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)

We propose that institutions consider establishing a position of “Ombudsman for Research Practice”. This person would assume several roles: as asounding board to those needing confidential consultation about research issues — basic, applied or clinical; as afacilitator for those wishing to pursue a formal grievance process; and as aneducator to distribute guidelines and standards, to raise the consciousness regarding sloppy or irregular practices in order to prevent misconduct and to promote the responsible conduct of research. While there are compelling features (...) to this position, many complex issues need to be considered and resolved. We invite readers to respond to questions we raise in the text. (shrink)

The bioethical principle of autonomy is problematic regarding the future of the embryo who lacks the ability to self-advocate but will develop this defining human capacity in time. Recent experiments explore the use of clustered regularly interspaced short palindromic repeats /Cas9 for germline engineering in the embryo, which alters future generations. The embryo’s inability to express an autonomous decision is an obvious bioethical challenge of germline engineering. The philosopher Joel Feinberg acknowledged that autonomy is developing in children. He advocated that (...) to reserve this future autonomy, parents should be guided to make ethical decisions that provide children with open futures. Here, Feinberg’s 1980 open future theory is extended to the human embryo in the context of CRISPR germline engineering. Although the embryo does not possess the autonomous decision-making capacity at the time of germline engineering, the parental decision to permanently change the unique genetic fabric of the embryo and subsequent generations disregards future autonomy. Therefore, germline engineering in many instances is objectionable considering Feinberg’s open future theory. (shrink)

Controversy and activism have long been linked to the subject of primate research. Even in the midst of raging ethical debates surrounding fertility treatments, genetically modified foods and stem-cell research, there has been no reduction in the campaigns of activists worldwide. Plying their trade of intimidation aimed at ending biomedical experimentation in all animals, they have succeeded in creating an environment where research institutions, often painted as guilty until proven innocent, have avoided addressing the issue for fear of becoming targets. (...) One area of intense debate is the use of primates in stroke research. Despite the fact that stroke kills more people each year than AIDS and malaria, and less than 5% of patients are candidates for current therapies, there is significant opposition to primate stroke research. A balanced examination of the ethics of primate stroke research is thus of broad interest to all areas of biomedical research. (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)

Numerous studies have shown almost uniformly positive opinions among patients and physicians regarding theconceptof advance directives (either a healthcare proxy or living will). Several of these studies have also shown that the actual use of advance directives is significantly lower than this enthusiasm would suggest, but they have not explained the apparent discordance. Nor have researchers explained why members of minority groups are much less likely to complete advance directives than are white patients. In this study, we used a focus (...) group methodology to examine the ways in which diverse populations of patients view the medical, philosophical, and practical issues surrounding advance directives. We were motivated by the significantly lower prevalence of advance directives among African-American and Hispanic patients at one urban teaching hospital (18% for Caucasians, 4% for African-Americans, and 2% for Hispanics). Our premise was that African-American and Hispanic populations, who have had higher rates of morbidity and mortality across numerous disease categories, and historically have had limited access to care and opportunities to discuss health concerns, may be more suspicious about the right of autonomy that an advance directive is designed to ensure. (shrink)

Numerous studies have shown almost uniformly positive opinions among patients and physicians regarding theconceptof advance directives (either a healthcare proxy or living will). Several of these studies have also shown that the actual use of advance directives is significantly lower than this enthusiasm would suggest, but they have not explained the apparent discordance. Nor have researchers explained why members of minority groups are much less likely to complete advance directives than are white patients. In this study, we used a focus (...) group methodology to examine the ways in which diverse populations of patients view the medical, philosophical, and practical issues surrounding advance directives. We were motivated by the significantly lower prevalence of advance directives among African-American and Hispanic patients at one urban teaching hospital (18% for Caucasians, 4% for African-Americans, and 2% for Hispanics). Our premise was that African-American and Hispanic populations, who have had higher rates of morbidity and mortality across numerous disease categories, and historically have had limited access to care and opportunities to discuss health concerns, may be more suspicious about the right of autonomy that an advance directive is designed to ensure. (shrink)

Controversy and activism have long been linked to the subject of primate research. Even in the midst of raging ethical debates surrounding fertility treatments, genetically modified foods and stem-cell research, there has been no reduction in the campaigns of activists worldwide. Plying their trade of intimidation aimed at ending biomedical experimentation in all animals, they have succeeded in creating an environment where research institutions, often painted as guilty until proven innocent, have avoided addressing the issue for fear of becoming targets. (...) One area of intense debate is the use of primates in stroke research. Despite the fact that stroke kills more people each year than AIDS and malaria, and less than 5% of patients are candidates for current therapies, there is significant opposition to primate stroke research. A balanced examination of the ethics of primate stroke research is thus of broad interest to all areas of biomedical research. (shrink)

The aim of this article is to analyse the internal mechanisms of corporate governance (board of directors and ownership structure), which influence voluntary disclosure of intangibles. The results appear to corroborate the view that an increase in institutional investor shareholding has a negative effect on voluntary disclosure, supporting the hypothesis of entrenchment, whereas an excessive ownership by institutional investors may have adverse effects on strategic disclosure decisions. The results also indicate that an increase in the number of members of the (...) board to up to 15 has a beneficial effect on the disclosure of intangibles. However, as this number increases, the effect inverts and becomes adverse to improving the capacity for supervision and control in the decision-making process regarding the voluntary disclosure of intangibles. The findings endorse the recommendation of the most of the Corporate Governance Codes regarding an advisable maximum of 15 members on a board to ensure its effectiveness and internal cohesion. (shrink)

