Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. (...) Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated. (shrink)

Dr. McGee presents a cogent argument for the patentability of the diagnosis of gene forms that are found to be associated with disease or other phenotypic manifestations. We're convinced he's wrong. An analogy will help explain why.

BackgroundFor over 35 years, Africa has continued to host HIV vaccine trials geared towards overturning the HIV/aids pandemic in the continent. However, the methods of sharing the vaccines, when available remain less certain. Therefore, the study aims to explore stakeholders’ perspectives in the global South, in this case, Tanzania, on how HIV vaccines ought to be fairly shared.MethodsThe study deployed a qualitative case study design. Data were collected through in-depth interviews and focus group discussions with a total of 37 purposively (...) selected participants. This included researchers, institutional review board members, a policymaker, HIV/aids advocates, and community advisory board members. The data obtained were inductively and deductively analyzed.Results Findings indicate that HIV vaccines can be shared fairly under the principles of distributive justice (contribution, need and equality). Thus, contribution-based sharing ought to be utilized upon the necessity to prioritize vaccine access or subsidized trial benefits to host communities. Need-based sharing ought to be considered for non-host communities that are at an increased risk of HIV infection. Lastly, equal-based sharing would be useful at later stages of vaccine distribution or when the aforementioned principles are deemed morally inappropriate. However, none of the benefit-sharing approaches is free of limitations and a counterbalancing sense of unfairness.ConclusionFair sharing of HIV vaccines, when available, ought to be informed by the contribution, need and equality principles of distributive justice. Countries in the global south including Tanzania are likely to be prioritized during the distribution of the HIV vaccines due to their participation in HIV vaccine trials and due to the disproportionate HIV burden evident in the region. (shrink)

Before we respond to Tamara Browne's proposal for an external ethics advisory review panel to oversee content in the Diagnostic and Statistical Manual of Mental Disorders, we wish to introduce ourselves. One of us is a professor of bioethics, a lawyer, and a doctor of public policy, and one of us is a philosopher of psychiatry who studies psychiatric nosology, and who has done bioethics work for two congressional advisory agencies. Based on our backgrounds, we flatter ourselves that we might (...) be considered as members of the DSM ethical review panel Browne proposes. However, we realize that one of us would likely be ineligible because of a lack of experience in psychiatry, and the other would... (shrink)

Physicians and other health care providers owe ethical and legal duties to patients to maintain the secrecy of the information learned during the course of patient care. This obligation is fulfilled by limiting access to such information to only those involved in the patient's care-that is, to those within the “circle of confidentiality.” As a general rule, providers may only disclose to others with the written prior consent of the patient. Exceptions may be “ethically and legally justified because of overriding (...) social considerations,” when permitted or compelled by law. For example, eleven states permit providers to disclose identified records to approved researchers.’ Many states compel disclosure in cases where a patient threatens serious bodily harm to another; require reporting to health or law enforcement authorities of communicable diseases, gunshot or knife wounds, or child abuse; and mandate reporting of cancer or other health care cases to state registries. (shrink)

Physicians and other health care providers owe ethical and legal duties to patients to maintain the secrecy of the information learned during the course of patient care. This obligation is fulfilled by limiting access to such information to only those involved in the patient's care-that is, to those within the “circle of confidentiality.” As a general rule, providers may only disclose to others with the written prior consent of the patient. Exceptions may be “ethically and legally justified because of overriding (...) social considerations,” when permitted or compelled by law. For example, eleven states permit providers to disclose identified records to approved researchers.’ Many states compel disclosure in cases where a patient threatens serious bodily harm to another; require reporting to health or law enforcement authorities of communicable diseases, gunshot or knife wounds, or child abuse; and mandate reporting of cancer or other health care cases to state registries. (shrink)

Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. (...) Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated. (shrink)

