ABSTRACTGiven its intimate relationship with the human body and its environment, biotechnology innovation, and more particularly stem cell research innovations as a part thereof, implicate diverse social and moral/ethical issues. This paper explores some of the most important and controversial moral concerns raised by human embryonic stem cell research , focusing on concerns relating to the wellbeing of the embryo and the wellbeing of society . It then considers how and whether these concerns are dealt with in regulatory instruments in (...) Argentina, a southern developing country, examining in particular whether the values underlying these concerns have been translated into practical and effective rules reflective of the primary moral positions advanced. It concludes that Argentina's current state of stem cell research governance fails to consistently reflect the moral positions that have formed and is inadequate given Argentina's activity in this field. (shrink)

The recent outbreak of Ebola in West Africa has killed thousands of people, including healthcare workers. African responses have been varied and largely ineffective. The WHO and the international community’s belated responses have yet to quell the epidemic. The crisis is characteristic of a failure to properly comply with the International Health Regulations 2005. More generally, it stems from a failure of international health justice as articulated by a range of legal institutions and instruments, and it should prompt us (...) to question the state and direction of approaches to the governance of global public health. This paper queries what might be done to lift global public health as a policy arena to the place of prominence that it deserves. It argues that there are at least two critical reasons for the past, present and easily anticipated future failings of the global public health regime. After exploring those, it then articulates a new way forward, identifying three courses of action that might be adopted in realising better health outcomes and global health justice, namely value, institutional and legal reform. (shrink)

In a world surrounded by smart objects from sensors to automated medical devices, the ubiquity of ‘smart’ seems matched only by its lack of clarity. In this article, we use our discussions with expert stakeholders working in areas of implantable medical devices such as cochlear implants, implantable cardiac defibrillators, deep brain stimulators and in vivo biosensors to interrogate the difference facets of smart in ‘implantable smart technologies’, considering also whether regulation needs to respond to the autonomy that such artefacts carry (...) within them. We discover that when smart technology is deconstructed it is a slippery and multi-layered concept. A device’s ability to sense and transmit data and automate medicine can be associated with the ‘sting’ of autonomy being disassociated from human control as well as affecting individual, group, and social environments. (shrink)

Science matters. Science matters to the development of knowledge, to the sustainability of development, and to the shaping of social mores. Countries transitioning from developing to developed must be prepared to make science work for them and to forge a vision to become competitors in some aspects of science innovation. Drawing on data generated by the “Governing Emerging Technologies: Social Values and Stem Cell Regulation in Argentina” Project, this paper places the current Argentine bioscience setting in context by reviewing the (...) development of biosciences in Argentina, explores understandings of the social dimensions of bioscience innovation in Argentina and the possibilities of enhancing public support for science, and offers some preliminary thoughts on a model for socio-legal activity directed at encouraging social engagement with and the uptake of high technologies in Argentina. (shrink)

In a world surrounded by smart objects from sensors to automated medical devices, the ubiquity of ‘smart’ seems matched only by its lack of clarity. In this article, we use our discussions with expert stakeholders working in areas of implantable medical devices such as cochlear implants, implantable cardiac defibrillators, deep brain stimulators and in vivo biosensors to interrogate the difference facets of smart in ‘implantable smart technologies’, considering also whether regulation needs to respond to the autonomy that such artefacts carry (...) within them. We discover that when smart technology is deconstructed it is a slippery and multi-layered concept. A device’s ability to sense and transmit data and automate medicine can be associated with the ‘sting’ of autonomy being disassociated from human control as well as affecting individual, group, and social environments. (shrink)

To state the obvious, “health matters”, but health (or its equitable enjoyment) is neither simple nor easy. Public health in particular, which encompasses a broad collection of complex and multidisciplinary activities which are critical to the wellbeing and security of individuals, populations and nations, is a difficult milieu to master effectively. In fact, despite the vital importance of public health, there is a relative dearth of ethico-legal norms tailored for, and directed at, the public health sector, particularly at the international (...) level. This is a state of affairs which is no longer tenable in the global environment. This article argues that public health promotion is a moral duty, and that international actors are key stakeholders upon whom this duty falls. In particular, the World Health Organization bears a heavy responsibility in this regard. The article claims that better health can and must be better promoted through a more robust interpretation of the WHO’s role, arguing that neither the WHO nor international law have yet played their necessary part in promoting health for all. (shrink)

This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze – as an example – the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in the (...) US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non-uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries. (shrink)

