Military genomic testing: proportionality,expected benefits,and the connection between genotypes and phenotypes

Mehlman and Li offer a framework for approaching the bioethical issues raised by the military use of genomics that is compellingly grounded in both the contemporary civilian and military ethics of medical research, arguing that military commanders must be bound by the two principles of paternalism and proportionality. I agree fully. But I argue here that this is a much higher bar than we may fully realize. Just as the principle of proportionality relies upon a thorough assessment of harms caused and military advantage gained, the use of genomic research, on Mehlman and Li''s view, will require an accurate understanding of the connection between genotypes and phenotypes – accurate enough to ameliorate the risk undertaken by our armed forces in being subject to such research. Recent conceptual work in evolutionary theory and the philosophy of biology, however, renders it doubtful that such knowledge is forthcoming. The complexity of the relationship between genotypic factors and realized traits (the so-called ‘G→P map’) makes the estimation of potential military advantage, as well as potential harm to our troops, incredibly challenging. Such fundamental conceptual challenges call into question our ability to ever satisfactorily satisfy the demands of a sufficiently rigorous ethical standard.     

Cloning and stem cell research: a critical overview of the present legislative regime in Australia and the way forward

The application of stem cell research in biomedical science has recently sparked debates similar to the calls nearly 25 years ago for a ban involving recombinant DNA. This article critically examines the present legislative framework in Australia governing stem cell research and cloning, after briefly seeking a clear understanding of what these procedures involve, as well as suggesting an ethical paradigm within which these issues can be approached. The deficiencies in the proposed legislative framework are also highlighted. Australia has a duty to future generations to pursue the benefits unlocked by this type of research and it is hoped that the next two years will lead to more insights regarding the potential of such research and hence a revision of the present legal impediments.     

Regulations and organ transplantation in Turkey.

The concrete expression of ethical values in legal arrangements may require a long period. In our experience, this period can sometimes be quite brief when it comes to bioethical issues, as it can be seen in the legal arrangement in Turkey concerning organ transplantations. Turkey can be considered a fortunate country with respect to legal arrangements for organ transplantation in that laws on organ transplantation in Turkey date back to twenty years ago. At the time this law went into effect, the ethical discussion on this issue were yet to begin. The rationale behind the law was to prevent physicians from legal prosecution due to organ transplantation. Yet, the attempt to place organ transplantation into a certain legal framework alleviates our ethical concerns.     

PGTandMe: social networking-based genetic testing and the evolving research model

The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and--highlighting the challenges associated with a new paradigm of "patient-driven" genomic research--focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article also explores potential ethical, legal, and regulatory issues that arise from the hybrid between personal genomic research and online social networking, particularly regarding informed consent, institutional review board (IRB) oversight, and ownership/intellectual property (IP) considerations.     

Enabling responsible public genomics

As scientific understandings of genetics advance, researchers require increasingly rich datasets that combine genomic data from large numbers of individuals with medical and other personal information. Linking individuals' genetic data and personal information precludes anonymity and produces medically significant information--a result not contemplated by the established legal and ethical conventions governing human genomic research. To pursue the next generation of human genomic research and commerce in a responsible fashion, scientists, lawyers, and regulators must address substantial new issues, including researchers' duties with respect to clinically significant data, the challenges to privacy presented by genomic data, the boundary between genomic research and commerce, and the practice of medicine. This Article presents a new model for understanding and addressing these new challenges--a "public genomics" premised on the idea that ethically, legally, and socially responsible genomics research requires openness, not privacy, as its organizing principle. Responsible public genomics combines the data contributed by informed and fully consenting information altruists and the research potential of rich datasets in a genomic commons that is freely and globally available. This Article examines the risks and benefits of this public genomics model in the context of an ambitious genetic research project currently under way--the Personal Genome Project. This Article also (i) demonstrates that large-scale genomic projects are desirable, (ii) evaluates the risks and challenges presented by public genomics research, and (iii) determines that the current legal and regulatory regimes restrict beneficial and responsible scientific inquiry while failing to adequately protect participants. The Article concludes by proposing a modified normative and legal framework that embraces and enables a future of responsible public genomics.     

Treating or Tracking? Regulatory Challenges of Nano‐Enabled ICT Implants

The increasing commercialisation of human ICT implants has generated debate over the ethical, legal, and social implications of their use. The convergence of nanotechnologies with ICT is likely to further challenge the current legal frameworks that regulate them. The aim of this article is to examine the effectiveness of the European data protection legal framework for regulating this “next generation” of nano‐enabled ICT human implantable devices. The article highlights the potential regulatory challenges posed by the applications and makes a series of recommendations as to how the current European legal framework on data protection will respond to them.     

