Putting together the pieces: recent proposals to fill in the genetic testing regulatory puzzle

The idea that genetic information is different from other medical information and therefore needs special protection has led to a regulatory puzzle where genetic testing is currently regulated under three separate schemes. Although genetic tests for over 2,000 diseases are available, less than 10% of these tests have been reviewed for clinical validity or utility. Recent action by some genetic testing companies has prompted the federal government to propose changes to the current regulatory scheme. This article discusses the current framework and the recent developments before examining some of the concerns and challenges that face the implementation of these proposed changes. The author evaluates the proposals and competing interests in order to suggest how genetic testing may best be regulated to meet the needs of the industry, clinicians, researchers, patients, and consumers.     

Go and tend the earth: a Jewish view on an enhanced world.

In this essay, the author considers how one particular faith community, contemporary Judaism, in all its internal diversity, has reflected on the issue of how far the project of genetic intervention ought to go when the subject of the future--embodied, willful, and vulnerable--is at stake. Knowing, naming, and acting to change is not only a narrative of faith traditions; it is a narrative of biological science as well.     

Underwhelmed: hyperbole,regulatory policy,and the genetic revolution

Rapid advances in the field of genetics in recent years have caused some commentators to suggest the emergence of a "genetic revolution." Such advances have been both praised as the "future of medicine" and condemned for encouraging the acceptance in society of laissez-faire eugenics. Yet the effect of technological advances flowing from the science of genetics appear somewhat overstated as few products of the genetic revolution, particularly in the areas of gene therapy and genetic testing, have managed to satisfy scientists' expectations to date. Furthermore, misdirected regulation of such advances can exacerbate the social, legal, and ethical problems associated with genetics, particularly in the context of health care, where issues of human cloning and the use of premature genetic testing technologies dominate current public debate. In this article, the author criticizes the hyperbolic rhetoric surrounding the genetic revolution and calls for a more balanced and informed approach to the development of genetic policies and regulations. Such an approach should include substantial interdisciplinary debate and an active role on the part of government in the identification and communication of accurate information relating to the effects of recent technological advances in the field of genetics.     

论我国基因信息不知情权的确立

基因信息对健康状况具有强烈的预测性,出于诸种原因当事人未必想知晓基因信息.为充分尊重自我决定权,比较法上承认权利人享有基因信息不知情权.基因信息不知情权指权利人有权预先决定是否接受基因信息的披露,其核心要义为“知情拒绝权”.基因信息不知情权旨在保障权利人对基因信息的自主控制,在我国隐私权与个人信息区分规制的立法模式下,...     

Criminality and moral dysfunctions: neurological,biochemical, and genetic dimensions

In this article, the author attempts to demonstrate a relationship between neurobiological dysfunctions and/or genetically determined deviant behavior and personality traits as well as moral abnormalities. Data from neuroscience show that a number of neurological dysfunctions are linked to cognitive and emotional disturbances. Cognitive and emotional abnormalities, in turn, are frequently related to moral dysfunctions. Moreover, neurological disorders can produce dramatic psychological and social problems, personality changes, and behavioral problems in patients. Those mental, emotional, and psychosocial problems and related moral dysfunctions are frequently linked to violence and/or criminal behavior. Genetic research found evidence of inheritability of antisocial traits, which interfere with moral development and activities. This information has consequences for any assessment and disposition within the legal system. More research on the interrelationship between neuro(bio)logical, genetic, emotional, and mental aspects of moral dysfunctions is needed for the development of adequate treatment, prevention, and intervention programs.     

The most personal information of all: an appraisal of genetic privacy in the shadow of the Human Genome Project

The advent of genetics and genetic testing has given rise to unique problems for the family. The discovery of a predisposition to a genetic condition in one individual also reveals information about the genetic make-up and potential risks of family members. There is, therefore, potential for conflict over access to and control of such information. Traditionally the duty of confidentiality owed by a health care professional to a patient has provided an appropriate means by which personal health information has been kept secured. It is not clear, however, that the problems which surrounds genetic information in the familial milieu can be adequately dealt with using confidentiality. This article examines these problems and argues for the value of an appeal to the concept of privacy in seeking to resolve some of the more intractable issues.     

