The Genetic Information Nondiscrimination Act of 2008 prohibits most forms of discrimination on the basis of genetic information in health insurance and employment. The findings cited as justification for the act, the almost universal political support for it, and much of the scholarly literature about genetic discrimination, all betray a confusion about what is really at issue. They imply that genetic discrimination is wrong mainly because of genetic exceptionalism: because some special feature (...) of genetic information makes discrimination on the basis thereof wrong. I suggest, to the contrary, that the best arguments against genetic discrimination assume that health care is an entitlement . I do this by examining two different exceptionalist arguments for genetic nondiscrimination, showing that they do not furnish good reasons for prohibiting genetic discrimination unless one supposes that health care is an entitlement. (shrink)

Numerous state laws and the federal Genetic Information Nondiscrimination Act (GINA) have been enacted to prevent or redress genetic discrimination in employment and health insurance, but laws protecting against genetic discrimination in life insurance have been less common and weak. Consequently, some individuals with a genetic risk of a serious illness have declined presymptomatic genetic testing, thereby decreasing their prevention and treatment options and increasing their mortality risk. In 2020, Florida became the first (...) state to prohibit life insurance companies from using the results of presymptomatic genetic tests in underwriting. Although the law was “only” intended to prevent genetic discrimination, a possible or even likely consequence of the law will be to encourage timely genetic testing by at‐rick individuals and thereby save lives. (shrink)

May 21, 2018, marks the tenth anniversary of the signing into law of the Genetic Information Nondiscrimination Act. The Congressional deliberations for GINA were long and difficult. The original bill was introduced in 1995, and for many years, it did not look as if the bill would ever emerge from committee. Several of its provisions raised concerns for insurers, employers, and other stakeholders. After thirteen years, the controversial provisions were either deleted, revised, or clarified. At this ten‐year (...) mark, it is appropriate to take stock of GINA. In light of GINA's glacial legislative history, it is reasonable to start thinking about the necessity, wisdom, and feasibility of amending GINA or enacting new legislation to address unresolved or emerging issues of genetic discrimination and trends in genetics, genomics, precision medicine, and related technologies. (shrink)

The Genetic Information Nondiscrimination Act of 2008 was passed to encourage patients to seek genetic testing that could improve health outcomes and provide opportunities for preventive measures. GINA protects individuals from discrimination based upon genetic information, but not upon manifested diseases and conditions. Because the manifestation of a disease establishes a threshold of protection for individuals under GINA, the definition of manifestation is crucial to understanding the scope of the bill. This paper examines the (...) range of possible legal definitions of disease manifestation and explores the historical struggle that courts have faced when trying to apply these different definitions. Specifically, the paper examines three frameworks that courts have used in the past to interpret the manifestation of a disease; “manifestation as apparent symptoms,”“manifestation as patient action,” and “manifestation as physician action.” We argue that the “manifestation as physician action” is the best framework to utilize in this law generally, but that the definition of manifestation should be read in the light most favorable to a plaintiff in order to achieve the underlying goals of GINA. (shrink)

The United States’ Genetic Information Nondiscrimination Act of 2008 was sweeping legislation intended to protect the privacy of genetic information and prevent discrimination based on genetic factors in health insurance and employment. It protects the genetic privacy of individuals in these contexts and limits the likelihood that genetic discrimination will occur. However, in the case of employment, it does so at the cost of safety, both to the individuals it is meant to (...) protect and to others. On occasion, adherence to the dictates of GINA could lead to serious and avoidable harm to many people. Odd as it may seem, then, there can be such a thing as justified genetic discrimination. There are times when knowledge of genetic factors and subsequent action overrides reasons against obtaining or using such information. Moreover, this knowledge can be obtained without violating one's genetic privacyx. (shrink)

Congress passed the Genetic Information Nondiscrimination Act of 2008 in order to remove a perceived barrier to clinical genetic testing. By banning health insurance companies and employers from discriminating against an individual based on his or her genetic information, legislators hoped that patients would be encouraged to seek genetic testing that could improve health outcomes and provide opportunities for preventive measures. Their explicit legislative goal was to fully protect the public from discrimination and (...) allay their concerns about the potential for discrimination, thereby allowing individuals to take advantage of genetic testing, technologies, research, and new therapies.However, GINA left a number of issues unresolved, most notably failing to define the concept of disease manifestation. GINA was structured such that it only provides protection against misuse of genetic information up until the point when an individual's disease has manifested. It protects an individual with a genetic predisposition for a disease, but not an individual actively suffering from that disease. (shrink)

Whole–exome sequencing (WES) has increased our ability to analyze large parts of the human genome, bringing with it a plethora of ethical, legal, and social implications. A topic dominating discussion of WES is identification of “secondary findings” (SFs), defined as the identification of risk in an asymptomatic individual unrelated to the indication for the test. SFs can have considerable psychosocial impact on patients and families, and patients with an SF may have concerns regarding genomic privacy and genetic discrimination. The (...) Genetic Information Nondiscrimination Act of 2008 (GINA) currently excludes protections for members of the military. This may cause concern in military members and families regarding genetic discrimination when considering genetic testing. In this report, we discuss a case involving a patient and family in which a secondary finding was discovered by WES. The family members have careers in the U.S. military, and a risk–predisposing condition could negatively affect employment. While beneficial medical management changes were made, the information placed exceptional stress on the family, who were forced to navigate career–sensitive “extra–medical” issues, to consider the impacts of uncovering risk–predisposition, and to manage the privacy of their genetic information. We highlight how information obtained from WES may collide with these issues and emphasize the importance of genetic counseling for anyone undergoing WES. (shrink)

