BackgroundMulti-centre studies generally cost more than single-centre studies because of larger sample sizes and the need for multiple ethical approvals. Multi-centre studies include clinical trials, clinical quality registries, observational studies and implementation studies. We examined the costs of two large Australian multi-centre studies in obtaining ethical and site-specific approvals.MethodsWe collected data on staff time spent on approvals and expressed the overall cost as a percent of the total budget.ResultsThe total costs of gaining approval were 38 % of the budget for (...) a study of 50 centres (mean cost AUD $6960 per site) and 2 % for a study of 11 centres (mean cost AUD $2300 per site). Seventy-five and 90 % of time was spent on repeated tasks, respectively, and many time-consuming tasks, such as reformatting documents, did nothing to improve the study design or participant safety.ConclusionsImprovements have been made to the ethical approval application system, but more gains could be made without increasing risks of harm to research participants. We propose that ethical review bodies and individual sites publish statistics on how long they take to process approvals which could then be nationally benchmarked. (shrink)

BackgroundCommunity engagement within biomedical research is broadly defined as a collaborative relationship between a research team and a group of individuals targeted for research. A Community Advisory Board is one mechanism of engaging the community. Within genomics research CABs may be particularly relevant due to the potential implications of research findings drawn from individual participants on the larger communities they represent. Within such research, CABs seek to meet instrumental goals such as protecting research participants and their community from research-related risks, (...) as well as intrinsic goals such as promoting the respect of participants and their community. However, successful community engagement depends on the degree to which CABs legitimately represent and engage with communities targeted for research. Currently, there is little literature describing the use of CABs in genomics research taking place in developing countries, and even less in the field of genomics research relating to mental illness. The aim of this article is to describe and consider the contributions made by a researcher-driven, population-specific CAB in a genomics of schizophrenia research project taking place in South Africa, from the perspective of the research team.DiscussionFour broad discussion topics emerged during the CAB meetings namely: 1) informed consent procedures, 2) recruitment strategies, 3) patient illness beliefs and stigma experiences, and 4) specific ethical concerns relating to the project. The authors consider these discussions in terms of their contributions to instrumental and intrinsic goals of community engagement.SummaryThe CAB gave valuable input on the consent processes and materials, recruitment strategies and suggested ways of minimizing the potential for stigma and discrimination. All of these contributions were of an instrumental nature, and helped improve the way in which the research took place. In addition, and perhaps more importantly, the CAB made a unique and important contribution relating to intrinsic functions such as promoting the respect and dignity of research participants and their community. This was particularly evident in ensuring sensitivity and respect of the community’s traditional beliefs about schizophrenia and its treatment, and in this way promoting a respectful relationship between the research team and the participants. (shrink)

Cell line immortalisation is a growing component of African genomics research and biobanking. However, little is known about the factors influencing consent to cell line creation and immortalisation in African research settings. We contribute to addressing this gap by exploring three questions in a sample of Xhosa participants recruited for a South African psychiatric genomics study: First, what proportion of participants consented to cell line storage? Second, what were predictors of this consent? Third, what questions were raised by participants during (...) this consent process? 760 Xhose people with schizophrenia and 760 controls were matched to sex, age, level of education and recruitment region. We used descriptive statistics to determine the proportion of participants who consented to cell line creation and immortalization. Logistic regression methods were used to examine the predictors of consent. Reflections from study recruiters were elicited and discussed to identify key questions raised by participants about consent. Approximately 40% of participants consented to cell line storage. The recruiter who sought consent was a strong predictor of participant’s consent. Participants recruited from the South African Eastern Cape, and older participants, were more likely to consent; both these groups were more likely to hold traditional Xhosa values. Neither illness nor education were significant predictors of consent. Key questions raised by participants included two broad themes: clarification of what cell immortalisation means, and issues around individual and community benefit. These findings provide guidance on the proportion of participants likely to consent to cell line immortalisation in genomics research in Africa, and reinforce the important and influential role that study recruiters play during seeking of this consent. Our results reinforce the cultural and contextual factors underpinning consent choices, particularly around sharing and reciprocity. Finally, these results provide support for the growing literature challenging the stigmatizing perception that people with severe mental illness are overly vulnerable as a target group for heath research and specifically genomics studies. (shrink)

