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)

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)

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)

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)

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)

Classical approaches to the idea of the imago Dei in the theology of creation have tended to postulate a distinctive element of the human being not found in other creatures, with the possible exception of angels. This is often combined with attempts to use the imago concept as an organizing principle within Christian theology. Such approaches are now problematic not merely on account of their exegetical findings, but for methodological reasons. In light of recent exegesis, the imago Dei in Genesis (...) 1:26–27 should be seen as a signifier of human life under God, rather than a single determining characteristic or essential attribute. Following the wisdom literature, the imago Dei can be understood, in a more diffused manner, as represented by human persons over long periods of evolutionary history in their characteristic quotidian forms of life, thus signifying the providential ordering of human life everywhere. The recent work of David Kelsey on theological anthropology is engaged in this context. (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)

Traveler, come with us! Do not be afraid. You will see sublime and melancholy, gay and beautiful scenes. Poet! Down there you will find poetic themes worthy of your most inspired verses. Artist! For you there are pictures of admirable freshness, painted by the hand of God. Writer! There you will encounter legends not yet written, legends of love and hate, of gratitude and vengeance, of hypocrisy and abnegation, of noble virtues and repugnant crimes; legends of fragrant romanticism and rich (...) in truth. Let us go there, plowing the dark and agitated waves of the restless Atlantic, through the islands of the Antilles, to the shores of Anáhuac.In the strictest sense, the Occident, (that prestigious union of nations, ideologies of progress, and export and import companies) discovered Mexico in the 19th century. Only at the end of Spanish domination—that never understood that “there are various kinds of excellence”—did other countries and Mexico itself begin to learn of the scope of the Conquest and regions affected by it, partially replacing Spanish mythology with another, more varied but equally remote. The greatness of the ancient Indians and their happy age was praised, while the living natives were reviled; the idealization of the pre-Columbian, which had been suspended by priests and encomenderos, was continued (Hernández wrote in 1577, “In this new world signs of avarice had never penetrated, nor had ambition been born until our compatriots arrived, carried by ships and the wind”); the possibilities of the new country were greedily examined; scornful notes were taken on the successive and simultaneous failures in the attempt to create a republic; the vices and virtues of those who were suddenly free were enumerated; a climate favorable to invasions and the amputation of territories was created; customs were observed with joy or alarm. (shrink)

The concept of providence is embedded in the life and theology of the church. Its uses are frequent and varied in understandings of politics, nature, and individual life-stories. Parallels can be discerned in other faiths. In this volume, David Fergusson traces the development of providential ideas at successive periods in church history. These include the early appropriation of Stoic and Platonic ideas, the codification of providence in the Middle Ages, its foregrounding in Reformed theology, and its secular applications in (...) the modern era. Responses to the Lisbon earthquake provide an instructive case study. Although confidence in divine providence was shaken after 1914, several models were advanced during the twentieth century. Drawing upon this diversity of approaches, Fergusson offers a chastened but constructive account for the contemporary church. Arguing for a polyphonic approach, he aims to distribute providence across all three articles of the faith. (shrink)

One of the most significant contributions to the field in recent times, David Clough's work On Animals: Volume 1, Systematic Theology, should ensure that theologies of creation, redemption, and eschatological fulfillment give proper attention to animals. In a landmark study, he draws upon resources in Scripture and tradition to present a systematic theology that is alert to the place of animals in the divine economy. Amidst his relentless criticism of all forms of anthropocentrism, however, it is asked whether some unresolved (...) tensions emerge in relation to the traditional doctrine of God, the use of the category of the “personal” in theology, and the incarnation of the Word of God as a human creature. (shrink)

An overview of the life and thought of influential Scottish thinker and Christian practitioner, John MacMurray.

At a time when secular liberalism is in crisis and when the civic contribution of religion is being re-assessed, the rich tradition of Christian political theology demands renewed attention. This book, based on the 2001 Bampton Lectures, explores the relationship of the church both to the state and civil institutions. Arguing that theological approaches to the state were often situated within the context of Christendom and are therefore outmoded, the author claims that a more differentiated approach can be developed by (...) attention to the concept of civil society. The book offers a critical assessment of the effect of the First Amendment in the USA and, in a concluding chapter, it defends the case for continuing disestablishment in England and Scotland. (shrink)

This volume comprises a multidisciplinary study of the work of the important Scottish philosopher, John Macmurray. Macmurray held university posts in London and Edinburgh and exercised a wide influence through his many writings and BBC radio broadcasts. More recently, his work has come to prominence through his acknowledged influence on British Prime Minister Tony Blair. The essays in this collection are from a range of international scholars in the humanities and social sciences. In addition to a biographical introduction, they cover (...) themes in philosophy, religion, political theory, psychology, and ethics. A comprehensive bibliography of Macmurray's publications is also included. (shrink)

Schools of Faith represents a diversity of essays from scholars in several continents. The contributors, all leading theologians and ethicists, offer reflections on historical and contemporary themes which are significant for wider debates in theological education and church life in today's world. The range of contributor and content provides a fitting tribute to the work of Iain R. Torrance over many years. Amid the numerous subjects discussed, the authors focus on liturgy, textual criticism, public theology, the ethics of war, Christian (...) doctrine, divine action, ecumenism, inter-faith dialogue, spiritual formation, the office of the minister, and the interface between religion and literature. The multi-faceted nature of this collection signifies its importance for historical, systematic and practical theology. (shrink)

