The child was 2 years, 8 months old and weighed 25 pounds, one-fifth the weight of her mother, for whom she was to be the bone marrow donor. The mother had suffered a relapse of acute myelogenous leukemia; her physicians recommended a bone marrow transplant. The child was the closest human leukocyte antigen match and thus the best donor candidate for her mother's transplant.

Some research is too risky to be conducted on anyone whose life expectancy is more than a few hours. Yet sometimes, the research can still be carried out using subjects who are brain dead or are soon to undergo a terminal wean, and who have articulated values that inclusion in the study can honor. So argues a team of ethicists and researchers at M.D. Anderson Cancer Center, where such research was recently undertaken.

Multiple groups, including the National Bioethics Advisory Commission, the American Society of Clinical Oncology, the National Coalition of Comprehensive Cancer Centers, Workgroup 6 of the Summit Series on Cancer, PRIM&R, the Bell Report, and prominent ethicists have called for replacing the current system of local institutional review with central review for multisite national trials. We argue that this need is particularly acute in pediatric oncology, as shown by the experience of the Children's Oncology Group.

Some research is too risky to be conducted on anyone whose life expectancy is more than a few hours. Yet sometimes, the research can still be carried out using subjects who are brain dead or are soon to undergo a terminal wean, and who have articulated values that inclusion in the study can honor. So argues a team of ethicists and researchers at M.D. Anderson Cancer Center, where such research was recently undertaken.

BackgroundAlthough patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to determine the patient-preferred presentation (...) of important information in consent forms for these trials.MethodsThe study consisted of two phases: (1) analyses of oncology FIH and Window consents; (2) interviews of trial participants. FIH consent forms were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH information); Window consents were analyzed for the location(s) of information stating the trial may delay SOC surgery (delay information). Participants were asked about their preferred placement of the information in their own trial’s consent form. The location of information in the consent forms was compared to the participants’ suggestions for placement. Results34 [17 FIH; 17 Window] of 42(81%) cancer patients approached participated. 25 consents [20 FIH; 5 Window] were analyzed. 19/20 FIH consent forms included FIH information, and 4/5 Window consent forms included delay information. 19/20(95%) FIH consent forms contained FIH information in the risks section 12/17(71%) patients preferred the same. Fourteen (82%) patients wanted FIH information in the purpose, but only 5(25%) consents mentioned it there. 9/17(53%) Window patients preferred delay information to be located early in the consent, before the “Risks” section. 3/5(60%) consents did this.ConclusionsDesigning consents that reflect patient preferences more accurately is essential for ethical informed consent; however, a one-size fits all approach will not accurately capture patient preferences. We found that preferences differed for FIH and Window trial consents, though for both, patients preferred key risk information early in the consent. Next steps include determining if FIH and Window consent templates improve understanding. (shrink)

Even appropriate, ethically sound recommendations can generate angst. In this case, the principal investigator is concerned about the ethics consult recommendation to not inform the participan...

Access to investigational drugs is a concern to patients and regulatory agencies. In order to determine potential trial participants’ views on access to investigational drugs, we surveyed one hundred people who had been referred to a phase I clinical trial. Most respondents indicated that patients had a right to investigational drugs, that the drugs should be offered only in the context of research, that getting access to these drugs is too hard, and that knowing the right people and being persistent (...) increased the likelihood of gaining access. Respondents did not think that investigational drugs should be given to anyone who wanted them, or that physicians were aware of the latest investigational agents. They most frequently recommended two allocation criteria: offering investigational drugs to those who would benefit most or were most needy; and allocating them to maximize scientific advancement. Respondents who understood the purpose of the trial were more likely to choose the second criterion. (shrink)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

Clinical trials for acute conditions such as myocardial infarction and stroke pose challenges related to informed consent due to time limitations, stress, and severe illness. Consent processes shou...

