Responsibilities of the data monitoring committee and motivating illustrations -- Composition of a data monitoring committee -- Independence of the data monitoring committee : avoiding conflicts of interest -- Confidentiality issues relating to the data monitoring committee -- Data monitoring committee meetings -- Data monitoring committee interactions with other trial components or related groups -- Statistical, philosophical and ethical issues in data monitoring -- Determining when a data monitoring committee is needed -- Regulatory considerations for the operation of data monitoring (...) committees -- Legal considerations for DMCs. (shrink)

Recent studies of early development in a number of ivertebrate and vertebrate species have suggested that growth factors and their receptors may play important roles in differentiation as well as cell proliferation. In the mouse embryo, the expression of the receptors for insulin and insulin‐like growth factors I and II (IGF‐I and ‐II) are temporally regulated. The ontogeny of receptor and ligand expression within the insulin and IGF gene family suggests that the very earliest stages of mammalian embryogenesis may be (...) subject to regulation by autocrine and paracrine factors from maternal and embryonic sources. (shrink)

The essays in this volume present versions of feminism that are explicitly liberal, or versions of liberalism that are explicitly feminist. By bringing together some of the most respected and well-known scholars in mainstream political philosophy today, Amy R. Baehr challenges the reader to reconsider the dominant view that liberalism and feminism are 'incompatible.'.

These essays showcase the value of the narrative arts in investigating complex conflicts of value in moral and political life, and explore the philosophical problem of moral dilemmas as expressed in ancient drama, classic and contemporary novels, television, film, and popular fiction. From Aeschylus to Deadwood, from Harriet Beecher Stowe to Harry Potter, the authors show how the narrative arts provide some of our most valuable instruments for complex and sensitive moral inquiry.

ABSTRACT In establishing National Bioethics Organisations (NBOs), liberal democracies seek to acknowledge the diversity of strongly held ethical positions and the imperative to engage in public debate about important bioethical decisions. NBOs are typically given a range of responsibilities, including contributing to and stimulating public debate; providing expert opinion on relevant issues for policy deliberations; and developing public policy. The state is now found to have an interest in areas previously thought to be a matter of individual choice. NBOs can (...) provide one way of opening up public debate to allow the diversity of views to be heard in a manner that is well‐informed, articulate and responsive to both expert and ‘lay’ public views. We draw on debates in political theory about democratic decision‐making and on the policy making roles of some key NBOs. We are particularly interested in examining the capacity of NBOs to meet the democratic ideal of effective participation by the public, or citizenry, especially by those who are directly affected by the policies, in the development of effective public policy. We provide a basic framework for policy development involving NBOs that can begin to meet this ideal, a process of ‘contested deliberation’. (shrink)

The influential threat simulation theory asserts that dreaming yields adaptive advantage by providing a virtual environment in which threat-avoidance may be safely rehearsed. We have previously found the incidence of biologically threatening dreams to be around 20%, with successful threat avoidance occurring in approximately one-fifth of such dreams. TST asserts that threat avoidance is over-represented relative to other possible dream contents. To begin assessing this issue, we contrasted the incidence of ‘avoidance’ dreams with that of their opposite: ‘approach’ dreams. Because (...) TST states that the threat-avoidance function is only fully activated in ecologically valid contexts, we also performed this contrast for populations living in both high- and low-threat environments. We find that ‘approach’ dreams are significantly more prevalent across both contexts. We suggest these results are more consistent with the view that dreaming is generated by reward-seeking systems than by fear-conditioning systems, although reward-seeking is clearly not the only factor determining the content of dreams. (shrink)

Some central ideas associated with developmental systems theory are outlined for non-specialists. These ideas concern the nature of biological development, the alleged distinction between “genetic” and “environmental” traits, the relations between organism and environment, and evolutionary processes. I also discuss some criticisms of the DST approach.

