An increasing number of European research projects return, or plan to return, individual genomic research results (IRR) to participants. While data access is a data subject’s right under the General Data Protection Regulation (GDPR), and many legal and ethical guidelines allow or require participants to receive personal data generated in research, the practice of returning results is not straightforward and raises several practical and ethical issues. Existing guidelines focusing on return of IRR are mostly project-specific, only discuss which results to (...) return, or were developed outside Europe. To address this gap, we analysed existing normative documents identified online using inductive content analysis. We used this analysis to develop a checklist of steps to assist European researchers considering whether to return IRR to participants. We then sought feedback on the checklist from an interdisciplinary panel of European experts (clinicians, clinical researchers, population-based researchers, biobank managers, ethicists, lawyers and policy makers) to refine the checklist. The checklist outlines seven major components researchers should consider when determining whether, and how, to return results to adult research participants: 1) Decide which results to return; 2) Develop a plan for return of results; 3) Obtain participant informed consent; 4) Collect and analyse data; 5) Confirm results; 6) Disclose research results; 7) Follow-up and monitor. Our checklist provides a clear outline of the steps European researchers can follow to develop ethical and sustainable result return pathways within their own research projects. Further legal analysis is required to ensure this checklist complies with relevant domestic laws. (shrink)

Volume 20, Issue 3, March 2020, Page 37-39.

Although rapid genomic sequencing (RGS) is improving care for critically ill children with rare disease, it also raises important ethical questions that need to be explored as its use becomes more widespread. Two such questions relate to the degree of consent that should be required for RGS to proceed and whether it might ever be appropriate to override parents’ decisions not to allow RGS to be performed in their critically ill child. To explore these questions, we first examine the legal (...) frameworks on securing consent for genomic sequencing and how they apply to the specific context of RGS for critically ill children. We then use a tool from clinical ethics, the Zone of Parental Discretion, to explore two case studies and identify under which circumstances it might be appropriate for parental refusal of RGS to be overridden. We argue that RGS may be a context where, in addition to assessing the complexity of the test offered, it is ethically appropriate to consider an effect on patient outcomes when deciding the degree of consent required. We also suggest that there are some contexts where it may be ethically justified to perform RGS, even when it is actively against the wishes of the parents. More work is needed to examine exactly how ‘time-sensitive’ exceptions to current guidance on consent for genomic sequencing could be formulated and operationalised for RGS for critically ill-children. (shrink)

Background While integrating genomic sequencing into clinical care carries clear medical benefits, it also raises difficult ethical questions. Compared to traditional sequencing technologies, genomic sequencing and analysis is more likely to identify unsolicited findings (UF) and variants that cannot be classified as benign or disease-causing (variants of uncertain significance; VUS). UF and VUS pose new challenges for genetic health professionals (GHPs) who are obtaining informed consent for genomic sequencing from patients.Methods We conducted semi-structured interviews with 31 GHPs across Europe, Australia (...) and Canada to identify some of these challenges.Results Our results show that GHPs find it difficult to prepare patients to receive results because a vast amount of information is required to fully inform patients about VUS and UF. GHPs also struggle to engage patients – many of whom may be focused on ending their ‘diagnostic odyssey’ – in the informed consent process in a meaningful way. Thus, some questioned how ‘informed’ patients actually are when they agree to undergo clinical genomic sequencing.Conclusions These findings suggest a tension remains between sufficient information provision at the risk of overwhelming the patient and imparting less information at the risk of uninformed decision-making. We suggest that a shift away from ‘fully informed consent’ toward an approach aimed at realizing, as far as possible, the underlying goals that informed consent is meant to promote. (shrink)

Background While integrating genomic sequencing into clinical care carries clear medical benefits, it also raises difficult ethical questions. Compared to traditional sequencing technologies, genomic sequencing and analysis is more likely to identify unsolicited findings (UF) and variants that cannot be classified as benign or disease-causing (variants of uncertain significance; VUS). UF and VUS pose new challenges for genetic health professionals (GHPs) who are obtaining informed consent for genomic sequencing from patients.Methods We conducted semi-structured interviews with 31 GHPs across Europe, Australia (...) and Canada to identify some of these challenges.Results Our results show that GHPs find it difficult to prepare patients to receive results because a vast amount of information is required to fully inform patients about VUS and UF. GHPs also struggle to engage patients – many of whom may be focused on ending their ‘diagnostic odyssey’ – in the informed consent process in a meaningful way. Thus, some questioned how ‘informed’ patients actually are when they agree to undergo clinical genomic sequencing.Conclusions These findings suggest a tension remains between sufficient information provision at the risk of overwhelming the patient and imparting less information at the risk of uninformed decision-making. We suggest that a shift away from ‘fully informed consent’ toward an approach aimed at realizing, as far as possible, the underlying goals that informed consent is meant to promote. (shrink)