Background The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. Methods A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of (...) test results. Results Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. Conclusion H3Africa research makes use of three consent models—specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa. (shrink)

Richard Stanley Peters appreciates the centrality of concepts for everyday life, however, he fails to recognize their pedagogical dimension. He distinguishes concepts employed at the first-order (our ordinary language-use) from second-order conceptual clarification (conducted exclusively by academically trained philosophers). This distinction serves to elevate the discipline of philosophy at the expense of our ordinary language-use. I revisit this distinction and argue that our first-order use of concepts encompasses second-order concern. Individuals learn and teach concepts as they use them. Conceptual understanding (...) is an obligation that all individuals, and not just academically trained philosophers, must fulfil. I conclude that the role of philosophy in education is to provide a conversational context for the pedagogical dimension of concepts. I draw upon the philosophies of Cora Diamond, Stephen Mulhall, Iris Murdoch and Rush Rhees. (shrink)

Contemporary educational theorists focus on the significance of Dewey’s conception of experience, learning-by-doing and collateral learning. In this essay, I reexamine the chapters of Dewey’s Democracy and Education, that pertain to thinking and highlight their relationship to Dewey’s How We Think: A Restatement of the Relation of Reflective Thinking in the Educative Process—another book written explicitly for teachers. In How We Think Dewey explains that nothing is more important in education than the formation of concepts. Concepts introduce permanency into an (...) otherwise impermanent world. He defines concepts as established meanings, or intellectual deposits used to found a better understanding of new experiences; they are what makes any experience educationally worthwhile. Dewey accuses traditional and progressive education of failing to appropriately form concepts in students. His position is that concepts are formed and transformed by experience, reflection and activity. He argues that the individual makes a personalized use of concepts for which he or she requires: continuity of experience, exposure to new or surprising possibilities, and sustained communication with others—all of which are discussed at length in Democracy & Education. I conclude with the practical recommendation that K-12 schools introduce philosophy into the curriculum. Philosophy not only invites students to engage their concepts in a reflective manner, but it also provides a valuable resource for that engagement. Most if not all of philosophy’s canonical texts are dedicated to analyzing such concepts as beauty, friendship, love and justice. The introduction of philosophy in K-12 education would, I suggest, offer a correction to both traditional and progressive education. (shrink)

It is twelve years since the article you are about to read was published. During that time, the philosophy in schools movement has expanded and diversified in response to curriculum developments, teaching guides, web-based resources, dissertations, empirical research and theoretical scholarship. Philosophy and philosophy of education journals regularly publish articles and special issues on pre-college philosophy. There are more opportunities for undergraduate and graduate philosophy students to practice and research philosophy for/with children in schools. The Ontario Philosophy Teachers Association reports (...) that in English-speaking Canada there are over 28,000 senior high school students studying philosophy in over 440 schools, and philosophy is now a Teachable Qualification. In the USA, the Philosophy Learning and Teaching Organization was founded in 2009 to create a network of pre-college philosophy teachers. With the loss of its founders—Matthew Lipman, Ann Margaret Sharp and Gareth Matthews —the Institute for the Advancement of Philosophy for Children is developing a digital archive in P4C. My original article was inspired by the design and pilot of a new philosophy elective for the Victorian Certificate of Education. This initiative garnered considerable interest from the P4C community because many believed that the decision to offer a VCE philosophy elective reflected the effectiveness and popularity of P4C in elementary schools, and the new philosophy elective would establish P4C as an essential prerequisite for the study of philosophy in senior secondary school and at university. In my view, enthusiasts overlooked an important difference in the conception of philosophy informing the new philosophy elective: it introduced students to the theoretical or academic discipline of philosophy, whereas P4C conceived of philosophy as a wisdom tradition—otherwise known as the art of living. (shrink)

This chapter contains sections titled: Introduction R. S. Peters and Analytic Philosophy of Education Revisiting First‐Order Ordinary Language‐Use Conclusion Notes References.

