Before participants can be enrolled in a clinical trial, an institutional review board must determine that the risks that the research poses to participants are ‘reasonable.’ This paper examines the two dominant frameworks for assessing research risks and argues that each approach suffers from significant shortcomings. It then considers what issues must be addressed in order to construct a framework for risk assessment that is grounded in a compelling normative foundation and might provide more operationally precise guidance to the deliberations (...) of various stakeholders. The paper concludes by sketching the outlines of what is referred to as the ‘Integrative Approach’ to risk assessment and by highlighting some of the ways in which this approach may be more promising than current alternatives. (shrink)

Recent debates over the use of sham surgery as a control for studies of fetal tissue transplantation for Parkinson’s disease have focused primarily on rival interpretations of the US federal regulations governing human-subjects research. Using the core ethical and methodological considerations that underwrite the equipoise requirement, we nd strong prima facie reasons against using sham surgery as a control in studies of cellular-based therapies for Parkinson’s disease and more broadly in clinical research. Additionally, we believe that these reasons can be (...) generalized to apply to the use of other placebo controls that carry signi cant risks of positive harms in and of themselves. As a result, our arguments are centrally relevant to the emerging drive to subject therapies with a surgical component to the same rigorous standards of evaluation as those governing the approval of new pharmaceuticals. (shrink)

London shows that principled leadership and business diplomacy not only provide direction for management, but they also enhance development of leadership in ...

This paper examines the role of equipoise in evaluating international research. It distinguishes two possible formulations of the equipoise requirement that license very different evaluations of international research proposals. The interpretation that adopts a narrow criterion of similarity between clinical contexts has played an important role in one recent controversy, but it suffers from a number of problems. An alternative interpretation that adopts a broader criterion of similarity does a better job of avoiding both exploitation of the brute fact of (...) social deprivation and the exploitation of needy populations for the benefit of more well-off populations. It also holds out the promise of reconciling the need to find interventions that can be employed in developing world contexts with the cluster of moral values that must constrain the way such research is carried out. (shrink)

Recent claims that artificial intelligence (AI) systems demonstrate “emergent abilities” have fueled excitement but also fear grounded in the prospect that such systems may enable a wider range of parties to make unprecedented advances in areas that include the development of chemical or biological weapons. Ambiguity surrounding the term “emergent abilities” has added avoidable uncertainty to a topic that has the potential to destabilize the strategic landscape, including the perception of key parties about the viability of nonproliferation efforts. To avert (...) these problems in the future, scientists, developers, policymakers, and other parties should take cred- ible steps to strengthen the health of the scientific ecosystem around AI. (shrink)

To cite this Article: , 'Two Dogmas of Research Ethics and the Integrative Approach to Human-Subjects Research', Journal of Medicine and Philosophy, 32:2, 99 - 116 To link to this article: DOI: 10.1080/03605310701255727 URL: http://dx.doi.org/10.1080/03605310701255727..

This book argues that the Fourth Gospel offers a potentially transformative response to the question of suffering and the human compulsion to blame. By engaging with the symbols of light, vision, and the Good Shepherd, readers can experience a theodical spirituality that transforms resentment and rage through divine forgiveness.

Recent claims that artificial intelligence (AI) systems demonstrate “emergent abilities” have fueled excitement but also fear grounded in the prospect that such systems may enable a wider range of parties to make unprecedented advances in areas that include the development of chemical or biological weapons. Ambiguity surrounding the term “emergent abilities” has added avoidable uncertainty to a topic that has the potential to destabilize the strategic landscape, including the perception of key parties about the viability of nonproliferation efforts. To avert (...) these problems in the future, scientists, developers, policymakers, and other parties should take credible steps to strengthen the health of the scientific ecosystem around AI. (shrink)

