Clinical trials for acute conditions such as myocardial infarction and stroke pose challenges related to informed consent due to time limitations, stress, and severe illness. Consent processes shou...

The demands of respect for persons when conducting clinical research are often reduced to respect for autonomy. In this paper, I re-examine the concept of respect for persons in light of important intuitions from our ordinary language usage of respect. I propose that there are many ways to respect persons as persons and that the core elements of respect for persons are: appreciating what is valuable or important about a person, recognizing the constraints or demands that such a valuation places (...) on one's own conduct, and acting in a way that expresses that recognition. On this account, in addition to autonomous agency, respect demands attention to important subjective experiences, persons' existence as part of communities, and considerations of comportment. This account has important implications for the conduct of clinical research with persons who are autonomous as well as with those who are not. Its implications, however, are different for these two populations, particularly with regard to concerns about well-being. (shrink)

In the article “Informed Consent: What Must be Disclosed and What Must be Understood?” Joseph Millum and Danielle Bromwich argue that informed consent requires satisfaction of certain disclosure an...

Friesen et al. (2023) describe barriers to research in patient populations that have been historically labeled as vulnerable and, as a result, are under-represented in research due to the Instituti...

Volume 19, Issue 5, May 2019, Page 20-22.

The shift away from paternalistic decision-making and toward patient-centered, shared decision-making has stemmed from the recognition that in order to practice medicine ethically, health care professionals must take seriously the values and preferences of their patients. At the same time, there is growing recognition that minor and seemingly irrelevant features of how choices are presented can substantially influence the decisions people make. Behavioral economists have identified striking ways in which trivial differences in the presentation of options can powerfully and predictably (...) affect people's choices. Choice-affecting features of the decision environment that do not restrict the range of choices or significantly alter the incentives have come to be known as “nudges.” Although some have criticized conscious efforts to influence choice, we believe that clinical nudges may often be morally justified. The most straightforward justification for nudge interventions is that they help people bypass their cognitive limitations—for example, the tendency to choose the first option presented even when that option is not the best for them—thereby allowing people to make choices that best align with their rational preferences or deeply held values. However, we argue that this justification is problematic. We argue that, if physicians wish to use nudges to shape their patients’ choices, the justification for doing so must appeal to an ethical and professional standard, not to patients’ preferences. We demonstrate how a standard with which clinicians and bioethicists already are quite familiar—the best-interest standard—offers a robust justification for the use of nudges. (shrink)

Volume 19, Issue 10, October 2019, Page 105-107.

BackgroundInformed consent forms are intended to facilitate research enrollment decisions. However, the technical language in institutional templates can be unfamiliar and confusing for decision-makers. Standardized language describing financial implications of participation, namely compensation for injury and costs of care associated with participating, can be complex and could be a deterrent for potential participants. This standardized language may also be misleading in the context of comparative effectiveness trials of standard care interventions, in which costs and risk of injury associated with participating (...) may not differ from regular medical care. In addition, the revised U.S. Common Rule contains a new requirement to present key information upfront; the impact of how this requirement is operationalized on comprehension and likelihood of enrollment for a given study is unknown.MethodsTwo online surveys assessed the impact of (1) changes to compensation for injury language (standard vs. tailored language form) and (2) changes to the key information page (using the tailored compensation language form with standard key information vs. modified key information vs. modified key information plus financial information) on both likelihood of enrollment in and understanding of a hypothetical comparative effectiveness trial.ResultsLikelihood of enrolling was not observed to be different between the standard and tailored language forms in Study 1 (73 vs. 75%; p = 0.6); however, the tailored language group had a higher frequency of understanding the compensation for injury process specific to the trial (25 vs. 51%; p < 0.0001). Modifications to the key information sheet in Study 2 did not affect likelihood of enrolling (88 vs. 85 vs. 85%; p = 0.6); however, understanding of randomization differed by form (44 vs. 59 vs. 46%; p = 0.002).ConclusionsThese findings suggest that refining consent forms to clarify key information and tailoring compensation for injury language to the nature of the study, especially in the context of comparative effectiveness trials, may help to improve study comprehension but may not impact enrollment. (shrink)

