) and medical students (n=1256) in Sri Lanka to find out more about their responses to novel interventions in human reproduction such as In-Vitro Fertilization, Pre-Implantation Genetic Diagnosis and genetic engineering. In the first part of the paper comparisons are drawn between this survey and a survey carried out in 1985 which also considered issues surrounding amniocentesis and therapeutic termination. The second part of the paper deals with more recent developments. The analysis reveals high levels of support for the use of new technologies in treating infertility and identifying genetic disorders. However, differences are apparent among the major religious communities represented in the sample and these are particularly in evidence in relation to prenatal genetic diagnosis. An important theme throughout both surveys is the continuing tension surrounding State policy and termination of pregnancy and the implications this has for the development of screening and counseling services where genetic disorders are concerned.     

"Be ready against cancer, now": direct-to-consumer advertising for genetic testing

A recent addition to the debate about the benefits and harms of direct-to-consumer (DTC) advertising of medicines and pharmaceuticals is a growing critique of DTC marketing and sale of genetic tests. Academic and policy literatures exploring this issue have, however, tended to focus on the sale of genetic tests, paying rather less attention to the particular implications of advertising. The globalization of broadcast media and ever increasing access to the Internet mean that public exposure to advertising for medical technologies is a reality that national regulatory bodies will be hard pressed to constrain. Working through a case study detailing Myriad Genetics' 2002 pilot advertising campaign for their BRACAnalysis genetic susceptibility test for hereditary breast and ovarian cancer, this paper highlights some of the diverse and often overlooked and unregulated approaches to DTC advertising, and the associated social, ethical and policy implications.     

Contemplating choice: attitudes towards intervening in human reproduction in Sri Lanka

To date, relatively little is known about the ethical, legal and social responses to recent advances in reproductive and genetic technology outside of Europe and North America. This article reports on a survey carried out among doctors (n?=?278) and medical students (n?=?1256) in Sri Lanka to find out more about their responses to novel interventions in human reproduction such as In-Vitro Fertilization, Pre-Implantation Genetic Diagnosis and genetic engineering. In the first part of the paper comparisons are drawn between this survey and a survey carried out in 1985 which also considered issues surrounding amniocentesis and therapeutic termination. The second part of the paper deals with more recent developments. The analysis reveals high levels of support for the use of new technologies in treating infertility and identifying genetic disorders. However, differences are apparent among the major religious communities represented in the sample and these are particularly in evidence in relation to pre-natal genetic diagnosis. An important theme throughout both surveys is the continuing tension surrounding State policy on termination of pregnancy and the implications this has for the development of screening and counseling services where genetic disorders are concerned.     

Genetic Testing: The Appropriate Means for a Desired Goal?

Scientists, the medical profession, philosophers, social scientists, policy makers, and the public at large have been quick to embrace the accomplishments of genetic science. The enthusiasm for the new biotechnologies is not unrelated to their worthy goal. The belief that the new genetic technologies will help to decrease human suffering by improving the public’s health has been a significant influence in the acceptance of technologies such as genetic testing and screening. But accepting this end should not blind us to the need for an evaluation of whether a particular means is adequate to achieve it. Lack of such evaluation notwithstanding, discussions of the ethical, legal, and social implications have tended to presuppose that the development and implementation of genetic testing will be an appropriate means to reduce human suffering in significant ways. I argue here that such an assumption is mistaken. In part this is the case because human biology is more complex than sometimes it is made to appear in these debates. But, the idea that human suffering resulting from disease can be reduced in significant ways with the use of genetic testing also ignores the social contexts in which these technologies are being developed and implemented.     

Ethical issues raised by genetic testing with oligonucleotide microarrays

Because genes and alterations within them determine the identity, characteristics, and inheritance of every individual, the application of genetic science to humans has long been surrounded by apprehension, controversy, and real or perceived potential for abuse. Crude eugenics practices of the past now find a theoretical rebirth and transformation through the use of modern molecular genetic technologies for mutation detection, predictive and prenatal diagnosis, and, ultimately, gene replacement. The advent of oligonucleotide microarray analysis, in which hundreds or thousands of genes and mutations can be tested in parallel, offers tremendous promise for more accurate, sensitive, and efficient genetic testing. At the same time, however, this powerful technology dramatically increases the number and scope of ethical concerns accompanying each individual test request. This article considers the evolution and implications of these concerns, from the initial ordering of a microarray test by the physician to such issues as informed consent, privacy, confidentiality, clinical utility, discrimination, stigmatization, ethnic and population impact, and reimbursement.     

