For nearly two decades, the process of reviewing the ethical merit of research involving human subjects has been based on the application of principles initially described in the U.S. National Commission's Belmont Report, and later articulated more fully by Beauchamp and Childress in their Principles of Biomedical Ethics. Recently, the use of ethical principles for deliberating about moral problems in medicine and research, referred to in the pejorative sense as “principlism”, has come under scrutiny. In this paper we argue that (...) these principles can provide a foundation for the source of ethical appraisal of human research, but are not themselves wholly adequate for this purpose. Therefore, we further propose that principles should be understood as heuristics that can be “specified” as described by DeGrazia , and that the principle‐based approach should be supplemented by formally incorporating “sensitivity to context” into the evaluation of clinical trials. (shrink)

Objective: There are benefits and risks of giving patients more granular control of their personal health information in electronic health record (EHR) systems. When designing EHR systems and policies, informaticists and system developers must balance these benefits and risks. Ethical considerations should be an explicit part of this balancing. Our objective was to develop a structured ethics framework to accomplish this. -/- Methods: We reviewed existing literature on the ethical and policy issues, developed an ethics framework called a “Points to (...) Consider” (P2C) document, and convened a national expert panel to review and critique the P2C. -/- Results: We developed the P2C to aid informaticists designing an advanced query tool for an electronic health record (EHR) system in Indianapolis. The P2C consists of six questions (“Points”) that frame important ethical issues, apply accepted principles of bioethics and Fair Information Practices, comment on how questions might be answered, and address implications for patient care. -/- Discussion: The P2C is intended to clarify whatis at stake when designers try to accommodate potentially competing ethical commitments and logistical realities. The P2C was developed to guide informaticists who were designing a query tool in an existing EHR that would permit patient granular control. While consideration of ethical issues is coming to the forefront of medical informatics design and development practices, more reflection is needed to facilitate optimal collaboration between designers and ethicists. This report contributes to that discussion. (shrink)

Ethics should guide the design of electronic health records (EHR), and recognized principles of bioethics can play an important role. This approach was adopted recently by a team of informaticists designing and testing a system where patients exert granular control over who views their personal health information. While this method of building ethics in from the start of the design process has significant benefits, questions remain about how useful the application of bioethics principles can be in this process, especially when (...) principles conflict. For instance, while the ethical principle of respect for autonomy supports a robust system of granular control, the principles of beneficence and non-maleficence counsel restraint due to the danger of patients being harmed by restrictions on provider access to data. Conflict between principles has long been recognized by ethicists and has even motivated attacks on approaches that state and apply principles. In this paper we show how using ethical principles can help in the design of EHRs by first, explaining how ethical principles can and should be used generally, and then by, discuss how attention to details in specific cases can show that the tension between principles is not as bad as it initially appeared. We conclude by suggesting further ways in which the application of these (and other) principles can add value to the ongoing discussion of patient involvement in their health care. This is a new approach to linking principles to informatics design that we expect will stimulate further interest. (shrink)

Most people do not know there are different kinds of medical studies; some are conducted on people who already have a disease or medical condition, and others are performed on healthy volunteers who want to help science find answers. No matter what sort of research you are invited to participate in, or whether you are a patient when you are asked, it’s entirely up to you whether or not to do it. This decision is important and may have many implications (...) for your health and well-being, as well as those of other patients now and in the future. Making a good decision – the right one for you – requires you to become educated about topics you may not have thought about before, some of which may be quite complicated. This chapter explains the key issues to help you make a good decision. (shrink)

Since the birth of bioethics, a persistent refrain has been that advances in science, technology, and health are occurring so quickly that they threaten to outpace society’s ability to understand and react to them. Genomics, big data, and synthetic biology preoccupy current scholarly and policy debates, just as organ transplantation, in vitro fertilization, human subjects research, and gene therapy did over the past forty years. But the history of bioethics is more than the topics it has addressed. It is also (...) the story of the people whose voices shaped its debates and built society’s capacity to manage the escalating pace of technological change.LeRoy Walters is one of those contributors who made a difference. He... (shrink)