BackgroundConcurrent with efforts to establish national and regional biorepositories in Africa is widespread endorsement of ethics committees as stewards of the interests of individual donors and their communities. To date, ethics training programs for IRB members in Botswana have focused on ethical principles and international guidelines rather than on the ethical dimensions of specific medical technologies and research methodologies. Little is known about the knowledge and concerns of current and prospective IRB members in Botswana with respect to export, reuse, storage, (...) and benefit-sharing of biospecimens.MethodsThis qualitative study examined perspectives of IRB members in Botswana about the collection and use of biospecimens in research. Forty-one IRB members representing five committees in Botswana participated in discussions groups in March 2013. Transcriptions of audiotapes and field notes were analyzed to identify issues of concern that might be alleviated through education and capacity-building, and areas that required ongoing discussion or additional regulatory guidance.ResultsAreas of concern included lack of understanding among patients and providers about the use of biospecimens in clinical care and research; reuse of biospecimens, particularly issues of consent, ownership and decision-making; export of specimens and loss of control over reuse and potential benefits; and felt need for regulatory guidance and IRB-member training. Local belief systems about bodily integrity and strong national identity in the construct of benefits may be at odds with initiatives that involve foreign biorepositories or consider such collections to be global public goods.ConclusionEducation is needed to strengthen IRB-member capacity to review and monitor protocols calling for the collection and use of biospecimens, guided by clear national policy on priority-setting, partnerships, review, and oversight. Engagement with local stakeholders is needed to harmonize fundamentally different ways of understanding the human body and community identity with the aims of contemporary biomedicine. (shrink)

This article presents a review of the literature, summarizes current initiatives, and provides a heuristic for assessing the effectiveness of a range of institutional review board collaborative strategies that can reduce the regulatory burden of ethics review while ensuring protection of human subjects, with a particular focus on international research. Broad adoption of IRB collaborative strategies will reduce regulatory burdens posed by overlapping oversight mechanisms and has the potential to enhance human subjects protections.

Background The world has come closer than ever to discovering a viable HIV vaccine. However, it remains less certain whether HIV vaccines should be made available to participants and communities in which trials are run no or subsidized cost. Hence the essence of this inquiry.Methodology This is a case study design using in-depth interviews (IDI) and focus group discussions (FGD) with researchers of HIV vaccine trials, institutional review board (IRB) members, HIV advocates, a policy maker, and members of community advisory (...) board (CAB) in Tanzania. Participants were purposively selected and data thematically analyzed using MAXQDA software.Results Hosting a vaccine trial and the financial incapacity of individuals at increased risk of HIV were among the reasons in favor of free access to HIV vaccines. In contrast, the view that vaccines should be provided at a subsidized cost was related to high costs of vaccine development, financial return expectations by investors, and the fear of labeling the free vaccine as less important. Moreover, apart from governments and international organizations, well-off individuals could share the cost burden.Conclusion Stakeholders engaging in active discussion about sharing the viable vaccine ought to take the aforementioned concerns into account and ensure unhindered access to individuals and host communities in Tanzania and beyond. (shrink)

Between 1993 and 2002, 39 clinical trial staff were investigated for scientific misconduct by the Office of Research Integrity (ORI). Analysis of ORI case records reveals practices regarding workload, training and supervision that enable misconduct. Considering the potential effects on human subjects protection, quality and reliability of data, and the trustworthiness of the clinical research enterprise, regulations or guidance on use of clinical trial staff ought to be available. Current ORI regulations do not hold investigators or institutions responsible for supervision (...) and training of clinical trial staff. Given the important issues at stake, the definition of research misconduct should encompass the intentional or negligent mismanagement of scientific projects. Individual institutions and professional associations not only can but should adopt stricter standards of conduct than those reflected in federal regulations. (shrink)

Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to downstream research results and products may increase the financial risks (...) and cliniinish potential payoffs of — and therefore motivation for — performing downstream research and development. In addition, very broad patent claims allowed by the U.S. Patent and Trademark Office, the sheer growth in patents claiming genetic sequences, and threats of overlapping patents create a veritable minefield for researchers in both academia and industry. The concern is that research may be stifled because of the high cost and hassle of negotiating access. (shrink)

Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to downstream research results and products may increase the financial risks (...) and cliniinish potential payoffs of — and therefore motivation for — performing downstream research and development. In addition, very broad patent claims allowed by the U.S. Patent and Trademark Office, the sheer growth in patents claiming genetic sequences, and threats of overlapping patents create a veritable minefield for researchers in both academia and industry. The concern is that research may be stifled because of the high cost and hassle of negotiating access. (shrink)

This chapter contains section titled: Introduction The Development of the Debate Varieties of Adaptationism The Role of Zoom and Grain References.

Debates over adaptationism can be clarified and partially resolved by careful consideration of the ‘grain’ at which evolutionary processes are described. The framework of ‘adaptive landscapes’ can be used to illustrate and facilitate this investigation. We argue that natural selection may have special status at an intermediate grain of analysis of evolutionary processes. The cases of sickle-cell disease and genomic imprinting are used as case studies.

