The most recent (Fifth) revision of the Declaration of Helsinki, adopted in October 2000 by the World Medical Association (WMA), reinforces the longstanding prohibition against offering placebo instead of effective therapy. The WMA left no doubt that if a beneficial treatment for a condition has already been recognised, it is unethical to offer placebo in place of such treatment to anyone in a study of the same condition. We have previously drawn attention to the discrepancy between the spirit of the (...) Declaration and the common practice of using placebo controls in randomised trials even if effective treatment exists. Despite the mandates of the Declaration of Helsinki and concern from ethicists and scientists, the US Food and Drug Administration (FDA) continues to demand and defend placebo‐controlled evidence of efficacy and safety for the development of many new pharmaceuticals, even if effective therapy exists. We suggest that the FDA's arguments defending their practice are insufficient to justify medical research that violates the Declaration of Helsinki. (shrink)

In October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. While it is the most widely accepted set of ethical principles for the protection of patients participating in medical research, the Declaration of Helsinki has also been subject of constant controversy. In particular, its paragraph on the use of placebo controls in clinical trials divides the research community into active-control and placebo orthodox proponents, both continuously demanding revisions of the Declaration of Helsinki in (...) favour of their position. The goal of the present project is to compare the mainly theoretical controversy with regulatory implementation. We distributed a questionnaire to national drug regulatory authorities from different countries to collect information on the authorities’ respective approaches to interpretation and implementation of the Declarations’ placebo paragraph in the conduct of medical research. Our findings suggest that the majority of drug regulatory authorities have established a practice of a middle ground, allowing placebo controls in some instances. Various interpretations of “serious harm” and “methodological reasons” are proposed as well as safeguards to avoid abuse of the option to use placebo-controls. Leaving the placebo paragraph open to various interpretation is a result of the Declaration of Helsinki’s character as a guidance document. With the current version controversy will continue. The Declaration should be continued to be strengthened to enforce the appreciation of conducting medical research with the highest ethical standard. (shrink)

Medical doctors are commissioned by the migration authorities and/or border police to assist in decision making about asylum seeker’s requests for residency permits in Sweden. They are asked to: (i) assess the formal written medical opinions made by physicians in support of asylum or humanitarian narratives in the asylum process and/or (ii) to make medical assessments of persons considered for deportation. This arrangement raises questions such as: How is the decision making process carried out? How is medical knowledge used, and (...) who ought to make decisions about medical evidence in the asylum process? Does this approach effect public health overall? There are longstanding concerns that medical assessments to certify whether a person is fit for transport or not, can have a direct, negative impact on persons in need of care and protection. A separate structure of doctors commissioned by the immigration authority seems to raise professional tensions, politicizes medical constructs and contributes to moral disengagement. Empirical data are used to illustrate this discussion with reference to medical issues, medical ethics, public health and legal discourses. I then reflect on key value conflicts using public health ethics theory and conclude with implications for public health ethic theory, policy and practice. (shrink)

How can anagreement between ethnic diversity and political integration be reached? When is the decision of a group justified? In order to analyse these questions, we will compare the situation of minorities in a clearly defined territory with that of immigrant minorities. Moreover, the necessity for recognition can be justified and as a result the need to live in accordance with cultural and linguistic peculiarities. Central for the desire for recognition is that a determinated self claims the right to determinate (...) her own political, economic and/or cultural matters for herself. This gives equal chances and thus equal treatment to all people. Self-determination can develop to the aspiration of secession, which is accompanied by conflicts. An open theory of selfdetermination shows new perspectives for conflict regulation. (shrink)

The challenges associated with the issue of migration have led to growing conflicts over the distribution of resources and have put the existing legal order in peril. This has also created dilemmas when it comes to matters of religion. These circumstances have called into question the theory of contemporary liberalism in Germany. In order to show this, I will analyze a few representatives of contemporary liberal theory. Among them are the philosophers John Rawls, with his „Theory of Justice“; Ronald Dworkin (...) and his proposal to further develop Rawls’ theory through the creation of an equal starting position; Michael Walzer and his counter to Rawls’ theory found in the book „Spheres of Justice“ in which he presents the idea of a complex equality; as well as Charles Taylor and his theoretical analysis. Based on this analysis, I will present a new concept-proposal of a liberal theory. (shrink)

