In the Caribbean as in many other areas costly biomedical resources and personnel are limited, and more and more people are turning to alternative medicine and folk practitioners for health care. To meet the goal of providing health care for all, research on nonbiomedical therapies is needed, along with legal recognition of folk practitioners to establish standards of practice.

Since their derivation, human embryonic stem (hES) cells have been used for a variety of applications including developmental biology, pathology, chemical biology, genomics, and proteomics. However, their most important potential application is the generation of cells and tissues, which can be used for cell‐based therapies. One of the main drawbacks of hES cell culture is that they are particularly sensitive to dissociation, which is required for passaging, expansion, cryopreservation, and other applications. Recently, it has been discovered that an inhibitor of (...) Rho kinase (ROCKi; Y‐27632) increases the survival rate of dissociated, single hES cells. This breakthrough has allowed new methods in hES cell culture to be developed, with the promise of increasing hES cell numbers into the realm of clinical relevance. In our studies demonstrating that ROCKi dramatically increases hES cell cryopreservation efficiency, we have observed that ROCKi treatment does not decrease hES cell's susceptibility to apoptosis. Rather, we hypothesize that ROCKi treatment desensitizes single hES cells to their environment reducing the odds that individual cells will undergo anoikis. (shrink)

Embryonic stem cells (ESCs) are now classified into two types of pluripotency: “naïve” and “primed” based upon their differing characteristics. Conventional human ESCs have much more in common with mouse epiblast stem cells and are now deemed to be primed. Naïve human ESCs that resemble mouse ESCs have recently been generated from their primed counterpart by cellular reprogramming. Isolation of naïve hESCs from human embryos has proven to be difficult. Is the inability to capture naïve hESCs the result of suboptimal (...) derivation conditions or because they are so transient they cannot be “captured” in vitro? Prevailing evidence surrounding this issue are inconclusive and require additional human embryo research. However, negative public opinion regarding human embryo research, may make this an uphill battle. The solution may come from cellular reprogramming. (shrink)

Embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) can self‐renew indefinitely and contribute to all tissue types of the adult organism. Stem cell‐based therapeutic approaches hold enormous promise for the cure of regenerative diseases. Over the last few years, several studies have attempted to decipher the important role of transcription factor networks and epigenetic regulatory signals in the maintenance of ESC pluripotency, but the exact underlying mechanisms have yet to be identified. Among the epigenetic factors, chromatin dynamics and (...) structure have been found to contribute greatly to maintenance of pluripotency and regulation of differentiation in ESCs. These modifications include: covalent histone acetylation and methylation, histone bivalents and chromatin remodeling, and DNA methylation. Studies in ESCs have shown that genes associated with early development are arranged within a bivalent chromatin structure. This is thought to be a “poised yet repressed” situation, which can be activated upon differentiation. The breakthrough of iPSCs has opened a new era in stem cell biology. During reprogramming, the chromatin state of differentiated cells is reset to an embryonic form via a largely unknown mechanism. In this review, the fundamental impact of chromatin dynamic in ESCs as well as its critical role in the generation of iPSCs is discussed. (shrink)

Various forms of research are essential in emergency, disaster and disease outbreak situations, but challenges exist including the long length of time it takes to get research proposals approved. Consequently, it would be very advantageous to have an acceptable model for efficient coordination and communication between and among research ethics committees/IRBs and ministries of health, and templates for expediting ethical review of research proposals in emergency and epidemic situations to be used across the Caribbean and in other low and middle (...) income countries. This project involved a literature search and the interviewing of ministry of health officials, public health practitioners, and research ethics committee/IRB members in Jamaica and St. Lucia, to obtain suggestions for the best model for efficient coordination and communication between research ethics committees, and developed a template for expediting review of research protocols in epidemic and emergency conditions. (shrink)

