Earlier in the pages of this journal (p 481), Wendler and Miller offered the "net risks test" as an alternative approach to the ethical analysis of benefits and harms in research. They have been vocal critics of the dominant view of benefit-harm analysis in research ethics, which encompasses core concepts of duty of care, clinical equipoise and component analysis. They had been challenged to come up with a viable alternative to component analysis which meets five criteria. The alternative must (...) (1) protect research subjects; (2) allow clinical research to proceed; (3) explain how physicians may offer trial enrolment to their patients; (4) address the challenges posed by research containing a mixture of interventions and (5) define ethical standards according to which the risks and potential benefits of research may be consistently evaluated. This response argues that the net risks test meets none of these criteria and concludes that it is not a viable alternative to component analysis. (shrink)

Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical only when the risks to participants (...) are reasonable.1 Appropriate implementation of this requirement is vital to protecting research participants and allowing research to proceed when it poses acceptable risks. Unfortunately, as the US National Bioethics Advisory Commission notes: “current regulations do not further elaborate how risks and potential benefits are to be assessed, and little additional guidance is available to IRBs.”1The NBAC, as well as numerous commentators, recommend that research ethics committees , ethics review committees and institutional review boards should adopt what may be called dual-track risk assessment.2–5 Yet, dual-track assessment unnecessarily divides research interventions into two different categories before assessing their risks and relies on the unclear distinction between therapeutic and non-therapeutic interventions. As a result, dual-track assessment provides RECs with confusing guidance and has the potential to block valuable research that poses acceptable risks. This paper describes one alternative, the net risks test, and argues that this approach offers a better method for assessing research risks, one that puts RECs in a position to protect participants without blocking appropriate research studies.BACKGROUNDClinical research exposes participants to interventions and procedures to gather systematic data that may be used to improve overall health and well-being. To ensure that research is ethical, RECs must ensure that the risks and burdens to participants are not excessive and that …. (shrink)

BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant (...) to do all the risk-benefit tasks; instead, RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision.ConclusionAs such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’ risk-benefit task. (shrink)

For each research protocol that they review, institutional review boards must assess whether the risks of the protocol are acceptable in relation to the potential direct benefits to study participants and/or society. This requirement means that an IRB should first identify risks that are not compensated by direct benefits to the subjects and then judge whether these so-called net risks are acceptable in relation to the benefits to society. We argue that the conventional approach to risk-benefit assessment is not (...) accurate enough to identify all net risks involved in any given protocol. Two relatively new approaches—the component analysis approach and the net risks test—can be of much more use to review boards, especially when used together. (shrink)

Genetic testing poses fundamental questions for insurance. Testing can predict a low probability of future illness and disability, which can help promote the insurability of individuals with a family history of genetic risk, but it can also invite insurers to reject applicants, increase premiums, exclude people with certain illnesses and disabilities, and otherwise adjust the underwriting processes for individuals with certain genotypes. In the workplace, these issues may cause employers who offer or pay for insurance to alter their hiring (...) behavior, either by selecting those with desirable genetic makeup or rejecting, dismissing, or reassigning those who carry an unwanted risk, ultimately threatening employability and the safety net that insurance is intended to provide. (shrink)

Net‐risk pediatric research encompasses interventions and studies that pose risks and do not offer a compensating potential for clinical benefit. These interventions and studies are central to efforts to improve pediatric clinical care. Yet critics argue that it is unethical to expose children to research risks for the benefit of unrelated others. While a number of ethical justifications have been proposed, none have received widespread acceptance. This leaves funders with uncertainty over whether they should support and institutional review boards (...) with uncertainty over whether they should approve net‐risk pediatric research. To try to answer these questions, this article describes a justification that I previously proposed and considers two objections to it. This analysis reveals that the opportunity to contribute to a valuable project can justify exposing children to risks even though some trials turn out to be valueless and others turn out to be harmful. It follows that, to protect pediatric participants, institutional review boards need to assess whether trials have the potential to collect socially valuable information and whether they are likely to enroll and retain a sufficient number of participants. (shrink)

