Bioethics and humanities (inclusive of medical ethics, health care ethics, environmental ethics, research ethics, philosophy and medicine, literature and medicine, and so on) seems like one field; yet colleagues come from different academic disciplines with distinct languages, methods, traditions, core curriculum and competency examinations. The author marks six related "framework" features that unite and make it one distinct field. It is a commitment to (1) work systematically on some of the momentous and well-defined sets of problems about the human condition (...) that drive our field (such as death and dying, disability, confidentiality, professionalism, informed consent, abortion, euthanasia, assisted suicide, personhood, health-care resource allocation and environmental ethics, as well as the impact of new technologies, including genetic and reproductive); (2) use interdisciplinary approaches to unravel them; (3) employ cases and practical reasoning to understand problems and solve answers; (4) apply teaching methods and goals associated with John Dewey to make students better problem-solvers; (5) find morally justifiable solutions to the problems driving our field; and (6) seek interdisciplinary and collaborative scholarship, service or teaching. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Human Genome Project and BioethicsEric T. Juengst, Ph.D. (bio)The fifteen-year "human genome project" at the National Institutes of Health and the Department of Energy officially began on October 1, 1990. With it began a new dimension in federally supported scientific research: concurrent funding for work to anticipate the social consequences of the project's research and to develop policies to guide the use of the knowledge it produces. As (...) a result, the National Center for Human Genome Research (NCHGR) at NIH will support the largest public investment in bioethical analysis to date.NCHGR was established to work with other federal, private, and international organizations on the scientific effort to characterize the form and content of the human genome. The research will yield information—high-resolution genetic linkage and physical maps of all the human chromosomes as well as human DNA sequence data—that will be a resource for studies of gene structure and function. It will greatly increase our understanding of the genetic aspects of human health and disease. That increased understanding will eventually provide insights into the prevention and treatment of the 3,000 known inherited disorders, and of conditions caused by our (gene-governed) physiological reactions to pathogens, toxins, and mutagens of external origin.It has been clear since the conception of the human genome project, however, that professional and public deliberations concerning the responsible use of genetic information must be a part of the process. The most immediate consequence of genome research will be the development of new diagnostic and predictive tests, well in advance of corresponding therapeutic or curative advances. The implications of acquiring and using that knowledge about individuals raise policy questions at many levels within society. The primary purpose of the Ethical, Legal and Social Implications Program at the NCHGR is to anticipate and address these questions early in the life of the scientific project, to help optimize the [End Page 71] benefits to human welfare and opportunity from the new knowledge, and to guard against its misuses.The program has identified three sets of questions as particularly important to pursue as the genome initiative proceeds:1.Issues involved in the integration of new genetic tests into medical practice. Human genome research is expected to increase greatly the number of gene-based diagnostic and prognostic tests available to health professionals. The bioethical policy problems involved in integrating those tests effectively into medical practice include developing standards for:— accuracy and quality control of genetic tests;— medical indications for testing and design of testing protocols;— professional responsibilities of clinicians who perform tests;— confidentiality of information obtained from testing;— access to and use of test results by third parties, such as health insurers; and— reimbursement for testing and test-related counseling.These are problems for both those charged with regulating the use of new genetic tests and for those establishing the standards of practice within the health professions. Thus, in addition to soliciting and funding scholarly research proposals on both the factual and normative questions raised by these problems, the program is commissioning a major new study by the National Academy of Sciences/Institute of Medicine aimed at providing professional guidelines for the integration of genetic services into mainstream medical practice.2. Issues involved in educating and counseling individuals about genetic test results. The primary risk that health professionals will face in using genetic tests is the misinterpretation of their findings and the resulting potential for psychological trauma, stigmatization, and discrimination. Sometimes, out of ignorance, patients, families, and social institutions already stigmatize genetic disorders and treat those with them unfairly. This risk broadens as the genetic elements of more health problems are uncovered and gene-based tests for susceptibilities and carrier states are developed.To protect against these risks, NCHGR is soliciting and supporting projects aimed at improving professional and public understanding of these tests and their implications. For example, a philosopher is leading a team of geneticists and physicians in a scholarly effort to clarify [End Page 72] concepts of genetic susceptibility and draw out the social meaning of their different interpretations. Other projects involve social scientific studies of genetic risk perceptions, stigmatization, and discrimination. The conclusions of these studies, and... (shrink)