Parents whose child is diagnosed with a serious disease such as trisomy 18 first rely on the medical community for an accurate description and prognosis. In the case of trisomy 18, however, many families are told the disease is “incompatible with life” even though some children with the condition live for several years. This paper considers parents’ response to current medical discourse concerning trisomy 18 by examining blogs written by the parents of those diagnosed. Using interpretive humanistic reading and foregrounding (...) Cathryn Molloy’s recuperative ethos theory, we find that parents demonstrate recuperative ethos in response to physicians’ descriptions of trisomy 18, particularly in rhetoric addressing survival, medicalized language, and religious and/or spiritual rhetoric. We argue that, by using language such as “incompatible with life,” physicians distance themselves from families, creating not care, but the very gulf that requires recuperation. We conclude that medical professionals would do well to engage with the trisomy 18 community—including learning from blogs and online forums— employ palliative care practices, and seek more accurate, descriptive language that is compatible with care. (shrink)

Do the humanities have a future? In the face of an increased emphasis on the so-called practical applicability of education, some educators worry that the presence of humanistic study in schools and universities is gravely threatened. In the short-term, scholars have rallied to defend the humanities by demonstrating how they do, in fact, advance our practical interests. Martha Nussbaum, for example, argues that the humanities uniquely support democratic citizenship by cultivating critical thinking and narrative imagination — two skills needed for (...) the development of sympathetic and autonomous judgment. Defending the humanities in this manner, however, puts practitioners of the humanities in an impossible position. In this essay, Megan Laverty explains that while arguments such as Nussbaum's, which defend the instrumental value of the humanities, are persuasive and strategic, their use is double-edged. They belie the fact that the humanities are valuable for their own sake. Such arguments imply that the humanities derive their value from their ability to provide extrinsic benefits such as critical thinking and narrative imagination. Moreover, they can prevent individuals from discovering that the value of the humanities is revealed over time and from the inside out. In fact, having to answer the question of why the humanities matter puts us in an impossible position precisely because humanistic study is what Laverty describes, drawing upon the work of Talbot Brewer and R. F. Holland, as a form of dialectical activity: one in which the activity's constitutive ideals and internal goods are progressively clarified by means of the individual's ongoing engagement in the activity itself. Having redescribed the humanities as intrinsically valuable, Laverty goes on to distinguish humanistic study from other forms of dialectical activity, arguing that the humanities call upon students to imagine alternative linguistic and conceptual possibilities — thereby connecting us with others. It is in the pursuit of this question about the nature of our humanity — not its answer, but the question itself — that the meaning of humanistic study continues, indefinitely, to unfold. (shrink)

Throughout history, philosophers have reflected on educational questions. Some of their ideas emerged in defense of, or opposition to, skepticism about the possibility of formal teaching and learning. These philosophers include Plato, Augustine, St Thomas Aquinas, Søren Kierkegaard, Martin Heidegger, and Ludwig Wittgenstein. Together, they comprise a tradition that establishes the impossibility of instruction and the imperative to undertake it. The value of this tradition for contemporary education is that it redirects attention away from performance assessments and learning outcomes to (...) the ethical, aesthetic, and metaphysical dimensions of schooling. I argue that philosophers of education are uniquely responsible for teaching this tradition so that instruction might be undertaken in the right spirit. To this end, my essay is divided into three parts. In the first part, I explain why instructional skepticism has not been prominent in philosophy of education. I follow up, in the second part, by clarifying my choice of the term ‘instruction.’ In the third part, I sketch the instructional philosophies that ‘book-end’ this tradition: those of Plato and Wittgenstein. (shrink)

In this paper, we explore the recent creation of “iBlastoids,” which are 3-D structures that resemble early human embryos prior to implantation which formed via self-organization of reprogrammed ad...