Medical imaging is predominantly a visual field. In this context, prenatal ultrasound images assume intense social, ethical, and psychological significance by virtue of the subject they represent: the fetus. This feature, along with the sophistication introduced by three-dimensional ultrasound imaging that allows improved visualization of the fetus, has contributed to the common impression that prenatal ultrasound scans are like photographs of the fetus. In this article we discuss the consistency of such a comparison. First, we investigate the epistemic role of (...) both analogic and digital photographic images as visual information-providing representations holding a high degree of objectivity. Second, we examine the structure and process of production of ultrasound scans and argue that a comparison between two-dimensional ultrasound and photography is justified. This is in contrast to 3D ultrasound images that, due to the intensive mathematical processing involved in their production, present some structural issues that obfuscate their ontological and epistemic status. (shrink)

Ellen Fox and collaborators have produced the most detailed description of healthcare ethics practices in the United States available. Some findings are shocking for anyone committed to promoting q...

Scholars and professional organizations in bioethics describe various approaches to “quality assessment” in clinical ethics. Although much of this work represents significant contributions to the literature, it is not clear that there is a robust and shared understanding of what constitutes “quality” in clinical ethics, what activities should be measured when tracking clinical ethics work, and what metrics should be used when measuring those activities. Further, even the most robust quality assessment efforts to date are idiosyncratic, in that they represent (...) evaluation of single activities or domains of clinical ethics activities, or a range of activities at a single hospital or healthcare system. Countering this trend, in this article we propose a framework for moving beyond our current ways of understanding clinical ethics quality, toward comprehensive quality assessment. We first describe a way to conceptualize quality assessment as a process of measuring disparate, isolated work activities; then, we describe quality assessment in terms of tracking interconnected work activities holistically, across different levels of assessment. We conclude by inviting future efforts in quality improvement to adopt a comprehensive approach to quality assessment into their improvement practices, and offer recommendations for how the field might move in this direction. (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)

Mr. C is a twenty‐two‐year‐old who was flown to a level‐1 trauma center after diving headfirst into shallow water. Prior to this accident, he was in excellent health. At the scene, he had been conscious but was paralyzed and had no sensation below his neck. The emergency medical services team immobilized Mr. C's neck with a cervical collar and intubated him for airway protection before transport. As Mr. C's medical care proceeds, he expresses a desire for extubation, although it was (...) not clear that he had the capacity to make this (or any other) decision. It also was unclear whether this desire reflected his authentic wishes to be allowed to die or stemmed from feelings of discomfort and agitation. Over a period of several days, Mr. C's sedation was lightened, and the psychiatry service conducted a formal decision‐making capacity assessment. Mr. C continues to express a desire to withdraw life‐sustaining medical treatment. However, the psychiatry service is concerned that Mr. C seems to lack adequate insight into what it would mean to die.What does it mean to respect Mr. C's autonomy? (shrink)

Hegel came to maturity as a philosopher during the first years of the nineteenth century, developing through prodigious intellectual struggles a highly original conception of dialectic as a method for rationally comprehending traumatic historical change. At the same time, he continued a process begun earlier, of critical engagement with the Christian gospel and its historical ethos. Hegel spent much of his youth reacting against this drama and its cultural expression. By the time he published his early masterpiece, the _Phenomenology of (...) Spirit_, he had found an ingenious way of reconstructing it in counterpoint with his new dialectical understanding of historical experience. _Dialectic and Gospel in the Development of Hegel's Thinking_ tells the story of this interplay as it develops in Hegel's thinking. It culminates in a fresh interpretation of the _Phenomenology of Spirit_ and a detailed commentary on larger portions of the text relevant to that story. Crites's reading of the masterpiece is contextualized by three substantial chapters detailing the course of Hegel's reflections on Christian themes through the first thirty-five years of his life. These chapters are both biographical and textual, treating not only the philosopher’s personal and intellectual development but also the major cultural influences that informed it. Hegel is seen to have begun as a child of the Enlightenment powerfully, affected by the Romantic reaction to the Enlightenment, who finds his way to his own position as a founding genius of German Idealism and its historical dialectic. His development is thus interpreted as an epitome of a major transformation in European intellectual history. (shrink)

