Clinical ethicists encounter the most emotionally eviscerating medical cases possible. They struggle to facilitate resolutions founded on good reasoning embedded in compassionate care. This book fills the considerable gap between current texts and the continuing educational needs of those actually facing complex ethics consultations in hospital settings. 28 richly detailed cases explore the ethical reasoning, professional issues, and the emotional aspects of these impossibly difficult consultations. The cases are grouped together by theme to aid teaching, discussion and professional growth. The (...) cases inform any reader who has a keen interest in the choices made in real-life medical dilemmas as well as the emotional cost to those who work to improve the situations. On a more advanced level, this book should be read by ethics committee members who participate in ethics consultations, individual ethics consultants, clinicians who seek education about complex clinical ethics cases, and bioethics students. (shrink)

As neural implants transition from engineering design and testing into human subjects research, careful consideration must be paid to the ethical elements in developing research protocols. Although these ethical aspects may be framed by the design choices of the engineering, a number of challenging choices arise. In spite of many ethical considerations for neural implant technologies being shared with generic research ethics questions, there are subsets needing special attention. Even in considerations requiring increased attention, substantial overlap can be found with (...) research ethics questions for general medical implants and for psychiatric pharmaceuticals. The special attention to specific ethical questions in neural implants exists because of the value placed on preserving cognition and control as well as our continued memory of significant past research abuses in neurosurgery. This paper focuses on three issues of particular saliency to neural implant testing: inclusion/exclusion of subjects with psychiatric conditions, consent withdrawal of research subjects, and enhancement as a goal. (shrink)

Gilbert and colleagues point out the discrepancy between the limited empirical data illustrating changes in personality following implantation of deep brain stimulating electrodes and the vast number of conceptual neuroethics papers implying that these changes are widespread, deleterious, and clinically significant. Their findings are reminiscent of C. P. Snow’s essay on the divide between the two cultures of the humanities and the sciences. This division in the literature raises significant ethical concerns surrounding unjustified fear of personality changes in the context (...) of DBS and negative perceptions of clinician-scientists engaged in DBS. These concerns have real world implications for funding future innovative, DBS trials aimed to reduce suffering as well as hampering true interdisciplinary scholarship. We argue that the philosophical tradition of pragmatism and the value it places on empirical inquiry, experiential knowledge, and inter-disciplinary scholarship – reflecting diverse ways of knowing – provides a framework to start to address the important questions Gilbert and colleagues raise. In particular, we highlight the importance of expert clinician knowledge in contributing to the neuroethical questions raised by Gilbert and colleagues. Finally, we provide illustrative examples of some of our interdisciplinary empirical research that demonstrate the iterative cycle of inquiry characteristic of pragmatism in which conceptual neuroethics questions have led to empirical studies whose results then raise additional conceptual questions that give rise to new empirical studies in a way that highlights the contributions of the humanities and the sciences. (shrink)

Gilbert and colleagues point out the discrepancy between the limited empirical data illustrating changes in personality following implantation of deep brain stimulating electrodes and the vast number of conceptual neuroethics papers implying that these changes are widespread, deleterious, and clinically significant. Their findings are reminiscent of C. P. Snow’s essay on the divide between the two cultures of the humanities and the sciences. This division in the literature raises significant ethical concerns surrounding unjustified fear of personality changes in the context (...) of DBS and negative perceptions of clinician-scientists engaged in DBS. These concerns have real world implications for funding future innovative, DBS trials aimed to reduce suffering as well as hampering true interdisciplinary scholarship. We argue that the philosophical tradition of pragmatism and the value it places on empirical inquiry, experiential knowledge, and inter-disciplinary scholarship – reflecting diverse ways of knowing – provides a framework to start to address the important questions Gilbert and colleagues raise. In particular, we highlight the importance of expert clinician knowledge in contributing to the neuroethical questions raised by Gilbert and colleagues. Finally, we provide illustrative examples of some of our interdisciplinary empirical research that demonstrate the iterative cycle of inquiry characteristic of pragmatism in which conceptual neuroethics questions have led to empirical studies whose results then raise additional conceptual questions that give rise to new empirical studies in a way that highlights the contributions of the humanities and the sciences. (shrink)

