We re-express our theorem on the strong-normalisation of display calculi as a theorem about the well-foundedness of a certain ordering on first-order terms, thereby allowing us to prove the termination of systems of rewrite rules. We first show how to use our theorem to prove the well-foundedness of the lexicographic ordering, the multiset ordering and the recursive path ordering. Next, we give examples of systems of rewrite rules which cannot be handled by these methods but which can be handled by (...) ours. Finally, we show that our method can also prove the termination of the Knuth-Bendix ordering and of dependency pairs. Keywords: rewriting, termination, well-founded ordering, recursive path ordering.. (shrink)

We compare several methods of implementing the display (sequent) calculus RA for relation algebra in the logical frameworks Isabelle and Twelf. We aim for an implementation enabling us to formalise within the logical framework proof-theoretic results such as the cut-elimination theorem for RA and any associated increase in proof length. We discuss issues arising from this requirement.

We use a deep embedding of the display calculus for relation algebras ÆRA in the logical framework Isabelle /HOL to formalise a machine-checked proof of cut-admissibility for ÆRA. Unlike other “implementations”, we explicitly formalise the structural induction in Isabelle /HOL and believe this to be the first full formalisation of cutadmissibility in the presence of explicit structural rules.

We describe how we used the interactive theorem prover Isabelle to formalise and check the laws of the Timed Interval Calculus (TIC). We also describe some important corrections to, clarifications of, and flaws in these laws, found as a result of our work.

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will (...) be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will (...) be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

In crafting our paper on addressing the ethical challenges in HIV prevention research with people who inject drugs,1 we had hoped to stimulate further discussion and deliberation about the topic. We are pleased that three commentaries on our paper have begun this process.2 3 4 The commentaries rightly bring up important issues relating to community engagement and problems in translating research into practice in the fraught environments in which PWID face multiple risks. These risks include acquisition of HIV as well (...) as criminalisation, stigma and lack of access to needed healthcare, prevention and social services. We take this opportunity to respond to the excellent points raised by the commentators. All of the commentaries support our emphasis on robust community engagement with PWID and other stakeholders in designing and conducting HIV prevention research, but urge us to go farther. Wolfe highlights the difficulty of even engaging with community members in oppressive settings, where authorities severely restrict civil liberties of PWID so that even discussing issues related to drug use and enforcement may place individuals at risk. To overcome such limitations, he appropriately suggests interviewing confidentially those who have previously been detained in closed settings as part of the community engagement process. Similarly, Wolfe observes that critical issues can be overlooked with a narrow focus on study procedures if contextual factors before, during or after a study are ignored. For example, he cites the risk of overdose for study participants who have been abstinent during a study and subsequently resume injecting when the study concludes. These kinds of risks may not be obvious …. (shrink)

In crafting our paper on addressing the ethical challenges in HIV prevention research with people who inject drugs, 1 we had hoped to stimulate further discussion and deliberation about the topic. We are pleased that three commentaries on our paper have begun this process. 2 3 4 The commentaries rightly bring up important issues relating to community engagement and problems in translating research into practice in the fraught environments in which PWID face multiple risks. These risks include acquisition of HIV (...) as well as criminalisation, stigma and lack of access to needed healthcare, prevention and social services. We take this opportunity to respond to the excellent points raised by the commentators. All of the commentaries support our emphasis on robust community engagement with PWID and other stakeholders in designing and conducting HIV prevention research, but urge us to go farther. Wolfe highlights the... (shrink)

We present a one per cent measurement of the cosmic distance scale from the detections of the baryon acoustic oscillations in the clustering of galaxies from the Baryon Oscillation Spectroscopic Survey, which is part of the Sloan Digital Sky Survey III. Our results come from the Data Release 11 sample, containing nearly one million galaxies and covering approximately 8500 square degrees and the redshift range 0.2 < z < 0.7. We also compare these results with those from the publicly released (...) DR9 and DR10 samples. Assuming a concordance Λ cold dark matter cosmological model, the DR11 sample covers a volume of 13 Gpc3 and is the largest region of the Universe ever surveyed at this density. We measure the correlation function and power spectrum, including density-field reconstruction of the BAO feature. The acoustic features are detected at a significance of over 7σ in both the correlation function and power spectrum. Fitting for the position of the acoustic features measures the distance relative to the sound horizon at the drag epoch, rd, which has a value of rd,fid = 149.28 Mpc in our fiducial cosmology. We find DV = at z = 0.32 and DV = at z = 0.57. At 1.0 per cent, this latter measure is the most precise distance constraint ever obtained from a galaxy survey. Separating the clustering along and transverse to the line of sight yields measurements at z = 0.57 of DA = and H =. Our measurements of the distance scale are in good agreement with previous BAO measurements and with the predictions from cosmic microwave background data for a spatially flat CDM model with a cosmological constant. © 2014 The Author Published by Oxford University Press on behalf of the Royal Astronomical Society. (shrink)

