The use of Ethics Decision‐Making Frameworks by Canadian Ethics Consultants: A Qualitative Study

In this study, Canadian healthcare ethics consultants describe their use of ethics decision‐making frameworks. Our research finds that ethics consultants in Canada use multi‐purpose ethics decision‐making frameworks, as well as targeted frameworks that focus on reaching an ethical resolution to a particular healthcare issue, such as adverse event reporting, or difficult triage scenarios. Several interviewees mention the influence that the accreditation process in Canadian healthcare organizations has on the adoption and use of such frameworks. Some of the ethics consultants we interviewed also report on their reluctance to use these tools. Limited empirical work has been done previously on the use of ethics decision‐making frameworks. This study begins to fill this gap in our understanding of the work of healthcare ethics consultants.     

The experiences of pregnant women in an interventional clinical trial: Research In Pregnancy Ethics (RIPE) study

There is increasing global pressure to ensure that pregnant women are responsibly and safely included in clinical research in order to improve the evidence base that underpins healthcare delivery during pregnancy. One supposed barrier to inclusion is the assumption that pregnant women will be reluctant to participate in research. There is however very little empirical research investigating the views of pregnant women. Their perspective on the benefits, burdens and risks of research is a crucial component to ensuring effective recruitment. The Research In Pregnancy Ethics (RIPE) study set out to ascertain the views of pregnant women about research participation using an inductive thematic analysis. We conducted semi‐structured interviews with 20 women who had participated in a double‐blind randomised placebo controlled trial in Wellington (New Zealand) while pregnant. Our results show that at least some pregnant women recognise the value and importance of research during pregnancy. The women we interviewed were deeply invested in the research process and outcomes. Key motivations for participating were altruism, playing a valuable civic role and the importance of research. The main perceived burdens related to inconvenience and time commitment. For some women, possible randomization to the placebo arm was regarded as a burden or disadvantage.     

医院动物实验与科研情况分析

目的:通过对沈阳军区总医院近5年的动物实验情况以及科研相关数据的分析,得出动物实验情况概况及发展规律,以期更好地为科研服务。方法:回顾性分析沈阳军区总医院整体的科研课题层次、数量、资助强度、动物实验人员的学历层次,以及实验动物种类和数量的相关资料,分析沈阳军区总医院实验动物概况。结果:沈阳军区总医院动物实验项目随科研课题数量的增加呈逐年递增态势,实验动物模型也向多样化发展。结论:沈阳军区总医院科研课题多数需要进行动物实验,动物实验已成为医院医教研一体化的重要组成部分,实验动物这门独立的学科成为医院科研必要的支撑条件。     

The Responsible Dog Owner: The Construction of Responsibility

ABSTRACT

Policy and campaigning messages related to dog ownership and welfare center on the concept of responsible ownership. However, the perspectives and experiences of pet owners and how they perceive and perform their responsibilities has not been studied in depth. This qualitative study used conversations about owning and walking dogs in order to elucidate beliefs and views about responsibility in dog ownership. Data comprised 12 in-depth interviews with dog-owning households, 14 short interviews with dog owners while walking their dogs or representing their breed at a dog show, and autoethnography of the first author’s experiences owning and walking dogs. All participants considered themselves responsible dog owners, yet there was great variation in key aspects of their dog-owning behavior. The feelings of responsibility were rooted in the valued unconditional and reciprocal love that owners believed underpinned their human–dog bond. Dogs were described as dependents, similar to, but different from, children. In deciding how to look after their dogs, owners sought to balance their views of dogs as kin, having individual needs to be met, with consideration of the needs of others. Four processes through which issues of irresponsible dog ownership may arise were suggested: owner–dog relationship being too weak or too strong; differences in interpretation of what is best for the dog; difficulties predicting and avoiding situations of conflict; and differences in tolerance of negative impacts of dog ownership. While “responsible dog ownership” has considerable appeal as a concept, how it is perceived and interpreted varies so extensively that simply telling owners that they should “be responsible” is of limited use as a message to promote behavior change. Facilitating “responsible dog ownership” and reducing “irresponsible dog owner” behaviors relies on a detailed understanding of the variables which influence how the dog’s role is constructed within the family and the wider society.     

