This thesis is a contribution to the ethical justification for clinical research with children. A research subject’s participation in a trial is usually justified, in part, by informed consent. Informed consent helps to uphold the moral principle of respect for persons. But children’s limited ability to make informed choices gives rise to a problem. It is unclear what, if anything, justifies their participation in research. Some research ethicists propose to resolve this problem by appealing to social utility, proxy consent, arguments (...) explaining why it is permissible to expose children to some harm, and an argument concerning the appropriate balance between research harms and benefits. I argue that each of these is a necessary part of the justification for research with children, but that the argument concerning harms and benefits is under-developed. It relies on the concept of minimal risk, but minimal risk is inadequately justified. I propose an interpretation of minimal risk. I defend the idea that minimal risk should be interpreted according to the risks of daily life. I reject the most prominent defense of daily life, which claims that daily risks are morally relevant because they replace, rather than add to, the risks a child would ordinarily face. Instead, I propose that these risks are part of a reasonable trade-off between personal safety and our ability to pursue meaningful lives. I then examine whose daily life should be captured in the concept of minimal risk. I reject arguments that minimal risk should refer to healthy children or the subjects of the research and propose instead that the referent should be children who are not unduly burdened by their lives. I argue that children are not unduly burdened when they fare well and defend the idea that children fare well when they possess sufficiently high degrees of the substantive goods of childhood. I conclude by analyzing a controversial case study using my interpretation of minimal risk. I draw on this case to argue that my interpretation offers clear guidance for research ethics review and contributes to a determination that is more plausible than its rivals. (shrink)

Human rights have increasingly been put forward as an important framework for bioethics. In this paper, it is argued that human rights offer a potentially fruitful approach to understanding the notion of Respect for Persons in bioethics. The idea that we are owed a certain kind of respect as persons is relatively common, but also quite often understood in terms of respecting people’s autonomous choices. Such accounts do however risk being too narrow, reducing some human beings to a second-class moral (...) status. This paper puts forward a political approach to our standing as persons and a strongly pluralistic account of human rights that lays the ground for a more broadly applicable conception of Respect for Persons. It is further argued that this model also provides an example of a more general approach to philosophical ethics, an approach which is here called taxonomical pluralism. When it comes to Respect for Persons specifically, this principle is developed in terms of five distinct core concerns. (shrink)

Why is there still debate about definitions of death in medicine and bioethics? Is it because of existential uncertainty and philosophical curiosity about when a person has died so the person’s dea...

Pediatric research without the potential for clinical benefit is vital to improving pediatric medical care. This research also raises ethical concern and is regarded by courts and commentators as unethical. While at least 10 justifications have been proposed in response, all have fundamental limitations. This article describes and defends a new justification based on the fact that enrollment in clinical research offers children the opportunity to contribute to a valuable project. Contributing as children to valuable projects can benefit individuals in (...) two ways. First, individuals may come to ?embrace? the contributions they made as children. Second, contributing to valuable projects can lead to a better overall life. Because these potential benefits can outweigh small research risks, they provide a justification for pediatric research without the potential for clinical benefit, when it poses low risks and has the potential to benefit others in important ways. (shrink)

In this study, I explore the challenges that ideological hegemonies of personhood imbibed by nurses and other healthcare workers could pose for the nursing profession, particularly in terms of inhibiting the acknowledgment of difference. Dominant or hegemonic conceptions of personhood in particular spaces often consist of self‐contained ideas and essentialist ontologies and normativity of what it means to be a person, lack of which results in the denial of personhood and the othering as non‐person or sub‐person. The other as the (...) residue of such self‐contained notions of personhood is most often denied the quality of care that the one who fits within such conceptions enjoy. For nurses and other healthcare workers to overcome such exclusionary tendencies in healthcare, they must overcome hegemonies and ideological dominance and be more open to alternative viewpoints and theories of personhood. I develop these lines of thought by focusing on the rich ideological traditions of Continental and African philosophies showing how exclusion takes place within these traditions based on conceptions of personhood and how such exclusion on the basis of difference impacts negatively on healthcare. I conclude by highlighting the need to go beyond hegemonic philosophies of personhood by decolonizing and demasculinizing healthcare, thereby allowing difference to flourish in an ecology of medical knowledge. (shrink)

