Volume 19, Issue 10, October 2019, Page 101-103.

Quality and service improvement (QSI) research employs a broad range of methods to enhance the efficiency of healthcare delivery. QSI research differs from traditional healthcare research and poses unique ethical questions. Since QSI research aims to generate knowledge to enhance quality improvement efforts, should it be considered research for regulatory purposes? Is review by a research ethics committee required? Should healthcare providers be considered research participants? If participation in QSI research entails no more than minimal risk, is consent required? The (...) lack of consensus on answers to these questions highlights the need for ethical guidance. Three distinct approaches to classifying QSI research in accordance with existing ethical principles and regulations can be found in the literature. In the first approach, QSI research is viewed as distinct from other types of healthcare research and does not require regulation. In the second approach, QSI research falls within regulatory guidelines but is exempt from research ethics committee review. In the third approach, QSI research is deemed to be part of the learning healthcare system and, as such, is subject to a different set of ethical principles entirely. In this paper, we critically assess each of these views. While none of these approaches is entirely satisfactory, we argue that use of the ethical principles governing research provides the best means of addressing the numerous questions posed by QSI research. (shrink)

Background Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. Methods We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Results Our (...) review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. Conclusion The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs. (shrink)

Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four (...) major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs. (shrink)

Pragmatic comparative effectiveness randomized controlled trials evaluate the effectiveness of one interventions under real-world clinical conditions. The results of ceRCTs are often directly generalizable to everyday clinical practice, providing information critical to decision-making by patients, clinicians, and healthcare policymakers. The PRECIS-2 framework identifies nine domains that serve to score a trial on a continuum between very explanatory to very pragmatic. According to the framework, pragmatic trials may have one or more of the following features: there are fewer eligibility criteria for (...) participants, in an... (shrink)

The increasing use of cluster randomised trials in low-resource settings raises unique ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials is the first international ethical guidance document specific to cluster trials, but it is unknown if it adequately addresses issues in low-resource settings. In this paper, we seek to identify any gaps in the Ottawa Statement relevant to cluster trials conducted in low-resource settings. Our method is to analyse a prototypical cluster trial conducted (...) in a low-resource setting with the Ottawa Statement; to identify ethical issues in the design or conduct of the trial not captured adequately and to make recommendations for issues needing attention in forthcoming revisions to the Ottawa Statement. Our analysis identified six ethical aspects of cluster randomised trials in low-resource settings that require further guidance. The forthcoming revision of the Ottawa Statement should provide additional guidance on these issues: streamlining research ethics committee review for collaborating investigators who are affiliated with other institutions; the classification of lay health workers who deliver study interventions as health providers or research participants; the dilemma experienced by investigators when national standards seem to prohibit waivers of consent; the timing of gatekeeper engagement, particularly when researchers face funding constraints; providing ancillary care in health services or implementation trials when a routine care control arm is known to fall below national standards and defining vulnerable participants needing protection in low-resource settings. (shrink)

The ethics of the Flexibility In duty hour Requirements for Surgical Trainees trial have been vehemently debated. Views on the ethics of the FIRST trial range from it being completely unethical to wholly unproblematic. The FIRST trial illustrates the complex ethical challenges posed by cluster randomised trials of policy interventions involving healthcare professionals. In what follows, we have three objectives. First, we critically review the FIRST trial controversy, finding that commentators have failed to sufficiently identify and address many of the (...) relevant ethical issues. The 2012 Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials provides researchers and research ethics committees with specific guidance for the ethical design and conduct of CRTs. Second, we aim to demonstrate how the Ottawa Statement provides much-needed clarity to the ethical issues in the FIRST trial, including: research participant identification; consent requirements; gatekeeper roles; benefit-harm analysis and identification of vulnerable participants. We nonetheless also find that the FIRST trial raises ethical issues not adequately addressed by the Ottawa Statement. Hence, third and finally, we raise important questions requiring further ethical analysis and guidance, including: Does clinical equipoise apply to policy interventions with little or no evidence-base? Do healthcare providers have an obligation to participate in research? Does the power-differential in certain healthcare settings render healthcare providers vulnerable to duress and coercion to participant in research? If so, what safeguards might be implemented to protect providers, while allowing important research to proceed? (shrink)

ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a (...) waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001).DiscussionNot obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public’s trust in research. (shrink)

Spinoza and modern thought, by Lawson P. Chambers.-- Existence and value, by George R. Dodson.-- The realm of necessity, by Charles E. Cory.

Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially (...) in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. Semi-structured interviews with key stakeholders, across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications. (shrink)

What does it mean to consider the world of AI through a Christian lens? Rapid developments in AI continue to reshape society, raising new ethical questions and challenging our understanding of the human person. Encountering Artificial Intelligence draws on Pope Francis’ discussion of a culture of encounter and broader themes in Catholic social thought in order to examine how current AI applications affect human relationships in various social spheres and offers concrete recommendations for better implementation. The document also explores questions (...) regarding personhood, consciousness, and the kinds of relationships humans might have with even the most advanced AI. Through these discussions, this book investigates the theoretical and practical challenges to interpersonal encounter raised by the age of AI. (AI Research Group for the Centre for Digital Culture of the Dicastery of Culture and Education of the Holy See). (shrink)

The present article proposes an integration between cultural psychology and developmental science. Such an integration would draw on the cultural-psychology principle of culture-psyche interactions, as well as on the developmental-science principle of person↔︎context relations. Our proposed integration centers on acculturation, which is inherently both cultural and developmental. Specifically, we propose that acculturation is governed by specific transactions between the individual and the cultural context, and that different types of international migrants (e.g., legal immigrants, undocumented immigrants, refugees, asylum seekers, crisis migrants) (...) encounter quite different culture-psyche interactions and person↔︎context relations. We outline the ways in which various acculturation-related phenomena, such as acculturation operating at macro-level versus micro-level time scales, can be viewed through cultural and developmental lenses. The article concludes with future directions in research on acculturation as an intersection of cultural and developmental processes. (shrink)

Larmore aims to recover three forms of moral complexity that have often been neglected by moral and political philosophers. First, he argues that virtue is not simply the conscientious adherence to principle. Rather, the exercise of virtue apply. He argues - and this is the second pattern of complexity - that recognizing the value of constitutive ties with shared forms of life does not undermine the liberal ideal of political neutrality toward differing ideals of the good life. Finally Larmore agrues (...) for what he calls the heterogeneity of morality. Moral thinking need not be exclusively deontological or consequentialist, and we should recognize that the ultimate sources of moral value are diverse. The arguments presented here do not attack the possibility of moral theory. But in addressing some of the central issues of moral and political thinking today thay attempt to restore to that thinking greater flexibility and a necessary sensitivity to our common experience. (shrink)

A new understanding of political philosophy from one of its leading thinkers What is political philosophy? What are its fundamental problems? And how should it be distinguished from moral philosophy? In this book, Charles Larmore redefines the distinctive aims of political philosophy, reformulating in this light the basis of a liberal understanding of politics. Because political life is characterized by deep and enduring conflict between rival interests and differing moral ideals, the core problems of political philosophy are the regulation (...) of conflict and the conditions under which the members of society may thus be made subject to political authority. We cannot assume that reason will lead to unanimity about these matters because individuals hold different moral convictions. Larmore therefore analyzes the concept of reasonable disagreement and investigates the ways we can adjudicate conflicts among people who reasonably disagree about the nature of the human good and the proper basis of political society. Challenging both the classical liberalism of Locke, Kant, and Mill, and more recent theories of political realism proposed by Bernard Williams and others, Larmore argues for a version of political liberalism that is centered on political legitimacy rather than on social justice, and that aims to be well suited to our times rather than universally valid. Forceful and thorough yet concise, What Is Political Philosophy? proposes a new definition of political philosophy and demonstrates the profound implications of that definition. The result is a compelling and distinctive intervention from a major political philosopher. (shrink)

The essays collected in this volume all explore the problem of the relation between moral philosophy and modernity. Charles Larmore addresses this problem by attempting to define the way distinctive forms of modern experience should orientate our moral thinking. Charles Larmore wonders whether the dominant forms of modern philosophy have not become blind to important dimensions of the moral life. The book argues against recent attempts to return to the virtue-centered perspective of ancient Greek ethics. As well as (...) exploring the differences between ancient and modern ethics, the author examines such topics as the roles of reason and history in our moral understanding, the inadequacy of philsophical naturalism, and the foundations of modern liberalism. There are also extended discussions of a number of leading contemporary philosophers: Rawls, Habermas, Williams and Rorty. (shrink)