PURPOSE: There is an increasing demand for researchers to provide research results to participants. Our aim was to define an appropriate process for this, based on needs and attitudes of participants. METHODS: A multicenter survey in five sites in the United States and Canada was offered to parents of children with cancer and adolescents with cancer. Respondents indicated their preferred mode of communication of research results with respect to implications; timing, provider, and content of the results; reasons for and against (...) providing results; and barriers to providing results. RESULTS: Four hundred nine parents (including 19 of deceased children) and 86 adolescents responded. Most parents (n = 385; 94.2%) felt that they had a strong right to research results. For positive results, most wanted a letter or e-mail summary (n = 238; 58.2%) or a phone call followed by a letter (n = 100; 24.4%). If the results were negative, phone call (n = 136; 33.3%) or personal visits (n = 150; 36.7%) were preferred. Parents wanted the summary to include long-term sequelae and suggestions for participants (n = 341; 83.4%), effect on future treatments (n = 341; 83.4%), and subsequent research steps (n = 284; 69.5%). Understanding the researcher was a main concern about receiving results (n = 145; 35.5%). Parents felt that results provide information to support quality of life (n = 315; 77%) and raise public awareness of research (n = 282; 68.9%). Adolescents identified similar preferences. CONCLUSION: Parents of children with cancer and adolescents with cancer feel strongly that they have a right to be offered research results and have specific preferences of how and what information should be communicated. (shrink)

PURPOSE: The offer to return research results to participants is increasingly recognized as an ethical obligation, although few researchers routinely return results. We examined the needs and attitudes of parents of children with cancer and of adolescents with cancer to the return of research results. METHODS: Seven experts in research ethics scored content validity on parent and adolescent questionnaires previously developed through focus group and phone interviews. The questionnaires were revised and provided to 30 parents and 10 adolescents in a (...) tertiary care oncology setting. RESULTS: The content validity index for individual questions and the overall questionnaires scored as 0.86 for both questionnaires. All 30 parents and 10 adolescents who agreed to participate returned questionnaires. The majority (>95%) indicated that they had a strong or very strong right to receive results. Letter or e-mail was a satisfactory means to return results described as good or neutral (66% parents, 100% adolescents) but more participants wished face-to-face disclosure of results with negative implications (50% parents, 60% adolescents). Very few wanted results disseminated through a Web site. The majority acknowledged the need for peer-review before disclosure (60% of adolescents and parents) but did not want "to be the last to know." CONCLUSIONS: Our data suggest that pediatric oncology patients and parents of children with cancer strongly feel that they have a right to research results, and that they wish to receive these in a timely manner. (shrink)

Background: Low rates of participation of adolescents and young adults (AYAs) in clinical oncology trials may contribute to poorer outcomes. Factors that influence the decision of AYAs to participate in health research and whether these factors are different from those that affect the participation of parents of children with cancer. Methods: This is a secondary analysis of data from validated questionnaires provided to adolescents (>12 years old) diagnosed with cancer and parents of children with cancer at 3 sites in Canada (...) (Halifax, Vancouver, and Montreal) and 2 in the United States (Atlanta, GA, and Memphis, TN). Respondents reported their own research participation and cited factors that would influence their own decision to participate in, or to provide parental authorization for their child to participate in health research. Results: Completed questionnaire rates for AYAs and parents were 86 (46.5%) of 185 and 409 (65.2%) of 627, respectively. AYAs (n = 86 [67%]) and parents (n = 409 [85%]) cited that they would participate in research because it would help others. AYAs perceived pressure by their family and friends (16%) and their physician (19%). Having too much to think about at the time of accrual was an impediment to both groups (36% AYAs and 47% parents). The main deterrent for AYAs was that research would take up too much time (45%). Nonwhite parents (7 of 56 [12.5%]) were more apt to decline than white parents (12 of 32 [3.7%]; P < .01). Conclusions: AYAs identified time commitment and having too much to think about as significant impediments to research participation. Addressing these barriers by minimizing time requirements and further supporting decision-making may improve informed consent and impact on enrollment in trials. (shrink)

Research involving recently deceased humans that are physiologically maintained following declaration of death by neurologic criteria—or ‘research involving the recently deceased’—can fill a translational research gap while reducing harm to animals and living human subjects. It also creates new challenges for honouring the donor’s legacy, respecting the rights of donor loved ones, resource allocation and public health. As this research model gains traction, new empirical ethics questions must be answered to preserve public trust in all forms of tissue donation and (...) in the practice of medicine while respecting the legacy of the deceased and the rights of donor loved ones. This article suggests several topics for immediate investigation to understand the attitudes and experiences of researchers, clinical collaborators, donor loved ones and the public to ensure research involving the recently deceased advances ethically. (shrink)

Volume 20, Issue 8, August 2020, Page W12-W13.