AimTo examine the relative cost-effectiveness of predictive genetic tests for familial breast and ovarian cancer provided by Genetic Services of Western Australia.MethodsThe relative cost-effectiveness was assessed using a decision analytic model.ResultsThe cost and outcomes of genetic testing was compared in first-degree relatives of known BRCA1/2 mutation-carriers who have a 50% risk of carrying the mutated gene (intervention group) to individuals with the same a priori risk but who do not undergo a genetic test (control subjects).Since genetic testing (...) enables the restriction of intensive surveillance to individuals with an identified BRCA1/2 gene mutation, net savings in the period observed (age 25-70) were $980-$1008 per woman in the ovarian intervention group and $1681-$1795 per woman in the breast intervention group, and delayed the onset of breast cancer (6mths BRCA1, 3mths BRCA2).Compared to control subjects undergoing population surveillance, it was estimated the onset of breast cancer could be delayed at a total net cost of $3055 (5.1yrs) to $3389 (3.2yrs) for women in the breast intervention group with BRCA1/2 mutations. Since population surveillance is not currently recommended for ovarian cancer, control subjects undergoing no surveillance were compared with the intervention group. The onset of ovarian cancer was delayed at a net cost of $1630 (3.5yrs) to $2509 (1.2years) for women with BRCA1/2 mutations.ConclusionsTesting allows targeted high-level surveillance for gene mutation carriers, which ensures the cost-effective use of resources and reduces cancer-related morbidity if clinical recommendations for intervention are adopted. (shrink)

Recent advances in biomarkers may soon make it possible to identify persons at high risk for late-onset Alzheimer’s disease at a presymptomatic stage. Popular demand for testing is increasing despite the lack of cure and effective prevention options and despite uncertainties regarding the predictive value of biomarker tests. This underscores the relevance of the ethical, cultural and social implications of predictive testing and the need to advance the bioethical debate beyond considerations of clinical consequences. Our qualitative study included three (...) groups of affected persons: People with mild neurocognitive disorder, their relatives and family caregivers of people with dementia. We explored their moral motivations regarding predictive, biomarker-based testing and preclinical diagnostics. We interviewed affected individuals in Germany and Israel. Transcripts of 12 focus groups and 12 semistructured interviews were content analysed with a focus on the moral motivations of affected persons in their justification of why they accept or reject predictive testing and early diagnosis. We grouped the underlying aspects of moral motivation into four ethical categories: beneficence as a form of personal utility focusing on well-being, the ties of responsibility linking families and their individual members, the importance of self-determination by later life planning and notions of a good life. In general, cultural parallels among these motives were very obvious. Cultural variation occurred mainly in openness to suicide, scepticism about test validity and emphasis on personal autonomy. The study underscores the importance of counselling for life-planning issues and of informing test candidates about problems with test validity and about the ambiguity of test results. All data relevant to the study are included in the article or uploaded as supplementary information. (shrink)

Research risks have to meet minimal risk requirements in order for the research to qualify for expedited ethics review, to be exempted from ethics review, or to be granted consent waivers. The definition of “minimal risk” in the Common Rule (45 CFR 46) relies on the risks-of-daily-life and risks-of-routine-tests as comparators against which research activities are assessed to meet minimal risk requirements. While either or both comparators have been adopted by major ethics codes, they have also been (...) criticized. In response to criticisms, elaborations, and alternative comparators have been proposed. In this paper, I approach the search for workable comparators from the point of view that ethical reasoning about minimal risk involves analogical reasoning using comparators. In this regard, I develop two necessary conditions for an adequate minimal risk conception, which I use to assess three comparators. I conclude that the risks-of-routine-tests best fits the analogical reasoning operating in minimal risk assessments. (shrink)

