In lieu of an abstract, here is a brief excerpt of the content:Lisa’s StoryLisa P. (wife of patient) and Jeanne KerwinMy husband suffered from sudden onset of heart failure with a very low ejection fraction and was on IV Milrinone at the age of 47. One of the most powerful things he told me was that he was not afraid to die and therefore did not want to move forward with Milrinone. He eventually “did it for the kids.” After (...) the Milrinone drip was no longer working, he was offered an LVAD (left ventricular assist device) to keep him alive. He refused, but the doctor again convinced him to “do it for your kids” and said, “we put these devices in 80-year-olds.” He did not have time to explore any other options and reluctantly accepted the LVAD. It was implanted in May of 2014 in a very long and complicated surgery with a long and difficult recovery. He was in the hospital for a long time, and then he refused to go to rehab upon discharge, making it difficult for our family to manage, as he was extremely weak and needed care of his wound dressing. He worried about the financial [End Page 7] impact of a heart transplant and the medications required, as we were already struggling with the medical bills. He refused to have more surgery with the potential complications and never agreed to get on the transplant waiting list.After the implanted LVAD, my husband was not able to do most of what he loved in life. He couldn’t work (he was a truck driver), he couldn’t go fishing or swimming in the ocean, he couldn’t go hunting and fishing, and his overall physical condition was so poor that he couldn’t cook, garden and, most aggravating to him, he could not take a regular hot shower. The LVAD had to be covered with plastic in order to avoid getting the drive-line area wet, so bathing was a complicated process. He had trouble with stairs, had neuropathic pain in his legs from diabetes, and because of the pain medications, he felt cloudy and dizzy and slept most of the day in his recliner. I took care of him, even after I had to go back to work, and at the same time, I managed our two children (ages 9 and 12 at the time of LVAD).After almost two years of living with the LVAD, multiple hospitalizations for GI bleeds then seizures, more medications, and weekly blood draws for INR1, my husband requested that the LVAD be de-activated and that he be allowed to die of his heart failure. He described his life as “miserable.” He watched as his misery impacted his children and me. He suffered daily and had none of the joys that made life worth living for him. When we approached the cardiac team that implanted and monitored his LVAD with his request, they said “no.” They would not de-activate the LVAD because it was working. It was keeping him alive and he had no other terminal illness. His palliative doctor, who was treating his pain, also heard his request and told us to call for an “ethics consult” to determine if he would be “allowed” to have the LVAD de-activated. We got the number and called on March 31, 2016.At the time of the call to Ethics, we had no idea what “Ethics” was, other than a general definition of the word ethics as in professional behaviors and such. We did not know what to expect but we called. We would never have known to call “Ethics” if the palliative doctor had not advised us to do so, and my husband might have suffered a longer, more painful life both mentally and physically prolonged by the LVAD.We explained the request to the ethics consultant. She listened to my husband describe his daily living and his dissatisfaction with the quality of his life, his physical and emotional suffering, and his wish to rid himself of the LVAD and allow nature to take its course. There was actually no decision to be made on his part. He had already made up... (shrink)

When making substituted judgments for incapacitated patients, surrogates often struggle to guess what the patient would want if they had capacity. Surrogates may also agonize over having the (sole) responsibility of making such a determination. To address such concerns, a Patient Preference Predictor (PPP) has been proposed that would use an algorithm to infer the treatment preferences of individual patients from population-level data about the known preferences of people with similar demographic characteristics. However, critics have suggested that even (...) if such a PPP were more accurate, on average, than human surrogates in identifying patient preferences, the proposed algorithm would nevertheless fail to respect the patient’s (former) autonomy since it draws on the ‘wrong’ kind of data: namely, data that are not specific to the individual patient and which therefore may not reflect their actual values, or their reasons for having the preferences they do. Taking such criticisms on board, we here propose a new approach: the Personalized Patient Preference Predictor (P4). The P4 is based on recent advances in machine learning, which allow technologies including large language models to be more cheaply and efficiently ‘fine-tuned’ on person-specific data. The P4, unlike the PPP, would be able to infer an individual patient’s preferences from material (e.g., prior treatment decisions) that is in fact specific to them. Thus, we argue, in addition to being potentially more accurate at the individual level than the previously proposed PPP, the predictions of a P4 would also more directly reflect each patient’s own reasons and values. In this article, we review recent discoveries in artificial intelligence research that suggest a P4 is technically feasible, and argue that, if it is developed and appropriately deployed, it should assuage some of the main autonomy-based concerns of critics of the original PPP. We then consider various objections to our proposal and offer some tentative replies. (shrink)

Recently, Jardas _et al_ have convincingly defended the patient preference predictor (PPP) against a range of autonomy-based objections. In this response, I propose a new autonomy-based objection to the PPP that is not explicitly discussed by Jardas _et al_. I call it the ‘objection from higher-order preferences’. Even if this objection is not sufficient reason to reject the PPP, the objection constitutes a pro tanto reason that is at least as powerful as the ones discussed by Jardas _et al._.

The practice of medicine—and especially the patient-doctor relationship—has seen exceptional shifts in ethical standards of care over the past few years, which by and large originate in occidental countries and are then extrapolated worldwide. However, this phenomenon is blind to the fact that an ethical practice of medicine remains hugely dependent on prevailing cultural and societal expectations of the community in which it serves. One model aiming to conceptualise the dichotomous efforts for global standardisation of medical care against differing (...) sociocultural expectations is the individualism-collectivism model, with the ‘West’ being seen as individualistic and the ‘East’ being seen as collectivistic. This has been used by many academics to explain differences in approach towards ethical practice on key concepts such as informed consent and patient autonomy. However, I argue that this characterisation is incomplete and lacks nuance into the complexities surrounding cross-cultural ethics in practice, and I propose an alternative model based on the ethics of clinical care in Hong Kong, China. Core ethical principles need not be culture-bound—indeed, their very existence mandates for them to be universal and non-derogable—but instead cultural alignment occurs in the particular implementation of these principles, insofar as they respect the general spirit of contemporary ethical standards. (shrink)