Karin Michels Werk hebt sich von der bisherigen Literatur zum Thema deutlich ab, indem sie zeigt, dass Kants Zeittheorie nicht ohne seine Theorie des Raumes und seine Idealismuskritik verständlich zu machen ist. Die Autorin legt eine Rekonstruktion von Kants Beweis der genuinen Subjektivität der Zeit vor. Sie berücksichtigt dabei Beweisform sowie Beweisinhalt und setzt sich außerdem durchgehend mit Kant-Kommentatoren und -kritikern auseinander. Verständlich wird dadurch nicht nur Kants radikaler Neuansatz in der Zeitphilosophie, sondern auch die Bedeutung des Beweises (...) für sein Gesamtprojekt der Vernunftkritik. (shrink)

ABSTRACTPeer action coordination has been often studied in terms of its underlying cognitive mechanisms, and little is known about its emotional processes. The aim of the present study was to inves...

We propose six guideposts that states and hospitals should follow to respect disability rights when designing policies for the allocation of scarce, lifesaving medical treatments. Four relate to criteria for decisions. First, do not use categorical exclusions, especially ones based on disability or diagnosis. Second, do not use perceived quality of life. Third, use hospital survival and near-term prognosis (e.g., death expected within a few years despite treatment) but not long-term life expectancy. Fourth, when patients who use ventilators in their (...) daily lives (e.g., home ventilation) present to acute care hospitals, their personal ventilators should not be reallocated to other patients. Fifth, designate triage officers to assess patients individually on the basis of objective medical evidence, not stereotypes or assumptions. Sixth, include disability rights advocates in policy development and dissemination. (shrink)

Interventions to decrease acquisition and transmission of sexually transmitted diseases among African American women using text messages versus small-group delivery modalities pose distinct research risks and benefits. Determining the relative risk–benefit ratio of studies using these different modalities has relied on the expertise of investigators and their institutional review boards. In this study, African American women participated in focus groups and surveys to elicit and compare risks and benefits inherent in these two intervention delivery modalities, focusing on issues such as (...) convenience, privacy, and stigma of participation. Some risk/benefit variables were implicated in willingness to participate the two intervention modalities. (shrink)

Background: Treatment of psychotic disorders in pregnancy is often ethically and clinically challenging, especially when psychotic symptoms impair decision-making capacity. There are several competing ethical obligations to consider: the ethical obligation to maternal autonomy, the maternal and fetal beneficence-based obligations to treat peripartum psychosis, and the fetal beneficence-based obligation to minimize teratogenic exposure. Objective: This article outlines an ethical framework for clinical decision-making for the management of chronic psychosis in pregnancy, with an emphasis on special considerations in the previable and (...) periviable period. Case Presentation: A 31-year-old gravida 2, para 1 with intrauterine pregnancy at 12 weeks and 4 days gestation was brought to the emergency department by her husband seven months after delivering her first child, due to sudden onset of behavioral changes that included self-isolation, not eating, and not taking care of her child. Her past medical history included hypothyroidism and inflammatory bowel disease, but no prior psychiatric illness. After being admitted to the psychiatric hospital, she continued to have poor oral intake and weight loss despite initial inpatient treatment with antipsychotics, levothyroxine, and discontinuation of corticosteroids. Her pregnancy was also complicated by the diagnosis of multiple fetal anomalies at 20 weeks gestation, when the fetus was periviable. Conclusions: For previable or periviable pregnancies, the patient and/or surrogate should decide whether to pursue prenatal genetic screening and invasive diagnostic testing, as well as whether to continue or terminate the pregnancy. When the choice is made to continue the pregnancy, initiation of long-term psychiatric treatment (including medications with potential adverse fetal effects) should be based on shared decision-making between the physician and the patient and/or surrogate. Although some pharmacologic interventions may have potential adverse effects on the developing fetus, the use of psychotropic medications can be ethically justified, even if the patient herself does not have the capacity to consent and requires a surrogate, when the goal is to restore maternal autonomy and minimize the risks of maternal and fetal harm from untreated psychiatric illness. (shrink)

This collection of essays is based on the 2005 Society for American Archaeology symposium and presents research that epitomizes Richard I. Ford’s approach of engaged anthropology. This transdisciplinary approach integrates archaeological research with perspectives from ethnography, history, and ecology, and engages the anthropologist with Native partners and with socio-natural landscapes. Research papers largely focus on the U.S. Southwest, but also consider other areas of North America, issues related to museums collections, and indigenous approaches to materials research.