Durch genomweite Analysen werden vielfältige gesundheitsrelevante Informationen über eine Person gewonnen. Solche Informationen können die Behandlung von Krankheiten verbessern. Sie ermöglichen aber auch Vorhersagen, ob eine Person und deren Verwandte in Zukunft möglicherweise erkranken werden. Der neuartige Charakter des Informationseingriffs und sein prädiktive Potential bedürfen der ethischen, juristischen und ökonomischen Reflexion, damit diese Technologie zum Wohl der Patienten, der Familienangehörigen und der Solidargemeinschaft eingesetzt werden kann. Die vorliegende Schrift leistet mit ihren interdisziplinären, vom BMBF finanzierten Analysen dazu einen Beitrag. Grundlagen (...) für einen ethisch und juristisch verantwortbaren Einsatz der Genomsequenzierung zu medizinischen Zwecken werden erörtert und Eckpunkte für Kostenanalysen sowie Elemente einer “Guten klinischen Praxis” präsentiert. (shrink)

In this article, consultation via the Internet and the use of the Internet as a source of medical information is examined from an ethical point of view. It is argued that important ethical aspects of the clinical interaction, such as dialogue and trust will be difficult to realise in an Internet-consultation. Further, it is doubtful whether an Internet doctor will accept responsibility. However, medical information via the Internet can be a valuable resource for patients wanting to know more about their (...) disease and, thus, it is a means to enhancing their autonomy. (shrink)

The utilization of alternative medical therapies and practitioners has increased dramatically in the U.S. in the last two to three decades. This trend seems paradoxical when one considers the rapid advances taking place in biomedical knowledge and technology during this same time period. Observers both inside and outside of the medical profession have attempted to explain the rising popularity of alternative medicine by proposing that it signals a growing sense of dissatisfaction and disenchantment with professional biomedical practices on the part (...) of the lay public. This paper challenges this thesis and offers an alternative explanation, arguing that the rise of alternative medicine is a consequence of the success and expanding influence of biomedicine rather than its failure and declining authority. The argument presented draws primarily on Ulrich Beck’s “risk society” perspective and theory of “reflexive modernization,” with specific attention to his analysis of the “reflexive scientization” process. The application of this perspective allows us to understand the emergence and development of alternative medicine as an unanticipated consequence of the process of reflexive biomedicalization in the late modern era. (shrink)

While legal rights to make medical treatment decisions at the end of one's life have been recognized by the courts, particular religious traditions put axiological and metaphysical meat on the bare bones of legal rights. Mere legal rights do not capture the full reality, meaning and importance of death. End-of-life decisions reflect not only the meaning we find in dying, but also the meaning we have found in living. The Christian religions bring particular understandings of the vision of life as (...) a gift from God, human responsibility for stewardship of that life, the wholeness of the person, and the importance of the dying process in preparing spiritually for life beyond earthly life, to bear on end-of-life decisions. (shrink)

Background In 1926, Fritz Jahr described bio-ethics (German: bio-ethik) as “the assumption of moral obligations not only towards humans, but towards all forms of life.” Jahr summarized his philosophy by declaring, “Respect every living being on principle as an end in itself and treat it, if possible, as such!.” Bioethics was thus originally an ethical system concerned with the “problems of interference with other living beings… and generally everything related to the balance of the ecosystem” according to the 1978 Encyclopedia (...) of Bioethics. This definition was predicated on the work of Fritz Jahr, Menico Torchio, and Van Rensselaer Potter. Methods In order to proceed with depthful analysis of the origin and major bioethical flare up, we will use critical analysis of existing literature, followed by a study trip to relevant bioethical localities (collecting photo and other documentations regarding Menico Torchio). Results While Jahr and Potter are typically given intellectual credit for developing the field of bioethics, the eco-ethical contributions of Menico Torchio have been forgotten.This article will first trace the origins of “bioethics” – now commonly bifurcated into “biomedical ethics” and “environmental bioethics.” The former was developed by Tom Beauchamp from the Philosophy Department and James Childress of the Religious Studies department at Georgetown University and is based on principlism, with a narrow focus on medical settings. The latter addresses the environmental impact of the medical industry and climate change health hazards. Second, we will present a panorama of Torchio’s significant intellectual contribution to bioethics. Menico Torchio’s concept of bioethics synthesized work of both Jahr and Potter, advocating “the need to expand our ethical obligations and embrace the most developed groups of animals, not only physically but also psychologically.” Third, we will reflect on the lasting legacy of “bioethics” on biomedical and environmental bioethics today. Thematic elements such as interconnectedness of planetary health and human health, dedication to living in harmony with nature, and emphasis on systems and symbiosis remain unchanged from the legacy of Tochio onward. Conclusion Our conclusion will underscore the necessity of understanding the connections between planetary, environmental, and human health. (shrink)