Gaucher disease is a rare, chronic,ethnic-specific genetic disorder affecting Jewsof Eastern European descent. It is extremelyexpensive to treat and presents difficultdilemmas for officials and patients in Israelwhere many patients live. First, high-cost,high-benefit, but low volume treatment forGaucher creates severe allocation dilemmas forpolicy makers. Allocation policies driven bycost effectiveness, age, opportunity or needmake it difficult to justify funding. Processoriented decision making based on terms of faircooperation or decisions invoking the ``rule ofrescue'''' risk discriminating against minoritieswho may already suffer from inequitabledistribution (...) of heath care resources. Apartfrom cost, Gaucher disease prompts questionsabout abortion. Unlike severe geneticdisorders, Gaucher offers no grounds forabortion and, in many ways, is analogous togender based abortions that are prohibitedregardless of fetal age. Finally, Gaucherraises concerns about the disclosure of geneticinformation. These affect potential carriersasked to participate in population studies andcarriers and patients who must considerdisclosure to others. These concerns weigh theright to privacy against communal interests andbilateral commitments. (shrink)

Significant breakthroughs in genetic research promoted by the human genome project, advances in molecular biology and new reproductive technologies have improved the understanding and the possibility of genetic interventions as a potential medication for diseases caused by differentiated disorders, especially those that originated in irregularities in individual genes. The progress achieved in contemporary studies has created the likelihood that the man has the technical capacity to modify the genes that will be transmitted to the next generations as well. (...) These are the so-called hereditary genetic modifications, i.e. any biomedical interventions which could be expected to transform the genome which a person could transfer to their offspring. The author analyses in this paper why even the hints of transformations of genes that will be passed on to future generations cause deep bioethical, theological, legal and political debates and controversies. He also believes that in the era of rapid strengthening of the social and technical and technological effects of science, it is very important that scientists, in their perceptions and insights, which particularly in the field of humanities, do not have the character of value beliefs, do not go below the achieved civilization standards of ethical and moral culture and to reflect on different themes with due care and awareness of the dilemmas that they can encounter in their professional work. An adequate interdisciplinary, multidisciplinary and pluriperspective approach, as well as the awareness of the essential compatibility of scientific freedom and responsibility, should ultimately result in a different and more sophisticated attitude of the scientists themselves to the possibilities of their own discipline and the significance of its effects. (shrink)

A current trend in bioethics considers genetic information as family property. This paper uses a logical approach to critically examine Matthew Liao’s proposal on the familial nature of genetic information as grounds for the duty to share it with relatives and for breach of confidentiality by the geneticist. The authors expand on the topic by examining the relationship between the arguments of probability and the familial nature of genetic information, as well as the concept of harm in (...) the context of genetic risk. Lastly, they examine the concept of harm in relation to the type of situations w the potential recipient of the information is not the person directly affected by the risk. (shrink)

Ethical questions about confidentiality arise when patients refuse to inform relatives who are at risk of a genetic condition. Specifically, healthcare providers may struggle with the permissibility of breaching confidentiality to warn patients’ at-risk relatives. In exploring this issue, several authors have converged around the idea that genetic cases differ from non-genetic cases (e.g., involving a threat of violence or the spread of an infectious disease) along two related dimensions: (1) In genetic cases, the risk of (...) harm is already present in an at-risk third party, whereas in non-genetic cases, it is not; and (2) In genetic cases, the patient does not create a risk of harm to a third party, whereas in non-genetic cases, the patient does. I argue that these distinctions do not exclusively differentiate genetic from non-genetic cases and should not bear on the permissibility of breaching confidentiality. Instead, such determinations should be based on other considerations. (shrink)

This open peer commentary critically examines the concept of unqualified medical confidentiality in the context of clinical genetics. The authors challenge two key assertions about maintaining absolute confidentiality: first, that preventing information sharing is the most effective way to minimize harm, and second, that individuals will take more responsibility for their health under strict confidentiality. Using a case study of a genetic condition with familial implications, they argue for a "qualified confidentiality" approach specific to clinical genetics. The commentary highlights (...) the unique nature of genetic information, which often has direct implications for family members. The authors suggest that in certain medical contexts, particularly those involving inheritable conditions, a more nuanced approach to confidentiality might better protect the health interests of multiple individuals, balancing patient privacy with potential preventative benefits for at-risk family members. (shrink)