An Aristotelian conception of practical ethics can be derived from the account of practical reasoning that Aristotle articulates in his Rhetoric and this has important implications for the way we understand the nature and limits of practical ethics. An important feature of this conception of practical ethics is its responsiveness to the complex ways in which agents form and maintain moral commitments, and this has important implications for the debate concerning methods of ethics in applied ethics. In particular, this feature (...) enables us to understand casuistry, narrative, and principlism as mutually supportive modes of moral inquiry, rather than divergent and mutually exclusive methods of ethics. As a result, an Aristotelian conception of practical ethics clears the conceptual common ground upon which practical ethicists can forge a stable and realistic self-understanding. (shrink)

Research ethics is often said to have been born of scandal. Whether or not this is true of the field in general, it does seem to be the case for much of the literature on the ethics of international research. But in When Experiments Travel: Clinical Trials and the Global Search for Human Subjects, the anthropologist Adriana Petryna sets out to portray not scandal, but the routine offshoring of clinical trials. Through gripping interviews and detailed case studies, she follows the (...) lifecycle of international research, tracing its connections to health systems, legal systems, and entitlement programs. She also provides a glimpse into the complex social relations on which the research process depends, allowing her reader to see the way the labor is divided, the responsibilities delegated, the risks shifted, and decisions with far-reaching social consequences shaped by a spectrum of market, regulatory, and cultural influences. (shrink)

These range from merely good reads to really outstanding books. A raw ranking of them would be of little use to others, unless I explained why I gave them the ranks I did, and anyway I'd probably give different rankings by the time your read this. (When I know of an on-line review about a book which I agree with --- e.g., because I wrote it --- I've included a link; also some exceedingly short remarks about interesting cases.).

This dissertation explores Plato's conception of the nature and value of wisdom and its relationship to the ethical virtues. It is argued that throughout what are referred to as Plato's early and middle dialogues, wisdom is identified with the political art and that, as such, those, dialogues consistently treat moral knowledge as a kind of craft knowledge. When this conception of wisdom is combined with the Socratic doctrine of the unity of the virtues, however, it raises serious problems for Socrates' (...) ethical theory. It is argued that the dilemma that results in the Euthydemus highlights these problems and that there is an important sense in which the Lysis, Gorgias, and Republic represent attempts to solve this dilemma. It is argued that in the early dialogues Plato focuses solely on the contributive value of virtue but that in these latter dialogues Plato changes his account of the nature and value of the ethical virtues. In these dialogues Plato articulates what I will call the "constitutive value" of virtue, where the value of the virtues is rooted the way in which they constitute the good order of the soul. Ultimately, this allows the ethical virtues to be put forth as the beneficial work that wisdom provides for us. A central goal of the dissertation, then, is to explain this new account of the value of the virtues and to explain the sense in which wisdom rules over or governs the other parts of the soul so as to make the soul good. In this way, the dissertation deals centrally with Plato's conception of value and his moral psychology. (shrink)

Although decision‐making algorithms are not new to medicine, the availability of vast stores of medical data, gains in computing power, and breakthroughs in machine learning are accelerating the pace of their development, expanding the range of questions they can address, and increasing their predictive power. In many cases, however, the most powerful machine learning techniques purchase diagnostic or predictive accuracy at the expense of our ability to access “the knowledge within the machine.” Without an explanation in terms of reasons or (...) a rationale for particular decisions in individual cases, some commentators regard ceding medical decision‐making to black box systems as contravening the profound moral responsibilities of clinicians. I argue, however, that opaque decisions are more common in medicine than critics realize. Moreover, as Aristotle noted over two millennia ago, when our knowledge of causal systems is incomplete and precarious—as it often is in medicine—the ability to explain how results are produced can be less important than the ability to produce such results and empirically verify their accuracy. (shrink)

To find more information on Rowman & Littlefield titles, please visit us at www.rowmanlittlefield.com.

Volume 24, Issue 12, December 2024, Page 29-32.

