Since its advent, predictive DNA testing has been perceived as a technology that may have considerable impact on the quality of people’s life. The decision whether or not to use this technology is up to the individual client. However, to enable well considered decision making both the negative as well as the positive freedom of the individual should be supported. In this paper, we argue that current professional and public discourse on predictive DNA-testing is lacking when it comes to supporting (...) positive freedom, because it is usually framed in terms of risk and risk management. We show how this ‘risk discourse’ steers thinking on the good life in a particular way. We go on to argue that empirical research into the actual deliberation and decision making processes of individuals and families may be used to enrich the environment of personal deliberation in three ways: (1) it points at a richer set of values that deliberators can take into account, (2) it acknowledges the shared nature of genes, and (3) it shows how one might frame decisions in a non-binary way. We argue that the public sharing and discussing of stories about personal deliberations offers valuable input for others who face similar choices: it fosters their positive freedom to shape their view of the good life in relation to DNA-diagnostics. We conclude by offering some suggestions as to how to realize such public sharing of personal stories. (shrink)

Since its advent, predictive DNA testing has been perceived as a technology that may have considerable impact on the quality of people’s life. The decision whether or not to use this technology is up to the individual client. However, to enable well considered decision making both the negative as well as the positive freedom of the individual should be supported. In this paper, we argue that current professional and public discourse on predictive DNA-testing is lacking when it comes to supporting (...) positive freedom, because it is usually framed in terms of risk and risk management. We show how this ‘risk discourse’ steers thinking on the good life in a particular way. We go on to argue that empirical research into the actual deliberation and decision making processes of individuals and families may be used to enrich the environment of personal deliberation in three ways: (1) it points at a richer set of values that deliberators can take into account, (2) it acknowledges the shared nature of genes, and (3) it shows how one might frame decisions in a non-binary way. We argue that the public sharing and discussing of stories about personal deliberations offers valuable input for others who face similar choices: it fosters their positive freedom to shape their view of the good life in relation to DNA-diagnostics. We conclude by offering some suggestions as to how to realize such public sharing of personal stories. (shrink)

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

: Common wisdom in genetic counseling, which is supported by Biesecker, holds that counselors should strive not to influence their clients' decision making. Such a presumption of nondirectiveness is challenged in this commentary.

ABSTRACT The part played by time in ethics is often taken for granted, yet time is essential to moral decision making. This paper looks at time in ethical decisions about having a genetic test. We use a patient‐centred approach, combining empirical research methods with normative ethical analysis to investigate the patients' experience of time in (i) prenatal testing of a foetus for a genetic condition, (ii) predictive or diagnostic testing for breast and colon cancer, or (iii) testing for Huntington's disease (...) (HD). We found that participants often manipulated their experience of time, either using a stepwise process of microdecisions to extend it or, under the time pressure of pregnancy, changing their temporal ‘depth of field’. We discuss the implications of these strategies for normative concepts of moral agency, and for clinical ethics. (shrink)

The field of bioethics is increasingly coming into contact with empirical research findings. In this article, we ask what role empirical research can play in the process of ethical clarification and decision-making. Ethical reflection almost always proceeds in three steps: the description of the moral question,the assessment of the moral question and the evaluation of the decision-making. Empirical research can contribute to each step of this process. In the description of the moral object, first of all, empirical research has a (...) role to play in the description of morally relevant facts. It plays a role in answering the “reality-revealing questions” (what, why,how, who, where and when), in assessing the consequences and in proposing alternative courses of action. Secondly, empirical research plays a role in assessing the moral question. It must be acknowledged that research possesses “the normative power of the factual,” which can also become normative by suppressing other norms. However, inductive normativity should always be balanced out by a deductive form of normativity. Thirdly, empirical research also has a role to play in evaluating the decision-making process. It can rule out certain moral choices by pointing out the occurrence of certain unexpected consequences or effects. It can also be useful, however, as a sociology of bioethics in which the discipline of bioethics itself becomes an object of research. (shrink)

Background: Biomedical science is producing an avalanche of data about risk factors, often with a small predictive value, associated with a broad diversity of diseases. Prevention and screening are increasingly moving from public health into the clinic. Therefore, the question of which risk factors to investigate and disclose in the individual patient, becomes ethically increasingly urgent. In line with Wilson and Jungner's public health-related 10 principles for screening, it seems crucial to distinguish important from unimportant health risks.Aim: to explore the (...) ways in which clinicians distinguish important from unimportant health risks.Methods: We interviewed 36 respondents (gastroenterologists and gynaecologists/obstetrics) in 5 focus group interviews and 15 open in-depth interviews on their interpretation of what makes a health risk important.Results: Physicians primarily interpreted importance as the severity of the possible harm, less often its probability. Possibilities of prevention or reassurance strongly influenced their judgment on importance.Discussion: It is not likely that interpreting ‘important’ as ‘severe’ will help in differentiating meaningful from meaningless risk knowledge. A more fundamental change in our ways of dealing with risk may be called for. We discuss existing literature on resilience as an alternative way to deal with risk. Balancing prevention and risk reduction with resilience could be a fruitful direction. (shrink)

The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental fndings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental fndings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of (...) this professional obligation to respond to incidental fndings, bearing in mind that the relationship between investigators and research participants differs fundamentally from the doctor-patient relationship. (shrink)

Human development is a matter of complex interactions between nutritional regimes, genes, educational regimes and other diverse developmental resources. I argue that there is no ethically salient difference between the contributions made to development by genes and the contributions made by these other resources. Since we think nutrition and schooling should be included in the calculus of distributive justice, we should include at least some genes in this calculus too. What is more, under the right circumstances genetic engineering may become (...) a useful tool for the distribution of developmental resources. This said, attention to the parity of genetic and environmental causation can also help to articulate the legitimate suspicions many groups have of genetic engineering. (shrink)

Bioethicists think about families in terms of conflicting interests. This mistake results from an impoverished notion of informed consent. Only by adequately characterizing the process of informed consent can we capture the phenomenon of shared decisionmaking.