Introduction The bioethics literature reflects significant interest in and concern with the use of genetic and genomic information in various settings. Because psychiatric treatment and research raises unique ethical, legal, and social issues, we conducted a scoping review of the biomedical, bioethics, and psychology literature regarding the application of genetic and genomic tools to psychiatric disorders (as listed in the DSM-5) and two associated behaviors or symptoms to provide a more detailed overview of the state of the field. (...) Objectives The primary objective was to examine the available bioethics, biomedical, and psychology literature on applying genetic and genomic tools to psychiatric disorders (other than neurodevelopmental disorders) and two behaviors or symptoms sometimes associated with them (aggression or violence and suicidality) to identify the disorders to which these tools have been applied, the contexts in or purposes for which they have been applied, the ethical, legal, or social concerns associated with those uses, and proposed recommendations for mitigating those concerns. Methods We used Arksey and O’Malley’s scoping review framework: (1) identify the research question; (2) identify relevant studies; (3) select studies; (4) chart the data; and (5) collate, summarize, and report results (2005). We relied on Levac et al. to inform our application of the framework (2010). The PRISMA extension for scoping reviews checklist informed our reporting (2018). We searched three electronic databases MEDLINE (PubMed), Embase, and PsycInfo (EbscoHost) for peer-reviewed journal articles in English to identify relevant literature. One author screened the initial results and additional screening was done in consultation with other authors. A data extraction form using DSM-5 diagnostic categories (excluding neurodevelopmental disorders) was developed and two authors independently each reviewed approximately half of the articles. Inter-rater reliability was ensured by double-coding approximately 10% of the papers. An additional author independently coded 10% of the articles to audit the data. Results In 365 coded publications, we identified 15 DSM-5 diagnostic categories in addition to the two pre-selected behaviors or symptoms (aggression or violence and suicidality) to which genetic or genomic tools have been applied. We identified 11 settings in or purposes for which these tools were applied. Twenty-two types of ethical, legal, or social concerns associated with the application of genetic or genomic tools to these disorders or behaviors/symptoms were identified along with 13 practices or policies that could mitigate these concerns. Conclusion Genetic and genomic tools have been applied to a wide range of psychiatric disorders. These raise a range of ethical, legal, and social concerns. Additional research is warranted to better understand the concerns and effective ways to address them. Advancing the literature to identify relevant ethical, legal, or social concerns and solutions to those problems likely requires greater attention to specific applications of genetic or genomic tools to particular psychiatric disorders and associated behaviors/symptoms as well as broad stakeholder engagement. (shrink)

The pursuit of genetic knowledge has such emotional, social, scientific, and financial importance that it has been compared to the divine quest for the Holy Grail, and to the calamity of opening Pandora's Box. Therefore, it comes as no surprise that the recent announcement of a completed blueprint for the human genome has fueled calls for both increased research and increased precautions. This new era, which holds the potential promise of advances in medicine, agriculture and other areas, also requires (...) the careful investigation of a myriad of issues. Those issues such as informed consent, patenting, privacy, and confidentiality, have been explored in at least some detail. Others, such as equity, mutual respect, empowering education, consensus building, and planning for long-term survival, have not been as fully examined, nor have they been as comprehensively integrated into mainstream thinking. To facilitate this, we need to implement an ethical approach that leads us to ask critical questions about the appropriate use of our new tools. (shrink)

Due to the potential ethical and psychological implications of screening, and especially inregard of screening on children without available and acceptable therapeutic measures, there is a common view that such procedures are not advisable. As part of an independent research- and bioethical case study, our aim was therefore to explore and describe bioethical issues among a representative sample of participant families (n = 17,055 children) in the ABIS (All Babies In South-east Sweden) research screening for Type 1 diabetes (IDDM).The primary (...) aim is the identification of risk factors important for the development of diabetes and other multifactorial immune-mediated diseases. Four hundred, randomly chosen, participant mothers were asked to complete a questionnaire exploring issues of information, informed consent, bio-material, confidentiality and autonomy, and of prevention/intervention. 293 completed the questionnaire, resulting in a response rate of 73.3%. The majority of questions had the form of 6-point Likert-type response scales (1–6).We found that the majority of respondents felt calm in regard of samples and written material, and also concerning the possibility of their child in the future being identified as having high risk of developing Type 1 diabetes. An important finding concerning access and control of mainly biological data was indicated, with the respondents expressing concern for potential future use. We believe our findings indicate that this kind of empirical studies can substantially contribute to our understanding of bioethical issues of medical research involving genetics. Issues, such as safeguards ensuring theethical criteria of autonomy and respect, were emphasised by our respondents. We believe theissues brought up may promote further discussion, and do suggest issues for consideration by, among others, researchers, bioethicists and Institutional Review Boards. (shrink)

The fields of HIV care in pregnancy and reproductive genetics have always been ‘exceptional’ in that patients are highly concerned about the potential for stigma and the corresponding need for privacy and confidentiality. However, the two fields have diverged in how they have addressed these concerns. The systematic review analyzed 61 manuscripts for similarities and differences between the fields of HIV care in pregnancy and reproductive genetics in the United States, with respect to privacy, confidentiality, disclosure, and stigma. The systematic (...) review revealed that the field of HIV care in pregnancy has insufficiently addressed patient concerns about privacy, confidentiality, and stigma compared to the field of reproductive genetics. Failure to adequately protect confidentiality of HIV-positive patients, and failure to reduce stigma associated with HIV testing and treatment are deficiencies in the delivery of care to HIV-positive pregnant woman and barriers to reducing vertical transmission of HIV. Im.. (shrink)

