This book is a comprehensive and unique text and reference in medical ethics. By far the most inclusive set of primary documents and articles in the field ever published, it contains over 100 selections. Virtually all pieces appear in their entirety, and a significant number would be difficult to obtain elsewhere. The volume draws upon the literature of history, medicine, philosophical and religious ethics, economics, and sociology. A wide range of topics and issues are covered, such as law and medicine, (...) truth-telling by the physician, research, population policy, genetics, abortion, dying, and individual rights in medical care. The selections span the centuries, beginning with material from the works of Hippocrates, continuing through Thomas Percival, John Stuart Mill, and Claude Bernard, down to modern commentators like Henry K. Beecher, Walsh McDermott, David L. Bazelon, Paul Freund, H. L. A. Hart, John Rawls, Paul Ramsey, Richard McCormick, Rashi Fein, and Bernard Barber. The text has eight major divisions, beginning with sections on the ethical dimensions of the physician-patient relationship in history; the moral bases of medical ethics; and regulation, compulsion, and protection of the consumer in clinical medicine and public health. Each of these sections includes key essays that appear for the first time. All of the book's major divisions contain primary documents: codes such as the Hippocratic Oath, Medieval Law for the Regulation of Medicine, and the first as well as the most recent code of the American Medical Association; court decisions, including those on Karen Quinlan and on abortion in the United States and West Germany; government documents such as the statement of the National Commission on the Protection of Human Subjects, the Tuskegee Syphilis Report, the British Parliamentary debate on euthanasia, and the Council of Europe on rights of the sick and dying; and various published guidelines such as the Harvard Medical School brain death criteria, the American Hospital Association on patient's rights, and Pope Pius XII on the prolongation of life. Cases that illustrate moral dilemmas are provided for discussion purposes. Each section is preceded by a succinct editor's introduction. The documents and essays are of practical value for practitioners and students in medicine, law, ethics, and counselling, and for individual patients and groups concerned with medical care. Through encompassing divergent viewpoints, the essays and primary documents were selected to encourage humane practices and deepen understanding of the multiple traditions that shaped and do shape the development of medicine. (shrink)

Human population genetic research (HPGR) seeks to identify the diversity and variation of the human genome and how human group and individual genetic diversity has developed. This book asks whether developing countries are well prepared for the ethical and legal conduct of human population genetic research, with specific regard to vulnerable target group protection. The book highlights particular issues raised by genetic research on populations as a whole, such as the capacity for current frameworks of Western developed countries (...) to provide adequate protections for target groups in human population genetic research, and explores potential groups of people that may suffer harm in this kind of research. Using The People's Republic of China as a key example, Yue Wang argues that since the target groups of HPGR are almost always vulnerable groups from isolated and rural areas of developing countries, the ethical and legal frameworks for human subject protection need to be reconsidered in order to eliminate, or at least reduce, the vulnerability of those groups. While most research in this field focuses on the impact on individuals, this book breaks new ground in exploring how the interests of target groups are also seriously implicated in genetic work. The book argues that current regulations are far from sufficient to prevent harm to vulnerable groups and puts forward an alternative model for group protection in the context of human population genetic research in developing countries. The book will be of great interest to students and academics of medical law, ethics, and the implications of genetic research. (shrink)

Conducting or overseeing research in correctional settings requires knowledge of specific federal rules and regulations designed to protect the rights of individuals in incarceration. To investigate the extent to which relevant groups possess this knowledge, using a 10-item questionnaire, we surveyed 885 IRB prisoner representatives, IRB members and chairs with and without experience reviewing HIV/AIDS correctional protocols, and researchers with and without correctional HIV/AIDS research experience. Across all groups, respondents answered 4.5 of the items correctly. Individuals who have overseen or (...) conducted correctional research had the highest scores; however, even these groups responded correctly only to slightly more than half of the items. These findings emphasize the need for ongoing training in federal guidelines governing correctional research, particularly for those individuals who are embarking on this type of research. (shrink)

For the purposes of conservation or suppression of species, gene drive technology has significant potential. Theoretically speaking, with the release of even relatively few animals with gene drive systems in an ecosystem, beneficial or harmful genes could be introduced into the entire wild-type population of that species. Given the profound impact that gene drives could have on species and ecosystems, their use is a highly contentious issue. Communities and groups have differing beliefs about nature and its conservation or preservation, (...) as well as concerns about the ecological safety of the eradication, replacement or enhancement of particular species of animals by means of genetic engineering. For all those reasons, the rigorous regulation of insects and other animals with gene drive systems is crucial. In this paper, we consider the question of whether the United States Food and Drug Administration is prepared to effectively regulate insects and other animals with gene drives. (shrink)