In this essay Megan J. Laverty argues that Jean-Jacques Rousseau's conception of humane communication and his proposal for teaching it have implications for our understanding of the role of listening in education. She develops this argument through a close reading of Rousseau's most substantial work on education, Emile: Or, On Education. Laverty elucidates Rousseau's philosophy of communication, beginning with his taxonomy of the three voices—articulate, melodic, and accentuated—illustrating the ways in which they both enhance and obfuscate understanding. Next, Laverty (...) provides an account of Rousseau's philosophical psychology, with specific reference to amour-propre and amour de soi. Listening plays a central role in Rousseau's philosophy of communication, Laverty maintains, because it is in the act of listening that humans fulfill, or fail to fulfill, the imperative that we seek to understand others. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:IntroductionStuart J. Youngner (bio), Laura A. Siminoff (bio), and Renie Schapiro (bio)This issue of the Kennedy Institute of Ethics Journal (KIEJ) centers on a piece of empirical research. The motivation behind the study of Laura Siminoff, Christopher Burant, and Stuart Youngner (2004) was to find out more about what the general public understands and believes about when a person is dead. More specifically, the study tried to determine how (...) members of the public define death, especially their acceptance and interpretation of the medical concept of "brain death," and their attitudes toward the so-called "dead donor rule," an informal but powerful social and legal norm insisting that the taking of organs for transplantation not cause the death of the source of those organs.As the demand for organs increases and the waiting list grows, the United States has explored multiple ways to expand the pool of potential donors. One approach has been to gerrymander (coherently or not) the line between life and death to shift patients who are extremely compromised but traditionally considered to be in the living category into the dead category. In this way, the dead donor rule remains technically intact. This reasoning is explicit in the report of the Harvard Medical School Ad Hoc Committee (1968) that "introduced" "brain death" to the American culture. Since then, other efforts to redraw the line have been proposed and rejected.One alternative to gerrymandering is to consider under what conditions, if any, it is morally acceptable to violate the dead donor rule. Some would argue that this alternative is the more "honest" approach. Rather than sidestepping moral problems by calling people dead, it brings the moral problems to the surface where the necessity of sticking to the rule can be considered on its own merits. However, when the Journal of the American Medical Association printed a position paper that proposed making anencepahlic newborns an exception to the dead donor rule, along with arguments about why this was acceptable, the outcry was so great that the proposal was retracted (AMA 1995).Clearly, our society has identified organ transplantation as a priority, although two papers in this volume (those by Courtney Campbell and by Megan Crowley-Matoka and Robert Arnold) take issue with that prioritization. The fact that the donor pool has remained relatively stable (and inadequate) despite massive efforts [End Page 211] to increase it speaks, at least in part, to the cultural and legal resistance to "new" ways to procure more organs. Voluntarism seems to have peaked. Financial incentives clash with the heavily endorsed notion of the "gift of life" and seem to many to violate the dignity of the human body. Presumed consent or eminent domain, in which the community has a greater claim to a person's organs than that person or his/her family, go against the grain of American individual freedom and the ethos of patient autonomy.Abandoning the dead donor rule generally is regarded as an even tougher sell to the American public and its legislators. The study by Siminoff and colleagues attempts, among other things, to gauge just how tough this sell would be. What the data actually demonstrate is a matter of interpretation, and this issue of the KIEJ is devoted to some of those interpretations. The authors, with the exception of Daniel Hausman, came together for a meeting in Cleveland, Ohio, during which the study's methods and data were presented with time for questions, clarifications, and general discussion. The authors then worked with the editors to generate the papers printed in this volume.The issue begins with a presentation of the study conducted by Siminoff and colleagues. The same paper also appears in the journal Social Science and Medicine, where it includes the conclusions of the authors (Siminoff, Burant, and Youngner 2004). In the current volume, we present only the methodology of and data from the study, allowing a number of distinguished commentators to offer their own conclusions and reflections.The first response comes from Tracy Schmidt, Executive Director of Intermountain Donor Services, one of our nation's organ procurement organizations (OPOs). For years, organ procurement professionals have reported anecdotal stories about families who wished to donate organs of... (shrink)

In “Developing a Reflexive, Anticipatory, and Deliberative Approach to Unanticipated Discoveries: Ethical Lessons from iBlastoids,” we proposed a RAD approach to meet the challenging issues...

