Toward an Anti-Maleficent Research Agenda.

Important advances in biomedical and behavioral research ethics have occurred over the past few decades, many of them centered on identifying and eliminating significant harms to human subjects of research. Comprehensive attention has not been paid to the totality of harms experienced by animal subjects, although scientific and moral progress require explicit appraisal of these harms. Science is a public good and the prioritizing within, conduct of, generation of, and application of research must soundly address questions about which research is morally defensible and valuable enough to support through funding, publication, tenure, and promotion. Likewise, educational pathways of re-imagined science are critical.

Genitourinary Systems Entangled with Shifting Environments in a Salvadoran Subsistence Farming Community.

Diseases of the genitourinary system are the leading cause of hospital deaths in El Salvador, and chronic kidney disease of unknown origin has been gaining attention as a public health problem among farmers in particular. Epidemiological studies point, in part, to environmental risk factors, which have shifted over time with the deployment of modern agricultural science and ongoing climate change. We examined how diseases of the genitourinary system were situated at several margins of an epidemic in one rural Salvadoran municipality where these environmental and epidemiological changes are occurring, albeit relatively slow. By using this approach to study diseases of the genitourinary system, we illustrate one way in which shifting human/environment entanglements can be experimentally "known" in the context of human diseases associated with them. Our approach offers a unique perspective in thinking with ethnographic data to compliment ongoing epidemiological investigations of kidney disease in El Salvador.

Twelve tips for incorporating the study of human rights into medical education.

In order for patients to be adequately cared for by clinicians, an awareness and acknowledgement of the factors that affect their well-being, including adherence to internationally recognized human rights, should be part of the professional education of all health care professionals. Worldwide conflicts, which have led to record forced global displacement, and ongoing international human rights violations have had profound effects on the health and well-being of millions of patients. Trainees early in their careers should be educated about these and related population-level issues that affect the health of their patients, so they can better care and advocate for their patients and communities throughout their careers.

A Belmont Report for Animals?

Human and animal research both operate within established standards. In the United States, criticism of the human research environment and recorded abuses of human research subjects served as the impetus for the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the resulting Belmont Report. The Belmont Report established key ethical principles to which human research should adhere: respect for autonomy, obligations to beneficence and justice, and special protections for vulnerable individuals and populations. While current guidelines appropriately aim to protect the individual interests of human participants in research, no similar, comprehensive, and principled effort has addressed the use of (nonhuman) animals in research. Although published policies regarding animal research provide relevant regulatory guidance, the lack of a fundamental effort to explore the ethical issues and principles that should guide decisions about the potential use of animals in research has led to unclear and disparate policies. Here, we explore how the ethical principles outlined in the Belmont Report could be applied consistently to animals. We describe how concepts such as respect for autonomy and obligations to beneficence and justice could be applied to animals, as well as how animals are entitled to special protections as a result of their vulnerability.

The little tissue that couldn't - dispelling myths about the Hymen's role in determining sexual history and assault.

Conclusions about women's and girls' sexual history are made in some settings based on assumptions about the hymen, a small membranous tissue with no known biological function, which typically occupies a portion of the external vaginal opening in females. Clinicians, however, continue to refer to changes in the hymen to assess for a history of consensual or nonconsensual sexual intercourse. We reviewed published evidence to dispel commonly held myths about the hymen and its morphology, function, and use as evidence in cases of sexual violence.An examination of the hymen is not an accurate or reliable test of a previous history of sexual activity, including sexual assault. Clinicians tasked with performing forensic sexual assault examinations should avoid descriptions such as "intact hymen" or "broken hymen" in all cases, and describe specific findings using international standards and terminology of morphological features.We call on clinicians to consider the low predictive value of a hymen examination and to: 1) avoid relying solely on the status of the hymen in sexual assault examinations and reporting; 2) help raise awareness of this issue among their peers and counterparts in law enforcement and the judicial system; and 3) promote fact-based discussions about the limitations of hymenal examinations as part of clinical education for all specialties that address the sexual or reproductive health of women and girls.

The ethical challenges of animal research.

In 1966, Henry K. Beecher published an article entitled "Ethics and Clinical Research" in the New England Journal of Medicine, which cited examples of ethically problematic human research. His influential paper drew attention to common moral problems such as inadequate attention to informed consent, risks, and efforts to provide ethical justification. Beecher's paper provoked significant advancements in human research policies and practices. In this paper, we use an approach modeled after Beecher's 1966 paper to show that moral problems with animal research are similar to the problems Beecher described for human research. We describe cases that illustrate ethical deficiencies in the conduct of animal research, including inattention to the issue of consent or assent, incomplete surveys of the harms caused by specific protocols, inequitable burdens on research subjects in the absence of benefits to them, and insufficient efforts to provide ethical justification. We provide a set of recommendations to begin to address these deficits.

