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)

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)

Two approaches have emerged to resolve discrepancies between predictions and observations at galactic and cosmological scales: introducing dark matter or modifying the laws of gravity. Practitioners of each approach claim to better satisfy a different explanatory ideal, either unification or simplicity. In this chapter, we take a closer look at the ideals and at the successes of these approaches in achieving them. Not only are these ideals less divisive than assumed, but moreover we argue that the approaches are focusing on (...) different aspects of the same ideal. This realisation opens up the possibility of a more fruitful trading zone between dark matter and modified gravity communities. (shrink)

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)

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

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)

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)

"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)

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)

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)

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)

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 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 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)

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)

Research using mHealth apps has the potential to positively impact health care management and outcomes. However, choosing an appropriate mHealth app may be challenging for the health researcher. The author team used existing evaluation tools, checklists, and guidelines to assess selected mHealth apps to identify strengths, challenges, and potential gaps within existing evaluation tools. They identified specific evaluation tool components, questions, and items most effective in examining app content, usability, and features, including literacy demand and cultural appropriateness; technical information; practical (...) aspects of app functionality; and evolving capabilities of mobile medical apps. Challenges included the subjective nature of the results, time required to complete the evaluation, lack of emphasis on evidence‐based content, and inadequate tool flexibility. Health researchers considering the integration of mobile apps into research will benefit from evaluation tools that assess both evidence‐based content and the ability of the mobile app to securely integrate with other digital technologies involved in patient care. Next steps will include the involvement of health care providers and professionals, including nurses a wide range of expertise, to develop an mHealth evaluation tool that focuses on identifying quality, evidence‐based mobile apps into patient outcomes research. (shrink)

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

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.

The principle of informed consent is so firmly established in bioethics and biomedicine that the term was soon bowdlerized in common practice, such that engaging in the informed decision-making process with patients or research subjects is now often called “consenting” them. This evolution, from the original concept to the rather questionable coinage that makes consent a verb, reveals not only a loss of rhetorical precision but also a fundamental shift in the potential meaning, value, and implementation of the informed consent (...) process. Too often, the sharing of information has been replaced by the mere acquisition of agreement with the authority ostensibly offering a choice.Scholars of informed consent agree that its salience and its legitimacy derive from a fiduciary duty to inform, in order to respect, protect, and promote autonomous decision making by those to whom the duty is owed. (shrink)

The intrusive state has long viewed women as fetal containers. The Dobbs decision goes further, essentially causing women to vanish when fetuses are abstracted from their relationships to pregnant persons. The ways in which women are first controlled and then made invisible are clearly connected with the move from obedience to omission that has historically affected black Americans. When personal decisionmaking and participation in democracy are regarded as threats, those threatened restrict decisional freedom and political power, deepening structural injustices relating (...) to sex, race, and poverty. Fear of Dobbs has health effects on conditions unrelated to pregnancy and connects with erasures of human value that are not health-related. We reaffirm solidarity as a countering influence. Taking account of the richly relational context in which issues like abortion and political representation arise should lead to better, more meaningful policies, making so many people impossible to unsee. (shrink)

Background Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Aim Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Method Postal survey of all RECs in Ireland. Results Response rate was 62.5% (n=50). 80% of RECs (...) reported not to have any established policy on the payment of research subjects while 20% had refused ethics approval to studies because the investigators proposed to pay research participants. The most commonly cited concerns were the potential for inducement and undermining of voluntary consent. Conclusions There is considerable variability among RECs on the payment of research participants and a lack of clear consensus guidelines on the subject. The development of standardised guidelines on the payment of research subjects may enhance recruitment of research participants. (shrink)

On September 8, 2015, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the “Common Rule.” The NPRM proposes several changes to the current system, including a dramatic shift in the approach to secondary research using biospecimens and data. Under the current rules, it is relatively easy to use biospecimens and data for secondary research. This approach systematically facilitates secondary research with (...) biospecimens and data, maximizing the capacity for substantial public benefit. However, it has been criticized as insufficiently protective of the privacy and autonomy interests of biospecimen and data sources. Thus, the NPRM proposes a more restrictive regime, although more so for biospecimens than data. Both the status quo and the NPRM's proposal are critically flawed. (shrink)