For nearly two decades, the process of reviewing the ethical merit of research involving human subjects has been based on the application of principles initially described in the U.S. National Commission's Belmont Report, and later articulated more fully by Beauchamp and Childress in their Principles of Biomedical Ethics. Recently, the use of ethical principles for deliberating about moral problems in medicine and research, referred to in the pejorative sense as “principlism”, has come under scrutiny. In this paper we argue that (...) these principles can provide a foundation for the source of ethical appraisal of human research, but are not themselves wholly adequate for this purpose. Therefore, we further propose that (1) principles should be understood as heuristics that can be “specified” as described by DeGrazia (1992), and (2) that the principle‐based approach should be supplemented by formally incorporating “sensitivity to context” into the evaluation of clinical trials. (shrink)

For nearly two decades, the process of reviewing the ethical merit of research involving human subjects has been based on the application of principles initially described in the U.S. National Commission's Belmont Report, and later articulated more fully by Beauchamp and Childress in their Principles of Biomedical Ethics. Recently, the use of ethical principles for deliberating about moral problems in medicine and research, referred to in the pejorative sense as “principlism”, has come under scrutiny. In this paper we argue that (...) these principles can provide a foundation for the source of ethical appraisal of human research, but are not themselves wholly adequate for this purpose. Therefore, we further propose that (1) principles should be understood as heuristics that can be “specified” as described by DeGrazia (1992), and (2) that the principle‐based approach should be supplemented by formally incorporating “sensitivity to context” into the evaluation of clinical trials. (shrink)

In a strike to permit extra billing, physicians in Ontario, Canada, sought to balance their concerns for professional autonomy with their primary call to beneficence. But the right to reasonable compensation within a nationalized health care system is not on the same moral plane as the public's right to health care. Having failed to convince either the provincial government or the public of the soundness of their position, Ontario's doctors must now repair the damage done to the relationship with their (...) patients. (shrink)

Expectations are high around the world that more research on human genomic variation will improve the utility of “precision medicine” and help address population health disparities through “precision public health”. In large measure, these expectations rest on the premise that researchers will be able to share human DNA samples and genomic data freely and widely across the international scientific community. The human genomics community pioneered polices of early deposit of genomic research data into open databases to facilitate the exchange and (...) use of data during the mapping and sequencing of the human genome in the 1990s, and the success of those policies has made a... (shrink)

Some experts have argued that patients should routinely be told the specific magnitude and absolute probability of potential risks and benefits of screening tests. This position is motivated by the idea that framing risk information in ways that are less precise violates the ethical principle of respect for autonomy and its application in informed consent or shared decisionmaking. In this Perspective, we consider a number of problems with this view that have not been adequately addressed. The most important challenges stem (...) from the danger that patients will misunderstand the information or have irrational responses to it. Any initiative in this area should take such factors into account and should consider carefully how to apply the ethical principles of respect for autonomy and beneficence. (shrink)

The purpose of this study is to compare and contrast the basic ethical values underpinning national health care policies in the United States and Canada. We use the framework of ethical theory to name and elaborate ethical values and to facilitate moral reflection about health care reform. Section one describes historical and contemporary social contract theories and clarifies the ethical values associated with them. Sections two and three show that health care debates and health care systems in both countries reflect (...) the values of this tradition; however, each nation interprets the tradition differently. In the U.S., standards of justice for health care are conceived as a voluntary agreement reached by self-interested parties. Canadians, by contrast, interpret the same justice tradition as placing greater emphasis on concern for others and for the community. The final section draws out the implications of these differences for future U.S. and Canadian health care reforms. (shrink)

Book reviewed in this article: Final Report: White House Advisory Committee on Human Radiation Experiments, (061‐000‐00‐848‐9).

Book reviewed in this article: Final Report: White House Advisory Committee on Human Radiation Experiments, (061‐000‐00‐848‐9).