Introduction Limited treatments for Mild Cognitive Impairment (MCI) highlight the need to explore innovations including Deep Brain Stimulation (DBS), with patient perspectives key to ethical protocol development.Methods Seven MCI patients and four care partners were interviewed (Feb 2023–Jan 2024) about daily MCI challenges, desired treatment outcomes, and views on DBS. Thematic analysis following COREQ guidelines identified key themes.Results DBS was a novel concept for all (7/7), and most expressed interest (6/7) despite concerns about invasiveness (6/7) and preference to exhaust (...) medications first (4/7). Care partners (4/4) shared concerns about invasiveness and emphasized proven efficacy. Key deciding factors included the involved procedural risk (6/7), desired significant outcomes (6/7), and prior testing for MCI (7/7). Most participants (6/7) were hesitant to be the first to try DBS, while one was willing.Conclusion Patient and care partner insights on DBS for MCI are crucial for balancing innovation with ethical, patient-centered research. (shrink)

We are grateful for the thoughtful commentaries to our article on patient selection for first clinical trials of cardiac xenotransplantation1 because they give us the opportunity to clarify and further sharpen our arguments in this response. In our article, we proposed a multicriteria approach to selecting patients for first clinical trials of (cardiac) xenotransplantation, encompassing the four criteria medical need, capacity to benefit, patient choice and compliance (used as an exclusion criterion). We also argued that clinical trials following (...) clearly defined study protocols should be favoured over further single compassionate use cases to gather reliable and valid knowledge about the benefits and risks of xenotransplantation. Continuous poor outcomes in compassionate use cases can impede a technology’s development. For example, early heart transplants led to moratoria in several countries due to public and professional backlash. This historical concern is also echoed within the xenotransplantation research community and should be considered when arguing, as Aparicio et al do in their comment, for continuing the expanded access pathway to further establish clinical xenotransplantation.2 We agree with Aparicio et al that patients in general should have access to innovative treatment strategies via expanded access. In cardiac xenotransplantation, however, only a small number of patients can currently be offered a xenotransplant because of limited treatment capacities with …. (shrink)

Moral relativism familiar in the Western philosophical tradition, according to David Lyons, is either agent relativism or appraiser relativism or appraiser group). As Lyons has convincingly argued, they are both problematic. However, in the ancient Chinese Daoist classic, the Zhuangzi, we can find a different type of moral relativism, which I call patient relativism. In the essay, I aim to argue in what sense Zhuangzi is a patient relativist and how patient relativism can avoid the problem of (...) agent relativism and appraiser relativism. (shrink)

We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated (...) risks. In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency, and partnership. (shrink)

In this paper we aim to discuss a theoretical explanation for the positive relationship between patients’ knowledge and their trust in healthcare personnel. Our approach is based on John Dewey’s notion of continuity. This notion entails that the individual’s experiences are interpreted as interrelated to each other, and that knowledge is related to future experience, not merely a record of the past. Furthermore, we apply Niklas Luhmann’s theory on trust as a way of reducing complexity and enabling action. Anthony Giddens’ (...) description and analysis of the high modern society provides a frame for discussing the preconditions for patient-healthcare personnel interaction. High modernity is dominated by expert systems and demands trust in these. We conclude that patient knowledge and trust in healthcare personnel is related because both knowledge and trust are future- and action-oriented concepts. The traits of high modernity provides opportunities and challenges as the personnel can and must perform discretion. This discretion must be made in a context where knowledge is considered uncertain and preliminary. (shrink)

Disclosure in clinical practice is aimed at promoting patient autonomy, usually culminating in patient choice (e.g., to consent to an operation or not, or between different medications). In medical ethics, there is an implicit background assumption that knowing more about (X) automatically translates to greater, or more genuine, autonomy with respect to one's choices involving (X). I challenge this assumption by arguing that in rare cases, withholding information can promote a patient's autonomy (understood as the capacity for (...) rational choice in alignment with one's values and goals). (shrink)

Background Informed consent is an integral component of good medical practice. Many researchers have investigated measures to improve the quality of informed consent, but it is not clear which techniques work best and why. To address this problem, we propose developing a core outcome set to evaluate interventions designed to improve the consent process for surgery in adult patients with capacity. Part of this process involves reviewing existing research that has reported what is important to patients and doctors in the (...) informed consent process. Methods This qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies. Results Searches of bibliographic databases returned 11,073 titles. Of these, 16 studies met the inclusion criteria. Studies were published between 1996 and 2016 and included a total of 367 patients and 74 health care providers. Thirteen studies collected data using in-depth interviews and constant comparison was the most common means of qualitative analysis. A total of 94 findings were extracted from the primary papers and divided into 17 categories and ultimately 6 synthesised findings related to: patient characteristics, knowledge, communication, the model patient, trust and decision making. Conclusions This qualitative meta-aggregation is the first to examine the issue of informed consent for surgery. It has revealed several outcomes deemed important to capture by patients and clinicians when evaluating the quality of a consent process. Some of these outcomes have not been examined previously in research comparing methods for informed consent. This review is an important step in the development of a COS to evaluate interventions designed to improve the consent process for surgery. Registration The study protocol was registered on the international prospective register for systematic reviews. (shrink)

In the realm of medical ethics, the foundational principle of respecting patient autonomy holds significant importance, often emerging as a central concern in numerous ethically complex cases, as authorizing medical assistance in dying or healthy limb amputation on patient request. Even though advocates for either alternative regularly utilize prima facie principles to resolve ethical dilemmas, the interplay between these principles is often the core of the theoretical frameworks. As the ramifications of the sustainability crisis become increasingly evident, there (...) is a growing need to integrate awareness for sustainability into medical decision-making, thus reintroducing potential conflict with patient autonomy. The contention of this study is that the ethical standards established in the 20th century may not adequately address the challenges that have arisen in the 21st century. The author suggests an advanced perception of patient autonomy that prioritizes fostering patients’ knowledge, self-awareness, and sense of responsibility, going beyond a sole focus on their intrinsic values. Empowering patients could serve as a tool to align patient autonomy, beneficence, and the aim to reduce resource consumption. (shrink)

