There is growing interest for implementing tools to monitor cognitive performance in naturalistic work and everyday life settings. The emerging field of research, known as neuroergonomics, promotes the use of wearable and portable brain monitoring sensors such as functional near infrared spectroscopy (fNIRS) to investigate cortical activity in a variety of human tasks out of the laboratory. The objective of this study was to implement an on-line passive fNIRS-based brain computer interface to discriminate two levels of working memory load during (...) highly ecological aircraft piloting tasks. Twenty eight recruited pilots were equally split into two groups (flight simulator vs. real aircraft). In both cases, identical approaches and experimental stimuli were used (serial memorization task, consisting in repeating series of pre-recorded air traffic control instructions, easy vs. hard). The results show pilots in the real flight condition committed more errors and had higher anterior prefrontal cortex activation than pilots in the simulator, when completing cognitively demanding tasks. Nevertheless, evaluation of single trial working memory load classification showed high accuracy (>76%) across both experimental conditions. The contributions here are two-fold. First, we demonstrate the feasibility of passively monitoring cognitive load in a realistic and complex situation (live piloting of an aircraft). In addition, the differences in performance and brain activity between the two experimental conditions underscore the need for ecologically-valid investigations. (shrink)

Unmanned aerial vehicles, particularly quadcopters, have several medical, agriculture, surveillance, and security applications. However, the use of this innovative technology for civilian applications is still very limited in low-income countries due to the high cost, whereas low-cost controllers available in the market are often tuned using the hit and trial approach and are limited for specific applications. This paper addresses this issue and presents a novel proof of concept low-cost quadcopter UAV design approach using a systematic Model-Based Design method (...) for mathematical modeling, simulation, real-time testing, and prototyping. The quadcopter dynamic model is developed, and controllers are designed using Proportional Integral, and Derivative, Pole Placement, and Linear Quadratic Regulator control strategies. The stability of the controllers is also checked using Lyapunov stability analysis. For verification and validation of the design, Software-in-the-Loop, Processor-in-the-Loop, Hardware-in-the-loop testing, and Rapid Control Prototyping have been performed. The V&V methods of the MBD approach showed practically valid results with a stable flight of the quadcopter prototype. The proposed low-cost POC quadcopter design approach can be easily modified to have enhanced features, and quadcopters with different design parameters can be assembled using this approach for a diverse range of applications. (shrink)

RationaleThere are growing concerns over the occurrence of adverse physiologic events occurring in pilots during operation of United States Air Force and Navy high-performance aircraft. We hypothesize that a heightened inspiratory work of breathing experienced by jet pilots by virtue of the on-board life support system may constitute a “distraction stimulus” consequent to an increased sensation of respiratory muscle effort. As such, the purpose of this study was to determine whether increasing inspiratory muscle effort adversely impacts on attentional performance.MethodsTwelve, healthy (...) participants were recruited for this study. Participants completed six repetitions of a modified Masked Conjunctive Continuous Performance Task protocol while breathing against four different inspiratory threshold loads to assess median reaction times. A computer-controlled threshold loading device was used to set the inspiratory threshold loads. Repeated measures analysis of variances were performed to examine: the efficacy of the threshold loading device to impose significantly higher loading at each loading condition; the effects of loading condition on respiratory muscle effort sensation; and the influence of hypercapnia on MCCPT scores during inspiratory threshold loading. Generalized additive mixed effects models were used to examine the potential non-linear effects of respiratory muscular effort sensation, device loading, and hypercapnia, on MCCPT scores during inspiratory threshold loading.ResultsInspiratory threshold loading significantly augmented inspiratory effort sensation and the inspiratory pressure-time product. Our analyses also revealed that median hit RT was positively associated with inspiratory effort sensation during inspiratory loading trials.ConclusionThe findings of this work suggest that it was not increasing inspiratory muscle effort per se, but rather participant’s subjective perception of inspiratory “load” that impacts negatively on attentional performance; i.e., as the degree of inspiratory effort sensation increased, sotoo did median hit RT. As such, it is reasonable to suggest that minimizing inspiratory effort sensation during high-performance flight operations may prove useful in reducing pilot RTs during complex behavioral tasks. (shrink)

When we reach to pick up an object, our actions are effortlessly informed by the object’s spatial information, the position of our limbs, stored knowledge of the object’s material properties, and what we want to do with the object. A substantial body of evidence suggests that grasps are under the control of “automatic, unconscious” sensorimotor modules housed in the “dorsal stream” of the posterior parietal cortex. Visual online feedback has a strong effect on the hand’s in-flight grasp aperture. Previous (...) work of ours exploited this effect to show that grasps are refractory to cued expectations for visual feedback. Nonetheless, when we reach out to pretend to grasp an object (pantomime grasp), our actions are performed with greater cognitive effort and they engage structures outside of the dorsal stream, including the ventral stream. Here we ask whether our previous finding would extend to cued expectations for haptic feedback. Our method involved a mirror apparatus that allowed participants to see a “virtual” target cylinder as a reflection in the mirror at the start of all trials. On “haptic feedback” trials, participants reached behind the mirror to grasp a size-matched cylinder, spatially coincident with the virtual one. On “no-haptic feedback” trials, participants reached behind the mirror and grasped into “thin air” because no cylinder was present. To manipulate haptic expectation, we organized the haptic conditions into blocked, alternating, and randomized schedules with and without verbal cues about the availability of haptic feedback. Replicating earlier work, we found the strongest haptic effects with the blocked schedules and the weakest effects in the randomized uncued schedule. Crucially, the haptic effects in the cued randomized schedule was intermediate. An analysis of the influence of the upcoming and immediately preceding haptic feedback condition in the cued and uncued random schedules showed that cuing the upcoming haptic condition shifted the haptic influence on grip aperture from the immediately preceding trial to the upcoming trial. These findings indicate that, unlike cues to the availability of visual feedback, participants take advantage of cues to the availability of haptic feedback, flexibly engaging pantomime, and natural modes of grasping to optimize the movement. (shrink)

