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)

While the phenomenon of ‘moral distress’ has been of interest to the nursing community since Jameton first described it in 1984, moral distress is now understood to effect healthcare professionals...

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...

Russell articulates compelling reasons that bioethicists and health care professionals should take individual responsibility for deconstructing structural injustices in healthcare through in...

In recent years, the phenomenon of moral distress has been critically examined—and for a good reason. There have been a number of different definitions suggested, some that claimed to be consistent with the original definition but in fact referred to different epistemological states. In this paper, we re‐examine moral distress by exploring its relationship with moral agency. We critically examine three conceptions of moral agency and argue that two of these conceptions risk placing nurses' values at the center of moral (...) action when it ought to be the patient's values that shape nurses' obligations. We propose that the conception of moral agency advanced by Aimee Milliken which re‐centers patient values, should be more broadly accepted within nursing. We utilize a case example to demonstrate a situation in which the values of a patient's parents (surrogates) justifiably constrained nurses' moral agency, creating moral distress. Through an examination of constraints on nurse agency in this case, we illustrate the problematic nature of ‘narrow' moral distress and the value of re‐considering moral distress. Finally, we provide an action‐oriented proposal identifying mediating steps that we argue have utility for nurses (and other healthcare professionals) to mediate between experiences of narrow moral distress and the exercise of moral agency. (shrink)

While Jameton’s (1984) definition of moral distress has been embraced by researchers and scholars for recognizing the many constraints that nurses experience on their moral agency, it has also been...

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)

Moral distress is a pervasive phenomenon in healthcare for which there is no straightforward “solution.” Rhetoric surrounding moral distress has shifted over time, with some scholars arguing that moral distress needs to be remedied, resolved, and eradicated, while others recognize that moral distress can have some positive value. The authors of this paper recognize that moral distress has value in its function as a warning sign, signaling the presence of an ethical issue related to patient care that requires deeper exploration, (...) rather than evidencing identification of the “right” course of action. Once the experience of moral distress is identified, steps ought to be taken to clarify the moral issue, and, if possible and reasonable, the patient’s values ought to be prioritized. This paper offers concrete actions steps, drawn from theory, which can be used in clinical practice to provide peer support or to facilitate self-reflection for morally distressed individuals. This approach empowers morally distressed individuals to explore ethical issues, identify concrete steps that can be taken, and mitigate feelings of powerlessness that are often associated with moral-constraint distress. The questions guide individuals and peers to reflect first on the micro-space and then more broadly on the institutional culture, facilitating meso- and macro-reflection and action. (shrink)

Herrera-Ferrá et al.’s (2023) attention to the cultural context of the neurorights movement contributes to the growing conversation on establishing neurorights in response to advancements in neuros...

What happens at the end of a clinical trial for an investigational neural implant? It may be surprising to learn how difficult it is to answer this question. While new trials are initiated with increasing regularity, relatively little consensus exists on how best to conduct them, and even less on how to ethically end them. The landscape of recent neural implant trials demonstrates wide variability of what happens to research participants after an neural implant trial ends. Some former research participants (...) continue to receive support for their devices (e.g., battery and component replacements, software updates, etc.). Others, when safe, have their neural implants removed through surgical explantation. Still others continue to live with a deactivated neural implant embedded in their body. In the United States, there are no uniform requirements to provide services, of any kind, after an neural implant study ends, and other nations are similarly facing this challenge. The existence of a post-trial gap in an expanding neural implant research ecosystem invites obvious questions: What is owed to neural implant research participants post-trial, and why has providing it been so difficult to accomplish in practice? To take a step forward on this difficult issue, we assembled one group of stakeholders – researchers funded for neuroethics grants by the National Institutes of Health – to explore possible starting points on one topic: ethical guidance for post-trial care of research participants in neural implant trials. Based on shared concerns discussed in the expert workshop the current paper is a call to action. It reports the key areas of convergence from the meeting and highlights important next steps towards developing much needed guidance. (shrink)

Supported decision making, as outlined by Peterson et al. highlights real-world challenges in the messy context of clinical care. We agree with Peterson et al. that patients...

The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified (...) purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others. (shrink)