The discursive explosion that was provoked by the new genetics could support the impression that the ethical and social problems posed by the new genetics are somehow exceptional in their very nature. According to this view we are faced with special ethical and social problems that create a challenge so fundamental that the special label of genethics is needless to justify. The historical account regarding the evolution of the gene concepts could serve us to highlight the limits of what we (...) know about genes and what we can do with genes. The widespread notion about the exceptionality of genetic knowledge and its applicative possibilities is hardly justifiable and leads to misunderstandings regarding the conceptualization of the ethical and social problems we might face. Following a more realistic interpretation of the role of genes in human life we might avoid a whole set of fictive dilemmas and counterproductive regulatory efforts in bioethics. Bioethical discourse should move from the gene-centered scientific discourse toward the more sophisticated and complex discourses where human development represented as a matter of complex interactions between genomes and environments, between genes, educational factors, nutritional regimes, and other different developmental resources. If a gene is seen as one among the different developmental resources that are shaping a given human trait then both genethics and genetic exceptionalism could hardly be represented as a justified approach in discussing the ethical and social problems of genetics. (shrink)

We will analyse the representations and conceptualisation of genetics and genetic information in bioethical discourse. Genetics and genetic information is widely believed to be revolutionizing medicine and is sometimes misconceived as having a high predictive value compared to traditional diagnostics. We will attempt to present the inherent limitations of genetic information within its health care context. We␣will also argue against the exceptional treatment of genetic information that seems to govern bioethical reflection and regulatory approaches. And finally, we will make the (...) claim that geneticization should be seen as a more serious threat to our privacy, autonomy and freedom, than genetic discrimination. (shrink)

A decade after the completion of the Human Genome Project, the widespread appeal of personalized genomic medicine's vision and potential virtues for health care remains compelling. Advocates argue that our current medical regime “is in crisis as it is expensive, reactive, inefficient, and focused largely on one size fits all treatments for events of late stage disease.” What is revolutionary about this kind of medicine, its advocates maintain, is that it promises to resolve that crisis by simultaneously increasing the ability (...) to be “personalized,” “predictive,” “preventive,” and “participatory.” Some call personalized genomic medicine “P4 Medicine,” inscribing these cardinal virtues into the movement's name. All of these putative virtues have interesting implications for the future of health care. In this essay, we are especially interested in the claims that personalized medicine will lead to a more “participatory” or “patient‐centered” approach to health care, in which patients are “empowered” to take more personal control over their care. The rhetoric of patient empowerment is nothing new in health care, but personalized medicine is an interesting case study because it portrays empowerment as one of its key virtues and as a mechanism for fixing the health care “crisis.”. (shrink)

The evidence-based medicine movement advocates basing all medical decisions on certain types of quantitative research data and has stimulated protracted controversy and debate since its inception. Evidence-based medicine presupposes an inaccurate and deficient view of medical knowledge. Michael Polanyi’s theory of tacit knowledge both explains this deficiency and suggests remedies for it. Polanyi shows how all explicit human knowledge depends on a wealth of tacit knowledge which accrues from experience and is essential for problem solving. Edmund Pellegrino’s classic treatment of (...) clinical judgment is examined, and a Polanyian critique of this position demonstrates that tacit knowledge is necessary for understanding how clinical judgment and medical decisions involve persons. An adequate medical epistemology requires much more qualitative research relevant to the clinical encounter and medical decision making than is currently being done. This research is necessary for preventing an uncritical application of evidence-based medicine by health care managers that erodes good clinical practice. Polanyi’s epistemology shows the need for this work and provides the structural core for building an adequate and robust medical epistemology that moves beyond evidence-based medicine. (shrink)

ABSTRACT Background: Biomedical science is producing an avalanche of data about risk factors, often with a small predictive value, associated with a broad diversity of diseases. Prevention and screening are increasingly moving from public health into the clinic. Therefore, the question of which risk factors to investigate and disclose in the individual patient, becomes ethically increasingly urgent. In line with Wilson and Jungner's public health‐related 10 principles for screening, it seems crucial to distinguish important from unimportant health risks. Aim: to (...) explore the ways in which clinicians distinguish important from unimportant health risks. Methods: We interviewed 36 respondents (gastroenterologists and gynaecologists/obstetrics) in 5 focus group interviews and 15 open in‐depth interviews on their interpretation of what makes a health risk important. Results: Physicians primarily interpreted importance as the severity of the possible harm, less often its probability. Possibilities of prevention or reassurance strongly influenced their judgment on importance. Discussion: It is not likely that interpreting ‘important’ as ‘severe’ will help in differentiating meaningful from meaningless risk knowledge. A more fundamental change in our ways of dealing with risk may be called for. We discuss existing literature on resilience as an alternative way to deal with risk. Balancing prevention and risk reduction with resilience could be a fruitful direction. (shrink)

Genetic research has moved from Mendelian genetics to sequence maps to the study of natural human genetic variation at the level of the genome. This past decade of discovery has been accompanied by a shift in emphasis towards the ethical principles of reciprocity, mutuality, solidarity, citizenry and universality.