The objective Bayesian view of proof (or logical probability, or evidential support) is explained and defended: that the relation of evidence to hypothesis (in legal trials, science etc) is a strictly logical one, comparable to deductive logic. This view is distinguished from the thesis, which had some popularity in law in the 1980s, that legal evidence ought to be evaluated using numerical probabilities and formulas. While numbers are not always useful, a central role is played in uncertain reasoning by the (...) ‘proportional syllogism’, or argument from frequencies, such as ‘nearly all aeroplane flights arrive safely, so my flight is very likely to arrive safely’. Such arguments raise the ‘problem of the reference class’, arising from the fact that an individual case may be a member of many different classes in which frequencies differ. For example, if 15 per cent of swans are black and 60 per cent of fauna in the zoo is black, what should I think about the likelihood of a swan in the zoo being black? The nature of the problem is explained, and legal cases where it arises are given. It is explained how recent work in data mining on the relevance of features for prediction provides a solution to the reference class problem. (shrink)

Overview * Part I: Introduction * Philip Appleman, Darwin: On Changing the Mind * Part II: Darwin’s Life * Ernst Mayr, Who Is Darwin? * Part III: Scientific Thought: Just before Darwin * Sir Gavin de Beer, Biology before the Beagle * Thomas Robert Malthus, An Essay on the Principle of Population * William Paley, Natural Theology * Jean Baptiste Pierre Antoine de Monet Lamarck, Zoological Philisophy * Charles Lyell, Principles of Geology * John Herschell, The Study of Natural Philosophy (...) * William Whewell, Astronomy and General Physics Considered with Reference to Natural Theology * Alfred Russel Wallace, On the Tendency of Varieties to Depart Indefinitely from the Original Type * Part IV: Selections from Darwin’s Work * The Voyage of the Beagle * o Chapter I. St. Jago-Cape de Verd Island o Chapter XVII. Galapagos Archipelago * On the Tendency of Species to Form Varieties; and On the Perpetuation of Varieties and Species by Natural Means of Selection * o I. Extract from an unpublished Work on Species, by C. Darwin, Esq.... o II.of Letter from C. Darwin, Esq., to Prof. Asa Gray, Boston, U.S., dated Down, September 5th, 1857 * An Historical Sketch of the Progress of Opinion on the Origin of Species, previously to the : Publication of This Work The Origin of Species * o Introduction o Chapter I. Variation under Domestication o Chapter II. Variation under Nature o Chapter III. Struggle for Existence o Chapter IV. Natural Selection o Chapter VI. Difficulties on Theory o Chapter IX. On the Imperfections of the Geological Record o Chapter XIII. Mutual Affinities of Organic Beings: Morphology: Embryology: Rudimentary Organs o Chapter XIV. Recapitulation and Conclusion * The Descent of Man * o Introduction o Chapter I. The Evidence of the Descent of Man from Some Lower Form o Chapter II. On the Manner of Development of Man from Some Lower Form o Chapter III. Comparison of the Mental Powers of Man and the Lower Animals o Chapter VI. On the Affinities and Genealogy of Man o Chapter VIII. Principles of Sexual Selection o Chapter XIX. Secondary Sexual Characters of Man o Chapter XX. Secondary Sexual Characters of Man-continued o Chapter XXI. General Summary and Conclusion * Part V: Darwin’s Influence on Science * THE VICTORIAN OPPOSITION TO DARWIN * o David L. Hull, Darwin and His Critics o Adam Sedgwick, Objections to Mr. Darwin’s Theory of the Origin of Species o Sir Richard Owen, Darwin on the Origin of Species o Fleeming Jenkin, Review of the Origin of Species * VICTORIAN SUPPORTERS OF DARWIN * o Joseph Dalton Hooker, Flora Tasmaniae o Thomas Henry Huxley, On the Relations of Man to the Lowe Animals o Charles Lyell, Principles of Geology o Alfred Russel Wallace, The Debt of Science to Darwin * DARWIN AND THE SHAPING OF MODERN SCIENCE * o Scientific Method in Evolution o National Academy of Sciences, Evolution and the Nature of Science o Richard Dawkins, Explaining the Very Improbable o Lewis Thomas, On the Uncertainty of Science o Noretta Koetge, Postmodernisms and the Problem of Scientific Literary o Richard Dawkins, Science and Sensibility o The Neo-Darwinian Synthesis o Peter Bowler, The Evolutionary Synthesis o The Human Genealogy o Adam Kuper, The Chosen Primate o Ian Tattersall, Out of Africa Again... and Again? o Stephen Jay Gould, The Human Difference o Punctuated Equilibrium o Stephen Jay Gould, [On Punctuated Equilibrium] o Niles Eldredge, The Great Stasis Debate o Rethinking Taxonomy o Kevin Padian, Darwin’s Views of Classification o David L. Hull, Cladistic Analysis o Kevin Padian and Luis M. Chiappe, Cladistics in Action: The Origin of Birds and Their Flight o Evolution as Observable Fact o James L. Gould and William T. Keeton with Carol Grant Gould, How Natural Selection Operates o Peter r. Grant, Natural Selection and Darwin’s Finches o John A. Endler, Natural Selection in the Wild * Part VI: Darwinian Patterns in Social Thought * COMPETITION AND COOPERATION * o Richard Hofstadter, The Vogue of Spencer o Andrew Carnegie, The Gospel of