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)

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)

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.

This paper reviews the experience of an integrated approach to CSR in the U.S. electric utility sector. The authors report on the results of Southern Company’s historical definition of CSR as a dynamic model, balancing stakeholder needs through shifting pressures to assure long-term shareholder value, superior customer, price performance, and sustainable economic development. Using financial and utility sector measures, the paper assesses the company’s “balancing” approach to addressing CSR, which weights corporate, environmental, community, and economic factors in driving successful and (...) sustained financial, social, and environmental performance. The paper concludes by suggesting that CSR success in this sector requires, first, that the global warming issue be governed by the same balancing considerations to which all stakeholders and their legitimate interests are subject, and second, an energy policy that embraces both atechnology policy and appropriate regulatory incentives. (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)

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)

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

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)

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)

Medical teams care for severely premature infants under conditions of emergency and uncertainty that make parental involvement very difficult. Parents can be invited into a decisional relationship with the team that enables them to assess more fully the meaning of their child's illness.

The target article retains the traditional account of saccades as conjugate eye movements. However, recent single-unit recordings of premotor cells in the saccade pathway (excitatory burster neurons [EBNs]) found that they do not encode conjugate eye velocity, but rather, monocular eye velocity. These data argue against the traditional concept of saccades as inherently conjugate. Instead, they suggest a monocular mechanism in the sensorimotor transformation stage of saccade generation. This commentary will discuss the implications of these data for the saccade generation (...) model proposed in Findlay & Walker's target article. (shrink)

A contribution to the sixth installment of the Common Knowledge symposium “Apology for Quietism,” this article explores the possibilities for quietist narrative. Since quietism suggests resistance or condescension to telos, suspense, will, and the kinds of spirituality, politics, and ways of being associated with them, it seems unlikely that a narrative would be written or read by a practitioner of “ideal indifference” or by anyone averse on principle to initiative. But Gilbert White's text of 1789, The Natural History and Antiquities (...) of Selborne comes as close to being a quietist narrative as is conceivable. Describing the environment of a single English parish, White's text places stillness on exhibit as an indication of commitment to an ethics of self-unregarding attentiveness. But the stillness of Selborne, King argues, is a conspicuous stillness—a practice of being still in face of the natural world. As an Anglican minister, White explicitly demonstrates the arguments of eighteenth-century natural theology. Having stilled his will to interfere, he can observe the activity of God's creations; and White does so in order to understand God better. Thus, White's desisting or withdrawal is in no way based in defeatism, indolence, or aimlessness. Moreover, King argues, White aims to produce stillness as a formal quality of his text and, through it, to produce a like stillness and attentiveness in the reader. Quietist narrative is meant to help the reader still his or her acquisitiveness and develop instead observational capabilities, a capacity simply to admire (or stand apart, in awe), and, above all, patience. To the extent that it fosters in us a principled “do nothing” stance with respect to our natural ecology, King concludes, quietism of Gilbert White's kind may represent the most radical of environmental politics. (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)

Science and revelation have been presented as two books with the same “author,” their reconciliation being called “concordism.” Teilhard opposed concordism, insisting that supposed “revelations” be treated as scientific hypotheses to be verified or not in experience. Applying his criterion for truth (Does it bring “coherence and fecundity” to the phenomena?) to Christian revelation, he told of finding “an explosion of dazzling flashes.” So Teilhard spoke of the hypothesis as the supreme spiritual act wherein the dust of experience takes on (...) form and is kindled at the fire of knowledge. (shrink)

. Several recent Roman Catholics who were known for their devotion have left accounts of their troubled faith. I consider three of these: St. Therese of Lisieux, Mother Teresa of Calcutta, and Pierre Teilhard de Chardin. Then I tell of the troubled atheism of Jean‐Paul Sartre. Finally, I use texts of Sartre and Teilhard to understand the unsettled nature of belief.

_Bioethics, Public Moral Argument, and Social Responsibility_ explores the role of democratically oriented argument in promoting public understanding and discussion of the benefits and burdens of biotechnological progress. The contributors examine moral and policy controversies surrounding biomedical technologies and their place in American society, beginning with an examination of discourse and moral authority in democracy, and addressing a set of issues that include: dignity in health care; the social responsibilities of scientists, journalists, and scholars; and the language of genetics and (...) moral responsibility. (shrink)