Approximately 1 in 30 people develop cancer due to an underlying familial predisposition. Genetic counselling and testing for people with (and at risk of) familial cancer are becoming more widely available, but service providers need to address challenging issues in relation to privacy and property. As in any counselling situation, a genetic counsellor seeks to ensure that the principles of autonomy, confidentiality, beneficence, and equity operate in favour of the client. But in dealing with a familial disorder, the (...) application of these principles to the individual must be balanced with the potential for these principles to apply to other family members. This paper summarises the recent experience of a familial cancer service in seeking to avoid situations in which these principles, operating for both individual clients and their relatives, can come into conflict. (shrink)

Definition of the problem: Recent progress in the pharmacological sciences provides a first glimpse of the development of an individual, genotype-based drug therapy in order to improve the efficiency of drug utilization. Genotyping of genetic polymorphisms in genes involved in drug response promises to optimize drug therapy fundamentally by identifying patients for whom a pharmaceutical agent may be effective and safe or contraindicated because of expected adverse drug reactions. Arguments: The new pharmacogenomic treatment strategies raise complex bioethical issues, because (...) genetic screening for drug therapy may identify asymptomatic patients who are at risk for a particular adverse outcome. Thus, pharmacogenomics will affect the relationship between the treating physician and the patient which is traditionally based on privacy, confidentiality, beneficience and non-maleficience. Conclusion: In the article presented some ethical aspects of these new pharmacogenomic approaches concerning the physician-patient relationship are discussed. (shrink)

Confidentiality in genetic testing posesimportant ethical challenges to the currentprimacy of respect for autonomy and patientchoice in health care. It also presents achallenge to approaches to decision-makingemphasising the ethical importance of theconsequences of health care decisions. In thispaper a case is described in which respect forconfidentiality calls both for disclosure andnon-disclosure, and in which respect forpatient autonomy and the demand to avoidcausing harm each appear to call both fortesting without consent, and testing only withconsent. This creates problems not only (...) forclinicians, families and patients, but also forthose who propose clinical bioethics as a toolfor the resolution of such dilemmas.In this paper I propose some practical waysin which ethical issues in clinical geneticsand elsewhere, might be addressed. Inparticular I call for a closer relationshipbetween ethics and communication in health caredecision-making and describe an approach to theethics consultation that places particularemphasis on the value of interpersonaldeliberation in the search for moralunderstanding. I reach these conclusionsthrough an analysis of the concept of `moraldevelopment'' in which I argue that theachievement of moral understanding is anecessarily intersubjective project elaboratedby moral persons. (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)

Communicating genetic information to family members has been the subject of an extensive debate recently in bioethics and law. In this context, the extent of the relatives’ right to know and not to know is examined. The mainstream in the bioethical literature adopts a liberal perception of patient autonomy and offers a utilitarian mechanism for solving familial tensions over genetic information. This reflects a patient-centred approach in which disclosure without consent is justified only to prevent serious harm or (...) death to others. Based on a legal and bioethical analysis on the one hand, and an examination of empirical studies on the other, this paper advocates the adoption of a relational perception of autonomy, which, in the context of genetics, takes into account the effect that any decision—whether to disclose or not to disclose—will have on the familial relationship and the dynamics of the particular family. Adding this factor to the criteria usually advocated by lawyers and ethicists will facilitate reaching a sensitive decision, which recognises the various interests of family members beyond the risk to physical health. Taking this factor into account will require a process of deliberation both between doctors and patients, and in the family. It will also require a relaxation of medical confidentiality, as the family rather than the patient is gradually perceived as the unit of care. Moreover, adopting such a relational approach will accord with current views of doctors and patients who base their decision primarily on the nature of the familial relationship. (shrink)

Many writers in bioethics, science, and medicine contend that embryo selection is a morally better way of avoiding genetic disorders then gene editing, as the latter has risks that the former does not. We argue that one reason to use gene editing is that in many cases it would be better for the person who would develop from the edited embryo, so that not to have done it would have been worse for that person. By contrast, embryo selection is (...) never better for the person who develops from the selected embryo. This reason to use gene editing has, however, been challenged on two grounds: first, that it makes no difference, morally, whether a bad effect is worse for someone, or a good effect better for someone; and, second, that beneficent gene editing would not be unequivocally better for the person who would develop from the edited embryo. We argue that both of these objections can be satisfactorily answered and thus that there is indeed a significant moral reason, at least in some cases, to use gene editing rather than embryo selection. (shrink)

Some ethicists argue that patient confidentiality is absolute and thus should never be broken. I examine these arguments that when critically scrutinised, become porous. I will explore the concept of patient confidentiality and argue that although, this is a very important medical and bioethical issue, this needs to be wisely delivered to reduce third party harm or even detriment to the patient. The argument for absolute confidentiality is particularly weak when it comes to genetic information and inherited disease.