The Lived Experience of Companion-animal Loss: A Systematic Review of Qualitative Studies

The aim of this systematic review was to evaluate qualitative studies of the lived experience of companion-animal loss and grief. Six electronic databases (PsycINFO, CINAHL Plus, Ovid MEDLINE, ProQuest, Scopus, and Web of Science) were searched for English language, peer-reviewed articles from 1970 to July 2015. Only primary empirical studies using a qualitative method with textual data describing a direct ongoing relationship with, and subsequent loss of, a companion animal were included. A narrative synthesis was conducted on 11 eligible studies using inductive open coding techniques. Analysis revealed that pets were often labeled as family, and strong emotional connections between animals and humans were reported in some studies, whereas in other studies findings were inconsistent. Loss experience was predominantly with prototypical animals (cats, dogs); two studies involved other animals (horse, fish). Grief was described in five studies, with participants’ experience ranging from low to overwhelming. Prolonged grief was associated with self-disenfranchisement, whereas subjective healing was associated with remembrance, in which the animal remained as a memory in a “new” normal. Clinical implications are discussed.     

An unethical trial and the politicization of the COVID-19 pandemic in Brazil: The case of Prevent Senior

The Brazilian Federal Senate created a Parliamentary Inquiry Commission (CPI) to investigate the Bolsonaro government's irregularities in the management of the COVID-19 pandemic. One of the cases that drew attention was the research conducted by Prevent Senior, a private health insurance company, on the early treatment of COVID-19. The article analyzes the scientific validity of the research and the ethical problems related to its implementation. It is based on analysis of Prevent Senior's report of the clinical study, the Brazilian and USA clinical trial registries, the Senate's CPI report, and on the information reported by the media. This case of scientific fraud and political-ideological bias exemplifies how Prevent Senior, using a questionable protocol to enhance its reputation and gain government support, was instrumental in building the “early treatment” narrative for COVID-19, and shows how it served as a basis for a government public policy that promoted the use of ineffective drugs.     

The status and issues of the Institutional Animal Care and Use Committee of Seoul National University: from its establishment to the present day

The Institutional Animal Care and Use Committee (IACUC) of Seoul National University (SNU) plays a key role in monitoring and managing the humane use of animals in scientific research. Here, as one of the pioneers of the IACUC in Korea, we reported SNU-IACUC operations and activities including committee establishment and legal formulation, protocol review, and post-approval monitoring of protocols, which the IACUC has undertaken in the last decade. In addition, legal regulations and improvements were also discussed, and encompassed the limited number of committee members and the single IACUC policy in Korea. As of December, 2020, amendments are on the table at the National Assembly. We also emphasized the independent nature of the IACUC in protecting activities, including approval and monitoring animal experiments, and its public role in narrowing the knowledge gap between society and scientists. Thus, the aim of this report is to help society and scientists understand the operations of the SNU-IACUC and its role in animal welfare.     

The Meaning of Companion Animals for Children and Adolescents with Autism: The Parents' Perspective

ABSTRACT

The aim of this study was to understand parents' perspectives on how children and adolescents with autism spectrum disorders (ASD) benefit from a relationship with companion animals. Parents were invited to participate in focus-group discussions. One open-ended question with follow-up questions was asked and the parents' responses were subsequently categorized. Three main themes emerged: the quality of the relationship with the companion animal; increased interaction with people; and optimization of the child's function and development. The results show that companion animals can contribute to social and behavioral development support, and improved mental health and quality of life. The children's and adolescents' interests and activities with companion animals were more social than nonsocial and of different quality than the restricted and repetitive activities in which children with ASD are normally engaged. Our findings describe a complementary developmental support for this vulnerable group of children and adolescents, which give them possibilities for expanded social contacts, diminished anxiety and depression, and facilitated learning.     

