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)

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)

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 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)

In lieu of an abstract, here is a brief excerpt of the content:Cloning without Prior Approval:A Response to Recent Disclosures of NoncomplianceRuth Macklin (bio)Editor's note: In September 1994, the Kennedy Institute of Ethics Journal published a special issue on the ethics of embryo splitting or "cloning," which included papers originally prepared for a workshop on embryo splitting sponsored by the National Advisory Board on Ethics in Reproduction (NABER) and NABER's report, Human Cloning through Embryo Splitting. The impetus for the project (...) was embryo-splitting research conducted by Drs. Jerry L. Hall, Robert J. Stillman, and others, at George Washington University and presented in October 1993 at a joint meeting of the American Fertility Society and the Canadian Fertility and Andrology Society. Media coverage at the time reported that the research had been approved by the university's formal review committees. However, it came to light in December 1994 that the researchers had not obtained approval from the university's institutional review board prior to conducting the research. Following a university investigation, the researchers were disciplined and instructed to destroy their data. The university also voluntarily forwarded the records of the incident to the Office for Protection from Research Risks at the National Institutes of Health. Dr. Hall resigned from George Washington University in September 1994.In the following postscript to her article on the ethics of embryo splitting (KIEJ, September 1994), Ruth Macklin discusses these events. The letters and memoranda that she cites were obtained from NIH through the Freedom of Information Act.My article, "Splitting Embryos on the Slippery Slope: Ethics and Public Policy" (KIEJ, September 1994), included a brief assessment of the ethics of the Hall-Stillman embryo-splitting experiment conducted at George Washington University (GWU). The article reviewed the researchers' stated purpose ("to help infertile couples by reproducing nature's ability to reproduce twins"), the features of the research itself (splitting embryos that never could become viable and with no plan to implant either the original or the split embryos), and the review procedures surrounding the experiment. I said that the researchers might be [End Page 57] faulted for not waiting until embryo research guidelines had been established at the national level; on the other hand, they surely could not fail to conform to such national guidelines when none existed.My conclusions were based on information that had been reported in the print media. Dr. Robert J. Stillman's statement that the experiment "had been approved by the university's formal review committees and peer reviewed by colleagues" was reported in the Washington Post on October 25, 1993, (Sawyer 1993). However, in light of the recent disclosure that the researchers had not obtained approval from George Washington University's IRB before proceeding with the research (Schwartz 1994), I now draw a sharply different conclusion about the ethics of the researchers' behavior.The most glaring flaw was the researchers' failure to submit a protocol to their institution's IRB in advance of embarking on the research. Following an investigation of the matter, the Office for Protection from Research Risks (OPRR) made the further determination that "the failure on the part of GWU research investigators and administrators to notify the IRB promptly about noncompliance in this research constitutes additional serious noncompliance" with research regulations (J. Thomas Puglisi, Chief of the Compliance Oversight Branch, Division of Human Subject Protections, OPRR, letter to Stephen J. Trachtenberg, President of George Washington University, 23 August 1994). Is it reasonable to suppose that these researchers were unaware of their obligations (a) to obtain prior review and approval from the IRB and (b) to notify the IRB promptly about their noncompliance? Regarding the latter item, Dr. Puglisi's letter to the President of GWU states that "the notification requirement has been a longstanding element of the GWU MPA [multiple project assurance], which should have been familiar to all members of the GWU research community." I shall concentrate on the researchers' more glaring ethical omission, failure to obtain prior review and approval from the IRB.Did either or both of these researchers contend that they were unaware of any review requirements for their research? Hall blames Stillman, Director of the Division of Reproductive Endocrinology, Fertility, and IVF Programs, for not making the requirement... (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)

Senior leadership transitions present daunting challenges. To promote inclusive development and comply with equal opportunity legislation, South African companies often fast-track careers of high-potential previously disadvantaged individuals. Organisations typically do not sufficiently support transitioning leaders, possibly acting unethically. The rate of failure is high with devastating effects for the individual and their organisation. The novel, empirically researched Transformative Transition Coaching framework, helps facilitate deep and lasting changes in meaning perspectives of transitioning leaders through coaching. The ability of the TTC framework (...) to support transitioning leaders is presented in this article. (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)

Response to "Embodied artificial intelligence", a commentary by Ron Chrisley.

(2014). Killing without Heart: Limits on Robotic Warfare in an Age of Persistent Conflict. Journal of Military Ethics: Vol. 13, No. 1, pp. 106-111. doi: 10.1080/15027570.2014.910017.

A caveat: The topic of abortion is both highly controversial and extremely complex, and I certainly cannot hope to address all of its important ethical aspects in the brief notes that follow. Readers are urged to consult a good annotated bibliography such as the one compiled by James DeHullu for references to more extensive scholarly treatments of abortion.

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).