: Research in emergency settings (RES) has become a major public issue with urgent policy implications. Significant attention has focused recently on RES in response to the trial of PolyHeme, a synthetic blood substitute, in trauma victims in hemorrhagic shock. Unfortunately, the discussion of the PolyHeme trial in the popular and scholarly press leaves important questions unanswered. This paper articulates three important lessons from the PolyHeme trial that have significant policy implications. First, the RES regulations should be re-visited, particularly the (...) requirement that existing treatments be unproven or unsatisfactory in order for research to be acceptable without consent. Second, further conceptual and empirical scholarship is needed to accomplish the goal of effectively involving communities. Third, a more subtle analysis is needed regarding how to balance the needs of maintaining public trust and protecting confidential trade information in the context of RES. (shrink)

Volume 20, Issue 8, August 2020, Page W12-W13.

Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little attention or analysis (...) but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study. (shrink)

Hastings Center Report, Volume 52, Issue 3, Page 9-17, May–June 2022.

Shared decision-making has become a new focus of health policy. Though its core elements are largely agreed upon, there is little consensus regarding which outcomes to prioritize for policy-mandated shared decision-making.

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

Research involving recently deceased humans that are physiologically maintained following declaration of death by neurologic criteria—or ‘research involving the recently deceased’—can fill a translational research gap while reducing harm to animals and living human subjects. It also creates new challenges for honouring the donor’s legacy, respecting the rights of donor loved ones, resource allocation and public health. As this research model gains traction, new empirical ethics questions must be answered to preserve public trust in all forms of tissue donation and (...) in the practice of medicine while respecting the legacy of the deceased and the rights of donor loved ones. This article suggests several topics for immediate investigation to understand the attitudes and experiences of researchers, clinical collaborators, donor loved ones and the public to ensure research involving the recently deceased advances ethically. (shrink)

Names, descriptions, and demonstratives raise well-known logical, ontological, and epistemological problems. Perhaps less well known, amongst philosophers at least, are the ways in which some of these problems not only recur with pronouns but also cross-cut further problems exposed by the study in generative linguistics of morpho-syntactic constraints on interpretation. These problems will be my primary concern here, but I want to address them within a general picture of interpretation that is required if wires are not to be crossed. That (...) picture will be sketched in sections 3 and 4; subsequent sections will focus on pronouns and binding, drawing heavily on what has preceded. (shrink)

In this study, we test the interactive effect on ethical decision-making of (1) personal characteristics, and (2) personal expectanciesbased on perceptions of organizational rewards and punishments. Personal characteristics studied were cognitive moral developmentand belief in a just world. Using an in-basket simulation, we found that exposure to reward system information influenced managers’ outcome expectancies. Further, outcome expectancies and belief in a just world interacted with managers’ cognitive moral development to influence managers’ ethical decision-making. In particular, low-cognitive moral development managers who (...) expected that their organization condoned unethical behavior made less ethical decisions while high cognitive moral development managers became more ethical in this environment. Low cognitive moral development managers also behaved less ethically when their belief in a just world was high. (shrink)

In this study, we test the interactive effect on ethical decision-making of (1) personal characteristics, and (2) personal expectanciesbased on perceptions of organizational rewards and punishments. Personal characteristics studied were cognitive moral developmentand belief in a just world. Using an in-basket simulation, we found that exposure to reward system information influenced managers’ outcome expectancies. Further, outcome expectancies and belief in a just world interacted with managers’ cognitive moral development to influence managers’ ethical decision-making. In particular, low-cognitive moral development managers who (...) expected that their organization condoned unethical behavior made less ethical decisions while high cognitive moral development managers became more ethical in this environment. Low cognitive moral development managers also behaved less ethically when their belief in a just world was high. (shrink)