This open access casebook addresses complex and important ethical challenges arising when health-related research in conducted in the context of epidemics and pandemics. This book provides contextually-rich real-world case studies illustrating research ethics issues encountered by researchers, ethics reviewers and regulators around the globe during the COVID-19 pandemic. The accompanying commentaries outline relevant conceptual approaches and ethical considerations. These promote understanding and reflection on relevant ethical issues, ethical approaches and competing considerations in a manner supporting thoughtful evaluation of their implications (...) for practice. As such the casebook is relevant to academic and professional audiences with an interest in global health, research ethics, and outbreaks and epidemics. (shrink)

BackgroundOne of the next frontiers in HIV research is focused on finding a cure. A new priority includes people with HIV (PWH) with non-AIDS terminal illnesses who are willing to donate their bodies at the end-of-life (EOL) to advance the search towards an HIV cure. We endeavored to understand perceptions of this research and to identify ethical and practical considerations relevant to implementing it.MethodsWe conducted 20 in-depth interviews and 3 virtual focus groups among four types of key stakeholders in the (...) United States (PWH, biomedical HIV cure researchers, HIV clinicians, and bioethicists) to obtain triangulated viewpoints because little was known about the ethics of this topic. Each group was queried as to ethical considerations, safeguards, and protections for conducting HIV cure-related research at the EOL to ensure this research remains acceptable.ResultsAll four key stakeholder groups generally supported HIV cure-related research conducted at the EOL because of the history of altruism within the PWH community and the potential for substantial scientific knowledge to be gained. Our informants expressed that: (1) Strong stakeholder and community involvement are integral to the ethical and effective implementation, as well as the social acceptability of this research; (2) PWH approaching the EOL should not inherently be considered a vulnerable class and their autonomy must be respected when choosing to participate in HIV cure-related research at the EOL; (3) Greater diversity among study participants, as well as multi-disciplinary research teams, is necessitated by HIV cure-related research at the EOL; (4) The sensitive nature of this research warrants robust oversight to ensure a favorable risk/benefit balance and to minimize the possibility of therapeutic misconception or undue influence; and (5) Research protocols should remain flexible to accommodate participants’ comfort and needs at the EOL.ConclusionBecause of the ethical issues presented by HIV cure-related research at the EOL, robust ethical safeguards are of utmost importance. The proposed ethical and practical considerations presented herein is a first step in determining the best way to maximize this research’s impact and social value. More much inquiry will need to be directed towards understanding context-specific and cultural considerations for implementing EOL HIV cure research in diverse settings. (shrink)

Revonsuo’s influential Threat Simulation Theory predicts that people exposed to survival threats will have more threat dreams, and evince enhanced responses to dream threats, compared to those living in relatively safe conditions. Participants in a high crime area differed significantly from participants in a low crime area in having greater recent exposure to a life-threatening event . Contrary to TST’s predictions, the SA participants reported significantly fewer threat dreams , and did not differ from the Welsh participants in responses to (...) dream threats . Overall, the incidence of threat in dreams was extremely low—less than 20% of dreams featured realistic survival threats. Escape from dream threats occurred in less than 2% of dreams. We conclude that this evidence contradicts key aspects of TST. (shrink)

Genome-wide association studies raise important ethical and regulatory issues. This is particularly true of the current move toward broad sharing of genomic and phenotypic data. Our survey study examined the opinions of professionals involved in human subjects protection regarding genetic research review. The majority indicated that it is important for their institutional review board to offer guidance about developing and using a data repository or biobank that includes genetic data, and also about sharing this data with other investigators. Only one-third (...) of respondents reported that the National Institutes of Health policy regarding data sharing among researchers in genome-wide association studies is clear. Another third answered that they did not know whether this policy is clear. Findings from this study suggest a need for increased education for IRB professionals regarding the existing data sharing policy, collaboration among IRB professionals and researchers to define best practices, and further empirical research into prospective research participants’ information needs and preferences in the context of wide data sharing. (shrink)

This essay examines the risks of racialized science as revealed in the American mustard gas experiments of World War II. In a climate of contested beliefs over the existence and meanings of racial differences, medical researchers examined the bodies of Japanese American, African American, and Puerto Rican soldiers for evidence of how they differed from whites.

