Volume 20, Issue 6, June 2020, Page 25-27.

The past decade has witnessed escalating legal and ethical challenges to the diagnosis of death by neurologic criteria. The legal tactic of demanding consent for the apnea test, if successful, can halt the DNC. However, US law is currently unsettled and inconsistent in this matter. Consent has been required in several trial cases in Montana and Kansas but not in Virginia and Nevada. In this paper, we analyze and evaluate the legal and ethical bases for requiring consent before apnea testing (...) and defend such a requirement by appealing to ethical and legal principles of informed consent and battery and the right to refuse medical treatment. We conclude by considering and rebutting two major objections to a consent requirement for apnea testing: a justice-based objection to allocate scarce resources fairly and a social utility objection that halting the diagnosis of brain death will reduce the number of organ donors. (shrink)

Volume 20, Issue 6, June 2020, Page 28-30.

Volume 20, Issue 6, June 2020, Page 20-22.

Ethically challenging situations routinely arise in the course of illness and healthcare. However, very few studies have surveyed patients and family members about their experiences with ethically challenging situations. To address this gap in the literature, we surveyed patients and family members at three hospitals. We conducted a content analysis of their responses to open-ended questions about their most memorable experience with an ethical concern for them or their family member. Participants described 219 unique ethical experiences that spanned many of (...) the prevailing themes of bioethics, including the patient-physician relationship, end-of-life care, decision-making capacity, healthcare costs, and genetic testing. Participants focused on relational issues in the course of experiencing illness and receiving medical care and concerns regarding the patient-physician encounters. Many concerns arose outside of a healthcare setting. These data indicate areas for improvement for healthcare providers but some concerns may be better addressed outside of the traditional healthcare setting. (shrink)

Volume 20, Issue 6, June 2020, Page 35-37.

Volume 20, Issue 6, June 2020, Page 73-75.

Volume 20, Issue 6, June 2020, Page W1-W5.

Volume 20, Issue 6, June 2020, Page 37-39.

Volume 20, Issue 6, June 2020, Page 65-67.

Volume 20, Issue 6, June 2020, Page 82-84.

Volume 20, Issue 6, June 2020, Page 42-44.

Volume 20, Issue 6, June 2020, Page 33-35.

Volume 20, Issue 6, June 2020, Page 77-80.

Volume 20, Issue 6, June 2020, Page 30-32.

Volume 20, Issue 6, June 2020, Page 47-49.

Volume 20, Issue 6, June 2020, Page 75-77.

Volume 20, Issue 6, June 2020, Page 49-51.

Volume 20, Issue 6, June 2020, Page 17-19.

Volume 20, Issue 6, June 2020, Page 1-3.

Volume 20, Issue 6, June 2020, Page 44-47.

Volume 20, Issue 6, June 2020, Page 80-82.

Volume 20, Issue 6, June 2020, Page 68-70.

Volume 20, Issue 6, June 2020, Page 40-42.

Volume 20, Issue 6, June 2020, Page 70-72.

Volume 20, Issue 6, June 2020, Page 22-24.

Volume 20, Issue 5, June 2020, Page 28-30.

Volume 20, Issue 5, June 2020, Page 26-28.

Volume 20, Issue 5, June 2020, Page W4-W11.

Volume 20, Issue 5, June 2020, Page 40-42.

Volume 20, Issue 5, June 2020, Page 62-64.

Volume 20, Issue 5, June 2020, Page W1-W3.

Volume 20, Issue 5, June 2020, Page 59-62.

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...

Volume 20, Issue 5, June 2020, Page 20-22.

Volume 20, Issue 5, June 2020, Page 38-40.

Volume 20, Issue 5, June 2020, Page 80-81.

Volume 20, Issue 5, June 2020, Page 64-66.

Volume 20, Issue 5, June 2020, Page 31-33.

Volume 20, Issue 5, June 2020, Page 69-71.

Volume 20, Issue 5, June 2020, Page 1-3.

Volume 20, Issue 5, June 2020, Page 36-37.

Volume 20, Issue 5, June 2020, Page 72-74.

Community engagement is gaining prominence in global health research. A number of ethical goals–spanning the instrumental, intrinsic, and transformative–have been ascribed to CE in global heal...

Volume 20, Issue 5, June 2020, Page 67-69.