Gilbert and colleagues point out the discrepancy between the limited empirical data illustrating changes in personality following implantation of deep brain stimulating electrodes and the vast number of conceptual neuroethics papers implying that these changes are widespread, deleterious, and clinically significant. Their findings are reminiscent of C. P. Snow’s essay on the divide between the two cultures of the humanities and the sciences. This division in the literature raises significant ethical concerns surrounding unjustified fear of personality changes in the context (...) of DBS and negative perceptions of clinician-scientists engaged in DBS. These concerns have real world implications for funding future innovative, DBS trials aimed to reduce suffering as well as hampering true interdisciplinary scholarship. We argue that the philosophical tradition of pragmatism and the value it places on empirical inquiry, experiential knowledge, and inter-disciplinary scholarship – reflecting diverse ways of knowing – provides a framework to start to address the important questions Gilbert and colleagues raise. In particular, we highlight the importance of expert clinician knowledge in contributing to the neuroethical questions raised by Gilbert and colleagues. Finally, we provide illustrative examples of some of our interdisciplinary empirical research that demonstrate the iterative cycle of inquiry characteristic of pragmatism in which conceptual neuroethics questions have led to empirical studies whose results then raise additional conceptual questions that give rise to new empirical studies in a way that highlights the contributions of the humanities and the sciences. (shrink)

Complex clinical ethics cases require a blend of compassion, sensitivity, and tenacity in order to navigate the hard work required of stakeholders. Each person comes to the table with rich historie...

The vulnerability of patients receiving significantly innovative neurosurgical procedures, either as research or as non-standard therapy, presents particularly potent challenges for those attempting to substantially advance clinical Neurosurgical practice in the most ethically and efficacious manner. This beginning formulation has built into it several important notions about research participation, balancing values, and clinical advancement in the context of neurological illness. For the time being, allow vulnerability to act as a placeholder for circumstances or states of being wherein the established checks (...) and balances of power and interest are no longer sufficient in promoting the just treatment of persons. Further, the phrase to substantially advance Neurosurgical practice encompasses radical innovation as well as significant research into new procedures. Finally, few of these explorations involve true randomized placebo controlled trials, but rather they enroll patients rightfully hoping for some benefit by means of undergoing the procedure.When a neurosurgeon asks me, as an ethicist, to meet with a patient who has medically refractory disease and no good standard therapy options remaining, he is asking for help concerning whether to offer, as a last chance, an unproven therapy as either innovation or research. (shrink)

Seven specific challenges in patient vulnerability related to neurosurgical advancement highlight needed augmentations for standards in innovation and research that do not unduly inhibit access to potential therapies while assuring just treatment of patients.

In “Potential Subjects’ Responses to an Ethics Questionnaire in a Phase I Study of Deep-Brain Stimulation in Early Parkinson’s Disease,” Finder, Bliton, Gill, Davis, Konrad, and Charles undertake informed consent research on what they describe as a Phase I trial of deep brain stimulation (DBS) for Parkinson’s disease. We argue that the authors should have more carefully characterized the nature of the DBS study at the start of their clinical study.

Approaches to clinical ethics dilemmas that rely on basic principles or rules are difficult to apply because of vagueness and conflict among basic values. In response, casuistry rejects the use of basic values, and specification produces a large set of specified rules that are presumably easily applicable. Balancing is a method employed to weigh the relative importance of different and conflicting values in application. We argue against casuistry and specification, claiming that balancing is superior partly because it most clearly exhibits (...) the reasoning behind moral decision-making. Hence, balancing may be most effective in teaching bioethics to medical professionals. (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)

Researchers designing a clinical trial may be aware of disputed evidence of serious risks from previous studies. These researchers must decide whether and how to describe these risks in their model informed consent document. They have an ethical obligation to provide fully informed consent, but does this obligation include notice of controversial evidence? With ACCORD as an example, we describe a framework and criteria that make clear the conditions requiring inclusion of important controversial risks. The ACCORD model consent document did (...) not include notice of prior trials with excess death. We develop and explain a new standard labeled risk in equipoise. We argue that our approach provides an optimal level of integrity to protect the informational needs of the reasonable volunteers who agree to participate in clinical trials. We suggest language to be used in a model consent document and the informed consent discussion when such controversial evidence exists. (shrink)