Malcolm-Smith, Solms, Turnbull and Tredoux [Malcolm-Smith, S., Solms, M., Turnbull, O., & Tredoux, C. . Threat in dreams: An adaptation? Consciousness and Cognition, 17, 1281–1291.] conducted a rigorous study that sampled two populations differentially exposed to threat in real life, and found that critical predictions from the Threat Simulation Theory of dreams [Revonsuo, A. . The reinterpretation of dreams: An evolutionary hypothesis of the function of dreaming. Behavioral and Brain Sciences, 23, 877-901.; Revonsuo, A. . Did ancestral humans (...) dream for their lives? Behavioral and Brain Sciences, 23, 1063–1082.] were not supported. Specifically, we found no evidence of increased realistic threats to physical survival or enhanced threat avoidance in the dreams of those from the exposed population. Revonsuo and Valli’s [Revonsuo, A., & Valli, K. . How to test the threat simulation theory. Consciousness and Cognition, 17, 1292-1296.] commentary on our study argues that the methods we used are so flawed as to render the results meaningless. In this response article, we address the criticisms raised in their commentary. (shrink)

“Doomsday prepping” is a phenomenon which involves preparing for feared societal collapse by stockpiling resources and readying for self-sufficiency. While doomsday prepping has traditionally been reported in the context of extremists, during the COVID-19 pandemic, excessive stockpiling leading to supply shortages has been reported globally. It is unclear what psychological or demographic factors are associated with this stockpiling. This study investigated doomsday prepping beliefs and behaviors in relation to COVID-19 proximity, demographics, coping strategies, psychopathology, intolerance of uncertainty (IU), and personality (...) in 384 participants (249 female) in an online study. Participants completed a number of questionnaires including the Post-Apocalyptic and Doomsday Prepping Beliefs Scale and a scale designed for the current study to measure prepping in the context of COVID-19. These were analyzed using ANOVAs, correlational, and mediation analyses to examine relationships between psychometric variables and stockpiling. Prepping beliefs and behaviors were higher in males than females and positively associated with anxiety, obsessive-compulsive symptoms, IU, and traditional masculinity traits. Older age, male gender, obsessive-compulsive symptoms, and traditional masculinity predicted unique variance in prepping. The relationship between gender and stockpiling was mediated by social learning (witnessing other people panic buying) and the perceived threat of COVID-19 (doomsday interpretations) while proximity and personal vulnerability to COVID-19 were non-significant. Results indicate that panic buying was influenced more by witnessing others stockpiling, personality, and catastrophic thinking rather than by proximity to danger. Education could target these factors in ongoing waves of the pandemic or future catastrophes. (shrink)

This essay examines the toxic legacy of American and Canadian sea disposal of mustard gas after World War II. Military ocean dumping of mustard gas and other chemical warfare material has created an enduring and global environmental and public health problem.

In 1946, Tom Brock spent part of his summer dumping mustard gas bombs off a barge into the Atlantic Ocean. Brock was a civilian employed by the United States Army Transport Service in Charleston, South Carolina. His job was to dispose of surplus bombs and drums filled with mustard gas. Sulphur mustard, commonly called “mustard gas,” can take several forms: a liquid, a solid, or a vapour. Mustard gas, named for its mustard-like color and smell, is a vesicant that is (...) toxic to humans and causes blistering and burns, affecting the lungs, eyes, and skin. Brock recalled that he and the soldiers enjoyed watching the occasional bomb explode as it sunk into the water. “We thought it was fun,” explained Brock. “I was 18 or 19 years old. We weren’t scared. We didn’t fear any explosive. We thought we were immortal.” Later that summer he was required to guard a barge of bombs that were leaking mustard gas, which looked to him like hot molasses. Due to the known health risks, Brock was told to wear a protective suit and gas mask. However, it was a hot day so he loosened the straps around his legs. As a result, enormous blisters developed, swelling out like a balloon from his toes to his knees. His summer job was no longer fun as he experienced firsthand the health hazards of exposure to mustard gas. (shrink)

Research suggests that some fathers and birth partners can experience post-traumatic stress disorder after witnessing a traumatic birth. Birth-related PTSD may impact on many aspects of fathers’ and birth partners’ life, including relationship breakdown, self-blame and reducing plans for future children. Despite the potential impact on birth partners’ lives there is currently no measure of birth-related PTSD validated for use with birth partners. The current study therefore adapted the City Birth Trauma Scale for use with birth partners. The City Birth (...) Trauma Scale is a 29-item questionnaire developed to measure birth-related PTSD according to DSM-5 criteria: stressor criteria, symptoms of re-experiencing, avoidance, negative cognitions and mood, and hyperarousal, as well as duration of symptoms, significant distress or impairment, and exclusion criteria or other causes. A sample of 301 fathers/birth partners was recruited online and completed measures of birth-related PTSD, bonding, and demographic details. Results showed the City Birth Trauma Scale had good reliability and psychometric and construct validity. The fathers/birth partners version has the same two-factor structure as the original scale: general symptoms and birth-related symptoms, which accounted for 51% of the variance. PTSD symptoms were associated with preterm birth and maternal and infant complications. Overall, the City Birth Trauma Scale provides a promising measure of PTSD following childbirth that can be used in research and clinical practice. (shrink)