ABSTRACT This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze – as an example – the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in (...) the US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non‐uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries. (shrink)

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was formed over 20 years ago with a goal of harmonizing research regulations among the European Union, United States, and Japan. Harmonization was intended to speed approval of pharmaceuticals, avoid unnecessary repetition of studies, and ensure protection of research participants. This paper examines United States, European Union, and ICH pediatric research regulations in five domains: parental permission, assent/dissent, payment, risk/benefit and inclusion (...) of disabled children/wards of state. The purpose is to examine similarities and differences among the regulations to help investigators, policy makers and the public to understand what each regulatory framework can learn from the others. Additionally, the paper suggests philosophical differences in how these entities view pediatric research which may serve as barriers to harmonization in the future. (shrink)

The Food and Drug Administration and the European Medicines Agency have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use as a (...) mechanism for harmonizing clinical research regulations. The intent of harmonization was to improve patients’ “access to new drugs, to prevent unnecessary global development delays and to avoid animal and human study duplications” through policy reconciliation.FDA/EMA efforts at collaboration call for a reassessment of past harmonization efforts: to what extent are ICH member policies already synchronized and to what extent can they be harmonized in the future? This paper will focus on these questions through the lens of pediatric investigation. (shrink)

The article analyses the legal regulation of electronic marketing in the European context. The historical and teleological perspective on past and present regulations of electronic marketing is provided. Emphasis is given on the ability of the legal rules to preserve the balance of private and entrepreneurial interests, and the desirable principles of the regulation of the socially beneficial electronic marketing. The paper concludes that the harmonization of legal regulation of electronic marketing at the European Union level is limited, which (...) causes numerous negative consequences, such as jurisdiction shopping. Some countries (e.g. Finland) follow opt-out regimes for at least some types of electronic marketing, while other countries (including Lithuania) prohibit most forms of electronic marketing without the prior consent of the customer (opt-in). Thus, further regulation and harmonization of the electronic marketing law is suggested at the regional (the EU) and national level, along with more self-regulation and a balanced approach towards future regulation. (shrink)

The Endosomal Sorting Complexes Required for Transport (ESCRTs) drive membrane remodeling in a variety of cellular processes that include the formation of endosomal intralumenal vesicles (ILVs) during multivesicular body (MVB) biogenesis. During MVB sorting, ESCRTs recognize ubiquitin (Ub) attached to membrane protein cargo and execute ILV formation by controlling the activities of ESCRT‐III polymers regulated by the AAA‐ATPase Vps4. Exactly how these events are coordinated to ensure proper cargo loading into ILVs remains unclear. Here we discuss recent work documenting the (...) ability of Bro1, an ESCRT‐associated Ub‐binding protein, to coordinate ESCRT‐III and Vps4‐dependent ILV biogenesis with upstream events such as cargo recognition. (shrink)

The compliance-based approach and the integrity approach have been the mainstream responses to corporate scandals. This paper proposes that, despite each approach comprising necessary elements, neither offers a comprehensive solution. Compliance and integrity, far from being mutually exclusive, reinforce each other. Working together, in a correct relationship, they build a harmonized system that yields positive synergies and which also advocates prudence. It enables the generation of a culture of compliance that tends to minimize the technical and ethical errors in decision (...) making. In order to explore an applied harmonized approach, we analyze the audit committee, a specific and broadly accepted regulatory instrument. Formed by non-executive members, regulation requires these members to be dedicated, qualified, and independent as a guarantee of efficiency. We show how the compound of those elements produces positive effects in a context of solid governance. We conclude that it is the strong relationship between efficiency and prudence, in the creation of a culture of compliance, which enables the minimization of errors. (shrink)

It is now typical for human subjects research to be regulated by review by an independent research ethics committee in most jurisdictions. However it is common for countries to opt to only compulsorily regulate medical research while leaving some or all non-medical research either unregulated or only regulated on a voluntary basis. In this paper I will argue, using regulation in the UK as an example, that it is difficult to justify this sharp distinction in practices. While I won’t come (...) to any definitive conclusions in this paper as to whether research ought to be regulated compulsorily I will suggest that we would be better to regulate all research, albeit perhaps with a lighter touch than the present UK system if we want to prevent some highly risky research avoiding appropriate regulation. I will examine several arguments to defend making such a distinction; that medical professionals have special moral duties, that medical research has a higher magnitude/frequency of risks and that regulating non-medical research constitutes the inappropriate imposition of the medical model onto non-medical research. Having critiqued these objections I will then discuss the advantages of harmonizing the regulation of research and conclude that there is not a good reason to treat medical and non-medical research as fundamentally different in kind. (shrink)

