Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a (...) chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s. (shrink)

Volume 20, Issue 7, July 2020, Page 82-84.

Available for the first time in English, this work explores a range of mental disorders in the context of Frankl's theory of human motivation. Skillfully translated and featuring extensive annotation, this English language edition remains true to the original while updating assessment and treatment protocols to be compatible with 21st century medicine. As the title suggests, On the Theory and Therapy of Mental Disorders applies a theoretical treatise to the practical treatment of variety of disorders. This long-awaited addition to the (...) body of English language literature introduces Viktor Frankl's clinical insights to a new generation of mental health professionals, and has much to offer to practitioners of all levels of experience. (shrink)

Expressing doubts about death criteria can serve healthy purposes, but can also cause a number of harms, including decreased organ donation rates and distress for donor families and health care staff. This paper explores the various causes of doubts about death criteria—including religious beliefs, misinformation, mistrust, and intellectual questions—and recommends responses to each of these. Some recommended responses are relatively simple and noncontroversial, such as providing accurate information. However, other responses would require significant changes to the way we currently do (...) business. Policymakers should establish minimum national standards for determining death to foster a trustworthy system; academics and publishers have a duty to publish only materials that substantially engage and advance the debate to minimize the harm caused by divided expert opinion; and opposition to the dead donor rule should be conceptually separated from doubts about death criteria. (shrink)

Evidence exists that behavioral and social science researchers have been frustrated with regulations and institutional review boards (IRBs) from the 1970s through today. Making matters worse, many human participants protection instruction programs - now mandated by IRBs - offer inadequate reasons why researchers should comply with regulations and IRBs. Promoting compliance either for its own sake or to avoid penalties is contrary to the developmental aims of moral education and may be ineffective in fostering the responsible conduct of research. This (...) article explores the concept of professional virtue and argues that compliance is capable of becoming a professional virtue like scientific honesty. This requires, however, that regulatory and IRB demands contribute to human well-being and to the aims of research as a profession and that researchers, therefore, internalize the norms that underlie regulatory and IRB demands. This, in turn, requires a series of changes in the way society develops, promulgates, and enforces regulatory and IRB rules. The challenge is, simply put, to embed compliance into the world of living morality. (shrink)

In this paper, we report on the development and validity of the Professional Decision-Making in Research measure, a vignette-based test that examines decision-making strategies used by investigators when confronted with challenging situations in the context of empirical research. The PDR was administered online with a battery of validity measures to a group of NIH-funded researchers and research trainees who were diverse in terms of age, years of experience, types of research, and race. The PDR demonstrated adequate reliability and parallel form (...) correlation. As hypothesized, the PDR was significantly negatively correlated with narcissism, cynicism, moral disengagement, and compliance disengagement; it was not correlated with socially desirable responding. In regression analysis, the strongest predictors of higher PDR scores were low compliance disengagement, speaking English as a native language, conducting clinical research with human subjects, and low levels of narcissism. Given that the PDR was written at an eighth grade reading level to be suitable for use with English as a second language participants and that only one-fourth of items focused on clinical research, further research into the possible roles of culture and research ethics training across specialties is warranted. This initial validity study demonstrates the potential usefulness of the PDR as an educational outcome assessment measure and a research instrument for studies on professionalism and integrity in research. (shrink)

In the world of research, compliance with research regulations is not the same as ethics, but it is closely related. One could say that compliance is how most societies with advanced research programs operationalize many ethical obligations. This paper reports on the development of the How I Think about Research questionnaire, which is an adaptation of the How I Think questionnaire that examines the use of cognitive distortions to justify antisocial behaviors. Such an adaptation was justified based on a review (...) of the literature on mechanisms of moral disengagement and self-serving biases, which are used by individuals with normal personalities in a variety of contexts, including research. The HIT-Res adapts all items to refer to matters of research compliance and integrity rather than antisocial behaviors. The HIT-Res was administered as part of a battery of tests to 300 researchers and trainees funded by the US National Institutes of Health. The HIT-Res demonstrated excellent reliability. Construct validity was established by the correlation of the HIT-Res with measures of moral disengagement, cynicism, and professional decision-making in research. The HIT-Res will enrich the set of assessment tools available to instructors in the responsible conduct of research and to researchers who seek to understand the factors that influence research integrity. (shrink)