Guideline 20 of the updated International Ethics Guidelines for Health‐related Research Involving Humans (2016) by the Council for International Organizations of Medical Sciences (CIOMS) provides guidance on research in disasters and disease outbreaks against the background of the need to generate knowledge quickly, overcome practical impediments to implementing such research, and the need to maintain public trust. The guideline recommends that research ethics committees could pre‐screen study protocols to expedite ethical reviews in a situation of crisis, that pre‐arrangements be made (...) regarding data sharing and biomedical sample sharing, and that sponsors and research ethics committees seek to minimize risk to researchers conducting research during a disaster. This paper critiques these recommendations against the background of the findings of a survey of public health officials and chairs of research ethics committees in the Caribbean during 2016, which sought to determine the best template for the expeditious ethical review of research proposals in emergency and epidemic situations in the Caribbean, and whose findings can serve as a model for other low‐ and middle‐income countries. (shrink)

This paper examines pain and pain relief in the Caribbean, where pain is widely perceived as an unavoidable part of life, and where unnecessary suffering results from untreated and under treated pain. Barriers to pain relief in the Caribbean include patient and family attitudes, inadequate knowledge among health professionals and unduly restrictive regulations on the medical use of opioids. Similar barriers exist all over the world. This paper urges medical, nursing and public health professionals, and educators to examine attitudes towards (...) pain and pain relief and to work towards making effective pain relief and palliation more accessible. It recommends that i) health professionals and officials be better educated about pain, palliation and opioids, ii) regulatory restrictions be updated in light of clinical and scientific evidence, iii) opioid procurement policies be adjusted to facilitate increased medical use, iv) medical charts and records be modified to routinely elicit and document patients levels of pain, and v) educational campaigns be developed to inform the public that moderate and severe pain can be safely relieved at the end of life and other stages of life. The professional, respectful, and beneficent response to patients in pain is to provide rapid and aggressive pain relief or to urgently consult a pain or palliative specialist. When a health system hinders such efforts the ethical response is to identify, facilitate and advocate for overcoming barriers to improvement. (shrink)

Realising the societal gains from publicly funded health and medical research requires a model for a reflexive evaluation precedent for the societal impact of research. This research explores UK Research Excellence Framework evaluators’ values and opinions and assessing societal impact, prior to the assessment taking place. Specifically, we discuss the characteristics of two different impact assessment extremes – the “quality-focused” evaluation and “societal impact-focused” evaluation. We show the wide range of evaluator views about impact, and that these views could be (...) conceptually reflected in a range of different positions along a conceptual evaluation scale. We describe the characteristics of these extremes in detail, and discuss the different beliefs evaluators had which could influence where they positioned themselves along the scale. These decisions, we argue, when considered together, form a dominant definition of societal impact that influences the direction of its evaluation by the panel. (shrink)

This paper examines pain and pain relief in the Caribbean, where pain is widely perceived as an unavoidable part of life, and where unnecessary suffering results from untreated and under treated pain. Barriers to pain relief in the Caribbean include patient and family attitudes, inadequate knowledge among health professionals and unduly restrictive regulations on the medical use of opioids. Similar barriers exist all over the world. This paper urges medical, nursing and public health professionals, and educators to examine attitudes towards (...) pain and pain relief and to work towards making effective pain relief and palliation more accessible. It recommends that i) health professionals and officials be better educated about pain, palliation and opioids, ii) regulatory restrictions be updated in light of clinical and scientific evidence, iii) opioid procurement policies be adjusted to facilitate increased medical use, iv) medical charts and records be modified to routinely elicit and document patients levels of pain, and v) educational campaigns be developed to inform the public that moderate and severe pain can be safely relieved at the end of life and other stages of life. The professional, respectful, and beneficent response to patients in pain is to provide rapid and aggressive pain relief or to urgently consult a pain or palliative specialist. When a health system hinders such efforts the ethical response is to identify, facilitate and advocate for overcoming barriers to improvement. (shrink)

The American conservative movement is a force of anti-reflexivity insofar as it attacks two key elements of reflexive modernization: the environmental movement and environmental impact science. Learning from its mistakes in overtly attacking environmental regulations in the early 1980s, this counter-movement has subsequently exercised a more subtle form of power characterized by non-decision-making. We examine the conservative movement’s efforts to undermine climate science and policy in the USA over the last two decades by using this second dimension of power. The (...) conservative movement has employed four non-decision-making techniques to challenge the legitimacy of climate science and prevent progress in policy-making. We argue that reflexive modernization scholars should focus more attention on similar forces of anti-reflexivity that continue to shape the overall direction of our social, political and economic order, and the life chances of many citizens. Indeed, better understanding of the forces and effectiveness of anti-reflexivity may very well be crucial for societal resilience and adaptation, especially in the face of global environmental problems like climate change. (shrink)

