SummaryThe dichotomy between ‘scientific’ and ‘practical’ approaches to guideline development is false and divisive. Instead we should concentrate on developing mechanisms to develop and implement valid guidelines to improve patient care. The development of valid guidelines requires considerable expertise and is time consuming and expensive. It is most efficiently done at a regional or national level. The implementation of valid guidelines requires local action including the identification and modification of valid guidelines and a coordinated evidence-based implementation strategy (Grimshaw & (...) Eccles 1998). (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)

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)

Owing to unique features of their design, cluster randomized trials complicate the interpretation of standard ethics guidelines. The recently published Ottawa statement on the ethical design and conduct of cluster randomized trials provides researchers and research ethics committees with detailed guidance on the design, conduct and review of cluster trials. The Ottawa statement sets out 15 recommendations, including guidance on the justification of study design, the need for research ethics committee review, the identification of research participants, obtaining informed consent, the (...) role of gatekeepers in protecting cluster interests, the assessment of benefits and harms, and the protection of vulnerable participants. (shrink)

Owing to unique features of their design, cluster randomized trials complicate the interpretation of standard ethics guidelines. The recently published Ottawa statement on the ethical design and conduct of cluster randomized trials provides researchers and research ethics committees with detailed guidance on the design, conduct, and review of cluster trials. The Ottawa statement sets out 15 recommendations, including guidance on the justification of study design, the need for research ethics committee review, the identification of research participants, obtaining informed consent, the (...) role of gatekeepers in protecting cluster interests, the assessment of benefits and harms, and the protection of vulnerable participants. (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)

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)

In 1859, Charles Darwin proposed a mechanism for biological evolution in his most famous work, On the Origin of Species. However, Origin makes little mention of humans. Despite this, Darwin thought deeply about humans and in 1871 published The Descent of Man, his influential and controversial book in which he applied evolutionary theory to humans and detailed his theory of sexual selection. February 2021 will mark the 150th anniversay of it's publication. In A Most Interesting Problem, twelve leading anthropologists, biologists, (...) and journalists revisit The Descent. Following the same organization as the first edition of Descent - less the large section on sexual selection -- each author reviews what Darwin wrote in Descent, comparing his words to what we now know now. There are chapters on evidence for human evolution, our place in the family tree, the origins of civilization, human races, intelligence, and sex differences. An introduction by Darwin biolographer and historian Janet Browne provides context for Descent and a conclusion by Science magazine journalist Ann Gibbons looks to the future of the study of human evolution. All the chapters are written with a broad audience in mind. Ultimately, readers learn that Darwin was remarkably prophetic in some of his predictions, such as that the earliest human fossils would be discovered in Africa. But he was wrong in other areas, particularly in regards to variations between the sexes and races. Thus, A Most Interesting Problem is not so much a celebration of Darwin as it is a tribute to how science works, how scientific ideas are tested, and the role of evidence in helping structure narratives of human origins. The reader is left with a view of how far we have come in our quest for understanding human origins, biological variation, behavior, and evolution. (shrink)

By focusing on the caloric composition of hunted prey species, optimal foraging research has shown that hunters usually make economically rational prey choice decisions. However, research by meat scientists suggests that the gustatory appeal of wildlife meats may vary dramatically. In this study, behavioral research indicates that Mayangna and Miskito hunters in Nicaragua inconsistently pursue multiple prey types in the optimal diet set. We use cognitive methods, including unconstrained pile sorts and cultural consensus analysis, to investigate the hypothesis that these (...) partial preferences are influenced by considerations of meat flavor. Native informants exhibit high agreement on the relative appeal of different meats. Given the absence of other noteworthy differences between spider monkeys (Ateles geoffroyi) and howler monkeys (Alouatta palliata), the unappealing flavor of howler monkeys seems to be a factor in the partial preference for this species. (shrink)

Accounts of spiritual formation which depend overmuch on individualism are likely distorted by that individualism, and this article argues that an account of collective-personhood can provide a necessary corrective to this anthropological distortion. The article begins by diagnosing the problem of individualism in formation, utilizing Charles Taylor’s Sources of the Self, and critiquing several common practices of spiritual formation. Following this, we consider Bonhoeffer’s theological vision for the collective-person from his first book, Sanctorum Communio. Next, we examine Murray Bowen’s Family (...) Systems Theory to help us envision, from a social scientific perspective, how such a collective-personhood might look. The article concludes with a provisional model for spiritual formation of collective-persons. (shrink)