This article reviews recent developments in health care law, focusing on the engagement of law as a partner in health care innovation. The article addresses: the history and contents of recent United States federal law restricting the use of genetic information by insurers and employers; the recent federal policy recommending routine HIV testing; the recent revision of federal policy regarding the funding of human embryonic stem cell research; the history, current status, and need for future attention to advance (...) directives; the recent emergence of medical–legal partnerships and their benefits for patients; the obesity epidemic and its implications for the child’s right to health under international conventions. (shrink)

This commentary proposes the need for greater normative debate about when, if ever, it is appropriate for insurers to access genetic information of insureds to combat anti-selection.

The question of whether “genetic information” is a merely causal factor in development or can be made sense of semantically, in a way analogous to a language or other type of representation, has generated a long debate in the philosophy of biology. It is intimately connected with another intense debate, concerning the limits of genetic determinism. In this paper I argue that widespread attempts to draw analogies between genetic information and information contained in books, (...) blueprints or computer programs, are fundamentally inadequate. In development, gene exons are the central part of an intricate and densely ramified semantic Genetic Informational Network. DNA in the entire genome is in a state of continuous positive and negative feedback with itself and with its ‘environment’, and is ‘read’ and acted upon by the cell in various alternative and complementary ways. The linear combinatorial coding relation between codons and amino acids is but one aspect of semantic genetic information, which is, when considered in its entirety, a far wider and richer concept. (shrink)

Neurocognitive enhancement, or cosmetic neurology, offers the prospect of improving the learning, memory and attention skills of healthy individuals well beyond the normal human range. Much has been written about the ethics of such enhancement, but policy-makers in the USA, the UK and Europe have been reluctant to legislate in this rapidly developing field. However, the possibility of discrimination by employers and insurers against individuals who choose not to engage in such enhancement is a serious threat worthy of legislative intervention. (...) While lawmakers should not prevent individuals from freely pursuing neurocognitive enhancement, they should act to ensure that such enhancement is not coerced. This paper offers one model for such legislation, based upon a proposed US law, the Genetic Information Nondiscrimination Act of 2008, to address precisely this particular pitfall of the impending neuroscience revolution. (shrink)

The combination of decreased genotyping costs and prolific social media use is fueling a personal genetic testing industry in which consumers purchase and interact with genetic risk information online. Consumers and their genetic risk profiles are protected in some respects by the 2008 federal Genetic Information Nondiscrimination Act (GINA), which forbids the discriminatory use of genetic information by employers and health insurers; however, practical and technical limitations undermine its enforceability, given the (...) everyday practices of online social networking and its impact on the workplace. In the Web 2.0 era, employers in most states can legally search about job candidates and employees online, probing social networking sites for personal information that might bear on hiring and employment decisions. We examine GINA's protections for online sharing of genetic information as well as its limitations, and propose policy recommendations to address current gaps that leave employees? genetic information vulnerable in a Web-based world. (shrink)

It has been pending in Congress for twelve years, despite the support of the last two presidential Administrations and the National Institutes of Health. It has been the subject of extensive affirmative lobbying by academic medical centers, pharmaceutical and biotech companies, genetic disease advocacy groups, and civil rights organizations. It has overcome vehement objections by employers and insurers. Its final passage, however, has been thwarted by a few Congressional leaders, who have prevented enactment despite overwhelming bipartisan support in both (...) houses of Congress.Based on this legislative history, one could not help but assume that the Genetic Information Nondiscrimination Act is a revolutionary piece of legislation that, if finally enacted, would provide extensive, effective, and comprehensive protection against genetic discrimination in health insurance and employment Unfortunately, such an assessment would be incorrect. Indeed, GINA may be a case of too much ado about too little. (shrink)

On January 25, 2013, the Federal Register published the Department of Health and Human Services omnibus amendments to the Health Insurance Portability and Accountability Act Privacy, Security, Enforcement, and Breach Notification Rules. These modifications also include the final versions of the HIPAA regulation amendments mandated by the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act. Although the amended rules were effective on March 26, 2013, covered entities and their business (...) associates have a compliance date of September 23, 2013.It has been 10 years since the April 14, 2003 compliance date for the original HIPAA Privacy Rule. Despite HHS’ clarification of some issues by posting answers to frequently asked questions, there have been no significant amendments to the Privacy Rule since 2003. (shrink)

On January 25, 2013, theFederal Registerpublished the Department of Health and Human Services omnibus amendments to the Health Insurance Portability and Accountability Act Privacy, Security, Enforcement, and Breach Notification Rules. These modifications also include the final versions of the HIPAA regulation amendments mandated by the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act. Although the amended rules were effective on March 26, 2013, covered entities and their business associates have (...) a compliance date of September 23, 2013.It has been 10 years since the April 14, 2003 compliance date for the original HIPAA Privacy Rule. Despite HHS’ clarification of some issues by posting answers to frequently asked questions, there have been no significant amendments to the Privacy Rule since 2003. (shrink)