First-in-human clinical trials represent a critical juncture in the translation of laboratory discoveries. However, because they involve the greatest degree of uncertainty at any point in the drug development process, their initiation is beset by a series of nettlesome ethical questions [1]: has clinical promise been sufficiently demonstrated in animals? Should trial access be restricted to patients with refractory disease? Should trials be viewed as therapeutic? Have researchers adequately minimized risks? The resolution of such ethical questions inevitably turns on claims (...) about future events like harms, therapeutic response, and clinical translation. Recurrent failures in clinical translation, like Eli Lilly's Alzheimer candidate semagacestat, highlight the severe limitations of current methods of prediction. In this case, patients in the active arm of the placebo-controlled trial had earlier onset of dementia and elevated rates of skin cancer [2]. Various authoritative accounts of human research ethics state that decision-making about risk and benefit should be careful, systematic, and non-arbitrary [3]–[5]. Yet, these sources provide little guidance about what kinds of evidence stakeholders should use to ensure their estimates of such events ground responsible ethical decisions. In this article, we suggest that investigators, oversight bodies, and sponsors often base their predictions on a flawed and inappropriately narrow preclinical evidence base. (shrink)

It is useful to be reminded that Spain produced, according to several estimates, about 10,000 plays during its literary Golden Age. Indeed, one of the many positive results from this enterprising b...

The debate over when medical research may be performed in developing countries has steered clear of the broad issues of social justice in favor of what seem more tractable, practical issues. A better approach will reframe the question of justice in international research in a way that makes explicit the links between medical research, the social determinants of health, and global justice.

Volume 24, Issue 12, December 2024, Page 89-91.

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

Nicolas Malebranche (1638–1715) holds that the senses, imagination, and passions aim at survival and the satisfaction of the body’s needs, rather than truth or the good of the mind. Each of these faculties makes a distinctive and, indeed, an indispensable contribution to the preservation of life. Commentators have largely focused on how the senses keep us alive. By comparison, the imagination and passions have been neglected. In this paper, I reconstruct Malebranche’s account of how the imagination contributes to the preservation (...) of the body by compensating for the limitations of the senses. First, the imagination represents non-actual states of affairs, such as probable or possible future states. Second, the imagination forges new and often helpful associations based on past experiences. Third, the imagination (mis)represents that objects will cause pleasure and pain, thereby imbuing them with emotional significance they would otherwise lack. Together, these features flesh out Malebranche’s view that the imagination is necessary for the preservation of life. (shrink)

International codes of ethics play an important role in guiding professional practice in developing countries. In the occupational health setting, codes developing by international agencies have substantial import on protecting working populations from harm. This is particularly so under globalisation which has transformed processes of production in fundamental ways across the globe. As part of the process of revising the Ethical Code of the International Commission on Occupational Health, an African Working Group addressed key challenges for the relevance and cogency (...) of an ethical code in occupational health for an African context through an iterative consultative process. (shrink)

The 2016 CIOMS International ethical guidelines for health‐related research involving humans states that ‘health‐related research should form an integral part of disaster response’ and that, ‘widespread emergency use [of unproven interventions] with inadequate data collection about patient outcomes must therefore be avoided’ (Guideline 20). This position is defended against two lines of criticism that emerged during the 2014 Ebola outbreak. One holds that desperately ill patients have a moral right to try unvalidated medical interventions (UMIs) and that it is therefore (...) unethical to restrict access to UMIs to the clinical trial context. The second holds that clinical trials in contexts of high‐mortality diseases are morally suspect because equipoise does not exist between a standard of care that offers little prospect of clinical benefit and a UMI that might offer some clinical advantage. (shrink)