Neil Levy offers the most prominent moral principles that are specifically and exclusively designed to apply to neuroethics. His two closely related principles, labeled as versions of the ethical parity principle , are intended to resolve moral concerns about neurological modification and enhancement [1]. Though EPP is appealing and potentially illuminating, we reject the first version and substantially modify the second. Since his first principle, called EPP , is dependent on the contention that the mind literally extends into external props (...) such as paper notebooks and electronic devices, we begin with an examination of the extended mind hypothesis and its use in Levy’s EPP . We argue against reliance on EMH as support for EPP . We turn to his second principle, EPP , which is not dependent on EMH but is tied to the acceptable claim that the mind is embedded in, because dependent on, external props. As a result of our critique of EPP , we develop a modified version of EPP , which we argue is more acceptable than Levy’s principle. Finally, we evaluate the applicability of our version of EPP. (shrink)

Volume 19, Issue 11, November 2019, Page 78-80.

Lukas J. Meier et al. offer the promise of a pathway for resolving clinical bioethical problems using an artificial intelligence interface. The ultimate goal, we assume, is...

Fox and her colleagues (2007) present an important and foundational study concerning the character of current ethics consultation services (ECSs). Although we have some concerns regarding the gener...

Once a neural implant has shown some efficacy during initial research trials, it begins to enter the world of clinical application. This culminates when the implant becomes approved for a particular indication. However, the ethical challenges continue as the technology is adopted as a standard of practice. Patient eligibility criteria, as documented by inclusion and exclusion criteria with any new treatment, are not always clearly quantified and defined. These vagaries can result in considerable debate regarding who should or should not (...) proceed with surgery. There is often considerable room for clinical judgment that can result in extension of the treatment to a wider range of patients. The ethical questions that arise in clinical decisionmaking differ significantly from those inherent in engineering design and research development. (shrink)

Background and Aims Progress towards validating amyloid beta as an early indicator of Alzheimer’s disease (AD) heightens the need for evaluation of stakeholders’ perspectives of the benefits and harms of preclinical testing in asymptomatic individuals. Methods Investigators conducted and analyzed 14 semi-structured interviews with family members of patients diagnosed with AD. Results Participants reported benefits, including the potential to seek treatment, make lifestyle changes, and prepare for cognitive impairment. Participants identified harms, including social harms, adverse life decisions, and psychological harms. (...) Nine participants reported either a “positive global perspective” or a “positive global perspective (qualified).” Conclusion Results from this study characterized stakeholders’ perspectives on the potential benefits and harms of clinical use of preclinical testing for AD. Investigators used data from this study to develop a framework that contributes to ongoing discussions that will evaluate widespread adoption of preclinical testing and will inform future research. (shrink)

Clear guidelines addressing the ethically appropriate use of anti-infectives in the setting of hospice care do not exist. There is lack of understanding about key treatment decisions related to infection treatment for patients who are eligible for hospice care. Ethical concerns about anti-infective use at the end of life include: (1) delaying transition to hospice, (2) prolonging a dying process, (3) prescribing regimens incongruent with a short life expectancy and goals of care, (4) increasing the reservoir of potential resistant pathogens, (...) (5) placing unreasonable costs on a capitated hospice system. Although anti-infectives are thought to be relatively safe, they can place a burden on patients and be inconsistent to particular care plans. The current complex, and at times fragmented, medical care often fails to address these issues in decision-making. In many ways, the ethics governing the end of life decisions related to dialysis, hydration/nutrition, and hypercalcemia parallel those of anti-infectives. In this article we articulate important elements in ethical decision-making in the application of anti-infectives for patients who are eligible for hospice care, and we point to the need for prospective studies to help refine particular guidelines in these cases. (shrink)