Genetic Information and the Challenge to Privacy

Genetic screening and testing techniques provide a new and powerful diagnostic tool for the acquisition of predictive information. The potential value of such diagnostic techniques cannot be overstated. Genetic diagnostic tests pave the way for the development of gene therapy techniques which may provide remedies for diseases previously considered untreatable. There are clearly tremendous opportunities for improving the quality of life of those who suffer from genetic disorders as well as opportunities for biotechnology and pharmaceutical companies to swell their profits. A complex of pressures and tensions is currently developing around the use of genetic technology for therapeutic purposes in human beings. This paper considers only one element of this complex and dynamic situation, that of the regulatory climate surrounding the use of genetic screening in Europe. If, as many pharmaceutical companies concede, the key to the development of successful gene therapy products is the freedom to use genotyping and genetic screening without significant legal restriction, then the regulatory climate has a crucial significance for the future of this technology. It emerges, however, that there are other interests at stake apart from just those of the patients and the pharmaceutical companies. Insurance companies and employers are also highly interested in the acquisition and use of genetic information. There are arguments both for and against permitting such entities to use or request genetic testing and screening which shall be traversed in the body of the paper. However, the interest of insurance companies and employers in genetic information has stimulated a countercurrent of public pressure for restrictions on the use that can be made of genetic diagnostic information. In a number of countries, this pressure has generated enough concern to stimulate legislatures to seek to enact laws that curtail the use and acquisition of genetic information. This pattern has clearly emerged in the United States and there are strong indications that similar trends are developing in Europe. This article catalogues and critiques the laws and regulations currently affecting genetic screening and testing in Europe.     

State legislative approaches to regulating the use of genetic information

As genetic testing becomes more prevalent and the uses for genetic information multiply, we are likely to witness more demand for comprehensive state legislation on the order of the Oregon law regulating the procedures for obtaining and using genetic information. In addition, the United States Senate has expressed an interest in the subject. The Senate Labor and Human Resources Committee reportedly agreed on August 2, 1995 to include in a health insurance reform bill (S. 1028) language prohibiting health plans from using genetic information when determining eligibility, continuation, enrollment, or contribution requirements. 4 BNA's Health Law Rep. at 1218 (Aug. 10, 1995). Insurance companies continue to maintain that genetic test results are simply another factor that should rightfully be used during underwriting, much as age, medical history, and physical examinations are routinely used today. Right to privacy advocates argue that genetic testing provides employers and insurance companies with too much information and offers a great potential for discrimination. As more states wrestle with this issue, these competing interests are likely to be debated in public forums throughout the country.     

Prevention for those who can pay: insurance reimbursement of genetic-based preventive interventions in the liminal state between health and disease

Clinical use of genetic testing to predict adult onset conditions allows individuals to minimize or circumvent disease when preventive medical interventions are available. Recent policy recommendations and changes expand patient access to information about asymptomatic genetic conditions and create mechanisms for expanded insurance coverage for genetic tests. The American College of Medical Genetics and Genomics (ACMG) recommends that laboratories provide incidental findings of medically actionable genetic variants after whole genome sequencing. The Patient Protection and Affordable Care Act (ACA) established mechanisms to mandate coverage for genetic tests, such as BRCA. The ACA and ACMG, however, do not address insurance coverage for preventive interventions. These policies equate access to testing as access to prevention, without exploring the accessibility and affordability of interventions. In reality, insurance coverage for preventive interventions in asymptomatic adults is variable given the US health insurance system''s focus on treatment. Health disparities will be exacerbated if only privileged segments of society can access preventive interventions, such as prophylactic surgeries, screenings, or medication. To ensure equitable access to interventions, federal or state legislatures should mandate insurance coverage for both predictive genetic testing and recommended follow-up interventions included in a list established by an expert panel or regulatory body.     

