Here we identify approximately 40,000 healthy human volunteers who were intentionally exposed to infectious pathogens in clinical research studies dating from late World War II to the early 2000s. Microbial challenge experiments continue today under contemporary human subject research requirements. In fact, we estimated 4,000 additional volunteers who were experimentally infected between 2010 and the present day. We examine the risks and benefits of these experiments and present areas for improvement in protections of participants with respect to safety. These are (...) the absence of maximum limits to risk and the potential for institutional review boards to include questionable benefits to subjects and society when weighing the risks and benefits of research protocols. The lack of a duty of medical care by physician–investigators to research subjects is likewise of concern. The transparency of microbial challenge experiments and the safety concerns raised in this work may stimulate further dialogue on the risks to participants of human experimentation. (shrink)

Controlled human infection studies (CHIs) involve the intentional infection of human subjects for a scientific aim. Though some past challenge trials have involved serious ethical abuses, in the last few decades, CHIs have had a strong track record of safety. Despite increased attention to the ethics of CHIs during the COVID‐19 pandemic, CHIs remain controversial, and there has been no in‐depth treatment of CHIs through the lens of virtue ethics. In this article, we argue that virtue theory can be helpful (...) for addressing CHIs that present a constellation of controversial, unresolved, and/or under‐regulated ethical issues. We begin with some brief background on virtue ethics. We then substantiate our claim that some CHIs raise a constellation of ethical issues that are unresolved in the ethics literature and/or lack adequate regulatory guidance by demonstrating that CHIs can present indeterminate social value, risks to third parties, limitations on the right to withdraw from research, and questions about the upper limit of allowable risk. We argue that the presence of a virtuous investigator, with virtues such as prudence, compassion, and integrity, is especially important when these unresolved research ethics issues arise, which is the case for certain types of controlled human infection studies. We use the historical example of Walter Reed and the Yellow Fever Commission to illustrate this claim, and we also highlight some contemporary examples. We end by sketching some practical implications of our view, such as ensuring that investigators with experience running CHIs are involved in novel CHI models. (shrink)

Binding theory (e.g., Chomsky, 1981) has played a central role in both syntactic theory and models of language processing. Its constraints are designed to predict that the referential domains of pronouns and reflexives are nonoverlapping, that is, are complementary; these constraints are also thought to play a role in online reference resolution. The predictions of binding theory and its role in sentence processing were tested in four experiments that monitored participants' eye movements as they followed spoken instructions to have a (...) doll touch a picture belonging to another doll. The instructions used pronouns and reflexives embedded in picture noun phrases (PNPs) containing possessor phrases (e.g., Pick up Ken. Have Ken touch Harry's picture of himself). Although the interpretations assigned to pronouns were generally consistent with binding theory, reflexives were frequently assigned interpretations that violated binding theory. In addition, the timing and pattern of eye movements were inconsistent with models of language processing that assume that binding theory acts as an early filter to restrict the referential domain. The interpretations assigned to reflexives in PNPs with possessors suggest that they are binding‐theory‐exempt logophors, a conclusion that unifies the treatment of reflexives in PNPs. (shrink)

Current guidelines treat palliative sedation to unconsciousness as an effective medical treatment for terminally ill patients who need relief from severe symptoms, yet also restrict its use in ways that are extraordinary for medical treatments. A closer look at the kinds of cases in which palliative sedation is used suggests a way of adjusting the guidelines to resolve this seeming contradiction.

The ‘best interests’ decision making standard is used in clinical care to make necessary health decisions for non-capacitated individuals for whom neither explicit nor inferred wishes are known. It has been also widely acknowledged as a basis for enrolling some non-capacitated adults into clinical research such as emergency, critical care, and dementia research. However, the best interests standard requires that choices provide the highest net benefit of available options, and clinical research rarely meets this criterion. In the context of modern (...) norms of bioethics, the best interests standard rarely supports surrogate consent for research and should not be accepted as a routine provision. (shrink)

With narrow exception, physicians’ treatment of incapacitated patients requires the consent of health surrogates. Although the decision-making authority of surrogates is appropriately broad, their moral authority is not without limits. Discerning these bounds is particularly germane to ethically complex treatments and has important implications for the welfare of patients, for the professional integrity of clinicians, and, in fact, for the welfare of surrogates. Palliative sedation is one such complex treatment; as such, it provides a valuable model for analyzing the scope (...) of surrogates’ moral authority. Guidelines for palliative sedation that present it as a “last-resort” treatment for severe and intractable suffering yet require surrogate consent in order to offer it are ethically untenable, precisely because the moral limits of surrogate authority have not been considered. (shrink)