This paper examines the consequences of a culture of “personal ethics” when using new methodologies, such as the use of social media sites as a source of data for research. Using SM research as an example, this paper explores the practices of a number of actors and researchers within the “Ethics Ecosystem” which as a network governs ethically responsible research behaviour. In the case of SM research, the ethical use of this data is currently in dispute, as even though it (...) is seemingly publically available, concerns relating to privacy, vulnerability, potential harm and consent blur the lines of responsible ethical research behaviour. The findings point to the dominance of a personal, bottom-up, researcher-led, ‘ethical barometer’ for making decisions regarding the permissibility of using SM data. We show that the use of different barometers by different researchers can lead to wide disparities in ethical practice - disparities which are compounded by the lack of firm guidelines for responsible practice of SM research. This has widespread consequences on the development of shared norms and understandings at all levels, and by all actors within the Ethics Ecosystem, and risks inconsistencies in their approaches to ethical decision-making. This paper argues that this governance of ethical behaviour by individual researchers perpetuates a negative cycle of academic practice that is dependent on subjective judgements by researchers themselves, rather than governed by more formalised academic institutions such as the research ethics committee and funding council guidelines. (shrink)

Capitalizing on the hype surrounding stem cell research, numerous clinics around the world offer “stem cell therapies” for a variety of medical conditions. Despite questions about the safety and efficacy of these interventions, anecdotal evidence suggests a relatively large number of patients are traveling to receive these unproven treatments — a practice called “stem cell tourism.” Because these unproven treatments pose risks to individual patients and to legitimate translational stem cell research, stem cell tourism has generated substantial policy concern and (...) inspired attempts to reduce these risks through the development of guidelines for patients and medical practitioners. This paper examines the roles and responsibilities of physicians in patients' home countries with respect to patients' decisions to try unproven stem cell therapies abroad. Specifically, it examines professional guidance from two organizations — the American Medical Association and the International Society for Stem Cell Research — and assesses physicians' professional and legal obligations to patients considering unproven stem cell therapies. Then, drawing on qualitative interviews conducted with patients who traveled abroad for unproven stem cell treatments, it explores the roles that physicians actually play in patients' decisions and compares these actual roles with their professional and legal responsibilities. The paper concludes with a discussion of strategies to help improve the guidance physicians provide to patients considering unproven treatments. (shrink)

Stem cell science, using both embryonic and a variety of tissue-specific stem cells, is advancing rapidly and offers promise to improve medical care in the future. Yet, with the notable exception of hematopoietic stem cell transplantation, a long-established approach to treating certain cancers of the blood system, this promise is long term and most stem cell research focuses on basic scientific questions or the collection of pre-clinical data. Although some clinical trials are underway, most are focused on safety, and novel (...) effective therapy is likely a long way off. Despite the preliminary nature of most stem cell research, however, numerous clinics around the world offer stem cell “therapies” to patients today outside the context of a clinical trial. Although the number of patients who have received these stem cell-based interventions is unknown, anecdotal reports suggest a substantial population of patients is willing to try them, despite unresolved questions about their safety and efficacy. (shrink)

Next SectionBecause of the radically incarnational nature of the Christian understanding of ethics and bioethics, according to Kierkegaard, there has always been an infinite gulf between Christian bioethics and secular bioethics. However, the process of the secularization of the public square has made this gulf more apparent and salient for the current ethical debates in biomedicine and the culture more generally.

