Limitations on reproductive decision making, including forced sterilization and involuntary birth control, raise significant ethical challenges. In the United States, these issues are further complicated by a disturbing history of the abuse and victimization of vulnerable populations. One particularly fraught challenge is the risk of teratogenicity posed by moodstabilizing psychiatric medications in patients who are incapable of appreciating such dangers. Long-acting reversible contraception (LARC) offers an intervention to prevent pregnancy among individuals who receive such treatments, but at a cost to (...) their reproductive autonomy. This article examines the ethical issues involved in the use of involuntary LARC for patients on teratogenic psychiatric medications (TPMs) and argues that such an approach can only be justified as a last resort after a careful consideration of the alternatives and an assessment of potential risks and benefits. (shrink)

First Published in 1999. Routledge is an imprint of Taylor & Francis, an informa company.

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the waiver (...) of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood—the standard treatment for hemorrhagic shock—is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards. (shrink)

In this article, I will outline an assessment model that allows instructors to continuing assigning term papers and argumentative papers without compromising the authenticity of student assessment. This path forward relies upon a pseudo flipped classroom model in which students will complete a scaffolded term paper through a series of in-class assessments that build upon previously completed components. The final steps of completing this assignment will require producing a draft and final version of a traditional term paper outside of the (...) classroom but only after the instructor ensures they have critically thought through the preceding components independently. The intention is to maintain the nuance, critical thinking, engagement with primary and secondary sources, and depth of content comprehension that a thoughtful paper requires, while also ensuring that students are completing the work themselves and not merely outsourcing bits and pieces of it to LLMs. (shrink)

Important advances in biomedical and behavioral research ethics have occurred over the past few decades, many of them centered on identifying and eliminating significant harms to human subjects of research. Comprehensive attention has not been paid to the totality of harms experienced by animal subjects, although scientific and moral progress require explicit appraisal of these harms. Science is a public good and the prioritizing within, conduct of, generation of, and application of research must soundly address questions about which research is (...) morally defensible and valuable enough to support through funding, publication, tenure, and promotion. Likewise, educational pathways of re-imagined science are critical. (shrink)

Argumentation as the public exchange of reasons is widely thought to enhance deliberative interactions that generate and justify reasonable public policies. Adopting an argumentation-theoretic perspective, we survey the norms that should govern public argumentation and address some of the complexities that scholarly treatments have identified. Our focus is on norms associated with the ideals of correctness and participation as sources of a politically legitimate deliberative outcome. In principle, both ideals are mutually coherent. If the information needed for a correct deliberative (...) outcome is distributed among agents, then maximising participation increases information diversity. But both ideals can also be in tension. If participants lack competence or are prone to biases, a correct deliberative outcome requires limiting participation. The central question for public argumentation, therefore, is how to strike a balance between both ideals. Rather than advocating a preferred normative framework, our main purpose is to illustrate the complexity of this theme. (shrink)

"The fixed person for fixed duties, who in older societies was such a godsend, in the future ill be a public danger." Twenty years ago, a single legal metaphor accurately captured the role that American society accorded to physicians. The physician was "c- tain of the ship." Physicians were in charge of the clinic, the Operating room, and the health care team, responsible - and held accountabl- for all that happened within the scope of their supervision. This grant of responsibility (...) carried with it a corresponding grant of authority; like the ship's captain, the physician was answerable to no one regarding the practice of his art. However compelling the metaphor, few would disagree that the mandate accorded to the medical profession by society is changing. As a result of pressures from a number of diverse directions - including technological advances, the development of new health professionals, changes in health care financing and delivery, the recent emphasis on consumer choice and patients' rights - what our society expects phy- cians to do and to be is different now. The purpose of this volume is to examine and evaluate the conceptual foundations and the moral imp- cations of that difference. Each of the twelve essays of this volume assesses the current and future validity of the "captain of the ship" metaphor from a different perspective. The essays are grouped into four sections. In Section I, Russell Maulitz explores the physician's role historically. (shrink)

Biodefense and emerging infectious disease animal research aims to avoid or ameliorate human disease, suffering, and death arising, or potentially arising, from natural outbreaks or intentional deployment of some of the world’s most dreaded pathogens. Top priority research goals include finding vaccines to prevent, diagnostic tools to detect, and medicines for smallpox, plague, ebola, anthrax, tularemia, and viral hemorrhagic fevers, among many other pathogens (National Institute of Allergy and Infectious Diseases [NIAID] priority pathogens). To this end, increased funding for conducting (...) research, developing research facilities, and purchasing (stockpiling) developed vaccines, diagnostic tools, and therapeutics .. (shrink)

Bioethics needs an expanded moral vision. It is now time for bioethics to take full account of the problems of health disparities and structural injustice that are made newly urgent by the COVID-19 pandemic and the effects of climate change. Nancy M. P. King, Gail E. Henderson, and Larry R. Churchill make the case for a more social understanding and application of justice, a deeper humility in assessing expertise in bioethics consulting, a broader and more relevant research agenda, and (...) greater appreciation of the profound health implications of global warming. (shrink)

A self-fulfilling prophecy in neuroprognostication occurs when a patient in coma is predicted to have a poor outcome, and life-sustaining treatment is withdrawn on the basis of that prediction, thus directly bringing about a poor outcome for that patient. In contrast to the predominant emphasis in the bioethics literature, we look beyond the moral issues raised by the possibility that an erroneous prediction might lead to the death of a patient who otherwise would have lived. Instead, we focus on the (...) problematic epistemic consequences of neuroprognostic SFPs in settings where research and practice intersect. When this sort of SFP occurs, the problem is that physicians and researchers are never in a position to notice whether their original prognosis was correct or incorrect, since the patient dies anyway. Thus, SFPs keep us from discerning false positives from true positives, inhibiting proper assessment of novel prognostic tests. This epistemic problem of SFPs thus impedes learning, but ethical obligations of patient care make it difficult to avoid SFPs. We then show how the impediment to catching false positive indicators of poor outcome distorts research on novel techniques for neuroprognostication, allowing biases to persist in prognostic tests. We finally highlight a particular risk that a precautionary bias towards early withdrawal of life-sustaining treatment may be amplified. We conclude with guidelines about how researchers can mitigate the epistemic problems of SFPs, to achieve more responsible innovation of neuroprognostication for patients in coma. (shrink)