Panel data from the German SOEP is used to test for risk vulnerability in the wider population. Two different survey responses are analysed: the response to the question about willingness-to-take risk in general and the chosen investment in a hypothetical lottery. A convenient indicator of background risk is the VDAX index, an established measure of volatility in the German stock market. This is used as an explanatory variable in conjunction with HDAX, the stock market index, which (...) proxies wealth. The impacts of these measures on risk attitude are identifiable by exploiting the time dimension of the panel and matching survey months with corresponding observations from these time-varying factors. Both of the survey responses allow us to test for decreasing absolute risk aversion ; in one case, we find strong evidence of DARA, while in the other, we do not. Both survey responses also allow us to test for RV, and in both cases we find strong evidence. In the case of the hypothetical lottery response, we are also able to estimate a “coefficient of risk vulnerability”. This is defined as the absolute amount by which absolute risk aversion rises in response to a doubling of background risk. We estimate CRV to be between 1.03 and 1.27. (shrink)

Diagnostic tests allow better informed medical decisions when there is uncertainty about a patient’s health status and, therefore, about the desirability to undertake treatment. This paper studies the relation between the expected value of diagnostic information and a patient's risk aversion. We show that the ex ante value of diagnostic information increases with risk aversion for diseases with low prevalence, but decreases with risk aversion for diseases with high prevalence. On the other hand, the ex post value (...) of diagnostic information always increases with the patient's degree of risk aversion. (shrink)

“Dutch Book” arguments and references to gambling theorems are typical in the debate between Bayesians and scientists committed to “classical” statistical methods. These arguments have rarely convinced non-Bayesian scientists to abandon certain conventional practices, partially because many scientists feel that gambling theorems have little relevance to their research activities. In other words, scientists “don’t bet.” This article examines one attempt, by Schervish, Seidenfeld, and Kadane, to progress beyond such apparent stalemates by connecting “Dutch Book”–type mathematical results with principles actually endorsed (...) by practicing experimentalists. (shrink)

It is commonly hypothesized that scientists are more likely to engage in data falsification and fabrication when they are subject to pressures to publish, when they are not restrained by forms of social control, when they work in countries lacking policies to tackle scientific misconduct, and when they are male. Evidence to test these hypotheses, however, is inconclusive due to the difficulties of obtaining unbiased data. Here we report a pre-registered test of these four hypotheses, conducted on papers (...) that were identified in a previous study as containing problematic image duplications through a systematic screening of the journal PLoS ONE. Image duplications were classified into three categories based on their complexity, with category 1 being most likely to reflect unintentional error and category 3 being most likely to reflect intentional fabrication. We tested multiple parameters connected to the hypotheses above with a matched-control paradigm, by collecting two controls for each paper containing duplications. Category 1 duplications were mostly not associated with any of the parameters tested, as was predicted based on the assumption that these duplications were mostly not due to misconduct. Categories 2 and 3, however, exhibited numerous statistically significant associations. Results of univariable and multivariable analyses support the hypotheses that academic culture, peer control, cash-based publication incentives and national misconduct policies might affect scientific integrity. No clear support was found for the “pressures to publish” hypothesis. Female authors were found to be equally likely to publish duplicated images compared to males. Country-level parameters generally exhibited stronger effects than individual-level parameters, because developing countries were significantly more likely to produce problematic image duplications. This suggests that promoting good research practices in all countries should be a priority for the international research integrity agenda. (shrink)

Recently proposed models of risky choice imply systematic violations of transitivity of preference. This study explored whether people show the predicted intransitivity of the two models proposed to account for the certainty effect in Allais paradoxes. In order to distinguish “true” violations from those produced by “error,” a model was fit in which each choice can have a different error rate and each person can have a different pattern of preferences that need not be transitive. Error rate for a choice (...) is estimated from preference reversals between repeated presentations of the same choice. Results showed that few people repeated intransitive patterns. We can retain the hypothesis that all participants were transitive. (shrink)