Dickert et al. (2020) effectively address how factors such as time limitations, stress, and illness severity in acute conditions warrant a deeper evaluation of how current consent processes serve patients. While data suggests that patients “prefer to be asked for permission upfront rather than waiving consent” (2), consent forms themselves “are frequently long and technical, follow rigid templates, and contain language that appears to prioritize institutional protection” (1). Such findings elucidate patients’ valuation of personal agency over settling for the “benefit (...) of the doubt” that physicians and the consent forms they provide are acting in the patients’ best interests. In response, the authors recommend revisions to consent forms in terms of content, structure, and tone to better facilitate patient understanding beyond the mere conveyance of information. We aim to build Dickert et al.’s discussion of how “consent processes serve functions beyond facilitating an informed, autonomous decision” (2), but with a broader focus on an underrecognized purpose of the consent process: namely, reaffirming a patient’s status as a capable, rational agent. Specifically, we argue that patients can exercise this agency when they thoroughly understand the consent process, per Grimm’s (2012) conception of understanding. (shrink)

Volume 20, Issue 5, June 2020, Page 57-59.

Volume 20, Issue 5, June 2020, Page 75-77.

Volume 20, Issue 5, June 2020, Page 24-25.

Volume 20, Issue 5, June 2020, Page 77-79.

Volume 20, Issue 5, June 2020, Page 18-20.

Volume 20, Issue 5, June 2020, Page 22-23.

Volume 20, Issue 5, June 2020, Page 4-6.

Volume 20, Issue 4, May 2020, Page 73-75.

Volume 20, Issue 4, May 2020, Page 51-53.

Volume 20, Issue 4, May 2020, Page 59-61.

Volume 20, Issue 4, May 2020, Page 54-55.

Volume 20, Issue 4, May 2020, Page 71-73.

Volume 20, Issue 4, May 2020, Page 46-48.

Volume 20, Issue 4, May 2020, Page 11-12.

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Volume 20, Issue 4, May 2020, Page 35-37.

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Volume 20, Issue 4, May 2020, Page 30-33.

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Volume 20, Issue 4, May 2020, Page 28-30.

Volume 20, Issue 4, May 2020, Page 86-88.

Volume 20, Issue 4, May 2020, Page 97-99.

Volume 20, Issue 4, May 2020, Page 108-110.

Volume 20, Issue 4, May 2020, Page 118-120.

Recent debates within the autism advocacy community have raised difficult questions about who can credibly act as a representative of a particular population and what responsibilities that...

Volume 20, Issue 4, May 2020, Page 78-80.

Volume 20, Issue 4, May 2020, Page 114-116.

Volume 20, Issue 4, May 2020, Page 48-50.

Volume 20, Issue 4, May 2020, Page 25-27.

Volume 20, Issue 4, May 2020, Page 89-91.

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Volume 20, Issue 4, May 2020, Page 33-34.

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Volume 20, Issue 4, May 2020, Page 106-108.

Volume 20, Issue 4, May 2020, Page 38-40.

We argue that once a normative claim is developed, there is an imperative to effect changes based on this norm. As such, ethicists should adopt an “implementation mindset” when formulating...

Volume 20, Issue 4, May 2020, Page 41-43.

Volume 20, Issue 4, May 2020, Page 104-105.

Volume 20, Issue 4, May 2020, Page 94-97.

Volume 20, Issue 4, May 2020, Page 102-103.

Volume 20, Issue 3, March 2020, Page 68-70.

Volume 20, Issue 3, March 2020, Page W1-W2.

Beneficence is a foundational ethical principle in medicine. To provide benefit to a patient is to promote and protect the patient’s wellbeing, to promote the patient’s interests. But there are different conceptions of wellbeing, emphasizing different values. These conceptions of wellbeing are contrary to one another and give rise to dissimilar ideas of what it means to benefit a patient. This makes the concept of beneficence ambiguous: is a benefit related to the patient’s goals and wishes, or is it a (...) matter of objective criteria that constitute wellbeing? This paper suggests a unified conception of wellbeing for use in medicine to determine what counts as a benefit. Two components of wellbeing are identified: objective functioning/health and the patient’s view of her own good. The paper explores how to apply, balance, and weigh these components in clinical situations to determine what counts as a benefit to a patient. (shrink)

Volume 20, Issue 3, March 2020, Page 50-52.