This paper advocates for the inclusion of patient perspectives in the diagnosis and treatment of eating disorders (EDs) for ethical, epistemological, and pragmatic reasons. We build upon the ideas of a recent editorial published in this journal. Using EDs as their example, the authors argue against dominant DSM-oriented approaches in favor of an increased focus on understanding patients’ subjective experiences. We argue that their analysis stops too soon for the development of practical—and actionable—insights into how to effect the integration (...) of first-person and third-person accounts of EDs. Methods Contextual analysis was used to make the case for patient perspectives. (shrink)

Background Non-invasive prenatal testing (NIPT), which can screen for aneuploidies such as trisomy 21, is being implemented in several public healthcare systems across Europe. Comprehensive communication and information have been highlighted in the literature as important elements in supporting women’s reproductive decision-making and addressing relevant ethical concerns such as routinisation. Countries such as England and France are adopting broadly similar implementation models, offering NIPT for pregnancies with high aneuploidy probability. However, we do not have a deeper understanding of how professionals’ (...) counselling values and practices may differ between these contexts. Methods In this paper, we explore how professionals in England and France support patient decision-making in the provision of NIPT and critically compare professional practices and values. We draw on data from semi-structured interviews with healthcare professionals. Results Both English and French professionals emphasised values relating to patient choice and consent. However, understandings and application of these values into the practice of NIPT provision differed. English interviewees placed a stronger emphasis on interpreting and describing the process of counselling patients and clinical care through a “principle” lens. Their focus was on non-directiveness, standardisation, and the healthcare professional as “decision-facilitator” for patients. French interviewees described their approach through a “procedural” lens. Their focus was on formal consent, information, and the healthcare professional as “information-giver”. Both English and French professionals indicated that insufficient resources were a key barrier in effectively translating their values into practice. Conclusion Our findings illustrate that supporting patient choice in the provision of NIPT may be held as an important value in common on a surface level, but can be understood and translated into practice in different ways. Our findings can guide further research and beneficially inform practice and policy around NIPT provision. (shrink)

The legal doctrine of informed consent has overwhelmingly failed to assure that the medical treatment patients get is the treatment patients want. This Article describes and defends an ongoing shift toward shared decision making processes incorporating the use of certified patient decision aids.

We explore an unsolved challenge in the era of evidence-based medicine (EBM): the recognition of the patient as an epistemic agent or ‘knower’. While patients are increasingly acknowledged as carriers of values and preferences, it seems more challenging to acknowledge them as carriers of important causal information. In contrast, the science of pharmacovigilance depends on patient testimonies as valuable sources of causal evidence. This incompatibility can give rise to cases of what has been called participatory epistemic injustice. We (...) analyse the testimony of a chronic pain patient and co-author of this article, Christine. Christine gives an auto-ethnographic account of her interactions with healthcare professionals trying to find the right pharmacological treatment for her condition. Through the analysis of her own story, she identifies some relevant themes for the epistemic interaction between healthcare professionals and chronic pain patients. We argue that such epistemic interactions are increasingly shaped by EBM and its conception of causality, which devalues patient subjective testimonies and emphasises statistical evidence. We conclude that outlier patients face an inherent risk of being left vulnerable to participatory epistemic injustice, particularly regarding the discovery of novel, rare adverse effects of medicines. (shrink)

Background: Over the last decade, new healthcare policies are transforming healthcare practices towards independent living and self-care of older people and people with a chronic disease or disability within the community. For professional caregivers in home care, such as nurses, this requires a shift from a caring attitude towards the promotion of patient autonomy. Aim: To explore how nurses in home care deal with the transformation towards fostering patient autonomy and self-care. Research design and context: A case study (...) was conducted in a professional development course (‘learning circle’) for home care nurses, including participant observations and focus groups. The theoretical notion of ‘relational agency’ and the moral concept of ‘practices of responsibility’ were used to conduct a narrative analysis on the nurses’ stories about autonomy. Participants: Eight nurses, two coaches and two university lecturers who participated in the learning circle. Ethical considerations: Informed consent was sought at the start of the course and again, at specific moments during the course of the learning circle. Findings: Three main themes were found that expressed the moral demands experienced and negotiated by the nurses: adapting to the person, activating patients’ strengths and collaboration with patients and informal caregivers. Discussion: On a policy and organisational level, the moral discourse on patient autonomy gets intertwined with the instrumental discourse on healthcare budget savings. This is manifested in the ambiguities the nurses face in fostering patient autonomy in their daily home care practice. To support nurses, critical thinking, moral sensitivity and trans-professional working should be part of their professional development. Conclusion: The turn towards autonomy in healthcare raises moral questions about responsibilities for care. Promoting patient autonomy should be a collaborative endeavour and deliberation of patients, professional and informal caregivers together. (shrink)

This paper demonstrates how ubuntu relational philosophy may be used to ground beneficial coercive care without necessarily violating a patient’s dignity. Specifically, it argues that ubuntu philosophy is a useful theory for developing necessary conditions for determining a patient’s potential dangerousness; setting reasonable limits to the duty to protect; balancing the long-term good of providing unimpeded therapy for patients who need it with the short-term good of protecting at-risk parties; and advancing a framework for future case law and (...) appropriate regulations in the care of psychotherapy patients. Issues regarding the decision to breach medical confidentiality in psychotherapeutic care are ultimately reserved for the courts. Professional assessment might be an important first step in this process, and court rulings govern most aspects of this assessment. However, current case law, especially in the United States, places an unreasonable expectation on psychotherapists to protect all at-risk parties or foresee that a patient intends to follow through on said threats. It has largely failed to guarantee psychotherapy patients unlimited access to care, while potentially inhibiting future honest communication between patients and health professionals and endangering the safety of others. Of these decisions, the two most prominent are the 1976 Tarasoff decision and the 2016 Volk decision. This paper argues for the possibility of grounding good laws in ubuntu African philosophy in a way that protects others from harm and ensures unimpeded access to care without necessarily breaching medical confidentiality. (shrink)