Institutional review boards and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction (...) of all the time and attention lavished on risk disclosure has been devoted to discussing whether and when potential benefit to subjects can reasonably be claimed and, if so, how it should be described in the consent form and process.Traditionally, IRBs and regulators have worked to ensure that clear lines can be drawn between research that, by definition, carries no potential for direct benefit — because it uses healthy volunteers or because it is not foreseeably focused on the development of treatments — and research that does have the development of effective treatments as its goal. (shrink)

Psychologists wish to identify and study the mechanisms and implications of nomothetic constructs that reveal truths about human nature and span across operationalizations. To achieve this goal, psychologists should spend more time carefully describing and measuring constructs across a wide range of methods and measures, and less time rushing to explain and predict.

Gene therapy is still a very crude way of treating very complicated problems. It's hard to get new genes to go where they're needed, and hard to keep them from going where they're not wanted. The worst‐case scenario is that they find their way into a patient's germ cells—eggs or sperm—and end up harming the patient's offspring. Yet this possibility is hard to study in human trials, and would be hard to deal with in the clinic. It should, instead, simply (...) be avoided. Doing so requires fundamentally changing our approach to gene therapy. (shrink)

Clinical gene transfer research has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee. This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.Clinical GTR is governed by the same (...) oversight system as most clinical trials, with a significant addition: the RAC. Like other research with human subjects, GTR, if it is affiliated with a federally funded institution, must be approved by an institutional review board whose activities are governed by the common rule, that is, the federal regulations for protection of human subjects in research. Like other research intended to produce a drug, device, or biologic to be marketed in the United States, GTR is also overseen by the Food and Drug Administration. (shrink)

The three important target articles make a strong case for regarding racism as a public health crisis. Each calls for advocacy by the bi...

Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and (...) honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime. (shrink)

Giving up the increasingly troubled distinction between “experiment” and “treatment” would make it easier to focus on informed consent and harder to beg questions about uncertainty and shared decisionmaking in medicine.

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

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...) Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)

The Covid‐19 pandemic has concentrated bioethics attention on the “lifeboat ethics” of rationing and fair allocation of scarce medical resources, such as testing, intensive care unit beds, and ventilators. This focus drives ethics resources away from persistent and systemic problems—in particular, the structural injustices that give rise to health disparities affecting disadvantaged communities of color. Bioethics, long allied with academic medicine and highly attentive to individual decision‐making, has largely neglected its responsibility to address these difficult “upstream” issues. It is time (...) to broaden our teaching, research, and practice to match the breadth of the field in order to help address these significant societal inequities and unmet health needs. (shrink)

The inaugural collection in an exciting new exchange between philosophers and geographers, this volume provides interdisciplinary approaches to the environment as space, place, and idea. Never before have philosophers and geographers approached each other's subjects in such a strong spirit of mutual understanding. The result is a concrete exploration of the human-nature relationship that embraces strong normative approaches to environmental problems.

Cheating through the use of illegal performance enhancements (such as doping) is a persistent problem in sport. It has been suggested that one response to this problem is to separate sport into two parallel leagues. One league would resemble sport as it is currently practised ? i.e. with restrictions on use of particular enhancements ? and the other would not possess these restrictions, allowing those that wish to use currently illegal enhancements to do so. In this paper I articulate the (...) ?two leagues? proposal further and subject it to critical scrutiny. The proposal fails. It does so by failing to address conceptual confusion regarding enhancement use in sport; by replicating in the new league the current problems associated with enhancement-based cheating; and by creating new problems. In an attempt to revive it I describe other possible justifications for the proposal, based on its promotion of personal autonomy, and rights-based justifications. These fail, with the exception of a group right claiming provision of the enhanced league as a participatory good. I conclude that this latter use of the proposal is the only sensible one, but it nevertheless faces significant obstacles. (shrink)

First-in-human research has several characteristics that require special attention with respect to ethics and human subjects protections. At least some nanomedical technologies may also have characteristics that merit special attention in clinical research, as other papers in this symposium show. This paper considers how to address these characteristics in the consent form and process for FIH nanomedicine research, focusing principally on experimental nanotherapeutic interventions but also considering nanodiagnostic interventions.It is essential, as a starting point, to recognize that the consent form (...) and process are by no means the primary protectors of human subjects. Instead, consideration of the form and content of informed consent becomes relevant only after a clinical trial has been reviewed and deemed scientifically and ethically acceptable.Two convergent types of challenges to informed consent are posed by nanomedicine FIH research. First, some issues appear generally applicable to FIH research, but have specific nanomedicine implications. (shrink)

One of my favorite bioethics quotes is nearing 50 years old:Let us not forget that progress is an optional goal, not an unconditional commitment, and that its tempo in particular, compulsive as it may become, has nothing sacred about it. Let us also remember that a slower progress in the conquest of disease would not threaten society, grievous as it is to those who have to deplore that their particular disease be not yet conquered, but that society would indeed be (...) threatened by the erosion of those moral values whose loss, possibly caused by too ruthless a pursuit of scientific progress, would make its most dazzling triumphs not worth having.Despite its age, this invocation seems to me increasingly relevant as time... (shrink)