Making Sense of Child Welfare When Regulating Human Reproductive Technologies

Policy-makers have attempted to frame the ethical requirements that are relevant to the creation of human beings via reproductive technologies. Various reports and laws enacted in New Zealand, Canada, Australia, and Britain have introduced tests for how we should weigh child welfare when using these technologies. A number of bioethicists have argued that child welfare should be interpreted as a “best interests” test. Others have argued that there are ethical reasons why we should abandon this kind of test. I will argue that at least some of the relevant policy can be interpreted as requiring those wishing to exercise their procreative liberty to have a reasonable plan to care and nurture any resulting child, thereby respecting the internal preconditions of that liberty. This interpretation of child welfare requirements answers some of the ethical worries about a child welfare test.     

Whakapapa, genealogy and genetics

This paper provides part of an analysis of the use of the Maori term whakapapa in a study designed to test the compatibility and commensurability of views of members of the indigenous culture of New Zealand with other views of genetic technologies extant in the country. It is concerned with the narrow sense of whakapapa as denoting biological ancestry, leaving the wider sense of whakapapa as denoting cultural identity for discussion elsewhere. The phenomenon of genetic curiosity is employed to facilitate this comparison. Four levels of curiosity are identified, in the Maori data, which penetrate more or less deeply into the psyche of individuals, affecting their health and wellbeing. These phenomena are compared with non-Maori experiences and considerable commonalities are discovered together with a point of marked difference. The results raise important questions for the ethical application of genetic technologies.     

Next-generation sequencing diagnostics for neurological diseases/disorders: from a clinical perspective

Neurological diseases encompass a broad, heterogeneous group of disorders ranging from pediatric neurodevelopmental diseases to late-onset neurodegenerative diseases, most of which are poorly understood and few of which are curable. Most of these diseases have a genetic basis and thus are expected to be amenable to genetic or genomic analysis by next-generation sequencing (NGS). While the advancement of contemporary technologies (such as NGS) is exciting, translating this tool into actual benefit for patients and clinicians can be challenging. In a clinical setting, a sequencing test that is fast, non-invasive, cheap and with perfect specificity would be ideal. However, in practice, there are several hurdles and caveats to consider even before a NGS diagnostic testing can be optimally applied. Proper definition of clinical phenotype, selection of the most appropriate subjects and the clinical setting, optimization of both sensitivity and specificity of the test, evaluation of the availability of the infrastructure and expertise, and consideration of economic, ethical and legal issues are vital in the final application of NGS diagnostic screening in the clinics.     

Genetic governance: The risks,oversight and regulation of genetic databases in the UK

Increasing scientific and commercial interest is being paid to the creation of large population-based genetic databases to study the relationship between genes and disease. This paper will use ideas from the sociology of technology to look at the network of actors involved in the production, use and commercial exploitation of human genetic data, the social and ethical issues posed by genetic databases and the development of new governance arrangements in this domain. It will be argued that we are witnessing the creation of a new type of research system in the field of human genetics, which also forms the centre of an emerging market for personal and population-based genetic information. Some proposals for improving the governance of human genetic data in the UK will be offered in conclusion.     

Testicular Tissue Cryopreservation and Ethical Considerations: A Scoping Review

Testicular tissue cryopreservation (TTCP) aims to preserve the future option of genetic reproduction for prepubescent cancer patients who are at risk of infertility as a result of their cancer therapies. This technology is experimental and currently only offered in the research context. As TTCP moves towards becoming more widely available, it is imperative that healthcare providers recognize the complex ethical issues surrounding this technology. This scoping review study identifies and assesses the range and depth of ethical concerns related to this testicular tissue cryopreservation technology. At present, no such scoping review of ethical concerns exists in the TTCP literature. The forty-three full-text articles included in this study yielded twenty-two different ethical considerations discussed in relation to TTCP. It was observed that these ethical considerations fit within a mainstream Principlism approach to bioethics. Accordingly, there are ethical gaps in the TTCP literature that can be identified with alternative moral lenses. In particular, it was found that ethical concerns related to context and relational aspects of identity were absent in nearly all ethical examinations of TTCP. Furthermore, only 9 per cent of articles reviewed in this study focused primarily on the ethics of TTCP, thus demonstrating a need for further in depth ethical analyses of this technology. The results of this study are important for supporting the ethical provision of TTCP and can contribute to policy and guideline development. The findings of this study demonstrate the need for greater depth and diversity in analyses of ethical considerations related to this technology.     