ABSTRACT Clear guidelines addressing the ethically appropriate use of anti‐infectives in the setting of hospice care do not exist. There is lack of understanding about key treatment decisions related to infection treatment for patients who are eligible for hospice care. Ethical concerns about anti‐infective use at the end of life include: (1) delaying transition to hospice, (2) prolonging a dying process, (3) prescribing regimens incongruent with a short life expectancy and goals of care, (4) increasing the reservoir of potential resistant (...) pathogens, (5) placing unreasonable costs on a capitated hospice system. Although anti‐infectives are thought to be relatively safe, they can place a burden on patients and be inconsistent to particular care plans. The current complex, and at times fragmented, medical care often fails to address these issues in decision‐making. In many ways, the ethics governing the end of life decisions related to dialysis, hydration/nutrition, and hypercalcemia parallel those of anti‐infectives. In this article we articulate important elements in ethical decision‐making in the application of anti‐infectives for patients who are eligible for hospice care, and we point to the need for prospective studies to help refine particular guidelines in these cases. (shrink)

In an effort to create new synergies to fill gaps in evaluation of value, assessment of quality, and definition of roles in clinical ethics programs we convened a meeting entitled Innovations in Clinical Ethics: A Working Un-Conference (the Un-Conference) in August 2018. The Un-Conference was conceived to be a working event aimed at promoting cross pollination and idea generation for innovative practices in clinical ethics. The event was attended by 95 individuals from 62 institutions, representing a wide diversity of healthcare (...) systems, who believed in the concept and brought their enthusiasm and expertise to share with others. As a product of the Un-Conference, whitepaper groups developed summaries and broad overviews of areas that need to be further addressed within our field. The whitepapers are being published in this issue of The Journal of Clinical Ethics. The first three whitepapers highlight the broad themes of demonstrating value to the institution, quality assessment, and emerging roles for clinical ethics programs and ethicists. The final whitepaper offers guidance to clinical ethicists engaged in pediatric ethics work and, in conversation with the emerging roles article, thoughtfully reflects on the role of pediatric ethicists. (shrink)

Despite an abundance of academic conferences, clinical ethicists lacked a forum to share innovative practices with peers and to generate solutions to common challenges. Organizers of the first Clinical Ethics Un-Conference developed a working event centered on active participation and problem solving through peer learning, with the goal of improving realworld practice. Registrants included 95 individuals from 64 institutions. Attendees were surveyed immediately after the Un-Conference, and again eight months later. After eight months, 85 percent (n = 33/39) of the (...) survey respondents reported that they found the event “highly impactful” or “some-what impactful” to their clinical practice, and 23 attendees reported that they had implemented ideas or projects inspired by the event. Three sets of best practice guidelines and four white papers were published from the event. As the field of clinical ethics continues to advance and evolve, this working event format offers an innovative, disruptive alternative to a traditional conference format and may serve as a model for future efforts aimed at improving real-world clinical ethics practice. (shrink)

The article Pragmatismand the Importance of Interdisciplinary Teams in Investigating Personality Changes Following DBS.

The American Journal of Bioethics, Volume 12, Issue 5, Page 11-12, May 2012.

This paper offers four contrasting perspectives on the role of the nurse ethicist from authors based in different areas of world, with different professional backgrounds and at different career stages. Each author raises questions about how to understand the role of the nurse ethicist. The first author reflects upon their career, the scope and purpose of their work, ultimately arguing that the distinction between ‘nurse ethicist’ and ‘clinical ethicist’ is largely irrelevant. The second author describes the impact and value that (...) a nurse in an ethics role plays, highlighting the ‘tacit knowledge’ and ‘lived experience’ they bring to clinical ethics consultation. However, the second author also warns that the ‘nurse ethicist’ must be cautious in their approach to avoid being viewed as a resource only for nurses. The third author questions the introduction of additional professional distinctions such as ‘nurse ethicist’ on the basis that distinctions threaten the creation of egalitarian healthcare systems, while also acknowledging that clinical ethicists ought not strive for objective attachment in their work. In direct contrast, the final author suggests that the nurse ethicist can play a pivotal role in highlighting and addressing ethical challenges that are specific to nurses. These four short pieces raise questions and point to concepts that will be expanded upon and debated throughout this special issue of Nursing Ethics. (shrink)

This is a follow-up article toPhilip Brey's ``The ethics of representation andaction in Virtual Reality'' (published in thisjournal in January 1999). Brey's call for moreanalysis of ethical issues of virtual reality(VR) is continued by further analyzing issuesin a specialized domain of VR – namelymulti-user environments. Several elements ofBrey's article are critiqued in order to givemore context and a framework for discussion.Issues surrounding representations ofcharacters in multi-user virtual realities aresurveyed in order to focus attention on theimportance of additional discussion andanalysis of (...) specialized aspects of VR. (shrink)

