Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management, self-tracking, self-management of diseases, and improved treatment adherence. These devices pose ethical challenges for patients, providers, and the social practice of medicine. For patients, having both informed consent and a user agreement raises questions of understanding for autonomy and informed consent, therapeutic misconception, external influences on decision making, confidentiality and privacy, and device dependability. For providers, (...) digital medicine changes the relationship where trust can be verified, clinicians can be monitored, expectations must be managed, and new liability risks may be assumed. Other ethical questions include direct third-party monitoring of health treatment, affordability, and planning for adverse events in the case of device malfunction. This article seeks to lay out the ethical landscape for the implementation of such devices in patient care. (shrink)

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

Although written consent forms are standard in clinical research, there is little regulatory or empirical guidance regarding how to most effectively review consent forms with potential participants. We developed an algorithm for embedding five questions with corrective feedback while reading consent forms with potential participants, and then applied it in the context of seven clinical research studies. A substantial proportion of participants within each protocol displayed initially inadequate responses to at least one question, but after the protocol elements were explained (...) again, most people demonstrated adequate understanding of them. These data illustrate the need for more attention not just to the content of consent forms, but also to the manner in which the forms are incorporated into the consent process. Embedding explicit inquiries about key protocol elements during consent form review and giving corrective feedback appears to be a simple yet effective way to foster better understanding of disclosed information. (shrink)

Recent discussions of cognitive enhancement often note that drugs and technologies that improve cognitive performance may do so at the risk of “cheapening” our resulting cognitive achievements Arguing about bioethics, Routledge, London, 2012; Harris in Bioethics 25:102–111, 2011). While there are several possible responses to this worry, we will highlight what we take to be one of the most promising—one which draws on a recent strand of thinking in social and virtue epistemology to construct an integrationist defence of cognitive enhancement.. (...) According to such a line, there is—despite initial appearances to the contrary—no genuine tension between using enhancements to attain our goals and achieving these goals in a valuable way provided the relevant enhancement is appropriately integrated into the agent’s cognitive architecture. In this paper, however, we show that the kind of integration recommended by such views will likely come at a high cost. More specifically, we highlight a dilemma for users of pharmacological cognitive enhancement: they can meet the conditions for cognitive integration at the significant risk of dangerous dependency, or remain free of such dependency while foregoing integration and the valuable achievements that such integration enables. After motivating and clarifying the import of this dilemma, we offer recommendations for how future cognitive enhancement research may offer potential routes for navigating past it. (shrink)

Surrogate (proxy) decision makers must make research decisions for people with dementia who lack decision-making capacity. Proxies’ decision-making processes are minimally understood. We randomly assigned 82 proxies of AD patients to informed consent for one of three hypothetical protocols with differing levels of risk and benefit. Proxies answered questions about potential benefits of the described research to the patient and society, as well as about whether they would enroll their relative and why or why not. Proxies interested in enrolling their (...) relative cited the potential for direct benefit to their relative, altruism, and trust in researchers. Those declining cited risks, inconvenience, and stage of illness. Proxies weighed numerous factors, incorporating both substituted judgment and best interests standards in their decision-making processes. Although further empirical work is needed to understand the influences on and adequacy of proxies’ decision making regarding research, these findings can help inform policy regarding surrogate consent. (shrink)

Despite substantial research on overall decision-making capacity levels in schizophrenia, the factors that cause individuals to make errors when making decisions regarding research participation or treatment are relatively unknown. We examined the responses of 84 individuals, middle-aged or older, with schizophrenia or schizoaffective disorder. We used a structured decision-making capacity measure, the MacArthur Competence Assessment Tool for Clinical Research, to determine the frequency and apparent cause of participants’ errors. We found that most errors were due to difficulty recalling the disclosed (...) information, particularly the study’s procedures, potential risks, and purpose. Errors attributable to concrete thinking, psychotic symptoms, or perceived coercion were rarer. These results suggest that informed consent procedures for this population might be improved by providing information in a way that facilitates learning and memory, such as iterative disclosure of the information, corrective feedback, and emphasis of key points of the study—for instance, its purpose, procedures, and potential risks. (shrink)