Volume 20, Issue 3, March 2020, Page 1-5.

Volume 20, Issue 3, March 2020, Page 73-74.

Volume 20, Issue 3, March 2020, Page 71-73.

Volume 20, Issue 3, March 2020, Page 6-8.

Volume 20, Issue 3, March 2020, Page 77-79.

Volume 20, Issue 3, March 2020, Page 83-85.

Volume 20, Issue 3, March 2020, Page 88-90.

Volume 20, Issue 3, March 2020, Page 37-39.

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Volume 20, Issue 3, March 2020, Page 85-87.

Volume 20, Issue 3, March 2020, Page 19-21.

Volume 20, Issue 3, March 2020, Page 79-81.

Volume 20, Issue 3, March 2020, Page 39-41.

Efforts to professionalize the field of bioethics have led to the development of the Healthcare Ethics Consultant-Certified Program intended to credential practicing healthcare ethics consultants. Our team of professional ethicists participated in the inaugural process to support the professionalization efforts and inform our views on the value of this credential from the perspective of ethics consultants. In this paper, we explore the history that has led to this certification process, and evaluate the ability of the HEC-C Program to meet the (...) goals it has set forth for HCECs. We describe the benefits and weaknesses of the program and offer constructive feedback on how the process might be strengthened, as well as share our team’s experience in preparing for the exam. (shrink)

Volume 20, Issue 3, March 2020, Page 32-34.

Volume 20, Issue 3, March 2020, Page 65-68.

Volume 20, Issue 3, March 2020, Page 42-44.

Volume 20, Issue 3, March 2020, Page 63-65.

Volume 20, Issue 3, March 2020, Page 46-50.

Volume 20, Issue 3, March 2020, Page 44-46.

Volume 20, Issue 3, March 2020, Page 21-24.

Volume 20, Issue 3, March 2020, Page 29-31.

Volume 20, Issue 3, March 2020, Page 75-77.

Volume 20, Issue 3, March 2020, Page 24-27.

Volume 20, Issue 3, March 2020, Page 35-37.

Volume 20, Issue 3, March 2020, Page 27-29.

Volume 20, Issue 2, February 2020, Page 38-41.

Incapacitated adult patients are commonly divided into two groups for purposes of decision making; those with a surrogate and those without. Respectively, these groups are often referred to as represented and unrepresented, and the relative ethics of decision making between them raises two particular issues. The first issue involves the differential application of the best interests standard between groups. Second is the prevailing notion that representedness and unrepresentedness are categorical phenomena, though it is more aptly understood as a multidimensional and (...) continuous variable based on relational moral authority. This paper examines the nature of representedness as it relates to ethical norms of surrogate decision making. (shrink)

Volume 20, Issue 2, February 2020, Page 25-27.

Berger (forthcoming) states that moral intimacy is important in applying the best interests standard. But what he calls moral intimacy requires that someone has overcome epistemic burdens needed to represent the patient. We argue elsewhere that good surrogate decision-making is first and foremost a matter of overcoming epistemic burdens, or those obstacles that stand in the way of a surrogate decision-maker knowing what a patient wants and how to satisfy those preferences. Berger’s notion of moral intimacy depends on epistemic intimacy: (...) the fact that a surrogate's epistemic burdens with respect to the best interests of the incapacitated patient have been adequately surmounted, plus some other feature. Thus, where a particular patient-surrogate relationship fails to be morally intimate, what is lacking is either epistemic intimacy or this second feature. Furthermore, Berger uses the notion of moral intimacy as an explanans for the application of the best interests standard. We argue that the notions of epistemic intimacy and epistemic burdens not only help to explain the notion of moral intimacy, but also better explain the application of the best interests standard. Given the role of epistemic burdens and the epistemic intimacy that overcoming them enables, bioethicists and physicians should consider a surrogate’s epistemic standing relative to the patient’s best interests before pronouncing on the former’s ethical probity. (shrink)

Volume 20, Issue 2, February 2020, Page 33-35.

Volume 20, Issue 2, February 2020, Page 64-66.

Volume 20, Issue 2, February 2020, Page 51-53.

Volume 20, Issue 2, February 2020, Page 27-30.

Volume 20, Issue 2, February 2020, Page 22-24.

Volume 20, Issue 2, February 2020, Page 49-50.