Precision medicine functions by grouping patients along genetic, molecular, and related ‘-omics’ factors. This stratification relies on large, growing databases of patient-volunteered information. Both private companies and government bodies incentivize patients to volunteer this genetic information appealing to the creation of collaborative patient partnerships and the concept of empowerment. This paper aims to address two related questions: (1) what is the actual nature of patient participation in precision medicine research? And (2) is this participation in precision medicine (...) research really that empowering for the average patient? I contend that firstly, the nature of this participation is best conceived of as merely contributory. Contributory participation, as it will be shown, falls short of collaboration. The partnership created by participation in precision medicine research is not one of sharing values, equal say in decisions, or shared benefit. Secondly, I contend that there are important caveats to claims that patient participation in precision medicine is empowering. Empowerment is hindered by the type of participation, the practical use or actionability of genetic data, genetic literacy, the cost of precision drugs for patients that qualify for them, and bioethical considerations of informed consent. (shrink)

In this paper, I argue that patient preferences concerning human physical attributes associated with race, culture, and gender should be excluded from public healthcare robot design. On one hand, healthcare should be (objective, universal) needs oriented. On the other hand, patient well-being (the aim of healthcare) is, in concrete ways, tied to preferences, as is patient satisfaction (a core WHO value). The shift toward patient-centered healthcare places patient preferences into the spotlight. Accordingly, the design of (...) healthcare technology cannot simply disregard patient preferences, even those which are potentially morally problematic. A method for handling these at the design level is thus imperative. By way of uncontroversial starting points, I argue that the priority of the public healthcare system is the fulfillment of patients’ therapeutic needs, among which certain potentially morally problematic preferences may be counted. There are further ethical considerations, however, which, taken together, suggest that the potential benefits of upholding these preferences are outweighed by the potential harms. (shrink)

In this issue of the Hastings Center Report, Joshua Rager and Peter Schwartz suggest using opioid treatment agreements as public health monitoring tools to inform patients about “the requirements entailed by undergoing opioid therapy,” rather than as contractual agreements to alter patients’ individual behavior or to benefit them directly. Because Rager and Schwartz's argument presents suspected OTA violations as a justification to stop providing opioids yet does not highlight the broader epistemic and systemic context within which clinicians prescribe these medications, (...) their proposal may perpetuate a climate of distrust and stigmatization without correcting systemic factors that may have placed patients and others at risk in the first place. Given the context of epistemic uncertainty regarding opioid safety and efficacy, insufficient training for opioid prescribers, and inadequate patient education, I propose replacing OTAs, which have a narrow focus on patient behaviors, with opioid treatment plans, which would promote mutual, collaborative, and shared decision-making on the most appropriate pain management program. An OTP can be ethically justified as a tool to prevent and treat iatrogenic addiction under a specific paradigm—one that adopts a default position of professional epistemic humility and holds all collaborative parties accountable in chronic pain management. (shrink)

The COVID-19 Pandemic a stress test for clinical medicine and medical ethics, with a confluence over questions of the proportionality of resuscitation. Drawing upon his experience as a clinical ethicist during the surge in New York City during the Spring of 2020, the author considers how attitudes regarding resuscitation have evolved since the inception of do-not-resuscitate orders decades ago. Sharing a personal narrative about a DNR quandry he encountered as a medical intern, the author considers the balance of patient (...) rights versus clinical discretion, warning about the risk of resurgent physician paternalism dressed up in the guise of a public health crisis. (shrink)

Background Informed consent is a process in which a healthcare provider obtains permission from an individual prior to surgery. Patient satisfaction with the informed consent process is one of the main indicators of healthcare service quality. This study aimed to assess patient satisfaction with surgical informed consent at Jimma Medical Center, Ethiopia, in 2020. Methods A facility-based cross-sectional study was conducted from April 1 to June 30, 2020, at Jimma Medical Center. Face-to-face interviews were conducted using structured questionnaires. (...) A systematic sampling technique was used to select the study participants. The collected data were coded, entered into Epi data version 3.1, and analyzed using SPSS version 25. Bivariate and multivariate regression analyses were performed to determine the association between patient satisfaction and socio-demographic and facility-related factors. In multivariate regression, predictors with a P-value of < 0.05 were considered statistically significant. Results Totally 372 study participants were interviewed with a response rate of 97.8%. Nearly two-fifths (43%) of patients were satisfied with surgical informed consent. Living in an urban area (AOR: 2.279, 95% CI 1.257–4.131), having current referred history (AOR: 1.856, 95% CI 1.033–3.337), consent form version (AOR: 2.076, 95% CI 1.143–3.773), time spent on the provision of informed consent (AOR: 5.227, 95% CI 2.499–10.936) and having better patient-health providers relationship (AOR: 5.419, 95% CI 3.103–9.464) predictors were positively associated with patient satisfaction. Conclusion Patient satisfaction with the surgical informed consent process was relatively low. Therefore, Health care professionals need to emphasize a way of delivering informed consent, patients' needs and obey a standard informed consent to improve patient satisfaction. (shrink)

In current medical decision-making, prioritizing patient autonomy and shared decision-making has reshaped the ethical landscape. Medical decisions are no longer solely driven by a strong physician paternalism, where doctors are assumed to know best, but are increasingly characterized by a sharing of information, collaboration on decisions, and incorporation of patient values and preferences. While this shift promotes shared decision-making and patient-centered care, it has also given rise to additional ethically-complex challenges, including what will be referred to here (...) as Patient-Initiated Non-Standard Care (PINSC) requests. PINSC requests emerge when patients or their surrogate decision-maker(s) seek interventions which fall outside accepted medical guidelines or evidence-based standards of care. This paper recounts various PINSC requests received at several hospitals in Ontario, Canada. Fundamental distinctions between PINSC requests and other cases of informed refusal are then established to highlight their novel ethical complexity, and I argue that this complexity gives rise to significant ethical and professional concerns that warrant increased attention. I then explore the reasons why clinicians often feel obligated to accede to PINSC requests, review the limitations of existing response strategies to addressing them, and propose that a model of shared decision-making called the Professionally-Driven Zone of Patient or Surrogate Discretion, or Professionally-Driven ZPSD, can be used as an ethically-defensible framework for navigating these cases. The Professionally-Driven ZPSD supports clinicians to develop a range of treatment options (“the zone”) for decision makers to choose from that are ethically permissible, as they would fall between those treatments which cause unjustifiable harm, and those (or that) which would be in the patient’s best interests to have if this can be defined. (shrink)