In The Autonomy of Morality Charles Larmore challenges two ideas that have shaped the modern mind. The world, he argues, is not a realm of value-neutral fact, nor does human freedom consist in imposing principles of our own devising on an alien reality. Rather, reason consists in being responsive to reasons for thought and action that arise from the world itself. Larmore shows that the moral good has an authority that speaks for itself. Only in this light does the (...) true basis of a liberal political order come into view, as well as the role of unexpected goods in the makeup of a life lived well. (shrink)

This article analyzes six ethical principles at work in the Pastoral Letter of the Roman Catholic Bishops on the United States economy. The first three principles derive from the Thomistic tradition with its attempt to avoid the extremes of collectivism and individualism. Human beings are by nature social and called to live in political society. The principle of subsidiarity guides the role of the state. Distributive and social justice furnish the criteria for a just distribution of human goods. The fourth (...) ethical principle which is a later development in the Catholic tradition recognizes human rights including economic rights. In keeping with recent emphases in Catholic teaching the fifth principle insists that the goods of creation exist to serve all and stresses the social aspect of property. The sixth principle enunciates a preferential option for the poor and has come to the fore in the light of recent liberation theology. (shrink)

An examination of split-brain syndrome, and whether split-brain patients have two minds.

This book intends to introduce readers to the work of Charles E. Butterworth, and thereby to introduce students to Medieval islamic political philosophy, of which Butterworth is one of the world's most prominent scholars. In a wider sense, the Festschrift introduces its readers to the current debates on Medieval islamic political philosophy, related as they are to the questions of the relationship between islam and Christianity, the Medieval to the Modern world, and reason and revelation. Butterworth's scholarship spans six (...) decades, primarily translating, editing, and interpreting the works of the Muslim political philosopher Alfarabi (d. 950) and Averroes (Ibn Rushd, d. 1198). He began his studies of Muslim political philosophy at a time when the Middle East and islam did not have the political salience they have acquired in more recent years. instead, Butterworth's reason for engaging with islam was rooted in the question of the relationship between reason and revelation. While one possible answer was pursued in the Christian, latin West, the islamic borderlands of Greek, Roman, and Muslim civilization offered another. By exploring Averroes, who provides the possibility of an Aristotelian-Islamic political philosophy, and Alfarabi, who pursues a Platonic-islamic political philosophy, Butterworth showed how islamic civilization provided a viable alternative to the theologico-political question reason v revelation, as well as serving as an inspiration to the latin West. (shrink)

This chapter discusses the opening to the world in the Vatican II document Gaudium et Spes, the Pastoral Constitution on the Church in the Modern World. The approach of Gaudium et Spes differs from the earlier method of Catholic social teaching, which employed primarily a natural law approach. Gaudium et Spes introduces a more biblical, faith-centered, Christological approach to life in the world. In discussing the document itself, some of the problems in the document are also mentioned, especially its overly (...) optimistic approach and its somewhat one-sided anthropological outlook. The discussion also points out the many subsequent developments building on Gaudium et Spes that occurred later, including the greater emphasis on the particular as illustrated in liberation and feminist theologies, the preferential option for the poor, and the importance of historical consciousness and the resultant pluralism in Catholic approaches to life in the world. The chapter develops by considering three significant methodological issues—a more theological approach to life in the world, a more personalist approach, and a more inductive approach. (shrink)

One of the major intellectual figures of the twentieth century, Paul Ricoeur has influenced a generation of thinkers.

During the past few decades, engineering ethics has been oriented towards protecting the public from professional misconduct by engineers and from the harmful effects of technology. This “preventive ethics” project has been accomplished primarily by means of the promulgation of negative rules. However, some aspects of engineering professionalism, such as (1) sensitivity to risk (2) awareness of the social context of technology, (3) respect for nature, and (4) commitment to the public good, cannot be adequately accounted for in terms of (...) rules, certainly not negative rules. Virtue ethics is a more appropriate vehicle for expressing these aspects of engineering professionalism. Some of the unique features of virtue ethics are the greater place it gives for discretion and judgment and also for inner motivation and commitment. Four of the many professional virtues that are important for engineers correspond to the four aspects of engineering professionalism listed above. Finally, the importance of the humanities and social sciences in promoting these virtues suggests that these disciplines are crucial in the professional education of engineers. (shrink)