Volume 20, Issue 2, February 2020, Page 66-68.

Berger (2019) argues effectively that “representativeness is more aptly understood as a variable that is multidimensional and continuous based on relational moral authority,” and also makes some useful suggestions about how taking this observation seriously might require changes in current patterns of practice regarding surrogates. But the essay raises additional important questions about how the Best Interest Standard (BIS) should be used among unrepresented patients and other patients as well because many surrogates besides those who “have no actionable knowledge of (...) a patient’s preferences” find themselves in positions in which they need to determine, with the physician, what is in the patient’s best interests. In this commentary, we therefore provide support for the ethical superiority of BIS judgments made by a multi-stakeholder process (rather than solo decision-makers), and sketch a process by which such judgments might be made. (shrink)

Volume 20, Issue 2, February 2020, Page 62-64.

Volume 20, Issue 2, February 2020, Page 35-38.

Although the principle of fair subject selection is a widely recognized requirement of ethical clinical research, it often yields conflicting imperatives, thus raising major ethical dilemmas regarding participant selection. In this paper, we diagnose the source of this problem, arguing that the principle of fair subject selection is best understood as a bundle of four distinct sub-principles, each with normative force and each yielding distinct imperatives: fair inclusion; fair burden sharing; fair opportunity; and fair distribution of third-party risks. We first (...) map out these distinct sub-principles, and then identify the ways in which they yield conflicting imperatives for the design of inclusion and exclusion criteria, and the recruitment of participants. We then offer guidance for how decision makers should navigate these conflicting imperatives to ensure that participants are selected fairly. (shrink)

Volume 20, Issue 2, February 2020, Page 20-22.

Volume 20, Issue 2, February 2020, Page 1-4.

Volume 20, Issue 2, February 2020, Page 30-32.

Volume 20, Issue 2, February 2020, Page 57-59.

Volume 20, Issue 2, February 2020, Page 55-57.

The article by MacKay and Saylor (2020) claims that the principle of fair subject selection yields conflicting imperatives (e.g. in the case of pregnant women) and should be understood as “a bundle of four distinct sub-principles” (i.e. fair inclusion, burden sharing, opportunity, distribution of third-party risks), each having conflicting normative recommendations (MacKay and Saylor 2020). The authors also offer guidance as to how we should navigate between subprinciples that may conflict with each other. The problem is a crucial one since (...) fair subject selection is one of the principles regulating clinical research that produces generalizable knowledge with the potential of improving people’s health. Therefore, there may be cases where the way in which participants are selected directly influences the generalizability (or its lack) of the clinically relevant knowledge and its value (if any) to different groups. In my commentary article, written from the philosophical perspective, I notice a number of interrelated problems which I believe have not been discussed thoroughly in the target article: (1) the precise way in which health care priority setting should influence the content of health research priority setting and fair inclusion principles; (2) the distinction between group and individual benefits and burdens from clinical research; (3) the reference class problem in medical research. (shrink)

ABSTRACTComparative effectiveness studies, referred to here as “usual-care” trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains “unusual” care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, (...) and subjects’ safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents. (shrink)

Pragmatic clinical trials offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question, yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as?pragmatic clinical trial collateral findings,? (...) or?PCT-CFs?. In this article, we explore the ethical considerations associated with the identification, assessment, and management of PCT-CFs, and how these considerations may vary based upon the attributes of a specific PCT. Our purpose is to map the terrain of PCT-CFs to serve as a foundation for future scholarship as well as policy-making and to facilitate careful deliberation about actual cases as they occur in practice. (shrink)

According to Macklin & Natanson (2019), one reason unusual practices can be misidentified as usual care is that “instead of using pertinent, accurate information describing usual care, investigators may rely on the opinion of ‘experts’ in the field, whose information may be out of date or otherwise inaccurate." We find Macklin & Natanson’s insights about misattributed expertise crucial, and suggest their discussion can be elucidated further by characterizing it in the context of Ballantyne (2018)’s recent exploration of what he calls (...) epistemic trespassing. What insights can be drawn from this characterization? In this commentary, we highlight two. First, the characterization elucidates the serious consequences that can result from epistemic trespassing. Second, the characterization of Macklin & Natanson’s cases as instances of epistemic trespassing offers us a potential roadmap for overcoming some of the problems the authors identify. (shrink)