The possibility of early diagnosis and intervention is radically changed by the advent of genetic testing. The recent report of the Nuffield Council on Bioethics is timely and helpful. I have suggested, that not only the severity of the disability indicated by genetic information, and the accuracy of the data, ought to govern the approach to the implementation of screening for genetic disorders. In addition, assessment of the value of the information to those involved should be considered. (...) The efficacy of the available therapeutic measures, combined with the prognostic data are important indices of the value of the information. These measures fall into three categories and thus indicate that three different courses of intervention may be appropriate. Three approaches to diagnosis and intervention are then outlined, drawing on the experience of various clinical initiatives. (shrink)

The practice of prenatal diagnosis has brought with it the utilization of pregnancy termination as a preventive approach. In this paper the genetic/teratologic, fetal and maternal indications for termination of pregnancy used in Hungary are described, as well as the legal requirements and the proposed mode of termination at the different stages of gestation. The author is the director of the largest prenatal genetic counseling service in Hungary. Keywords: elective abortion, medico-legal aspects, prenatal diagnosis, genetic disorders, Hungary, (...) bioethics CiteULike Connotea Del.icio.us What's this? (shrink)

Community health workers (CHW) are the backbone of the public health system in developing countries. Little is known about the practice of ethics and professionalism in their work. This study was conducted to explore the experiential wisdom of ethics and professionalism among CHWs in Tamil Nadu. We conducted a qualitative study among 125 CHWs in six districts of Tamil Nadu. We found that the CHWs went beyond the call of their duty to do good to the community. Their conceptualization of (...) autonomy ranged from shared to full paternalistic decision making. The CHWs were sensitive to issues of privacy and confidentiality, but the discussion on these topics were limited. They reflected the societal norms of gender, class, and caste hierarchies in their work. They had to work amidst difficult power struggles and had their own innovative strategies to subvert power. In conclusion, there is a need for framing a code of ethics and professionalism for CHWs and training in ethics and professionalism for them to help them effectively deliberate on ethical issues. (shrink)

_Engaging Bioethics: An Introduction with Case Studies_ draws students into this rapidly changing field, helping them to actively untangle the many issues at the intersection of medicine and moral concern. Presuming readers start with no background in philosophy, it offers balanced, philosophically based, and rigorous inquiry for undergraduates throughout the humanities and social sciences as well as for health care professionals-in-training, including students in medical school, pre-medicine, nursing, public health, and those studying to assist physicians in various capacities. Written by (...) an author team with more than three decades of combined experience teaching bioethics, this book offers Flexibility to the instructor, with chapters that can be read independently and in an order that fits the course structure Up-to-date coverage of current controversies on topics such as vaccination, access to health care, new reproductive technologies, genetics, biomedical research on human and animal subjects, medically assisted death, abortion, medical confidentiality, and disclosure Attention to issues of gender, race, cultural diversity, and justice in health care Integration with case studies and primary sources Pedagogical features to help instructors and students, including Chapter learning objectives Text boxes and figures to explain important terms, concepts, and cases End-of-chapter summaries, key words, and annotated further readings Discussion cases and questions Appendices on moral reasoning and the history of ethical issues at the end and beginning of life An index of cases discussed in the book and extensive glossary/index A companion website with a virtual anthology linking to key primary sources, a test bank, topics for papers, and PowerPoints for lectures and class discussion. (shrink)

The question of ‘who owns genetic information‘ is increasingly a focus of ethical inquiry. Applied to predictive testing, several recent critiques suggest that persons with a genetic disorder have a moral duty to disclose that information to other family members. The justification for this obligation is that genetic information belongs to and may benefit not only a single individual, but also members of a biological kinship. This paper considers this issue from a different vantage point: How does (...) gender intersect with the moral duty to disclose genetic information? Scholars have argued that gender is partly comprised of distinct assignments and assumptions of responsibility. Thus, there is a danger that gendered patterns of socialization will make women feel that they should take primary responsibility for disclosing genetic information to others. This article explores issues of responsibility and disclosure of risk information by drawing on an empirical study of women and men who have undergone genetic testing for hereditary breast/ovarian cancer. The research study suggests that disclosure of genetic information is a gendered activity, with both the benefits and burdens of this task falling primarily on women. It also illustrates that when disclosure is understood contextually, it is a far more complicated matter than when viewed through a theoretical lens. The article considers the relevance of these findings on ethical debate and genetic counselling practices. (shrink)

One of the most prominent justifications for the use of germline gene editing (GGE) is that it would allow parents to have a “genetically related child” while preventing the transmission of genetic disorders. However, we argue that since future uses of GGE may involve large-scale genetic modifications, they may affect the genetic relatedness between parents and offspring in a meaningful way: Due to certain genetic modifications, children may inherit much less than 50% of their DNA from (...) each parent. We show that the reduction in genetic relatedness between parents and offspring has three important social and legal implications. First, the desire for a genetically related child may end up not being the strong justification it is currently thought to be for the use of GGE. Second, prospective parents may be reluctant to use GGE because of a potential loss of genetic relatedness. Third, in some jurisdictions, parents who would not pass on “enough” DNA to their child may not be recognized as the child's legal parents. We further argue that the reduction in genetic relatedness challenges current conceptions of genetic parenthood that rely on the quantity of DNA shared with the child or on whether the child was directly derived from the parent's genes. We suggest that genetic parenthood should instead be determined based on the nature of the genetic modifications and whether the child's numerical identity has been preserved after the editing process. (shrink)