It is not uncommon to hear that poor school performance, welfare dependancy, youth unemployment, and criminal activity result more from shortcomings in the personal makeup of individuals than from societal forces beyond their control. Are American values declining as so many suggest? And are those values at the root of many social problems today?Shaped by experience and public policies, people's values and social norms do change. What role can or should a democratic government play in shaping values? And how do (...) these values conditon the efficacy of public policy?In this book, six distinguished social scientists identify trends in America's values and their consequences, and consider public policy tools with which some of those values might be changed.Daniel Yankelovich begins with a discussion of how American values have shifted in the last half-century, and argues that affluence is the driving force behind these changes in values. James Q. Wilson argues that destructive habits which can lead to social pathologies, like crime and drug use, are set early in life; he examines how public policy might intervene when children are young to promote better values. David Popenoe maintains that America has veered too far towards industrialist values, and explores the resulting decline of families and many attendant social ills. Nathan Glazer describes the history and present status of the dispute over multicultural education. Jane Mansbridge examines the process of building cooperation, consensus, and public spirit. And George Akerlof and Janet L. Yellen discuss the problem of gang criminality.Inthe past, social scientists have often sidestepped questions about values as undefinable, unquantifiable, and somehow unscientific. The essays in this volume address these questions at last.Henry J. Aaron, director of the Economic Studies program at Brookings, is the authorof numerous books, including most recently Serious and Unstable Condition: Financing America's Health Care (1991), and coeditor of Setting Domestic Priorities (1992). Thomas E. Mann is director of the Brookings Governmental Studies program, coeditor of Media Polls in American Politics (1992), and coauthor of the Renewing Congress series (1993). Timothy Taylor is managing editor of the Journal of Economic Perspectives at Stanford University. (shrink)

Social media and Internet technologies present several emerging and ill-explored issues for a modern healthcare workforce. One issue is patient-targeted Googling, which involves a healthcare professional using a social networking site or publicly available search engine to find patient information online. The study’s aim was to address a deficit in data and knowledge regarding PTG, and to investigate medical student use of SNSs due to a close association with PTG. The authors surveyed final year medical students at the Otago Medical (...) School, University of Otago in January 2016. A subset completed focus groups that were analysed using thematic analysis to identify key themes relating to students’ attitudes towards PTG, and reasons why they might engage in PTG. Fifty-four students completed the survey, which showed that PTG was uncommon. Attitudes were varied and context dependent. Most participants saw problems with PTG and favoured more explicit guidance on the issue. SNS usage was high ; participants were concerned by the content of their SNS profiles and who they were connecting with online. Participants showing high SNS use were 1.83 times more likely to have conducted PTG than lower use groups. The diverse attitudes uncovered in this study indicated that teaching or guidelines could be useful to healthcare professionals considering PTG. Though ethically problematic, PTG may be important to patient care and safety. The decision to conduct PTG should be made with consideration of ethical principles and the intended use of the information. (shrink)

Background Social media and Internet technologies present several emerging and ill-explored issues for a modern healthcare workforce. One issue is patient-targeted Googling, which involves a healthcare professional using a social networking site or publicly available search engine to find patient information online. The study’s aim was to address a deficit in data and knowledge regarding PTG, and to investigate medical student use of SNSs due to a close association with PTG. Method The authors surveyed final year medical students at the (...) Otago Medical School, University of Otago in January 2016. A subset completed focus groups that were analysed using thematic analysis to identify key themes relating to students’ attitudes towards PTG, and reasons why they might engage in PTG. Results Fifty-four students completed the survey, which showed that PTG was uncommon. Attitudes were varied and context dependent. Most participants saw problems with PTG and favoured more explicit guidance on the issue. SNS usage was high ; participants were concerned by the content of their SNS profiles and who they were connecting with online. Participants showing high SNS use were 1.83 times more likely to have conducted PTG than lower use groups. Conclusions The diverse attitudes uncovered in this study indicated that teaching or guidelines could be useful to healthcare professionals considering PTG. Though ethically problematic, PTG may be important to patient care and safety. The decision to conduct PTG should be made with consideration of ethical principles and the intended use of the information. (shrink)

In this article we consider the material dimensions of schooling as constitutive of the possibilities inherent in “fixing” education. We begin by mapping out the problem of “fixing education,” pointing to the necrophilic tendencies of contemporary education—a desire to kill what otherwise might be life-giving. In this sense, to “fix” education is to make otherwise fluid processes-of-living static. We next point to the material realities of this move to fix. After establishing the material consequences of perpetually fixing schools, we provide (...) a brief overview of two critical perspectives that might be shown as attempts to “unfix” education: critical pedagogy and unschooling. Though both offer critiques of normative education, these approaches are also bound by their failure to fully engage with the material dimensions of schooling. As such, both critical pedagogy and unschooling inadvertently cut off key possibilities for human flourishing within educational environments. In their rush to “unfix”—to counter the necrophilic tendencies of contemporary education—these approaches exclude or otherwise foreclose upon resistive challenges to the normative order that extend from the margins. In response, we turn to the possibilities for unschooling within the materially public spaces of schools. These are the spaces where fixity fails—possibility extends from unschooling in schools, from unfixing the process of fixing education. We end by considering the possibilities inherent in Community Service Learning as a valuable means to engage in a radically public, and unfixed, educational system. (shrink)