As clinical trials end, little is understood about how participants exiting from clinical trials approach decisions related to the removal or post-trial use of investigational brain implants, such as deep brain stimulation (DBS) devices. This empirical bioethics study examines how research participants experience the process of exit from research at the end of clinical trials of implanted neural devices. Using a modified grounded theory study design, we conducted semi-structured, in-depth interviews with 16 former research participants from clinical trials of DBS (...) and responsive neurostimulation (RNS). Open-ended questions elicited motivations for joining the trial, understanding of study procedures at the time of initial informed consent, the process of exiting from research, and decisions about device removal or post-trial device use. Thematic analysis identified categories related to: limited preparedness for the end of research participation, straightforwardness of decisions to explant or keep the device, reconciling with the end of research participation, reconciling post-trial expectations, and achieving a sense of closure after exit from research. A preliminary theoretical model describes contextual factors influencing the process and experience of exit from research. Experiences of clinical trial participants should guide research practices to enhance the ethical design and conduct of clinical trials in DBS and other brain devices. (shrink)

Abstract:Vulnerability is an important criterion to assess the ethical justification of the inclusion of participants in research trials. Currently, vulnerability is often understood as an attribute inherent to a participant by nature of a diagnosed condition. Accordingly, a common ethical concern relates to the participant’s decisionmaking capacity and ability to provide free and informed consent. We propose an expanded view of vulnerability that moves beyond a focus on consent and the intrinsic attributes of participants. We offer specific suggestions for how (...) relational aspects and the dynamic features of vulnerability could be more fully captured in current discussions and research practices. (shrink)

Objective: To examine changes in patients’ desired control of the deep brain stimulator and perception of global life control throughout DBS.Methods: A consecutive cohort of 52 patients with Parkinson’s disease was recruited to participate in a prospective longitudinal study over three assessment points. Semi-structured interviews assessing participants’ desire for stimulation control and perception of global control were conducted at all three points. Qualitative data were coded using content analysis. Visual analog scales were embedded in the interviews to quantify participants’ perceptions (...) of control over time.Results: Participants reported significant increases in their perception of global control over time and significant declines in their desired control of the stimulation. These changes were unrelated to improvements in motor symptoms. Improvements in global control were negatively correlated with a decline in desired stimulation control. Qualitative data indicate that participants have changed, nuanced levels of desired control over their stimulators. Increased global life control following DBS may be attributed to increased control over PD symptoms, increased ability to engage in valued activities, and increased overall self-regulation, while other domains related to global control remained unaffected by DBS.Conclusions: There are few empirical data documenting patients’ desire for stimulation control throughout neuromodulation and how stimulation control is related to other aspects of control despite the growing application of neuromodulation devices to treat a variety of disorders. Our data highlight distinctions in different types of control and have implications for the development of patient-controlled neurostimulation devices. (shrink)

Clinical ethics consultants should show bold moral courage in discharging their duties to patients, families, and healthcare providers. Given the corrosive impact on trust, and on the appropriate d...

The coronavirus disease (COVID-19) crisis provoked an organizational ethics dilemma: how to develop ethical pandemic policy while upholding our organizational mission to deliver relationship- and patient-centered care. Tasked with producing a recommendation about whether healthcare workers and essential personnel should receive priority access to limited medical resources during the pandemic, the bioethics department and survey and interview methodologists at our institution implemented a deliberative approach that included the perspectives of healthcare professionals and patient stakeholders in the policy development process. Involving (...) the community more, not less, during a crisis required balancing the need to act quickly to garner stakeholder perspectives, uncertainty about the extent and duration of the pandemic, and disagreement among ethicists about the most ethically supportable way to allocate scarce resources. This article explains the process undertaken to garner stakeholder input as it relates to organizational ethics, recounts the stakeholder perspectives shared and how they informed the triage policy developed, and offers suggestions for how other organizations may integrate stakeholder involvement in ethical decision-making as well as directions for future research and public health work. (shrink)