This essay examines the strategies that Berkeley and Dharmakīrti utilize to deny that idealism entails solipsism. Beginning from similar arguments for the non-existence of matter, the two philosophers employ markedly different strategies for establishing the existence of other minds. This difference stems from their responses to the problem of intersubjective agreement. While Berkeley’s reliance on his Cartesian inheritance does allow him to account for intersubjective agreement without descending into solipsism, it nevertheless prevents him from establishing the existence of other finite (...) minds. I argue that Dharmakīrti, in accounting for intersubjective agreement causally, is able to avoid Berkeley’s shortcoming. I conclude by considering a challenge to Dharmakīrti’s use of inference that Ratnakīrti, a Buddhist successor of Dharmakīrti, advances in his “Disproof of the Existence of Other Minds” and briefly exploring a possible response that someone who wants to advocate an idealist position could give. (shrink)

The growing recognition by cognitive neuroscientists that areas of vertebrate brains may be reused for multiple purposes either functionally during development or during evolution echoes a similar realization made by neuroscientists working on invertebrates. Because of these animals' relatively more accessible nervous systems, neuronal reuse can be examined at the level of individual identified neurons and fully characterized neural circuits.

Although aesthetics began with an interest in a teleological order, the classical question was largely disparaged and rejected in mainstream academic circles by the twentieth century. The two dogmas of musical modernism were the presumption of formalism and the assertion of aestheticism. Historically, philosophers defending the objectivity of aesthetic value focused on the question of Beauty per se. But what if beauty is descriptive of something else? Our conviction of justice runs deeper than convictions of beauty. This essay explores the (...) significance of human anticipation concerning justice and how moral conviction relates to music as an encounter with teleological convictions. Music is fundamentally an individualized philosophical experience engaging the question of order, based upon a universal teleological presupposition. We do not find the arts to be meaningful because we believe them to be beautiful; we ascribe beauty to that which we find to be deeply meaningful--a way-it-should-be. (shrink)

Literature reviews have repeatedly emphasized the need to further investigate relationships between corporate social responsibility and micro-organizational variables. The present research attempts to address this call by examining the direct and indirect relationship between individual perceptions of CSR and employees’ organizational citizenship behaviors. Multiphasic data from 207 workplace supervisor–subordinate dyads recruited from an online panel were analyzed to show that organizational identification mediated the relationship between CSR and OCBs. Furthermore, supervisor transformational leadership style moderated the mediation, such that the indirect (...) effect of the organizational identification on the relationship between CSR and OCBs became nonsignificant under low transformational leadership. Based on these results, we make suggestions for using embeddedness programs to improve perceptions of CSR. (shrink)

Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from (...) considering them in their decisions. Yet IRBs often do consider the social implications of research protocols and sometimes create significant delays in initiating or even prevent such research. The social implications of research are important topics for public scrutiny and professional discussion. This article examines the reasons that the federal regulations preclude IRBs from assessing the social risks of research, and examines alternative approaches that have been used with varying success by national advisory groups to provide such guidance. The article concludes with recommendations for characteristics of a national advisory group that could successfully fulfill this need, including sustainability, independence, diverse and relevant expertise, and public transparency. (shrink)