One of the most pressing ethical challenges facing phase I cancer research centres is the process of informed consent. Historically, most scholarship has been devoted to redressing therapeutic misconception, that is, the conflation of the nature and goals of research with those of therapy. While therapeutic misconception continues to be a major ethical concern, recent scholarship has begun to recognise that the informed consent process is more complex than merely a transfer of information and therefore cannot be evaluated only according (...) to how well an individual understands such information. Other components of decision-making operate independently of understanding and yet still may compromise the quality of informed consent. Notable among these components is unrealistic optimism, an event-specific belief that one has a better chance of receiving benefit than others similarly situated. In this article, we consider responses to interviews with parents who had recently completed an informed consent conference for enrolling their child in a phase I cancer clinical trial to examine how this influence manifests and how investigators might address it during informed consent. (shrink)

The article [Title], written by [AuthorNames], was originally published electronically on the publisher’s internet portal on [date of OnlineFirst publication] without open access.

I want in these brief Notes to offer some critical observations on a text I admire very much. It appeared only after I had finally finished writing a work of my own, entitled Dialectic and Gospel in the Development of Hegel’s Thinking. This work focuses on Hegel’s assessments, interpretations, and transformations in Phenomenology of Spirit and writings that preceded it, of the basic religious narrative, from creation to last judgment, that Christian writers have avowed but variously interpreted since New Testament (...) times. So I will be discussing Hegel’s Ladder from a point of view formed in my long labors on that work, and with its focus in mind. I will be brief and as clear as I am able to be, painting with a broad brush without documentation, because my views have been documented in some detail in my book. Judging, in fact, from the fair-minded review of the book by Daniel Shannon that appeared in the Spring 2001 issue of the Owl, I may have been so detailed as to have lost the forest in the trees: all the more reason to keep things uncluttered here, so as to join a few issues. Not included in issues I consider worth discussing, however, are such questions as whether Hegel was a Christian, or a Christian apologist, or an atheist, or whether any sort of Christian might be eligible for Professor Harris’s Republic of the Learned. (shrink)

With the increasing professionalization of clinical ethics, some hospitals and health systems utilize both ethics committees and professional clinical ethicists to address their ethics needs. Drawing upon historical critiques of ethics committees and their own experiences, the authors argue that, in ethics programs with one or more professional clinical ethicists, ethics committees should be dissolved when they fail to meet minimum standards of effectiveness. The authors outline several criteria for assessing effectiveness, describe the benefits of a model that places primary (...) responsibility for ethics work with professional clinical ethicists—the PCE-primary model, and offer suggestions for alternative ethics program structures that empower healthcare professionals to contribute to ethics work in ways more tailored to their strengths and skills while minimizing the shortcomings of ethics committees. (shrink)

I. The word ‘history’ and its derivatives are used in many different senses among modern philosophers, theologians, and historians. While we need not rehearse here the various meanings of the word in current use, it will serve our purpose to call attention to a very general distinction which seems quite essential to any attempt to do so. Some meanings of ‘history’ or ‘historical’ refer to an actual course of events as they occur or are enacted. Other meanings refer to the (...) recollection, the piecing together, the reconstruction and interpretation of such a course of events after it has occurred, pre-eminently through the scholarly craft of the historian. Admittedly, even this innocent sounding distinction is fraught with difficulties. It is not as though there were an independent access to past events which could dispense with the historian’s methods. But to every event there is one relationship that requires no access at all: that of its participants, who enact it and are directly affected by it. They are in the event and it, so to speak, is in them. Indeed, though there are nonhuman factors in any event, it is the transaction of human participants which makes the event historical, which, in fact, constitutes the historical event. (shrink)

This review praises Hodgson’s study for exhibiting the experimental openness of Hegel’s thinking: far from being part of a closed system, Hegel’s philosophy of religion is a work in progress. But the review criticizes the final chapter of the study for hedging this openness, for narrowing Hegel’s contemporary legacy to a few currently fashionable gestures.

This review praises Hodgson’s study for exhibiting the experimental openness of Hegel’s thinking: far from being part of a closed system, Hegel’s philosophy of religion is a work in progress. But the review criticizes the final chapter of the study for hedging this openness, for narrowing Hegel’s contemporary legacy to a few currently fashionable gestures.