Rare genetic diseases collectively impact millions of individuals in the United States. These patients and their families share many challenges including delayed diagnosis, lack of knowledgeable providers, and limited economic incentives to develop new therapies for small patient groups. As such, rare disease patients and families often must rely on advocacy, including both self-advocacy to access clinical care and public advocacy to advance research. However, these demands raise serious concerns for equity, as both care and research for a given disease (...) can depend on the education, financial resources, and social capital available to the patients in a given community. In this article, we utilize three case examples to illustrate ethical challenges at the intersection of rare diseases, advocacy and justice, including how reliance on advocacy in rare disease may drive unintended consequences for equity. We conclude with a discussion of opportunities for diverse stakeholders to begin to address these challenges. (shrink)

Despite advances in medical knowledge regarding pain management, pain continues to be significantly undertreated in the United States. There are many drug and nondrug treatments, but the use of controlled substances, particularly the opioid analgesics, is universally accepted for the treatment of pain from cancer. Although opioid analgesics are safe and effective in treating chronic pain, there is continued research and discussion about patient selection and long-term effects. A number of barriers in the health care and drug regulatory systems account (...) for the gap between what is known about pain management and what is practiced. Among the barriers are physicians’ fears of being disciplined by state regulatory boards for inappropriate prescribing.State medical boards are in a unique position not only to address physicians’ concerns about being investigated, but also to encourage pain management. Prior to 1989, a few state medical boards had policies relating to controlled substances or pain. Subsequently, state medical boards began adopting policies regarding the prescribing of opioids for the treatment of pain; many of these specifically addressed physicians’ fear of regulatory scrutiny. (shrink)

Despite advances in medical knowledge regarding pain management, pain continues to be significantly undertreated in the United States. There are many drug and nondrug treatments, but the use of controlled substances, particularly the opioid analgesics, is universally accepted for the treatment of pain from cancer. Although opioid analgesics are safe and effective in treating chronic pain, there is continued research and discussion about patient selection and long-term effects. A number of barriers in the health care and drug regulatory systems account (...) for the gap between what is known about pain management and what is practiced. Among the barriers are physicians’ fears of being disciplined by state regulatory boards for inappropriate prescribing.State medical boards are in a unique position not only to address physicians’ concerns about being investigated, but also to encourage pain management. Prior to 1989, a few state medical boards had policies relating to controlled substances or pain. Subsequently, state medical boards began adopting policies regarding the prescribing of opioids for the treatment of pain; many of these specifically addressed physicians’ fear of regulatory scrutiny. (shrink)

The objective of this study was to take a closer look at defense-related expenses for medical malpractice cases over time. We conducted a retrospective review of medical malpractice claims reported to the Physician Insurers Association of America's Data Sharing Project with a closing date between January 1, 1985 and December 31, 2008. On average a medical malpractice claim costs more than $27,000 to defend. Claims that go to trial are much more costly to defend than are those that are dropped, (...) withdrawn, or dismissed. However, since the overwhelming majority of claims are dropped, withdrawn, or dismissed, the total amount spent to defend them surpasses that spent on claims that go to trial. Defense attorney expenses account for the majority of defense-related expenses (74%), while expert witness expenses and other expenses split the remaining 26%. A strong association was also found between the average indemnity payment and the amount it costs to defend individual claims by specialty. Our study found that defense-related expenses for medical malpractice claims are not an insignificant cost. As state and federal governments debate how to repair the malpractice system, addressing the high cost of defending claims should not be ignored. (shrink)

