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)

Integrated developmental and elemental information in teeth provide a unique framework for documenting breastfeeding histories, physiological disruptions, and neurotoxicant exposure in humans and our primate relatives, including ancient hominins. Here we detail our method for detecting the consumption of mothers’ milk and exploring health history through the use of laser ablation‐inductively coupled plasma‐mass spectrometry (LA‐ICP‐MS) mapping of sectioned nonhuman primate teeth. Calcium‐normalized barium and lead concentrations in tooth enamel and dentine may reflect milk and formula consumption with minimal modification during (...) subsequent tooth mineralization, particularly in dentine. However, skeletal resorption during severe illness, and bioavailable metals in nonmilk foods, can complicate interpretations of nursing behavior. We show that explorations of the patterning of multiple elements may aid in the distinction of these important etiologies. Targeted studies of skeletal chemistry, gastrointestinal maturation, and the dietary bioavailability of metals are needed to optimize these unique records of human health and behavior. (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)

Good listening is an essential element in the provision of quality healthcare (Attree 2001). Good listening also supports accurate diagnosis, patient adherence to medical recommendations, and stron...

Factors such as subsistence turnover, warfare, or interaction between different groups can be major sources of cultural change in human populations. Global demographic shifts such as the transition to agriculture during the Neolithic and more recently the urbanization and globalization of the twentieth century have been major catalysts for cultural change. Here, we test whether cultural traits such as patri/matrilocality and postmarital migration persist in the face of social upheaval and gene flow during the past 150 years in postcolonial South (...) Africa. The recent history of South Africa has seen major demographic shifts that resulted in the displacement and forced sedentism of indigenous Khoekhoe and San populations. During the expansion of the colonial frontier, the Khoe-San admixed with European colonists and enslaved individuals from West/Central Africa, Indonesia, and South Asia, introducing novel cultural norms. We conducted demographic interviews among Nama and Cederberg communities representing nearly 3,000 individuals across three generations. Despite the history of colonial expansion, and the subsequent incorporation of Khoe-San and Khoe-San-descendant communities into a colonial society with strong patrilocal norms, patrilocality is the least common postmarital residence pattern in our study populations today. Our results suggest that more recent forces of integration into the market economy are likely the primary drivers of change in the cultural traits examined in our study. Birthplace had a strong effect on an individual’s odds of migration, distance moved, and postmarital residence form. These effects are at least partially explained by the population size of the birthplace. Our results suggest that market factors local to birthplaces are important drivers of residence decisions, although the frequency of matrilocal residence and a geographic and temporal cline in migration and residence patterns also indicate the persistence of some historic Khoe-San cultural traits in contemporary groups. (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)

I argue that, because God is the author of history and has a purpose for his creation, evolution has a plot and can be analyzed with tools drawn from literary criticism. This necessitates engagement with the “epic of evolution” genre of scientific literature. I survey several prominent versions of the epic and distinguish between a purely naturalistic epic of evolution and a goal‐oriented Christian epic of evolution (CEE). In dealing with CEE, I use the thought of J. R. R. Tolkien, (...) along with Kevin Vanhoozer and Dorothy Sayers, to discuss the ways in which we can theologically legitimate speaking of God as the “author” of evolutionary history. (shrink)

The writings of Stanley Cavell and Jacques Derrida share many points of intersection. One of these is their mutual interest in Shakespeare’s Hamlet; another is their assessments of J.L. Austin’s philosophy, and his concept of performativity. In this paper, we demonstrate that Cavell’s and Derrida’s respective essays on Hamlet offer a surprising insight into their views on Austin’s notion of performativity. Since Hamlet abounds with oaths and promises, testimonies and bearing witness, what is surprising is not that these (...) philosophers should have identified this theme but rather how they respond to it. We show that Derrida’s writings on Hamlet repeatedly draw and depend on the idea of performativity, amounting to a rapprochement with Austin’s concept; and we also show that Cavell questions the effectiveness of performatives in the play, in ways that sometimes resemble Derrida’s invocation of spectrality in the play. (shrink)

Discuto neste artigo o fragmento de Protágoras sobre a existência dos deuses e a sua coerência teórica com outras teses do sofista. Primeiramente, utilizo dados históricos e biográficos para iluminar o subjetivismo da primeira linha do fragmento. Em seguida, discuto os obstáculos epistemológicos mencionados por Protágoras e sugiro uma nova tradução para o termo brachýs, um dos conceitos centrais que ele propõe. Na seção 2, analiso o ataque à transcendência que distingue suas ideias sobre a matemática e a percepção sensível. (...) Finalmente, na seção 3, mostro como a sua postura teológica está de acordo com a tese do homo-mensura e com a sua abordagem antilógica. A conclusão ressalta a unidade do pensamento de Protágoras e a sua posição no Iluminismo grego. (shrink)

Writing from a scientifically and philosophically informed perspective, the authors provide a critical overview of the conceptual difficulties encountered in many current neuroscientific and psychological theories.

Greek text, english translation and commentary on the surviving fragments of Empedocles (fragments as known in 1981, does not include more recent finds).

Looking at the recent spate of claims about “fake news” which appear to be a new feature of political discourse, I argue that fake news presents an interesting problem in epistemology. Te phenomena of fake news trades upon tolerating a certain indiference towards truth, which is sometimes expressed insincerely by political actors. Tis indiference and insincerity, I argue, has been allowed to fourish due to the way in which we have set the terms of the “public” epistemology that maintains what (...) is considered “rational” public discourse. I argue one potential salve to the problem of fake news is to challenge this public epistemology by injecting a certain ethical consideration back into the discourse. (shrink)