No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

As social media becomes increasingly popular, human subjects researchers are able to use these platforms to locate, track, and communicate with study participants, thereby increasing participant retention and the generalizability and validity of research. The use of social media; however, raises novel ethical and regulatory issues that have received limited attention in the literature and federal regulations. We review research ethics and regulations and outline the implications for maintaining participant privacy, respecting participant autonomy, and promoting researcher transparency when using social (...) media to locate and track participants. We offer a rubric that can be used in future studies to determine ethical and regulation-consistent use of social media platforms and illustrate the rubric using our study team’s experience with Facebook. We also offer recommendations for both researchers and institutional review boards that emphasize the importance of well-described procedures for social media use as... (shrink)

Two potentially lifesaving protocols, emergency preservation and resuscitation and uncontrolled donation after circulatory determination of death, currently implemented in some U.S. emergency departments, have similar eligibility criteria and initial technical procedures, but critically different goals. Both follow unsuccessful cardiopulmonary resuscitation and induce hypothermia to “buy time”: one in trauma patients suffering cardiac arrest, to enable surgical repair, and the other in patients who unexpectedly die in the ED, to enable organ donation. This article argues that to fulfill patient-focused fiduciary obligations (...) and maintain community trust, institutions implementing both protocols should adopt and publicize policies to guide ED physicians to utilize either protocol for particular patients, in order to address the appearance of conflict of interest arising from the protocols' similarities. It concludes by analyzing ethical implications of incentives that may influence institutions to develop the expertise required for uDCDD but not EPR. (shrink)

Volume 20, Issue 7, July 2020, Page 77-80.

This paper argues against considering incidental fndings as potential benefts of research when assessing the social value of proposed research, determining the appropriateness of a study's risk/beneft ratio, and identifying and disclosing the risks and benefts of participation during informed consent. The possibility of generating IFs should be disclosed during informed consent as neither a risk nor beneft, but as a possible outcome collateral to participation. Whether specifc IFs will be disclosed when identifed is a separate question whose answer is (...) material to determining whether IFs constitute a risk or a potential indirect beneft of participation. Finally, three types of IF should be distinguished and treated diferently during informed consent: those that will be routinely generated , those that can reasonably be characterized in terms of their nature and frequency of generation , and those of unpredictable nature and frequency that can be characterized only in general terms. Research protocols should provide a rationale for sharing or not sharing IFs of these three types with participants. Regulatory review of such plans should not, however, be confused with regarding IFs as potential benefts when assessing the study's risk/beneft ratio or merit. (shrink)

It is well known that when resolution occurs in the stichic iambics and trochaics of tragedy word-end is not found between the two shorts so produced: w or, more accurately, that the first short of resolution must not be the last syllable of a polysyllabic word. Moreover, the syllables in resolution most often form part of the same word as the following short or anceps, e.g.: Ion 1143.

The possibility of generating incidental findings — in both research and clinical contexts — has long been regarded as a risk of these enterprises. Should incidental findings in research also be regarded as potential benefits? At first glance, it would seem they ought to be. After all, in particular circumstances or given a particular set of values, any piece of information can be beneficial. Therefore, it may seem incoherent or unduly paternalistic to regard IFs only as risks. Moreover, developments in (...) science and technology increasingly transform what was once of uncertain meaning and dubious value into information that is likely to have clear meaning and potential personal value, if not obvious clinical utility. For these reasons, it would seem that in the future, IFs should be treated as potential benefits in the design and regulation of research. (shrink)

This paper illustrates a role that bioethics should play in developing and criticizing protocols for breast cancer genetic screening. It demonstrates how a critical bioethics, using approaches and reflecting concerns of contemporary philosophy of science and science studies, may critically interrogate the normative and conceptual schemes within which ethical considerations about such screening protocols are framed. By exploring various factors that influence the development of such protocols, including politics, cultural norms, and conceptions of disease, this paper and the critical bioethics' (...) approach it endorses illuminate and critically assess some of the competing worldviews informing protocol development. One of the frequently neglected worldviews in traditional bioethics' treatment of protocols concerning breast care is constituted by women's own views of their breasts and breast cancer, both within the technologically-oriented social practice of American medicine and in light of the social construction of their breasted experience in American society. This paper attempts to redress and critically assess this neglect on the part of traditional bioethics. Finally, in contrast to traditional bioethics, critical bioethics critically interrogates its own normative and conceptual commitments. In this final capacity, a critical bioethics' approach makes a valuable contribution to the evolution of bioethics. (shrink)