Medical research involving human subjects raises complex ethical, legal and social issues. Investigators sometimes find that their obligations with respect to a research project come into conflict with their obligations to individual patients. The ethical conduct of research rests on 3 guiding principles: respect for persons, beneficience, and justice. Respect for persons underlies the duty to obtain informed consent from study participants. Beneficence demands a favourable balance between the potential benefits and harms of participation. Justice requires that vulnerable people not (...) be exploited and that eligible candidates who may benefit from participation not be excluded without good cause. Studies must be designed in a way that ensures the validity of findings and must address questions of sufficient importance to justify the risks of participation. In any clinical trial there must be genuine uncertainty as to which treatment arm offers the most benefit, and placebo controls should not be used if effective standard therapies exist. Researchers have a responsibility to inform themselves about the ethical, legal and policy standards that govern their activities. When difficulties arise, they should consult the existing literature and seek the advice of experts in research ethics. (shrink)

Ethical issues related the responsible conduct of research involve questions concerning the rights and obligations of investigators to propose, design, implement, and publish research. When a principal investigator transfers institutions during a grant cycle, financial and recognition issues need to be addressed to preserve all parties’ obligations and best interests in a mutually beneficial way. Although grants often transfer with the PI, sometimes they do not. Maintaining a grant at an institution after the PI leaves does not negate the grantee (...) institution’s obligation to recognize the PI’s original ideas, contributions, and potential rights to some forms of expression and compensation. Issues include maintaining a role for the PI in determining how to take credit for, share and publish results that involve his or her original ideas. Ascribing proper credit can become a thorny issue. This paper provides a framework for addressing situations and disagreements that may occur when a new PI continues the work after the original PI transfers. Included are suggestions for proactively developing institutional mechanisms that address such issues. Considerations include how to develop solutions that comply with the responsible conduct of research, equitably resolve claims regarding reporting of results, and avoid the possibility of plagiarism. (shrink)

While several tests and strategies are recommended for colorectal cancer (CRC) screening, studies suggest that primary care providers often recommend colonoscopy without providing information about its risks or alternatives. These observations raise concerns about the quality of informed consent for screening colonoscopy.

