Objective: To develop an approach for seeking informed consent to examine tissues retained from a previous study of sudden infant death syndrome as part of a study on asthma, and to document responses and participation rate.Design: Pilot open-ended approach to 10 volunteer SIDS parents, followed by staged approach to seek consent from the target SIDS families for the asthma study.Participants: Parents of SIDS infants known to SIDS and Kids Victoria and parents of SIDS infants from the 1991–2 SIDS in Victoria (...) case–control study.Main outcomes: Qualitative responses of the piloted parents and study parents, and participation rates.Results: The pilot group responses were used to refine the written material to be provided. Of the 72 families for which contact details were available, 45 gave verbal consent for contact by the Victorian Institute of Forensic Medicine regarding the asthma study, three refused and 24 did not respond to two letters. Thirty-three completed consent forms, all positive for participation in the asthma study, giving a positive response rate of 73% .Conclusions: The use of postmortem tissue for research is acceptable to the next of kin when an approach is sensitive to their concerns and needs and is made by experienced counsellors from a familiar organisation. Despite the painful memories evoked by the approach of the research group, the acceptance rate among those who could be contacted was high. (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)

Multidisciplinary healthcare committees meet regularly to discuss patients’ candidacy for emerging functional neurosurgical procedures, such as Deep Brain Stimulation . Through debate and discussion around the surgical candidacy of particular patients, functional neurosurgery programs begin to mold practice and policy supported both by scientific evidence and clear value choices. These neurosurgical decisions have special considerations not found in non-neurologic committees. The professional time used to resolve these conflicts provides opportunities for the emergence of careful, ethical practices simultaneous with the expansion (...) of therapy applications. (shrink)

The field of emotion regulation has developed rapidly, and a number of emotion regulatory strategies have been identified. To date, empirical attention has focused on contrasting specific regulatio...

Background: Limited knowledge of the experiences of conflicts of conscience found in nursing literature. Objectives: To explore the individual experiences of a conflict of conscience for neonatal nurses in Alberta. Research design: Interpretive description was selected to help situate the findings in a meaningful clinical context. Participants and research context: Five interviews with neonatal nurses working in Neonatal Intensive Care Units throughout Alberta. Ethical consideration: Ethics approval from the Health Research Ethics Board at the University of Alberta. Findings: Three common (...) themes emerged from the interviews: the unforgettable conflict with pain and suffering, finding the nurse’s voice, and the unique proximity of nurses. Discussion and conclusion: The nurses described a conflict of conscience when the neonate in their care experienced undermanaged pain and unnecessary suffering. During these experiences, they felt guilty, sad, hopeless, and powerless when they were unable to follow their conscience. Informal ways to follow their conscience were employed before declaration of conscientious objection was considered. This study highlights the vital importance of respecting a conflict of conscience to maintain the moral integrity of neonatal nurses and exposes the complexities of conscientious objection. (shrink)

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)

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

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)

PURPOSE: To evaluate the effects of social support on comprehension and recall of consent form information in a study of Parkinson disease patients and their caregivers.DESIGN and METHODS: Comparison of comprehension and recall outcomes among participants who read and signed the consent form accompanied by a family member/friend versus those of participants who read and signed the consent form unaccompanied. Comprehension and recall of consent form information were measured at one week and one month respectively, using Part A of the (...) Quality of Informed Consent Questionnaire .RESULTS: The mean age of the sample of 143 participants was 71 years . Analysis of covariance was used to compare QuIC scores between the intervention group and control group . In the 1-week model, no statistically significant intervention effect was found . However, the intervention status by patient status interaction was statistically significant . In the 1-month model, no statistically significant intervention effect was found . Again, however, the intervention status by patient status interaction was statistically significant . At both time periods, intervention group patients scored higher on the QuIC than did intervention group caregivers, and control group patients scored lower on the QuIC than did control group caregivers.IMPLICATIONS: Social support played a significant role in enhancing comprehension and recall of consent form information among patients. (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)

Reappraisal is a frequently used and often successful emotion regulation strategy. However, its underlying cognitive mechanisms are not well understood. In this paper, we seek to clarify these mechanisms by expanding upon our recently proposed reAppraisal framework. According to this framework, reappraisal consists of appraisal shifts that arise from changes to the mental construal of a situation (reconstrual) or from changes to the goals that are used to evaluate the construal (repurposing). Here we propose that reappraisal can target both object-level (...) construals and goals representing states in the environment as well as meta-level construals and goals about different states in the mind. We also propose that reappraisal can operate by facilitating decommitment from a dominant construal or goal as well as by facilitating commitment to alternative construals or goals. We demonstrate that the 2 × 2 × 2 matrix formed by crossing the three distinctions between reconstrual and repurposing, between object-level and meta-level representations, and between decommitment and commitment operations forms a useful map of different reappraisal tactics. We draw examples of each of the 8 reappraisal tactics from basic and clinical research. We conclude by considering future research inspired by the expanded reAppraisal framework. (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.

