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)
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.
Depression is often diagnosed in patients nearing the end of their lives and medication or psychotherapy is prescribed. In many cases this is appropriate. However, it is widely agreed that a health care professional should treat sick persons so as to improve their condition as they define improvement. This raises questions about the contexts in which treatment of depression in late life is appropriate. This article reviews a problematic case concerning the appropriateness of treatment in light of the literature in (...) bioethics. Specific attention is paid to the concept of authenticity and the role of suffering. Suffering is often the result of a situation in which one's self is damaged. In some circumstances, this suffering should not be seen as a symptom of illness but as a reflection, in a difficult life context, of the individual's authentic nature. Assessment of depression in the elderly must go beyond a symptom list and must consider both the context of the individual's situation and his or her authentic self. When the symptoms reflect the individual's assessment of the situation in the context of the authentic self, they may be "appropriate." However, even when the symptoms are appropriate, if they interfere with life assessment and adjustment, treatment should be considered. (shrink)
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)
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)
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)
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)
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)
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)
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)
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.
This paper describes the first three-year experience of the Consortium Ethics Program (CEP-1) of the University of Pittsburgh Center for Medical Ethics, and also outlines plans for the second three-year phase (CEP-2) of this experiment in continuing ethics education. In existence since 1990, the CEP has the primary goal of creating a cost-effective, permanent ethics resource network, by utilizing the educational resources of a university bioethics center and the practical expertise of a regional hospital council. The CEP's conception and specific (...) components stem from recognition of the need to make each hospital a major focus of educational efforts, and to provide academic support for the in-house activities of the representatives from each institution. (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)
In 1951 Henrietta Lacks felt a lump in her cervix, entered Johns Hopkins Hospital, and was examined in a colored-only exam room by a physician who biopsied the lump. Called back to Hopkins for treatment of diagnosed carcinoma of the cervix, Henrietta signed a one-line “Operation Permit,” and under general anesthesia received her first round of radium treatment. Before sewing a tube of radium into her cervix, the surgeon on duty took samples of tumor and healthy tissue, and as with (...) many other samples taken from charity patients at Hopkins, handed the samples to researchers trying to develop an immortal human cell line (an important research tool, an immortal cell line is a population of cells from a multicellular .. (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.
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)
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.
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)