Wealth o Peter Kropotkin, Mutual Aid o Martin A. Nowak, Robert M. May, and Karl Sigmund, The Arithmetics of Mutual Help * NATURE AND NURTURE * o Edward O. Wilson, Sociobiology: The New Synthesis o Stephen Jay Gould, Biological Potentiality vs. Biological Determination o Barbara Ehrenreich and Janet McIntosh, The New Creationism: Biology under Attack * EVOLUTION AND GENDER * o Elizabeth Cady Stanton, The Woman’s Bible o Nancy Makepeace Tanner, On Becoming Human o Evelleen Richards, Darwin and the Descent of Woman o James Eli Adams, Woman Red in Tooth and Claw * EVOLUTION AND OTHER DISCIPLINES * o Edward O. Wilson, [On Consilience] o Randolph H. Nesse and George C. Williams, Evolution and the Origin of Disease o Steven Pinker, How the Mind Works o Steve Jones, The Set within the Skull * Part VII: Darwinian Influences in Philosophy and Ethics * John Dewey, The Influence of Darwin on Philosophy * Daniel C. Dennett, Darwin’s Dangerous Idea: Natural Selection as an Algorithmic Process * Michael Ruse Darwinian Epistemology * Thomas Henry Huxley, Evolution and Ethics * Julian Huxley, Evolutionary Ethics * Michael Ruse and Edward O. Wilson, The Evolution of Ethics * Frans de Waal, Good Natured: The Origin of Right and Wrong in Humans and Other Animals * Matt Ridley, The Origins of Virtue * Part VIII: Evolutionary Theory and Religious Theory * MAINSTREAM RELIGIOUS SUPPORT FOR EVOLUTION * o Pope John Paul II, Message to the Pontifical Academy of Sciences o Central Conference of American Rabbis, On Creationism in School Textbooks o United Presbyterian Church in the U.S.A., Evolution and Creationsim o The Lutheran World Federation, [Statement on Evolution] o The General Convention of the Episcopal Church, Resolution on Evolutionism and Creationism o Unitariuan Universalist Association, Resolution Opposing "Scientific Creationism" * FUNDAMENTALIST CREATIONISM * o Eugene C. Scott, Antievolution and Creationism in the United States o The Scopes Trial o Thomas McIver, Orthodox Jewish Creationists o Harun Yahya, [Islamic Creationism] o Seami Srila Prabhupada, [A Hare Krishna on Darwinian Evolution] o Institute for Creation Research, Tenets of Creationism o Henry M. Morris, Scientific Creationism o Thomas J. Wheeler, Review of Morris o Richard D. Sjolund and Betty McCollister, Evolution at the Grass Roots o Richard D. Sjolund, [Creationism versus Biotechnology] o Betty McCollister, [The Politics of Creationism] o Molleen Matsumara, What Do Christians Really Believe about Evolution? o National Center for Science Education, Seven Significant Court Decisions Regarding Evolution/Creation Issues * PERSONAL INCREDULITY AND ANTIEVOLUTIONISM * o Richard Dawkins, [The Argument from Personal Incredulity] o Phillip E. Johnson, Darwin on Trial o Eugenie C. Scott, Review of Johnson o Michael Behe, Darwin’s Black Box o Robert Dorit, Review of Behe o Michael Ruse, Darwin’s New Critics on Trial * SCIENTISTS’ OPPOSITION TO CREATIONISM * o American Association for the Advancement of Science, Forced Teaching of Creationist Beliefs in Public School Science Education o American Institute of Biological Sciences, Resolution Oposing Creationism in Science Courses o National Association of Biology Teachers, Statement on Teaching Evolution o National Academy of Sciences, Frequently Asked Questions about Evolution and the Nature of Science * FUNDAMENTALIST CREATIONISM AND THE VALUE OF SATIRE * o Michael Shermer, Genesis Revisted: A Scientific Creation Story o Philip Appleman, Darwin’s Ark * Part IX: Darwin and the Literary Mind * DARWIN’S LITERARY SENSIBILITY * o Charles Darwin, Autobiography o L. Robert Stevens, Darwin’s Humane Reading o George Levine, Darwin and Pain: Why Science Made Shakespeare Nauseating o Gillian Beer, Darwin’s Plots * DARWIN’S INFLUENCE ON LITERATURE * o Lionel Stevenson, Darwin among the Poets o George Levine, Darwin among the Novelists o Joseph Wood Krutch, The Tragic Fallacy o Herbert J. Muller, Modern Tragedy o Philip Appleman, Darwin-Sightings in Recent Literature. (shrink)

This paper discusses the utilization of pilots' physiological indications such as electroencephalographic signals, ocular parameters, and pilot performance-based quantitative metrics to estimate cognitive workload. The study aims to derive a non-invasive technique to estimate pilot's cognitive workload and study their correlation with standard physiological parameters. Initially, we conducted a set of user trials using well-established psychometric tests for evaluating the effectiveness of pupil and gaze-based ocular metrics for estimating cognitive workload at different levels of task difficulty and lighting conditions. Later, (...) we conducted user trials with the NALSim flight simulator using a business class Learjet aircraft model. We analyzed participants' ocular parameters, power levels of different EEG frequency bands, and flight parameters for estimating variations in cognitive workload. Results indicate that introduction of secondary task increases pilot's cognitive workload significantly. The beta frequency band of EEG, nearest neighborhood index specifying distribution of gaze fixation, L1 Norm of power spectral density of pupil diameter, and the duty cycle metric indicated variations in cognitive workload. (shrink)