Much has been written about the escalating intolerance of worldviews other than one's own. Reasoned arguments based on facts and data seem to have little impact in our increasingly post-truth culture dominated by social media, fake news, tribalism, and identity politics. Recent advances in the study of human cognition, however, offer insights on how to counter these troubling social trends. In this book, psychologist Jon F. Wergin calls upon recent research in learning theory, social psychology, politics, and the arts to (...) show how a deep learning mindset can be developed in both oneself and others. Deep learning is an acceptance that our understanding of the world around us is only temporary and is subject to constant scrutiny. Someone who is committed to learning deeply does not simply react to experiences, but engages fully with that experience, knowing that the inevitable disquietude is what leads to efficacy in the world. (shrink)

Three recent genome‐wide studies in mice and humans have produced the most definitive map to date of genomic imprinting (gene expression that depends on parental origin) by incorporating multiple tissue types and developmental stages. Here, we explore the results of these studies in light of the kinship theory of genomic imprinting, which predicts that imprinting evolves due to differential genetic relatedness between maternal and paternal relatives. The studies produce a list of imprinted genes with around 120–180 in mice and ∼100 (...) in humans. The studies agree on broad patterns across mice and humans including the complex patterns of imprinted expression at loci like Igf2 and Grb10. We discuss how the kinship theory provides a powerful framework for hypotheses that can explain these patterns. Finally, since imprinting is rare in the genome despite predictions from the kinship theory that it might be common, we discuss evolutionary factors that could favor biallelic expression. (shrink)

This paper examines a number of questions about the degree to which the clinical practice of medicine is affected, if at all, by the legal systems in four countries: Chile, Germany, Japan and the United States. The focus on these four countries in four different regions of the world offers a unique perspective within which to examine medical treatment decisions made by patients and their proxies or surrogates, the potential role for universal written instruments such as advance directives, the cross-professional (...) tensions between clinical and legal concerns in very distinct cultures, and the degree to which legal activities can change or affect clinical realities in the context of these different political and health care systems. We have incorporated, whenever relevant, the insights of many disciplines, including the social sciences, in analyzing the existing interrelations between law and behavior in this specific context. Der Beitrag untersucht, inwieweit die klinische Praxis in vier Ländern mit unterschiedlichen Rechtssystemen und Berufskulturen durch Rechtsnormen oder das Verständnis von Recht beeinflußt wird. Es wird gefragt, welche Funktion rechtliche Interventionen bei der Veränderung von Verhaltensnormen in unterschiedlichen Gesundheitssystemen haben können. Folgende Themenbereiche werden diskutiert: Entscheidungen über die medizinische Behandlung, die von Patienten und ihren Angehörigen oder Stellvertretern getroffen werden; die mögliche Rolle umfassender schriftlicher Verfügungen wie z.B. der Patiententestamente ; die berufsübergreifenden Spannungen zwischen medizinischen und rechtlichen Belangen in sehr unterschiedlichen Kulturen; der Einfluß, den gesetzgeberische Aktivitäten im Kontext der verschiedenen politischen und Gesundheitssysteme auf die medizinische Wirklichkeit haben. Bei ihrer Analyse der in diesem Zusammenhang bestehenden Beziehungen im Verhältnis von Recht und Verhalten haben die Autoren die Erkenntnisse vieler Disziplinen unter Einschluß der Sozialwissenschaften, soweit sie als relevant erscheinen, in ihren Beitrag eingearbeitet. (shrink)

Social roles theorists claim that differences between the sexes are of limited consequence. Such misperceptions lead to misunderstanding the important role of sexual selection in explaining phenotypic differences both between species and within humans. Countering these claims, we explain how sexual dimorphism in humans affect expressions of artistic display and patterns of male and female aggression across the ovulatory cycle.