From a Levinasian perspective, the interaction between two people is an ethical encounter, a face-to-face interaction that calls the subject into question and renders them vulnerable to the ritual of rupture. But what if your embodiment renders you, in the moment of encounter, less than human? How can we bring the imperative of pre-ontological responsibility to bear on the present moment, fractured as we are in our understandings of embodiment and the hauntings of history? In this paper, I hope to (...) respond to the previous question by articulating the problems and possibilities of Levinas’s thought in conversation with urgent considerations of racially-bodied Others. To begin, I briefly explore critiques of Levinas’s Eurocentrism. Then, drawing on the concept of incarnate historiography, I examine the difficulties of skin as “seen.” Next, I elaborate the prospect of how diachronous time affords a second register that takes seriously the historical experience of pain and oppression as responsibility. Finally, I argue that the recognition of responsibility is essential to education, proposing pedagogy that preserves alterity and makes space for the new. (shrink)

We investigated how color preferences vary according to season and whether those changes could be explained by the ecological valence theory. To do so, we assessed the same participants’ preferences for the same colors during fall, winter, spring, and summer in the northeastern United States, where there are large seasonal changes in environmental colors. Seasonal differences were most pronounced between fall and the other three seasons. Participants liked fall-associated dark-warm colors—for example, dark-red, dark-orange, dark-yellow, and dark-chartreuse—more during fall than other (...) seasons. The EVT could explain these changes with a modified version of Palmer and Schloss’ weighted affective valence estimate procedure that added an activation term to the WAVE equation. The results indicate that color preferences change according to season, as color-associated objects become more/less activated in the observer. These seasonal changes in color preferences could not be characterized by overall shifts in weights along cone-contrast axes. (shrink)

Considerations of justice and concern for well-being support conducting mental health research and addressing ethical concerns specific to mental health research are critical. We discuss these concerns, provide recommendations to enable the ethical conduct of mental health research, and argue that participants’ interests should be given primary weight in resolving apparent dilemmas. We also comment on provisions of two legislative actions in India relevant to mental health research: Rights of Persons with Disability Act 2016 and the Mental Health Care Act (...) 2017. Both conform to the 2006 United Nations Convention on Rights of Persons with Disabilities of which India is a signatory. Both provide protections and enumerate rights relevant to people with mental health conditions but with differing focus. The commonalities and differences between the three are discussed in the background of international literature on research in mental health conditions. Studies involving deception and future directions for ethical requirements regarding genetic research are discussed. (shrink)

The clinical years of medical student education are an ideal time for students to practise and refine ethical thinking and behaviour. We piloted a new clinical ethics teaching activity this year with undergraduate medical students within the Rural Clinical School at the University of New South Wales. We used a modified teaching ward round model, with students bringing deidentified cases of ethical interest for round-table discussion. We found that students were more engaged in the subject of clinical ethics after attending (...) the teaching sessions and particularly appreciated having structured time to listen to and learn from their peers. Despite this, we found no change in student involvement in managing or planning action in situations that they find ethically challenging. A key challenge for educators in clinical ethics is to address the barriers that prevent students taking action. (shrink)

Education has a responsibility to respond to the threat of deteriorating democracies. The post-truth era is marked by an erosion of trust in public institutions and extreme polarisation. This paper begins with an examination of the ways by which current literacy and media literacy education is not simply outmoded, but also limited by a grounding in neoliberal conceptions of rationality and individualism. Offering a counterpoint to the status quo, and foregrounding the significance of affect, I work with Levinas’s conception of (...) ethics to illustrate the tensions between affective reactionism and non-intentional affectivity, enjoyment and its disruption as a premise for intersubjectivity, and contrasting manifestations of anger. I conclude the paper with a proposal for literacy education that comprises intentional focus on relationality, responsibility, and affect. (shrink)