The present study assessed the degree to which probabilistic reasoning performance and thinking style influenced perception of risk and self-reported levels of terrorism-related behaviour change. A sample of 263 respondents, recruited via convenience sampling, completed a series of measures comprising probabilistic reasoning tasks (perception of randomness, base rate, probability, and conjunction fallacy), the Reality Testing subscale of the Inventory of Personality Organization (IPO-RT), the Domain-Specific Risk-Taking Scale, and a terrorism-related behaviour change scale. Structural equation modelling examined three progressive (...) models. Firstly, the Independence Model assumed that probabilistic reasoning, perception of risk and reality testing independently predicted terrorism-related behaviour change. Secondly, the Mediation Model supposed that probabilistic reasoning and reality testing correlated, and indirectly predicted terrorism-related behaviour change through perception of risk. Lastly, the Dual-Influence Model proposed that probabilistic reasoning indirectly predicted terrorism-related behaviour change via perception of risk, independent of reality testing. Results indicated that performance on probabilistic reasoning tasks most strongly predicted perception of risk, and preference for an intuitive thinking style (measured by the IPO-RT) best explained terrorism-related behaviour change. The combination of perception of risk with probabilistic reasoning ability in the Dual-Influence Model enhanced the predictive power of the analytical-rational route, with conjunction fallacy having a significant indirect effect on terrorism-related behaviour change via perception of risk. The Dual-Influence Model possessed superior fit and reported similar predictive relations between intuitive-experiential and analytical-rational routes and terrorism-related behaviour change. The discussion critically examines these findings in relation to dual-processing frameworks. This includes considering the limitations of current operationalisations and recommendations for future research that align outcomes and subsequent work more closely to specific dual-process models. (shrink)

Background Genetic testing is moving from targeted investigations of monogenetic diseases to broader testing that may provide more information. For example, recent health economic studies of genetic testing for an increased risk of breast cancer suggest that it is associated with higher cost-effectiveness to screen for pathogenic variants in a seven gene panel rather than the usual two gene test for variants in BRCA1 and BRCA2. However, irrespective of the extent to which the screening of the panel is (...) cost-effective, there may be ethical reasons to not screen for pathogenic variants in a panel, or to revise the way in which testing and disclosing of results are carried out. Main text In this paper we discuss the ethical aspects of genetic testing for an increased risk of breast cancer with a special focus on the ethical differences between screening for pathogenic variants in BRCA1/2 and a seven gene panel. The paper identifies that the panel increases the number of secondary findings as well as the number of variants of uncertain significance as two specific issues that call for ethical reflection. Conclusions We conclude that while the problem of handling secondary findings should not be overstated with regard to the panel, the fact that the panel also generate more variants of uncertain significance, give rise to a more complex set of problems that relate to the value of health as well as the value of autonomy. Therefore, it is insufficient to claim that the seven gene panel is preferable by only referring to the higher cost effectiveness of the panel. (shrink)

The ability to determine genetic predisposition to cancer represents an opportunity to expand cancer control efforts in a manner that was previously unimaginable. This possibility also forces individual patients, families, health care professionals, and society to confront difficult questions about genetic knowledge. Although genetic testing or screening for cancer risk may hold promise of cancer control benefits, this prospect also raises significant ethical and legal concerns that must inform and shape policy decisions. In “Cancer Genetic Susceptibility Testing,” Benjamin Wilfond (...) and the Cancer Genetic Screening Consortium present a status report and an ambitious agenda for future examination of ethical and policy issues in this embryonic field. The paper provides a provocative and timely discussion of some extremely vexing issues, but it also misses on several critical points. (shrink)