Until recently, genetics counselors and medical geneticists considered themselves lucky if they could provide parents with predictive information about a small number of severe genetic disorders. Testing and counseling were indicated primarily for conditions of thithis s sort. Out of respect for the autonomy of parental reproductive decision making, the prevailing ethic of genetic counseling stressed nondirectiveness and value neutrality As summarized by Arthur Caplan, the hallmarks of this stance includea willingness to provide testing and counseling to all (...) who voluntarily seek it, the presentation of information concerning findings in a manner that is balanced and comprehensible to patients or clients, the fair and balanced presentation of all options for action if a problem is discovered, a willingness to answer all questions asked by those seeking services, and an obligation to protect privacy and confidentiality at all times regardless of societal needs or benefits. (shrink)

: New genetic technologies continue to emerge that allow us to control the genetic endowment of future children. Increasingly the claim is made that it is morally "irresponsible" for parents to fail to use such technologies when they know their possible children are at risk for a serious genetic disorder. We believe such charges are often unwarranted. Our goal in this article is to offer a careful conceptual analysis of the language of irresponsibility in an effort to (...) encourage more care in its use. Two of our more important sub-claims are: A fair judgment of genetic irresponsibility necessarily requires a thick background description of the specific reproductive choice; and there is no necessary connection between an act's being morally wrong and its being irresponsible. These are distinct judgments requiring distinct justifications. (shrink)

ABSTRACT This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants (...) to be permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to (...) be permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

Genetic testing reveals information about a patient's health status and predictions about the patient's future wellness, while also potentially disclosing health information relevant to other family members. With the increasing availability and affordability of genetic testing and the integration of genetics into mainstream medicine, the importance of clarifying the scope of confidentiality and the rules regarding disclosure of genetic findings to genetic relatives is prime. The United Nations International Declaration on Human Genetic Data urges an (...) appreciation for principles of equality, justice, solidarity and responsibility in the context of genetic testing, including a commitment to honoring the privacy and security of the person tested. Considering this global mandate and recent professional statements in the context of a legal amendment to patient privacy policies in Australia, a fresh scrutiny of the legal history of a physician's duty to warn is warranted. This article inquiries whether there may be anything ethically or socially amiss with a potential future recommendation for health professionals or patients to universally disclose particular cancer predisposition genetic diagnosis to genetic family members. While much of the discussion remains applicable to all genetic diagnosis, the article focuses on the practice of disclosure within the context of BRCA1/2 diagnosis. An ‘ethic of care’ interpretation of legal tradition and current practice will serve to reconcile law and medical policy on the issue of physician disclosure of genetic results to family members without patient consent. (shrink)

Genetics is a biomedical science that investigates heredity, variability, occurrence of genetic diseases and their prevention. Genetic science has many fields of science, which deal with different genetic processes, methods, aspects and fields of application. The genetic research in Europe related to the individual as the main subject of the research is exposed to a wide range of ethical and legal issues. From the developments in genetic science other sciences have evolved, thanks to which the (...) modern world is able to protect the genetic information of data, and to receive the sanction while ignoring the laws of such data. However, many problems still persist in the field of protection of personal genetic information, such as regulatory standards, the inviolability of an individual, the assurance of freedom and privacy of information. This manuscript attempts to reveal the main aspects of genetic human data protection, to research conduct regulations, ethics and issues related to the protection of individuals, such as protection of privacy, discrimination, confidentiality, etc. The article mainly focuses on the Conventions and Protocols elaborated by the Council of Europe because of its role in bioethics and focus on human rights. The author examined the documents such as the Convention on Human Rights and Biomedicine, the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and others. Genetic discrimination is strictly forbidden by international conventions and declarations, which means that discrimination on the grounds of personal genetic information (diseases, abnormalities) is not possible in all areas, including employment and insurance. However, individuals face some problems in getting a job due to the publicity and information disclosure to their employers, or in increasing the amount of insurance premiums. However, the disclosure of genetic information may have relevant, statutory consequences and the victims may apply to court for defending these rights. It is essential to protect genetic rights, as any form of discrimination against a person on the grounds of their genetic heritage is prohibited and intervention in the health field or disclosure of such information is only possible after the person concerned has given their free and informed consent. (shrink)

The paper suggests an application of the precautionary principle to the use of genetics in psychiatry focusing on scientific uncertainty. Different levels of uncertainty are taken into consideration—from the acknowledgement that the genetic paradigm is only one of the possible ways to explain psychiatric disorders, via the difficulties related to the diagnostic path and genetic methods, to the value of the results of studies carried out in this field. Considering those uncertainties, some measures for the use of genetics (...) in psychiatry are suggested. Some of those measures are related to the conceptual limits of the genetic paradigm; others are related to present knowledge and should be re-evaluated. (shrink)

This chapter contains sections titled: Information Management: Confidentiality, Autonomy and Non‐Directiveness Predictive Genetic Testing Childhood Genetic Testing Genetic Screening Informed Consent to Screening Newborn Screening Carrier Screening Prenatal Screening Susceptibility Screening Further Information Management Goals of Genetic Screening: Public Health vs Individual Choice Conclusion References Further reading.