BackgroundCritical Incident Reporting Systems (CIRS) provide a well-proven method to identify clinical risks in hospitals. All professions can report critical incidents anonymously, low-threshold, and without sanctions. Reported cases are processed to preventive measures that improve patient and staff safety. Clinical ethics consultations offer support for ethical conflicts but are dependent on the interaction with staff and management to be effective. The aim of this study was to investigate the rationale of integrating an ethical focus into CIRS.MethodsA six-step approach combined (...) the analysis of CIRS databases, potential cases, literature on clinical and organizational ethics, cases from ethics consultations, and experts’ experience to construct a framework for CIRS cases with ethical relevance and map the categories with principles of biomedical ethics.ResultsFour main categories of critical incidents with ethical relevance were derived: (1) patient-related communication; (2) consent, autonomy, and patient interest; (3) conflicting economic and medical interests; (4) staff communication and corporate culture. Each category was refined with different subcategories and mapped with case examples and exemplary related ethical principles to demonstrate ethical relevance.ConclusionThe developed framework for CIRS cases with its ethical dimensions demonstrates the relevance of integrating ethics into the concept of risk-, quality-, and organizational management. It may also support clinical ethics consultations’ presence and effectiveness. The proposed enhancement could contribute to hospitals’ ethical infrastructure and may increase ethical behavior, patient safety, and employee satisfaction. (shrink)

This article reports on a pilot study soliciting patient and caregiver views on trauma-informed principles to influence the provision of trauma-informed ethics consultation (TIEC). The study conducted case-based focus groups with participants (1) to assess the feasibility and efficacy of focus group methodology for collecting information to better understand and describe patient and family perspectives relevant to TIEC and (2) to analyze participant reflections so as to further conceptualize and operationalize TIEC. Overall, the case-based focus group methodology was (...) generally effective. Findings show that patients and families conceptualize trauma-informed principles in ways that overlap with and reinforce each other. For example, safety supports inclusion, and inclusion supports a sense of safety. Preliminary thematic analysis suggests that how one may construe actions and practices as “trauma informed” in ethics consultation is influenced by the individual’s identity, background, and experiences, suggesting that TIEC is an active, iterative process. (shrink)

The fiduciary nature of the patient-physician relationship requires clinicians to act in the best interest of their patients. Patients are vulnerable due to their health status and lack of medical knowledge, which makes them dependent on the clinicians’ expertise. Competent patients, however, may reject the recommendations of their physician, either refusing beneficial medical interventions or procedures based on their personal views that do not match the perceived medical indication. In some instances, the patients’ refusal may jeopardize their health or (...) life but also compromise the clinician’s moral responsibility to promote the patient’s best interests. In other words, health professionals have to deal with patients whose behavior and healthcare decisions seem counterproductive for their health, or even deteriorate it, because of lack of knowledge, bad habits or bias without being the patients’ free voluntary choice. The moral dilemma centers on issues surrounding the limits of the patient’s autonomy (rights) and the clinician’s role to promote the well-being of the patient (duties). In this paper we argue that (1) the use of manipulative strategies, albeit considered beneficent, defeats the purpose of patient education and therefore should be rejected; and (2) the appropriate strategy is to empower patients through patient education which enhances their autonomy and encourages them to become full healthcare partners as opposed to objects of clinical intervention or entities whose values or attitudes need to be shaped and changed through education. First, we provide a working definition of the concept of patient education and a brief historical overview of its origin. Second, we examine the nature of the patient-physician relationship in order to delineate its boundaries, essential for understanding the role of education in the clinical context. Third, we argue that patient education should promote self-rebiasing, enhance autonomy, and empower patients to determine their therapeutic goals. Finally, we develop a moral framework for patient education. (shrink)

Background The significance of medical implants goes beyond technical functioning and reaches into everyday life, with consequences for individuals as well as society. Ethical aspects associated with the everyday use of implants are relevant for individuals’ lifeworlds and need to be considered in implant care and in the course of technical developments. Methods This scoping review aimed to provide a synthesis of the existing evidence regarding ethically relevant psychosocial and cultural aspects in cochlear, glaucoma and cardiovascular implants in patient-centered (...) empirical research. Systematic literature searches were conducted in EBSCOhost, Philpapers, PsycNET, Pubmed, Web of Science and BELIT databases. Eligible studies were articles in German or English language published since 2000 dealing with ethically relevant aspects of cochlear, glaucoma and passive cardiovascular implants based on empirical findings from the perspective of (prospective) implant-wearers and their significant others. Following a descriptive-analytical approach, a data extraction form was developed and relevant data were extracted accordingly. We combined a basic numerical analysis of study characteristics with a thematically organized narrative synthesis of the data. Results Sixty-nine studies were included in the present analysis. Fifty were in the field of cochlear implants, sixteen in the field of passive cardiovascular implants and three in the field of glaucoma implants. Implant-related aspects were mainly found in connection with autonomy, freedom, identity, participation and justice, whereas little to no data was found with regards to ethical principles of privacy, safety or sustainability. Conclusions Empirical research on ethical aspects of implant use in everyday life is highly relevant, but marked by ambiguity and unclarity in the operationalization of ethical terms and contextualization. A transparent orientation framework for the exploration and acknowledgment of ethical aspects in “lived experiences” may contribute to the improvement of individual care, healthcare programs and research quality in this area. Ethics-sensitive care requires creating awareness for cultural and identity-related issues, promoting health literacy to strengthen patient autonomy as well as adjusting healthcare programs accordingly. More consideration needs to be given to sustainability issues in implant development and care according to an approach of ethics-by-design. (shrink)