Animal health is key to successful livestock production in developing countries. The development and delivery of vaccines against major epidemic diseases is one component of improving animal health. This paper presents a case study from Kenya on the production and delivery of a vaccine against Contagious Caprine Pleuropneumonia (CCPP), a major disease of goats. The vaccine, while technically a viable preventative measure against CCPP, has not been well integrated into Kenya's animal health care system. From February through November, 1992, the (...) authors explored the organizational and policy constraints to vaccine production and distribution. Data were obtained through interviews, field visits, and available documents. Results suggest an animal health system that 1) does not have a well developed infrastructure to track, identify, and control animal diseases; 2) tends to place greater emphasis on cattle, rather than small ruminant health care; and 3) is not well linked in terms of research, development, and extension services. (shrink)

We remember in social contexts. We reminisce about the past together, collaborate to remember shared experiences, and, even when we are alone, we remember in the context of our communities and cultures. Taking an interdisciplinary approach throughout, this text comprehensively covers collaborative remembering across the fields of developmental psychology, cognitive psychology, social psychology, discourse processing, philosophy, neuropsychology, design, and media studies. It highlights points ofoverlap and contrast across the many disciplinary perspectives and, with its sections on "Approaches of Collaborative Remembering" (...) and "Applications of Collaborative Remembering", also connects basic and applied research.Written with late-stage undergraduates and early-stage graduates in mind, the book is also a valuable tool for memory specialists and academics in the fields of psychology, cognitive science and philosophy who are interested in collaborative memory research. (shrink)

PurposeAsian Americans comprise 21% of matriculating medical students in the United States but little is known about their mental health. With the growing focus on addressing the mental health of medical students, this systematic, nationwide survey assesses the relationship between anxiety and depression symptoms and coping skills among Asian American medical students.Materials and methodsA survey tool comprised of Patient Health Questionnaire-9, General Anxiety Disorder-7, and questions related to coping were emailed to members of the Asian Pacific American Medical Students Association (...) enrolled in a United States medical school during the 2016–2017 academic year. We evaluated associations between anxiety and coping as well as depression and coping.ResultsA total of 511 Asian American medical students completed the survey. Anxiety symptoms were positively correlated with an increase in negative coping skills. Depressive symptoms were not correlated with an increase in negative coping skills.ConclusionProfessionals and medical schools that aim to improve the mental health of medical students should be aware of the needs of specific populations. Asian American students who experience anxiety were more likely to utilize avoidant or negative coping strategies. In addition, Asian American students who experience depressive symptoms were not more likely to utilize these negative coping strategies. Further research must be done to evaluate the factors that influence the use of negative coping strategies to better address anxiety within the Asian American medical student population. (shrink)

Researchers from diverse disciplines, including organismal and cellular physiology, sports science, human nutrition, evolution and ecology, have sought to understand the causes and consequences of the surprising variation in metabolic rate found among and within individual animals of the same species. Research in this area has been hampered by differences in approach, terminology and methodology, and the context in which measurements are made. Recent advances provide important opportunities to identify and address the key questions in the field. By bringing together (...) researchers from different areas of biology and biomedicine, we describe and evaluate these developments and the insights they could yield, highlighting the need for more standardisation across disciplines. We conclude with a list of important questions that can now be addressed by developing a common conceptual and methodological toolkit for studies on metabolic variation in animals. (shrink)

It has been assumed that at the whole organismal level, the mitochondrial reactive oxygen species (ROS) production is proportional to the oxygen consumption. Recently, a number of researchers have challenged this assumption, based on the observation that the ROS production per unit oxygen consumed in the resting state of mitochondrial respiration is much higher than that in the active state. Here, we develop a simple model to investigate the validity of the assumption and the challenge of it. The model highlights (...) the significance of the time budget that mitochondria operate in the different respiration states. The model suggests that under three physiologically possible conditions, the difference in ROS production per unit oxygen consumed between the respiration states does not upset the proportionality between the whole animal ROS production and oxygen consumption. The model also shows that mitochondrial uncoupling generally enhances the proportionality. (shrink)

Hastings Center Report, Volume 51, Issue 5, Page 8-11, September‐October 2021.