Whenever health care reform is debated, the state of the medical professional liability system in the United States re-emerges as an issue of importance. What exactly is broken with the MPL system and what the implications are is a point of contention among different stakeholder groups. Recent data demonstrate that medical liability premiums have been improving in recent years and the majority of premiums remained flat in 2010. General agreement still exists, however, that medical professional liability insurance premiums have become (...) unaffordable for many physicians, and coverage has become less available, especially for certain medical specialties and in specific areas of the country.Multiple factors go into the determination of medical professional liability insurance premiums including return on investments, reinsurance costs, claims frequency, average amount paid out on malpractice claims, defense expenses, and administrative costs such as underwriting expense. (shrink)

Counter storytelling, used in critical race theory and narrative ethics, is a tool used to contradict and expose the oppression in a dominant narrative, by focusing attention on the stories of the...

Epistemic justifications for democracy have been offered in terms of two different aspects of decision-making: voting and deliberation, or ‘votes’ and ‘talk.’ The Condorcet Jury Theorem is appealed to as a justification in terms votes, and the Hong-Page “Diversity Trumps Ability” result is appealed to as a justification in terms of deliberation. Both of these, however, are most plausibly construed as models of direct democracy, with full and direct participation across the population. In this paper, we explore how these results (...) hold up if we vary the model so as to reflect the more familiar democratic structure of a representative hierarchy. We first recount extant analytic work that shows that representation inevitably weakens the voting results of the Condorcet Jury Theorem, but we question the ability of that result to shine light on real representative systems. We then show that, when we move from votes to talk, as modeled in Hong-Page, representation holds its own and even has a slight edge. (shrink)

The authors present a materialist analysis of the effects of neoliberalism in education. Specifically, they contend that neoliberalism is a form of cultural invasion that begets necrophilia. Neoliberalism is necrophilous in promoting a cultural desire to fix fluid systems and processes. Such desire manufactures both individuals known and culturally felt experiences of alienation which are, it is argued, symptomatic of an imperialist nostalgia that permeates educational policy and practice. The authors point to ‘unschooling in schools’ as a mechanism for resisting (...) the necrophilous tendencies of contemporary formations of education. (shrink)

Physician concern about regulatory scrutiny as a barrier to appropriate prescribing for pain management has been identified and studied. A 1991 Pain Research Group survey demonstrated a need to provide updated information about opioids and pain management to state medical board members. Indeed, a national survey even showed a need to provide more education about pain management to oncology Physicians. Two approaches for responding to these concerns have been undertaken in several states by the state medical boards and the pain (...) management community: the development and adoption of administrative policies designed to bring disciplinary standards in line with clinical practice; and the creation of education programs for state medical board members and staffs. Each can have a substantial impact on removing real and perceived regulatory barriers to effective pain relief. (shrink)

Physician concern about regulatory scrutiny as a barrier to appropriate prescribing for pain management has been identified and studied. A 1991 Pain Research Group survey demonstrated a need to provide updated information about opioids and pain management to state medical board members. Indeed, a national survey even showed a need to provide more education about pain management to oncology Physicians. Two approaches for responding to these concerns have been undertaken in several states by the state medical boards and the pain (...) management community: the development and adoption of administrative policies designed to bring disciplinary standards in line with clinical practice; and the creation of education programs for state medical board members and staffs. Each can have a substantial impact on removing real and perceived regulatory barriers to effective pain relief. (shrink)

A great deal has been learned in the past fifteen years from the study of pain mechanisms. More recently, the relief of pain has begun to receive much needed attention as well. Although most, if not all, acute and cancer pain can be relieved, recent evidence shows that inadequate treatment of pain is still common among the general population—even for pain due to cancer. Inadequate treatment of cancer pain is even more likely if the patient is a member of an (...) ethnic minority, female, elderly, or a child. Evidence also suggests that substance abusers are at risk for poor pain treatment.A number of barriers which involve problems of knowledge, attitudes, and laws and regulations affect health care professionals, patients, and the health care system; collectively, they contribute to the inadequate treatment of pain. (shrink)