Genetic use restriction technologies: a review

Genetic use restriction technologies (GURTs), developed to secure return on investments through protection of plant varieties, are among the most controversial and opposed genetic engineering biotechnologies as they are perceived as a tool to force farmers to depend on multinational corporations' seed monopolies. In this work, the currently proposed strategies are described and compared with some of the principal techniques implemented for preventing transgene flow and/or seed saving, with a simultaneous analysis of the future perspectives of GURTs taking into account potential benefits, possible impacts on farmers and local plant genetic resources (PGR), hypothetical negative environmental issues and ethical concerns related to intellectual property that have led to the ban of this technology.     

Genetic enhancement--a threat to human rights?

Genetic enhancement is the modification of the human genome for the purpose of improving capacities or 'adding in' desired characteristics. Although this technology is still largely futuristic, debate over the moral issues it raises has been significant. George Annas has recently leveled a new attack against genetic enhancement, drawing on human rights as his primary weapon. I argue that Annas' appeal to human rights ultimately falls flat, and so provides no good reason to object to genetic technology. Moreover, this argument is an example of the broader problem of appealing to human rights as a panacea for ethical problems. Human rights, it is often claimed, are 'trumps': if it can be shown that a proposed technology violates human rights, then it must be cast aside. But human rights are neither a panacea for ethical problems nor a trump card. If they are drafted into the service of an argument, it must be shown that an actual human rights violation will occur. Annas' argument against genetic technology fails to do just this. I shall conclude that his appeal to human rights adds little to the debate over the ethical questions raised by genetic technology.     

The challenge of including social and ethical aspects in the development of nanobiotechnology

Nanotechnology as an enabling technology for many future medical applications touches on issues such as sensitivity of genetic information, the gap between diagnosis and therapy, health care resources and tensions between holistic and functional medicine. On the other hand nanotechnology will add a new dimension to the bio (human) and non-bio (machine) interface such as brain chips or implants, which eventually might raise new ethical issues specific to NanoMedicine. This requires careful analysis of ethical aspect in view of existing standards and regulations by ethics committees at the European scale. At the same time new nanomedical inventions have to be evaluated for new ethical aspects by Ethical, Legal and Social Aspects — specialists. The most crucial point in this regard is an early proactive analysis of new technological developments to identify and discuss possible issues as soon as possible. This requires a close collaboration and co-learning of technology developers and ethics specialists assisted by communication experts to ensure open and efficient information of the public about ethical aspects (old or new) related to nanomedicine. This co-evolution will ensure a socially and ethically accepted development of innovative diagnostic and therapeutic tools in NanoMedicine.     

The ethical landscape of gene drive research

Gene drive technology has immense potential. The ability to bypass the laws of Mendelian inheritance and almost ensure the transmission of specific genetic material to future generations creates boundless possibilities. But alongside these boundless possibilities are major social and ethical issues. This article aims to introduce gene drive technology, some of its potential applications, and some of the social and ethical issues that arise during research into the technology. For example, is investigation into gene drives hubristic? Would applications of gene drives count as technological fixes? Or does research into such a technology sit on a slippery slope or lock us in to its full‐scale use? Are there perverse effects of engaging in research, and, most importantly, who ought to be included in the decision‐making process regarding research and field trials? Understanding the basic ethical landscape of this technology will prove invaluable to the public, scientists, and policy‐makers as research moves forward.     

Points to Consider: Ethical,Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents

In 1995, the American Society of Human Genetics (ASHG) and American College of Medical Genetics and Genomics (ACMG) jointly published a statement on genetic testing in children and adolescents. In the past 20 years, much has changed in the field of genetics, including the development of powerful new technologies, new data from genetic research on children and adolescents, and substantial clinical experience. This statement represents current opinion by the ASHG on the ethical, legal, and social issues concerning genetic testing in children. These recommendations are relevant to families, clinicians, and investigators. After a brief review of the 1995 statement and major changes in genetic technologies in recent years, this statement offers points to consider on a broad range of test technologies and their applications in clinical medicine and research. Recommendations are also made for record and communication issues in this domain and for professional education.