The genetic testing industry is in a period of potentially major structural change driven by several factors. These include weaker patent protections after Association for Molecular Pathology v. Myriad Genetics and Mayo Collaborative Services v. Prometheus Laboratories, Inc.; a continuing shift from single-gene tests to genome-scale sequencing; and a set of February 2014 amendments to the Clinical Laboratory Improvement Amendments of 1988 regulations and the Health Insurance Portability and Accountability Act Privacy Rule. This article explores the nature of these (...) changes and why they strain existing regulatory frameworks for protecting patients, research subjects, and other consumers who receive genetic testing.Oversight of genetic testing has, at least to date, had two major thrusts: privacy and ethical protections and traditional consumer health and safety regulations. Examples of the first are the Genetic Information Nondiscrimination Act and the HIPAA Privacy Rule, which after 2013 amendments expressly protects genetic privacy as well as other medical privacy. (shrink)

Purpose Human genomic research demands very large pools of data to generate meaningful inference. Yet, the sharing of one’s genetic data for research is a voluntary act. The collection of data sufficient to fuel rapid advancement is contingent on individuals’ willingness to share. Privacy risks associated with sharing this unique and intensely personal data are significant. Genetic data are an unambiguous identifier. Public linkage of donor to their genetic data could reveal predisposition to diseases, behaviors, paternity, heredity, (...) intelligence, etc. The purpose of this paper is to understand individuals’ willingness to volunteer their private information in this high-risk/high-reward context. Design/methodology/approach The authors collect survey data from 273 respondents and use structural equation modeling techniques to analyze responses. Findings The authors find statistical support for our theorization. They find that while heightened awareness of the benefits and risks of sharing correlates with increased privacy concerns, the net impact is an increase in intention to share. Social implications The findings suggest that prescriptive awareness might be an effective tool with which policy-makers can gain the sufficient voluntary participation from individuals necessary to drive large-scale medical research. Originality/value This study contributes a theoretically and empirically informed model which demonstrates the impact of awareness and privacy concern on individuals’ willingness to share their genetic data for large-scale HGR. It helps inform a rising class of data sufficiency problems related to large-scale medical research. (shrink)

Mature spermatozoa are permeable to foreign DNA and RNA molecules. Here I propose a model, whereby extrachromosomal genetic information, mostly encoded in the form of RNA in somatic cells, can cross the Weismann barrier and reach epididymal spermatozoa. LINE‐1 retrotransposon‐derived reverse transcriptase (RT) can play key roles in the process by expanding the RNA‐encoded information. Retrotransposon‐encoded RT is stored in mature gametes, is highly expressed in early embryos and undifferentiated cells, and becomes downregulated in differentiated cells. In (...) turn, RT plays a role in developmental control, as its inhibition arrests developmental progression of early embryos with globally altered transcriptomic profiles. Thus, sperm cells act as recipients, and transgenerational vectors of somatically derived genetic information which they pass to the next generation with the potential to modify the fate of the developing embryos. (shrink)

Down syndrome (Trisomy 21) is a mild to moderate intellectual disability. Historically, this condition has been a primary target for prenatal testing. However, Down syndrome has not been targeted for prenatal testing because it is an especially severe illness. The condition was just one that could be easily identified prenatally using the techniques first available decades ago. We are moving into an era in which we can prenatally test for a vast range of human traits. I argue that when we (...) can test for anything, there is no longer any reason to continue targeting Down syndrome. I present an argument based on the value of nondiscrimination. It is justified to set limits on access to prenatal information if the information is going to be used for discriminatory purposes. I use the examples of (1) prenatal testing for misogynistic fetal sex selection, and (2) homophobia-motivated prenatal testing for potential homosexuality, as compelling analogies. (shrink)

We describe an approach to measuring biological information where ‘information’ is understood in the sense found in Francis Crick’s foundational contributions to molecular biology. Genes contain information in this sense, but so do epigenetic factors, as many biologists have recognized. The term ‘epigenetic’ is ambiguous, and we introduce a distinction between epigenetic and exogenetic inheritance to clarify one aspect of this ambiguity. These three heredity systems play complementary roles in supplying information for development. -/- We then (...) consider the evolutionary significance of the three inheritance systems. Whilst the genetic inheritance system was the key innovation in the evolution of heredity, in modern organisms the three systems each play important and complementary roles in heredity and evolution. -/- Our focus in the earlier part of the paper is on ‘proximate biology’, where information is a substantial causal factor that causes organisms to develop and causes offspring to resemble their parents. But much philosophical work has focused on information in ‘ultimate biology’. Ultimate information is a way of talking about the evolutionary design of the mechanisms of development and inheritance. We conclude by clarifying the relationship between the two. Ultimate information is not a causal factor that acts in development or heredity, but it can help to explain the evolution of proximate information, which is. (shrink)

In the last few years, a great deal of attention has been paid to the effects that the achievements of the Human Genome Project will have on the confidentiality of medical information. The Genetic Privacy Act is an attempt to address the privacy, confidentiality, and property rights relating to obtaining, requesting, using, storing, and disposing of genetic material. The GPA grew out of concerns over the vast amount of genetic information that is a product of (...) the Human Genome Project. The central goals of the GPA are twofold: to define an individual's right to control access to their genetic material and the privilege to control the information derived therefrom; and to prevent potential and actual abuse of genetic information by third parties, such as insurance companies, employers, and government. The GPA is one of a group of proposals that seek to control the flow of medical information from the individual to health care professionals and to other persons. (shrink)