Background: There is little research comparing clinicians’ and managers’ views on priority settings in the healthcare services. During research on two different qualitative research projects on healthcare prioritisations, we found a striking difference on how hospital executive managers and clinical healthcare professionals talked about and understood prioritisations. Aim: The purpose of this study is to explore how healthcare professionals in mental healthcare and somatic medicine prioritise their care, to compare different ways of setting priorities among managers and clinicians and to (...) explore how moral dilemmas are balanced and reconciled. Research design and participants: We conducted qualitative observations, interviews and focus groups with medical doctors, nurses and other clinical members of the interdisciplinary team in both somatic medical and mental health wards in hospitals in Norway. The interviews were recorded and transcribed verbatim. Ethical considerations: Basic ethical principles for research ethics were followed. The respondents signed an informed consent for participation. They were assured anonymity and confidentiality. The studies were approved by relevant ethics committees in line with the Helsinki Convention. Findings: Our findings showed a widening gap between the views of clinicians on one hand and managers on the other. Clinicians experienced a threat to their autonomy, to their professional ideals and to their desire to perform their job in a professional way. Prioritisations were a cause of constant concern and problematic decisions. Even though several managers understood and empathised with the clinicians, the ideals of patient flow and keeping budgets balanced were perceived as more important. Discussion: We discuss our findings in light of the moral challenges of patient-centred individual healthcare versus demands of distributive justice from healthcare management. Conclusion: The clinicians’ ideals of autonomy and good medical and nursing care for the individual patients were perceived as endangered. (shrink)

This paper analyses self-declared aims and representation of dementia patient organizations and advocacy groups in relation to two recent upheavals: the critique of social stigmatization and biomedical research focusing on prediction. Based on twenty-six semi-structured interviews conducted in 2016–2017 with members, service recipients, and board representatives of POs in Germany and Israel, a comparative analysis was conducted, based on a grounded theory approach, to detect emerging topics within and across the POs and across national contexts. We identified a heterogeneous (...) landscape, with the only Israeli PO focusing strongly on caretakers, whereas in Germany several POs claim to represent this patient collective. Shared aims of all POs were fighting social stigma, balancing the loss of patients’ individual autonomy, and the well-being of caretakers. By highlighting the emergence of new groups of dementia self-advocacy against the more traditional advocacy by others, this study highlights how advocacy and representation in the context of AD are embedded in the discursive context of stigmatization and revised disease conception. Future developments in early diagnosis and prediction of dementia, with more affected people likely to conduct dementia self-advocacy, might challenge existing representation structures even more. (shrink)

Designing and manufacturing medical devices for specific patients is becoming increasingly feasible with developments in 3D printing and 3D imaging software. This raises the question of how patient-specific devices can be evaluated, since our ‘gold standard’ method for evaluation, the randomised controlled trial, requires that an intervention is standardised across a number of individuals in an experimental group. I distinguish several senses of patient-specific device, and focus the discussion on understanding the problem of variations between instances of an (...) intervention for RCT evaluation. I argue that, despite initial appearances, it is theoretically possible to use RCTs to evaluate some patient-specific medical devices. However, the argument reveals significant difficulties for ensuring the validity of such trials, with implications for how we should think about methods of evidence gathering and regulatory approaches for these technologies. (shrink)

Respect and dignity are central to moral life, and have a particular importance in health care settings such as the intensive care unit (ICU). We conducted 15 semistructured interviews with 21 participants during an ICU admission to explore the definition of, and specific behaviors that demonstrate, respect and dignity during treatment in the ICU. We transcribed interviews and conducted thematic qualitative analysis. Seven themes emerged that focused on what it means to be treated with respect and/or dignity: treated as a (...) person; Golden Rule; acknowledgement; treated as family/friend; treated as an individual; treated as important/valuable; and treated as equal. Participants described particular behaviors or actions that were considered related to demonstrating treatment with respect and dignity: listening; honesty/giving information; attention to body/modesty/appearance; caring/bedside manner; patient and family as an information source; attention to pain; and responsiveness. These behaviors provide a framework for improving experiences with care in the ICU. (shrink)

ABSTRACT In this paper, I address some of the shortcomings of established clinical ethics centring on personal autonomy and consent and what I label the Doctrine of Respecting Personal Autonomy in Healthcare. I discuss two implications of this doctrine: 1) the practice for treating patients who are considered to have borderline decision‐making competence and 2) the practice of surrogate decision‐making in general. I argue that none of these practices are currently aligned with respectful treatment of vulnerable individuals. Because of ‘structural (...) arbitrariness’ in the whole process of how we assess decision‐making competence, this area is open to disrespectful treatment of people. The practice of surrogate decision‐ making on the basis of a single person's judgment is arguably not consistent with ethical and political requirements derived from the doctrine itself. In response to the inadequacies of the doctrine, I suggest a framework for reasonableness in surrogate decision‐making which might allow practice to avoid the problems above. I conclude by suggesting an extended concept of Patient Autonomy which integrates both personal autonomy and the regulative idea of morality that is required by reasonableness in deciding for non‐competent others. (shrink)

Therapeutic misconception involves the failure of subjects either to understand or to incorporate into their own expectations the distinctions in nature and purpose of personally responsive therapeutic care, and the generic relationship between subject and investigator which is constrained by research protocols. Researchers cannot disregard this phenomenon if they are to ensure that subjects engage in research on the basis of genuine informed consent. However, our presumption of patient autonomy must be sustained unless we have compelling evidence of serious (...) misunderstanding. This article argues that the mere expression of aspects of therapeutic misconception should not necessarily displace the presumption of subject autonomy or undermine ethical inclusion in research for at least three reasons. First, some interpretations of the empirical data do not suggest misunderstanding. Second, assessment of misestimation and optimism are delicate and value-laden, and turn quickly from questions of autonomy to questions of judgment. Third, incomplete understanding may yet be sufficient to allow a subject to engage in a substantially autonomous decision-making process. Our point is not to dismiss the possibility of genuine therapeutic misconception, but to question its frequency and fatality to the consent process. (shrink)

With the increasing attention paid to patient participation in both health care policy-making and health care research, McCoy and colleagues (2020) point to a key ethical issue, namely the quest fo...