The article critically examines the Assisted Reproductive Technology (Regulation) Act 2021, its development process spanning 15 years, and its potential shortcomings in addressing the needs of India’s 27 million infertile couples. By scrutinizing the recommendations presented in the Parliamentary Standing Committee on Health and Family Welfare’s 129th report, the critique argues that the Act may not effectively cater to the diverse reproductive rights of the population. The article claims that most of its suggestions are in opposition to redefining (...) families and accepting inclusive family structures other than heterosexual marriages. The study posits that the Act, with its inherent limitations, perpetuates the reinforcement of patriarchal family structures that medical science intends to disrupt. In order to foster inclusivity and comprehensibility, the article advocates for necessary amendments that align with the interest of the general populace. (shrink)

Aesthetic medicine has become a booming industry in the world. However, there are widespread social and health risks posed by aesthetic medicine, including illegal practice, and misleading information from aesthetic medicine institutes. Social media and advertisement play important roles in leading to appearance anxiety among young people nowadays. Regarding the chaotic situation in the aesthetic medical field, there is a fact that the practice of aesthetic medicine has been marginally regulated, even in some developed countries. China has the largest (...) class='Hi'>population in the world as well as the large number of aesthetic medical customers. Regarding the protection of people from harm, there is a great challenge for the Chinese government. So, China has enacted the toughest governance these years both on the supply and demand side. Some of the strategies may be useful for health authorities in certain countries. (shrink)

This article examines the regulation of Latina youth sexualities in the context of sexual and reproductive health care provision. In-depth interviews with health care providers working in two Latino-serving community health centers are analyzed for how they interpret and respond to the sexual and reproductive practices of their low-income Latina teen patients. The author finds that providers emphasize teenage pregnancy as a social problem among this population to the exclusion of other dimensions of youth sexualities and encourage Latina (...) girls’ adherence to a life course trajectory that conforms to middle-class, heteronormative ideals as a solution to this problem. By relying on such understandings, providers construct meanings of sexual citizenship that require participation in bourgeois heteronormativity. These findings suggest that Latino-serving community health centers, their providers, and their teen patients could benefit from questioning the assumptions that inform providers’ appraisals of Latina youth and developing a more inclusive approach to Latina youth sexualities beyond a discourse of pregnancy prevention. Such efforts could allow community health centers to actively participate in disrupting the structural inequalities that shape their young patients’ lives. (shrink)

In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools. In August 2016, the US Food and Drug Agency (...) (FDA) approved the uncaged field trial of a GE Aedes aegypti mosquito in Key Haven, Florida. The FDA’s decision was based on its assessment of the risks of the proposed experimental public health research project. The FDA is considered a global regulatory standard setter. So, its approval of the uncaged field trial could be used by proponents of GE mosquitoes to urge countries in the global South to permit the use of those bio-technologies. -/- From a public health ethics perspective, this paper evaluates the FDA’s 2016 risk assessment of the proposed uncaged field trial of the GE mosquito to determine whether it qualified as a realistic risk evaluation. -/- The FDA’s risk assessment of the proposed uncaged field trial did not proximate the conditions under which the GE mosquitoes would be used in regions of the global South where there is a high prevalence of mosquito-borne diseases. -/- Given that health and disease have political-economic determinants, whether a risk assessment of a product is realistic or not particularly matters with respect to interventions meant for public health problems that disproportionately impact socio-economically marginalized populations. If ineffective public health interventions are adopted based on risk evaluations that do not closely mirror the conditions under which those products would actually be used, there could be public health and ethical costs for those populations. (shrink)

The facilitation of tight regulatory frameworks necessary to ensure that new drugs are safe and effective have yet to be effectively applied within the paediatric population. Utilization of unlicensed and off-label drugs in children results in a variety of problems ranging from inefficacy, adverse reactions and in some cases death. This ethically questionable behaviour has led the European government to legally force pharmaceutical companies to propose paediatric applications and carry out clinical studies at early stages of drug development. The (...) new European Paediatric Regulation implemented in 2007 opens a new era of paediatric drug development and will offer the opportunity to vastly improve children's health. However, this brighter outlook for the paediatric community might encourage potentially unethical behaviour in a pharmaceutical industry that finds itself in economically unstable times. The article records the gradual evolution of the US Paediatric Exclusivity Plan and the underlying principle of the newly introduced European Paediatric Regulation. It discusses some of the potential drawbacks and detrimental consequences of implementing the new European regulation, and the prospects of avoiding these by critically evaluating the difficulties experienced by the US. (shrink)

This commentary examines the laws and policies on reproduction adopted in New China since 1949 and reflects on how they have regulated womanhood and whether they have promoted gender equality. By doing so, it also demonstrates how the regulation of reproduction constructs the notion of an ideal womanhood in order to justify the state’s enforcement of the population policy and its exercise of control over women’s fertility.