In the last few years, a great deal of attention has been paid to the effects that the achievements of the Human Genome Project will have on the confidentiality of medical information. The Genetic Privacy Act is an attempt to address the privacy, confidentiality, and property rights relating to obtaining, requesting, using, storing, and disposing of genetic material. The GPA grew out of concerns over the vast amount of genetic information that is a product of (...) the Human Genome Project. The central goals of the GPA are twofold: to define an individual's right to control access to their genetic material and the privilege to control the information derived therefrom; and to prevent potential and actual abuse of genetic information by third parties, such as insurance companies, employers, and government. The GPA is one of a group of proposals that seek to control the flow of medical information from the individual to health care professionals and to other persons. (shrink)

Despite its focus on consent the new Human Tissue Act 2004 allows for testing without consent where a relative could benefitIn recognition of the fact that genetic test results in people can have implications for close relatives, the new Human Tissue Act 2004 allows for a direction to access a person’s tissue so that testing can be carried out for the benefit of a relative, without the consent of that person. Clinical practice governed by common law and statute, before (...) this act, acknowledged that the disclosure, without consent, of the results of a genetic test, is ethically permissible in extreme situations for the benefit of a relative. New testing for the benefit of a relative without donor consent challenges the principle that informed or adequate consent should be obtained before a genetic test with considerable predictive powers is carried out. The debate surrounding the analogous situation of HIV testing concluded that in very rare cases, disclosure of an HIV result without consent may be justified, but testing without consent is a professional misconduct. This part of the legislation is controversial and deserves further debate. The Human Tissue Authority should take measures to limit the potential harm that can be caused by this provision.IntroductionAfter much debate, the new Human Tissue Act 2004 was passed by parliament in November 2004. Implementation of this act may be staggered, but it will be fully operational in May 2006. This act has several provisions that have implications in clinical practice for the use of stored tissue or samples containing cells. These provisions allow the Human Tissue Authority to permit access to human tissue for the purpose of obtaining scientific or medical information about a person for the benefit of another family member, without the consent of the donor . …. (shrink)

Only 27 percent of Americans in a 1995 Harris poll said they had read or heard “quite a lot” about genetic tests. Nonetheless, 68 percent said they would be either “very likely” or “somewhat likely” to undergo genetic testing even for diseases “for which there is presently no cure or treatment.” Perhaps most astonishing, 56 percent found it either “very” or “somewhat acceptable” to develop a government computerized DNA bank with samples taken from all newborns, and their names (...) attached to the samples. This does not necessarily mean the public is unconcerned about genetic privacy. More likely it means that the public is still uninformed about the risks associated with genetic testing, and has not thought at all about the risks involved in storing identifiable DNA samples.A central question presented by genetic screening and testing is whether the genetic information so obtained is different in kind from other medical information, and, if so, whether this means that it should receive special legal protection. (shrink)

Only 27 percent of Americans in a 1995 Harris poll said they had read or heard “quite a lot” about genetic tests. Nonetheless, 68 percent said they would be either “very likely” or “somewhat likely” to undergo genetic testing even for diseases “for which there is presently no cure or treatment.” Perhaps most astonishing, 56 percent found it either “very” or “somewhat acceptable” to develop a government computerized DNA bank with samples taken from all newborns, and their names (...) attached to the samples. This does not necessarily mean the public is unconcerned about genetic privacy. More likely it means that the public is still uninformed about the risks associated with genetic testing, and has not thought at all about the risks involved in storing identifiable DNA samples.A central question presented by genetic screening and testing is whether the genetic information so obtained is different in kind from other medical information, and, if so, whether this means that it should receive special legal protection. (shrink)

Parents influence the development of their offspring in many ways beyond the transmission of DNA. This includes transfer of epigenetic states, nutrients, antibodies and hormones, and behavioural interactions after birth. While the evolutionary consequences of such nongenetic inheritance are increasingly well understood, less is known about how inheritance mechanisms evolve. Here, we present a simple but versatile model to explore the adaptive evolution of non-genetic inheritance. Our model is based on a switch mechanism that produces alternative phenotypes in response (...) to different inputs, including genes and non-genetic factors transmitted from parents and the environment experienced during development. This framework shows how genetic and non-genetic inheritance mechanisms and environmental conditions can act as cues by carrying correlational information about future selective conditions. Differential use of these cues is manifested as different degrees of genetic, parental or environmental morph determination. We use this framework to evaluate the conditions favouring non-genetic inheritance, as opposed to genetic determination of phenotype or within-generation plasticity, by applying it to two putative examples of adaptive non-genetic inheritance: maternal effects on seed germination in plants and transgenerational phase shift in desert locusts. Our simulation models show how the adaptive value of non-genetic inheritance depends on its mechanism, the pace of environmental change, and life history characteristics. (shrink)