How One Health Instrumentalizes Nonhuman Animals.

This article interrogates anthropocentrism and nonhuman animal instrumentalization in One Health (OH). It argues that OH's approach to human health and zoonosis focuses too narrowly on furthering certain human interests at the expense of nonhuman animals, which is not sustainable, just, or compassionate. This article also offers an alternative vision for protecting and promoting health for all over the long term that includes the human right to self-determination and the nonhuman animal right to not be exploited or abused. This rights-based approach recognizes that the root causes of zoonosis should be identified and addressed via policies and actions that challenge nonhuman animal exploitation.

Where are we in the justification of research involving chimpanzees?

On December 15, 2011, the Institute of Medicine (IOM) Committee on the Use of Chimpanzees in Biomedical and Behavioral Research issued a final report commissioned by the National Institutes of Health (NIH). It changed the landscape of discussion about the necessity of using chimpanzees in research. The Committee advanced three principles of scientifically warranted research on chimpanzees, but NIH's statement of task provided inadequate opportunity for the Committee to investigate moral problems and their implications for public policy. The IOM Committee's report is a landmark document, but it has weaknesses in its justificatory framework, largely resulting from the Committee's narrow remit from NIH and IOM. We analyze cases mentioned in the report and argue that numerous central ethical issues are neglected, especially ones of justification. Additionally, we consider whether the principles offered by the Committee could be used as criteria governing the use of other animals in biomedical and behavioral research.

Genome-wide association studies in an isolated founder population from the Pacific Island of Kosrae.

It has been argued that the limited genetic diversity and reduced allelic heterogeneity observed in isolated founder populations facilitates discovery of loci contributing to both Mendelian and complex disease. A strong founder effect, severe isolation, and substantial inbreeding have dramatically reduced genetic diversity in natives from the island of Kosrae, Federated States of Micronesia, who exhibit a high prevalence of obesity and other metabolic disorders. We hypothesized that genetic drift and possibly natural selection on Kosrae might have increased the frequency of previously rare genetic variants with relatively large effects, making these alleles readily detectable in genome-wide association analysis. However, mapping in large, inbred cohorts introduces analytic challenges, as extensive relatedness between subjects violates the assumptions of independence upon which traditional association test statistics are based. We performed genome-wide association analysis for 15 quantitative traits in 2,906 members of the Kosrae population, using novel approaches to manage the extreme relatedness in the sample. As positive controls, we observe association to known loci for plasma cholesterol, triglycerides, and C-reactive protein and to a compelling candidate loci for thyroid stimulating hormone and fasting plasma glucose. We show that our study is well powered to detect common alleles explaining >/=5% phenotypic variance. However, no such large effects were observed with genome-wide significance, arguing that even in such a severely inbred population, common alleles typically have modest effects. Finally, we show that a majority of common variants discovered in Caucasians have indistinguishable effect sizes on Kosrae, despite the major differences in population genetics and environment.

Parallels in sources of trauma, pain, distress, and suffering in humans and nonhuman animals.

It is widely accepted that animals often experience pain and distress as a result of their use in scientific experimentation. However, unlike human suffering, the wide range of acute, recurrent, and chronic stressors and trauma on animals is rarely evaluated. In order to better understand the cumulative effects of captivity and laboratory research conditions on animals, we explore parallels between human experiences of pain and psychological distress and those of animals based on shared brain structures and physiological mechanisms. We review anatomical, physiological, and behavioral similarities between humans and other animals regarding the potential for suffering. In addition, we examine associations between research conditions and indicators of pain and distress. We include 4 case studies of common animal research protocols in order to illustrate incidental and experimental factors that can lead to animal suffering. Finally, we identify parallels between established traumatic conditions for humans and existing laboratory conditions for animals.

Human and animal research guidelines: aligning ethical constructs with new scientific developments.

Both human research and animal research operate within established standards and procedures. Although the human research environment has been criticized for its sometimes inefficient and imperfect process, reported abuses of human subjects in research served as the impetus for the establishment of the Nuremberg Code, Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the resulting Belmont Report. No similar, comprehensive and principled effort has addressed the use of animals in research. Although published policies regarding animal research provide relevant regulatory guidance, these policies have not emerged from the process of specifying consistent and reasoned ethical principles. The lack of a fundamental effort to explore the ethical issues and principles regarding the use of animals in research has led to unclear and disparate policies. Recent studies have increased our understanding of animal cognition and emotion, suggesting that animals' potential for experiencing a wide variety of harms, such as pain and fear, is greater than has been previously appreciated. Furthermore, relationships between methods of captivity and certain laboratory procedures and the resulting adverse physical, social and psychological effects have been established. In light of this information, current protections may need to be reconsidered and modified. This paper explores the historical convergence and divergence in the creation of human and animal research guidelines, as well as opportunities to align ethical frameworks with new scientific discoveries.