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.1 (2002) 95-102 [Access article in PDF] Bioethics Inside the Beltway Some Initial Reflections on NBAC Eric M. Meslin and Harold T. Shapiro On 3 October 2001, Executive Order 12975 expired, and with it so too did the National Bioethics Advisory Commission (NBAC). Established by President Bill Clinton in 1995, NBAC was the fifth national committee since 1974 created to advise the (...) U.S. government on bioethics policy. In the long political tradition in this country that national bioethics policy advice should use temporary rather than permanent bodies, NBAC followed in the footsteps of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78); the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1980-83); the Ethics Advisory Board (1978-80); and the Biomedical Ethics Advisory Committee (1988-89). Arguably, other distinguished panels could lay claim to recognition as a "national bioethics committee" including the Advisory Committee on Human Radiation Experiments (ACHRE) (1994-95); the Fetal Tissue Transplantation Research Panel (1988); the Human Embryo Research Panel (1994); and the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC), which continues to function.These committees and commissions form a kind of a continuum, albeit occasionally interrupted by periods during which no such bodies existed. Each arose from a particular confluence of events and circumstances. NBAC was no different; its history can be traced both to a series of discussions within the White House Office of Science and Technology Policy beginning in 1993 (NBAC 1998a, p. 3), and to a specific recommendation from ACHRE that called for a national committee to address ethical issues in human subjects research (ACHRE 1995, p. 817). Nbac's Impact In his useful comparison of the accomplishments of the National Commission and the President's Commission, Brad Gray concluded that seven lessons were learned, the sixth of which was that "nothing substitutes for having a perceptible impact on either policy or practice" (Gray 1995, p. 304). Assessing NBAC's [End Page 95] impact on "policy or practice" is difficult, particularly given the fact that it so recently completed its work. More time may be needed before a full assessment can be undertaken of the impact of its six reports (and their total of 120 recommendations). Instead, in this essay we offer some reflections on NBAC's initial impact, using some specific examples of how bioethics gets done Inside the Beltway. Eliciting Reaction If immediate reaction by the White House is any measure of impact, then Cloning Human Beings (NBAC 1997) had a significant one. The day after he received this report in a Rose Garden ceremony, President Clinton submitted a bill to Congress that would have extended the moratorium on federal funding to create a child using somatic cell nuclear transfer. This bill never passed, nor has any other bill emerged that has enjoyed the support of the House and the Senate. Five states have enacted legislation to date, but these vary in their permissibility from bans on all forms of cloning to bans similar to the one proposed by NBAC, which recommended a time-limited prohibition only on somatic cell transfer to create a child (reproductive cloning).If the Cloning report elicited speedy action from the White House, this paled in comparison to the reaction that led to and, in turn, was created by Ethical Issues in Human Stem Cell Research (NBAC 1999a). Those who believe that government moves slowly need only be reminded of the events of 8-14 November 1998 (and, as we shall mention below, the further events of 14 July 1999). Some will recall that early in the second week of November 1998, James Thomson and his colleagues published in Nature and John Gearhart and his colleagues published in the Proceedings of the National Academy of Sciences that they had isolated and cultured human primordial stem cells and germ cells respectively. Within days of these remarkable reports, Advanced Cell Technology (ACT) announced via an article written by Nicholas Wade in the... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Ethical, Legal, and Social Implications Research Program at the National Human Genome Research InstituteEric M. Meslin (bio), Elizabeth J. Thomson (bio), and Joy T. Boyer (bio)Organizers of the Human Genome Project (HGP) understood from the beginning that the scientific activities of mapping and sequencing the human genome would raise ethical, legal, and social issues that would require careful attention by scientists, health care professionals, government officials, and (...) the public. The establishment of the ELSI (ethical, legal, and social implications) programs at the National Human Genome Research Institute (NHGRI) and the Department of Energy (DOE) was thought to be vital to the success of the HGP in the United States. It also provided a novel approach to the simultaneous study of ethical, legal, and social issues and basic scientific issues. Eric Juengst, the first director of the ELSI program, described its origins in a previous issue of the Kennedy Institute of Ethics Journal (Juengst 1991). Now in its seventh year, the ELSI program has accomplished much. This article summarizes the evolution and goals of the ELSI program at NHGRI, outlines the program’s current research priorities with examples of activities within each priority area, and provides a look to the future, including the initiation of a strategic planning process.Evolution and Goals of the ELSI Research ProgramThe HGP’s “genomic” goals are unique: to map and sequence the entire human genome—some 3 billion base pairs that make up approximately 80–100,000 genes—and the genomes of related model organisms by the year 2005. This goal was particularly ambitious since, when it was proposed, the technologies for mapping and sequencing had yet to be developed. When the HGP was first established, its organizers also elaborated a set of ELSI goals, which they saw as vital to the success of the genome project. The original ELSI goals were: (1) to anticipate and address the implications of the HGP for individuals and society and (2) to examine the ELSI consequences of mapping and sequencing the human genome in order to stimulate public discussion. To meet these goals, the NHGRI created its ELSI research program in 1990. Along with mapping, sequencing, [End Page 291] and mammalian genetics, ELSI was one of four original branches in the NHGRI Division of Extramural Research that funded research in those areas. Although the individual “branches” no longer exist, the mechanisms for funding research remain much the same. While the overall goals of the program have not changed, the specific ways of achieving the goals have continued to evolve. The importance of the ELSI program lies not in the collection of a full set of data that will be valuable in and of itself, but in the value of using and interpreting this new set of information.Early on, the NHGRI described a set of somewhat more specific goals: (1) to develop a program to help understand the ethical, legal, and social implications of the human genome project and (2) to identify and define the major issues of concern and develop policy options to address them. These more specific goals have been largely met. As the most recent biennial NHGRI Progress Report notes, “a robust ELSI research and education program has been established, many of the most urgent ELSI issues have been identified, and many policy options to address these issues have been proposed” (NCHGR 1995, p. 21). Between 1990 and 1996, ELSI provided more than $32.5 million in funding through 128 research and education grants in more than 30 states and in Canada (Table 1). The ELSI research budget is unique in that when originally created, it was specifically tied to the amount of money provided for the overall NHGRI budget. The NHGRI originally devoted 3 percent of its extramural budget to fund ELSI projects, but in FY 1991, it increased the ELSI budget to 5 percent, a figure that remains today. Table 2 lists the expenditures for each fiscal year since 1990 and the cumulative expenditures to date. The ELSI research budget at NHGRI this year will be about $7 million. When other sources of funding—e.g., co-funding arrangements with other institutes and agencies and the funding of ELSI... (shrink)