This monograph will be devoted to a cluster of related issues arising between two formidable bodies of work: between the philosophical works of G.W.F. Hegel (1770-1831) and the very different flavored writings of Soren Kierkegaard (1813-1855). These two thinkers are commonly regarded as polar opposites. Certainly they thought and wrote in altogether different styles, and Kierkegaard frequently gave vent to vigorous anti-Hegelian polemics. Yet ever since I was a graduate student in the late 1950s, Hegel and Kierkegaard have together supplied (...) most of my intellectual nourishment. Superficially the issues between them are obvious. With careful study they come mus less obvious, much harder to pin down, and yet, one sense, much more important than one had supposed. (shrink)

I want in these brief Notes to offer some critical observations on a text I admire very much. It appeared only after I had finally finished writing a work of my own, entitled Dialectic and Gospel in the Development of Hegel’s Thinking. This work focuses on Hegel’s assessments, interpretations, and transformations in Phenomenology of Spirit and writings that preceded it, of the basic religious narrative, from creation to last judgment, that Christian writers have avowed but variously interpreted since New Testament (...) times. So I will be discussing Hegel’s Ladder from a point of view formed in my long labors on that work, and with its focus in mind. I will be brief and as clear as I am able to be, painting with a broad brush without documentation, because my views have been documented in some detail in my book. Judging, in fact, from the fair-minded review of the book by Daniel Shannon that appeared in the Spring 2001 issue of the Owl, I may have been so detailed as to have lost the forest in the trees: all the more reason to keep things uncluttered here, so as to join a few issues. Not included in issues I consider worth discussing, however, are such questions as whether Hegel was a Christian, or a Christian apologist, or an atheist, or whether any sort of Christian might be eligible for Professor Harris’s Republic of the Learned. (shrink)

Intensified and extensive data production and data storage are characteristics of contemporary western societies. Health data sharing is increasing with the growth of Information and Communication Technology platforms devoted to the collection of personal health and genomic data. However, the sensitive and personal nature of health data poses ethical challenges when data is disclosed and shared even if for scientific research purposes. With this in mind, the Science and Values Working Group of the COST Action CHIP ME ‘Citizen's Health through (...) public-private Initiatives: Public health, Market and Ethical perspectives’ identified six core values they considered to be essential for the ethical sharing of health data using ICT platforms. We believe that using this ethical framework will promote respectful scientific practices in order to maintain individuals’ trust in research. We use these values to analyse five ICT platforms and explore how emerging data sharing platforms are reconfiguring the data sharing experience from a range of perspectives. We discuss which types of values, rights and responsibilities they entail and enshrine within their philosophy or outlook on what it means to share personal health information. Through this discussion we address issues of the design and the development process of personal health data and patient-oriented infrastructures, as well as new forms of technologically-mediated empowerment. (shrink)

Benchmarks against which healthcare ethics consultation (HCEC) services can assess their performance are needed. As first-generation benchmarks continue to be developed, it is the obligation of the field to continually evaluate how these measures reflect the performance of any single HCEC service. This will be possible only with widespread reporting of standardized data points. In their article in this issue of The Journal of Clinical Ethics, Glover and colleagues provide a valuable preliminary approach for assessing appropriate consult volumes for a (...) HCEC service. The limitations of their study read as a call to action for the field of clinical ethics to expand and standardize data reporting so that more robust metrics can be developed. In response to this call by Glover and colleagues, the Cleveland Clinic HCEC service provides consult data from 2015 through 2019 for one of its medical centers, and offers an additional volumebased metric, consult-to-ICU-to-bed ratio (CiBR), that may add nuance to any normative assessment of HCEC service consult volume. Given that volume-based metrics are the native language of the clinical environment, efforts to improve such metrics in the field through transparency and standardization are warranted. However, the expositive power of volume-based metrics is limited; additional domains related to quality and outcomes are needed. (shrink)

Participation in healthcare decision-making is considered to be an important right of minors, and is highlighted in both international legislation and public policies. However, despite the legal recognition of children’s rights to participation, and also the benefits that children experience by their involvement, there is evidence that legislation is not always translated into healthcare practice. There are a number of factors that may impact on the ability of the child to be involved in decisions regarding their medical care. Some of (...) these factors relate to the child, including their capacity to be actively involved in these decisions. Others relate to the family situation, sociocultural context, or the underlying beliefs and practices of the healthcare provider involved. In spite of these challenges to including children in decisions regarding their clinical care, we argue that it is an important factor in their treatment. The extent to which children should participate in this process should be determined on a case-by-case basis, taking all of the potential barriers into account. (shrink)