This chapter explores the concept of judgmentalism: what it is and why it’s morally problematic. After criticizing an account offered by Gary Watson, the paper argues for a broader understanding of what it is to be judgmental, encompassing not just the overall beliefs that we form about someone else, but also the very pattern of our thoughts about those with whom we are involved in interpersonal relationships. The thesis is that to care about someone is to be oriented toward them, (...) or to see them through a particular mental lens, in a way that produces a particular pattern of salience and silence. That is: caring about someone (at least ideally) has the effect of making some features of that person particularly salient, and silencing or screening off other features from one’s consciousness. One is aptly described as judgmental when one’s thoughts do not display this sort of pattern, indicating a failure to fully adopt the orientation that constitutes properly caring about the person. (shrink)

According to pancomputationalism, all physical systems – atoms, rocks, hurricanes, and toasters – perform computations. Pancomputationalism seems to be increasingly popular among some philosophers and physicists. In this paper, we interpret pancomputationalism in terms of computational descriptions of varying strength—computational interpretations of physical microstates and dynamics that vary in their restrictiveness. We distinguish several types of pancomputationalism and identify essential features of the computational descriptions required to support them. By tying various pancomputationalist theses directly to notions of what counts as (...) computation in a physical system, we clarify the meaning, strength, and plausibility of pancomputationalist claims. We show that the force of these claims is diminished when weaknesses in their supporting computational descriptions are laid bare. Specifically, once computation is meaningfully distinguished from ordinary dynamics, the most sensational pancomputationalist claims are unwarranted, whereas the more modest claims offer little more than recognition of causal similarities between physical processes and the most primitive computing processes. (shrink)

Despite a long period of neglect, research on emotion in organizational behavior has developed into a major field over the past 15 years, and is now seen to be part of an affective revolution in the organization sciences. In this article, we review current research on emotion in the organizational behavior field based on five levels of analysis: within person, between persons, dyadic interactions, leadership and teams, and organization-wide. Specific topics we cover include affective events theory, state and trait affect (...) and mood, emotional intelligence, emotional labor, emotional contagion, emotions and leadership, and building a healthy emotional climate. We conclude with suggestions for future research. (shrink)

This paper reports the results of a survey of ethical attitudes, values, and propensities in public sector employees in Australia. It was expected that demographic variables, personal values, and contextual variables at the individual level, and group- and organisational-level values would predict use of formal codes of ethics and ethical tolerance (tolerance of unethical behaviour). Useable data were received from 500 respondents selected at random across public sector organisations in a single Australian state. Results supported the study hypotheses, but indicated (...) that different mechanisms underlie each of the criterion variables. Use of ethical codes was determined primarily on the basis of a perception that others use the code, while ethical tolerance was determined by personal values. At an applied level, the research highlights the need for orgasnizations to establish a critical mass of code users, so that this operates as a normative influence on others in the organization. (shrink)

1. Metaphysics -- 2. The mind -- 3. Desire and emotion -- 4. Freedom from bondage -- 5. Transcendence.

Efforts to contain the spread of the coronavirus emphasize the central role of citizens’ compliance with self-protective behaviors. Understanding the processes underlying the decision to self-protect is, therefore, essential for effective risk communication during the COVID-19 pandemic. In the present study, we investigate the determinants of perceived threat and engagement in self-protective measures in the United Kingdom, Italy, and Austria during the first wave of the pandemic. The type of disease and the type of numerical information regarding the disease were (...) manipulated. Participants’ cognitive and emotional risk assessment as well as self-reported engagement in protective behaviors were measured. Results show that worry was the best predictor of perceived threat in all countries. Moreover, a path analysis revealed that worry and perceived threat serially mediated the effect of type of disease on engagement in self-protective behaviors. The numerical framing manipulation did not significantly impact behavior but had a direct effect on worry and an indirect effect on perceived threat. These results are in line with theoretical accounts that identify emotions as a central determinant for risk perception. Moreover, our findings also suggest that effective risk communication during the COVID-19 pandemic should not stress comparisons to other, well-known viral diseases, as this can ultimately reduce self-protective behaviors. (shrink)