Although ethics is increasingly integrated in the curriculum of U.S. medical schools, it remains not well integrated with system issues, and social and structural contexts of illness. Moreover, ethical analysis is not often taught as a clinical skill. To address these issues, an outcomes driven course in Social Sciences, Humanities, Ethics and Professionalism (SHEP) was created. Within the course, a web-based concept mapping device, SHEP Case Analysis Tool (SCAT), was created which schematizes the structure and flow of clinical cases from (...) diagnosis to treatment options, to shared decision making to outcome, and includes key stakeholders, influences, and structural features of the health system. In the course, each student analyzes a case in which they were directly involved using SCAT and presents their analysis to faculty and peers. This exercise 1) reinforces knowledge-based portions of the course pedagogy, 2) supports meta-cognition and critical thinking through concept mapping, 3) applies multidimensional analysis to identify ethical, social, and system issues that impact patient-care. 4) develops problem solving skills, 5) counters the hidden curriculum/support professional identity formation, and 6) develops skills in reflective discourse. This paper outlines the development and use of this concept mapping case analysis tool in an undergraduate medical education curriculum. (shrink)

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 7, July 2020, Page 112-114.

The American Journal of Bioethics, Volume 11, Issue 6, Page 46-47, June 2011.

(2010). Insult to Injury: Ethical Confusion in American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. The American Journal of Bioethics: Vol. 10, No. 1, pp. 68-70.

During a catastrophe that disables the health system, ethically charged situations will undoubtedly emerge that will challenge patients, relatives, clinicians, and others involved in health delivery. This second of two special sections of The Journal of Clinical Ethics includes discussions of the implications of a system collapse on particularly vulnerable member of society, children, pregnant women, and those who are socio-economically, culturally, and linguistically disempowered. Additionally, it offers insights into the processes used by committees to plan for catastrophic care.

The American Journal of Bioethics, Volume 11, Issue 11, Page 20-21, November 2011.

A number of influential reports on influenza pandemic preparedness include recommendations for extra-autonomous decisions to withdraw mechanical ventilation from some patients, who might still benefit from this technology, when demand for ventilators exceeds supply. An unintended implication of recommendations for nonvoluntary and involuntary termination of life support is that it make pandemic preparedness plans vulnerable to patients’ claims for assisted suicide and active euthanasia. Supporters of nonvoluntary passive euthanasia need to articulate why it is both morally different and morally superior (...) to voluntary active euthanasia if they do not wish to invite expansion of end-of-life options during health system catastrophe. (shrink)

Discussions about resource allocation commonly invoke concerns of unfair and variable decisions when physicians ration at the bedside. This concern is no less germane in disaster medicine, in which physicians make triage and allocation decisions under duress, and patients and their families may be challenged to self-advocate. Unfortunately, a real-time mechanism to support a process for ethical decision making may not be available to medical relief workers. Yet, resources for ethics decision support can be important for the moral well-being of (...) the clinician, the ethical integrity of the relief effort, and to bolster the trust and confidence of the population receiving medical services. The need for clinical ethical support should be anticipated in disaster preparedness planning. (shrink)

With 40 years in public service, and 23 years on the Senate Foreign Relations committee, Richard Lugar's career and views are of particular interest today, when the U.S. must be particularly careful to choose a wise course of foreign policy. In this collection of essays, distinguished scholars, government officials, public servants and businessmen honor the man who sees Teddy Roosevelt's 'big stick...not as a substitute for good sense, but an expression of it, ' in addition to analyzing the U.S.'s responsibilities (...) and possible courses of action in the Middle East, in building democratic allies, in using intelligence, and much more. (shrink)

Health disparities are primarily driven by structural inequality including systemic racism. Medical educators, led by the AAMC, have tended to minimize these core drivers of health disparities. Ins...

Robert Hopkins _Picture, Image, and Experience_ Cambridge: Cambridge University Press, 1998 ISBN 0521-58259-8 (hbk) 205 pp.

Proportionality, as it pertains to palliative sedation, is the notion that sedation should be induced at the lowest degree effective for symptom control, so that the patient’s consciousness may be preserved. The pursuit of proportionality in palliative sedation is a widely accepted imperative advocated in position statements and guidelines on this treatment. The priority assigned to the pursuit of proportionality, and the extent to which it is relevant for patients who qualify for palliative sedation, have been overstated.