Ethical issues in international biomedical research: an overview

Human subjects research has been the focus of numerous controversies over the years. The dilemma lies between the potential harm to individuals who participate in research and the knowledge to be gained from the research study that might benefit society. When research is conducted in developing countries by researchers and sponsors from the United States and other industrialized countries, differences in history, culture, politics, wealth, and power between the countries give rise to unique challenges. In this Article, the author identifies several ethical issues to be considered when research is conducted in developing countries and provides the legal and ethical framework for their resolution.     

Values ethics and legal ethics: the QLD and LETR Recommendations 6, 7, 10, and 11

The Legal Education and Training Review (LETR) Report recommended increased attention to ethics and values and to critical thinking. These aims could be achieved jointly through teaching ethical thinking: not as theory but as part of developing the capacity for ethical conduct. Such a pedagogy has the potential to become a qualifying law degree (QLD) signature pedagogy supporting “life-narratives” of students. The LETR Report recommends a review of the QLD emphasising legal values and ethics. Concern with values and ethics is linked to concern with professional conduct. Maintaining the law degree as a general or liberal qualification is also strongly desired. These potentially conflicting drivers generate ambivalence towards legal ethics as a subject for study, especially if legal ethics are perceived as teaching the professional codes.

Resolution of this tension is achievable through recognising the potential role of ethical teaching as part of an identity apprenticeship. Developing ethical character is as much a liberal as a professional aim. Ethics teaching can play an integrative role in the QLD. Formation of student identity is a central part of higher education taking colouration from being situated in legal education. In this context teaching legal ethics becomes the use of a salient example for carrying out the broader project of developing ethical capacity.     

Ethics, Information Technology, and Public Health: New Challenges for the Clinician-Patient Relationship

Increasingly widespread adoption of health information technology tools in clinical care increases interest in ethical and legal issues related to the use of these tools for public health and the effects of these uses on the clinician-patient relationship. It is argued that patients, clinicians, and society have generally uncontroversial duties to support civil society's public health mission, information technology supports this mission, and the effects of automated and computerized public health surveillance are likely to have little if any effect on the clinician-patient relationship. It is also suggested, nevertheless, that electronic public health surveillance raises interesting and important ethical issues, some of which can be addressed if not resolved by empirical research, especially regarding patient preferences about secondary use of health data and their moral obligation to contribute to population- based health.     

Life after death: preservation of the immortal seed

In today's brave new world, women who suffer the loss of their husband or lover can call upon medical science to create a souvenir baby. The rights of the decedent over his genetic material and the rights of the child who is created therefrom are the subject of an evolving legal process. This Essay examines legal, moral and ethical issues which arise from post-mortem artificial insemination. It discusses the attendant conflicts of procreative rights, finality of probate, psychological issues, international law, and recent cases. Ultimately, comprehensive legislation must be enacted to address these issues.     

Navigating tissue banking regulation: conceptual frameworks for researchers, administrators, regulators and policy-makers

In the "post-genomic" age of biomedical research, researchers often wish to utilise collections of human tissue. This type of research raises many ethical and legal issues and anyone wishing to use such collections is faced with an enormously complex set of regulatory requirements, many of which are still ambiguous, reflecting ongoing ethical and legal debate. Whilst there is no way of entirely avoiding such regulatory complexity and ambiguity, conceptual frameworks can assist those who wish to use, administer, authorise and generate policy on tissue banking research. Two conceptual frameworks are described here: a taxonomy of tissue banking practices, aimed at assisting those who need to ensure that tissue banks meet ethical and legal requirements; and a "syncretic" approach to policy-making, for those who wish to generate new policy, or streamline existing policy relating to tissue banking research.     

Legal and ethical issues in the use of antiandrogens in treating sex offenders

Antiandrogen treatment of sexual offenders raises serious legal and ethical considerations in both the medical profession and in the courts. Discussion is offered on the use of antiandrogens in both an involuntary and voluntary context. The potential negative impact of this treatment modality on such constitutional issues as privacy interests, right to procreative freedom, freedom of speech and communication, and freedom from cruel and unusual punishment is explored and notable, germane court cases are presented. The need for clear ethical guidelines for the administration of this treatment is stressed.     

Trauma and Psychological Injury: Practice, Clinical, Legal, and Ethical Issues

Psychologists need continuing education in areas pertinent to their practice. The area of psychological injury and law presents issues and conundrums that need careful ongoing evaluation for appropriate clinical practice, adherence to ethical standards, and functioning in the legal context. In this article, we prepared a series of vignettes that illustrate these difficulties in the practice, clinical, legal, and ethical spheres related to the area of psychological injury and law. The vignettes, together with accompanying commentaries, are meant for use in workshops, and they aim to educate, stimulate, and provoke. Furthermore, the article has been written with the aim of interaction with readers, in that we seek commentaries from readers both for purposes of publication and use in workshops.     