Innovation is disruptive and a deeply social phenomenon. As a result, discussions of innovation in the Anglo-American philosophical tradition are often tightly bound up with concerns about individual freedom and pluralism, including pluralism about ethical values. In response, stakeholders looking to evaluate and assess ethical aspects of the innovation ecosystem are often driven to pragmatic approaches that utilize a set of ethical values that can be regarded as “free-standing,” or “thin” in the sense that they are not tied to any (...) particular, substantive conception of the good. This set often includes values such as beneficence, nonmaleficence, respect for autonomy, fairness, and justice. Discussions focused on justice, however, are the least extensive and least well-developed. As a result, most approaches are well-suited to surfacing first-order or direct effects of the discrete activities of a relatively narrow set of stakeholders. Paradoxically, however, such analyses are often not well-suited to identifying and evaluating (a) quintessentially social or higher-order effects (such as network-level or institutional level effects), (b) the role of a larger number of stakeholders who shape the innovation ecosystem in more indirect ways, and (c) some of the positive ethical claims of individuals that are relevant to evaluating innovation. After articulating these shortcomings, I argue that they might be overcome by adopting a justice-led framework for evaluating innovation. (shrink)

Wars must be won if our country … is to be protected from unthinkable outcomes, as the events on September 11th most recently illustrated…. This best protection unequivocally requires armed forces having military physicians committed to doing what is required to secure victory…. As opposed to needing neutral physicians, we need military physicians who can and do identify as closely as possible with the military so that they, too, can carry out the vital part they play in meeting the needs (...) of the mission.Counterpoint:We believe the role of the “physician–soldier” to be an inherent moral impossibility because the military physician, in an environment of military control, is faced with the difficult problems of mixed agency that include obligations to the “fighting strength” and … “national security.”. (shrink)

Background: International codes of ethics play an important role in guiding professional practice in developing countries. In the occupational health setting, codes developed by international agencies have substantial import on protecting working populations from harm. This is particularly so under globalisation which has transformed processes of production in fundamental ways across the globe. As part of the process of revising the Ethical Code of the International Commission on Occupational Health, an Africa Working Group addressed key challenges for the relevance and (...) cogency of an ethical code in occupational health for an African context through an iterative consultative process. Discussion: Firstly, even in the absence of strong legal systems of enforcement, and notwithstanding the value of legal institutionalisation of ethical codes, guidelines alone may offer advantageous routes to enhancing ethical practice in occupational health. Secondly, globalisation has particularly impacted on health and safety at workplaces in Africa, challenging occupational health professionals to be sensitive to, and actively redress imbalance of power. Thirdly, the different ways in which vulnerability is exemplified in the workplace in Africa often places the occupational health professional in invidious positions of Dual Loyalty. Fourth, the particular cultural emphasis in traditional African societies on collective responsibilities within the community impacts directly on how consent should be sought in occupational health practice, and how stigma should be dealt with, balancing individual autonomy with ideas of personhood that are more collective as in the African philosophy of ubuntu. To address stigma, practitioners need to be additionally sensitive to how power imbalances at the workplace intersect with traditional cultural norms related to solidarity. Lastly, particularly in the African context, the inseparability of workplace and community means that efforts to address workplace hazards demand that actions for occupational health extend beyond just the workplace. Summary: A stronger articulation of occupational health practice with advocacy for prevention should be an ethical norm. Ethical codes should ideally harmonize and balance individual and community needs so as to provide stronger moral authority guidelines. There is a need to consider an African Charter on Bioethics as complementary and strengthening of existing codes for the region. (shrink)

To give substance to the rhetoric of ‘learning health systems’, a variety of novel trial designs are being explored to more seamlessly integrate research with medical practice, reduce study duration and reduce the number of participants allocated to ineffective interventions. Many of these designs rely on response adaptive randomisation. However, critics charge that RAR is unethical on the grounds that it violates the principle of equipoise. In this paper, I reconstruct critiques of RAR as holding that it is inconsistent with (...) five important ethical principles. I then argue that these criticisms rest on a faulty view of equipoise encouraged by the idea that a RAR study models the beliefs of a single rational agent about the relative merits of the interventions being studied. I outline a view in which RAR models an idealised health system in which diverse communities of fully informed experts shrink or grow as their constituent members update their expert opinions in light of reliable medical evidence. I show how a proper understanding of clinical equipoise can reconcile this conception of RAR with these five ethical principles. This analysis removes an in-principle objection to RAR and sheds important light on the relationship between clinical equipoise and transient diversity in the scientific community. (shrink)