Currently there are several psychotherapy modalities utilising theory and research from neuroscience in treatment frameworks for mental health and recovery from trauma. In Australia this includes: the Conversational Model of Psychodynamic Psychotherapy, a contemporary psychodynamic approach used for treating Borderline Personality Disorder and other trauma-related disorders; Electroencephalogram Neurofeedback, a brain training therapy which has been used as an adjunct to counselling/psychotherapy in traumatic stress and developmental trauma; and Somatic Experiencing, an integrative mind-body approach based on body responses to threat and (...) fear, especially thwarted attempts to enact fight or flight in the face of threat. These modalities have a promising but still-limited evidence base. This paper explores the role of different types of evidence to frame a descriptive review of the current evidence base available for clinicians practicing in these three modalities. While large clinical trials can provide evidence of comparative effectiveness, case studies, observational, qualitative and practice-based enquiry can assist in discovering other aspects of therapy important for individual clients and practitioners. Existing frameworks of evidence- and ethics-informed health and clinical decision-making suggest an ethical approach can incorporate new, developing and evidence-building therapies. Recommendations include careful consideration of informed consent for therapy including disclosure of efficacy and safety, and specific to psychotherapies incorporating neuroscience, a need for practitioners to reflectively assess their own knowledge, competence, heuristic approaches and biases. (shrink)

Fifty years have passed since Norwood Russell Hanson's unexpected death, yet he remains an important voice in philosophy of science. This book is a revised and expanded edition of a collection of Hanson's essays originally published in 1971, edited by Stephen Toulmin and Harry Woolf. The new volume features a comprehensive introduction by Matthew Lund (Rowan University) and two new essays. The first is "Observation and Explanation: A Guide to Philosophy of Science", originally published as a posthumous book by Harper (...) and Row. This essay, written near the end of Hanson’s life, represents his mature philosophy of science. The second new addition, Hanson's essay "The Trial of Galileo", is something of a "lost" work – it was only published in a small run collection on famous trials and was left out of the published lists of Hanson’s works. Ever the outspoken firebrand, Hanson found many lessons and warnings from Galileo's trial that were relevant to Cold War America. -/- This volume not only contains Hanson's best-known work in history and philosophy of science, but also highlights the breadth of his philosophical thought. Hanson balanced extreme versatility with a unified approach to conceptual and philosophical problems. Hanson's central insight is that philosophy and science both strive to render the world intelligible -- the various concepts central to our attempts to make sense of the world are interdependent, and cannot operate, or even be fully understood, independently. The essays included in this collection present Hanson's thinking on religious belief, theory, observation, meaning, cosmology, modality, logic, and philosophy of mind. This collection also includes Hanson's lectures on the theory of flight, Hanson's greatest passion. (shrink)

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization (...) of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (shrink)

This study investigated the effects of the 6 Minutes Journal, a commercial diary combining several positive psychology interventions, including gratitude, goal-setting, and self-affirmation exercises, on several mental health outcome measures. In a randomized controlled trial, university students were randomly assigned to one of two groups: 6MT and a wait list control group. Participants in the intervention group were instructed to follow the instructions of the 6MT for 4 weeks. Participants in both groups completed measures of perceived stress, positive and (...) negative affect, self-efficacy and resilience at baseline, after 2, and 4 weeks. We used path-analyses with autoregressive and cross-lagged effects to test our hypotheses of the effects of the 6MT. Participants in the intervention group reported decreased levels of perceived stress and negative affect, as well as increased levels of resilience and self-efficacy compared to the control group. Positive affect was not statistically significantly influenced. The data showed a statistically significant increased levels of self-efficacy and resilience only after 4 weeks, suggesting that changing these constructs needs more time. The 6-minute diary does not appear to make individuals fundamentally more positive. However, the intervention may have a protective function against negative influences on well-being. (shrink)

I begin by discussing the ways in which a would‐be blamer's own prior conduct towards the person he seeks to blame can undermine his standing to blame her (to call her to account for her wrongdoing). This provides the basis for an examination of a particular kind of ‘bar to trial’ in the criminal law – of ways in which a state or a polity's right to put a defendant on trial can be undermined by the prior misconduct (...) of the state or its officials. The examination of this often neglected legal phenomenon illuminates some central features of the criminal law and the criminal process, and some of the preconditions for the legitimacy of the criminal law in a liberal republic. (shrink)

I begin by discussing the ways in which a would-be blamer's own prior conduct towards the person he seeks to blame can undermine his standing to blame her. This provides the basis for an examination of a particular kind of 'bar to trial' in the criminal law – of ways in which a state or a polity's right to put a defendant on trial can be undermined by the prior misconduct of the state or its officials. The examination (...) of this often neglected legal phenomenon illuminates some central features of the criminal law and the criminal process, and some of the preconditions for the legitimacy of the criminal law in a liberal republic. (shrink)

Background: Although ethics consultation has been introduced to clinical practice for many years, the results of empirical studies to evaluate the effectiveness of ethics consultation are still controversial. The design of randomised controlled trials is considered the best research design to evaluate the effect of a clinical practice on the outcomes of interests. In order to understand the effects of ethics consultation, we conducted this search for studies with the design of randomised controlled trials to evaluate ethics consultation.Objective: To provide (...) an integrated review of studies with the design of randomised controlled trials to evaluate the effectiveness of ethics consultation.Methods: PubMed was used to search for studies using the randomised controlled trial design to evaluate the effectiveness of ethics consultation. The search term used was “ethics consultation”. The selection criterion was limited to “randomised controlled trial”.Results: Four articles that met both search criteria were retrieved. One of these articles reported a study that did not actually use the design of a randomised controlled trial and is excluded from the following discussion.Conclusions: To apply randomised controlled trials to evaluate the effectiveness of ethics consultation is extremely difficult as long as two issues are not resolved: the standardisation of ethics consultation and a placebo for ethics consultation to eliminate the placebo effect. Thus, the results generated by the design of randomised controlled trials are always problematic. Furthermore, as long as the two issues exist, the results generated by the design of quantitative research methods always pose problems. (shrink)