A great deal has been learned in the past fifteen years from the study of pain mechanisms. More recently, the relief of pain has begun to receive much needed attention as well. Although most, if not all, acute and cancer pain can be relieved, recent evidence shows that inadequate treatment of pain is still common among the general population—even for pain due to cancer. Inadequate treatment of cancer pain is even more likely if the patient is a member of an (...) ethnic minority, female, elderly, or a child. Evidence also suggests that substance abusers are at risk for poor pain treatment.A number of barriers which involve problems of knowledge, attitudes, and laws and regulations affect health care professionals, patients, and the health care system; collectively, they contribute to the inadequate treatment of pain. (shrink)

From the earliest application of modern randomized controlled trials in medical research, scientists and observers have deliberated the ethics of randomly allocating study participants to trial control arms. Adaptive RCT designs have been promoted as ethically advantageous over conventional RCTs because they reduce the allocation of subjects to what appear to be inferior treatments. Critical assessment of this claim is important, as adaptive designs are changing medical research, with the potential to significantly shift how clinical trials are conducted. Policy-makers are (...) swiftly moving to encourage greater use of adaptive designs. In 2016, the newly enacted 21st Century Cures Act instructed the Food and Drug Administration to help product sponsors incorporate adaptive methods into proposed clinical trial protocols and applications for investigational drugs and also biological products. In this article, we review the ethical justifications commonly offered for adaptive designs, explore these arguments in the context of actual trials, and contend that clinical equipoise is a useful standard for adaptive-trial ethics. We distinguish between theoretical and clinical equipoise and explain why ethical arguments related to adaptive trials tend to focus on the former. Yet we contend that theoretical equipoise can be an unreliable standard for adaptive ethics. While we contend that clinical equipoise is the most critical principle for the primary ethical concerns posed by adaptive trials, we suggest ethical approaches to deal with some additional concerns unique to adaptive designs. (shrink)

North America is in the grips of an epidemic of opioid-related poisonings. Overdose education and naloxone distribution programmes emerged as an option for structurally vulnerable populations who could not or would not access mainstream emergency medical services in the event of an overdose. These task shifting programmes utilize lay persons to deliver opioid resuscitation in the context of longstanding stigmatization and marginalization from mainstream healthcare services. OEND programmes exist at the intersection of harm reduction and emergency services. One goal of (...) OEND programmes is to help redress the health-related inequities common among people who use drugs, which include minimizing the gap between people who use drugs and the formal healthcare system. However, if this goal is not achieved these inequities may be entrenched. In this article, we consider the ethical promises and perils associated with OEND as task shifting. We argue that public health practitioners must consider the ethical aspects of task shifting programmes that may inadvertently harm already structurally vulnerable populations. We believe that even if OEND programmes reduce opioid-related deaths, we nevertheless question if, by virtue of its existence, OEND programmes might also unintentionally disenfranchise structurally vulnerable populations from comprehensive healthcare services, including mainstream emergency care. (shrink)

Patient report of functioning is one component of the neurocognitive exam following traumatic brain injury, and standardized patient-reported outcomes measures are useful to track outcomes during rehabilitation. The Traumatic Brain Injury Quality of Life measurement system is a TBI-specific extension of the PROMIS and Neuro-QoL measurement systems that includes 20 item banks across physical, emotional, social, and cognitive domains. Previous research has evaluated the responsiveness of the TBI-QOL measures in community-dwelling individuals and found clinically important change over a 6-month assessment (...) interval in a sample of individuals who were on average 5 years post-injury. In the present study, we report on the responsiveness of the TBI-QOL Cognition–General Concerns and Executive Function item bank scores and the Cognitive Health Composite scores in a recently injured sample over a 1-year study period. Data from 128 participants with complicated mild, moderate, or severe TBI within the previous 6 months were evaluated. The majority of the sample was male, white, and non-Hispanic. The participants were 18–92 years of age and were first evaluated from 0 to 5 months post-injury. Eighty participants completed the 1-year follow-up assessment. Results show acceptable standard response mean values for all measures and minimal detectable change values ranging from 8.2 to 8.8 T-score points for Cognition–General Concerns and Executive Functioning measures. Anchor rating analysis revealed that changes in scores on the Executive Function item bank and the Cognitive Health Composite were meaningfully associated with participant-reported changes in the areas of attention, multitasking, and memory. Evaluation of change score differences by a variety of clinical indicators demonstrated a small but significant difference in the three TBI-QOL change scores by TBI injury severity grouping. These results support the responsiveness of the TBI-QOL cognition measures in newly injured individuals and provides information on the minimal important differences for the TBI-QOL cognition measures, which can be used for score interpretation by clinicians and researchers seeking patient-reported outcome measures of self-reported cognitive QOL after TBI. (shrink)