To better understand ethical issues involved in the field of human genetics and promote debate within the scientific community, the author surveyed scientists who engage in human genetics research about the pros, cons, and ethical implications of genetic testing. This study contributes systematic data on attitudes of scientific experts. The survey finds respondents are highly supportive of voluntary testing and the right to know one's genetic heritage. The majority consider in utero testing and consequent pregnancy termination acceptable for (...) cases involving likelihood of serious disease but disapprove for genetic reasons they consider arbitrary, leaving a gray area of distinguishing between treatment of disorders and enhancement still to be resolved. While safeguarding patient confidentiality versus protecting at-risk third parties presents a dilemma, preserving privacy from misuse by institutional third parties garners strong consensus for legislation against discrimination. Finally, a call is made for greater genetic literacy. (shrink)

Ethical issues regarding research biobanks continue to be a topic of intense debate, especially issues of confidentiality, informed consent, and child participation. Although considerable empirical literature concerning research biobank ethics exists, very little information is available regarding the opinions of medical professionals doing genetics research from the Middle East, especially Arabic speaking countries. Ethical guidelines for research biobanks are critically needed as some countries in the Middle East are starting to establish national research biobanks. Islam is the dominant religion in (...) these countries, and it affects people’s behavior and influences their positions. Moreover, communities in these countries enjoy a set of customs, traditions and social norms, and have social and familial structures that must be taken into account when developing research policies. We interviewed 12 medical professionals from the Middle East currently working with stored tissue samples to document their opinions. We found general agreement. Participants’ primary concerns were similar to the views of researchers internationally. Since children tend to represent a high percentage of Middle Eastern populations, and because children’s bodies are not just small adult bodies, the interviewed professionals strongly believed that it is imperative to include children in biobank research. Participants generally believed that protecting confidentiality is socially very important and that informed consent/assent must be obtained from both adult and child participants. This study provides a starting point for additional studies. (shrink)

As knowledge increases about the human genome,prenatal genetic testing will become cheaper,safer and more comprehensive. It is likelythat there will be a great deal of support formaking prenatal testing for a wide range ofgenetic disorders a routine part of antenatalcare. Such routine testing is necessarilycoercive in nature and does not involve thesame standard of consent as is required inother health care settings. This paper askswhether this level of coercion is ethicallyjustifiable in this case, or whether pregnantwomen have a right (...) to remain in ignorance ofthe genetic make-up of the fetus they arecarrying. While information gained by genetictesting may be useful for pregnant women whenmaking decisions about their pregnancy, it doesnot prevent harm to future children. It isargued that as this kind of testing providesinformation in the interests of the pregnantwomen and not in the interests of any futurechild, the same standards of consent that arenormally required for genetic testing should berequired in this instance. (shrink)