In this article we describe our approach to understanding wrongdoing in medical research and practice, which involves the statistical analysis of coded data from a large set of published cases. We focus on understanding the environmental factors that predict the kind and the severity of wrongdoing in medicine. Through review of empirical and theoretical literature, consultation with experts, the application of criminological theory, and ongoing analysis of our first 60 cases, we hypothesize that 10 contextual features of the medical environment (...) (including financial rewards, oversight failures, and patients belonging to vulnerable groups) may contribute to professional wrongdoing. We define each variable, examine data supporting our hypothesis, and present a brief case synopsis from our study that illustrates the potential influence of the variable. Finally, we discuss limitations of the resulting framework and directions for future research. (shrink)

In almost every clinical interaction, clinicians must navigate interpersonal challenges with near‐instantaneous responses to patients. Yet medical ethics has largely overlooked these small, interpersonal exchanges, instead focusing on “big” ethical problems, such as euthanasia, brain death, or genetic modification. In 1995, Paul Komesaroff proposed the concept of microethics as a nonprinciplist approach to ethics that focuses on “what happens in every interaction between every doctor and every patient.” We aim to develop a microethics framework to guide everyday clinical encounters, with (...) a special focus on communication with patients and family members. We will advance three core insights: First, communication is an ethical act in ways seldom considered. Second, microethics is an essential lens through which to view the ethics of communication. Third, virtue can bridge reflective and automatic processes. Our intuitionist framework for microethics is thus based on this understanding of the role of virtue, and we propose six virtues that contribute to the goal of healing communication. (shrink)

Adolf Reinach was one of the leading figures of the Munich and Göttingen circles of phenomenology, and Husserl's first real co-worker. Although his writings are highly original and remarkably clear, Reinach's tragic death in the First World War prevented him from formulating a definitive statement of his phenomenology, leaving his name virtually unknown to all but a small circle. In his ground-breaking study, Judgment and Sachverhalt, DuBois shows how Reinach succeeds in developing a realist ontology and epistemology based on (...) rigorous argumentation and phenomenological elucidation. Drawing from numerous texts and the developments of Reinach's students and colleagues - Roman Ingarden, Alexander Pfänder and Dietrich von Hildebrand above all - DuBois presents, refines and defends Reinach's `phenomenological realism'. Confrontations of Reinach's theories of states of affairs, concepts and speech acts with the work of contemporary authors like Chisholm and Searle allow readers to evaluate Reinach's philosophy, not only in the light of the later developments of Husserl, but also in the light of certain Anglo-American developments. (shrink)

This article engages two fundamentally different kinds of so-called natural law arguments in favor of specific moral absolutes: Elizabeth Anscombe's claim that certain actions are known to be intrinsically wrong through intuition, and John Finnis's claim that such actions are known to be wrong because they involve acting directly against a basic human good. Both authors maintain, for example, that murder and contraceptive sexual acts are known to be wrong, always and everywhere, through their respective epistemological lens. This article uses (...) the counter-example of anesthesia to challenge these two approaches to substantiating natural law claims. The paper concludes by rejecting the view shared by Professors Finnis and Anscombe that once one rejects these foundations for moral absolutes, one is left with moral subjectivism. In fact, one is left with moral absolutes of a more restricted nature, which are known philosophically, and with more robust moral absolutes held on religious grounds. Virtues are needed in the moral life, among other reasons, because such norms require discernment and integrity for their correct application. (shrink)

The family of a patient who is unconscious and respirator-dependent has made a decision to discontinue medical treatment. The patient had signed a donor card. The family wants to respect this decision, and agrees to non-heart-beating organ donation. Consequently, as the patient is weaned from the ventilator, he is prepped for organ explantation. Two minutes after the patient goes into cardiac arrest, he is declared dead and the transplant team arrives to begin organ procurement. At the time retrieval begins, it (...) is not certain that the patient's brain is dead or that cardiac function cannot be restored. Procurement follows uneventfully, and two transplantable kidneys are retrieved. (shrink)

The seven articles included in the AJOB Neuroscience special issue map important ethical issues that have and will continue to emerge with advances in neuroscience and neurotechnology. A critical c...