The perceived importance of a global experience in higher education is hard to underestimate. University presidents are known to boast of their “percentage,” or the proportion of undergraduates who study abroad. At least part of the rationale is a cosmopolitan one: an essential part of being acknowledged as educated derives in part from an appreciation of different cultures and development of worldliness. The expectation is that a global experience will stand out as an enduring memorial of an encounter with others. (...) These experiences are edified in resumes and narrated with veneration, further illuminating their cultural importance as coming-of-age rituals, particularly among a striding upper middle class... (shrink)

The reconstruction of philosophy, of education, and of social ideals and methods thus go hand in hand.In society today, we are inundated with reports on climate change, nuclear accidents, sectarian violence, terrorism, school shootings, police brutality, shrill mainstream politics, dire poverty, civil wars, and migration crises. As we observe their proliferation and escalation, it can feel as if we lack not only solutions to these social ills, but, even more fundamentally, ways to communicate about and make sense of their conditions (...) and consequences. Unfortunately, our failure to parse these events will not make them go away. To the contrary, their full impact will be endured for generations to come. As with other... (shrink)

As one might expect of an author of the complexity of John of Salisbury, there is little scholarly agreement regarding the proper interpretation of the major features of his social and political thought. The twelfth-century church-man has always been a controversial figure. Since the late Middle Ages, the ideas contained in his main contribution to political theory, the Policraticus , have been widely analyzed and interpreted. In more recent years, controversy has raged about the nature and significance of many of (...) his main doctrines , his source materials, and his attitudes towards contemporary events and people. (shrink)

The functional basis of disgust in disease avoidance is widely accepted; however, there is disagreement over what disgust is. This is a significant problem, as basic questions about disgust require...

Dynamic Consent is both a model and a specific web-based tool that enables clear, granular communication and recording of participant consent choices over time. The DC model enables individuals to know and to decide how personal research information is being used and provides a way in which to exercise legal rights provided in privacy and data protection law. The DC tool is flexible and responsive, enabling legal and ethical requirements in research data sharing to be met and for online health (...) information to be maintained. DC has been used in rare diseases and genomics, to enable people to control and express their preferences regarding their own data. However, DC has never been explored in relationship to historical collections of bioscientific and genetic heritage or to contexts involving Aboriginal and Torres Strait Islander people.In response to the growing interest by First Peoples throughout Australia in genetic and genomic research, and the increasing number of invitations from researchers to participate in community health and wellbeing projects, this article examines the legal and ethical attributes and challenges of DC in these contexts. It also explores opportunities for including First Peoples' cultural perspectives, governance, and leadership as a method for defining DC on cultural terms that engage best practice research and data analysis as well as respect for meaningful and longitudinal individual and family participation. (shrink)

Ethics courses are most commonly evaluated using reaction measures. However, little is known about the specific types of reaction data being collected and how these reaction data relate to improvements in trainee performance. Using a sample of 381 ethics training sessions, major reaction data categories were identified. Content and course satisfaction were the most frequently collected types of reaction criteria. Furthermore, content relevance and course satisfaction showed strong, positive relationships with performance criteria, whereas content satisfaction demonstrated a moderate, negative relationship. (...) These results and future directions for ethics training evaluation are discussed. (shrink)

Informed consent procedures for participation in psychiatric genomics research among individuals with mental disorder and intellectual disability can often be unclear, particularly because the underlying ethos guiding consent tools reflects a core ethical tension between safeguarding and inclusion. This tension reflects important debates around the function of consent tools, as well as the contested legitimacy of decision-making capacity thresholds to screen potentially vulnerable participants. Drawing on human rights, person-centred psychiatry and supported decision-making, this paper problematises the use of consent procedures (...) as screening tools in psychiatric genomics studies, particularly as increasing normative emphasis has shifted towards the empowerment and participation of those with mental disorder and intellectual disabilities. We expound on core aspects of supported decision-making, such as relational autonomy and hermeneutic competence, to orient consent procedures towards a more educative, participatory framework that is better aligned with developments in disability studies. The paper concludes with an acknowledgement of the pragmatic and substantive challenges in adopting this framework in psychiatric genomics studies if this participatory ethos towards persons with mental disorder and intellectual disability is to be fully realised. (shrink)