Wish to die statements are becoming a frequent phenomenon in terminally ill patients. Those confronted by these statments need to understand the complexity of such wishes, so they can respond competently and compassionately to the requests. If misunderstood, the statements can be taken at face-value and the practitioner may not recognise that a patient is in fact experiencing ambivalent feelings at the end of life, or they may misinterpret the expressed wish to die as a sign of clinical depression. (...) Public debate about the morality and ethics of various end-of-life care options has exploded in recent years. However, it has never been sensitive to the finer aspects of clinical reality or the experiences of patients. The Patient's Wish to Die: Research, Ethics, and Palliative Care brings together that reality and the patient's voice, combining them with different research approaches. It presents the best available knowledge and research methodologies about patients' wishes at the end-of-life, together with a series of ethical views and a discussion about the clinical implications for palliative care. The book presents material in an open and unbiased manner whilst remaining sensitive to the spiritual and existential dimensions of dying, and to the different cultural views that provide meaning to the individual. Written by the best specialists and ethics scholars from around the world, including palliative care practitioners and end-of-life scholars from countries where assisted dying practices are legalized and from those where it isn't, The The Patient's Wish to Die: Research, Ethics, and Palliative Care will prove essential reading for all those working or studying in the field of palliative care. (shrink)

Participation of end users in decision-making on science is increasingly practiced, as witnessed by the growing body of scientific literature on case evaluations. In the biomedical field, however, end-user participation in decision-making is rare. Some scholars argue that because patients are stakeholders and relevant experts, they could also provide important contributions to decision-making within the field of biomedical research. But what strategies could be used to effectively implement patient participation in decision-making on biomedical research? In this article, we analyze (...) strategies for patient participation and conclude that these can hardly be regarded effective because they do not ensure patients' structural influence on decision-making. We identify obstacles for effective patient participation, which seem to reflect a resilience of the current biomedical decision-making network. We subsequently elaborate on the concept of transition management in the search for clues on how to breach this resilience and change the network toward the inclusion of patients. (shrink)

The conception of the doctor–patient relationship under Australian law has followed British common law tradition whereby the relationship is founded in a contractual exchange. By contrast, this article presents a rationale and framework for an alternative model—a “Trust Model”—for implementation into law to more accurately reflect the contemporary therapeutic dynamic. The framework has four elements: an assumption that professional conflicts with patient safety, motivated by financial or personal interests, should be avoided; an onus on doctors to disclose these (...) conflicts; a proposed mechanism to contend with instances where doctors choose not to disclose; and sanctions for non-compliance with the regime. (shrink)

Background The bioethical principle of respect for patients' autonomy should be implemented in every area of health care. The German rehabilitation system has some characteristics (e.g. the prevalence of inpatient rehabilitation) that make the topic particularly relevant. The aim of the study is to determine the current state of respecting patient autonomy in inpatient medical rehabilitation in Germany and to identify barriers and promoting factors from the perspective of relevant groups. Methods A multi-center, prospective, cross-sectional study is being conducted, (...) including interviews with patients (n = 24), interviews with professionals (n = 21) and a survey of medical directors (n = 900). The empirical findings are then reviewed in three validation workshops. In addition, consensus recommendations for practice are derived by means of a Delphi process with experts (n = 30). Discussion This study will address an important gap in the empirical literature by identifying the current state and needs of patients, professionals and medical directors of rehabilitation clinics regarding the practice of respecting patient autonomy in inpatient medical rehabilitation in Germany. It is expected that the results can contribute to coming closer to the ideal of respect for patient autonomy in rehabilitation practice. Trial registration The study was registered with the German Clinical Trials Registry (ID: DRKS00035893). (shrink)

Narrative medicine is defined as medicine practiced with the competence to absorb, interpret, and respond to narratives. We hereby present a resource compiling narrative medicine texts, aiming to make narratives created by patients and/or their families fully accessible to citizens, by developing a documentary database and describing its characteristics. Active bibliographic search, March–June 2022 for narratives in Spanish and/or Catalan written after the year 2000 by patients and/or their companions. Subsequently, narratives up to June 2024 were included. The compilation is (...) available in a searchable and open-source web (https://osf.io/pk9b3/). Three hundred seventeen narratives, 50.14% written by women, are showing an increase from 2020 onwards. Texts are related to cancer/hematological diseases (45.11%), mental illnesses (10.41%), neurodegenerative diseases (9.4%). Personal stories (28.7%), autobiographical (11.29%), companion stories (5%), children’s or young adult stories/narratives (8.87%). There are studies, websites, and digital platforms that recognize the importance of narrative as part of the therapeutic process and how it improves the experience of illness (either one’s own or that of a family member). Despite this, to date, no one had compiled a collection of patient texts in Spanish and Catalan. For this reason, we believe our database is innovative and can pave the way for improving the patient-professional relationship. (shrink)

We are members of the Bioethics Working Group of the Japanese Institute for Public Engagement (Ji4pe), composed of patients and the public. Since 2020, we have been continuing monthly Web meetings to learn the World Medical Association (WMA)’s Declaration of Helsinki (DoH) and have achieved mainly the following three publications:“Our WMA Declaration of Helsinki”: a Japanese paper in which each article of the DoH was paraphrased into our plain language together with our opinionsAn English paper consolidating the above opinionsThe (...) class='Hi'>Patient Public Declaration of Research EthicsDuring the process, we submitted our opinions in response to two periods of public consultation on the revision of the DoH, organised by the WMA.We hope that the 2024 DoH will be adhered to by all the relevant parties and that our opinions can be included in future global norms. We believe that expressing our opinions will help maximise the impact of the new DoH. This chapter introduces the above process and reproduces the Patient Public Declaration of Research Ethics. (shrink)