The family of a patient who is unconscious and respirator-dependent has made a decision to discontinue medical treatment. The patient had signed a donor card. The family wants to respect this decision, and agrees to non-heart-beating organ donation. Consequently, as the patient is weaned from the ventilator, he is prepped for organ explantation. Two minutes after the patient goes into cardiac arrest, he is declared dead and the transplant team arrives to begin organ procurement. At the time retrieval begins, it (...) is not certain that the patient's brain is dead or that cardiac function cannot be restored. Procurement follows uneventfully, and two transplantable kidneys are retrieved.Many people now consider such cases of non-heart-beating organ donation to be ethically permissible. However, widespread disagreement persists as to how such practices are to be justified and whether such practices are compatible with the Uniform Declaration of Death Act. In this paper, I argue that non-heart-beating organ donation can be ethically justified, that in the justified cases the patients are in fact dead, and that the early declarations of death required for such donation do comply with the UDDA. (shrink)

Ten qualitative research articles published from July 2013 through June 2014 on ethical topics in healthcare and health research are examined here. Full reference information is given for each article. A brief summary of the background, objectives, methods, results and conclusions is offered. These articles were chosen based on the quality of the work done and how well the work fits the interests of Narrative Inquiry in Bioethics readers.

In lieu of an abstract, here is a brief excerpt of the content:Editors’ NoteJames M. DuBois, Ana S. Iltis, and Heidi A. WalshFrom childhood, David Slakter had undergone tests and invasive procedures to monitor his nephritis. It was not a surprise when in 2015, doctors told him he needed a kidney transplant. The wife of a childhood friend was a close match and gave him one of her kidneys. Before his transplant, aerobic exercise was difficult; a few months after (...) transplant, Slakter could ride his bike, hike, and work out with a personal trainer. He no longer had to weigh food or gauge his potassium consumption, a concern for people with kidney failure. For Slakter, “life post-transplant has been a significant improvement.”Individuals or family members of those who have received an organ transplant from a living or deceased donor share their stories in this issue of Narrative Inquiry in Bioethics. The symposium is titled “Receiving the Gift of Life: Stories from Organ Transplant Recipients.” Organ transplantation can extend an individual’s life by decades. It can also greatly improve an individual’s quality of life, as was Slakter’s experience. At the same time, organ transplantation is expensive and stressful. Recipients can experience complications, including organ rejection, and there are few appealing alternatives.After her heart transplant, author Leilani R. Graham required four open-heart surgeries, ECMO, and an intra-aortic balloon pump. She experienced delirium, necrotizing pneumonia, and severe muscular atrophy that required her to re-learn how to walk. She struggled with weight gain, explosive mood swings, hair loss, and was terrified that her body would reject the new heart. For Graham, “[Transplant] was not the miracle [she] was hoping for.” Graham says she felt unprepared for and inadequately informed about what to expect after her transplant, which left her “battered, beaten, and bruised” with a 12-inch line from neck to navel and “bullet holes” up and down her torso from the chest tubes. When reflecting on her experience post-transplant, Graham says, “It wasn’t the physical trauma that hurt the most. It was that no one seemed surprised [by the aftereffects of transplant].” Seemingly no one, that is except Graham, who calls on transplant providers to “prioritize empathy.”The symposium editors are Jason T. Eberl and Tristan McIntosh. Three commentary articles, written by Macey Leigh Levan, Heather Lannon, and Vidya A. Fleetwood, Roslyn B. Mannon & Krista L. Lentine, offer important insights into the authors’ stories. The editors thank Mid-America Transplant, the UCSF Lung Transplant Program, Donor Connect, William L. Freeman, MD, MPH, MJIL, CIP, Janet Monk, and the individuals who gave anonymous donations to support the publication of this issue, an open-access VOICES edition of the symposium, and accompanying teaching guides.The research article in this issue, “‘A Shell of My Former Self’: Using Figurative Language to Promote Communication about Patient Suffering,” was written by Tyler Tate, Elizabeth Stein, and Robert A. Pearlman. The relief of suffering is a primary goal of medicine. However, the authors note that clinicians often miss or ignore suffering because they focus on the causes rather than the experience of suffering, or the subjective nature of suffering makes it difficult to discuss. The authors believe that “the key to communicating about suffering lies in finding [End Page vii] the right kind of words to describe the experience” and say that figurative language offers a promising approach. In their research, the authors performed qualitative analysis on 52 works of literature and identified 254 excerpts of figurative language with themes of non-physical or psychological suffering. The authors found 13 salient themes: brokenness, diminishment, disorientation, drowning, emptiness, imprisonment, battle, darkness, isolation, invisibility, lifelessness, punishment, and torture. The authors reiterate that developing a shared language of suffering could foster a therapeutic patient-clinician relationship and improve clinicians’ ability to recognize and address a patient’s experience of suffering.María Susana Ciruzzi wrote the first of two case studies included in this issue. “The Sword of King Solomon” addresses a tragic and difficult subject—how to navigate the situation posed by conjoined twins when “any decision will produce damage and suffering.” The case involves two infant male patients born at 37 weeks gestation as omphalo-ischiopagus conjoined twins... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Introduction: Conflicting Interest in Medicine: Stories by Physicians on How Financing Affects Their WorkJames M. DuBois, Symposium EditorPhysicians frequently enter into special relationships that establish personal financial interests that could conflict with their patients’ best interests. Examples include receiving gifts from drug companies, sharing a patent on a medical device, or accepting funding from industry to conduct a drug study. In recent years, such “conflicts of interests” in (...) medicine have received growing attention from medical associations (Association of American Medical Colleges, 2008, 2010), policy bodies (Institute of Medicine, 2009), industry (Pharmaceutical Research and Manufacturers of America, 2008), journalists (Caputo, 2009; Nguyen, Ornstein, & Weber, 2010), and even Congress, which included in the 2010 Patient Protection Affordable Care Act a Physician Payment Sunshine provision requiring industry to report a wide variety of ties to physicians. All of these efforts appear motivated by a similar assumption: Gifts and financially beneficial relationships can unconsciously motivate physicians to prioritize their own or industry’s interests over patients’ interests when providing care, conducting medical research, or educating physicians (American Association of Medical Colleges, 2008; Dana & Loewenstein, 2003).The call for stories produced for this narrative symposium provided the following request:We are interested in hearing about positive and negative experiences associated with a variety of financial relationships. The stories should give readers a sense of what it is like to be a physician in the midst of complex relationships to industry, physician practices, and third–party payers—relationships that go beyond ordinary reimbursement for care or research expenses.Obtaining stories proved more challenging than anticipated for reasons related to our theme. Precisely because access to physicians is considered valuable, it is highly restricted. Listservs and blogs that serve physicians typically prohibit postings from anyone except physician members, and even they are sometimes not allowed to post messages freely. While at least one listserv circulated our call to members (at the request of a member), others rejected our request, and one blog offered to post our call as a 1–month ad for $20,000. This contrasts radically with the relatively easy access we have had to other groups, including mental health consumers and living organ donors, who have broad grass root communication systems, and bioethicists, who have several listservs and blogs that readily share news about relevant scholarly opportunities.The collection of stories obtained resulted from extensive personal networking and a small amount of arm twisting. The collection was not what we expected to obtain, but is in many ways even more interesting. One story (Hodges) explicitly addresses the impact that pharmaceutical representatives can have on prescribing patterns—the classic, voluntary, conflicted relationship, insofar as sales reps are [End Page 65] welcomed in facilities, often bearing free samples, free lunches, and glossy articles on their products, all in the hopes of influencing prescribing patterns. But most stories do not fit the typical mold found in discussions of conflicts of interest. Among those expressing concerns about the impact of financial factors on medical practice, one focuses on the insufficient management of bias within the Food and Drug Administration (Perlmutter); three focus on the bias that is introduced through our current fee–for–service reimbursement system (Mikulec, Nagaldine, and Zientek)—of these, two illustrate ways that third parties seek to manipulate physician practices to maximize profits; one notes how any kind of clinical trial—whether government or industry sponsored—may affect patient care decisions (Cruz); while two argue that worries over industry sponsorship of research are disproportionate (Bierut and Sofair), and two address widespread concerns about industry sponsorship of educational activities, with one illustrating how bias might be reduced (Seitz & Diao), and another illustrating the potential harms of prohibiting educational sponsorship (Peppin).To be clear, all of these narratives are responsive to our call for stories that “describe positive and negative experiences associated with a variety of financial relationships.” Yet they are not classic conflict of interest stories; rather, they represent the conflicting interests that concern physicians today—conflicts that are often intrinsic to our current healthcare and research systems rather than special relationships courted by physicians.While making no pretense of representativeness or comprehensiveness, these stories provide fertile ground for reflection, as seen in our... (shrink)

Twelve personal narratives address the challenges, benefits, and pitfalls of genetic testing. Three commentary articles explore these stories and suggest lessons that can be learned from them. The commentators come from backgrounds that include bioethics, public health, psychology, and philosophy.