The Pets of Hurricane Matthew: Evacuation and Sheltering with Companion Animals

The purpose of this research was to understand the ways in which ownership of companion animals influences evacuation decision-making, using Hurricane Matthew of 2016 as a case study. Using stated-choice surveys, this research identifies behavioral decisions made during and after the evacuations associated with the hurricane, and details how decisions were made for different types of pets and the various stressors and problems encountered during the evacuation process. The data were collected via a web-based survey posted in pets’ interest and animal rescue groups following Hurricane Matthew. Respondents lived in Georgia, Florida, North Carolina, and South Carolina. Findings suggest that respondents had transportation logistics problems evacuating with their animals, and respondents with cats were more likely to leave some of their pets behind when they evacuated. Sheltering decisions and the wellbeing of pets also were themes identified from the data, especially as it relates to stress and attachment to animals. Implications from this research include a closer examination of how human–animal bonds can affect the ways in which evacuation and sheltering unfold. If humans have plans and access to resources for their pets during evacuations, they may be more likely to adhere to evacuation orders and to experience less stress throughout the process.     

Qualitative Risk Assessment of Surface Water Contamination with Cryptosporidium Sp. Oocysts: A Case Study of Three Agricultural Catchments

In recent years there have been a number of waterborne outbreaks of cryptosporidiosis in some major urban centers in Ireland. The Irish Environmental Protection Agency has adapted and modified the qualitative “Scottish Water Directions” to help prevent such outbreaks. When this risk assessment method was applied to three small agricultural river catchments in Ireland, the results suggested an equal risk of water contamination for each catchment. A survey was conducted in each catchment focusing on agricultural activity and surface waters. Fecal samples were collected from 1–8-week-old calves along with associated slurry and dung from beef and dairy farms and water samples were collected monthly at the outlet of the three catchments. Two of the catchments had much higher infection rates among neonatal calves as well as higher oocyst contamination of surface waters than the remaining one. It was concluded that the qualitative risk assessment could be more robust if cognizance was taken of the temporal and epidemiological aspects of cryptosporidiosis in beef and dairy herds.     

Relative Risk of Acute Myocardial Infarction in People with Schizophrenia and Bipolar Disorder: A Population-Based Cohort Study

Objective

Despite high mortality associated with serious mental illness, risk of acute myocardial infarction (AMI) remains unclear, especially for patients with bipolar disorder. The main objective was to investigate the relative risk of AMI associated with schizophrenia and bipolar disorders in a national sample.

Method

Using nationwide administrative data, an 11-year historic cohort study was assembled, comprised of cases aged 18 and above who had received a diagnosis of schizophrenia or bipolar disorder, compared to a random sample of all other adults excluding those with diagnoses of serious mental illness. Incident AMI as a primary diagnosis was ascertained. Hazard ratios stratified by age and gender were calculated and Cox regression models were used to adjust for other covariates.

Results

A total of 70,225 people with schizophrenia or bipolar disorder and 207,592 people without serious mental illness were compared. Hazard ratios in men adjusted for age, income and urbanization were 1.15 (95% CI 1.01~1.32) for schizophrenia and 1.37 (1.08~1.73)for bipolar disorder, and in women, 1.85 (1.58~2.18) and 1.88(1.47~2.41) respectively. Further adjustment for treated hypertension, diabetes and hyperlipidaemia attenuated the hazard ratio for men with schizophrenia but not the other comparison groups. Hazard ratios were significantly stronger in women than men and were stronger in younger compared to older age groups for both disorders; however, gender modification was only significant in people with schizophrenia, and age modification only significant in people with bipolar disorder.

Conclusions

In this large national sample, schizophrenia and bipolar disorder were associated with raised risk of AMI in women and in the younger age groups although showed differences in potential confounding and modifying factors.     