"... stimulating and insightful... a thoroughly researched and timely contribution to the secondary literature of ethics... " —Library Journal "His important new work establishes Scott... as one of the foremost interpreters of the Continental philosophical tradition of the US.... Necessary for anyone working in ethics or the Continental tradition." —Choice "... a provocative discourse on the consequences of the ethical in the thought of Nietzsche, Foucault, and Heidegger." —The Journal of Religion Charles E. Scott's challenging book advances the broad (...) claim that ethics as a way of judging and thinking has come into question as philosophers have confronted suffering and conflicts that arise from our traditional systems of value. (shrink)

In this book, Charles Larmore develops an account of morality, freedom, and reason that rejects the naturalistic metaphysics shaping much of modern thought. Reason, Larmore argues, is responsiveness to reasons, and reasons themselves are essentially normative in character, consisting in the way that physical and psychological facts - facts about the world of nature - count in favor of possibilities of thought and action that we can take up. Moral judgments are true or false in virtue of the moral (...) reasons there are. We need therefore a more comprehensive metaphysics that recognizes a normative dimension to reality as well. Though taking its point of departure in the analysis of moral judgment, this book branches widely into related topics such as freedom and the causal order of the world, textual interpretation, the nature of the self, self-knowledge, and the concept of duties to ourselves. (shrink)

This essay focuses on three of Islam's best-known philosophers: Farabi, Avicenna, and Averroes. It sets forth and compares their ethical teaching on the following basic issues: (1) the relation of philosophy to religion, (2) the communal basis of ethics and the comcomitant role of statecraft, and (3) some specific charac- teristics of their ethical teaching. Throughout the essay the close connection of medieval Islamic with classical Greek philosophy is noted.

One of the major intellectual figures of the twentieth century, Paul Ricoeur has influenced a generation of thinkers. In this, the first philosophically informed biography of Ricoeur, student, colleague, and confidant Charles E. Reagan provides an unusually accessible look at both the philosophy of this extraordinary thinker and the pivotal experiences that influenced his development. "A valuable introduction to Ricoeur; highly recommended."—_Library Journal_ "[A] lively introduction to the life and thought of one of this century's most notable philosophers."—Norman Wirzba, (...) _Christian Century_ "Reagan lucidly explains Ricoeur's difficult philosophy while shining overdue light on the personality behind it."—Carlin Romano, _Philadelphia Inquirer_ "Combines biographical and philosophical essays with a more personal memoir that makes Ricoeur's humane and magnanimous nature abundantly evident. Four revealing interviews, coupled with photographs, and an extensive bibliography of primary and secondary sources, complete this illuminating study."—_Choice_. (shrink)

The sic of this passage is ordinarily taken as meaning, ‘on this condition,’ viz. the condition implied in reddas and serues. But du Mesnil urged that this interpretation was illogical. The fulfilment of the condition implied in reddas involves in itself the realization of the wish expressed in regat, and so makes that wish unnecessary. To this objection two answers have been made. Schütz expresses the opinion that the prayer is for the perpetual enjoyment of the favourable conditions enumerated in (...) verses 1–4. But apart from the unnaturalness of this explanation, it involves the north-west wind as the perpetual attendant of the vessel. This would prevent its easy return to Italy. The other answer is that such ‘matter of fact’ criticism should not be applied to poetry. But to the minds of many this seems a mere evasion of the question at issue. Most students of Horace, I venture to say, are far from satisfied with the traditional interpretation of the passage. (shrink)

The sic of this passage is ordinarily taken as meaning, ‘on this condition,’ viz. the condition implied in reddas and serues. But du Mesnil urged that this interpretation was illogical. The fulfilment of the condition implied in reddas involves in itself the realization of the wish expressed in regat, and so makes that wish unnecessary. To this objection two answers have been made. Schütz expresses the opinion that the prayer is for the perpetual enjoyment of the favourable conditions enumerated in (...) verses 1–4. But apart from the unnaturalness of this explanation, it involves the north-west wind as the perpetual attendant of the vessel. This would prevent its easy return to Italy. The other answer is that such ‘matter of fact’ criticism should not be applied to poetry. But to the minds of many this seems a mere evasion of the question at issue. Most students of Horace, I venture to say, are far from satisfied with the traditional interpretation of the passage. (shrink)