The new Companion to Erasmus in the Renaissance Society of America's Texts and Studies Series draws on the insights of an international team of distinguished experts whose contributions are arrayed in eleven chapters followed by a detailed chronological catalogue of Erasmus' works and an up-to-date bibliography of secondary sources. The ambition of this companion is to illuminate every aspect of Erasmus' life, work, and legacy while providing an expert synthesis of the most inspiring research in the field. This volume will (...) be of invaluable assistance to students and teachers working in any of the numerous disciplines to which Erasmus devoted his tireless efforts, including philosophy, religion, history, rhetoric, education, and the history of the book. (shrink)

The Moral Foundations of Trust seeks to explain why people place their faith in strangers, and why doing so matters. Trust is a moral value that does not depend upon personal experience or on interacting with people in civic groups or informal socializing. Instead, we learn to trust from our parents, and trust is stable over long periods of time. Trust depends on an optimistic world view: the world is a good place and we can make it better. Trusting people (...) are more likely to give through charity and volunteering. Trusting societies are more likely to redistribute resources from the rich to the poor. Trust has been in decline in the United States for over 30 years. The roots of this decline are traceable to declining optimism and increasing economic inequality, which Uslaner supports by aggregate time series in the United States and cross-sectional data across market economies. (shrink)

I analyzed 298 open-ended responses of undergraduate students who have been reported for cheating to the question, “What, if anything, would have stopped you from committing your act of academic dishonesty?” These responses included a few major themes: students pled ignorance of what constitutes academic dishonesty and the consequences/seriousness associated with violations; students tended to deflect blame, usually by saying that their professor could have done something differently ; students did not feel they had enough time, resources, and/or skills to (...) get the desired result without taking responsibility for this lack of time, resources, and/or skills ; students felt they did not manage their time well with accepting the blame for the poor time management; and that a bad grade was not an option. These data and results are discussed in relation to the extant literature on the topic. (shrink)

Though contemporary European philosophy and critical theory have long had a robust engagement with Christianity, there has been no similar engagement with Buddhism—a surprising lack, given Buddhism’s global reach and obvious affinities with much of Continental philosophy. This volume fills that gap, focusing on “nothing”—essential to Buddhism, of course, but also a key concept in critical theory from Hegel and Marx through deconstruction, queer theory, and contemporary speculative philosophy. Through an elaboration of emptiness in both critical and Buddhist traditions; an (...) examination of the problem of praxis in Buddhism, Marxism, and psychoanalysis; and an explication of a “Buddhaphobia” that is rooted in modern anxieties about nothingness, Nothing opens up new spaces in which the radical cores of Buddhism and critical theory are renewed and revealed. (shrink)

This paper explores how image worship was conceptualized and represented by Chinese authors during the first four centuries of Buddhist presence in China. Previous scholarship has argued that image worship was initially seen in China as a distinctively Buddhist practice, so much so that Buddhism was even known to the Chinese as the “Religion of Images”. By examining the history of the interpretation of this term, the evolution of stories about sacred images, and the presentation of image worship in debates (...) about the compatibility of Buddhism with Chinese culture, I will argue that image worship was first seen as a distinctly Buddhist or non-Chinese practice only in the late fifth century. Ironically, image worship came to be seen or represented as “foreign” only long after it had already become part of most forms of Chinese religion. (shrink)

Only a small proportion of academically dishonest students ever receive an official report of academic dishonesty, and the sociology of deviance literature is ripe with studies illustrating disproportionalities in detecting, policing, and prosecuting crimes. This study addresses the degree to which disproportionalities exist in the application of relatively few official sanctions levied upon students for academic dishonesty. I compared the demographics of those who have been reported for cheating with those of an entire undergraduate student body and of self-reported cheaters (...) in the literature. I found that international students are much more likely than domestic students to get reported. (shrink)

Consider manipulation in which one agent, avoiding force, threat, or fraud mobilizes some non-concern motive of another so as to induce this other to behave or move differently than she would otherwise have behaved or moved, given her circumstances and her initial ranking of concerns. As an instance, imagine that I get us to miss the opening of a play that I have grudgingly agreed to attend by engaging your sublimated compulsive tendency to check the stove when we are halfway (...) to the theatre. Such motive manipulation is, I take it, widely regarded as morally worrisome. If it really is morally worrisome, then we should be able to explain adequately why it is so. But existing condemnations of manipulation come up short in this regard. In this paper, I develop and defend a more plausible account of the moral status of this phenomenon. (shrink)