The word yoginī is an ambivalent term, generally defined as a female yogin. For the purposes of the University of Hawai′i′s Center for South Asian Studies’ Symposium on the Ineffable in Religion and Ritual, I envisioned the ambivalence of the yoginī as characterized by semantic ineffability. This ineffability is seen in the divergence of definitions and descriptions of the yoginī in text and ethnography. The tantras portray her as flying, blood thirsty, and the object of tantric sex rites; she is (...) rarely portrayed as a yoga practitioner. Human yoginīs in India, by in contrast, often identify themselves as sannyāsinī (renunciate), practice some form of yoga, and are often celibate. To address the question of why textual and human yoginīs bear little in common, I render a polythetic definition of the yoginī by first looking at the many modes of definition and classification used to render meaning of the concepts that are integral to the formation of the yoginī. I then problematize the categorical construction of the yoginī and the disjunction between textual references to the yoginī in tantras of the Vidyāpīṭha (“Wisdom Mantra Corpus” or “Seat of Wisdom”), the Śaiva and Śākta Purāṇas, and ethnographic accounts of embodied yoginīs. These three sources, which emerge from various sectarian, historical, and social milieus offer interrelated yet distinct descriptions of the yoginī and as such provide a broad base of signification upon which to render a polythetic definition. (shrink)

Recent studies show that psychiatry residents express a relatively greater need for ethics curricula than their colleagues in other specialties. Such studies have been limited in their generalizability because they were conducted at one site. This study of 151 psychiatry residents at seven U.S. psychiatry programs aims to address that limitation. Residents were surveyed on issues pertaining to ethics and professionalism education. Participants were found to support such curricula during training and to value its relevance to the practice of psychiatry. (...) Gender differences and the influence of the “hidden curriculum” on such results merit further study. (shrink)

The effects of research ethics training on medical students' attitudes about clinical research are examined. A preliminary randomized controlled trial evaluated 2 didactic approaches to ethics training compared to a no-intervention control. The participant-oriented intervention emphasized subjective experiences of research participants (empathy focused). The criteria-oriented intervention emphasized specific ethical criteria for analyzing protocols (analytic focused). Compared to controls, those in the participant-oriented intervention group exhibited greater attunement to research participants' attitudes related to altruism, trust, quality of relationships with researchers, desire (...) for information, hopes about participation and possible therapeutic misconception, importance of consent forms, and deciding quickly about participation. The participant-oriented group also agreed more strongly that seriously ill people are capable of making their own research participation decisions. The criteria-oriented intervention did not affect learners' attitudes about clinical research, ethical duties of investigators, or research participants' decision making. An empathy-focused approach affected medical students' attunement to research volunteer perspectives, preferences, and attributes, but an analytically oriented approach had no influence. These findings underscore the need to further examine the differential effects of empathy-versus analytic-focused approaches to the teaching of ethics. (shrink)

The effects of research ethics training on medical students' attitudes about clinical research are examined. A preliminary randomized controlled trial evaluated 2 didactic approaches to ethics training compared to a no-intervention control. The participant-oriented intervention emphasized subjective experiences of research participants. The criteria-oriented intervention emphasized specific ethical criteria for analyzing protocols. Compared to controls, those in the participant-oriented intervention group exhibited greater attunement to research participants' attitudes related to altruism, trust, quality of relationships with researchers, desire for information, hopes about (...) participation and possible therapeutic misconception, importance of consent forms, and deciding quickly about participation. The participant-oriented group also agreed more strongly that seriously ill people are capable of making their own research participation decisions. The criteria-oriented intervention did not affect learners' attitudes about clinical research, ethical duties of investigators, or research participants' decision making. An empathy-focused approach affected medical students' attunement to research volunteer perspectives, preferences, and attributes, but an analytically oriented approach had no influence. These findings underscore the need to further examine the differential effects of empathy-versus analytic-focused approaches to the teaching of ethics. (shrink)