The General Data Protection Regulation (GDPR) was introduced in 2018 to harmonize data privacy and security laws across the European Union (EU). It applies to any organization collecting personal data in the EU. To date, service-level consent has been used as a proportionate approach for clinical trials, which implement low-risk, routine, service-wide interventions for which individual consent is considered inappropriate. In the context of public health research, GDPR now requires that individuals have the option to choose whether their data may (...) be used for research, which presents a challenge when consent has been given by the clinical service and not by individual service users. We report here on development of a pragmatic opt-out solution to this consent paradox in the context of a partner notification intervention trial in sexual health clinics in the UK. Our approach supports the individual’s right to withhold their data from trial analysis while routinely offering the same care to all patients. (shrink)

The term 'sociobiology' was introduced in E. O. Wilson's Sociobiology: The New Synthesis (1975) as the application of evolutionary theory to social behavior. Sociobiologists claim that many social behaviors have been shaped by natural selection for reproductive success, and they attempt to reconstruct the evolutionary histories of particular behaviors or behavioral strategies. This survey attempts to clarify and evaluate the aim of sociobiology. Given that a neutral account is impossible, this entry does the next best thing. It takes sociobiology as (...) well as its critics seriously. On the one hand, by demonstrating that current studies of evolution and human behavior are based on Darwin's arguments for evolution (properly updated), we gain a strong rationale for thinking that something closer to sociobiology than to disconnectionism is needed to properly understand human sociality. Nevertheless, this survey reconstructs sociobiology in its best light, according to its aims. Consequently, criticism of sociobiology as it is actually practiced is not ignored or dismissed. This approach reveals what is best about sociobiology, while remaining sensitive to many of the problems it has generated. (shrink)

Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International (...) Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. (shrink)

As policy makers struggle to develop regulatory oversight models for nanotechnologies, there are important lessons that can be drawn from previous attempts to govern other emerging technologies. Five such lessons are the following: public confidence and trust in a technology and its regulatory oversight is probably the most important factor for the commercial success of a technology; regulation should avoid discriminating against particular technologies unless there is a scientifically based rationale for the disparate treatment; regulatory systems need to be flexible (...) and adaptive to rapidly changing technologies; ethical and social concerns of the public about emerging technologies need to be expressly acknowledged and addressed in regulatory oversight; and international harmonization of regulation may be beneficial in a rapidly globalizing world. (shrink)

Evolutionary psychology is a science in the making, working toward the goal of showing how psychological adaptation underlies much human behavior. The knee-jerk reaction that sociobiology is unscientific because it tells just-so stories has become a common charge against evolutionary psychology as well. My main positive thesis is that inference to the best explanation is a proper method for evolutionary analyses, and it supplies a new perspective on the issues raised in Schlinger's (1996) just-so story critique. My main negative thesis (...) is that, like many nonevolutionist critics, Schlinger's objections arise from misunderstandings of the evolutionary approach.Evolutionary psychology has progressed beyond telling just-so stories. It has found a host of ingenious special techniques to test hypotheses about the adaptive significance and proximate mechanisms of behavior. Naturalistic data using the comparative method combined with controlled tests using statistical analyses of data provide good evidence for a variety of hypotheses about behavioral control mechanisms — whether in nonhumans or in humans. For instance, the work of Gangestad and Thornhill on evolved mate preferences and fluctuating asymmetry of body type (FA) is a model of success. As the quantity and quality of evidence increase, we are entitled not just to regard such evolutionary hypotheses as preferable, but also as true. Such studies combine to show that the best explanation of the psychic unity of humankind — common patterns across societies, history, and cultures exposed by evolutionists — is the gendered, adapted, evolved species-typical design of the mind. (shrink)

This book provides a fresh look at one of the most enduring, absorbing, and universal questions human beings face: What happens to us after we die? In secular thought, the standard answer is simple: we disappear into oblivion. David Harmon takes us in a different direction, by making the case that a nonconscious portion of our personality survives death-literally, not figuratively-and explains how this kind of naturalistic afterlife can be emotionally relevant to us while we are still living. Combining insights (...) from the arts, history, philosophy, and science, a compelling argument takes shape for an afterlife without God.. (shrink)

Medthics is an online graphic novel series comprising of six issues . What is often viewed as pop culture escapism, this "comic book" series tackles the complex world of medicine and its moral/ethical intricacies. From topics about physician identity formation to humane patient care, Medthics brings to the forefront subject matter essential to clinical practice. The art of medicine is depicted through stylized characters as they live their lives through a fictional world inspired by true events.