While new generations of implantable brain computer interface devices are being developed, evidence in the literature about their impact on the patient experience is lagging. In this article, we address this knowledge gap by analysing data from the first-in-human clinical trial to study patients with implanted BCI advisory devices. We explored perceptions of self-change across six patients who volunteered to be implanted with artificially intelligent BCI devices. We used qualitative methodological tools grounded in phenomenology to conduct in-depth, semi-structured interviews. (...) Results show that, on the one hand, BCIs can positively increase a sense of the self and control; on the other hand, they can induce radical distress, feelings of loss of control, and a rupture of patient identity. We conclude by offering suggestions for the proactive creation of preparedness protocols specific to intelligent—predictive and advisory—BCI technologies essential to prevent potential iatrogenic harms. (shrink)

The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) has been the focal point of many different criticisms regarding the ethics of the study ever since publication of the trial's findings in 2010 and 2012. In this article, we focus on a concern that the technical design and implementation details of the study were ethically flawed. While the federal Office Human Research Protections focused on the consent form, rather than on the study design and implementation, OHRP's critiques of (...) the consent form reveal views about the study design and implementation that we believe are fundamentally flawed. These criticisms about the design and implementation of SUPPORT, if generalized, become relevant concerns about these aspects of many comparative effectiveness research studies.Our analytical approach will be to use SUPPORT as a prime example of comparative effectiveness research and show why it challenges some prevailing assumptions about the riskiness of research. We will address five aspects of the study design and implementation: 1) randomization, 2) treatment by protocol, 3) choice of endpoints, 4) lack of a “standard care” control group, and 5) the use of altered oximeters. Examining these aspects will allow us to answer two specific central questions. The first is a methodological question with ethical implications: was the study designed in such a way as to answer the primary study question? The second question is whether the study design added or decreased risk to the babies enrolled in the study compared to babies who were not in the study. (shrink)

In a typical comparative clinical trial the randomization scheme is fixed at the beginning of the study, and maintained throughout the course of the trial. A number of researchers have championed a randomized trial design referred to as ‘outcome-adaptive randomization.’ In this type of trial, the likelihood of a patient being enrolled to a particular arm of the study increases or decreases as preliminary information becomes available suggesting that treatment may be superior or inferior. While the (...) design merits of outcome-adaptive trials have been debated, little attention has been paid to significant ethical concerns that arise in the conduct of such studies. These include loss of equipoise, lack of processes for adequate informed consent, and inequalities inherent in the research design which could lead to perceptions of injustice that may have negative implications for patients and the research enterprise. This article examines the ethical difficulties inherent in outcome-adaptive trials. (shrink)

Assessing social risks has proven difficult for IRBs. We undertook a novel effort to empirically investigate social risks before an HIV prevention trial among drug users in Thailand and China. The assessment investigated whether law, policies and enforcement strategies would place research subjects at significantly elevated risk of arrest, incarceration, physical harm, breach of confidentiality, or loss of access to health care relative to drug users not participating in the research. The study validated the investigator's concern that drug users (...) were subject to serious social risks in the site localities, but also suggested that participation in research posed little or no marginal increase in risk and might even have a protective effect. Our experience shows that it is feasible to inform IRB deliberations with actual data on social risks, but also raises the question of whether and when such research is an appropriate use of scare research resources. (shrink)

ABSTRACTDespite being held in something approaching universal esteem for its capacity to promote prosocial behavior and inhibit antisocial behavior, empathy has recently become the recipient of strong criticism from some of today’s leading academics. Two of the more high-profile criticisms of empathy have come from philosopher Jesse Prinz and psychologist Paul Bloom, each of whom challenges the view that empathy has an overall beneficial influence on human behavior. In this essay, I discuss the basis of their criticisms as well as (...) why I am not compelled by their arguments to believe that empathy does more harm than good. In the process of responding to empathy’s critics, I discuss the important role that empathy plays in our moral lives. I argue that, rather than employing rational considerations to minimize the role that empathy plays in our moral and political judgments, such considerations are put to better use by expanding empathy when conducive to the common good and suppressing it when it opposes th... (shrink)

BackgroundAs the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words.DiscussionParents want to do their best for their children, and socially and legally their role is to (...) care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual parents will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make.SummaryDiscussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials, and ultimately, may help improve the experience of trial recruitment for all parties. (shrink)

Translational science is a 21st century mission. Government officials and industry leaders are making huge investments in an attempt to transform more basic science discoveries into therapeutic applications. Scientists and policymakers express great excitement about the medical advances that could come with the current bench-to-bedside campaign.A key step in translational science is the move from animal and other preclinical studies to initial human testing. Researchers ability to predict human effects is limited, and first-in-human tests present significant uncertainty. Participants in this (...) form of research face risks and can experience serious, even lethal, harm. Well-known incidents involving Jolee Mohr and Jesse Gelsinger, as well as subjects in the 2006 study of the investigational agent TGN1412, show the dangers that can arise in early human research.The bench-to-bedside campaign will need many volunteers to participate in early human testing. Investigators and regulators must not allow the policy enthusiasm for translational science to overshadow the commitment to protect human subjects. Participants in exploratory research are diverse and as a group lack characteristics usually associated with vulnerable populations, such as impaired decisional ability or economic or educational disadvantage. (shrink)