This essay describes and critically evaluates a co-operative educational program to train Ugandan health care workers in bioethics. It describes one bottom-up effort, a week-long intensive workshop in bioethics provided by the authors to health care professionals in a developing country—Uganda. We will describe the background and circumstances that led to the organization of the workshop, and review its planning, design, curriculum, and outcome. We will focus especially on measures taken to make the workshop relevant for the audience of Ugandan (...) professionals, and describe lessons learned after two presentations of the workshop. Finally, we will discuss the strengths and weaknesses of such a format, and its potential value in raising bioethical expertise in developing countries. (shrink)

1 Some philosophers defend the thesis that women are adult human females. Call this the adult human female thesis (AHF). There are two versions of this thesis—one modal and one definitional. Accord...

Realist ideology critique (RIC) is a strand of political realism recently developed in response to concerns that realism is biased toward the status quo. RIC aims to debunk an individual's belief that a social institution is legitimate by revealing that the belief is caused by that very same institution. Despite its growing prominence, RIC has received little critical attention. In this article, I buck this trend. First, I improve on contemporary accounts of RIC by clarifying its status and the role (...) of motivated reasoning. Second, I show that realist ideology critics face a dilemma: either their account makes deeply implausible epistemological assumptions, or they temper its epistemology at the expense of rendering it toothless. I argue for each horn in turn before revealing the dilemma to be a false one by making a novel distinction between varying strengths of RIC based on their underlying epistemological assumptions. I propose Moderate RIC as a solution: upon discovering that one reason for your belief that a social institution is legitimate is likely malignantly epistemically circular, the belief should undergo further epistemic testing. I respond to three potential objections and suggest that Moderate RIC would make a fruitful addition to political theorists' methodological toolkit. (shrink)

I provide a critical interpretation of Morgenröthe: Gedanken über die moralischen Vorurteile that identifies the key philosophical work done by Nietzsche in this text, as well as presenting the text as a type of medical narrative. I show how Nietzsche engages with three main questions, drawing thematic connections between themes of physical and psychological health and of ethics, in order to develop a foundation for his critical transvaluation project: First, what is the nature of, and relationship between psycho-physiological and cultural (...) health? Second, by which method of critical engagement may our health be diagnosed and promoted? And third, what virtues are required for such work? (shrink)

This book brings together international academics from a range of Social Science and Humanities disciplines to reflect on how Deleuze's philosophy is opening up and shaping methodologies and practices of empirical research.

Subject perspectives : the missing element in research ethics -- Personal knowledge and study participation -- The everyday ethics of human research -- The hidden world of subjects : rule-breaking in clinical trials -- Participants as partners in genetic research -- Terminally ill patients and the right to try experimental drugs -- Embedded ethics in developing country research -- Research subjects as literary subjects -- How to hear subjects.

Realist ideology critique (RIC) is a strand of political realism recently developed in response to concerns that realism is biased toward the status quo. RIC aims to debunk an individual's belief that a social institution is legitimate by revealing that the belief is caused by that very same institution. Despite its growing prominence, RIC has received little critical attention. In this article, I buck this trend. First, I improve on contemporary accounts of RIC by clarifying its status and the role (...) of motivated reasoning. Second, I show that realist ideology critics face a dilemma: either their account makes deeply implausible epistemological assumptions, or they temper its epistemology at the expense of rendering it toothless. I argue for each horn in turn before revealing the dilemma to be a false one by making a novel distinction between varying strengths of RIC based on their underlying epistemological assumptions. I propose Moder-ate RIC as a solution: upon discovering that one reason for your belief that a social institution is legitimate is likely malignantly epistemically circular, the belief should undergo further epistemic testing. I respond to three potential objections and suggest that Moderate RIC would make a fruitful addition to political theorists' methodological toolkit. (shrink)

Th is chapter outlines the experiences of non-consented vaginal examinations that women have shared with Birthrights and the Association for Improvements in the Maternity Services (AIMS). It gives a flavour of the issues that arise in cases brought to our attention, the impact on women who have to live with these experiences, and the lack of opportunity for proper redress faced by women. This chapter uses case studies to illustrate the experiences which lead women to seek support from AIMS and (...) Birthrights. These are real case studies: real women. They are almost certainly the tip of the iceberg. As this chapter will show, one issue with vaginal examinations is that women oft en do not know that they can decline consent, and/or do not feel confident in doing so. Th ere are no statistics held on the number of women who experience non-consented vaginal examinations but, with a system that includes vaginal examinations within standard maternity care, Birthrights and AIMS are certain that many more cases exist than those which have come to our attention. (shrink)

Argues that many popular approaches to questions of social justice are illiberal and offers an alternative vision for social justice based on liberal principles, adapted from the Wall Street Journal bestseller Cynical Theories.