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.United States research regulations are derived largely from the deliberations and report of the National Commission for the Protection of Human Subjects of Biomedical (...) and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses. (shrink)

Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services, to require that investigators follow the same rules for conducting human research., though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission for the (...) Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission was appointed in 1974 as part of the National Research Act in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study. (shrink)

BackgroundThe nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.Results and conclusionIn this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty (...) to provide the patient/subject with clinical care can vary from one situation to the next, as a function of several factors, including: the research design, benefits and risks of the research; the subject's reasonable expectations, motivations, and vulnerabilities; the investigator's ability to benefit the subject; and the investigator's prior relationship with the subject. These and other factors need to be considered when determining the clinical investigator's obligations to provide clinical care to human research subjects. In some research contexts, the investigator has extensive clinical obligations to the patient/subject; in others, the investigator has minimal ones. (shrink)

The article offers an approach to inquiry about, the foundation of medical ethics by addressing three areas of conceptual presupposition basic to medical ethical theory. First, medical ethics must presuppose a view about the nature of medicine. it is argued that the view required by a cogent medical morality entails that medicine be seen both as a healing relationship and as a practical art. Three ways in which medicine inherently involves values and valuation are presented as important, i.e., in being (...) aimed at the good of health, in being a cognitive art evaluating towards that good, and as a manifestation of a virtuous disposition concerning that good. Finally, a value ontology drawn from these considerations is seen as necessarily underlying medical ethics. A set of three such basic values are promoted as crucial: the value of health; the value of the individual patient; and the value of altruism that mediates the class of potential patients. (shrink)

In the last decade there has been a pragmatic turn in the work of those doing Christian ethics, especially as represented by the work of Jeffrey Stout and Franklin Gamwell. The pragmatic turn represents a critique of the highly influential work of Stanley Hauerwas and Alasdair MacIntyre, which argues for a strongly intra-church ethics. The pragmatists are correct in arguing that Christian ethics must engage the public sphere. However, I argue that they are deeply mistaken in their claim that this (...) engagement must rest on a weak or non-existent theology. I show that the claim that robust theology adds nothing to ethics, and that we can get along without it, is unsustainable. (shrink)

Donating, distributing and ultimately transplantingorgans each has distinct ethical problems. In thispaper I suggest that the first ethical question is notwhat should be done but what is a fair way in whicheach of these problems can be addressed. Experts –whether these be transplant surgeons, policy analysts,political scientists or ethicists – can help guidebut cannot by themselves make such decisions. Inmaking these decisions the difference betweenidentified and non-identified lives is crucial. Isuggest that an approach in which reason is temperedby compassion (``compassionate (...) rationality'') whendealing with identified lives and in whichcompassion is controlled by reason (``rationalcompassion'') in dealing with unidentified lives mustserve us well. Ultimately decisions of this sort areprone to sturdy democratic process which is possibleonly when the preconditions of person, economic andeducational democracy are met. (shrink)

From time to time medical ethicists bemoan the loss of a religious perspective in medical ethics. The discipline had its origins in the thinking of explicitly religious thinkers such as Paul Ramsey and Joseph Fletcher. Furthermore, many of those who contributed to the early development of the discipline had training in theology. One thinks of Daniel Callahan, Richard McCormick, Albert Jonsen, Sam. Banks. As the discipline becomes more and more self-reflective, with attention being paid to methodological and conditional concerns, it (...) is only natural that the roots are due for a reexamination. The time has therefore come for some reassessment. The first steps here are taken in the form of a dialogue between the coauthors to clarify authentic contributions and weed out unauthentic ones. (shrink)

In 1927, Fritz Jahr coined the term “bioethics” to indicate an “environmental ethics based on biopsychics”. In 1970, Van Rensselaer Potter also coined the term “bioethics” to indicate a “new global ethics based on biology”. As the same Potter wrote, after 1971 “in the USA there was an immediate explosion of the use of the word bioethics” but with a completely different meaning which became dominant and spread worldwide. He went on to say, “their [the public's] image of bioethics delayed (...) the [global] emergence of what now exists”. Elsewhere I have analyzed how this happened, here I analyze why. (shrink)