In this article we explore the contribution from social anthropology to the medical ethical debates about the use of informed consent in research, based on blood samples and other forms of tissue. The article springs from a project exploring donors’ motivation for providing blood and healthcare data for genetic research to be executed by a Swedish start-up genomics company. This article is not confined to empirical findings, however, as we suggest that anthropology provides reason to reassess the theoretical understanding (...) of autonomy as generally defined by Beauchamp and Childress. Careful consideration of the trust expressed by donors through the act of donation, furthermore, suggests that there is reason to redirect the ethical scrutiny from informed consent to issues concerning institutional arrangements and social responsibility. In particular, we suggest that an anthropological approach could facilitate a reconsideration of the political implications of using informed consent as a regulatory practice in tissue-based research. (shrink)

Genetic testing has familial implications. Counsellors find themselves in (moral) conflict between medical confidentiality (towards the patient) and a potential right or even duty to warn at-risk relatives. Legal regulations vary between countries. English literature about German law is scarce. We reviewed the literature of relevant legal cases, focussing on German law, according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. This article aims to familiarise counsellors with their responsibilities, compare the situation between countries and point (...) out legally unresolved areas.According to the German Genetic Diagnostics Act (Gendiagnostikgesetz) in case of an ‘avoidable or treatable’ genetic disorder, geneticists ought to confine themselves to the obligated advice to the patient. Whether a breach of the duty of confidentiality can be justified in exceptional cases by ‘necessity as justification’ for actively informing relatives at risk remains legally unclear. In case of a ‘neither avoidable nor treatable’ genetic disease, geneticists should also refrain from actively informing relatives as the justifiable state of emergency does not permit to break the duty of confidentiality. (shrink)

This article investigates a high-profile and ongoing dilemma for healthcare professionals, namely whether the existence of a duty of care to genetic relatives of a patient is a help or a hindrance in deciding what to do in cases where a patient’s genetic information may have relevance to the health of the patient’s family members. The English case ABC v St George’s Healthcare NHS Trust and others considered if a duty of confidentiality owed to the patient and (...) a putative duty of care to the patient’s close relatives could coexist in this context. This article examines whether embracing the concept of coexisting duties could enable HCPs to respect duties in line with their clinical judgement, thereby providing legal support and clarity to professionals to allow them to provide the best possible genetics service to both the patient and their family. We argue that these dual duties, framed as a novel, composite duty to consider the interests of genetic relatives, could allow HCPs to exercise and act on their professional judgements about the relative value of information to family members, without fears of liability for negligence or breach of confidence. (shrink)

In the struggle over the durability of the Affordable Care Act, defenders of the ACA stand guard at many fronts. A major contribution of the ACA to nondiscrimination law, however, appears increasingly vulnerable. The ACA established significant new nondiscrimination protections for patients under section 1557 and its implementing regulations. Several of these regulations—including protections on the basis of gender identity and pregnancy termination—are now under reconsideration at the Department of Health and Human Services, after a nationwide injunction lasting (...) almost a year. Nondiscrimination laws matter, of course, because they promote equal access to health care. But focusing on discriminatory behavior alone is a narrow view of the purpose and potential of nondiscrimination rules—and underestimates the stakes of softening section 1557. To evaluate these protections, we must consider not only their impacts on discriminatory behavior but also their behavioral and attitudinal impacts on patients and communities. This is because supportive or stigmatizing rules can exert an expressive effect: laws communicate information about prevailing social norms, they give some norms greater authority by virtue of the state's support, and they can shape community values. Through these expressive impacts, nondiscrimination laws may affect not only discriminatory behavior in health activities but also the attitudes, beliefs, and decisions of people who are legally protected. (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 science and technology of genetic testing is rapidly advancing with the consequences that genetic testing may well offer the prospect of being able to detect the onset of future disabilities. Some recent research also indicates that certain behavioural profiles may have a strong genetic basis, such as the determination to succeed and win or the propensity for risk-taking, which may be of interest to third parties. However, as this technology becomes more prevalent there is a danger (...) that the genetic information may be misused by entities such as employers, insurance companies, educational facilities, and finance companies and that people with particular genetic profiles may be discriminated against.This book explores the different types and the potential uses of genetic testing. The book highlights the ethical and legal dilemmas and the challenges arising as a result of emerging and rapidly advancing genetic science. Chapters in the book assess the importance and impact of the US Genetic Information Non-Discrimination Act (GINA) in the employment and health insurance contexts asking whether it is proving to be an effective tool in addressing the issue of genetic discrimination and alleviating individuals' fears of discrimination. The book then goes on to make the case for regulation at the European Union level in order to protect the privacy of genetic information and to prevent the discriminatory use of genetic information in Europe. It considers what can be learnt from the experience of the US in addressing ethical and legal issues as well as the impact that the UN Convention on the Rights of Persons with Disabilities is having on this debate within the EU. (shrink)

The Genetic Privacy Act is a comprehensive effort to protect individuals from unauthorized analysis of their DNA and from unauthorized disclosure of information resulting from genetic analysis. Irrespective of merit, every bill must survive legislative scrutiny. This is a considerable challenge, particularly for a bill as complex and far-reaching as the GPA. To illustrate my point, I describe the fate of two bills introduced into the Maryland Senate in 1995 by Senator Jennie Forehand. The first, also entitled (...) the Genetic Privacy Act, was a slightly modified version of the model legislation prepared by Annas, Glantz, and Roche. After a hearing, the bill received a 9-2 unfavorable vote from the Economic and Environmental Affairs Committee. The second was a much shorter bill, DNA Testing – Informed Consent and Confidentiality, which simply stated that “DNA analysis may only be performed with the informed consent of the person being analyzed” and that the results of such analysis “are the exclusive property of the person tested, are confidential, and may not be disclosed without the consent of the person being tested.” This bill had a hearing but was never put to a vote by the Judicial Proceedings Committee. My principal aim is to examine the testimony on these bills. I will conclude with some suggestions about accomplishing the goals of genetic privacy legislation. (shrink)