Spinoza's avowed aim is to discover and present the essential stages in achieving the life of human blessedness. The most important element in this progression is knowledge, of one's own nature as man, and of one's place in the universe. Utility as opposed to truth of belief will not serve Spinoza's purpose. Spinoza assumes the unity of the human individual without question, and it is doubtful whether this assumption is justified on his own principles. The concept of the human individual (...) is examined first as a system of modifications of substance under the attributes of extension and thought, then as enduring and finally as an agent. The conclusion is reached that unity and self?identity are illusions, but the question then arises: Who or what could be under such illusions ? The possibility of false claims to self?identity is examined and found to be difficult to accept. Nevertheless, if Spinoza is taken as speaking suitably at varying levels of discourse, he has enlightening things to say about the human person, even though from one point of view his enterprise may be seen as self?stultifying. (shrink)

Three studies were conducted to explore the psychological determinants of COVID-deterrent behaviors. In Study 1, using data collected and analyzed both before and after the release of COVID-19 vaccines, mask-wearing, other preventative behaviors like social distancing, and vaccination intentions were positively related to assessments of the Coronavirus Behavioral Health Mindset ; belief in the credibility of science; progressive political orientation; less use of repressive and more use of sensitization coping; and the attribution of COVID-19 safety to effort rather than ability, (...) powerful forces, fate, or luck. In Study 2, favorable COVID-19 vaccination intentions were related to greater willingness to work, lower emotional distress, and greater customer experience mindset. Study 3 examined the personality and motives of individuals who volunteered to help deliver COVID-19 inoculations to the local community. The vaccine-giving volunteers, especially those with prosocial motives, had high CVBHM scores, belief in the credibility of science, low use of repressive coping, greater attribution of COVID-19 protection to effort, low likelihood of voting conservative, were older, and had more education than others. The majority of public health volunteers expressed prosocial motives to help people or join a cause, but many expressed the personal motives of getting the COVID-19 vaccination for themselves, conveying a public image of compassion, or structuring time. Based on the three research studies, a COVID-19 Mindset Hierarchy model is proposed to integrate the results. (shrink)

This article reviews some of the definitions in circulation that reveal the varied perspectives and goals of the field of neuroethics. It discusses a brief taxonomy of neuroethical questions. It deals with two specific contentious issues, one clinical and one from social sciences and shows how neuroethicists can serve to inform and to protect. Neuroethicists need education that encompasses many domains. The study describes the academic grounding and qualifications that should be required and also considers the pivotal roles neuroethicists should (...) play. It contributes views that may help define the field of neuroethics and give structure and relevance to its activities. Finally, it concludes that neuroethicists are needed, now more than ever. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Response to Emily A. Largent, Franklin G. Miller and Steven Joffe, A Prescription for Ethical Learning, Hastings Center Report, 43, s1, (S28-S29), (2013).

Advocates for the professionalization of clinical bioethics argue that bioethics professionals play an important role in contemporary medicine and patient care, especially when addressing complex ethical questions that arise in the delivery of reproductive medicine. For bioethics consultants to serve effectively, they need adequate training in the medical and ethical issues that patients and clinicians will face, and they need skills to facilitate effective dialog among all parties. Because clinical ethics consultation is a “high‐stakes endeavor” that can acutely affect patient (...) care, efforts are under way to ensure that bioethics consultants have the competence to provide such guidance. Yet to date, no studies have examined whether the training of bioethics consultants meets the needs of health care professionals who are on the front lines of such issues. In fact, limited information is available on the reproductive health issues that bioethics training programs address or the degree to which these programs meet the needs of patients confronting reproductive health decisions and their clinicians. It is therefore important to answer this key question: What are the primary ethical issues encountered in reproductive medicine that currently affect patient care? Equally important, are bioethics training programs prepared to address those issues?To begin to answer these questions, we conducted parallel surveys of directors of graduate bioethics training programs and obstetrician‐gynecologists. The goal of this project is to lay the groundwork to establish a working partnership between bioethics educators and reproductive medicine practitioners to address the often troubling and frequently complex ethical issues in reproductive medicine. (shrink)

In recent years, the right of employees to know about health hazards in the workplace has emerged as a major issue in occupational health policy. A general consensus has gradually evolved that there is a right to know, and correlatively that there is a moral obligation to disclose relevant information to workers. For example, the National Institute for Occupational Safety and Health, and several other U.S. federal agencies, informed the U.S. Senate as early as July 1977 that ‘workers have the (...) right to know whether or not they are exposed to hazardous chemical and physical agents regulated by the Federal Government.’ In 1980, the Occupational Safety and Health Adminstration promulgated regulations guaranteeing workers access to medical and exposure records. (shrink)

Em intervalos frequentes ao longo dos anos, o professor Chomsky vituperou tanto contra noções do senso comum quanto contra noções técnicas de linguagem pública ou “linguagem externalizada”, afirmando que elas são confusas, mal definidas ou desprovidas de qualquer interesse científico. Como cientista, ele somente estaria interessado na linguagem pública se ela fosse um “objeto real do mundo real” (Chomsky, 1993, p. 39), e não uma noção “artificial” e “arbitrária” (Chomsky, 1985, p. 26). Proponho articular tal noção de linguagem pública para (...) ele. Chomsky também condena a noção que de o propósito da linguagem é a comunicação. Sustentarei, ao contrário, que uma função primária da faculdade humana da linguagem é apoiar convenções linguísticas, e que estas têm uma função essencialmente comunicativa. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

This is a collection of essays on themes of legal philosophy which have all been generated or affected by Hart's work. The topics covered include legal theory, responsibility, and enforcement of morals, with contributions from Ronald Dworkin, Rolf Sartorius, Neil MacCormach, David Lyons, Kent Greenawalt, Michael Moore, Joseph Raz, and C.L. Ten, among others.