To what extent do the mother's and father's jobs and occupational sex-typing influence the status and sex-typing of their children's occupation at first entry into the labour market? Referring to a database containing 5027 respondents of two merged Dutch surveys held between 1992 and 1995, this study finds that the effect of the mother's occupational status on her daughter's is significant, but smaller than either the effect of father's status on his son's or his daughter's status. The mother's occupational sex-typing (...) is related to her daughter's occupational sex-typing. The more female sex-typed the daughter's occupation, the lower her occupational status. In the same way, the father's occupational sex-typing is related to his son's occupational sex-typing. While the extension of the classical status attainment models by the mother's occupation and occupational sex-typing leads to interesting and new coefficients, the authors conclude that the more elementary classical model is not invalidated by these new perspectives. (shrink)

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can (...) meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance. (shrink)

In this paper, we discuss the prevailing view amongst philosophers and many mathematicians concerning mathematical proof. Following Cellucci, we call the prevailing view the “axiomatic conception” of proof. The conception includes the ideas that: a proof is finite, it proceeds from axioms and it is the final word on the matter of the conclusion. This received view can be traced back to Frege, Hilbert and Gentzen, amongst others, and is prevalent in both mathematical text books and logic text books.

Is it possible, and in the first place is it even desirable, to define what "development" means and to determine the scope of the field called "developmental biology"? Though these questions appeared crucial for the founders of "developmental biology" in the 1950s, there seems to be no consensus today about the need to address them. Here, in a combined biological, philosophical, and historical approach, we ask whether it is possible and useful to define biological development, and, if such a definition (...) is indeed possible and useful, which definition can be considered as the most satisfactory. (shrink)

In this study, we explore a 100 years of Work and Organizational Psychology. To do this, we carry out a bibliometric performance and network analysis to understand the evolution structure and the most important themes in the field of study. To perform the BNPA, 8,966 documents published since 1919 were exported from the Web of Science and Scopus databases. The SciMAT software was used to process data and to create the evolution structure, the strategic diagram, and the thematic network structure (...) of the strategic themes of the field of WOP. We identified 29 strategic clusters and discuss the most important themes and their relationship with other clusters. This research presents the complete evolution of the field of study, identifying emerging themes and others with a high degree of development. We hope that this work will support researchers and future research in the field of WOP. (shrink)

Background Respect is essential to providing high quality healthcare, particularly for groups that are historically marginalized and stigmatized. While ethical principles taught to health professionals focus on patient autonomy as the object of respect for persons, limited studies explore patients’ views of respect. The purpose of this study was to explore the perspectives of a multiculturally diverse group of low-income women living with HIV (WLH) regarding their experience of respect from their medical physicians. Methods We analyzed 57 semi-structured interviews conducted (...) at HIV case management sites in South Florida as part of a larger qualitative study that explored practices facilitating retention and adherence in care. Women were eligible to participate if they identified as African American (n = 28), Hispanic/Latina (n = 22), or Haitian (n = 7). They were asked to describe instances when they were treated with respect by their medical physicians. Interviews were conducted by a fluent research interviewer in either English, Spanish, or Haitian Creole, depending on participant’s language preference. Transcripts were translated, back-translated and reviewed in entirety for any statements or comments about “respect.” After independent coding by 3 investigators, we used a consensual thematic analysis approach to determine themes. Results Results from this study grouped into two overarching classifications: respect manifested in physicians’ orientation towards the patient (i.e., interpersonal behaviors in interactions) and respect in medical professionalism (i.e., clinic procedures and practices). Four main themes emerged regarding respect in provider’s orientation towards the patient: being treated as a person, treated as an equal, treated without blame or prejudice, and treated with concern/emotional support. Two main themes emerged regarding respect as evidenced in medical professionalism: physician availability and considerations of privacy. Conclusions Findings suggest a more robust conception of what ‘respect for persons’ entails in medical ethics for a diverse group of low-income women living with HIV. Findings have implications for broadening areas of focus of future bioethics education, training, and research to include components of interpersonal relationship development, communication, and clinic procedures. We suggest these areas of training may increase respectful medical care experiences and potentially serve to influence persistent and known social and structural determinants of health through provider interactions and health care delivery. (shrink)