In clinical studies, it is important to investigate the effectiveness of different therapeutic designs, especially, multiple treatment groups to one control group. The paper mainly studies homogeneity test of many-to-one risk differences from correlated binary data under optimal algorithms. Under Donner’s model, several algorithms are compared in order to obtain global and constrained MLEs in terms of accuracy and efficiency. Further, likelihood ratio, score, and Wald-type statistics are proposed to test whether many-to-one risk differences are equal (...) based on optimal algorithms. Monte Carlo simulations show the performance of these algorithms through the total averaged estimation error, SD, MSE, and convergence rate. Score statistic is more robust and has satisfactory power. Two real examples are given to illustrate our proposed methods. (shrink)

The integration of artificial intelligence throughout the economy makes the ethical risks it poses a mainstream concern beyond technology circles. Building on their growing role bringing greater transparency to climate risk, institutional investors can play a constructive role in advancing the responsible evolution of AI by demanding more rigorous analysis and disclosure of ethical risks.

As genetic testing for the presence of potentially health-affecting mutations becomes available for more genetic conditions, many people will soon be faced with the decision of whether or not to have a genetic test. Making an informed decision requires an understanding and evaluation of the arguments for and against having the test. As a case in point, this paper considers argumentation involving the decision of whether to have a BRCA gene test, one of the first commercially available (...) genetic tests. First, argumentation in a five-page patient brochure from a for-profit company that provides BRCA gene testing, is analyzed. Next, for comparison, argumentation on BRCA testing in materials for healthcare consumers written by a not-for-profit health plan and a government organization, is analyzed. In view of the challenges identified by considering these examples, this article discusses how argumentation-oriented computer systems may be able to help the healthcare consumer to make informed decisions about genetic testing. (shrink)

We show that if among the tested hypotheses the number of true hypotheses is not equal to the number of false hypotheses, then Neyman-Pearson theory of testing hypotheses does not warrant minimal epistemic reliability. We also argue that N-P does not protect from the possible negative effects of the pragmatic value-laden unequal setting of error probabilities on N-P’s epistemic reliability. Most importantly, we argue that in the case of a negative impact no methodological adjustment is available to neutralize it, so (...) in such cases the discussed pragmatic-value-ladenness of N-P inevitably compromises the goal of attaining truth. (shrink)

Tests for hereditary predispositions to breast and ovarian cancer have figured among the first medical applications of the new knowledge gleaned from the Human Genome Project. These applications have set off heated debates on general issues such as intellectual property rights. The genetic diagnosis of breast cancer risks, and the management of women “at risk” has nevertheless developed following highly localized paths. There are major differences in the organization of testing, uses of genetic tests, and the follow up of (...) patients. This article studies testing practices and ways of managing breast cancer risk in France and compares them with those in the United States and United Kingdom. It shows how the complex interaction between global and local factors shapes the multiple meanings assumed by the phrase cancer risk. (shrink)

Background: Genetic tests for schizophrenia may introduce risks and benefits. Among young adults at clinical high risk for psychosis, little is known about their concerns and how they assess potential risks. Methods: We conducted semistructured interviews with 15 young adults at clinical high risk for psychosis to ask about their concerns. Results: Participants expressed concerns about test reliability, data interpretation, stigma, psychological harm, family planning, and privacy. Participants’ responses showed some departure from the ethics literature insofar as (...) participants were primarily interested in reporting their results to people to whom they felt emotionally close, and expressed little consideration of biological closeness. Additionally, if tests showed an increased genetic risk for schizophrenia, four clinical high-risk persons felt obligated to tell an employer and another three would “maybe” tell an employer, even in the absence of clinical symptoms. Conclusions: These findings suggest opportunities for clinicians and genetic counselors to intervene with education and support. (shrink)

This article examines the home rapid HIV test as a new practice of US biocitizenship. Via an analysis of discourse surrounding self-diagnostics, I conclude that while home HIV tests appear to expand consumer rights, they are in fact the vanguard of a new form of self-testing that carries a moral urgency to protect one’s own body and to manage societal risk. In addition, these tests extend biomedical authority into the private domain, while appearing to do the exact opposite. (...) Furthermore, access to these tests may be stratified, contradicting the intent expressed by the manufacturer to reach populations in need of it most and reinforcing stigma against them. Lastly, diagnostics such as the rapid home HIV test represent new obligations for surveillance of one’s own health and that of others. The new public health effort to test the population at large has given rise to a new ‘risky’ population: the untested bodies. (shrink)