This book's importance is derived from three sources: careful conceptualization of teacher induction from historical, methodological, and international perspectives; systematic reviews of research literature relevant to various aspects of teacher induction including its social, cultural, and political contexts, program components and forms, and the range of its effects; substantial empirical studies on the important issues of teacher induction with different kinds of methodologies that exemplify future directions and approaches to the research in teacher induction.

The U.S. National Institute of Allergies and Infectious Diseases and the National Institute of Mental Health have a new research priority: inclusion of terminally ill persons living with HIV in HIV cure-related research. For example, the Last Gift is a clinical research study at the University of California San Diego for PLWHIV who have a terminal illness, with a prognosis of less than 6 months. As end-of-life HIV cure research is relatively new, the scientific community has a timely opportunity to (...) examine the related ethical challenges. Following an extensive review of the EOL and HIV cure research ethics literature, combined with deliberation from various stakeholders and our experience with the Last Gift study to date, we outline considerations to ensure that such research with terminally ill PLWHIV remains ethical, focusing on five topics: 1) protecting autonomy through informed consent, 2) avoiding exploitation and fostering altruism, 3) maintaining a favorable benefits/risks balance, 4) safeguarding against vulnerability through patient-participant centeredness, and 5) ensuring the acceptance of next-of-kin/loved ones and community stakeholders. EOL HIV cure-related research can be performed ethically and effectively by anticipating key issues that may arise. While not unique to the fields of EOL or HIV cure-related research, the considerations highlighted can help us support a new research approach. We must honor the lives of PLWHIV whose involvement in research can provide the knowledge needed to achieve the dream of making HIV infection curable. (shrink)

Broadening access to both computational and educational resources is crit- ical to diffusing machine learning (ML) innovation. However, today, most ML resources and experts are siloed in a few countries and organizations. In this article, we describe our pedagogical approach to increasing access to applied ML through a massive open online course (MOOC) on Tiny Machine Learning (TinyML). We suggest that TinyML, applied ML on resource-constrained embedded devices, is an attractive means to widen access because TinyML leverages low-cost and globally (...) accessible hardware and encourages the development of complete, self-contained applications, from data collection to deployment. To this end, a collaboration between academia and industry produced a four part MOOC that provides application-oriented instruction on how to develop solutions using TinyML. The series is openly available on the edX MOOC platform, has no prerequisites beyond basic programming, and is designed for global learners from a variety of backgrounds. It introduces real-world applications, ML algorithms, data-set engineering, and the ethi- cal considerations of these technologies through hands-on programming and deployment of TinyML applications in both the cloud and on their own microcontrollers. To facili- tate continued learning, community building, and collaboration beyond the courses, we launched a standalone website, a forum, a chat, and an optional course-project com- petition. We also open-sourced the course materials, hoping they will inspire the next generation of ML practitioners and educators and further broaden access to cutting-edge ML technologies. (shrink)

This collection of essays, offered in honor of the distinguished career of prominent political philosophy professor Clifford Orwin, brings together internationally renowned scholars to provide a wide context and discuss various aspects of the virtue of “humanity” through the history of political philosophy.

Responding to volatile criticisms frequently leveled at Leo Strauss and those he influenced, the prominent contributors to this volume demonstrate the profound influence that Strauss and his students have exerted on American liberal democracy and contemporary political thought. By stressing the enduring vitality of classic books and by articulating the theoretical and practical flaws of relativism and historicism, the contributors argue that Strauss and the Straussians have identified fundamental crises of modernity and liberal democracy.

Although living conditions have improved throughout history, protest, at least in the last few decades, seems to have increased to the point of becoming a normal phenomenon in modern societies. Contributors to this volume examine how and why this is the case and argue that although problems such as poverty, hunger, and violations of democratic rights may have been reduced in advanced Western societies, a variety of other problems and opportunities have emerged and multiplied the reasons and possibilities for protest.