The status of constructivism as a metaethical or metanormative theory is unclear partly due to the lack of a clear semantics for central normative terms such as ‘reason’ and ‘ought’. In a series of recent papers, Sharon Street has attempted to clarify the central commitments of constructivism by focusing on the idea of a practical point of view and what follows from it. We improve upon the informal understanding provided by Street and attempt to provide a semantics for ‘ought’. Our (...) semantics respects the core intuition of the constructivist that normative claims are made true because of our practical commitments as agents and also reflects the constructivist’s commitment to the centrality of practical deliberation to normative truth. On our view, a normative claim of the form ⌜S ought to ϕ⌝ is true if ϕ is entailed from S’s set of evaluative attitudes. We argue that a virtue of our definition is that it allows us to see precisely what is distinctive about constructivism as opposed to realism and expressivism. (shrink)

Intended for courses in sensation and perception, this book covers the anatomy, physiology and phenomenology of the way humans sense and perceive the world. It is grounded in physiology to explain perceptual phenomena, on the theory that understanding sensation and perception is based in the physiology of the sensory organs and the brain.

It is estimated that 300,000 children 0–14 years of age are diagnosed with cancer worldwide each year. While the absolute risk of cancer in children is low, it is the leading cause of death due to disease in children in high‐income countries. In spite of this, the etiologies of pediatric cancer are largely unknown. Environmental exposures have long been thought to play an etiologic role. However, to date, there are few well‐established environmental risk factors for pediatric malignancies, likely due to (...) technical barriers in collecting biological samples prospectively in pediatric populations for direct measurements. In this review, we propose the use of novel or underutilized biospecimens (dried blood spots and teeth) and molecular approaches for exposure assessment (epigenetics, metabolomics, and somatic mutational profiles). Future epidemiologic studies of pediatric cancer should incorporate novel exposure assessment methodologies, data on molecular features of tumors, and a more complete assessment of gene‐environment interactions. (shrink)

Nijhawan's theory rests on the assumption that transient signals compete with predictive signals to generate the visual percept. We describe experiments that show that this assumption is incorrect. Our results are consistent with an alternative theory that proposes that vision is instead postdictive, in that the perception of an event is influenced by occurrences after the event.

Theories of children's developing understanding of mind tend to emphasize either individualistic processes of theory formation, maturation, or introspection, or the process of enculturation. However, such theories must be able to account for the accumulating evidence of the role of social interaction in the development of social understanding. We propose an alternative account, according to which the development of children's social understanding occurs within triadic interaction involving the child's experience of the world as well as communicative interaction with others about (...) their experience and beliefs (Chapman 1991; 1999). It is through such triadic interaction that children gradually construct knowledge of the world as well as knowledge of other people. We contend that the extent and nature of the social interaction children experience will influence the development of children's social understanding. Increased opportunity to engage in cooperative social interaction and exposure to talk about mental states should facilitate the development of social understanding. We review evidence suggesting that children's understanding of mind develops gradually in the context of social interaction. Therefore, we need a theory of development in this area that accords a fundamental role to social interaction, yet does not assume that children simply adopt socially available knowledge but rather that children construct an understanding of mind within social interaction. Key Words: language; Piaget; social interaction; theories of mind; Vygotsky; Wittgenstein. (shrink)

People tend to perceive ongoing continuous activity as series of discrete events. This partitioning of continuous activity may occur, in part, because events correspond to dynamic patterns that have recurred across different contexts. Recurring patterns may lead to reliable sequential dependencies in observers' experiences, which then can be used to guide perception. The current set of simulations investigated whether this statistical structure within events can be used 1) to develop stable internal representations that facilitate perception and 2) to learn when (...) to update such representations in a self-organizing manner. These simulations demonstrate that experience with recurring patterns enables a system to accurately predict upcoming stimuli within an event, to identify boundaries between such events based on transient increases in prediction error, and to use such boundaries to improve prediction about subsequent activities. (shrink)