Changes in the scope of health policy in the United States are creating opportunities and obligations for lawmakers and the lawyers who advise them. These changes are the result of a new politics of policy for the health of populations. The new politics is connecting areas of policy that, because they have had separate histories, are governed by distinct, usually uncoordinated laws and regulations.The subject of the new politics of health policy is what the Iowa Senate President, speaking in a (...) plenary at the 2003 conference on Public Health Law in the 21st Century, called the “quality of life, what the people think is important.” An increasing number of leaders in general govemment–people who run for office and their staff–have practical reasons to make policy that acknowledges the expanding scope of what their constituents define as health policy. (shrink)

Purpose– This paper aims to consider selected results from the Arts and Humanities Research Council -funded “Managing Access to the internet in Public Libraries” project, from 2012-2014. MAIPLE has explored the ways in which public library services manage use of the internet connections that they provide for the public. This included the how public library services balance their legal obligations and the needs of their communities in a public space and the ethical dilemmas that arise.Design/methodology/approach– The researchers used a mixed-method (...) approach involving a review of the literature, legal analysis, a questionnaire survey and case studies in five public library authorities.Findings– UK public library services use a range of methods to regulate internet access. The research also confirms previous findings that filtering software is an ubiquitous tool for controlling access to and protecting library users from “inappropriate”, illegal and harmful internet content. There is a general, if sometimes reluctant, acceptance of filtering software as a practical tool by library staff, which seems to contrast with professional codes of ethics and attitudes in other countries. The research indicates that public library internet access will be a valued service for some time to come, but that some aspects of how public library services regulate internet access is currently managed can have socially undesirable consequences, including blocking legitimate sites and preventing users from accessing government services. Education could play a greater part in helping the general population to exercise judgement in selection of materials to view and use. This does not preclude implementing stricter controls to protect children, whilst allowing public libraries to continue providing a social good to those who are unable to otherwise participate in the digital age.Research limitations/implications– The response to the survey was 39 per cent meaning that findings may not apply across the whole of the UK. The findings of this study are compared with and supplemented by other quantitative sources, but a strength of this study is the depth of understanding afforded by the use of case studies.Originality/value– This paper provides both a quantitative and qualitative analysis of how internet access is managed in UK public libraries, including how library services fulfil their legal obligations and the ethical implications of how they balance their role in facilitating access to information with their perceived role as a safe and trusted environment for all members of their communities. The findings add to the international discussion on this issue and stimulate debate and policy making in the UK. (shrink)

Many are calling for transformative food systems changes to promote population and planetary health. Yet there is a lack of research that considers whether current food policy frameworks and regulatory approaches are suited to tackle whole of food systems challenges. One such challenge is responding to the rise of ultra-processed foods (UPF) in human diets, and the related harms to population and planetary health. This paper presents a narrative review and synthesis of academic articles and international reports to (...) critically examine whether current food policy frameworks and regulatory approaches are sufficiently equipped to drive the transformative food systems changes needed to halt the rise of UPFs, reduce consumption and minimise harm. We draw on systems science approaches to conceptualise the UPF problem as an emergent property of complex adaptive food systems shaped by capitalist values and logics. Our findings reveal that current food policy frameworks often adjust or reform isolated aspects of food systems (e.g., prices, labels, food composition), but under-emphasise the deeper paradigms, goals and structures that underlie the rise of UPFs as a systems phenomenon, and its socio-ecological implications. We propose that a ‘leverage points’ framework illuminates where to intervene in food systems to generate multi-level changes, while the theory of ecological regulation highlights how to respond to complex multi-factorial problems, like the rise of UPFs, in diverse ways that respect planetary boundaries. More research is needed to better understand the transformative potential of ecological regulation to advance food systems transformation and attenuate whole of food systems challenges. (shrink)

Every rational person knows that there is a finite limit to the carrying capacity of the earth. No ecologist was needed to tell us this, for the statement that finite systems cannot sustain infinite magnitudes is a truth of logic no sane person can choose to ignore and still claim to be rational. The question concerning how we shall approach the limits to population growth, and at what cost, is still an open question. Human beings have increasingly taken on (...) a "cybernetic role" in the ecosystem which sustains them. The question facing humankind relative to population control is, Will the cybernetic role of human beings on the earth's ecosystem be expanded to include the regulation of human numbers, or will nature reassume this function? If this role in regulating human numbers is assumed by people, what forms will it take? (shrink)

Mounting evidence suggests that socioeconomic status is a determinant of health. As nations around the globe increasingly rely on market-based economies, the corporate sector has come to have a powerful influence on the socioeconomic gradient in most nations and hence upon the health status of their populations. At the same time, it has become more difficult for any one nation to influence corporate activities, given the increasing ease with which corporations relocate their operations from country to country, As a result (...) of all of these factors, nations wishing to assure the health of their populations will need to both involve the corporate sector and cooperate with other nations.In this article, we review the business ethics literature and consider what justification it might provide for requiring multinational corporations to attend to concerns about population health. (shrink)

In The legal determinants of health: Harnessing the power of law for global health and sustainable development, Gostin et al. provide a sustained account of how law can and should be used as an instrument of health promotion. We pick up on the themes of this report with a specific focus of the importance of abortion for women’s sexual and reproductive health and the impact that particular ways of framing abortion in law can have on the lives of women and (...) girls. In this short comment, we wish to emphasize that abortion regulations need to move beyond frameworks based on narrow understandings of harm towards more progressive agendas that take into account the social determinants of health in order to reduce barriers to care. This contribution is particularly relevant to the Commission’s criticism that those ‘[l]aws that stigmatise or discriminate against marginalized populations are especially harmful and exacerbate health disparities’. (shrink)