Selective justice,genetic discrimination,and insurance: should we single out genes in our laws?

This article discusses the desirability of legislation focusing on genetic discrimination, in particular in the context of insurance. Many American states and some European countries as well as the Council of Europe have introduced protective measures against discrimination on the basis of genetic susceptibility. The author questions their effectiveness and queries whether they may be inequitable, because they fail to address more fundamental underlying issues related to the nature of insurance, access to health care, and unequal distribution of wealth. There is also a problem of definition in these statutes. They fail to capture what constitutes genetic information. Nonetheless, the author argues it is important to consider the social consequences of genetic testing. Michael Walzer's theory of justice is used to examine the role of insurance and health care. Using this approach, the author finds the American system of distribution for health care to be problematic. This is then used to inform the author's discussion of the future of health care in Canada. Anti-discrimination provisions could be used in a way that is consistent with Walzer's theory of justice. They would encompass both genetic and non-genetic health factors. These can be modelled on current anti-discrimination statutes in Canada. The author then proposes administrative committee structures to regulate the use of genetic data in Canada.     

Direct‐to‐Consumer Genetic Testing,Gamete Donation,and the Law

Once thousands of dollars, direct‐to‐consumer (DTC) genetic testing has become affordable and readily accessible in recent years. The technology can reveal a wealth of information to consumers: health risks, ancestry composition, and connections to genetic matches through relative databases. However, the law has not yet regulated many aspects of this new technology. This article analyzes how the law should regulate DTC genetic testing within the context of gamete donation. It will argue that gamete donors’ privacy interests warrant state regulation of DTC genetic testing kits and their associated genetic relative databases. It will also explore how state regulation should balance the competing interests of gamete donors and of donor‐conceived individuals.     

Alternatives to punishment beatings and shootings in a Loyalist community in Belfast

The author is a former Loyalist prisoner who recently carried out a piece of research in the Loyalist community of the Greater Shankill District of Belfast. That research was designed to explore with a range of community activists (including Loyalist paramilitaries) the potential for an alternative strategy to the current system of punishment beatings and shootings. The author argues that this can only be achieved by distinguishing between the types of activities that attract the attention of Loyalist paramilitaries and focusing intervention only upon those areas where it may readistically have an effect, i.e. that matter relating to the internal discipline of Loyalist paramilitary members and disputes between groupings relating to drugs will by necessity fall outside any potential intervention. He goes on to offer the outline of a programme designed as an alternative to punishment beatings which could prove to be effective within those parameters despite the acknowledged difficulties.     

Advancing institutional anomie theory: a microlevel examination connecting culture, institutions, and deviance

Institutional anomie theory (IAT) contends that crime can be explained by an examination of American society, particularly the exaggerated emphasis on economic success inherent in American culture, which has created a "cheating orientation" that permeates structural institutions, including academia. Consistent with its macrosocial perspective, previous tests of IAT have examined IAT variables at the structural level only. The current study tests the robustness of IAT by operationalizing IAT variables at the individual level and looking at a minor form of deviance, student cheating. The author also examines the role statistical modeling has in testing the theory at the microlevel. Undergraduates, 122 American born and 48 international, were surveyed about their cheating behaviors and adherence to economic goal orientations. Results related to the hypothesis that American students, relative to foreign-born students, will have an increased adherence to economic goal orientations that increase cheating behaviors are presented, as are suggestions for future studies.     

Genetic Determinism and Discrimination: A Call to Re-Orient Prevailing Human Rights Discourse to Better Comport with the Public Implications of Individual Genetic Testing

Genetic testing can not only provide information about diseases but also their prevalence in ethnic, gender, or other vulnerable populations. While offering the promise of significant therapeutic benefits and serving to highlight our commonality, genetic information also raises a number of sensitive human rights issues touching on identity and the perception thereof, as well as the possibility of discrimination and social stigma. It stands to reason that the results of individual screenings could haplessly be used to make general assumptions about entire ethnic or gender groups. In this manner, genetic information can directly influence identity by impacting and perhaps even reframing conceptions of group rights and dimensions of self-identification, thus importing constitutional scrutiny on questions of dignity and discrimination in particular. Is there a risk of collective stigmatization deriving from discrete testing of self-identified individuals? Would such stigmatization impinge on individual dignity by the exogenous imposition of ethnic or gender/sexual identity? If so, what norms can most adequately respond if and when individual and group interests diverge? These questions are examined from a comparative perspective.     