There is a gap of knowledge about the extent to which gratitude is indeed the working mechanism of change in gratitude interventions aiming to promote mental well-being. This study explores the mediational role of gratitude as mood in the context of a recently conducted randomized controlled trial on the effects of a 6-week gratitude intervention on mental well-being in comparison with a waitlist control group. Gratitude as mood was measured at 2, 4, and 6 weeks. Both simple and multiple (...) mediation models were conducted as well as various sensitivity analyses. Results showed a gradual increase of gratitude as mood during the intervention. The effects of the 6-week gratitude intervention on mental well-being were mediated by increases of gratitude as mood at 4 weeks but not at 2 weeks. These findings suggest a dose-response relationship for gratitude interventions, but more research is warranted. (shrink)

Leszek Kolakowski delves into some of the most intellectually vigorous questions of our time in this remarkable collection of essays garnished with his characteristic wit. Ten of the essays have never appeared before in English. "Exemplary.

There is a gap in evidence regarding how research trial closure processes are managed to ensure continuity of HIV care for HIV positive participants following trial closure within low income settin...

This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone. The wording of the current (...) version of the Declaration of Helsinki could in fact be interpreted to broaden the scope to include other collateral benefits by applying such a broad fair benefits framework. We argue that this possibility should be utilised by low and middle income countries’ health research ethics committees in order to ensure that research participants who enrol in clinical trials so as to receive medical care continue to access care after the trial is concluded, as befits their dignity. Although each LMIC has unique concerns, nonetheless there are common challenges based especially on emerging issues, such as post-trial access to healthcare. Accordingly, the South African perspective is used to draw lessons that can benefit other LMICs. (shrink)

To investigate the effects of two different modes of physical activity on body composition, physical fitness, cardiometabolic risk, and psychological responses in female adolescents participating in a multi-disciplinary program. The 12-week randomized intervention included 25-adolescents with overweight divided into two groups: sports practice-SPG and functional training-FTG. The SPG intervention was divided into three sports: basketball, handball, and futsal. SPG participants performed one sport 3-times/week, over the course of 1 month. The FTG performed concurrent exercises 3-times/week. This study was registered in (...) Clinical Trials Registry Platform under number: RBR-45ywtg and registered in Local Ethics Committee number: 2,505.200/2018. The intensity of physical exercises-PE was matched between groups by the rating of perceived exertion. The primary outcome was body composition, and secondary outcomes were physical fitness, cardiometabolic risk, and psychological responses. There was a significant time-effect for body mass, body mass index, and low-density lipoprotein, all being reduced. There were increases over time for musculoskeletal mass, aerobic fitness, and high-density lipoprotein. There was a group time interaction with body fat percentage being lower post-intervention in the SPG. No significant differences were observed for the other variables. Both physical activity models were effective in improving a subset of obesity-related health parameters. The findings should be extended by further investigation using more sophisticated measures of energy expenditure.Clinical Trial Registration:https://ensaiosclinicos.gov.br/, identifier: RBR-45ywtg. (shrink)

Patient narratives from two investigational deep brain stimulation trials for traumatic brain injury and obsessive‐compulsive disorder reveal that injury and illness rob individuals of personal identity and that neuromodulation can restore it. The early success of these interventions makes a compelling case for continued post‐trial access to these technologies. Given the centrality of personal identity to respect for persons, a failure to provide continued access can be understood to represent a metaphorical identity theft. Such a loss recapitulates the pain (...) of an individual's initial injury or illness and becomes especially tragic because it could be prevented by robust policy. A failure to fulfill this normative obligation constitutes a breach of disability law, which would view post‐trial access as a means to achieve social reintegration through this neurotechnological accommodation. (shrink)

We investigated whether, in the emergency department, educational video-assisted informed consent is superior to the conventional consent process, to inform trauma patients undergoing surgery about the procedure, benefits, risks, alternatives, and postoperative care. We conducted a prospective randomized controlled trial, with superiority study design. All trauma patients scheduled to receive trauma-related debridement surgery in the ED of Kaohsiung Medical University Hospital were included. Patients were assigned to one of two education protocols. Participants in the intervention group watched an educational (...) video illustrating informed consent information, whereas those in the control group read an informed consent document. The primary outcome was knowledge scores and the secondary outcome was assessment of patient satisfaction. A multivariable regression model, with predefined covariates, was used to analyze differences in knowledge scores and patient satisfaction levels between the groups. A total of 142 patients were enrolled, with 70 and 72 assigned to the intervention and control groups, respectively. Mean knowledge scores were higher in the intervention ) than in the control group. By multivariate analysis, the intervention group had significantly greater differences in knowledge scores. Age, injury severity score, and baseline knowledge score significantly affected the differences in knowledge scores. Significant improvements were observed in patients’ perception of statements addressing comprehension of the information provided, helpfulness of the supplied information for decision making, and satisfaction with the informed consent process. Multivariate analysis showed significant correlations between video education and patient satisfaction. Both the educational approach and severity of injury may have an impact on patient understanding during the informed consent process in an emergency environment. Video-assisted informed consent may improve the understanding of surgery and satisfaction with the informed consent process for trauma patients in the ED. Institutions should develop structured methods and other strategies to better inform trauma patients, facilitate treatment decisions, and improve patient satisfaction. The ClinicalTrials.gov Identifier is NCT01338480. The date of registration was April 18, 2011. (shrink)