When it comes to dealing with population growth, there are a number of misconceptions about the position of the Catholic Church. Official teaching during the twentieth century gradually moved toward the acceptance of limiting family size and endorsed the concept of responsible parenthood during the Second Vatican Council. One cannot, therefore, justifiably claim that the church is against birth control. It is an entirely different matter, however, when it comes to the practical question about how a couple might go (...) about regulating fertility. Since the publication of Pope Paul VI's 1968 encyclical, an intense controversy has taken place within the church about the use of artificial contraception. Behind that controversy lies an important methodological issue. For, the traditional teaching to which Paul VI returned in his letter was based upon the presumption that it is possible to morally judge a physical, material act without any consideration of the persons who performed that act, the circumstances within which it took place, or the reasons why the act was chosen. This behavioural approach to morality stands in some contrast to the way that other moral questions are dealt with. Inflicting pain or even taking a person's life, for instance, can be justified for a good reason when one acts in a virtuous manner to instil discipline or safeguard justice. Until this methodological controversy is addressed, the problem of using artificial means to regulate fertility will not be resolved. A helpful key for solving the methodological ambiguities is to use moral language in a consistent and understandable manner. (shrink)

Taiwan is an island country situated in the northwest Pacific, close to the southeast of China. The land area is about 36,000 square kilometers. The population of Taiwan is about 23 million, and it consists of the majority Han ethnic groups and dozens of minority groups who are collectively called “Formosan,” an appellation for indigenous peoples in Taiwan. Formosans can be divided into Pingpu and Gaoshan by their living area. In recent years, marriages between Taiwanese, Mainland Chinese, and Southeast (...) Asians have increased significantly. Because of the genetic background of the Taiwanese people, it was thought to be highly beneficial for Taiwan to establish a biobank specifically designed for the Taiwanese population, as it would enable large-scale cohort studies to be carried out for common diseases occurring in Taiwan. (shrink)

This brief commentary reappraises the issue of emigration of physicians from developing countries to developed countries. A methodological framework is developed for assessing the impact of physician emigration on population health outcomes. The evidence from macro and micro studies suggest that developing countries especially in sub-Saharan Africa would benefit from regulating physician emigration because the loss of physicians can lower quality of healthcare services and lead to worse health outcomes. Further discussion is contained in an e-letter: http://jme.bmj.com/content/early/2013/05/30/medethics-2013-101409/reply.

In vitro fertilization (IVF) and surrogacy have enabled many to achieve their dreams of parenthood. With a turnover of $500 million, reproductive tourism in India has helped transform the country into a “global baby factory.” However, as the surrogacy industry grew, so did concerns of women’s exploitation, commodification of motherhood, and human rights violations. In an effort to prevent women from being exploited, the Indian government had taken successive administrative measures to regulate surrogacy. The Surrogacy (Regulation) Bill, 2016 and (...) Assisted Reproductive Technologies Bill 2008 were introduced in the Parliament to regulate various aspects of surrogacy arrangements. Yet, it was not until 25 January 2022, that the Surrogacy (Regulation) Act, 2021 went into effect. The Act does, however, leave certain important points unaddressed. The article claims that the legislation’s purposeful exclusion of the LGBTQ population and emphasis on “familial altruism” stinks of inequity and moral conservatism. It also delineates the mechanics of altruistic surrogacy by examining documents that illustrate how the connections between money and morality are framed via the framing of altruism. The article therefore demands that a comprehensive dialogue must be held considering the socio-economic realities of Indian society, or else India risks enacting yet another law that cannot be implemented or that society dislikes. (shrink)

Biobank-based research in Mexico is mostly governed by research and data protection laws. There is no direct mention of biobanks in either statutory or regulatory law besides a requirement that the Federal Ministry of Health and a Mexican institution devoted to scientific research approve the transfer of biological materials outside of Mexico for population genetics research purposes. Such requirements are the basis of Genomic Sovereignty in Mexico, but such requirements have not prevented international collaboration. In addition, Mexican law singles (...) out genetic research in informed consent provisions, but it does not specify whether all biobank-based research is genetic research. In order to facilitate international collaboration on biobank-based research, Mexico should directly address biobanking in its laws, building on the research framework and data protection framework already in place. (shrink)

Spain occupies an area of 504.645 km, and it has a population of 46.5 million people, out of which 4,538,503 are immigrants. Life expectancy is 82.5 years. Its economy grew 1.4 % in 1014. Its current Constitution was enacted in 1978. It has been part of the European Union since 1986. Spain is a social and democratic state subject to the rule of law. Liberty, justice, equality, and political pluralism are the highest values of the legal order of the (...) rule of law. Spain is a constitutional monarchy with a parliamentary government. The legislative power rests upon two chambers: the Congress and Senate. The government exercises the executive powers and the regulatory powers. There have been six presidents since 1978 from all parties, socialist, centrist, and conservative. The judicial power rests upon the courts and tribunals established by law. (shrink)