The author argues that to explore what is distinctly Christian about Christian bioethics requires clarity about what is Christian. He distinguishes between the Christian (that which can be identified as authentically Christian), Christianity (the sum of that which is authentically Christian), and ecclesiastical traditions (the historic communities of faith and practice that are predicated upon both Christian and extra-Christian tradition) to critically assess what is to be declared Christian. In addition to exploring the role of New Testament scripture in identifying (...) the Christian, the author emphasizes the need to recognize the extent to which the content of Christianity is Hebraic and Jewish. (shrink)

Two contemporary strategies in cadaver organ transplantation, both with the potential to affect significantly expanding organ transplant waiting list sizes, have evolved: elective ventilation and use of nonheart-beating donors. Both are undergoing a period of critical review. It is not clear how widely EV is practiced around the world. In Great Britain, the Royal Devon and Exeter Hospital was the first hospital to develop an EV protocol, in 1988, after which other British hospitals followed suit. In the 1980s, new NHBD (...) protocols of two distinct types were implemented worldwide, although both rely on death confirmed by traditional cardiopulmonary criteria. The first type involves the removal of organs immediately after death, the preeminent example being the University of Pittsburgh Medical Center Protocol. The second involves the perfusion and cooling of kidneys immediately following death and subsequent organ removal. Protocols of this type have sprung up in Holland, Great Britain, Italy, France, Spain, Japan, and the United States. (shrink)

The voluntary and informed consent of subjects has been the central focus of concern in research reviews, overshadowing the importance of all other considerations. The Nuremberg Code, with its rights-based protection of the subject's autonomy above all else, made it difficult to justify research with no intended benefit when subjects are incompetent to make a valid informed choice to participate. Subsequent codes providing for research with incompetent subjects followed the lead of Nuremberg, substituting the informed authorization of a proxy for (...) the informed consent of the subject. (shrink)

The essays in this issue of JMP are devoted to critical engagement of my book, The Anticipatory Corpse. The essays, for the most part, accept the main thrust of my critique of medicine. The main thrust of the criticism is whether the scope of the critique is too totalizing, and whether the proposed remedy is sufficient. I greatly appreciate these interventions because they allow me this occasion to respond and clarify, and to even further extend the argument of my book. (...) In this response essay, I maintain that the regnant social imaginary of medicine is the regnant social imaginary of our time. It is grounded in a specific ontotheology: where ontology is a power ontology; where material is malleable to the open-ended organization of power and dependent only on working out the efficient mechanisms of its enactment; where ethically it is oriented only to the immanent telos of utility maximization in the short run, and ultimately to some posthuman future in the long run. This ontotheology originates in the anticipatory corpse and is ordered toward some god-like posthuman being. The entire ontotheology finds enactment through the political economy of neoliberalism. This social imaginary constantly works to insulate itself from other social imaginaries through the use of its institutional power, through marginalization, circumscription, or absorption. The modern social imaginary of neoliberal societies marginalizes and politically isolates other social imaginaries, or transforms them into something acceptable to the neoliberal imaginary. Yet, these other social imaginaries could influence the larger social imaginary in novel ways, sometimes through withdrawal and sometimes through challenges. These other practices—again, usually practices ordered according to different ontological and teleological purposes—might serve as a source of renewal and transformation, but only if the practitioners of these other social imaginaries understand the ontotheological powers that they are up against. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 19-21, June 2011.

When health professionals experience moral distress during routine clinical practice, they are challenged to maintain integrity through conscientious practice guided by ethical principles and virtues that promote the dignity of all human beings who need care. Their integrity also needs preservation during a crisis like the COVID-19 pandemic, especially when faced with triage protocols that allocate scarce resources. Although a crisis may change our ability to provide life-saving treatment to all who need it, a crisis should not change the ethical (...) values that should always be guiding clinical care. Enduring ethical commitments should encourage clinicians to base treatment decisions on the medical needs of individual patients. This approach contrasts with utilitarian attempts to maximize selected aggregate outcomes by using scoring systems that use short-term and possibly long-term prognostic estimates to discriminate between patients and thereby treat them unequally in terms of their eligibility for life-sustaining treatment. During times of crisis and calm, moral communication allows clinicians to exercise moral agency and advocate for their individual patients, thereby demonstrating conscientious practice and resisting influences that may contribute to compartmentalization, moral injury, and burnout. (shrink)