The Vulnerability of Study Participants in the Context of Transnational Biomedical Research: From Conceptual Considerations to Practical Implications

Outsourcing clinical trials sponsored by pharmaceutical companies from industrialized countries to low‐ (middle)‐income countries – summarized as transnational biomedical research (TBR) – has lead to many concerns about ethical standards. Whether study participants are particularly vulnerable is one of those concerns. However, the concept of vulnerability is still vague and varies in its definition. Despite the fact that important international ethical guidelines such as the Declaration of Helsinki by the World Medical Association or the Ethical Guidelines for Biomedical Research Involving Human Subjects by the Council of International Organizations of Medical Sciences refer to vulnerability as ethical principle, each of their approaches are different. To overcome these shortcomings, we analyze and unite different approaches of vulnerability and develop practical criteria in order to operationalize the concept especially for the context of TBR. These criteria refer to the context of a study as well as the characteristics and the current living situation of study participants. Based on a case study of an HIV‐vaccine‐trial conducted in India we demonstrate how those criteria can be applied in a retrospective way to identify potential ethical conflicts. The criteria can also indicate a prospective function for ethical pre‐assessment. For this, we provide an outlook for three major topics: 1. Vulnerability as a normative concept: Different ways of protection; 2. The relevance of transparency and 3. Vulnerability as an instrument to increase decision participation of human subjects.     

Ethical issues associated with HIV phylogenetics in HIV transmission dynamics research: A review of the literature using the Emanuel Framework

The reduced costs of DNA sequencing and the use of such data for HIV‐1 clinical management and phylogenetic analysis have led to a massive increase of HIV‐1 sequences in the last few years. Phylogenetic analysis has shed light on the origin, spread and characteristics of HIV‐1 epidemics and outbreaks. Phylogenetic analysis is now also being used to advance our knowledge of the drivers of HIV‐1 transmission in order to design effective interventions. However, HIV phylogenetic analysis presents unique ethical challenges, which have not been fully explored. This review presents an analysis of what appear to be key ethical issues in HIV phylogenetics in the hope of stimulating further conceptual and empirical work in this rapidly emerging area. We structure the review using the Emanuel Framework, a systematic, holistic framework, which has been adapted for use in developing countries, which bear the brunt of the HIV‐1 pandemic.     

The Humanity of Animals and the Animality of Humans: A View from Biological Anthropology Inspired by J. M. Coetzee's Elizabeth Costello

In his novel Elizabeth Costello (2003), J. M. Coetzee's title character espouses philosophical perspectives on cruelty and the human condition in a series of fictionalized lectures. In particular, she takes on the question of human cruelty to animals. As novelist, Coetzee relies on lyrical statements about the nature of cruelty, analogies between the atrocities of fascism and factory farms, and ethical elitism to address these issues. In this article, I use anthropological data to investigate such constructed notions of "human cruelty" and "human nature." I end with a discussion of cross-cultural variation in animal use by humans and of the current animal rights movement. The goal of this article is to engage, anthropologically, perspectives on cruelty in human natures and our relations with other animals.     

The Neural Mechanisms of Moral Cognition: A Multiple-Aspect Approach to Moral Judgment and Decision-Making

We critically review themushrooming literature addressing the neuralmechanisms of moral cognition (NMMC), reachingthe following broad conclusions: (1) researchmainly focuses on three inter-relatedcategories: the moral emotions, moral socialcognition, and abstract moral reasoning. (2)Research varies in terms of whether it deploysecologically valid or experimentallysimplified conceptions of moral cognition. Themore ecologically valid the experimentalregime, the broader the brain areas involved.(3) Much of the research depends on simplifyingassumptions about the domain of moral reasoningthat are motivated by the need to makeexperimental progress. This is a valuablebeginning, but as more is understood about theneural mechanisms of decision-making, morerealistic conceptions will need to replace thesimplified conceptions. (4) The neuralcorrelates of real-life moral cognition areunlikely to consist in anything remotely like a``moral module' or a ``morality center.' Moralrepresentations, deliberations and decisionsare probably highly distributed and notconfined to any particular brainsub-system. Discovering the basic neuralprinciples governing planning, judgment anddecision-making will require vastly more basicresearch in neuroscience, but correlatingactivity in certain brain regions withwell-defined psychological conditions helpsguide neural level research. Progress on socialphenomena will also require theoreticalinnovation in understanding the brain'sdistinctly biological form of computationthat is anchored by emotions, needs, drives,and the instinct for survival.     