In 1999, Neale Donald Walsch wrote three little books, each focusing on different areas of life: Neale Donald Walsch on Relationships, Neale Donald Walsch on Holistic Living, and Neale Donald Walsch on Abundance and Right Livelihood. In 2010, these three books were published in a single volume as Neale Donald Walsch's Little Book of Life. Walsch describes this book as a thousand pages of dialogue in the Conversations with God series reduced down to a few salient points and a few (...) very direct observations about how to render them functional. Readers can think of this book as either Conversations with God in a Nutshell or the Essential Conversations with God. Here are the basic principles for: Satisfying personal relationships; Living a joyful, harmonious life; Discovering authentic prosperity. Walsch's words provide hope and help for readers living in particularly challenging times. This is indeed Walsch's essential life guide for twenty-first century readers."--Back cover. (shrink)

CRISPR keeps me up at night. I marvel at its potential to cure insidious genetic diseases and scourges like malaria. I shudder at the ways it might be misused to create biological weapons. What frightens me most, though, is what I can't predict: how will we use CRISPR? How will it change evolution? How will it redefine the very nature of our existence?CRISPR is an ingenious cut-and-paste system that homes in on a particular DNA gene sequence and then, using Cas9 (...) enzymes, snips it out. That sequence is then replaced with a new one that rewrites or repairs the original. Two different cells—somatic, from the body, and germline, from gametes—can be manipulated... (shrink)

Comprising eight revised essays and seven new pieces, this work provides a comprehensive resource for students, scientists, bioethicists, physicians, and laypeople to better understand and discuss the ethical issues underlying this technology that has the potential to forever change the world.

This book offers the first sustained reflection on the significance of futurity for the phenomenological method itself.

In 1999, Dan Zahavi’s Self Awareness and Alterity: A Phenomenological Investigation initiated a critique of the standard interpretation of the distinction between the second and third levels of Husserl’s analysis of time-constituting consciousness. At stake was the possibility of a coherent account of self-awareness (Zahavi’s concern), but also the possibility of prereflectively distinguishing the acts of consciousness (Brough and Sokolowski’s rebuttal of Zahavi’s critique). Using insights gained from Husserl’s Analyses Concerning Passive Synthesis rather than the work on time-consciousness, this paper (...) provides a new, more precise vocabulary in which to carry on the debate, in the hopes of bringing it to a mutually satisfactory resolution. After briefly laying out the terms of the Zahavi–Brough/Sokolowski debate (Sect. 2), I then elaborate a three-fold distinction in consciousness from the Analyses (Sect. 3) and relate that back to the issue of objectivity in the debate (Sect. 4). I end by suggesting how this three-fold model from the Analyses helps us preserve the essentially tripartite structure (as Brough and Sokolowski insist we do) while not making one of these levels the object of another (in keeping with Zahavi’s critique) (Sect. 5). (shrink)

Background: The importance of respecting patients and participants in clinical research is widely recognised. However, what it means to respect persons beyond recognising them as autonomous is unclear, and little is known about what patients find to be respectful. Objective: To understand patients’ conceptions of respect and what it means to be respected by medical providers. Design: Qualitative study from an academic cardiology clinic, using semistructured interviews with 18 survivors of sudden cardiac death. Results: Patients believed that respecting persons incorporates (...) the following major elements: empathy, care, autonomy, provision of information, recognition of individuality, dignity and attention to needs. Conclusions: Making patients feel respected, or valued as a person, is a multi-faceted task that involves more than recognising autonomy. While patients’ views of respect do not determine what respect means, these patients expressed important intuitions that may be of substantial conceptual relevance. (shrink)

A central question for psychologists, economists, and philosophers is how human lives should be valued. Whereas egalitarian considerations give rise to models emphasizing that every life should be valued equally, empirical research has demonstrated that valuations of lives depend on a variety of factors that often do not conform to specific normative expectations. Such factors include emotional reactions to the victims and cognitive considerations leading to biased perceptions of lives at risk (e.g., attention, mental imagery, pseudo-inefficacy, and scope neglect). They (...) can lead to a valuation function with decreasing marginal value and sometimes even decreasing absolute value as the number of victims increases. As a result, people spend more money to save an individual while at the same time being insensitive and apathetic to large losses of life, despite endorsing egalitarian norms. In this conceptual paper, we propose a descriptive model highlighting the role of different motivations and the conditions under which cognitions and emotions result in deviations from egalitarian normative valuations of human lives. (shrink)