Questions have been raised on what role the knowledge provided by sustainability science actually plays in the transition to sustainability and what role it may play in the future. In this paper we investigate different approaches to sustainability transformation of food systems by analyzing the rationale behind transformative acts-the ground that the direct agents of change act upon- and how the type of rationale is connected to the role of research and how the agents of change are involved. To do (...) this we employ Max Weber’s distinction between instrumental rationality and value-rationality in social action. In particular, we compare two different approaches to the role of research in sustainability transformation: (1) Performance-based approaches that measure performance and set up sustainability indicator targets and benchmarks to motivate the agents in the food system to change; (2) Values-based approaches that aim at communicating and mediating sustainability values to enable coordinated and cooperative action to transform the food system. We identify their respective strengths and weaknesses based on a cross-case analysis of four cases, and propose that the two approaches, like Weber’s two types of rationality, are complementary-because they are based on complementary observer stances—and that an optimal in-between approach therefore cannot be found. However, there are options for reflexive learning by observing one perspective-and its possible blind spots-from the vantage point of the other, so we suggest that new strategies for sustainability transformation can be found based on reflexive rationality as a third and distinct type of rationality. (shrink)

This study provides current data on key questions about retraction of scientific articles. Findings confirm that the rate of retractions remains low but is increasing. The most commonly cited reason for retraction was research error or inability to reproduce results; the rate from research misconduct is an underestimate, since some retractions necessitated by research misconduct were reported as being due to inability to reproduce. Retraction by parties other than authors is increasing, especially for research misconduct. Although retractions are on average (...) occurring sooner after publication than in the past, citation analysis shows that they are not being recognised by subsequent users of the work. Findings suggest that editors and institutional officials are taking more responsibility for correcting the scientific record but that reasons published in the retraction notice are not always reliable. More aggressive means of notification to the scientific community appear to be necessary. (shrink)

This is the first of a three-volume work dedicated to exploring the influence of G.W.F. Hegel's philosophical thinking in Golden Age Denmark. The work demonstrates that the largely overlooked tradition of Danish Hegelianism played a profound and indeed constitutive role in many spheres of the Golden Age culture. This initial tome covers the period from the beginning of the Hegel reception in the Danish Kingdom in the 1820s until the end of 1836. The dominant figure from this period is the (...) poet and critic Johan Ludvig Heiberg, who attended Hegel's lectures in Berlin in 1824 and then launched a campaign to popularize Hegel's philosophy among his fellow countrymen. Using his journal Kjøbenhavns flyvende Post as a platform, Heiberg published numerous articles containing ideas that he had borrowed from Hegel. Several readers felt provoked by Heiberg's Hegelianism and wrote critical responses to him, many of which appeared in Kjøbenhavnsposten, the rival of Heiberg's journal. Through these debates Hegel's philosophy became an important part of Danish cultural life. (shrink)

Participants struck 500 golf balls to a concealed target. Outcome feedback was presented at the subjective or objective threshold of awareness of each participant or at a supraliminal threshold. Participants who received fully perceptible feedback learned to strike the ball onto the target, as did participants who received feedback that was only marginally perceptible . Participants who received feedback that was not perceptible showed no learning. Upon transfer to a condition in which the target was unconcealed, performance increased in both (...) the subjective and the objective threshold condition, but decreased in the supraliminal condition. In all three conditions, participants reported minimal declarative knowledge of their movements, suggesting that deliberate hypothesis testing about how best to move in order to perform the motor task successfully was disrupted by the impoverished disposition of the visual outcome feedback. It was concluded that sub-optimally perceptible visual feedback evokes implicit processes. (shrink)

This book taps the best American thinkers to answer the essential American question: How do we sustain our experiment in government of, by, and for the people? Authored by an extraordinary and politically diverse roster of public officials, scholars, and educators, these chapters describe our nation's civic education problem, assess its causes, offer an agenda for reform, and explain the high stakes at risk if we fail.

This book highlights some of the most pressing safety, ethical, legal and societal issues related to the diverse contexts in which robotic technologies apply. Focusing on the essential concept of well-being, it addresses topics that are fundamental not only for research, but also for industry and end-users, discussing the challenges in a wide variety of applications, including domestic robots, autonomous manufacturing, personal care robots and drones.

Graphical AbstractDriving patterns of coral bleaching over reefs are a suite of biophysical interactions where the physical environment modulates organism response through an interplay with intrinsic biological functioning. Flow conditions over reefs can mitigate the physiological impacts of thermal stress across multiple spatial scales. More details can be found in article number 1800226 by Charlotte E. Page et al., Seeking Resistance in Coral Reef Ecosystems: The Interplay of Biophysical Factors and Bleaching Resistance under a Changing Climate, DOI: 10.1002/bies.201800226.