Background: Ideas always have and always will change the world; with ideas-engagement enabling individuals to become more knowledgeable, better able to make good decisions and better positioned to re-align their values in response to new progressive norms and beliefs. Given these potential benefits, of primary interest is how citizens can be most effectively encouraged to engage with new ideas. Methods: With this study we test the efficacy of two approaches designed to enhance citizen’s perceptions regarding the value of ideas-engagement. Specifically, (...) we recontextualise a previously undertaken small-scale randomised control trial designed to stimulate states of either curiosity or pragmatic prospection amongst two randomly allocated groups of respondents. Our target variables involve the importance respondents attribute to staying up to date, as well as to four related attitudinal variables. Our target audience is the voting age population of England. Results: 515 participants took part in the experiment, with 269 receiving the curiosity stimulating intervention and 246, the prospection intervention. Our findings suggest that, by the end of four weeks, only the intervention designed to promote pragmatic prospection had significantly impacted on the importance respondents attribute to staying up to date. It also positively impacted the value- scores for one of the secondary attitudinal variables (relating to the importance of supporting physical and mental-health). Conclusions: While this study provides useful insight regarding ideas-engagement, further work is needed. In particular, future studies will require a larger sample, so as to ascertain the impact of these approaches on ‘ideas refusers’. Also required is the inclusion of a control group to provide a definitive counter factual. Furthermore, since positive changes in attitudes towards ideas- engagement also ideally leads to changes in behaviours, questions are also needed to examine the sources of ideas respondents subsequently engage with (or not) as a result of these interventions. (shrink)

Background: Family members are often required to act as substitute decision-makers when health care or research participation decisions must be made for an incapacitated relative. Yet most families are unable to accurately predict older adult preferences regarding future health care and willingness to engage in research studies. Discussion and documentation of preferences could improve proxies' abilities to decide for their loved ones. This trial assesses the efficacy of an advance planning intervention in improving the accuracy of substitute decision-making and (...) increasing the frequency of documented preferences for health care and research. It also investigates the financial impact on the healthcare system of improving substitute decision-making. Methods/DesignDyads (n = 240) comprising an older adult and his/her self-selected proxy are randomly allocated to the experimental or control group, after stratification for type of designated proxy and self-report of prior documentation of healthcare preferences. At baseline, clinical and research vignettes are used to elicit older adult preferences and assess the ability of their proxy to predict those preferences. Responses are elicited under four health states, ranging from the subject's current health state to severe dementia. For each state, we estimated the public costs of the healthcare services that would typically be provided to a patient under these scenarios. Experimental dyads are visited at home, twice, by a specially trained facilitator who communicates the dyad-specific results of the concordance assessment, helps older adults convey their wishes to their proxies, and offers assistance in completing a guide entitled My Preferences that we designed specifically for that purpose. In between these meetings, experimental dyads attend a group information session about My Preferences. Control dyads attend three monthly workshops aimed at promoting healthy behaviors. Concordance assessments are repeated at the end of the intervention and 6 months later to assess improvement in predictive accuracy and cost savings, if any. Copies of completed guides are made at the time of these assessments. DiscussionThis study will determine whether the tested intervention guides proxies in making decisions that concur with those of older adults, motivates the latter to record their wishes in writing, and yields savings for the healthcare system. Trial RegistrationISRCTN89993391. (shrink)

The primary purpose of this randomized controlled trial (RCT) was to evaluate the efficacy of an unguided, two-week internet-based training program to overcome procrastination, called ON.TOP. Because adherence is a typical problem among individuals who tend to procrastinate, especially with internet-based interventions, the secondary purpose of the present study was to investigate whether adding SMS support increases subjects’ frequency of engagement in training. In a three-armed RCT (N = 161), the effects of the intervention alone and intervention with daily (...) SMS-support were compared to a waiting list control condition in a sample of students. The primary outcome of interest was procrastination. The secondary outcome of interest was the extent of training behavior. Baseline (T0), immediate post-treatment (T1) and 8-week post-treatment (T2) assessments were conducted. Results indicated that procrastination decreased significantly only with intervention group with daily SMS support, relative to control. Moreover, incorporating SMS support also may enhance extent of training behavior. (shrink)

Background Ensuring individual free and informed decision‐making for research participation is challenging. It is thought that preliminarily informing communities through ‘community sensitization’ procedures may improve individual decision‐making. This study set out to assess the relevance of community sensitization for individual decision‐making in research participation in rural Gambia. Methods This anthropological mixed‐methods study triangulated qualitative methods and quantitative survey methods in the context of an observational study and a clinical trial on malaria carried out by the Medical Research Council Unit (...) Gambia. Results/discussion Although 38.7% of the respondents were present during sensitization sessions, 91.1% of the respondents were inclined to participate in the trial when surveyed after the sensitization and prior to the informed consent process. This difference can be explained by the informal transmission of information within the community after the community sensitization, expectations such as the benefits of participation based on previous research experiences, and the positive reputation of the research institute. Commonly mentioned barriers to participation were blood sampling and the potential disapproval of the household head. Conclusion Community sensitization is effective in providing first‐hand, reliable information to communities as the information is cascaded to those who could not attend the sessions. However, further research is needed to assess how the informal spread of information further shapes people's expectations, how the process engages with existing social relations and hierarchies (e.g. local political power structures; permissions of heads of households) and how this influences or changes individual consent. (shrink)