Carnivores,Colonization, and Conflict: A Qualitative Case Study on the Intersectional Persecution of Predators and People in Namibia

Nonhuman carnivores have historically been demonized, lethally controlled, and extirpated throughout many parts of the world—indeed, they bear the brunt of this in some places still today. To understand why this is still occurring, it is important to appreciate the historical events that have shaped and led to this situation. We use a qualitative case study in Namibia that draws on an archival review and eight months of ethnography to describe the widespread control of nonhuman carnivores in the country, from the 1800s to the present day. Calling upon Val Plumwood’s eco-feminist typology of domination of the “Other,” and integrating it with current advances in inter- sectional theory, we explain the apparent parallels in this process of domi- nation of Namibian nonhuman predators alongside its Indigenous peoples by European settlers. We discuss the process of colonization of predators and people, highlighting how perceived power differentials provided an ideal situation to dominate these presumed “Others.” We conclude with a number of recommendations that could begin to reconcile conflicts between people and predators, and between different groups of people.     

Justifying the risks of COVID-19 challenge trials: The analogy with organ donation

In the beginning of the COVID pandemic, researchers and bioethicists called for human challenge trials to hasten the development of a vaccine for COVID. However, the fact that we lacked a specific, highly effective treatment for COVID led many to argue that a COVID challenge trial would be unethical and we ought to pursue traditional phase III testing instead. These ethical objections to challenge trials may have slowed the progress of a COVID vaccine, so it is important to evaluate their merit. One common way of doing so is to make an analogy to other social practices that are relevantly similar and which we currently sanction. We submit that non-directed live organ donation (NDLOD) is a promising analogy. After arguing that the risks to volunteers for each activity appear similar, we explore potential disanalogies that would undermine the comparison. We note that there are differences in both the kind and certainty of benefit secured by NDLOD compared to challenge trials. We conclude these differences are insufficient to make NDLOD permissible and challenge trials impermissible. Ultimately, if we think the risks associated with NDLOD are ethically permissible, then we should think the same of the risks associated with COVID challenge trials.     

The Incidence and Relative Risk of Stroke among Patients with Bipolar Disorder: A Seven-Year Follow-Up Study

Objective

This study aimed to estimate the incidence and relative risk of stroke and post-stroke all-cause mortality among patients with bipolar disorder.

Methods

This study identified a study population from the National Health Insurance Research Database (NHIRD) between 1999 and 2003 that included 16,821 patients with bipolar disorder and 67,284 age- and sex-matched control participants without bipolar disorder. The participants who had experienced a stroke between 1999 and 2003 were excluded and were randomly selected from the NHIRD. The incidence of stroke (ICD-9-CM code 430–438) and patient survival after stroke were calculated for both groups using data from the NIHRD between 2004 and 2010. A Cox proportional-hazards model was used to compare the seven-year stroke-free survival rate and all-cause mortality rate across the two cohorts after adjusting for confounding risk factors.

Results

A total of 472 (2.81%) patients with bipolar disorder and 1,443 (2.14%) controls had strokes over seven years. Patients with bipolar disorder were 1.24 times more likely to have a stroke (95% CI = 1.12–1.38; p<0.0001) after adjusting for demographic characteristics and comorbid medical conditions. In addition, 513 (26.8%) patients who had a stroke died during the follow-up period. The all-cause mortality hazard ratio for patients with bipolar disorder was 1.28 (95% CI = 1.06–1.55; p = 0.012) after adjusting for patient, physician and hospital variables.

Conclusions

The likelihood of developing a stroke was greater among patients with bipolar disorder than controls, and the all-cause mortality rate was higher among patients with bipolar disorder than controls during a seven-year follow-up period.