The process of dehumanization, or thinking of others as less than human, is a phenomenon with significant societal implications. According to Haslam's model, two concepts of humanness derive from comparing humans with either animals or machines: individuals may be dehumanized by likening them to either animals or machines, or humanized by emphasizing differences from animals or machines. Recent work in cognitive neuroscience emphasizes understanding cognitive processes in terms of interactions between distributed cortical networks. It has been found that reasoning about (...) internal mental states is associated with activation of the default mode network and deactivation of the task positive network ; whereas reasoning about mechanical processes produces the opposite pattern. We conducted two neuroimaging studies. The first examined the neural bases of dehumanization and its relation to these two brain networks, using images and voice-over social narratives which either implicitly contrasted or implicitly likened humans to either animals or machines. The second study addressed a discrepancy between findings from the first study and prior work on the neural correlates of dehumanization: using a design similar to prior work we examined neural responses to pictures of humans, animals and machines, presented without any social context. In both studies, human and humanizing conditions were associated with relatively high activity in the DMN and relatively low activity in the TPN. However, the non-human and dehumanizing conditions deviated in different ways: they demonstrated more marked changes either in the DMN or in the TPN. Notably, differences between the animal dehumanizing and humanizing conditions were most evident in regions associated with mechanistic reasoning, not in the mentalizing network. Conjunction analysis of contrasts from both paradigms revealed that only one region was consistently more active when participants saw human, a medial parietal region regarded as the central hub of the DMN. These findings provide a neural basis for Haslam's distinction between two types of dehumanization, and suggest that the DMN and TPN play opposing roles in creating a sense of moral concern. (shrink)

Prominent tuberculosis (TB) actors are invoking solidarity to motivate and justify collective action to address TB, including through intensified development and implementation (D&I) of technologies such as drugs and diagnostics. We characterize the ethical challenges associated with D&I of new TB technologies by drawing on stakeholder perspectives from 23 key informant interviews and we articulate the ethical implications of solidarity for TB technology D&I. The fundamental ethical issue facing TB technological D&I is a failure within and beyond the TB community (...) to stand in solidarity with persons with TB in addressing the complex sociopolitical contexts of technological D&I. The failure in solidarity relates to two further ethical challenges raised by respondents: skewed power dynamics that hinder D&I and uncertainties around weighing risks and benefits associated with new technologies. Respondents identified advocacy and participatory research practices as necessary to address such challenges and to motivate sustained collective action to accelerate toward TB elimination. We present the first empirical examination of bioethical accounts of solidarity in public and global health. Our study suggests that solidarity allows us better to understand and address the ethical challenges that arrest the D&I of new TB technologies. Solidarity lends credence to policies and practices that address the relational nature of illness and health through collective action. (shrink)

: In light of information uncovered about human radiation experiments conducted during the Cold War, an important charge for the Advisory Committee on Human Radiation Experiments was to assess the current state of protections for human research subjects. This assessment was designed to enhance the Committee's ability to make informed recommendations for the improvement of future policies and practices for the protection of research subjects. The Committee's examination of current protections revealed great improvement over those from the past, yet some (...) problems remain. Although the data collected by the Committee highlight specific areas in need of attention, the Committee's work should be viewed in part as the beginning of a series of ongoing assessments of the adequacy and effectiveness of the protections afforded to human subjects. (shrink)

This paper explores the notion of reciprocity in the context of active pulmonary and laryngeal tuberculosis treatment and related control policies and practices. We seek to do three things: First, we sketch the background to contemporary global TB care and suggest that poverty is a key feature when considering the treatment of TB patients. We use two examples from TB care to explore the role of reciprocity: isolation and the use of novel TB drugs. Second, we explore alternative means of (...) justifying the use of reciprocity through appeal to different moral and political theoretical traditions. We suggest that each theory can be used to provide reasons to take reciprocity seriously as an independent moral concept, despite any other differences. Third, we explore general meanings and uses of the concept of reciprocity, with the primary intention of demonstrating that it cannot be simply reduced to other more frequently invoked moral concepts such as beneficence or justice. We argue that reciprocity can function as a mid-level principle in public health, and generally, captures a core social obligation arising once an individual or group is burdened as a result of acting for the benefit of others. We conclude that while more needs to be explored in relation to the theoretical justification and application of reciprocity, sufficient arguments can be made for it to be taken more seriously as a key principle within public health ethics and bioethics more generally. (shrink)