Genomic research can reveal ‘unsolicited’ or ‘incidental’ findings that are of potential health or reproductive significance to participants. It is widely thought that researchers have a moral obligation, grounded in the duty of easy rescue, to return certain kinds of unsolicited findings to research participants. It is less widely thought that researchers have a moral obligation to actively look for health-related findings. This paper examines whether there is a moral obligation, grounded in the duty of easy rescue, to actively hunt (...) for genomic secondary findings. We begin by showing how the duty to disclose individual research findings can be grounded in the duty of easy rescue. Next, we describe a parallel moral duty, also grounded in the duty of easy rescue, to actively hunt for such information. We then consider six possible objections to our argument, each of which we find unsuccessful. Some of these objections provide reason to limit the scope of the duty to look for secondary findings, but none provide reason to reject this duty outright. We argue that under a certain range of circumstances, researchers are morally required to hunt for these kinds of secondary findings. Although these circumstances may not currently obtain, genomic researchers will likely acquire an obligation to hunt for secondary findings as the field of genomics continues to evolve. (shrink)

Genomic sequencing technologies (GS) pose novel challenges not seen in older genetic technologies, making traditional standards for fully informed consent difficult or impossible to meet. This is due to factors including the complexity of the test and the broad range of results it may identify. Meaningful informed consent is even more challenging to secure in contexts involving significant time constraints and emotional distress, such as when rapid genomic testing (RGS) is performed in neonatal intensive care units. In this article, we (...) propose that informed consent matters not for its own sake, but because obtaining it furthers a range of morally important goals, such as promoting autonomy, well‐being, and trust in medicine. These goals form the basis of a new framework [PROmoting Morally Important Consent Ends (PROMICE)] for assessing the ethical appropriateness of various informed consent models. We illustrate this framework with two examples: (a) a tiered and layered consent model for obtaining consent for GS, and (b) consent for RGS in critically ill newborns. We conclude that appropriately—rather than fully—informed consent provides the correct standard for genomic medicine and research. (shrink)

This is an exemplary edition of translated lectures by Hegel, both in the quality of the translation and in its editorial matter. The translated text is preceded by an Introduction devoted to historical and textual concerns, and is followed by a brief section-by-section commentary on its substance. A student who works his way through the entire volume will be well initiated into this important region of Hegel’s thought. It is good news that editions of the first and second parts of (...) the Lectures on the Philosophy of Religion are projected in conformity with the format and standard of this edition of Part III. (shrink)

Although Next Generation Sequencing (NGS) has increased our ability to test and diagnose, its results are often not clear-cut and require a complex interpretation and negotiation process by both healthcare professionals and patients involved. In this paper, we explore how diagnoses identified through NGS are socially shaped under influence of the broader social context. Using an analytical framework stemming from the sociology of health and illness and science and technology studies, with a focus on the construction of diagnosis and the (...) role of uncertainty in medicine, we analyze the existing corpus of literature on NGS diagnostic practices. We show how in this early implementation phase of NGS, in which standardization efforts are not yet solidified, the boundary struggles around diagnoses obtained through NGS are particularly visible. We discuss the different steps in the diagnosis shaping process and what it subsequently entails to give and a receive a diagnosis using NGS. (shrink)

Recently, Australia became the second jurisdiction worldwide to legalize the use of mitochondrial donation technology. The Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 allows individuals with a family history of mitochondrial disease to access assisted reproductive techniques that prevent the inheritance of mitochondrial disease. Using inductive content analysis, we assessed submissions sent to the Senate Committee as part of a programme of scientific inquiry and public consultation that informed drafting of the Bill. These submissions discussed a range of bioethical (...) and legal considerations of central importance to the political debate. Significantly, submissions from those with a first-hand experience of mitochondrial disease, including clinicians and those with a family history of mitochondrial disease, were in strong support of this legislation. Those in support of the Bill commended the two-staged approach and rigorous licencing requirements as part of the Bill’s implementation strategy. Submissions which outlined arguments against the legislation either opposed the use of these techniques in general or opposed aspects of the implementation strategy in Australia. These findings offer a window into the ethical arguments and perspectives that matter most to those Australians who took part in the Senate inquiry into mitochondrial donation. The insights garnered from these submissions may be used to help refine policy and guidelines as the field progresses. (shrink)

