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 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)

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)

This is the third edition, with updated notes and appendices, of Cicero's speech defending Caelius Rufus. It gives an insight into the political events of the period, and also helps to reconstruct the 'social background' of Catullus. It is of particular interest to the literary historian.

Of these lines Markland wrote in 1728 ‘patet ignari cuiusdam et barbari interpolatoris esse’; Dr. Trapp in 1735 found them ‘in themselves flat, and improper, and altogether unworthy of Virgil’; ‘in his ipsis miror qui factum sit ut Viri Doctissimi non agnouerint orationis uim et elegantiam’ ; ‘finding in them … all Virgil's usual ease and suavity … [we] hail those verses with joy, and reinstate them in their rightful … position as the commencing verses of the great Roman epic’ (...) ; ‘uersus praeclarissimos iniuria poeta abiudicauerunt editores plerique’. (shrink)

The clear affinity between Quintilian's art-criticism and the comparable portions of Pliny's Natural History has often been remarked. Pliny's principal sources for his chapters on art have long been recognized as going back through Varro to the great third-century critics, Xenocrates of Sicyon and Antigonus of Carystus, the latter of whom worked over Xenocrates' treatise and incorporated new material of his own; an earlier Greek source was Duris of Samos, on whom Antigonus drew for the anecdotic element in his tradition. (...) The careful work of many patient scholars has been successful in disentangling to a considerable extent the characteristic contributions of these and other authorities to Pliny's medley of information. On the other hand, Quintilian's incursion into the same field seems never to have been studied independently, but only incidentally to research on the Plinian sources. The purpose of this paper is to examine Quintilian's contribution afresh; my indebtedness to earlier studies, in particular to those of Robert, will be readily apparent. (shrink)

On Aen. 2. 277 DServius notes ‘non sine ratione etiam hoc de crinibus dolet Aeneas, quia illis maxime Hector commendabatur, adeo ut etiam tonsura ab eo nomen acceperit, sicut Graeci poetae docent.’ Fraenkel showed that the reference in Graeci poetae is to Lycophron , the source of the comment being provided by Eustathius 1276. 29, a scholion on Il. 22. 401 f. He adds a caution against supposing that Servius’ source referred not only to Lycophron but also to other Greek (...) poets, ‘e.g. some Attic comedians’. That such allusions were in fact made in Comedy is proved by Pollux. (shrink)

The MS. tradition of Prudentius is particularly interesting, since in the famous Codex Puteanus we have a MS. dating from the early sixth century—i.e. but little more than a hundred years after the publication of the collected poems in 405. Yet it has only been of late years that due consideration has been given to this ancient Codex, which is the actual MS. corrected by Vettius Mavortius' own hand. Mr. Winstedt has spoken of the neglect which it has suffered for (...) the most part from editors, and also of the similar lack of attention paid even by Dressel to its seventh-century companion at Milan—the Codex Ambrosianus; while, later, J. Bergman shewed himself enthusiastic in its praise . A confirmation is now available of a curious and generally discredited reading in this MS. , from that same Arma glossary of ‘saec. viii.-ix’ which bears witness to the readings of a lost Terence MS. of the δ-family, the best minuscule family, older than any extant MS., as I shewed in the April, 1925, number of this journal. At Prud. Apoth. 895 the reading of Puteanus is— Agenitus genitusque deus, pater et patre natus. (shrink)

The MS. tradition of Prudentius is particularly interesting, since in the famous Codex Puteanus we have a MS. dating from the early sixth century—i.e. but little more than a hundred years after the publication of the collected poems in 405. Yet it has only been of late years that due consideration has been given to this ancient Codex, which is the actual MS. corrected by Vettius Mavortius' own hand. Mr. Winstedt has spoken of the neglect which it has suffered for (...) the most part from editors, and also of the similar lack of attention paid even by Dressel to its seventh-century companion at Milan—the Codex Ambrosianus; while, later, J. Bergman shewed himself enthusiastic in its praise. A confirmation is now available of a curious and generally discredited reading in this MS., from that same Arma glossary of ‘saec. viii.-ix’ which bears witness to the readings of a lost Terence MS. of the δ-family, the best minuscule family, older than any extant MS., as I shewed in the April, 1925, number of this journal. At Prud. Apoth. 895 the reading of Puteanus is—Agenitus genitusque deus, pater et patre natus. (shrink)

Few critics can ever have shown more light-hearted thoughtlessness towards an anxious posterity than Servius in his casual preservation of the ‘Helen-episode’, lacking in our ancient manuscripts of Virgil and primarily extant only in this precarious form. A pity that Servius spoke at all, if he could not tell us more; and to make matters worse, he ignored the lines in his commentary. Aelius Donatus says nothing of them. Tiberius Claudius Donatus passes peacefully in his interpretatio from 2. 566 to (...) 2. 589; his prosy conscientiousness nowhere else allows him to skip so much. The passage so rashly preserved forms an exasperating Tummelplatz for students of Virgil: ‘quadereviridoctiiampridem inter se certarunt semperque, ni fallor, certabunt.’ The purpose of this paper is to suggest that Servius told the truth about the lines, and was not planting a forgery on a credulous world. (shrink)

This volume provides new insights on lying and (intentionally) misleading in and out of the courtroom, a timely topic for scholarship and society. Not all deceptive statements are lies; not every lie under oath amounts to perjury---but what are the relevant criteria? Taxonomies of falsehood based on illocutionary force, utterance context and speakers' intentions have been debated by linguists, moral philosophers, social psychologists and cognitive scientists. Legal scholars have examined the boundary between actual perjury and garden-variety lies. The fourteen previously (...) unpublished essays in this book apply theoretical and empirical tools to delineate the landscape of falsehood, half-truth, perjury, and verbal manipulation, including puffery, bluffing, and bullshit. The papers in this collection address conceptual and ethical aspects of lying vs. misleading and the correlation of this opposition with the Gricean pragmatic distinction between what is said and what is implicated. The questions of truth and lies addressed in this volume have long engaged the attention of scholars in linguistics, philosophy, psychology, cognitive science, organizational research, and the law, and researchers from all these fields will find this book of interest. (shrink)