Ethical decision-making in public health rarely involves simply avoiding a bad choice in favor of a good choice. Instead, it requires policymakers to strike a balance among conflicting goals that are all good—goals such as the health of populations and individuals, knowledge gained through scientific research, autonomy, social justice, and the efficient use of limited resources. This balance can be elusive, and perfect examples are the legal instruments governing dual-use research, a term describing scientific endeavors meant to produce beneficial knowledge (...) or technology, but that could also be misapplied. Dual-use research of concern policies were implemented... (shrink)

This paper explores the analytical relevance of Foucault's notion of biopower in the context of regulating and managing non-human lives and populations, specifically those animals that are the focus of livestock breeding based on genetic techniques. The concept of biopower is seen as offering theoretical possibilities precisely because it is concerned with the regulation of life and of populations. The paper approaches the task of testing the 'analytic mettle' of biopower through an analysis of four policy documents concerned with (...) farm animal genetics: the UK's National Scrapie Plan (2003); the UK National Action Plan on Farm Animal Genetic Resources (2006); the Agriculture and Environment Biotechnology Committee's report on Animals and Biotechnology (2002); and the Farm Animal Welfare Council's report on the Welfare Implications of Animal Breeding and Breeding Technologies in Commercial Agriculture (2004). Of interest is whether and how the four policy case studies articulate a form of biopower in relation to human-livestock animal relations in the context of genetic approaches to livestock breeding, and how biopower is variably expressed in relation to the different policy issues addressed. In concluding, the paper considers the overall applicability and relevance of biopower in the context of regulating animal lives within livestock breeding, highlighting both possibilities and limitations, and offers suggestions for taking forward research on livestock populations from a neo-Foucaultian perspective. (shrink)

The right to refuse treatment is generally accepted in the legal and bioethics discourses; however, the use of advance directives remains contentious. Some jurisdictions have introduced statutory frameworks to govern the creation and implementation of advance directives, underpinned primarily by the recognition of respect for personal autonomy. Although there are no legislation and judicial decisions on advance decision-making in Malaysia, the considered view is that healthcare practitioners perceived its utility in managing patient care. This paper examines the potential and challenges (...) of applying a statutory framework in Malaysia, drawing from relevant regulatory examples. It argues for greater public awareness within the healthcare discourse and knowledge dissemination regarding the availability, usage and clinical guidance on advance decision-making. The main conclusion drawn from this exploratory analysis is that further understanding of and education about advance decision-making within the population and healthcare practitioners should precede the implementation of a statutory regime in Malaysia. (shrink)

Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s, international regulatory frameworks defined the paediatric population as vulnerable due to unaddressed public health needs. More recently, ethical recommendations have promoted the active engagement of minors as research partners. In this paper, (...) I adopt a post-structuralist approach to policy analysis to examine deep-seated assumptions and presuppositions underlying the changes in the problematisation of children as biomedical research participants over time. While biomedical research ethics focuses on the autonomy and vulnerability of minors, ethical guidelines are situated in specific sociocultural contexts, shaped, among other things, by contingent public health needs and changing conceptions of the value of research and science for society. In the process, I demonstrate the challenge of moving away from an approach that in taking adults as the model overshadows the complexity of children’s lived experiences as well as their personal, cultural, and social lives. The lack of acknowledgement of this complexity makes children vulnerable to epistemic injustice, which is particularly crucial to address in public involvement initiatives. (shrink)

Since Foucault introduced the notion of biopolitics, it has been fiercely debated—usually in highly generalized terms—how to interpret and use this concept. This article argues that these discussions need to be situated, as biopolitics have features that do not travel from one site to the next. This becomes apparent if we attend to an aspect of biopolitics that has only received scant attention so far: the knowledge practices required to constitute populations as intelligible objects of government. To illustrate this point, (...) the article focuses on processes of biopolitical bordering: the delineation of the target population that is to be known via statistical practices. Drawing on the example of Estonia I show that methodological decisions involved in this work have important biopolitical implications as they affect the size and composition of the population, thus shaping the design of programmes of government aiming at its regulation. (shrink)

Multiple scholars and institutions have asked what distinguishes public health research from public health practice. Most often, they ask in order to have a clear definition of what one does in various public health settings to assess oversight and/or regulation of human subjects research. More importantly, however, whether something is considered public health research or public health practice has real ethical implications in terms of the general moral considerations at stake and the obligations of public health researchers/practitioners to the (...) populations they serve or study.Numerous examples in recent history of research ethics, including the Kennedy Krieger Lead Abatement Study and EPA’s Children’s Environmental Exposure Research Study, suggest that an exploration of the ethics of public health, or more generally population-based research, may be warranted. Although we acknowledge that there are important ethical issues to consider in the implementation of public health practice, we leave that discussion for other authors. (shrink)

Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory (...) protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research. (shrink)