The purpose of this article is to provide a critical examination of two aspects of culture and biomedicine that have helped to shape the meaning and practice of genetic testing for breast cancer. These are: the cultural construction of fear of breast cancer, which has been fuelled in part by the predominance of a ‘risk’ paradigm in contemporary biomedicine. The increasing elaboration and delineation of risk factors and risk numbers are in part intended to help women to (...) contend with their fear of breast cancer. However, because there is no known cure or foolproof prevention for breast cancer, risk designations bring with them recommendations for vigilant surveillance strategies and screening guidelines. We argue that these in effect exacerbate women’s fears of breast cancer itself. The volatile combination of discourses of fear, risk and surveillance have significant ethical and social consequences for women’s lives and well-being. Genetic testing decisions are made within this context; if nurses understand this context they can play an important role in helping women to cope with the anxiety and fear of breast cancer risk. (shrink)

The purpose of this article is to provide a critical examination of two aspects of culture and biomedicine that have helped to shape the meaning and practice of genetic testing for breast cancer. These are: (1) the cultural construction of fear of breast cancer, which has been fuelled in part by (2) the predominance of a ‘risk’ paradigm in contemporary biomedicine. The increasing elaboration and delineation of risk factors and risk numbers are in part intended to help (...) women to contend with their fear of breast cancer. However, because there is no known cure or foolproof prevention for breast cancer, risk designations bring with them recommendations for vigilant surveillance strategies and screening guidelines. We argue that these in effect exacerbate women’s fears of breast cancer itself. The volatile combination of discourses of fear, risk and surveillance have significant ethical and social consequences for women’s lives and well-being. Genetic testing decisions are made within this context; if nurses understand this context they can play an important role in helping women to cope with the anxiety and fear of breast cancer risk. (shrink)

As schizotypal personality disorder increasingly prevails in the general population, a rapid and comprehensive measurement instrument is imperative to screen individuals at risk for SPD. To address this issue, we aimed to develop a computerized adaptive testing for SPD using a non-clinical Chinese sample, consisting of a calibration sample and a validation sample. The item pool of SPD was constructed from several widely used SPD scales and statistical analyses based on the item response theory via a calibration sample using (...) a graded response model. Finally, 90 items, which measured at least one symptom of diagnostic criteria of SPD in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders and had local independence, good item fit, high slope, and no differential item functioning, composed the final item pool for the CAT-SPD. In addition, a simulated CAT was conducted in an independent validation sample to assess the performance of the CAT-SPD. Results showed that the CAT-SPD not only had acceptable reliability, validity, and predictive utility but also had shorter but efficient assessment of SPD which can save significant time and reduce the test burden of individuals with less information loss. (shrink)

The debate over the genetic testing of minors has developed into a major bioethical topic. Although several controversial questions remain unanswered, a degree of consensus has been reached regarding the policies on genetic testing of minors. Recently, several commentators have suggested that these policies are overly restrictive, too narrow in focus, and even in conflict with the limited empirical evidence that exists on this issue. We respond to these arguments in this paper, by first offering a clarification of three key (...) concepts—autonomy of the minor, future autonomy, and parental authority—which must be disentangled. We then respond to the arguments by noting the uncertainty of the value of predictive genetic information, and by assessing the psychosocial risks still involved in genetic testing of minors, which are also largely unknown. We conclude that the current consensus position is justified at this stage, in light of the predictions of harm resulting from genetic testing of minors that have not been adequately proved to be unwarranted. (shrink)