The absent Arendt -- Arendt reading Aristotle -- Arendt reading Kant -- Arendt relating to Karl Jaspers -- Arendt thinking through Heidegger -- Arendt along with the existentialists -- Arendt as atypical -- Arendt in anticipation.

Can films philosophize rather than simply represent philosophical ideas developed outside of the cinematic medium? Taking up this question crucial to the emergent field of film philosophy, this book argues that the films of the American avant-garde do "do" philosophy and illuminates the ethical and political stakes of their aesthetic interventions. The book traces the avant-garde's philosophy by developing a history and theory of its investment in dimensional, conceptual, and material in-betweens, clarifying how this cinema's reflections on the creation and (...) reception of images construct an ethics of perception itself, a responsibility to perpetuate thought in an enduring re-encounter with the world and with meaning's unfinished production. This entails the avant-garde's locating of cinema's-and thought's-ends or meanings in their means, and their advancement of an image of truth that is made rather than found that unites their films with the philosophies of Ludwig Wittgenstein and Ralph Waldo Emerson who believed the "journey's end is found in every step of the road" (Cavell). Rectifying film-philosophy's neglect of the American avant-garde, the book demonstrates how rather than showing their interest in the revelation of authoritative truths, the avant-garde's interest in the re-encounter and review of the seen and known emerges from an American Transcendentalist tradition that opposes such notions. Sheehan reads the avant-garde's interest in the contingencies of spectatorial experience as also an extension of Pragmatism's commitment to replacing the authority of a priori knowledge with that of individual experience. She also shows how Emerson's influence on Friedrich Nietzsche connects the American avant-garde's philosophies to Deleuze's time-image, premised largely upon Nietzsche's "powers of the false.". (shrink)

In 1997, when Oregon became the first U.S. jurisdiction authorizing medical aid in dying (MAID), its law included a requirement that patients be legal residents of the state. Other U.S. jurisdictions legalizing MAID followed Oregon in adopting residency requirements. Recent litigation challenges the legality, as well as the justification, for such requirements. Facing such challenges, Oregon and Vermont eliminated their MAID residency requirements. More states could follow this move, for, in certain circumstances, the U.S. Constitution's privileges and immunities clause protects (...) citizens' right to travel to secure medical care. Policy considerations could also motivate states to reexamine whether such requirements are justified in light of existing evidence of how MAID laws have been applied. (shrink)

Acknowledgements -- Introduction: transformation, potential, futures -- Screening affect : images, representational thinking and the actualization of the virtual -- Bringing the image to life : interactive mirrors and intensive experience -- Becoming different : makeover television, proximity and immediacy -- Immanent measure : interaction, attractors and the multiple temporalities of online dieting -- Pre-empting the future : obesity, prediction and change4life -- Conclusion : transforming images : sociology, the future and the virtual -- Bibliography -- Index.

In January 2014, seven‐year‐old Charlotte Benjamin wrote a letter to LEGO in which she described a lack of LEGO options for girls. Charlotte's letter has since gone viral. Many critics of the LEGO Friends theme have cited it in articles and blog posts about how this girls theme reinforces negative gender stereotypes. LEGO introduced the Friends theme in early 2012 explicitly as the "girls theme" to replace the unsuccessful LEGO Belville theme. Many fans of LEGO found the gender imbalance unfortunate, (...) because, as studies indicate, playing with blocks, in particular in structural play, can significantly enhance spatial and mathematical skills. LEGO's solution was to create a theme in which purple and pink colors dominate the fictional place: Heartlake City. LEGO also introduced a new kind of figure: the mini‐doll. The mini‐doll is different from the traditional LEGO minifigures in being less blocky, more styled and taller; it is also a bit more feminine in appearance. (shrink)

The oblivion of the interval -- Being in place -- The aporia between envelope and things -- Dualism in Bergson -- Interval, sexual difference -- Beyond man: rethinking life and matter -- Conclusion: interval as relation, interval as becoming.