Children and individuals with developmental disabilities compared to typical participants are disadvantaged not only by virtue of being vulnerable to risks inherent in research participation but also by the higher likelihood of exclusion from research altogether. Current regulatory and ethical guidelines although necessary for their protection do not sufficiently ensure fair distributive justice. Yet, in view of disproportionately higher burdens of co-occurring physical and mental disorders in individuals with DD, they are better positioned to benefit from research by equitable participation. (...) Greater elucidation of this ethical dilemma is called for by researchers, institutional review boards, and funding agencies to urgently redress the imbalance. This article discusses many of the regulatory principles to ensure better research participation of children and individuals with DD: human rights, validity, distributive justice, beneficence/nonmaleficence, and autonomy. (shrink)

When a patient visits his doctor there is, as well as a spoken dialogue, also an unspoken, or tacit, dialogue between them. This may not be evident unless that dialogue breaks down when the psychological or moral terms of reference of each are seen to be different. The author of this paper tries to elucidate the framework in which physician and patient think, and in so doing allow an understanding of why the physician may appear to be rigid and authoritarian (...) in his dealing with his patients and the patient uncooperative. (shrink)

Early in the COVID-19 pandemic in the United States, concern that there could be a shortage of ventilators raised the possibility of rationing care. Denying patients life-saving care captures our moral imagination, prompting the demand for a defensible framework of ethical principles for determining who will live and who will die. Behind the moral dilemma posed by the shortage of a particular medical good lies a broad moral geography encompassing important and often unarticulated societal values, as well as assumptions about (...) the nature and purpose of health care and the consequences of long-standing choices about health care as a social good. This article explores what COVID-19 has exposed concerning values and choices around health care in the United States. Employing the lens of Catholic Social Thought, it argues for an approach to rationing that is grounded in respect for human dignity, committed to distributing social goods in light of the common good, and self-conscious about the construction of vulnerability to illness and death. (shrink)

Past ages of medical care are condemned in modern philosophical and medical literature as being too paternalistic. The normal account of good medicine in the past was, indeed, paternalistic in an offensive way to modern persons. Imagine a Jean Paul Sartre going to the doctor and being treated without his consent or even his knowledge of what will transpire during treatment! From Hippocratic times until shortly after World War II, medicine operated in a closed, clubby manner. The knowledge learned in (...) medicine was not shared with the patients, who were in general poorly educated and for the most part completely ignorant of the craft of medicine and the physicians (but not, perhaps, of folk medicine). Physicians were cautioned against telling patients too much about their Illness and/or their recovery, perhaps because physicians themselves did not have an enormous armamentarium to confront disease. (shrink)

The nature and scope of medical humanities are under debate. Some regard this field as consisting of those parts of the humanistic sciences that enhance our understanding of clinical practice and of medicine as historical phenomenon. In this article it is argued that aesthetic experience is as crucial to this project as are humanistic studies. To rightly understand what medicine is about we need to acknowledge the equal importance of two modes of understanding, intertwined and mutually reinforcing: the mode of (...) aesthetic imagination and the mode of analytical reflection. (shrink)

Children's consent to treatment remains a contentious topic, with confusing legal precepts and advice. This paper proposes that informed consent in children should be regarded as shared between children and their families, the balance being determined by implicit, developmentally based negotiations between child and parent--a "family rule" for consent. Consistent, operationalized procedures for ethically obtaining consent can be derived from its application to both routine and contentious situations. Therefore, use of the "family Rule" concept can consistently define negligent procedure in (...) obtaining consent from children, and could be used as a unifying framework in the development of new professional guidelines. A "guideline"-based approach to children's consent to treatment may offer greater individuality than a "rights"-based approach, though careful training and oversight will be needed for it to be effective. (shrink)

Intentionally or not, our clinical practice is informed by our philosophical premises. A subtle misunderstanding can have frequent, though insidious, implications in day-to-day clinical encounters....

The doctor-patient relationship is examined an emphasis on the comparison between professional and moral principles. Many therapeutic measures have opposite-directed alternative steps with an equal degree of justification, so that no logical preference is attainable and conflicts ensue. Thus patients come for relief and are ordered to endure further pain and discomfort; or weaker individuals exaggerate their complaints hypochomdriacally, and thus need a great deal of understanding, yet paradoxically they are prone to receive less support than stronger ones. Further conflicts (...) arise between our devotion to human well-being and dignity, and our obligation to disrespect some of their rights for self-determination. Furthermore, various dutifully performed doctoring activities run counter to our own social needs and interests; last, but not least, human imperfection colours some of our decisions, putting a definite blemish on their value. In conclusion, physicians must bear the constant burden of paradoxically-opposed alternatives, and they confront pitfalls of worongdoing at every therapeutic step. Their only guidelines are intuition and professional dedication. (shrink)