Uncoupling proteins (UCPs) regulate mitochondrial function, and thus cellular metabolism. Angiotensin‐converting enzyme (ACE) is the central component of endocrine and local tissue renin–angiotensin systems (RAS), which also regulate diverse aspects of whole‐body metabolism and mitochondrial function (partly through altering mitochondrial UCP expression). We show that ACE expression also appears to be regulated by mitochondrial UCPs. In genetic analysis of two unrelated populations (healthy young UK men and Scandinavian diabetic patients) serum ACE (sACE) activity was significantly higher amongst UCP3‐55C (rather than (...) T) and UCP2 I (rather than D) allele carriers. RNA interference against UCP2 in human umbilical vein endothelial cells reduced UCP2 mRNA sixfold (P < 0·01) whilst increasing ACE expression within a physiological range (<1·8‐fold at 48 h; P < 0·01). Our findings suggest novel hypotheses. Firstly, cellular feedback regulation may occur between UCPs and ACE. Secondly, cellular UCP regulation of sACE suggests a novel means of crosstalk between (and mutual regulation of) cellular and endocrine metabolism. This might partly explain the reduced risk of developing diabetes and metabolic syndrome with RAS antagonists and offer insight into the origins of cardiovascular disease in which UCPs and ACE both play a role. (shrink)

This study aims to investigate the influence of self-awareness on students’ ethical compliance, examine the impact of self-integrity on students’ ethical compliance, explore the effect of self-regulation on students’ ethical compliance, and analyze the influence of ethics education on students’ ethical compliance. Additionally, the research investigates whether ethics education taught in schools or universities has a greater impact compared to an individual’s personality on students’ ethical compliance. The population in this study comprises students in Indonesia. Data collection involves (...) distributing questionnaires through Google Forms, allowing one month for questionnaire completion. The study employs a significance level of 5% to examine the influence of independent variables on the dependent variable. The research findings demonstrate that self-awareness, self-integrity, self-regulation, and ethics education have significant influences on students’ ethical compliance. Furthermore, the study reveals that ethics education does not have a higher impact on students’ ethical compliance compared to the individual’s personality. Therefore, it is crucial to ensure that students possess good self-awareness, high levels of self-integrity, and self-regulation, and understand the ethics education they receive, as this will help enhance students’ ethics compliance. (shrink)

Résumé Durant l’entre-deux-guerres, la Pologne est décrite dans les travaux démographiques et les congrès internationaux comme un pays surpeuplé, où, selon des raisonnements malthusiens, la « loi de la nature » voue l’accroissement de la population à des issues fatales. Cet article décrit comment, dans les années 1930, deux nouveaux courants vont lever la trappe malthusienne. L’un au sein de la démographie, suivant une nouvelle approche biologique de la reproduction, lance une enquête sur la natalité qui saisit la diffusion (...) des pratiques anticonceptionnelles. L’autre porté par des militants réunissant des activistes pour l’émancipation des femmes, la liberté sexuelle, et contre la pénalisation de l’avortement, revendique le contrôle des naissances. Dans les deux cas, les termes malthusiens sont remplacés : la biologie est substituée à la nature, la régulation « consciente » des naissances à la fécondité naturelle non contrôlée. Les milieux catholiques qui opposent méthodes naturelle et artificielle, défendent l’adoption par les femmes de la nouvelle méthode Ogino, avec celle-ci s’entre-ouvre la possibilité d’une nature régulée. (shrink)

Objective: There is a demonstrated link between the mental health and substance use comorbidities experienced by young adults, however the vast majority of psychological interventions are disorder specific. Novel psychological approaches that adequately acknowledge the psychosocial complexity and transdiagnostic needs of vulnerable young people are urgently needed. A modular skills-based program for emotion regulation and impulse control addresses this gap. The current one armed open trial was designed to evaluate the impact that 12 weeks exposure to ERIC alongside usual (...) care had on young people's ability to regulate emotions, as well as examine potential moderating mechanisms.Methods: Seventy nine young people were enrolled to the 12 week intervention period. Twenty one practitioners from youth and community health services delivered relevant ERIC modules adjunct to usual care. Linear mixed effects regression was used to examine change over time across the primary outcome of emotion dysregulation and secondary outcomes of depression, anxiety, stress, experiential avoidance and mindfulness. Moderation analyses were conducted to test whether the magnitude of change in emotion dysregulation moderated change over time in secondary outcomes.Results: Analyses revealed significant improvement in the primary outcome of emotion dysregulation with a moderate effect size, in addition to decreases in the secondary outcomes of depression, anxiety, stress and experiential avoidance. No improvements in mindfulness were reported. Moderation analyses revealed that the residualised change over time in emotion dysregulation moderated the change over time in symptoms of distress, depression, anxiety, stress, experiential avoidance, and mindfulness.Conclusion: Reductions in the severity of emotion dysregulation, depression, anxiety, stress and experiential avoidance are promising, and were evident despite the complexity of the participants and the diversity of the service setting. The improvements found in each outcome were only observed for those young people whose emotion regulation also improved, providing preliminary evidence for the role of emotion regulation as a key treatment target in this population. (shrink)