A multicomponent intervention reduces body weight and cardiovascular risk at a GEICO corporate site.

PURPOSE: To determine whether a multicomponent nutrition intervention program at a corporate site reduces body weight and improves other cardiovascular risk factors in overweight individuals. DESIGN: Prospective clinical intervention study. SUBJECTS/SETTING: Employees of the Government Employees Insurance Company (GEICO) (N = 113), aged 21 to 65 years, with a body mass index > or =25 kg/m(2) and/or previous diagnosis of type 2 diabetes. INTERVENTION: A 22-week intervention including a low-fat, vegan diet. MEASURES: Changes in body weight, anthropometric measures, blood pressure, lipid profile, and dietary intake. ANALYSIS: Multivariate analyses of variance were calculated for clinical and nutrient measures, followed by univariate analyses of variance, to determine the significance of differences between groups in changes over time. RESULTS: Intervention-group participants experienced greater weight changes compared with control-group participants (mean, -5.1 [SE, .6] kg vs. + .1 [SE, .6] kg, p < .0001), as well as greater changes in waist circumference (mean, -4.7 [SE, .6] cm vs. + .8 [SE, .6] cm, p < .0001) and waistratiohip ratio (mean, -.006 [SE, .003] vs. + .014 [SE, .005], p = .0007). Weight loss of 5% of body weight was more frequently observed in the intervention group (48.5%) compared with the control group (11.1%) (chi(2)[1, N = 113] = 16.99, p < .0001). CONCLUSIONS: Among individuals volunteering for a 22-week worksite research study, an intervention using a low-fat, vegan diet effectively reduced body weight and waist circumference.

A worksite programme significantly alters nutrient intakes.

OBJECTIVE: To examine whether a worksite nutrition programme using a low-fat vegan diet could significantly improve nutritional intake. DESIGN: At two corporate sites of the Government Employees Insurance Company, employees who were either overweight (BMI > or = 25 kg/m2) and/or had type 2 diabetes participated in a 22-week worksite-based dietary intervention study. SETTING: At the intervention site, participants were asked to follow a low-fat vegan diet and participate in weekly group meetings that included instruction and group support (intervention group). At the control site, participants received no instruction (control group). At weeks 0 and 22, participants completed 3 d dietary records to assess energy and nutrient intake. SUBJECTS: A total of 109 participants (sixty-five intervention and forty-four control). RESULTS: In the intervention group, reported intake of total fat, trans fat, saturated fat and cholesterol decreased significantly (P < or = 0.001), as did energy and protein (P = 0.01), and vitamin B12 (P = 0.002), compared with the control group. Intake (exclusive of any use of nutritional supplements) of carbohydrate, fibre, vitamin C, magnesium and potassium increased significantly (P < or = 0.0001), as did that for beta-carotene (P = 0.0004), total vitamin A activity (P = 0.004), vitamin K (P = 0.01) and sodium (P = 0.04) in the intervention group, compared with the control group. CONCLUSIONS: The present study suggests that a worksite vegan nutrition programme increases intakes of protective nutrients, such as fibre, folate and vitamin C, and decreases intakes of total fat, saturated fat and cholesterol.

A worksite vegan nutrition program is well-accepted and improves health-related quality of life and work productivity.

BACKGROUND/AIMS: Vegetarian and vegan diets are effective in preventing and treating several chronic diseases. However, their acceptability outside a clinical trial setting has not been extensively studied. The aim of this study was to determine the acceptability of a worksite vegan nutrition program and its effects on health-related quality of life and work productivity. METHODS: Employees of a major insurance corporation with a body mass index > or =25 kg/m(2) and/or a previous diagnosis of type 2 diabetes received either weekly group instruction on a low-fat vegan diet (n = 68) or received no diet instruction (n = 45) for 22 weeks. RESULTS: The vegan group reported improvements in general health (p = 0.002), physical functioning (p = 0.001), mental health (p = 0.03), vitality (p = 0.004), and overall diet satisfaction (p < 0.001) compared with the control group. The vegan group also reported a decrease in food costs (p = 0.003), and increased difficulty finding foods when eating out (p = 0.04) compared with the control group. The vegan group reported a 40-46% decrease in health-related productivity impairments at work (p = 0.03) and in regular daily activities (p = 0.004). CONCLUSIONS: A worksite vegan nutrition program is well-accepted and can be implemented by employers to improve the health, quality of life, and work productivity of employees.

A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes.