ObjectiveCo-morbid insomnia and sleep apnea is a common and debilitating condition that is more difficult to treat compared to insomnia or sleep apnea-alone. Emerging evidence suggests that cognitive behavioral therapy for insomnia is effective in patients with COMISA, however, those with more severe sleep apnea and evidence of greater objective sleep disturbance may be less responsive to CBTi. Polysomnographic sleep study data has been used to predict treatment response to CBTi in patients with insomnia-alone, but not in patients with COMISA. (...) We used randomized controlled trial data to investigate polysomnographic predictors of insomnia improvement following CBTi, versus control in participants with COMISA.MethodsOne hundred and forty five participants with insomnia and sleep apnea [apnea-hypopnea index ≥ 15] were randomized to CBTi or no-treatment control. Mixed models were used to investigate the effect of pre-treatment AHI, sleep duration, and other traditional, and novel [quantitative electroencephalography ] polysomnographic predictors of between-group changes in Insomnia Severity Index scores from pre-treatment to post-treatment.ResultsCompared to control, CBTi was associated with greater ISI improvement among participants with; higher AHI, less wake after sleep onset, and less N3 sleep. No quantitative electroencephalographic, or other traditional polysomnographic variables predicted between-group ISI change.DiscussionAmong participants with COMISA, higher OSA severity predicted a greater treatment-response to CBTi, versus control. People with COMISA should be treated with CBTi, which is effective even in the presence of severe OSA and objective sleep disturbance. (shrink)

An emerging consensus regards domestic amnesties for international crimes as generally inconsistent with international law. This legal consensus rests on a norm against impunity: the chief role of international criminal law, and of the fledgling International Criminal Court , is to end impunity for violators of the worst of criminal acts. But the anti-impunity norm, and the anti-amnesty consensus that has arisen from it, now face serious difficulties. The ICC's role in the ongoing conflict in Northern Uganda illustrates the deadlock (...) that has now emerged between countries wishing to retain the power to use domestic politics and criminal law as tools for negotiation with current or outgoing perpetrators, on the one side, and the ICC's determination to apply a consistent international anti-impunity norm, on the other. The paper argues that the anti-impunity norm itself is based on a narrowly retributivist conception of criminal justice. A broader norm for democratic accountability, by contrast, would continue to prefer prosecutions over amnesties in international law, less for the opportunity for deserved retribution for perpetrators than for the public enactment of the deliberative procedures associated with the rule of law.Keywords: amnesty; impunity; international law; international criminal court. (shrink)

Background We report a randomised controlled clinical trial of neurofeedback therapy intervention for ADHD/ADD in adults. We focus on internal mechanics of neurofeedback learning, to elucidate the primary role of cortical self-regulation in neurofeedback. We report initial results; more extensive analysis will follow. Methods Trial has two phases: intervention and follow-up. The intervention consisted of neurofeedback treatment, including intake and outtake measurements, using a waiting-list control group. Treatment involved $\sim$40 hour-long sessions 2-5 times per week. Training involved either (...) theta/beta or sensorimotor-rhythm regimes, adapted by adding a novel 'inverse-training' condition to promote self-regulation. Follow-up (ongoing) will consist of self-report and executive function tests. Setting Intake and outtake measurements were conducted at University of Helsinki. Treatment was administered at partner clinic Mental Capital Care, Helsinki. Randomisation We randomly allocated half the sample then adaptively allocated the remainder to minimise baseline differences in prognostic variables. Blinding Waiting-list control design meant trial was not blinded. Participants 54 adult Finnish participants (mean age 36 years; 29 females) were recruited after screening by psychiatric review. 44 had ADHD diagnoses, 10 had ADD. Measurements Symptoms were assessed by computerised attention test (T.O.V.A.) and self-report scales, at intake and outtake. Performance during neurofeedback trials was recorded. Results Participants were recruited and completed intake measurements during summer 2012, before assignment to treatment and control, September 2012. Outtake measurements ran April-August 2013. After dropouts, 23 treatment and 21 waiting-list participants remained for analysis. Initial analysis showed that, compared to waiting-list control, neurofeedback promoted improvement of self-reported ADHD symptoms, but did not show transfer of learning to T.O.V.A. Comprehensive analysis will be reported elsewhere. Trial Registration "Computer Enabled Neuroplasticity Treatment (CENT)", ISRCTN13915109. Partly funded by Finnish science agency TEKES, project #440078. (shrink)

Visual cortical prostheses (VCPs) have the potential to provide artificial vision for visually impaired persons. However, the nature and utility of this form of vision is not yet fully understood. Participants in the early feasibility trial for the Orion VCP were interviewed to gain insight into their experiences using artificial vision, their motivations for participation, as well as their expectations and assessments of risks and benefits. Analyzed using principles of grounded theory and an interpretive description approach, these interviews yielded (...) six themes, including: the irreducibility of benefit to device functionality, mixed expectations for short-term device functionality and long-term technological advancement of visual prostheses, and a broad range of risks, concerns, and fears related to trial participation. We argue that these narratives motivate a nuanced set of ethical considerations related to the complex relationship between functionality and benefit, the intersection of user experience with disability justice, and the import of expectations and indirect risks on consent. (shrink)

A document discovered in the Roman archives of the Jesuits sheds new light on the involvement of the Jesuit mathematician Christoph Scheiner in the trial of Galileo. The document suggests that Scheiner did not initiate the 1632–33 proceedings against Galileo, despite a long suspicion of his role in the events leading to Galileo’s condemnation, abjuration, and house arrest. An exploration of the contrasting conceptions of the scientific enterprise competing for hegemony within the Society of Jesus at the time of (...) the trial leads to the development of a model of scientific exchange based on money rather than gift giving. (shrink)