Despite having paved the way for face, womb and penis transplants, hand transplantation today remains a small hybrid of reconstructive microsurgery and transplant immunology. An exceptionally limited patient population internationally complicates medical researchers’ efforts to parse outcomes “objectively.” Presumed functional and psychosocial benefits of gaining a transplant hand must be weighed in both patient decisions and bioethical discussions against the difficulty of adhering to post-transplant medications, the physical demands of hand transplant recovery on the patient, and the serious long-term health (...) risks of immunosuppressant drugs. This paper relates five narratives of hand transplantation drawn from an oral history project to show how narrative methods can and should inform ethical evaluations and the clinical process of hand transplantation. The interviews with patients and their partners analyzed here lead us to suggest that qualitative accounts of patient experiences should be used to complement clinical case studies reported in medical journals and to help develop instruments to assess outcomes more systematically. (shrink)

As described by the ancient metricians, catalexis is a matter of arithmetic rather than rhythm. They develop the idea in their usual way, mechanically and mathematically, adding and subtracting elements, so as to produce ‘brachycatalexis’ and ‘hypercatalexis’. These are now mere metrical-glossary terms, but in catalexismodern metricians have seen a genuine relationship between cola and a rhythmic effect more or less comprehensible even to us. Wilamowitz, T.D. Goodell, and A.M. Dale explore the concept to some extent, but current hand books (...) and general treatises give it only perfunctory and superficial treatment, while casual appearances of the term offer the reader glimpses of a theoretical substructure which hasnot been explicitly and coherently explained. (shrink)

In late December 1998, Renada Daniel-Patterson's father offered to donate a kidney to his daughter and ignited a controversy in the bioethics community. Renada had been born with only one kidney, which began to fail early in her childhood. At age 6, Renada had to receive dialysis three times a week. She was unable to attend school or venture very far from home. This pattern continued until Renada was 13, when Mr. Patterson called from prison to offer her his kidney. (...) Renada was surprised to hear from her father, who was serving 12 years at California State Prison for burglary and drug convictions. Mr. Patterson was determined to be a compatible donor, and the family proceeded with the transplant operation. As a result of this surgery, Renada was able to live the life of a healthy girl for 2 years. Because the medication to prevent rejection of the transplanted organ made her feel ill and bloated and caused her to develop a hump on her back, Renada gradually began to skip doses. As a result, her donated kidney began to fail. It was under these circumstances that David Patterson offered to donate his second kidney to his daughter in 1998. (shrink)

This paper explores the concept of time in education. It argues that the neoliberal capitalist construct of time as a resource to be deployed in service of labour—ever-accelerating—has permeated education, with implications for curriculum, teaching, and learning. To slow the effects of neoliberal capitalism in schools requires a reconsideration of time that permits both different understandings of how time is encountered and different values orienting how one spends one’s time. Using Hägglund’s argument for finitude and Levinas’ idea of time as (...) a gift, the paper articulates the philosophical rationale and pedagogical implications for making the most of one’s educational time. (shrink)

The possibility of genetic enhancement to increase the likelihood of success in sport and life’s prospects raises questions for accounts of sport and theories of justice. These questions obviously include the fairness of such enhancement and its relationship to the goals of sport and demands of justice. Of equal interest, however, is the effect on our understanding of individual effort, merit, and desert of either discovering genetic contributions to components of such effort or recognizing the influence of social factors on (...) the development and exercise of individual effort. This paper analyzes arguments about genetic enhancement with the goal of raising questions about how sport and justice regard unchosen, undeserved inequalities and what is assumed to be their opposite—namely, the exercise and results of individual effort. It is suggested that contemplating enhancement of natural assets previously outside human control may reinforce recognition of responsibility to intervene with regard to social advantages so as to support individual effort and improve individuals’ life prospects. (shrink)

Identifiable excess surgical tissue is an important resource for medical research but we have become overly restrictive about consent requirements. I suggest we devolve consent to ethics committees for ordinary research projects involving human tissue, retaining the requirement for explicit consent only for those sensitive research situations where there is significant risk of harm to individual interests in privacy.