BACKGROUND: Although therapeutic diets are critical to diabetes management, their acceptability to patients is largely unstudied. OBJECTIVE: To quantify adherence and acceptability for two types of diets for diabetes. DESIGN: Controlled trial conducted between 2004 and 2006. SUBJECTS/SETTING: Individuals with type 2 diabetes (n=99) at a community-based research facility. Participants were randomly assigned to a diet following 2003 American Diabetes Association guidelines or a low-fat, vegan diet for 74 weeks. MAIN OUTCOME MEASURES: Attrition, adherence, dietary behavior, diet acceptability, and cravings. STATISTICAL ANALYSES: For nutrient intake and questionnaire scores, t tests determined between-group differences. For diet-acceptability measures, the related samples Wilcoxon sum rank test assessed within-group changes; the independent samples Mann-Whitney U test compared the diet groups. Changes in reported symptoms among the groups was compared using chi(2) for independent samples. RESULTS: All participants completed the initial 22 weeks; 90% (45/50) of American Diabetes Association guidelines diet group and 86% (42/49) of the vegan diet group participants completed 74 weeks. Fat and cholesterol intake fell more and carbohydrate and fiber intake increased more in the vegan group. At 22 weeks, group-specific diet adherence criteria were met by 44% (22/50) of members of the American Diabetes Association diet group and 67% (33/49) of vegan-group participants (P=0.019); the American Diabetes Association guidelines diet group reported a greater increase in dietary restraint; this difference was not significant at 74 weeks. Both groups reported reduced hunger and reduced disinhibition. Questionnaire responses rated both diets as satisfactory, with no significant differences between groups, except for ease of preparation, for which the 22-week ratings marginally favored the American Diabetes Association guideline group. Cravings for fatty foods diminished more in the vegan group at 22 weeks, with no significant difference at 74 weeks. CONCLUSIONS: Despite its greater influence on macronutrient intake, a low-fat, vegan diet has an acceptability similar to that of a more conventional diabetes diet. Acceptability appears to be no barrier to its use in medical nutrition therapy.

D2 dopamine receptor Taq1A polymorphism, body weight, and dietary intake in type 2 diabetes.

OBJECTIVE: Certain D2 dopamine receptor Taq 1A genotypes (A1A1, A1A2) have been associated with obesity and substance abuse. We hypothesized that their presence would be associated with reduced efficacy of dietary interventions in individuals with type 2 diabetes. METHODS: In the course of a randomized clinical trial in an outpatient research center in which 93 adults with type 2 diabetes were assigned to a low-fat vegan diet or a diet following 2003 American Diabetes Association guidelines for 74 wk, Taq 1A genotype was determined. Nutrient intake, body weight, and hemoglobin A1c (A1c) were measured over 74 wk. RESULTS: The A1 allele was highly prevalent, occurring in 47% of white participants (n = 49), which was significantly higher than the 29% prevalence previously reported in non-diabetic whites (P = 0.01). The A1 allele was found in 55% of black participants (n = 44). Black participants with A1(+) genotypes had significantly greater mean body weight (11.2 kg heavier, P = 0.05) and greater intake of fat (P = 0.002), saturated fat (P = 0.01), and cholesterol (P = 0.02) compared with A2A2 (A1(-)) individuals; dietary changes during the study did not favor one genotype group. Among whites, baseline anthropometric and nutrient differences between gene groups were small. However, among whites in the vegan group, A1(+) individuals reduced fat intake (P = 0.04) and A1c (P = 0.01) significantly less than did A1(-) individuals. CONCLUSION: The A1 allele appears to be highly prevalent among individuals with type 2 diabetes. Potential influences on diet, weight, and glycemic control merit further exploration.

Asylum Medicine: Standard and Best Practices.

Due to global events in recent years, applications for political asylum have increased, although the number of people granted asylum in the United States and elsewhere has declined. Physicians and other health care professionals can play a crucial role in the evaluation of individuals seeking asylum, since appropriately documented objective clinical evidence of torture and other forms of persecution can increase the likelihood that survivors of human rights abuses obtain asylum. Many clinicians have the requisite expertise and skills needed to conduct forensic asylum evaluations. However, despite growing interest in this area, the demand for medical and psychiatric forensic evaluations exceeds the number of clinicians who are prepared to conduct asylum evaluations. In an effort to increase the number of qualified clinicians interested and involved in medical and psychiatric evaluations of asylum seekers, this article offers a summary of standard and best practices in the area, including recommended qualifications and competencies relevant to the practice of forensic asylum evaluations, guidance on effective approaches to the medical and psychiatric evaluation of asylum seekers, and recommendations related to medicolegal documentation and testimony. We also highlight gaps in evidence regarding best practices.