Genetic Testing and the Future of Disability Insurance: Ethics, Law & Policy

Predictive genetic testing poses fundamental questions for disability insurance, a crucial resource funding basic needs when disability prevents income from work. This article, from an NIH-funded project, presents the first indepth analysis of the challenging issues: Should disability insurers be permitted to consider genetics and exclude predicted disability? May disabilities with a recognized genetic basis be excluded from coverage as pre-existing conditions? How can we assure that private insurers writing individual and group policies, employers, and public insurers deal competently and appropriately with genetic testing?     

Luck, Genes, and Equality

This essay considers principles of distributive justice for access to reproductive biotechnologies which make it possible to enhance the traits of human offspring. The author provides prima facie reason to think that redistributive principles apply to genetic goods and proceed to evaluate the way in which four distributive patterns--egalitarianism, luck egalitarianism, prioritarianism, and suffcientarianism--would implement a just distribution of genetic goods. He argues that the currency of genetic redistribution consists in natural primary goods like health, vision, and rationality as these goods contribute to the biological component of basic capabilities, like being healthy, seeing properly, and being able to reason. The author develops a mixed sufficiency/priority approach to genetic enhancement, and defends this approach against objections.     

Mobsters are human too: Behavioural science and organized crime investigation

The paper describes the organized criminal, and the fight against organized crime from a behavioural point of viiew. The author considers the organized criminal a crime-entrepreneur who has to operate in an enduring violent entrepreneurial landscape in which he has to cope with the problem of social information management. The article described how the police can add a social psychological approach to the traditional investgative methods. I provides some experience obtained in the Netherlands in which the psychologist assisted the crime squad during the investigation, trial preparation and trial. It argues in favour of a more analytical, hypothesis testing method in whch the behavioural scientist is integrated in the operational organized crimesquad instead of acting as an outside consultant.     

Judicial intervention of the DNA test (comment on decisions of the Second Chamber of the Supreme Court No. 501/2005, of April 19, 2005, and No. 1311/2005, of October 14, 2005)]

The controversy has been arisen by the Spanish Supreme Court in two recent judgments, as they clearly show the lack of a unique criterion in the Spanish jurisprudence when genetic data have to be analysed in the course of a criminal process, in order to identify a person. The DNA proof cannot be practised without judicial intervention under Spanish law.     

权利与责任——浅谈舆论监督中的法律关系问题

权利与责任始终是一对相互依赖又相互矛盾的概念。而在新闻媒介这个敏感的领域中,权利与责任更是一个让人欲罢不能的问题。在我国的法律中有明确规定,“人民有知晓重大事件的权利”。获得这种“知晓权”的渠道就是大众传播。但媒介在行使这种舆论监督的权利时却往往遭遇尴尬,有时法律上的援助也显得那么苍白无力。本篇文章就舆论监督中的法律关系问题是从三个方面来讨论的。最后作者认为,权利和责任的平衡不是单方面的事情,是全社会努力才能达到的。     

Privacy and intra-familiy communication of genetic information.

The new knowledge (and predictions) created by DNA tests and the family nature of genetic information has already lead to a new problem: the intra-familiar communication of genetic data. This raises questions such as the following. Is there a duty to inform in cases when treatment is possible and the patient does not permit disclosure of genetic results to relatives? Is there an obligation to warn or merely an authorization (that could be used or not)? Could privacy protection be maintain as an individual interest but with some justified violations? A balance needs to be establishes between the interest of privacy and the need to disclose secret information.