In April 1992 the Food and Drug Administration (FDA) announced it was restricting the availability of silicone gel-filled breast implants to women enrolled in clinical trials. All candidates for breast reconstruction, but only a "very limited" number of augmentation candidates, would have access to the implants. This policy has been criticized as paternalistic, sexist, and unjustified by scientific data. I examine these charges and conclude that controversy surrounding the scientific data weakens the FDA's paternalistic mandate and that its policy of (...) treating reconstruction and augmentation candidates differently results in increased social injustice and perpetuates cultural biases concerning female beauty and women's rights to control their bodies. I also argue that these cultural biases shape women's subjective experience of their physical selves and should not, contrary to some feminist arguments, be viewed as precluding their giving informed consent to breast surgery. (shrink)

It is generally stated that diaeresis after the first metron, obligatory in recitative dimeters, is not the rule in catalectic dimeters, or paroemiacs. An examination of the material, however, yields the following results. The paroemiacs of Tyrtaeus' consistendy observe metron-diaeresis. Out of a total of 348 recitative paroemiacs in the Attic dramatists, only 34 disregard metron-diaeresis altogether. A further 75 overlap metron-diaeresis by one short syllable . Apparently, the practice with regard to metron-diaeresis is fundamentally the same in paroemiacs as (...) in full dimeters, only the licences are a little more frequent. The poets occasionally take advantage of the interruption in the movement produced by the catalectic colon in order to break away still farther from regular anapaestic rhythm. Aristophanes, in particular, rather likes to round off an anapaestic period with a rattling, and often abusive, polysyllable: Vesp. 326. (shrink)

Implementation of guidelines regarding breaches of electronic health information requires an anticipatory stance and physician and patient education regarding security and monitoring measures and methods of redress. Adopting a preventive ethics, rather than a crisis management, model may also increase physician awareness of how the information they choose to include and privilege within the health record may expose patients to added harms if not done mindfully.

It is not clear whether breast cancer screening is a public health intervention or an individual clinical service. The question is important because the concepts best suited for ethical reasoning in public health might be different to the concepts commonly employed in biomedical ethics. We consider it likely that breast screening has elements of a public health intervention and used an empirical ethics approach to explore this further. If breast screening has public health characteristics, it is probable that policy and (...) practice experts will employ socially embedded concepts when reasoning about it. We gathered data on whether and how these concepts existed in the discussion and reasoning of Australian breast screening experts. We found that experts employed these concepts when talking about the purpose and practices of breast screening, and the behaviour of breast screening professionals and consumers. Experts gave varied judgements about breast screening based on reasoning with these concepts, considering it to be more or less successful in contributing to the public interest and in incorporating socially embedded concepts into its operational agenda. Our findings are compatible with breast screening having public health characteristics. We advocate for the incorporation of socially embedded concepts in breast screening policy and practice. (shrink)

In this essay, I argue that the way American bioethics has traditionally conceived of the distinction between public and private has given rise to some ethically problematic blind spots in its analyses to date. Furthermore, I argue that bioethics's view of the public and private spheres has reinforced a shortsighted view of bioethics's analytical sphere of influence. In particular, it has led bioethics to conceptualize issues largely from the perspective of health professionals, eschewing analyses of the problems of health and (...) health information that patients and their intimates face outside of professional relationships and traditional health-care settings. It has also led some bioethical analyses to reflect, and to some degree reinforce, relationships of power that they might instead challenge. (shrink)

BackgroundIn the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort, participants underwent magnetic resonance imaging (MRI) of the brain, heart, and abdomen, that generated incidental findings (IFs). The approach to managing these unexpected results remain a complex issue. Our objectives were to describe the CAHHM policy for the management of IFs, to understand the impact of disclosing IFs to healthy research participants, and to reflect on the ethical obligations of researchers in future MRI studies.MethodsBetween 2013 and 2019, 8252 participants (...) (mean age 58 ± 9 years, 54% women) were recruited with a follow-up questionnaire administered to 909 participants (40% response rate) at 1-year. The CAHHM policy followed a restricted approach, whereby routine feedback on IFs was not provided. Only IFs of severe structural abnormalities were reported.ResultsSevere structural abnormalities occurred in 8.3% (95% confidence interval 7.7–8.9%) of participants, with the highest proportions found in the brain (4.2%) and abdomen (3.1%). The majority of participants (97%) informed of an IF reported no change in quality of life, with 3% of participants reporting that the knowledge of an IF negatively impacted their quality of life. Furthermore, 50% reported increased stress in learning about an IF, and in 95%, the discovery of an IF did not adversely impact his/her life insurance policy. Most participants (90%) would enrol in the study again and perceived the MRI scan to be beneficial, regardless of whether they were informed of IFs. While the implications of a restricted approach to IF management was perceived to be mostly positive, a degree of diagnostic misconception was present amongst participants, indicating the importance of a more thorough consent process to support participant autonomy.ConclusionThe management of IFs from research MRI scans remain a challenging issue, as participants may experience stress and a reduced quality of life when IFs are disclosed. The restricted approach to IF management in CAHHM demonstrated a fair fulfillment of the overarching ethical principles of respect for autonomy, concern for wellbeing, and justice. The approach outlined in the CAHHM policy may serve as a framework for future research studies.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/nct02220582. (shrink)