New developments in genetics could affect a variety of real property rights. Mortgage lenders, mortgage insurers, real estate sellers, senior living centers, retirement communities, or other parties in residential real estate transactions begin requiring predictive genetic information as part of the application process. One likely use would be by retirement communities to learn an individual's genetic risk for Alzheimer's disease. The federal Fair Housing Act prohibits discrimination based on disability, but it is not clear that it would (...) apply to genetic risk assessments. Only California law explicitly applies to this situation and there have been no reported cases. (shrink)

Since 1991, over half the states have enacted laws that restrict or prohibit insurers’ use of genetic information in pricing, issuing, or structuring health insurance. Wisconsin was the first state to do so, in 1991, followed by Ohio in 1993, California and Colorado in 1994, and then several more states a year in each of the next five years. Similar legislation has been pending in Congress for several years. Also, a 1996 federal law known as the Health Insurance (...) Portability and Accountability Act prohibits group health insurers from applying “preexisting condition” exclusions to genetic conditions that are indicated solely by genetic tests and not by any actual symptoms. (shrink)

Since 1991, over half the states have enacted laws that restrict or prohibit insurers’ use of genetic information in pricing, issuing, or structuring health insurance. Wisconsin was the first state to do so, in 1991, followed by Ohio in 1993, California and Colorado in 1994, and then several more states a year in each of the next five years. Similar legislation has been pending in Congress for several years. Also, a 1996 federal law known as the Health Insurance (...) Portability and Accountability Act prohibits group health insurers from applying “preexisting condition” exclusions to genetic conditions that are indicated solely by genetic tests and not by any actual symptoms. (shrink)

U.S Courts have ruled that one’s genetic information is covered by the Fourth Amendment to the Constitution, which affords persons protection against unreasonable search and seizures of their personal property and personal space. The Genetic Information Non-Discrimination Act (GINA) protects people from discrimination in health insurance and employment based on genetic information. The European Union issued the General Data Protection Regulation, which included genetic information. Yet with the development and application of DNA (...) identification in criminal investigations, governments have amassed the genetic information of millions of people. And, with the rise of consumer genetics, especially since DNA ancestry tests went commercial in 2000, dozens of companies have amassed millions of personal DNA samples that are sold to various companies for analysis beyond their intended genealogical purpose. Where is the balance between the protection of people’s genetic information and the commercial and forensic acquisition of personal genetic data? How can genetic information be protected under the Fourth Amendment’s privacy provisions, as well as privacy laws in other countries, and yet be so whimsically distributed throughout society, so easily acquired by police, and voluntarily released to companies? (shrink)

The struggle over genetically-engineered (GE) maize in Mexico reveals a deep conflict over the criteria used in the governance of agri-food systems. Policy debate on the topic of GE maize has become “scientized,” granting experts a high level of political authority, and narrowing the regulatory domain to matters that can be adjudicated on the basis of scientific information or “managed” by environmental experts. While scientization would seem to narrow opportunities for public participation, this study finds that Mexican activists acting (...) “in defense of maize” engage science in multiple ways, using and producing scientific knowledge as well as treating scientific discussions as a stage for launching complex social critiques. Drawing from research in science and technology studies, this article assesses the impacts and pitfalls of three tactics used by maize activists that respond to the scientization of biotechnology politics: (1) using scientific information as a resource; (2) participating in scientific research; and (3) reframing policy problems as broadly social, rather than as solely scientific or technical. The obstacles that maize activists have faced in carrying out each of these efforts indicate that despite diverse and sophisticated engagements between social movements and the scientific field, scientization remains a significant institutional barrier to democratizing agricultural governance. (shrink)

BackgroundClinical ethical practice (CEP) is required for healthcare workers (HCWs) to improve health-care delivery. However, there are gaps between accepted ethical standards and CEP in Ethiopia. There have been limited studies conducted on CEP in the country. Therefore, this study aimed to determine the magnitude and associated factors of CEP among healthcare workers in healthcare facilities in Ethiopia.MethodFrom February to April 2021, a mixed-method study was conducted in 24 health facilities, combining quantitative and qualitative methods. Quantitative (survey questionnaire) and qualitative (...) (semi-structured interviews) data were collected. For quantitative and qualitative data analysis, Stata version 14 and Atlas.ti version 7 were utilized. Multiple logistic regression and thematic analysis for quantative and qualitative respectively used.ResultsFrom a total of 432 study participants, 407 HCWs were involved in the quantitative analysis, 36 participants were involved in five focus group discussions (FGDs), and eleven key informant interviews (KIIs) were involved in the qualitative analysis. The score of good CEP was 32.68%. Similarly, the scores of good knowledge and attitude were 33.50% and 25.31%, respectively. In the multiple logistic regression models, satisfaction with the current profession, availability of functional CECs, compassionate leaders, previously thought clinical ethics in pre-service education and good attitude were significant factors associated with CEP. Among these significant factors, knowledge, compassionate leaders, poor infrastructure, a conducive environment and positive attitudes were also determinants of CEP according to qualitative findings.ConclusionsThe CEP in health care services in Ethiopia is low. Satisfaction with the current profession, functional CECs, positive attitude, compassionate leaders and previously thought clinical ethics were significant factors associated with CEP. The Ministry of Health (MoH) should integrate interventions by considering CECs, compassionate leadership, and positive attitudes and enhance the knowledge of health professionals. Additionally, digitalization, intersectoral collaboration and institutionalization are important for promoting CEP. (shrink)