The Internet and social media have opened niches for political exploitation of human dispositions to hyper-alarmed states that amplify perceived threats relative to their objective probabilities of occurrence. Researchers should aim to observe the dynamic “ramping up” of security threat mechanisms under controlled experimental conditions. Such research necessarily begins from a clear model of standard baseline states, and should involve adding treatments to established experimental protocols developed by experimental economists. We review these protocols, which allow for joint estimation of (...) class='Hi'>risk preferences and subjective beliefs about probabilities and their distributions. Results we have obtained on such estimates, from populations in various countries, are gathered for comparison. Most people show moderate risk aversion in non-alarmed states. We also find universal heterogeneity in risk preference structures, with substantial sub-samples weighting probabilities in such a way as to display “probability pessimism”, while others make risky choices in accordance with expected utility theory. (shrink)

This paper examines women’s experiences with decision-making about non-invasive prenatal testing (NIPT). Such tests offer knowledge about chromosomal disorders early in pregnancy, without the risk of miscarriage associated with invasive procedures such as amniocentesis. Based on qualitative interviews with women in Germany who used, or declined, NIPT, we show how some women, who would not consider amniocentesis due to the risk of miscarriage, welcome the knowledge provided by, and the additional agency resulting from, NIPT. For others, declining the (...) offer to “know more” becomes increasingly difficult to articulate. The absence of risk strips women of a “good reason” to justify their decision not to test, thus implicitly challenging their “right not to know.” Moreover, NIPT heightens moral dilemmas within relationships with partners, existing children, and sometimes other close relatives. While clinically “non-invasive,” we argue that NIPT changes decision-making in an ethically and socially highly significant way. (shrink)

Direct-to-consumer genetic testing is a growing phenomenon, fuelled by the notion that knowledge equals control. One ethical question that arises concerns the proband’s duty to share information indicating genetic risks in their relatives. However, such duties are unenforceable and may result in the realisation of anticipated harm to relatives. We argue for a shift in responsibility from proband to provider, placing a duty on test providers in the event of identified actionable risks to relatives. Starting from Parker and Lucassen’s (...) 'joint account model', we adapt Kilbride’s application of the rule of rescue and balance it against the relative’s right not to know, placing responsibility on the providers of direct-to-consumer genetic testing. Where the risk of disease to a relative is actionable, we argue providers ought to share results even in the face of the proband’s objections. Confidentiality issues are navigated by a pre-emptive consent model, whereby consumers agree to the sharing of certain information with their relatives ahead of testing and as a condition of testing. When a relative is informed, the proband’s privacy is protected by maximal deidentification, and the rights of the relative are met by a stepwise approach to informing that allows them to decide how much information they receive. (shrink)

Millions of Americans are dependent on what is often called the “safety net.” These loosely-organized networks of health and social service providers serve the many Americans who are uninsured, dependent on public coverage, or for a variety of reasons unable to access other private systems of care. The Institute of Medicine report, America’s Health Care Safety Net: Intact but Endangered, called attention to both the fragility and the resilience of this health care safety net. The IOM report underscored the critical (...) importance of the safety net to the health and well-being of millions of individuals and called for efforts to strengthen it and improve the nation’s ability to monitor its viability. Given this central role, any health care reform efforts need to be fully informed by an understanding of what the safety net includes, how it is financed, and how it is responding to a series of challenges it now faces. (shrink)

Millions of Americans are dependent on what is often called the “safety net.” These loosely-organized networks of health and social service providers serve the many Americans who are uninsured, dependent on public coverage, or for a variety of reasons unable to access other private systems of care. The Institute of Medicine report, America’s Health Care Safety Net: Intact but Endangered, called attention to both the fragility and the resilience of this health care safety net. The IOM report underscored the critical (...) importance of the safety net to the health and well-being of millions of individuals and called for efforts to strengthen it and improve the nation’s ability to monitor its viability. Given this central role, any health care reform efforts need to be fully informed by an understanding of what the safety net includes, how it is financed, and how it is responding to a series of challenges it now faces. (shrink)