Early life stress precedes alterations to neuro-immune activation, which may mediate an increased risk for stress-related psychiatric disorders, potentially through alterations of central kynurenine pathway metabolites, the latter being relatively unexplored. We hypothesized that ELS in a non-human primate model would lead to a reduction of neuroprotective and increases of neurotoxic KP metabolites. Twelve adult female bonnet macaques reared under conditions of maternal variable foraging demand were compared to 27 age- and weight-matched non-VFD-exposed female controls. Baseline behavioral observations of social (...) affiliation were taken over a 12-week period followed by the first cerebrospinal fluid sample. Subjects were then either exposed to a 12-week repeated separation paradigm or assigned to a “no-RSP” condition followed by a second CSF. We used high-performance liquid chromatography for kynurenine, tryptophan, 5-hydroxyindoleacetic acid, kynurenic acid, and anthranilic acid as a proxy for quinolinic acid determination. At baseline, social affiliation scores were reduced in VFD-reared versus control subjects. CSF log KYNA and log KYNA/KYN ratio were lower in VFD-reared versus control subjects. CSF log KYNA/KYN was positively correlated with CSF log ANTH in VFD only. Controlling for log KYNA/KYN, log ANTH was elevated in VFD-reared subjects versus controls. CSF log KYNA/KYN obtained post-RSP was positively correlated with mean social affiliation scores during RSP, specifically in VFD. ELS is associated with a reduced neuroprotective and increased neurotoxic pathway products. That the two contrasting processes are paradoxically correlated following ELS suggests a cross-talk between two opposing KP enzymatic systems. (shrink)

A challenge of performing research in the paediatric emergency and acute care setting is obtaining valid prospective informed consent from parents. The ethical issues are complex, and it is important to consider the perspective of participants, health care workers and researchers on research without prospective informed consent while planning this type of research. We performed a systematic review according to PRISMA guidelines, of empirical evidence relating to the process, experiences and acceptability of alternatives to prospective informed consent, in the paediatric (...) emergency or acute care setting. Major medical databases and grey sources were searched and results were screened and assessed against eligibility criteria by 2 authors, and full text articles of relevant studies obtained. Data were extracted onto data collection forms and imported into data management software for analysis. Thirteen studies were included in the review consisting of nine full text articles and four abstracts. Given the heterogeneity of the methods, results could not be quantitatively combined for meta-analysis, and qualitative results are presented in narrative form, according to themes identified from the data. Major themes include capacity of parents to provide informed consent, feasibility of informed consent, support for alternatives to informed consent, process issues, modified consent process, child death, and community consultation. Our review demonstrated that children, their families, and health care staff recognise the requirement for research without prior consent, and are generally supportive of enrolling children in such research with the provisions of limiting risk, and informing parents as soon as possible. Australian data and perspectives of children are lacking and represent important knowledge gaps. (shrink)

If stem cell-based therapies are developed, we will likely confront a difficult problem of justice: for biological reasons alone, the new therapies might benefit only a limited range of patients. In fact, they might benefit primarily white Americans, thereby exacerbating long-standing differences in health and health care.

Recent legislation, such as the Patient Self-Determination Act, establishes advance directives as an acceptable procedural means of incorporating patients’ preferences for life-sustaining treatments into their medical care. Advance directives can enhance medical decision making since they provide patients with an opportunity to communicate their preferences before suffering from an acute illness that may preclude their ability to do so.Although patients expect discussions about life-sustaining therapies to be initiated by their physicians, very little is known about what prompts physicians to discuss (...) advance directives with their patients. As in other areas of clinical decision making, there is evidence that patients’ sociodemographic factors influence whether discussions about advance directives occur between patients and their physicians. In one study of persons with the acquired immunodeficiency syndrome, those who had not had discussions about advance directives with their physicians tended to be non-white, have no prior hospitalization, and were more likely to have been cared for in a health maintenance organization than in a teaching hospital. (shrink)

Recent legislation, such as the Patient Self-Determination Act, establishes advance directives as an acceptable procedural means of incorporating patients’ preferences for life-sustaining treatments into their medical care. Advance directives can enhance medical decision making since they provide patients with an opportunity to communicate their preferences before suffering from an acute illness that may preclude their ability to do so.Although patients expect discussions about life-sustaining therapies to be initiated by their physicians, very little is known about what prompts physicians to discuss (...) advance directives with their patients. As in other areas of clinical decision making, there is evidence that patients’ sociodemographic factors influence whether discussions about advance directives occur between patients and their physicians. In one study of persons with the acquired immunodeficiency syndrome, those who had not had discussions about advance directives with their physicians tended to be non-white, have no prior hospitalization, and were more likely to have been cared for in a health maintenance organization than in a teaching hospital. (shrink)

We are less optimistic than Madole & Harden that family-based genome-wide association studies (GWASs) will lead to significant second-generation causal knowledge. Despite bearing some similarities, family-based GWASs and randomised controlled trials (RCTs) are not identical. Most RCTs assess a relatively homogenous causal stimulus as a treatment, whereas GWASs assess highly heterogeneous causal stimuli. Thus, GWAS results will not translate so easily into second-generation causal knowledge.