According to the Institute of Medicine, chronic pain affects at least 116 million adults in the United States, which is more than the total affected by heart disease, cancer, and diabetes combined. Pain costs the nation up to $635 billion each year in medical treatment and lost productivity. It has been conceptualized as a public health problem due to its prevalence, seriousness, disparities, vulnerable populations, the utility of population health strategies, and the importance of prevention at both the (...) class='Hi'>population and individual levels. For many patients, treatment of pain is inadequate due to uncertain diagnoses, societal stigma, the lack of effective treatments, and inadequate patient and clinician knowledge about the best ways to manage pain. This article explores the inadequate treatment of pain in the U.S. and the subsequent rise of prescription painkiller abuse, misuse, and overdoses. This is followed by a review of the actions taken by states to regulate the prescribing of controlled substances. (shrink)

This article provides an analysis of bioprinting personalised medical device technology and its ethical challenges to regulation and research ethics. I argue the inclusion of bioprinting applications within existing regulatory frameworks does not adequately address the technologies disruption to the traditionally siloed activities of research and treatment. Using the conceptual framework of liminality, I offer a meaningful way to engage with this technology and address some identified concerns with how it will be categorised and the appropriate recognition of its (...) evidentiary thresholds. I demonstrate these concerns through the exploration of limited conventional research methodologies tasked with the production of generalisable knowledge, specifically population-based evidence that is derived from Randomised Clinical Trials. I use Australian regulatory amendments introduced in 2021 as an example of current regulatory trajectories and highlight why I believe this approach to be insufficient. The significance of this argument will be to demonstrate the disruption of bioprinting applications to current approaches in medical policy, and how various jurisdictions are enacting regulation that is not fit for purpose. (shrink)

Using a comprehensive sample of U.S. non-profit hospitals from 2011 to 2015, we examine the effects of state community benefits regulation on the amount of charity care provided by and the operational efficiency of U.S. non-profit hospitals. First, we document that, under such regulations, non-profit hospitals provide more charity care and less compensated care as a proportion of net revenue. We infer from these findings that CBR has the potential to increase both non-profit hospitals’ amount of charity care and (...) their efficiency of operations. Second, by examining variation in CBR types, we find no differences between having provision or having reporting requirements on the amount of charity care offered. Moreover, when we consider CBR with both provision and reporting requirements, the combination of these two requirements does not incrementally enhance charity care offerings, suggesting that the requirements may serve as substitutes with comparable effect. Lastly, we show that several state-level characteristics influence the relationship between CBR and charity care: CBRs in states with a higher gross domestic product and percentage of revenue received in taxes have incrementally lower associations with charity care, while hospitals in states where populations have, on average, higher household incomes have greater associations between CBR and charity care. Our findings highlight the effects that state-enacted regulation can have on socially beneficial behavior by non-profits. (shrink)

This article is contextualized within the recent evolution of household employment in Spain. In the context of the strong demand for personal care services – due to rapid population ageing, mass incorporation of women into the labour market and insufficient collective provision of care services – the growth of domestic work is closely related to the overall social organization of care and specific migration policies that have eased, both implicitly and explicitly, the labour supply of foreign women into Spanish (...) households. In line with ongoing debates in the academic literature as well as in the political sphere, this article seeks to explain the extent to which domestic work can or should be considered as any other job in terms of social and employment rights and obligations. To that end, it evaluates changes in the regulation of household employment in Spain since the creation of the Special Regime for Household Employees in 1969 until the most recent 2011 reform. Following the recommendations of the ILO Convention for Domestic Workers, this latest reform puts domestic workers on equal footing with other dependent employees. It thus implies a sea change in relation to the discriminatory treatment embedded in previous legal frameworks. The main hindrance to the effective transposition of the norm however remains the strong presence of the informal economy and a dubious political commitment to ensure its application. (shrink)

Public policy in post-apartheid South Africa has been characterized by a mix of state regulation and ‘neo-liberalism’. This article argues that this mix is rooted in the model of economic modernity adopted in South Africa in the 1920s and 1930s, and underpinned by the institutions of a modern state. In an economy transformed by mining and subsequent secondary industrialization, the state played a central role in facilitating capitalist growth, including through the regulation of labour. I argue that, contrary (...) to the conventional understanding, the enduring characteristic of the political economy of modernization in South Africa was not so much the mobilization of cheap African labour, mostly migrants from across Southern Africa, but was rather the institutionalization of high wages and protected incomes for economic, social and political insiders. Anglo-centric institutions and conceptions of industrial and social citizenship were adapted to the colonial context in South Africa. The imperatives of both gold-led capitalist industrialization and the governance of a society in which the settler or immigrant population remained a minority required that the African population was excluded from most dimensions of this citizenship. But the institutions, discourses and ideologies associated with high wages (for citizens) continued to structure economic life in South Africa through and after the apartheid period. South Africa’s mode of economic modernization thus reflects the possibly unique interaction of a British model of economic modernization with the social, economic and political realities of a colonial society. (shrink)