The mind-body problem lies at the heart of the clinical practice of both psychiatry and psychosomatic medicine. In their recent publication, Schwartz and Wiggins address the question of how to understand life as central to the mind-body problem. Drawing on their own use of the phenomenological method, we propose that the mind-body problem is not resolved by a general, evocative appeal to an all encompassing life-concept, but rather falters precisely at the insurmountable difference between.

Retrieval practice, relative to further study, leads to long-term memory enhancement known as the “testing effect.” The neurobiological correlates of the testing effect at retrieval, when the learning benefits of testing are expressed, have not been fully characterized. Participants learned Swahili-English word-pairs and were assigned randomly to either the Study-Group or the Test-Group. After a week delay, all participants completed a cued-recall test while undergoing functional magnetic resonance imaging. The Test-Group had superior memory for the word-pairs compared to the Study-Group. (...) While both groups exhibited largely overlapping activations for remembered word-pairs, following an interaction analysis the Test-Group exhibited differential performance-related effects in the left putamen and left inferior parietal cortex near the supramarginal gyrus. The same analysis showed the Study-Group exhibited greater activations in the dorsal MPFC/pre-SMA and bilateral frontal operculum for remembered vs. forgotten word-pairs, whereas the Test-Group showed the opposite pattern of activation in the same regions. Thus, retrieval practice during training establishes a unique striatal-supramarginal network at retrieval that promotes enhanced memory performance. In contrast, study alone yields poorer memory but greater activations in frontal regions. (shrink)

In this article we consider the material dimensions of schooling as constitutive of the possibilities inherent in “fixing” education. We begin by mapping out the problem of “fixing education,” pointing to the necrophilic tendencies of contemporary education—a desire to kill what otherwise might be life-giving. In this sense, to “fix” education is to make otherwise fluid processes-of-living static. We next point to the material realities of this move to fix. After establishing the material consequences of perpetually fixing schools, we provide (...) a brief overview of two critical perspectives that might be shown as attempts to “unfix” education: critical pedagogy and unschooling. Though both offer critiques of normative education, these approaches are also bound by their failure to fully engage with the material dimensions of schooling. As such, both critical pedagogy and unschooling inadvertently cut off key possibilities for human flourishing within educational environments. In their rush to “unfix”—to counter the necrophilic tendencies of contemporary education—these approaches exclude or otherwise foreclose upon resistive challenges to the normative order that extend from the margins. In response, we turn to the possibilities for unschooling within the materially public spaces of schools. These are the spaces where fixity fails—possibility extends from unschooling in schools, from unfixing the process of fixing education. We end by considering the possibilities inherent in Community Service Learning as a valuable means to engage in a radically public, and unfixed, educational system. (shrink)

This paper extends three decades of work arguing that researchers who discuss consciousness should not restrict themselves only to (adult) human minds, but should study (and attempt to model) many kinds of minds, natural and artificial, thereby contributing to our understanding of the space containing all of them. We need to study what they do or can do, how they can do it, and how the natural ones can be emulated in synthetic minds. That requires: (a) understanding sets of requirements (...) that are met by different sorts of minds, i.e. the niches that they occupy, (b) understanding the space of possible designs, and (c) understanding complex and varied relationships between requirements and designs. Attempts to model or explain any particular phenomenon, such as vision, emotion, learning, language use, or consciousness lead to muddle and confusion unless they are placed in that broader context. A methodology for making progress is summarised and a novel requirement proposed for a theory of how human minds work: the theory should support a single generic design for a learning, developing system that, in addition to meeting familiar requirements, should be capable of developing different and opposed philosophical viewpoints about consciousness, and the so-called hard problem. In other words, we need a common explanation for the mental machinations of mysterians, materialists, functionalists, identity theorists, and those who regard all such theories as attempting to answer incoherent questions. No designs proposed so far come close. (shrink)