It is widely assumed that informing prospective subjects about the risks and possible benefits of research not only protects their rights as autonomous decisionmakers, but also empowers them to protect their own interests. Yet interviews with patient‐subjects conducted under the auspices of the Advisory Committee on Human Radiation Experiments suggest this is not always the case. Patient‐subjects often trust their physician to guide them through decisions on research participation. Clinicians, investigators, and IRBs must assure that such trust is not misplaced.

Newborn screening (NBS) began in the 1960s by testing all newborns for a single condition—phenylketonuria, or PKU—which, when identified and treated early, significantly reduces morbidity. Over the...

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)

It has been acknowledged on numerous occasions that personal religiousness is a potential source of ethical norms, and consequently, an influence in ethical evaluations. An extensive literature review provides little in the way of empirical investigation of this recognized affect. This investigation conceptualizes religiousness as a motivation for ethical action, and discovers significant differences in ethical judgements among respondents categorized by personal religious motivation. Suggestions as to the source of these differences, and the implications which they offer to managers are (...) discussed and supported from the literature. (shrink)

We report on the deliberations of an interdisciplinary group of experts in science, law, and philosophy who convened to discuss novel ethical and policy challenges in stem cell research. In this report we discuss the ethical and policy implications of safety concerns in the transition from basic laboratory research to clinical applications of cell-based therapies derived from stem cells. Although many features of this transition from lab to clinic are common to other therapies, three aspects of stem cell biology pose (...) unique challenges. First, tension regarding the use of human embryos may complicate the scientific development of safe and effective cell lines. Second, because human stem cells were not developed in the laboratory until 1998, few safety questions relating to human applications have been addressed in animal research. Third, preclinical and clinical testing of biologic agents, particularly those as inherently complex as mammalian cells, present formidable challenges, such as the need to develop suitable standardized assays and the difficulty of selecting appropriate patient populations for early phase trials. We recommend that scientists, policy makers, and the public discuss these issues responsibly, and further, that a national advisory committee to oversee human trials of cell therapies be established. **NB we did not reccommend a NAC, we think it might be appropriate**. (shrink)

Acceptance of elderly or marginal health individuals as kidney donors is debated, with practices varying between centres. Transplant recipients, live kidney donors and health-care professionals caring for patients with renal failure were surveyed regarding their views on live donor kidney transplantation (LDKT) of marginal health (diabetes, hypertension, atherosclerosis, obesity, etc.) and elderly donors. Participants were recruited within a tertiary renal and transplant centre and invited to participate in focus groups and structured interviews. They also completed an anonymous questionnaire. Of 464 (...) participants who completed the questionnaire (36% health-care professionals and 64% patients), 49% and 64%, respectively, stated that marginal and elderly donors should be accepted for LDKT. In the structured interviews, emphasis was given to presenting to donor, recipient and their respective families a calculated risk regarding the effect that either a nephrectomy or transplant has on long-term quality of life. Participants stated that an independent third party in addition to the transplant team should discuss involved risks. Issues of ‘how desperate’ the recipient's situation is should also be considered. Health-care professionals stated that regardless of the strength of will of an individual to donate a kidney (despite age, health problems or personal risk), they should always have the right to say ‘no’ if performing a specific LDKT was against their professional and ethical values. About half of those surveyed considered that marginal health and elderly donors were acceptable for LDKT. Emphasis was given to the explanation to donors and recipients of the risks involved in such transplantation. (shrink)

A common quest among theoretical psychologists is the transformation of psychology to accommodate human agency and meaning. Several strong experimental methods are used in cognitive neuroscience but are based almost entirely upon a mechanistic ontology. A step toward rapprochement is proposed using precise and powerful experimental methods that are holistic, individualized, and compatible with an agentive ontology. Such methods must be applicable to all aspects of human experience, the subjective and agentive aspects, as well as the behavioural and the neurophysiological (...) Multivariate methods are capable of expressing and capturing the holistic isomorphism among multiple aspects of human existence and might even help provide insight into the mind-body problem. Results from a cognitive neuroscience study are used to illustrate this approach. 2012 APA, all rights reserved). (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)

Davey suggests that increased resistance to extinction of CRs conditioned to fear-relevant stimuli may be due to more persistent expectancies of the UCS following these stimuli. However, this viewpoint is contradicted by existing empirical evidence that fear-relevant CRs survive an extinction trials series producing extinction of expectancies whereas CRs conditioned to non-fear-relevant CSs do not.