This review is focused on recent advances in our understanding of the development of coordinated cell polarity, through experiments on the Drosophila compound eye. Each eye facet (or “ommatidium”) contains a set of eight photoreceptor cells, placed so that their rhabdomeres form an asymmetric trapezoid. The array of ommatidia is organized so that these trapezoids are aligned in two mirror-image fields, dorsal and ventral to the eye midline (or “equator”). The development of this pattern depends on two systems of positional (...) information that inform the cluster of cells that will form an ommatidium of anterior/posterior (a/p) and dorsal/ventral (d/v) direction. The former (a/p) is encoded by a progressive wave of development (the morphogenetic furrow). The latter (d/v) involves molecules known to act in tissue polarity in other organs and organisms. Our understanding of the function of these molecules rests not only on their mutant phenotypes, biochemistry, and expression patterns, but also on the spatial effects when mutant patches of cells are made (genetic mosaics). BioEssays 21:275–285, 1999. © 1999 John Wiley & Sons, Inc. (shrink)

This paper explores the implications of human reproductive cloning for our notions of parenthood. Cloning comes in numerous varieties, depending on the kind of cell to be cloned, the age of the source at the time the clone is created, the intended social relationship, if any, between source and clone, and whether the clone is to be one of one, or one of many, genetically identical individuals alive at a time. The moral and legal character of an act of cloning (...) may, moreover, differ in light of these distinctions. Surprisingly, however, reproductive cloning in all its variety seems to undermine the view of parenthood that is most popular among proponents of reproductive technology in the bioethics literature. This view, geneticism, has much to recommend it. I will show, however, that as commonly understood, geneticism is incompatible with the reproductive view of cloning. I then canvass alternative accounts of parenthood—namely, conventionalism, gestationalism, and intentionalism—but none succeeds in explaining reproductive cloning. I thus return to a reconstructed version of geneticism. I argue that the problem for geneticism rests not with the notion of genetic parenthood as such but with a particular, flawed, understanding of it, which I call informational geneticism. Informational geneticism should be rejected in favor of a “physicalistic” version of geneticism, which treats genes as particular objects, not abstract types, and takes seriously the essentially embodied character of reproduction. For these reasons, physicalistic geneticism survives the challenge represented by reproductive cloning. Additionally, physicalistic geneticism accommodates attractive aspects of competing views of parenthood, meeting some powerful objections in the process. (shrink)

In this chapter I argue that the old common law concept of the commons can make a major contribution to how we regulate human tissue and genetic information in the twenty-first century. But if we want to use this concept, we will have to act fast, because private corporate interests have already realised the relevance of the commons for holdings in human tissue and genetic information. Instead of a commonly created and held resource, however, they have (...) sought to create one derived from many persons' mutual labour but owned privately: what I call, with deliberate irony, a 'corporate commons'. (shrink)

Although the philosophical literature on the ethics of human prenatal genetic alteration purports to inform us about how to act, it rarely explicitly recognizes the perspective of those who will be making the PGA decision in practice. Here I approach the ethics of PGA from a distinctly virtue-based perspective, taking seriously what it means to be a good parent making this decision for one’s child. From this perspective, I generate a sound verdict on the moral standing of human PGA (...) : given the current state of the art, good parents have compelling reason not to consent to PGA for their child, especially as part of the first wave of PGA research participants and especially for non-medically oriented purposes. This is because doing otherwise is inconsistent with a plausible and defensible understanding of virtuous parenting and parental virtues, founded on a genuine concern for promoting the overall flourishing of the eventual child. In essence, given the current and foreseeable state of the art, parents who allow prenatal genetic alteration of their children are less-than-virtuous parents to those children, even in cases where they have a right to do so and even if PGA turns out to be beneficial to the eventual child. (shrink)