We discuss some research that has examined approach motivational urges and how this research clarifies the definition of approach motivation. Our research and that of others have raised doubts about the commonly accepted definition of approach motivation, which views it as a positive affective state triggered by positive stimuli. We review evidence that suggests: (a) that approach motivation is occasionally evoked by negative stimuli; (b) that approach motivation may be experienced as a negative state; and (c) that stimuli are unnecessary (...) to evoke approach motivation. (shrink)

This volume moves beyond ethics as problem-solving or ethics as etiquette to offer a look at ethics in primary care—as opposed to life-or-death—medical care. Professional Ethics and Primary Care Medicine deals with the ethics of routine, day-to-day encounters between doctors and patients. It probes beneath the hard decisions to look at the moral frameworks, habits of thought, and customs of practice that underlie choices. Harmon Smith and Larry Churchill argue that primary care, far from being merely a setting for the (...) rendering of care, provides a new understanding of both physician and patient, and thereby offers a fresh basis for medical ethics. (shrink)

An emerging trend in cognitive science is to explore central epistemological questions using psychological methods. Early work in this growing area of research has revealed that epistemologists’ theories of knowledge diverge in various ways from the ways in which ordinary people think of knowledge. Reflecting the practices of epistemology as a whole, the vast majority of these studies have focused on the concept of propositional knowledge, or knowledge-that. Many philosophers, however, have argued that knowing how to do something is importantly (...) different from knowing that something is the case. Hence, in this paper we turn our attention to people’s concept of knowledge-how. We present data from two experiments that employed a sentence recognition task as an implicit measure of conceptual activation. The data from this implicit measure suggest that, contrary to prominent intellectualist theories of know-how, according to which know-how is a species of propositional knowledge, people’s concept of know-how more closely aligns with anti-intellectualism, the view that knowing how to perform some task consists in having the appropriate skills or abilities. (shrink)

AUTHORITY AND INEQUALITY UNDER CAPITALISM AND SOCIALISM: USA, USSR, AND CHINA by Barrington Moore, Jr. Oxford: Clarendon Press, 1987. 142 pp., $29.95.

In The Adapted Mind (1992), Cosmides and Tooby argue for the thesis that biological evolution endowed the human mind with a system of content‐specific computational mechanisms designed to solve long‐standing adaptive problems humans encountered as hunter‐gatherers, and not just a generalized "capacity for culture" or all‐purpose "learning capacity". I analyze three types of arguments they offer: historical arguments for the rise of content‐Specific psychology; programmatic arguments for the aims, theory, concepts, and methods of their evolutionary approach; and experimental arguments for (...) the content‐dependence of reasoning. Their arguments stand or fall on the claim that functionally specialized adaptations must be richly structured in a content‐specific way. (shrink)

Critics of evolutionary psychology object that it is not rigorous science compared to other evolutionary science. Advocates reply that it is rigorous science, and that the critics are uninformed. Still, informed people having opposing preconceptions of what counts as rigor may reach opposing evaluative conclusions. I shall clarify the very idea of rigorous evolutionary histories in relation to the basic objection that “evolution without history” is not rigorous.

The fundamental unit of assessment in the sociobiology debate is neither a field nor a theory, but a framework of group commitments. Recourse to the framework concept is motivated, in general, by post-Kuhnian philosophy of scientific change and, in particular, by the dispute between E. O. Wilson and R. C. Lewontin. The framework concept is explicated in terms of commitments about problems, domain, disciplinary relations, exemplars, and performance evaluations. One upshot is that debate over such charges as genetic determinism, reductionism, (...) adaptationism, and the biologization of human nature has been vexed. It has lost sight of human sociobiology's central problem, namely to help show that the modern synthesis is complete. (shrink)

Mealey's work has several interesting implications: It refutes the charge that sociobiology paints a cynical portrait of human nature and adopts a one-sided reductionism; it exemplifies a general theoretical scheme for constructing evolutionary biopsychosocial models of human behavior; and it has the practical effect of promoting and informing early intervention in children at risk for psychopathic disorder.