Genomic sequencing (GS) is increasingly used in paediatric medicine to aid in screening, research and treatment. Some health systems are trialling GS as a first-line test in newborn screening programmes. Questions about what to do with genomic data after it has been generated are becoming more pertinent. While other research has outlined the ethical reasons for storing deidentified genomic data to be used in research, the ethical case for storing data for future clinical use has not been explicated. In this (...) paper, we examine the ethical case for storing genomic data with the intention of using it as a lifetime health resource. In this model, genomic data would be stored with the intention of reanalysis at certain points through one’s life. We argue this could benefit individuals and create an important public resource. However, several ethical challenges must first be met to achieve these benefits. We explore issues related to privacy, consent, justice and equality. We conclude by arguing that health systems should be moving towards futures that allow for the sequential interrogation of genomic data throughout the lifespan. (shrink)

Background There is ongoing debate regarding whether and under which circumstances secondary findings (SF) should be offered in the pediatric context. Although studies have examined patient perspectives on receiving SF, little research has been conducted examining the experiences of clinicians offering SF to parents of newborns receiving genomic sequencing for a recently diagnosed medical condition.Methods To address this, we conducted qualitative interviews exploring the views and experiences of 12 clinicians who offered SF to parents of infants who had diagnostic exome (...) sequencing (ES) to identify the cause of their hearing loss. Interviews explored clinicians’ accounts of parents’ choices and decision-making about receiving SF, their views on whether and when to offer SF, their experiences returning SF, and any ethical challenges they encountered. Interviews were audio-recorded, transcribed and analyzed using inductive content analysis.Results Clinicians reported parents who declined all SF often felt finding out about future conditions unrelated to their child’s hearing loss may be unhelpful, or even harmful, or were overwhelmed by their child’s diagnosis. Clinicians also reported that some parents chose SF because they felt obliged to, even if they did not want to receive them. They explained that while some parents experienced decision-making regarding SF as positive, for others, this process was challenging or distressing. While clinicians generally agreed SF should be offered, mainly to promote parental choice, most felt SF should be offered after disclosing diagnostic results, primarily to avoid overwhelming parents. Clinicians encountered several ethical challenges, including balancing parental autonomy with non-maleficence, wanting to report or not report certain SF, and questioning whether parents can make an autonomous choice regarding SF.Conclusions Our findings, which are novel as they relate to parents of young infants with a recent diagnosis of hearing loss, add new insights into clinicians’ and parents’ decision-making regarding SF in pediatrics. (shrink)

BackgroundCarrier screening is generally performed with the aim of identifying healthy couples at risk of having a child affected with a monogenic disorder to provide them with reproductive options. Expanded carrier screening, which provides the opportunity for multiple conditions to be screened in one test, offers a more cost-effective and comprehensive option than screening for single disorders. However, implementation of ECS at a population level would have implications for genetic counseling practice.MethodsWe conducted semi-structured interviews with sixteen European clinical and molecular (...) geneticists with expertise in carrier screening to explore their views on the implementation of ECS in the clinical setting.ResultsUsing inductive content analysis, we identified content categories relevant to the pre- and post-test settings. Participants believed ECS would ideally be targeted at couples before pregnancy. There was some disagreement regarding the acceptability of performing ECS in individuals, with several participants actively opposing individual-based screening. In addition, participants discussed the importance of ensuring informed and voluntary participation in ECS, recommending measures to minimize external pressure on prospective parents to undergo testing. A need for adequate counseling to foster informed, autonomous reproductive decision-making and provide support for couples found to be at risk was emphasized.ConclusionsPractical challenges in optimizing pre-test education and post-test counseling should not be underestimated and they should be carefully addressed before implementing ECS in the clinical setting. (shrink)

Organizational ethics programs often are created to address tensions in organizational values that have been identified through repeated clinical ethics consultation requests. Clinical ethicists possess some core competencies that are suitable for the leadership of high-quality organizational ethics programs, but they may need to develop new skills to build these programs, such as familiarity with healthcare delivery science, healthcare financing, and quality improvement methodology. To this end, we suggest that clinical ethicists build organizational ethics programs incrementally and via quality improvement (...) projects undertaken in collaboration with senior clinical leaders. Organizational ethics programs often differ from clinical ethics programs in their membership and processes, and likely will require ethicists to forge new partnerships with a wide array of organizational leaders. With attention to the ways that organizational ethics programs differ from clinical ethics programs, and investment in quality improvement methodology and formal institutional needs assessments, clinical ethics leaders can position an organizational ethics program to advocate effectively for visible and compelling alignment of leadership decision making with the values of the organization. (shrink)