© 2014 Taylor Francis. The Centers for Disease Control and Prevention recommends routine human immunodeficiency virus testing of every client presenting for services in venues where HIV prevalence is high. Because older adults have particularly poor prognosis if they receive their diagnosis late in the course of HIV disease, any screening provided to younger adults in these venues should also be provided to older adults. We examined aging-related disparities in recent and ever HIV testing in a probability sample of at-risk (...) adults seeking services in needle exchange sites, sexually transmitted disease clinics, and Latino community clinics that provide HIV testing. Using multiple logistic regression with generalized estimating equations, we estimated associations between age category and each HIV testing outcome. Even after controlling for covariates such as recent injection drug use, older adults had 40% lower odds than younger adults did of having tested in the past 12 months or ever. Aging-related disparities in HIV testing exist among clients of these high HIV prevalence venues and may contribute to known aging-related disparities in late diagnosis of HIV infection and poor long-term prognosis. (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)

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.

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)

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...

An ethics consultant’s scope of practice is best understood as equipping stakeholders to achieve closure over time following after the ethics consultation. This is in contrast to Autumn Fiester’s position in the article, “Neglected Ends: Clinical Ethics Consultation and the Prospects for Closure,” where she claims that moral closure is a necessary condition for the proper completion of an ethics consultation case.

Readable and accessible collection of papers re thinking machines.

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...

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)

Background: Informed consent is regarded as a contract between autonomous and equal parties and requires the elements of information disclosure, understanding, voluntariness and consent. The validity of informed consent for critically ill patients has been questioned. Little is known about how these patients experience the process of consent.Objective: The aim of this study was to explore critically ill patients’ experience with the principle of informed consent in a clinical trial and their ability to give valid informed consent.Design: 11 stroke patients (...) who had been informed about thrombolytic treatment and had been through the process of deciding whether or not to participate in a thrombolysis trial went through repeated qualitative semistructured interviews.Results: None of the patients had any clear understanding of the purpose of the trial. Neither did they understand the principles of randomisation and voluntariness. Reasons for giving or not giving consent were trust, conceptions of benefits and risks and altruism. Several patients found it immoral to involve patients in the consent procedure and argued that this was the doctors’ responsibility. Others argued that it is a duty to question patients and perceived it as a sign of being treated with respect and dignity. A majority of the patients found the consent process vague and ambiguous.Conclusions: The results indicate that the principle of informed consent from critically ill patients cannot be seen as a contract between equal and autonomous parties. Further studies are needed to explore critically ill patients’ experiences with the process of informed consent. (shrink)

Objective: To determine the views of people with multiple sclerosis (MS) and professionals in relation to confidentiality, consent and access to data within a proposed MS register in the UK. Design: Qualitative study using focus groups (10) and interviews (13). Setting: England and Northern Ireland. Participants: 68 people with MS, neurologists, MS nurses, health services management professionals, researchers, representatives from pharmaceutical companies and social care professionals. Results: People with MS expressed open and altruistic views towards the use of their personal (...) information to facilitate service provision and research, placing trust in responsible guardianship and legitimate use of their information. Participant’s proposed that people with MS should be able to select their individual level of involvement in a register using levels of consent. It was agreed that access to the register should be governed by a guardianship committee composed of a range of stakeholders. People with MS did not wish their details to be used by marketing agencies and did not consider this a legitimate use of their data. Whilst participants were positive of the role a register could play in promoting research, participants felt that access to data by pharmaceutical industries should be administered by the guardianship committee. People with MS are concerned should their employers be able to access their personal information. Professionals were more cautious than people with MS in their approach to the use of patient personal data within a register. Conclusions: Whilst all stakeholders were positive of the benefits of an MS register, development of such a resource must incorporate robust data security and guardianship measures in order to ensure that, whilst opportunities are maximised, risks to the privacy of individuals and legal challenges to professionals are avoided. (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)

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)

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)

In this volume, critical scholars and educational activists explore the intricate dynamics between the enclosure of global commons and radical visions of a common social future that breaks through the logics of privatization, ecological degradation, and dehumanizing social hierarchies in education. In its institutional and informal configurations alike, education has been identified as perhaps the key stake in this struggle. Insisting on the urgency of an education that breaks free of the bonds of enclosure, the essays included in this volume (...) weave together bright threads of radical thought into a vivid tapestry illustrating a critical framework for enacting a global educational commons. (shrink)

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...