Academic dishonesty occurs at alarming rates in higher education. In the present study, we examined predictors of academic cheating behaviors, and beliefs in the acceptability of cheating, in disliked courses at two large universities, using structural equation modeling. Perceived mastery and extrinsic goal structures were related to beliefs about cheating but not cheating behaviors. Beliefs in the acceptability of cheating were more likely to be endorsed in math and science courses. College students were more likely to cheat and to believe (...) in the acceptability of cheating when they reported a high need for sensation. (shrink)

This paper examines Charles Peirce's graphical notation for first-order logic with identity. The notation forms a part of his system of "existential graphs," which Peirce considered to be his best work in logic. In this paper a Tarskian semantics is provided for the graphical system.

Recently a gender-selective harvesting strategy has been proposed for possible control of aquatic invasive species, wherein females of the invasive species are harvested, whilst stocking the males (abbreviated as FHMS strategy) (Lyu et al. in Nat Resour Model 33(2):e12252, 2020). We consider the FHMS strategy with a weak Allee effect, and show that its extinction boundary need not be hyperbolic. To the best of our knowledge, this is the first example of a non-hyperbolic extinction boundary in two-compartment mating models structured (...) by sex. The model possesses a rich dynamical structure, with several local co-dimension one bifurcations occurring. We also show the occurrence of a global homoclinic bifurcation, which has applicability for large scale strategic bio-control. (shrink)

Recently, the US has joined many European jurisdictions in extending civil marriage to same sex as well as different sex dyads. Many liberals regard this as a development worth entrenching. But a prominent recent liberal challenge to civil marriage claims otherwise. According to this challenge, by defining and conferring civil marriage, the state privileges some relationships over others that serve equally well the important liberal goal of fostering effective liberal citizenship, in violation of a prominent interpretation of the doctrine of (...) state neutrality. Theorists who press this challenge, such as Elizabeth Brake and Tamara Metz, argue that it can be met effectively only by dismantling civil marriage and replacing it with more inclusive state-maintained arrangements. So far, prominent responses to this neutralist challenge to civil marriage have focused on the special value of either the relationships to which civil marriage currently extends, or the special value of civil marriage itself. In this article, I develop an alternative reply to this neutralist challenge to civil marriage, one focusing instead on the special vulnerabilities of some of the liberally valuable relationships to which civil marriage currently extends, amorous caregiving dyads. (shrink)

Aggressive medical and surgical interventions have not been clearly demonstrated to improve survival in neonates with trisomy 18; there are no data that demonstrates improved quality of life for these children after these interventions; and these interventions are clearly associated with significant morbidity, resource allocation, and cost.

The problematic Sui-dynasty catalog Lidai sanbao ji 歷代三寶紀 is well known for its many incorrect translator attributions for early canonical Chinese Buddhist texts, attributions that in large measure were accepted by the later tradition and which have remained in place even within modern editions of the Chinese Buddhist canon. The question of how its compiler Fei Changfang 費長房 arrived at his information—and whether he acted in good or bad faith in presenting it—has long been debated. Recent scholarship has argued that (...) patterns in how the Lidai sanbao ji draws from earlier sources demonstrate that Fei Changfang engaged in a deliberate manipulation of his data. This essay, in contrast, introduces manuscripts from Dunhuang of earlier and otherwise lost catalogs of Chinese Buddhist texts to demonstrate that these patterns can be explained in other ways. More broadly, it is suggested that the errors of the Lidai sanbao ji should be understood not as the products of a solitary forger, but as a sign of a wider loss of literary historical consciousness that impacted Chinese Buddhism between ca. 550–650 CE. (shrink)

Let the marriage bond be the set of extralegal obligations to one another that individuals acquire in getting married. And let a conception of the marriage bond be an account of the nature and content of these. Here, I argue that the conception of this bond dominant among us is uncongenial to romantic love among individuals of a certain psychological type. Then, after articulating a conception more congenial to romantic love among such individuals, I argue that if we wish to (...) make marriage safer for love, we should make room in our thinking and practice for this conception, embracing a form of marital pluralism. (shrink)