Stop and Risk: Policing,Data, and the Digital Age of Discrimination

Predictive policing is the newest innovation in the field of law enforcement. Predictive policing programs use algorithms to analyze existing crime data in an attempt to make predictions about future crimes: What crimes are likely to be committed, where crimes are likely to be committed, and a list of potential victims and offenders. Proponents of predictive policing champion the practice as an effective, proactive form of law enforcement that is free from bias due to its data-driven nature. However, as a matter of justice policy, predictive policing is just as discriminatory as traditional police practices, such as stop and frisk: Both are relatively ineffective; both have the potential to disproportionately target minorities; both are challenging forms of surveillance that create several important ethical and legal issues; and both are presented as objective, impartial, and equitable. This article has three primary goals: Highlight the potential and problematic similarities between stop and frisk and predictive policing; present the problems associated with predictive policing, including its questionable effectiveness, biased foundation, and faulty legal and ethical footing; and discuss the ways in which discriminatory criminal justice programs, such as stop and frisk and predictive policing, are presented to the public as objective, non-discriminatory policies.

     

Administrative,legal, and ethical practices in the psychological testing of law enforcement officers

Recently, more law enforcement agencies have chosen to use psychological testing as an important component of their preemployment screening programs. Important legal and ethical issues have been raised by the increased use of psychological testing for this purpose. These issues include the applicant's right to privacy, the validity of the psychological instrument(s) used, the definition of what constitutes an “unsuitable” candidate, and the existence of racial and/or sexual bias. This article presents ten suggestions that address some of these issues and that may aid law enforcement agencies in adopting the spirit of the Uniform Guidelines on Employee Selection Procedures and other psychological-testing standards.     

‘Good soldiers are made,not born’⊥: the dangers of medicalizing ability in the military use of genetics

Advances in genetic and genomic science are of particular interest to the United States military. Responding to Maxwell J. Mehlman''s and Tracy Yeheng Li''s article Ethical, Legal, Social, and Policy Issues in the Use of Genomic Technology by the U.S. Military, this Commentary explores the social consequences of medicalizing what it means to be a good soldier. It begins by reviewing the well-documented consequences of medicalization in the contexts of the eugenics movement and modern genetic and genomic science. It then applies that analysis to the military use of genetics and genomics, focusing on the ways in which genetic or genomic accounts of military ability could entrench existing gender and racial disparities.     

Autonomous weapon system: Law of armed conflict (LOAC) and other legal challenges

The legality of autonomous weapon systems (AWS) under international law is a swiftly growing issue of importance as technology advances and machines acquire the capacity to operate without human control. This paper argues that the existing laws are ineffective and that a different set of laws are needed. This paper examines several issues that are critical for the development and use of AWS in warfare. It argues that a preemptive ban on AWS is irrelevant at this point and urges the appropriate authorities to develop a modern legal framework that is tailored to embrace these state-of-the-art weapons as the Law of Armed Conflict (LOAC) develops. First, this paper explores the myriad of laws designed to govern the potential future development and deployment of artificial intelligence and AWS in the context of International Humanitarian Law or LAOC. Second, the paper argues that it will be challenging for AWS to fulfill the requirements laid out under the International Committee of the Red Cross and LOAC for the rules of humanity, military necessity, distinction, proportionality and precaution, especially as it is related to noncombatants. Third, the paper discusses command responsibility and argues that states should establish accountability for wrongful acts committed by the AWS. Finally, this paper contends that there is an urgent need for a new legal framework to regulate these AWS and presents different solutions for the legal framework of AWS.     

Consent,commercialisation and benefit-sharing

This article considers two issues in relation to the increasing commercial exploitation of biological materials: first, whether the consent of the individual who is the source of biological material is needed for the material to be used commercially; and secondly, whether the source has any right to share in the profits. Whilst the legal requirement for consent to commercial use is uncertain, the overwhelming view from ethical statements suggests that such consent is appropriate. With regard to profit-sharing, source individuals have no legal right to share in the profits of commercial exploitation of their sample. However, there is support in some ethical statements for benefit-sharing with source individuals and their communities.     

Introduction: International Perspectives on Health Policy

This special issue of Law & Policy examines legal, bioethical, and social science perspectives on the critical problems and choices arising from the rapid changes in the health care systems throughout the industrialized world. Advances in medical technology, the rising costs of health care, and the aging of the industrial populations have made health care a crucible for many of the broader policy concerns facing the world in the new millennium. The purpose of the special issue was for these issues to be addressed in a multidisciplinary forum, to add to the broader spectrum of socio–legal scholarship. Scholars from diverse countries examined a variety of issues from ethical, social science, and clinical perspectives.     

Conflict over Conflicts of Interest: An Analysis of the New NIH Rules

Concern over research integrity at the NIH led to the adoption of strict conflict of interest rules in 2005. An outcry from NIH scientists followed. This paper analyzes the legal and ethical issues raised by the new rules, and suggests potential areas for modification.