Emotion is normally regulated in the human brain by a complex circuit consisting of the orbital frontal cortex, amygdala, anterior cingulate cortex, and several other interconnected regions. There are both genetic and environmental contributions to the structure and function of this circuitry. We posit that impulsive aggression and violence arise as a consequence of faulty emotion regulation. Indeed, the prefrontal cortex receives a major serotonergic projection, which is dysfunctional in individuals who show impulsive violence. Individuals vulnerable to faulty (...) class='Hi'>regulation of negative emotion are at risk for violence and aggression. Research on the neural circuitry of emotion regulation suggests new avenues of intervention for such at-risk populations. (shrink)

BPA Production and Associated Health Risks Bisphenol A is a chemical agent found in many everyday products, including canned goods and plastic food containers. BPA exposure is linked to a variety of adverse health effects, such as obesity and diabetes. To protect the public's health — especially the health of vulnerable fetuses, infants, children, and pregnant women — BPA regulations should encompass products intended specifically for these populations. Even with tremendous public outcry against the use of BPA, current federal restrictions (...) do not reach far enough. The U.S. Food and Drug Administration recently banned the use of BPA in children's sippy cups and baby bottles, but failed to address its inclusion in canned infant formula or plastic tableware.BPA production began in the 1950s to make epoxy resins and was later employed to create polycarbonate plastic products. (shrink)

Heart rate variability (HRV) is an indicator of the regulation of the heart, see Task Force (Circulation 93(5):1043–1065, 1996). This study compares the regulation of the heart in two cases of healthy subjects within real life situations: Marathon runners and shift workers. After an update on the state of the art on HRV processing, we specify our probabilistic model: We choose modeling heartbeat series by locally stationary Gaussian process (Dahlhaus in Ann Stat 25, 1997). HRV is then processed (...) by the combination of two statistical methods: (1) Continuous wavelet transform for calculating the spectral density energy in the high frequency (HF) and low frequency (LF) bands and (2) Change point analysis to detect changes of heart regulation. Next, we plot the variations of the HF and LF energy in extreme conditions for both populations. This puts in light, that physical activities (rest, moderate sport, marathon race) can be ordered in a logical continuum. This allows to define a new index based on HF and LF energy that is log HF + log LF which appears relevant to measure HR regulation. The results obtained are pertinent but have to be completed by further studies. (shrink)

New advances in genomics changed the research landscape significantly in the last few years. The power and significance of already existing tissue collections is enhanced by their growing size, and all over the world national projects aim to connect with each other at the international level, calling for integrated and common regulations in the transnational research field. The post genomics era faces problems that are partially different from those within the classical bioethical framework. The challenge is to find new ways (...) to deal with regulations in order to facilitate research without frustrating personal rights. Informed Consent has been the center of this wide debate. We propose a model for rethinking consent in an open-time/open-goal framework suitable to genomics research. Consensus becomes more than a single legal step and goes more in the direction of a participated governance mechanism, a circular open process of communication which the IC sheet signature is just one instance of. This approach provides a governance framework based on different levels of consensus and participation that already contains mechanisms to resolve conflicts between different instances and to protect both the interest of research and the rights of participants. (shrink)

With Artificial Intelligence entering our lives in novel ways—both known and unknown to us—there is both the enhancement of existing ethical issues associated with AI as well as the rise of new ethical issues. There is much focus on opening up the ‘black box’ of modern machine-learning algorithms to understand the reasoning behind their decisions—especially morally salient decisions. However, some applications of AI which are no doubt beneficial to society rely upon these black boxes. Rather than requiring algorithms to be (...) transparent we should focus on constraining AI and those machines powered by AI within microenvironments—both physical and virtual—which allow these machines to realize their function whilst preventing harm to humans. In the field of robotics this is called ‘envelopment’. However, to put an ‘envelope’ around AI-powered machines we need to know some basic things about them which we are often in the dark about. The properties we need to know are the: training data, inputs, functions, outputs, and boundaries. This knowledge is a necessary first step towards the envelopment of AI-powered machines. It is only with this knowledge that we can responsibly regulate, use, and live in a world populated by these machines. (shrink)

In an earlier article, I responded to Ted Benton's charge that Marx and Engels, upon realising the political conservatism associated with Malthusian natural limits arguments, retreated from materialism to a social-constructionist conception of human production and reproduction. I showed that Benton artificially dichotomises the material and social elements of historical materialism, thereby misreading Marx and Engels's recognition of the historical specificity of material conditions as an outright denial of all natural limits. In place of Marx and Engels's materialist and class-relational (...) approach to population issues and the reserve army of the unemployed, Benton employs a partially Malthusianised Marxism heavily reliant on ahistorical notions of natural limits. (shrink)

Some 41 million Americans, many of them children, currently live below the official poverty level. As a proportion of the population, the number has been stable for several decades. But what it mea...