Employing the National Institute of Mental Health-funded Prevention of Suicide in Primary Care Elderly Collaborative Trial as a case study, we discuss 2 sets of ethical issues: obtaining informed consent for a clinic-based intervention study and using treatment as usual (TAU) as the control condition. We then address these ethical issues in the context of the debate about the quality improvement efforts of health care organizations. Our analysis reveals the tension between ethics and scientific integrity involved with using TAU as (...) a control condition and the difficulty in designing high-quality research in a community-based setting. (shrink)

Employing the National Institute of Mental Health-funded Prevention of Suicide in Primary Care Elderly Collaborative Trial as a case study, we discuss 2 sets of ethical issues: obtaining informed consent for a clinic-based intervention study and using treatment as usual (TAU) as the control condition. We then address these ethical issues in the context of the debate about the quality improvement efforts of health care organizations. Our analysis reveals the tension between ethics and scientific integrity involved with using TAU as (...) a control condition and the difficulty in designing high-quality research in a community-based setting. (shrink)

Candidate evaluation for breast implantation presents a more important obstacle to the fulfillment of the normative requirements of informed consent than do the social roles of women or cultural norms governing female beauty. I argue that women's decisions to receive breast implants may indeed be informed, competently made, and substantially voluntary, but that the cultural construction of beauty may undermine women's autonomy by influencing the evaluation of surgical candidates and risk disclosure during informed consent.

ABSTRACT:Drawing on insights from feminist epistemology and experience in genomics-related bioethics research, this essay offers three suggestions that may enable bioethics to contribute more persuasively to urgent issues affecting the health and well-being of individuals, communities, and the world they inhabit. First, it suggests that bioethics pay more attention to people's feelings, particularly those that help constitute their self-identities, and to the role of those feelings in their health-relevant behaviors. Further, it proposes conceiving of health-relevant behaviors expansively. Second, it suggests (...) that bioethics advocate for a longer time horizon for the conduct of empirical bioethics research and other types of research addressing complex, systemic factors influencing health. Third, it suggests that bioethics play a larger role in illuminating and applauding the evolving nature of scientific knowledge. (shrink)

The renormalization group is used to analyze the behavior of certain gravitationally significant renormalized coupling constants under a scaling of the spacetime curvature. After discussing a simple example, the results are summarized for a class of grand unified theories.

Individual and institutional conflicts of interest arise with increasing frequency and negative sequelae as universities and their principals, as well as individual faculty members, engage in research with support from profit/not-for-profit entities. This essay examines how institutional and individual conflicts of interest arise for ethics centers and their faculty/staff, respectively. It defines COI, endorses a reasonable person standard for determining when COI exist, and considers problems that arise when disclosure of COI is embraced as a remedy for them. It argues (...) that transparency and disclosure are generally inadequate measures to address COI, especially those of ethics centers. It concludes by sketching other measures that may be ingredients in attempts to avoid, manage, or mitigate the COI of ethics centers and their faculty/staff. (shrink)

Disparities in access to, and utilization of, treatment for depression among African-American and Caucasian elderly adults have been well-documented. Less fully explored are the multidimensional factors responsible for these disparities. The intersection of cultural constructs, socioeconomic factors, multiple levels of racism, and stigma attending both mental health issues and older age may help to explain disparities in the treatment of the depressed elderly. Personalized medicine with its promise of developing interventions tailored to an individual's health needs and genetically related response (...) to treatment might seem a promising antidote to the documented underutilization of standard depression treatments by African Americans. However, this paper examines the multidimensional factors associated with disparities in effective treatment of depression among African-American and Caucasian elderly adults and argues the scientific and ethical importance of pursuing various paths to address multiple levels and sources of stigma and mistrust if pharmacogenomics is to help, rather than exacerbate, disparities in depression treatment. Seven recommendations are offered to increase the likelihood that developments in pharmacogenomics will reduce disparities in depression treatment. (shrink)