According to Epicurus, philosophy’s sole task is to ensure the well-being of the soul. Human souls are often riddled with diseases; the most serious are the fear of the gods and the fear of death. Thus, the Epicureans offered several arguments designed to demonstrate that, for instance, “death is nothing to us,” and should therefore not be feared. Since their creation there has been much discussion, both in antiquity and by contemporary philosophers, about these arguments. In this thesis, I argue (...) that Epicurean philosophical arguments are patient-relative; they necessarily adapt themselves so as to be therapeutically effective for their intended audience. The end result is that when we evaluate Epicurean philosophical arguments, we must do so in light of the audience for whom they were intended. (shrink)

In contemporary bioethics, the autonomy of the patient has assumed considerable importance. Progressing from a more limited notion of informed consent, shared decision making calls upon patients to voice the desires and preferences of their authentic self, engaging in choice among alternatives as a way to exercise deeply held values. One influential opinion in Jewish bioethics holds that Jewish law, in contradistinction to secular bioethics, limits the patient's exercise of autonomy only in those instances in which treatment choices (...) are sensitive to preferences. Here, we analyze a discussion in the Mishna, a foundational text of rabbinic Judaism, regarding patient autonomy in the setting of religiously mandated fasting, and commentaries in the Babylonian and Palestinian Talmuds, finding both a more expansive notion of such autonomy and a potential metaphysical grounding for it in the importance of patient self-knowledge. (shrink)

In their target article “Two Minds, One Patient,” Moore and colleagues’ (2022) stated goal is “to help clinicians, ethicists, and patients locate [the] source” (38) of a patient’s ambivalence in or...

Over one hundred years after Max Weber delivered his lecture “Science as a Vocation,” his description of the work of the physician in a disenchanted world still resonates. As a chronically ill patient who interacts with physicians frequently, I struggle with reconciling my understanding of my ill body with how my physician makes sense of my illness. My diagnosis created an existential crisis that caused me to search for meaning in my embodied experience, but I soon learned there is (...) little room for such a search within modern biomedicine. Instead, I turned to fine art to help me make sense of my ill body and its purpose in my life. With the aid of my printmaker sister, Darian Goldin Stahl, I have transformed the magnetic resonance images of my body into works of art, which help to re-enchant my body and give purpose to my illness. (shrink)

This article examines the role of patient organizations as mediators between patients and researchers in stem cell research in Australia. We conducted semi-structured interviews with stem cell researchers and patient organization representatives as part of a broader project to deepen public understanding and foster more robust scientific practices in stem cell-based research and therapies. We used Habermas’s Theory of Communicative Action as our theoretical framework to explore the relationships between patient organizations and researchers. Using this framework allowed (...) the identification of two different ways of conceptualizing health and illness—one based on patients’ experiences, which we call “the lifeworld,” and another grounded on researchers’, health professionals’, and policymakers’ professional perspectives, which we call “the rational system.” We found that the different conceptualizations identified influenced the interactions between patients and researchers (and other professionals involved in the healthcare system). Patient organizations, then, act as articulators of patients’ viewpoints in this scenario, which can have advantages and disadvantages. We also found that researchers need to develop less transactional forms of communication with these organizations and that policymakers and regulators could benefit from developing guidelines to encourage researchers to use diverse strategies to engage more meaningfully with patients at individual and organizational levels. (shrink)

Recent media articles have stirred controversy over anecdotal reports of medical students practising educational pelvic examinations on women under anaesthesia without explicit consent. The understandable public outrage that followed merits a substantive response from the medical community. As medical students, we offer a unique perspective on consent for trainee involvement informed by the transitional stage we occupy between patient and physician. We start by contextualising the role of educational pelvic examinations under anaesthesia (EUAs) within general clinical skill development in (...) medical education. Then we analyse two main barriers to achieving explicit consent for educational pelvic EUAs: ambiguity within professional guidelines on how to operationalize ‘explicit consent’ and divergent patient and physician perspectives on harm which prevent physicians from understanding what a reasonable patient would want to know before a procedure. To overcome these barriers, we advocate for more research on patient perspectives to empower the reasonable patient standard. Next, we call for minimum disclosure standards informed by this research and created in conjunction with students, physicians and patients to improve the informed consent process and relieve medical student moral injury caused by performing ‘unconsented’ educational pelvic exams. (shrink)

The prelims comprise: Seeing Infectious Disease as Central The Birth of Bioethics Amid the Decline of Infectious Disease The Shifting Concerns of Public Health Bioethics and Public Health: How the Twain Didn't Meet The Case of HIV Bridging the Gap: Seeing Bioethics in Terms of the Patient as Victim and Vector An Ordinary Example Summing Up: Autonomous Agency in the Context of Infectious Disease Notes.

The growth of personalised medicine and patient partnerships in biomedical research are reshaping both the emotional and material intersections between human patients and animal research. Through tracing the creative work of patients, publics, scientists, clinicians, artists, film-makers, and campaigning groups this chapter explores how ‘patient voices’ are being rearticulated and represented around animal research. The figure of ‘the patient’ has been a powerful actor in arguments around animal research, mostly ‘spoken for’ by formal organisations, especially in publicity (...) material making ethical justifications for the need and funding of medical research. Here, patient voices make corporeal needs legible, gather expectations and resources, and provide the horizon for embodying future hopes. However, the accessibility of digital media, alongside local institutional experiments in openness, is creating alternative spaces for voicing patient interfaces with animal research. On research establishment websites, and elsewhere, patients’ perspectives are emerging in short films, taking up positions as narrators, tour guides, and commentators, inviting the public to follow them into these previously inaccessible spaces. The embodied experience of patients, sometimes severely affected by the current absences in biomedical research, are used to authorise their presence in these places, and allow them to ask questions of animal researchers. The films are powerful and emotional vehicles for voicing patient experiences and opening up animal research. They also refigure the affective responsibilities around animal research, resituating a public debate around ethics within the body of the patient. The future expectations personified in the abstract figure of the patient, are rendered turbulent in the ambiguous corporeal encounter between human and animals undergoing similar experiences of suffering. (shrink)