The philosopher Michael Dummett has argued that a commitment to realism in a given domain must display the following marks: a conception of reality as determinate and mind-independent, the correspondence theory of truth, and a truth conditions theory of meaning. In his own and others' philosophy we see a series of arguments at work in the theory of meaning, in epistemology and in the philosophy of science which converge upon a common rejection of such realism. It is not surprising that (...) in such an intellectual climate we see a rise in non-realist theories of religion. Religious realities are here recognised as projected; theological truth is fixed by pragmatic criteria; and meaning is handled in terms of assertibility conditions. This rise of regulative religion has met with a variety of reactions ranging from a horror of being imprisoned by an alien philosophy to a delight that the true nature of religion has at last been brought into sharper focus. (shrink)

The three sections of the collection deal respectively with Doctrinal Themes, Philosophical Engagements and Church and Society. Core doctrines to be explored include God, creation, Christology, anthropology and eschatology. The philosophical material represents theological interactions with Humean scepticism, the ambivalence of Adam Smith's religious commitments, the possibility of a natural theology after Darwin, and recent work on religion and science. The final section deals more broadly with issues in contemporary church life and the contested place of theology in the university.

Any contemporary doctrine of sanctification faces certain problems, including the charges of individualism, Pelagianism, and detachment from the concerns of the world. Nevertheless, a strong doctrine of sanctification is the necessary counterpoint to a doctrine of justification. In an increasingly fragmented culture, sanctification needs to be set within an account of the church as a community of moral and spiritual formation.

The latest volume in the OUP History of Philosophy series comprises twelve essays, which provide in-depth study of a selection of philosophers who worked in the four ancient Scottish universities after 1800. Particular attention is dedicated to Thomas Brown, William Hamilton, James Frederick Ferrier, Alexander Bain, George Davie, and John Macmurray. Further chapters are devoted to the Scottish interpretation of Kant, idealism, and the international exporting of Scottish philosophy, especially its reception in American pragmatism. Introductory and concluding essays by the (...) editor consider the distinctiveness of Scottish philosophy and the contested ways in which it can be judged a coherent intellectual... (shrink)

This volume concentrates on the period from the beginning of the 18th century to the latter part of the 20th. It is impossible to depict a single school of philosophical theology in Scotland across three centuries, yet several strains have been identified that suggest some recurrent themes or intellectual habits. These include the following: the mutually beneficial cross-fertilisation of the disciplines of philosophy and theology; the tendency to eschew powerful philosophical systems that might threaten to imprison theological ideas; a stress (...) on both the providential limitations and reliability of human reason; a suspicion of reductive theories of a materialist inclination; and a determination to inspect critically the proposals of theology and to place these in positive relation to other disciplines. (shrink)

This three-volume series provides a critical examination of the history of theology in Scotland from the early middle ages to the close of the twentieth century. Volume I covers the period from the appearance of Christianity around the time of Columba to the era of Reformed Orthodoxy in the seventeenth century.

This three-volume series provides a critical examination of the history of theology in Scotland from the early middle ages to the close of the twentieth century. Volume II begins with the early Enlightenment and concludes in late Victorian Scotland.

This three-volume series provides a critical examination of the history of theology in Scotland from the early middle ages to the close of the twentieth century. In Volume Three, the 'long twentieth century' is examined with reference to changes in Scottish church life and society.

Following with the discovery of the electron by J. J. Thomson at the end of the nineteenth century a steady elucidation of the structure of the atom occurred over the next 40 years culminating in the discovery of nuclear fission in 1938–1939. The significant steps after the electron discovery were: discovery of the nuclear atom by Rutherford (Philos Mag 6th Ser 21:669–688, 1911 ), the transformation of elements by Rutherford (Philos Mag 37:578–587, 1919 ), discovery of artificial radioactivity by Joliot-Curie (...) and Joliot-Curie (Comptes Rendus Acad Sci Paris 198:254–256, 1934 ), and the discovery of the neutron by Chadwick (Nature 129:312, 1932a , Proc R Soc Ser A 136:692–708, 1932b ; Proc R Soc Lond Ser A 136:744–748, 1932c ). The neutron furnished scientists with a particle able to penetrate atomic nuclei without expenditure of large amounts of energy. From 1934 until 1938–1939 investigations of the reaction between a neutron and uranium were carried out by E. Fermi in Rome, O. Hahn, L. Meitner and F. Strassmann in Berlin and I. Curie and P. Savitch in Paris. Results were interpreted as the formation of transuranic elements. After sorting out complex radio-chemistry and radio-physics O. Hahn and F. Strassmann came to the conclusion, beyond their belief, that the uranium nucleus split into smaller fragments, that is nuclear fission. This was soon followed in 1939 by its theoretical interpretation by L. Mietner and O. Frisch. (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)

Hume's thoroughgoing religious scepticism is set within the context of the Scottish Enlightenment. Against some interpreters, it is argued that, although elusive, his ‘attenuated deism’ (Gaskin) is not wholly dismissive of all forms of religious thought and practice. His position is further compared with contemporary expressions of ‘new atheism’. Despite some obvious similarities, Hume's position is judged more nuanced both in terms of content and rhetorical strategy.

This book explores some issues on the borderland between moral philosophy and Christian theology. Particular attention is paid to the issues at stake between liberals and communitarians and the dispute between realists, non-realists and quasi-realists. In the course of the discussion the writings of Alasdair MacIntyre, George Lindbeck and Stanley Hauerwas are examined. While sympathetic to many of the typical features of post-liberalism, the argument is critical at selected points in seeking to defend realism and accommodate some aspects of liberalism. (...) The position that emerges is more neo-Barthian than post-liberal. In maintaining the distinctiveness of Christian ethics and community, the book also seeks to acknowledge common moral ground held by those within and without the church. (shrink)