In this paper it is analyzed from the informational perspective the relation between mind and body, an ancient philosophic issue defined as a problem, which still did not receive up to date an adequate solution. By introducing/using the concept of information, it is shown that this concept includes two facets, one of them referring to the common communications and another one referring to a hidden/structuring matter-related information, effectively acting in the human body and in the living systems, which (...) determines the dynamic inter-change of information between specific structures of the organism by electric/electronic/chemical agents and genetic/epigenetic processes. It is shown that the maintenance of body, permanently and obligatory depending on the external matter (foods, air, water) resources, needed to provide both the structuring/restructuring basic material and energy, determines the necessary existence of an info-managing system, administrating the internal mechano-chemical/physical processes. As a natural consequence, such a system should organize and assure own survival by an effective informational operability to detect the external food resources, to select the appropriate interest information and to decide as a function of circumstances. One important component in such an informational system is memory, allowing to dispose of the reference informational data for analysis/comparison and the selection between good and bad binary possible decisions. The memory receives and stores therefore signals from external reality and from the body itself, referring to the emotional reaction, digestion status, creation, and inherited predilections, within specific info-neural communication circuits between the brain and body execution/sensitive organs, the human body appearing as an integrated info-matter self-managed dynamic system. The specific body components memorize information with different degrees of info-integration: short/long-term integration, emotive/action reaction, info-abilities, culminating with the integration in the chromosomal structures by epigenetic processes. The new acquired information is transgenerationally transmissible, and is manifested as new traits, showing the adaptation capability of the human and close relation between mind and body. Analyzing the results of such a mind-body informational model in comparison with the earlier assumed/proposed/asserted archaic, Greek and Occidental philosophies, which represent only partial aspects of this relation, it is shown that this informational model, elaborated in terms of information on the basis of scientific reasons and arguments, constitutes a general, realist, and coherent model of the mind-body relation, able to integrate and/or explain most of the others. (shrink)

This review is unashamedly from the perspective of English law because busy United Kingdom criminal law solicitors and barristers mostly wish to know what the law states, which case is a precedent case and whether the author has provided up-to-date legal information. This is because legal practitioners deal with real and urgent cases. The English Income Tax Act gained Royal Assent in 1799 the first government attempt to stop early tax avoidance. Later, tax avoidance schemes (which in English Law (...) were deemed a legitimate method of minimising one payment of taxation) became de rigueur all over the world and often involved creation of Deeds of Covenant and Trusts, notably Discretionary Trusts under civil law. Man’s ingenuity knows no bounds and this applies to man’s characteristic of criminality as it does to scholarship, enterprise and innovation. Despite protestations by some countries police agencies, contrary to the rise of crime, the fact is that that crime is increasing exponentially worldwide, but the number of people committing crime is not increasing because many crimes are repeated crimes committed by persons with habitual criminal behaviour, ie hard-core criminals. (shrink)

Along with many jurisdictions, Australia is struggling with the unique issues raised by genetic information in the context of privacy laws and medical ethics. Although the consequences of disclosure of most private information are generally confined to individuals, disclosure of genetic information has far-reaching consequences, with a credible argument that genetic relatives have a right to know about potential medical conditions. In 2006, the Privacy Act was amended to permit disclosure of an individual's (...) class='Hi'>genetic information, without their consent, to genetic relatives, if it was to avoid or mitigate serious illness. Unfortunately, additional amendments required for operation of the disclosure amendment were overlooked. Public Interest Determinations —delegated legislation issued by the privacy commissioner—have, instead, been used to exempt healthcare providers from provisions which would otherwise make disclosure unlawful. This paper critiques the PIDs using documents obtained under the Freedom of Information Act—specifically the impact of both the PIDs and the disclosure amendment on patients and relatives—and confidentiality and the procedural validity of subordinate laws regulating medical privacy. (shrink)

Since the 1970s and more rigorously since the 1990s, many countries have regulated data protection and privacy laws in order to ensure the safety and privacy of personal data. First, a comparison is made of different acts regarding genetic information that are in force in the EU, the USA, and China. In Turkey, changes were adopted only recently following intense debates. This study aims to explore the experts’ opinions on the regulations of the health information systems, data (...) security, privacy, and confidentiality in Turkey, with a particular focus on genetic data, which is more sensitive than other health data as it is a permanent identifier that is inherited to next of kin and shared with other family members. Two focus groups with 18 experts and stakeholders were conducted, discussing topics such as central data collection, legalized data sharing, and the management of genetic information in health information systems. The article concludes that the new Turkish personal data protection law is problematic as the frame of collectible data is wide-ranging, and the exceptions are extensive. Specific laws or articles dedicated to genetic data that also overlook the dimension of discrimination based on genetic differences in Turkey should be taken into consideration. In broader terms, it is intended to put up for discussion that in addition to ethical aspects, economic aspects and legal aspects of health should be included in the discussion to be carried out within the framework of socio-political analyses with culture-specific approaches and cross-culture boundaries simultaneously. (shrink)

This paper suggests that many of the pressing dilemmas of bioethics are global and structural in nature. Accordingly, global ethical frameworks are required which recognize the ethically significant factors of all global actors. To this end, ethical frameworks must recognize the rights and interests of both individuals and groups (and the interrelation of these). The paper suggests that the current dominant bioethical framework is inadequate to this task as it is over-individualist and therefore unable to give significant weight to the (...) ethical demands of groups (and by extension communal and public goods). It will explore this theme by considering the inadequacy of informed consent (the ‘global standard’ of bioethics) to address two pressing global bioethical issues: medical tourism and population genetics.Using these examples it will show why consent is inadequate to address all the significant features of these ethical dilemmas. Four key failures will be explored, namely,• That the rights and interests of those related (and therefore affected) are neglected;• That consent fails to take account of the context and commitments of individuals which may constitute inducement and coercion;• That consent alone does not have the ethical weight to negate exploitation or make an unjust action just (‘the fallacy of sufficiency’);• That consent is a single one-off act which is inappropriate for the types of decision being made.It will conclude by suggesting that more appropriate models are emerging, particularly in population genetics, which can supplement consent. (shrink)