Psychiatric genetic research investigates the genetic basis of psychiatric disorders with the aim of more effectively understanding, treating, or, ultimately, preventing such disorders. Given the challenges of recruiting research participants into such studies, the potential for long‐term benefits of such research, and seemingly minimal risk, a strong claim could be made that all non‐acute psychiatric inpatients, including forensic and involuntary patients, should be included in such research, provided they have capacity to consent. There are tensions, however, regarding the (...) ethics of recruiting psychiatric inpatients into such studies. In this paper our intention is to elucidate the source of these tensions from the perspective of research ethics committee interests and decision‐making. We begin by defining inpatient status and outline some of the assumptions surrounding the structures of inpatient care. We then introduce contemporary conceptions of vulnerability, including Florencia Luna’s account of vulnerability which we use as a framework for our analysis. While psychiatric inpatients could be subject to consent‐related vulnerabilities, we suggest that a particular kind of exploitation‐related vulnerability comes to the fore in the context of our case study. Moreover, a subset of these ethical concerns takes on particular weight in the context of genetic research in low‐ and middle‐income countries. At the same time, the automatic exclusion of inpatients from research elicits justice‐related vulnerabilities. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:News from the President’s Council on BioethicsF. Daniel Davis (bio) and Diane M. Gianelli (bio)As most readers of this column already know, the President's Council on Bioethics went through a major transition during the past year when Leon Kass—in October 2005—handed the chairman's gavel over to Georgetown University's Edmund Pellegrino. Dr. Kass has remained on the Council as a member.1When the gavel change took place, the Council's phone started (...) ringing. Everyone wanted to know the same thing: What topics would the Council take up this term? Dr. Pellegrino's answer was always the same: The Council's agenda would be established through a consultative process with the members themselves and with an eye to those problems and controversies in bioethics to which we, as a body, can make a contribution.Taking its cue from the list of potential topics suggested by members, the Council—over the course of the next several meetings—listened to experts on such topics as children and bioethics (with a focus on children in clinical research), organ transplantation, and that oft-cited-but-hard-to-define concept, "human dignity."The latter topic entered the arena of discussion because it is a concept that is cited frequently in the bioethics literature, and it is also one that has figured prominently in Council discussions and documents. Although the concept is widely invoked, there is no universal understanding of what it means, and it is not easy to encapsulate into a one-size-fits-all definition. Indeed, some critics maintain that appeals to human dignity are fig leaves used to camouflage unconvincing arguments. So between December 2005 and April 2006, the Council devoted several sessions to various perspectives on "human dignity: its meaning, its foundations, and its relevance to bioethics." After hearing from James Childress, Patricia Churchland, Daniel Sulmasy, and Paul Weithman2 on the topic, the Council decided to issue a volume of approximately 20 essays, some by Council members and others by scholars from a variety of relevant disciplines.3 The volume is expected to encompass a broad array of opinion on the topic of human dignity and is scheduled to be published next spring."Children" were also the focus of several sessions during the past year. The Council's last report addressed care giving for the elderly.4 After it was issued, several members suggested it was time to focus on the youngest members of [End Page 375] society. The challenge, of course, was to find a topic that was both timely and relevant—and one about which the Council was uniquely qualified to make a contribution. A number of experts in a variety of related fields testified before the Council about possible issues it could explore: newborn screening for genetic disorders; decision-making standards for those who lack capacity; ethical issues in neonatal and pediatric intensive care; pharmacology and psychiatric disorders in children; and children and clinical research. In addition, a number of groups and individuals involved in related topics met with staff to discuss their interests and concerns.This exploratory engagement with facets of the broad topic of children and bioethics led the Council to focus, more narrowly, on a cluster of issues concerning newborn screening for genetic disorders—a topic on which it is likely that the Council will issue a white paper, possibly by next summer. The stimulus for this particular focus has been the American College of Medical Genetics's recommendation that all newborns in the U.S. be screened for a panel of 29 disorders.5 Currently, each state decides for its residents which conditions are subject to mandated screening, so it is possible to get early diagnoses of treatable disorders in one geographical area but not in another. Proponents of screening find the federal approach to mandated screening more equitable. Potential ethical problems, however, exist with the proposal. Some want to ensure that newborns are screened only for treatable conditions on grounds that it would be too burdensome to discover one is carrying the gene for a late-onset disease that cannot be prevented. Others want to make sure that insurance coverage for individuals and their families is... (shrink)

Moral reasoning in bioethics -- Bioethics and moral theories -- Paternalism and patient autonomy -- Truth-telling and confidentiality -- Informed consent -- Human research -- Abortion -- Reproductive technology -- Genetic choices -- Euthanasia and physician assisted suicide -- Dividing up health care resources.

Advances in genetic technologies raise a multitude of ethical issues, some of which give rise to novel dilemmas for medical practice. One of the most controversial problems arising in clinical genetics is that of confidentiality and who may disclose genetic health information. This paper considers the question of when it is appropriate for health professionals to disclose clinically significant genetic information without patient consent. Existing ethical principles offer little guidance in relation to this issue. We build on (...) suggestions that genetic information may be viewed as collective or shared information, and we introduce the concept of ‘familial comity’ as a fresh way to consider the issues. (shrink)

Predictive genetic testing for susceptibility to psychiatric conditions is likely to become part of standard practice. Because the onset of most psychiatric diseases is in late adolescence or early adulthood, testing minors could lead to early identification that may prevent or delay the development of these disorders. However, due to their complex aetiology, psychiatric genetic testing does not provide the immediate medical benefits that current guidelines require for testing minors. While several authors have argued non-medical benefits may play (...) a crucial role in favour of predictive testing for other conditions, little research has explored such a role in psychiatric disorders. This paper outlines the potential non-medical benefits and harms of psychiatric genetic testing in minors in order to consider whether the non-medical benefits could ever make such testing appropriate. Five non-medical themes arise in the literature: psychological impacts, autonomy/self-determination, implications of the biomedical approach, use of financial and intellectual resources, and discrimination. Non-medical benefits were prominent in all of them, suggesting that psychiatric genetic testing in minors may be appropriate in some circumstances. Further research needs to empirically assess these potential non-medical benefits, incorporate minors in the debate, and include normative reflection to evaluate the very purposes and motivations of psychiatric genetic testing in minors. (shrink)